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1.
Ferrán Catalá-López Diego Macías Saint-Gerons Diana González-Bermejo Giuseppe M. Rosano Barry R. Davis Manuel Ridao Abel Zaragoza Dolores Montero-Corominas Aurelio Tobías César de la Fuente-Honrubia Rafael Tabarés-Seisdedos Brian Hutton 《PLoS medicine》2016,13(3)
Background
Medications aimed at inhibiting the renin–angiotensin system (RAS) have been used extensively for preventing cardiovascular and renal complications in patients with diabetes, but data that compare their clinical effectiveness are limited. We aimed to compare the effects of classes of RAS blockers on cardiovascular and renal outcomes in adults with diabetes.Methods and Findings
Eligible trials were identified by electronic searches in PubMed/MEDLINE and the Cochrane Database of Systematic Reviews (1 January 2004 to 17 July 2014). Interventions of interest were angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), and direct renin (DR) inhibitors. The primary endpoints were cardiovascular mortality, myocardial infarction, and stroke—singly and as a composite endpoint, major cardiovascular outcome—and end-stage renal disease [ESRD], doubling of serum creatinine, and all-cause mortality—singly and as a composite endpoint, progression of renal disease. Secondary endpoints were angina pectoris and hospitalization for heart failure. In all, 71 trials (103,120 participants), with a total of 14 different regimens, were pooled using network meta-analyses. When compared with ACE inhibitor, no other RAS blocker used in monotherapy and/or combination was associated with a significant reduction in major cardiovascular outcomes: ARB (odds ratio [OR] 1.02; 95% credible interval [CrI] 0.90–1.18), ACE inhibitor plus ARB (0.97; 95% CrI 0.79–1.19), DR inhibitor plus ACE inhibitor (1.32; 95% CrI 0.96–1.81), and DR inhibitor plus ARB (1.00; 95% CrI 0.73–1.38). For the risk of progression of renal disease, no significant differences were detected between ACE inhibitor and each of the remaining therapies: ARB (OR 1.10; 95% CrI 0.90–1.40), ACE inhibitor plus ARB (0.97; 95% CrI 0.72–1.29), DR inhibitor plus ACE inhibitor (0.99; 95% CrI 0.65–1.57), and DR inhibitor plus ARB (1.18; 95% CrI 0.78–1.84). No significant differences were showed between ACE inhibitors and ARBs with respect to all-cause mortality, cardiovascular mortality, myocardial infarction, stroke, angina pectoris, hospitalization for heart failure, ESRD, or doubling serum creatinine. Findings were limited by the clinical and methodological heterogeneity of the included studies. Potential inconsistency was identified in network meta-analyses of stroke and angina pectoris, limiting the conclusiveness of findings for these single endpoints.Conclusions
In adults with diabetes, comparisons of different RAS blockers showed similar effects of ACE inhibitors and ARBs on major cardiovascular and renal outcomes. Compared with monotherapies, the combination of an ACE inhibitor and an ARB failed to provide significant benefits on major outcomes. Clinicians should discuss the balance between benefits, costs, and potential harms with individual diabetes patients before starting treatment.Review registration
PROSPERO CRD42014014404 相似文献2.
Hirohito Mori Hideki Kobara Takaaki Tsushimi Noriko Nishiyama Shintaro Fujihara Tsutomu Masaki 《PloS one》2015,10(4)
Objective
Objective evaluation of resected specimen and tumor size is critical because the tumor diameter after endoscopic submucosal dissection affects therapeutic strategies. In this study, we investigated whether the true tumor diameter of gastrointestinal cancer specimens measured by flexible endoscopy is subjective by testing whether the specimen is correctly attached to the specimen board after endoscopic submucosal dissection resection and whether the size differs depending on the endoscopist who attached the specimen.Methods
Seventy-two patients diagnosed with early gastric cancer who satisfied the endoscopic submucosal dissection expanded-indication guideline were enrolled. Three endoscopists were randomly selected before every endoscopic submucosal dissection. Each endoscopist separately attached the same resected specimen, measured the maximum resection diameter and tumor size, and removed the lesion from the attachment board.Results
The resected specimen diameters of the 3 endoscopists were 44.5±13.9 mm (95% Confidence Interval (CI): 23–67), 37.4±12.0 mm (95% CI: 18–60), and 41.1±13.3 mm (95% CI: 20–63) mm. Comparison among 3 groups (Kruskal Wallis H- test), there were significant differences (H = 6.397, P = 0.040), and recorded tumor sizes were 38.3±13.1 mm (95% CI: 16–67), 31.1±11.2 mm (95% CI: 12.5–53.3), and 34.8±12.8 (95% CI: 11.5–62.3) mm. Comparison among 3 groups, there were significant differences (H = 6.917, P = 0.031).Conclusions
Human errors regarding the size of attached resected specimens are unavoidable, but it cannot be ignored because it affects the patient’s additional treatment and/or surgical intervention. We must develop a more precise methodology to obtain accurate tumor size.Trial Registration
University hospital Medical Information Network UMIN No. 000012915 相似文献3.
Background
This study (NCT01682005) aims to assess clinical and cost impacts of complete and incomplete rotavirus (RV) vaccination.Methods
Beneficiaries who continuously received medical and pharmacy benefits since birth were identified separately in Truven Commercial Claims and Encounters (2000–2011) and Truven Medicaid Claims (2002–2010) and observed until the first of end of insurance eligibility or five years. Infants with ≥1 RV vaccine within the vaccination window (6 weeks-8 months) were divided into completely and incompletely vaccinated cohorts. Historically unvaccinated (before 2007) and contemporarily unvaccinated (2007 and after) cohorts included children without RV vaccine. Claims with International Classification of Disease 9th edition (ICD-9) codes for diarrhea and RV were identified. First RV episode incidence, RV-related and diarrhea-related healthcare resource utilization after 8 months old were calculated and compared across groups. Poisson regressions were used to generate incidence rates with 95% confidence intervals (CIs). Mean total, inpatient, outpatient and emergency room costs for first RV and diarrhea episodes were calculated; bootstrapping was used to construct 95% CIs to evaluate cost differences.Results
1,069,485 Commercial and 515,557 Medicaid patients met inclusion criteria. Among commercially insured, RV incidence per 10,000 person-years was 3.3 (95% CI 2.8–3.9) for completely, 4.0 (95% CI 3.3–5.0) for incompletely vaccinated, and 20.9 (95% CI 19.5–22.4) for contemporarily and 40.3 (95% CI 38.6–42.1) for historically unvaccinated. Rates in Medicaid were 7.5 (95% CI 4.8–11.8) for completely, 9.0 (95% CI 6.5–12.3) for incompletely vaccinated, and 14.6 (95% CI 12.8–16.7) for contemporarily and 52.0 (95% CI 50.2–53.8) for historically unvaccinated. Mean cost for first RV episode per cohort member was $15.33 (95% CI $12.99-$18.03) and $4.26 ($95% CI $2.34-$6.35) lower for completely vaccinated versus contemporarily unvaccinated in Commercial and Medicaid, respectively.Conclusions
RV vaccination results in significant reduction in RV infection. There is evidence of indirect benefit to unvaccinated individuals. 相似文献4.
Young Kwang Chae Danai Khemasuwan Anastasios Dimou Stefan Neagu Lakshmi Chebrolu Shikha Gupta Alejandra Carpio Jongoh Kim Jeong Hyun Yun Athanasios Smyrlis Alan Friedman William Tester 《PloS one》2014,9(1)
Background
Arterial and venous thrombosis may share common pathophysiology involving the activation of platelets and inflammatory mediators. A growing body of evidence suggests prothrombotic effect of renin angiotensin system (RAS) including vascular inflammation and platelet activation. We hypothesized that the use of angiotensin converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs) plays a role in protecting against venous thromboembolism (VTE) in patients atherosclerosis.Methods
We conducted a retrospective study, reviewing 1,100 consecutive patients admitted to a teaching hospital with a diagnosis of either myocardial infarction or ischemic stroke from 2005 to 2010. Patients who had been treated with anticoagulation therapy before or after the first visit were excluded. The occurrence of VTE during the follow up period, risk factors for VTE on admission, and the use of ACEIs or ARBs during the follow up period were recorded.Results
The mean age of the entire study population was 68.1 years. 52.0% of the patients were female and 76.5% were African American. 67.3% were on RAS inhibitorsThe overall incidence of VTE was 9.7% (n = 107). Among the RAS inhibitor users, the incidence of VTE events was 9.0% (54/603) for the ACEI only users, 7.1% (8/113) for the ARB only users, and 0% (0/24) for the patients taking combination of ACEI and ARB. Among patients on RAS inhibitors, 8.4% (62/740) developed a VTE, compared with 12.5% (45/360) in the nonuser group [HR (hazard ratio), 0.58; 95% CI (confidence interval), 0.39–0.84; P<0.01]. Even after controlling for factors related to VTE (smoking, history of cancer, and immobilization, hormone use) and diabetes, the use of RAS inhibitors was still associated with a significantly lower risk of developing VTE (AHR, 0.59; 95% CI, 0.40–0.88; P = 0.01).Conclusions
The use of RAS inhibitors appears to be associated with a reduction in the risk of VTE. 相似文献5.
Grace Mhalu Jerry Hella Basra Doulla Francis Mhimbira Hawa Mtutu Helen Hiza Mohamed Sasamalo Liliana Rutaihwa Hans L. Rieder Tamsyn Seimon Beatrice Mutayoba Mitchell G. Weiss Lukas Fenner 《PloS one》2015,10(9)
Objective
We examined the effect of an instructional video about the production of diagnostic sputum on case detection of tuberculosis (TB), and evaluated the acceptance of the video.Trial Design
Randomized controlled trial.Methods
We prepared a culturally adapted instructional video for sputum submission. We analyzed 200 presumptive TB cases coughing for more than two weeks who attended the outpatient department of the governmental Municipal Hospital in Mwananyamala (Dar es Salaam, Tanzania). They were randomly assigned to either receive instructions on sputum submission using the video before submission (intervention group, n = 100) or standard of care (control group, n = 100). Sputum samples were examined for volume, quality and presence of acid-fast bacilli by experienced laboratory technicians blinded to study groups.Results
Median age was 39.1 years (interquartile range 37.0–50.0); 94 (47%) were females, 106 (53%) were males, and 49 (24.5%) were HIV-infected. We found that the instructional video intervention was associated with detection of a higher proportion of microscopically confirmed cases (56%, 95% confidence interval [95% CI] 45.7–65.9%, sputum smear positive patients in the intervention group versus 23%, 95% CI 15.2–32.5%, in the control group, p <0.0001), an increase in volume of specimen defined as a volume ≥3ml (78%, 95% CI 68.6–85.7%, versus 45%, 95% CI 35.0–55.3%, p <0.0001), and specimens less likely to be salivary (14%, 95% CI 7.9–22.4%, versus 39%, 95% CI 29.4–49.3%, p = 0.0001). Older age, but not the HIV status or sex, modified the effectiveness of the intervention by improving it positively. When asked how well the video instructions were understood, the majority of patients in the intervention group reported to have understood the video instructions well (97%). Most of the patients thought the video would be useful in the cultural setting of Tanzania (92%).Conclusions
Sputum submission instructional videos increased the yield of tuberculosis cases through better quality of sputum samples. If confirmed in larger studies, instructional videos may have a substantial effect on the case yield using sputum microscopy and also molecular tests. This low-cost strategy should be considered as part of the efforts to control TB in resource-limited settings.Trial Registration
Pan African Clinical Trials Registry PACTR201504001098231 相似文献6.
Karl Emil Nelveg-Kristensen Majbritt Busk Madsen Christian Torp-Pedersen Lars K?ber Martin Egfjord Henrik Berg Rasmussen Peter Riis Hansen 《PloS one》2015,10(12)
Background
Evidence for pharmacogenetic risk stratification of angiotensin-converting enzyme inhibitor (ACEI) treatment is limited. Therefore, in a cohort of ACEI-treated patients with congestive heart failure (CHF), we investigated the predictive value of two pharmacogenetic scores that previously were found to predict ACEI efficacy in patients with ischemic heart disease and hypertension, respectively. Score A combined single nucleotide polymorphisms (SNPs) of the angiotensin II receptor type 1 gene (rs275651 and rs5182) and the bradykinin receptor B1 gene (rs12050217). Score B combined SNPs of the angiotensin-converting enzyme gene (rs4343) and ABO blood group genes (rs495828 and rs8176746).Methods
Danish patients with CHF enrolled in the previously reported Echocardiography and Heart Outcome Study were included. Subjects were genotyped and categorized according to pharmacogenetic scores A and B of ≤1, 2 and ≥3 each, and followed for up to 10 years. Difference in cumulative incidences of cardiovascular death and all-cause death were assessed by the cumulative incidence estimator. Survival was modeled by Cox proportional hazard analyses.Results
We included 667 patients, of whom 80% were treated with ACEIs. Differences in cumulative incidences of cardiovascular death (P = 0.346 and P = 0.486) and all-cause death (P = 0.515 and P = 0.486) were not significant for score A and B, respectively. There was no difference in risk of cardiovascular death or all-cause death between subjects with score A ≤1 vs. 2 (HR 1.03 [95% CI 0.79–1.34] and HR 1.11 [95% CI 0.88–1.42]), score A ≤1 vs. ≥3 (HR 0.80 [95% CI 0.59–1.08] and HR 0.91 [95% CI 0.70–1.20]), score B ≤1 vs. 2 (HR 1.02 [95% CI 0.78–1.32] and HR 0.98 [95% CI 0.77–1.24]), and score B ≤1 vs. ≥3 (HR 1.03 [95% CI 0.75–1.41] and HR 1.05 [95% CI 0.79–1.40]), respectively.Conclusions
We found no association between either of the analyzed pharmacogenetic scores and fatal outcomes in ACEI-treated patients with CHF. 相似文献7.
Woo Yeong Park Eun Sil Koh Su-Hyun Kim Young Ok Kim Dong Chan Jin Ho Chul Song Euy Jin Choi Yong-Lim Kim Yon-Su Kim Shin-Wook Kang Nam-Ho Kim Chul Woo Yang Yong Kyun Kim 《PloS one》2015,10(9)
Background
Gamma-glutamyltransferase (GGT) is a biomarker of liver injury. GGT has also been reported to be a marker of oxidative stress and a predictor of mortality in the general population. Hemodialysis (HD) patients suffer from oxidative stress. The aim of our study was to investigate the relationship between serum GGT levels and clinical outcomes in HD patients.Methods
A total of 1,634 HD patients were enrolled from the Clinical Research Center registry for end-stage renal disease, a prospective cohort in Korea. Patients were categorized into three groups by tertiles of serum GGT levels. The primary outcome was all-cause, cardiovascular, or infection-related mortality and hospitalization.Results
During the median follow-up period of 30 months, the highest tertile of serum GGT levels had a significantly higher risk for all-cause mortality (hazard ratio (HR) 2.39, 95% confidence interval (CI), 1.55–3.69, P<0.001), cardiovascular mortality (HR 2.14, 95% CI, 1.07–4.26, P = 0.031) and infection-related mortality (HR 3.07, 95% CI, 1.30–7.25, P = 0.011) using tertile 1 as the reference group after adjusting for clinical variables including liver diseases. The highest tertile also had a significantly higher risk for first hospitalization (HR 1.22, 95% CI, 1.00–1.48, P = 0.048) and cardiovascular hospitalization (HR 1.42, 95% CI, 1.06–1.92, P = 0.028).Conclusions
Our data demonstrate that high serum GGT levels were an independent risk factor for all-cause, cardiovascular, and infection-related mortality, as well as cardiovascular hospitalization in HD patients. These findings suggest that serum GGT levels might be a useful biomarker to predict clinical outcomes in HD patients. 相似文献8.
Courtney D. Fitzhugh Matthew M. Hsieh Darlene Allen Wynona A. Coles Cassie Seamon Michael Ring Xiongce Zhao Caterina P. Minniti Griffin P. Rodgers Alan N. Schechter John F. Tisdale James G. Taylor VI 《PloS one》2015,10(11)
Background
Adults with sickle cell anemia (HbSS) are inconsistently treated with hydroxyurea.Objectives
We retrospectively evaluated the effects of elevating fetal hemoglobin with hydroxyurea on organ damage and survival in patients enrolled in our screening study between 2001 and 2010.Methods
An electronic medical record facilitated development of a database for comparison of study parameters based on hydroxyurea exposure and dose. This study is registered with ClinicalTrials.gov, number NCT00011648.Results
Three hundred eighty-three adults with homozygous sickle cell disease were analyzed with 59 deaths during study follow-up. Cox regression analysis revealed deceased subjects had more hepatic dysfunction (elevated alkaline phosphatase, Hazard Ratio = 1.005, 95% CI 1.003–1.006, p<0.0.0001), kidney dysfunction (elevated creatinine, Hazard Ratio = 1.13, 95% CI 1.00–1.27, p = 0.043), and cardiopulmonary dysfunction (elevated tricuspid jet velocity on echocardiogram, Hazard Ratio = 2.22, 1.23–4.02, p = 0.0082). Sixty-six percent of subjects were treated with hydroxyurea, although only 66% of those received a dose within the recommended therapeutic range. Hydroxyurea use was associated with improved survival (Hazard Ratio = 0.58, 95% CI 0.34–0.97, p = 0.040). This effect was most pronounced in those taking the recommended dose of 15–35 mg/kg/day (Hazard Ratio 0.36, 95% CI 0.17–0.73, p = 0.0050). Hydroxyurea use was not associated with changes in organ function over time. Further, subjects with higher fetal hemoglobin responses to hydroxyurea were more likely to survive (p = 0.0004). While alkaline phosphatase was lowest in patients with the best fetal hemoglobin response (95.4 versus 123.6, p = 0.0065 and 96.1 versus 113.6U/L, p = 0.041 at first and last visits, respectively), other markers of organ damage were not consistently improved over time in patients with the highest fetal hemoglobin levels.Conclusions
Our data suggest that adults should be treated with the maximum tolerated hydroxyurea dose, ideally before organ damage occurs. Prospective studies are indicated to validate these findings. 相似文献9.
Alain Hendlisz Amelie Deleporte Thierry Delaunoit Rapha?l Maréchal Marc Peeters Stéphane Holbrechts Marc Van den Eynde Ghislain Houbiers Bertrand Filleul Jean-Luc Van Laethem Sarah Ceyssens Anna-Maria Barbuto Renaud Lhommel Gauthier Demolin Camilo Garcia Hazem El Mansy Lieveke Ameye Michel Moreau Thomas Guiot Marianne Paesmans Martine Piccart Patrick Flamen 《PloS one》2015,10(9)
Background
Tumoral heterogeneity is a major determinant of resistance in solid tumors. FDG-PET/CT can identify early during chemotherapy non-responsive lesions within the whole body tumor load. This prospective multicentric proof-of-concept study explores intra-individual metabolic response (mR) heterogeneity as a treatment efficacy biomarker in chemorefractory metastatic colorectal cancer (mCRC).Methods
Standardized FDG-PET/CT was performed at baseline and after the first cycle of combined sorafenib (600mg/day for 21 days, then 800mg/day) and capecitabine (1700 mg/m²/day administered D1-14 every 21 days). MR assessment was categorized according to the proportion of metabolically non-responding (non-mR) lesions (stable FDG uptake with SUVmax decrease <15%) among all measurable lesions.Results
Ninety-two patients were included. The median overall survival (OS) and progression-free survival (PFS) were 8.2 months (95% CI: 6.8–10.5) and 4.2 months (95% CI: 3.4–4.8) respectively. In the 79 assessable patients, early PET-CT showed no metabolically refractory lesion in 47%, a heterogeneous mR with at least one non-mR lesion in 32%, and a consistent non-mR or early disease progression in 21%. On exploratory analysis, patients without any non-mR lesion showed a significantly longer PFS (HR 0.34; 95% CI: 0.21–0.56, P-value <0.001) and OS (HR 0.58; 95% CI: 0.36–0.92, P-value 0.02) compared to the other patients. The proportion of non-mR lesions within the tumor load did not impact PFS/OS.Conclusion
The presence of at least one metabolically refractory lesion is associated with a poorer outcome in advanced mCRC patients treated with combined sorafenib-capecitabine. Early detection of treatment-induced mR heterogeneity may represent an important predictive efficacy biomarker in mCRC.Trial Registration
ClinicalTrials.gov NCT01290926 相似文献10.
Pavani K. Ram Margaret A. DiVita Kaniz Khatun-e-Jannat Manoshi Islam Kimberly Krytus Emily Cercone Badrul Munir Sohel Makhdum Ahmed Abid Mahmud Quaiyum Rahman Mustafizur Rahman Jihnhee Yu W. Abdullah Brooks Eduardo Azziz-Baumgartner Alicia M. Fry Stephen P. Luby 《PloS one》2015,10(6)
Rationale
There is little evidence for the efficacy of handwashing for prevention of influenza transmission in resource-poor settings. We tested the impact of intensive handwashing promotion on household transmission of influenza-like illness and influenza in rural Bangladesh.Methods
In 2009–10, we identified index case-patients with influenza-like illness (fever with cough or sore throat) who were the only symptomatic person in their household. Household compounds of index case-patients were randomized to control or intervention (soap and daily handwashing promotion). We conducted daily surveillance and collected oropharyngeal specimens. Secondary attack ratios (SAR) were calculated for influenza and ILI in each arm. Among controls, we investigated individual risk factors for ILI among household contacts of index case-patients.Results
Among 377 index case-patients, the mean number of days between fever onset and study enrollment was 2.1 (SD 1.7) among the 184 controls and 2.6 (SD 2.9) among 193 intervention case-patients. Influenza infection was confirmed in 20% of controls and 12% of intervention index case-patients. The SAR for influenza-like illness among household contacts was 9.5% among intervention (158/1661) and 7.7% among control households (115/1498) (SAR ratio 1.24, 95% CI 0.92–1.65). The SAR ratio for influenza was 2.40 (95% CI 0.68–8.47). In the control arm, susceptible contacts <2 years old (RRadj 5.51, 95% CI 3.43–8.85), those living with an index case-patient enrolled ≤24 hours after symptom onset (RRadj 1.91, 95% CI 1.18–3.10), and those who reported multiple daily interactions with the index case-patient (RRadj 1.94, 95% CI 1.71–3.26) were at increased risk of influenza-like illness.Discussion
Handwashing promotion initiated after illness onset in a household member did not protect against influenza-like illness or influenza. Behavior may not have changed rapidly enough to curb transmission between household members. A reactive approach to reduce household influenza transmission through handwashing promotion may be ineffective in the context of rural Bangladesh.Trial Registration
ClinicalTrials.gov NCT00880659 相似文献11.
Background
Mental health problems affect society as a whole and no group is immune to mental disorders; however, students have significantly high level of mental distress than their community peers.Objectives
The purpose of this study was to assess the prevalence and associated factors of mental distress among undergraduate students of University of Gondar, Northwest Ethiopia.Methods
Institution based cross sectional study was conducted among 836 students from April 9–11/2014. Stratified multistage sampling technique was used to select the study participants. Data were collected using pretested and structured self-administered questionnaire. Bivariate and multivariate logistic regression model was fitted to identify factors associated with mental distress among students. An adjusted odds ratio with 95% confidence interval was computed to determine the level of significance.Results
Prevalence of mental distress among students was found to be 40.9%. Female sex (AOR = 1.65; 95% CI 1.17–2.30), lack of interest towards their field of study (AOR = 2.28; 95% CI 1.49–3.50), not having close friends (AOR = 1.48; 95% CI 1.03–2.14), never attend religious programs (AOR = 1.58; 95% CI 1.02–2.46), conflict with friends (AOR = 1.93; 95% CI 1.41–2.65), having financial distress (AOR1.49 = 95% CI 1.05, 2.10), family history of mental illness (AOR = 2.12; 95% CI 1.31–3.45), Ever use of Khat (AOR = 1.71; 95% CI 1.12–2.59), lower grade than anticipated(AOR = 2.07; 95% CI 1.51–2.83), lack of vacation or break (AOR = 1.46; 95% CI 1.06–2.02), and low social support(AOR = 2.58; 95% CI 1.58–4.22) were significantly associated with mental distress.Conclusion
The overall prevalence of mental distress among students was found to be high. Therefore, it is recommended that mental distress needs due attention and remedial action from policy makers, college officials, non-governmental organizations, parents, students and other concerned bodies. 相似文献12.
Hai-Ha Le Chadia El-Khatib Margaux Mombled Frédéric Guitarian Muaamar Al-Gobari Mor Fall Perrine Janiaud Ivanny Marchant Michel Cucherat Théodora Bejan-Angoulvant Fran?ois Gueyffier 《PloS one》2016,11(2)
Background and Objectives
Sudden cardiac death (SCD) is a severe burden of modern medicine. Aldosterone antagonist is publicized as effective in reducing mortality in patients with heart failure (HF) or post myocardial infarction (MI). Our study aimed to assess the efficacy of AAs on mortality including SCD, hospitalization admission and several common adverse effects.Methods
We searched Embase, PubMed, Web of Science, Cochrane library and clinicaltrial.gov for randomized controlled trials (RCTs) assigning AAs in patients with HF or post MI through May 2015. The comparator included standard medication or placebo, or both. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed. Event rates were compared using a random effects model. Prospective RCTs of AAs with durations of at least 8 weeks were selected if they included at least one of the following outcomes: SCD, all-cause/cardiovascular mortality, all-cause/cardiovascular hospitalization and common side effects (hyperkalemia, renal function degradation and gynecomastia).Results
Data from 19,333 patients enrolled in 25 trials were included. In patients with HF, this treatment significantly reduced the risk of SCD by 19% (RR 0.81; 95% CI, 0.67–0.98; p = 0.03); all-cause mortality by 19% (RR 0.81; 95% CI, 0.74–0.88, p<0.00001) and cardiovascular death by 21% (RR 0.79; 95% CI, 0.70–0.89, p<0.00001). In patients with post-MI, the matching reduced risks were 20% (RR 0.80; 95% CI, 0.66–0.98; p = 0.03), 15% (RR 0.85; 95% CI, 0.76–0.95, p = 0.003) and 17% (RR 0.83; 95% CI, 0.74–0.94, p = 0.003), respectively. Concerning both subgroups, the relative risks respectively decreased by 19% (RR 0.81; 95% CI, 0.71–0.92; p = 0.002) for SCD, 18% (RR 0.82; 95% CI, 0.77–0.88, p < 0.0001) for all-cause mortality and 20% (RR 0.80; 95% CI, 0.74–0.87, p < 0.0001) for cardiovascular mortality in patients treated with AAs. As well, hospitalizations were significantly reduced, while common adverse effects were significantly increased.Conclusion
Aldosterone antagonists appear to be effective in reducing SCD and other mortality events, compared with placebo or standard medication in patients with HF and/or after a MI. 相似文献13.
Paolo Pandolfi Alessandro Zanasi Muriel Assunta Musti Elisa Stivanello Lara Pisani Sabrina Angelini Francesca Maffei Silvana Hrelia Cristina Angeloni Corrado Zenesini Patrizia Hrelia 《PloS one》2015,10(8)
Background
Socio-economic, cultural and environmental factors are becoming increasingly important determinants of chronic obstructive pulmonary disease (COPD). We conducted a study to investigate socio-demographic, lifestyle and clinical factors, and to assess their role as predictors of acute events (mortality or hospitalization for respiratory causes) in a group of COPD patients.Methods
Subjects were recruited among outpatients who were undertaking respiratory function tests at the Pneumology Unit of the Sant’Orsola-Malpighi Hospital, Bologna. Patients were classified according to the GOLD Guidelines.Results
229 patients with COPD were included in the study, 44 with Mild, 68 Moderate, 52 Severe and 65 Very Severe COPD (GOLD stage). Significant differences among COPD stage, in terms of smoking status and fragility index, were detected. COPD stage significantly affected the values of all clinical tests (spirometry and ABG analysis). Kaplan-Meier estimates showed a significant difference between survival curves by COPD stage with lower event-free probability in very severe COPD stage. Significant risk factors for acute events were: underweight (HR = 4.08; 95% CI 1.01–16.54), having two or more comorbidities (HR = 4.71; 95% CI 2.52–8.83), belonging to moderate (HR = 3.50; 95% CI 1.01–12.18) or very severe COPD stage (HR = 8.23; 95% CI 2.35–28.85).Conclusions
Our findings indicate that fragility is associated with COPD stage and that comorbidities and the low body mass index are predictors of mortality or hospitalization. Besides spirometric analyses, FeNO measure and comorbidities, body mass index could also be considered in the management and monitoring of COPD patients. 相似文献14.
Fangfang Lv Jun Cao Zhebin Liu Zhonghua Wang Jian Zhang Sheng Zhang Leiping Wang Xinmin Zhao Zhimin Shao Biyun Wang Xichun Hu 《PloS one》2015,10(3)
Purpose
Metastatic breast cancer (MBC) remains an incurable disease despite major therapeutic advances. Pseudomonas aeruginosa–mannose-sensitive hemagglutinin (PA-MSHA) has been established to have anti-proliferative effects against breast cancer cells in preclinical experiments, and is indicated for treatment of cancer in China. We performed a phase II trial combining PA-MSHA with capecitabine in patients with heavily pretreated MBC.Methods
Eligibility criteria included human epidermal growth factor receptor 2–negative MBC, prior therapy with anthracyclines and taxanes, at least one prior chemotherapy regimen for metastatic disease or early relapse after a taxane plus anthracycline adjuvant regimen, and adequate organ function and performance status. PA-MSHA 1 mg was administered subcutaneously every other day and capecitabine 1000 mg/m2 orally twice a day for 2 weeks on, 1 week off. The primary end point was progression-free survival.Results
A total of 97 patients were enrolled. Median progression-free survival (PFS) was 4.0 months [95 % confidence interval (CI) 3.0–4.9], which was not significantly different from that in historical controls. However, median PFS was significantly longer (8.2 months; 95 % CI 6.7–9.7) in 24 patients with moderate immune-related adverse events (irAEs) such as fever or skin induration at the injection site than in those with no or mild irAEs (3.1 months, 95 % CI 2.5–3.6; p = 0.003). Overall survival was also improved in these patients (25.4 vs. 16.4 months; p = 0.044). PA-MSHA has a good safety profile, with only 6 patients (6.2 %) discontinuing treatment. PA-MSHA did not increase capecitabine-related toxicities such as hand-foot syndrome, nausea, and vomiting.Conclusion
Adding PA-MSHA to capecitabine has a good safety profile in patients with heavily pre-treated MBC, although benefit from this regimen might occur only in patients with moderate PA-MSHA–related adverse events.Trial Registration
ClinicalTrials.gov NCT01380808 相似文献15.
Objectives
To examine epidemiological trends of Traumatic Brain Injury (TBI) treated in the Emergency Department (ED), identify demographic groups at risk of TBI, and determine the factors associated with hospitalization following an ED visit for TBI.Methods
A province-wide database was used to identify all ED visits for TBI in Ontario, Canada between April 2002 and March 2010. Trends were analyzed using linear regression, and predictors of hospital admission were evaluated using logistic regression.Results
There were 986,194 ED visits for TBI over the eight-year study period, resulting in 49,290 hospitalizations and 1,072 deaths. The age- and sex-adjusted rate of TBI decreased by 3%, from 1,013.9 per 100,000 (95% CI 1,008.3–1,010.6) to 979.1 per 100,000 (95% CI 973.7–984.4; p = 0.11). We found trends towards increasing age, comorbidity level, length of stay, and ambulatory transport use. Children and young adults (ages 5–24) sustained peak rates of motor vehicle crash (MVC) and bicyclist-related TBI, but also experienced the greatest decline in these rates (p = 0.003 and p = 0.005). In contrast, peak rates of fall-related TBI occurred among the youngest (ages 0–4) and oldest (ages 85+) segments of the population, but rates remained stable over time (p = 0.52 and 0.54). The 5–24 age group also sustained the highest rates of sports-related TBI but rates remained stable (p = 0.80). On multivariate analysis, the odds of hospital admission decreased by 1% for each year over the study period (OR = 0.991, 95% CI = 0.987–0.995). Increasing age and comorbidity, male sex, and ambulatory transport were significant predictors of hospital admission.Conclusions
ED visits for TBI are involving older populations with increasingly complex comorbidities. While TBI rates are either stable or declining among vulnerable groups such as young drivers, youth athletes, and the elderly, these populations remain key targets for focused injury prevention and surveillance. Clinicians in the ED setting should be cognizant of factors associated with hospitalization following TBI.Level of Evidence
III.Study Design
Cross-sectional. 相似文献16.
Anne Pauly Carolin Wolf Andreas Mayr Bernd Lenz Johannes Kornhuber Kristina Friedland 《PloS one》2015,10(10)
Background
In psychiatry, hospital stays and transitions to the ambulatory sector are susceptible to major changes in drug therapy that lead to complex medication regimens and common non-adherence among psychiatric patients. A multi-dimensional and inter-sectoral intervention is hypothesized to improve the adherence of psychiatric patients to their pharmacotherapy.Methods
269 patients from a German university hospital were included in a prospective, open, clinical trial with consecutive control and intervention groups. Control patients (09/2012-03/2013) received usual care, whereas intervention patients (05/2013-12/2013) underwent a program to enhance adherence during their stay and up to three months after discharge. The program consisted of therapy simplification and individualized patient education (multi-dimensional component) during the stay and at discharge, as well as subsequent phone calls after discharge (inter-sectoral component). Adherence was measured by the “Medication Adherence Report Scale” (MARS) and the “Drug Attitude Inventory” (DAI).Results
The improvement in the MARS score between admission and three months after discharge was 1.33 points (95% CI: 0.73–1.93) higher in the intervention group compared to controls. In addition, the DAI score improved 1.93 points (95% CI: 1.15–2.72) more for intervention patients.Conclusion
These two findings indicate significantly higher medication adherence following the investigated multi-dimensional and inter-sectoral program.Trial Registration
German Clinical Trials Register DRKS00006358 相似文献17.
Background
Epidemiological studies evaluating treatments for infantile hemangiomas have produced inconsistent results. A meta-analysis of published data was conducted to investigate the effectiveness and safety of oral propranolol versus other treatments for infantile hemangiomas.Methods
A meta-analysis was conducted based on literature (published from 1960 to December 1, 2014) found on the PubMed, EMBASE, and OVID search engines. Pooled odds ratios (ORs) and 95% confidence intervals (CIs) were estimated for the outcome measures. Heterogeneity, publication bias and subgroup analysis were performed.Results
A total of 61 studies involving 5,130 participants met the inclusion criteria. Propranolol was found to be a more effective modality in treating IHs (ORs = 0.92; 95%CI, 0.89–0.95) and had fewer complications compared to the other treatments including systemic steroids (ORs = 0.68; 95% CI, 0.59–0.76); laser ablation (ORs = 0.55; 95% CI, 0.43–0.67); other beta-adrenergic blockers (ORs = 0.56; 95% CI, 0.50–0.61) and surgery (ORs = 0.55; 95% CI, 0.28–0.81). A subgroup analysis of propranolol showed that a dose of 2 mg/kg/day or more yielded better outcomes (ORs = 0.92; 95% CI, 0.88–0.95; ORs = 0.95; 95% CI, 0.89–1.00), and IHs that had not been previously treated had better responses to propranolol treatment (ORs = 0.95; 95% CI, 0.91–0.98).Conclusions
The meta-analysis demonstrated that propranolol was more effective and safer than other therapies in treating IHs. It provides strong evidence for supporting the use of propranolol as a first-line therapy for IHs. 相似文献18.
Susan Jordan Marie Ellenor Gabe-Walters Alan Watkins Ioan Humphreys Louise Newson Sherrill Snelgrove Michael S Dennis 《PloS one》2015,10(10)
Background
People with dementia are susceptible to adverse drug reactions (ADRs). However, they are not always closely monitored for potential problems relating to their medicines: structured nurse-led ADR Profiles have the potential to address this care gap. We aimed to assess the number and nature of clinical problems identified and addressed and changes in prescribing following introduction of nurse-led medicines’ monitoring.Design
Pragmatic cohort stepped-wedge cluster Randomised Controlled Trial (RCT) of structured nurse-led medicines’ monitoring versus usual care.Setting
Five UK private sector care homesParticipants
41 service users, taking at least one antipsychotic, antidepressant or anti-epileptic medicine.Intervention
Nurses completed the West Wales ADR (WWADR) Profile for Mental Health Medicines with each participant according to trial step.Outcomes
Problems addressed and changes in medicines prescribed.Data Collection and Analysis
Information was collected from participants’ notes before randomisation and after each of five monthly trial steps. The impact of the Profile on problems found, actions taken and reduction in mental health medicines was explored in multivariate analyses, accounting for data collection step and site.Results
Five of 10 sites and 43 of 49 service users approached participated. Profile administration increased the number of problems addressed from a mean of 6.02 [SD 2.92] to 9.86 [4.48], effect size 3.84, 95% CI 2.57–4.11, P <0.001. For example, pain was more likely to be treated (adjusted Odds Ratio [aOR] 3.84, 1.78–8.30), and more patients attended dentists and opticians (aOR 52.76 [11.80–235.90] and 5.12 [1.45–18.03] respectively). Profile use was associated with reduction in mental health medicines (aOR 4.45, 1.15–17.22).Conclusion
The WWADR Profile for Mental Health Medicines can improve the quality and safety of care, and warrants further investigation as a strategy to mitigate the known adverse effects of prescribed medicines.Trial Registration
ISRCTN 48133332 相似文献19.
Miguel A. Salinero-Fort Francisco J. San Andrés-Rebollo Carmen de Burgos-Lunar Paloma Gómez-Campelo Rosa M. Chico-Moraleja Ana López de Andrés Rodrigo Jiménez-García MADIABETES Group 《PloS one》2015,10(4)
Objective
To evaluate the incidence rate of Chronic Kidney Disease (CKD) stage 3-5 (persistent decreased kidney function under 60 mL/min per 1.73 m2) among patients with type 2 diabetes over five years, to identify the risk factors associated with CKD, and develop a risk table to predict five-year CKD stage 3-5 risk stratification for clinical use.Design
The MADIABETES Study is a prospective cohort study of 3,443 outpatients with type 2 diabetes mellitus, sampled from 56 primary health care centers (131 general practitioners) in Madrid (Spain).Results
The cumulative incidence of CKD stage 3-5 at five-years was 10.23% (95% CI = 9.12–11.44) and the incidence density was 2.07 (95% CI = 1.83–2.33) cases per 1,000 patient-months or 2.48 (95% CI = 2.19–2.79) cases per 100 patient-years. The highest hazard ratio (HR) for developing CKD stage 3-5 was albuminuria ≥300 mg/g (HR = 4.57; 95% CI= 2.46-8.48). Furthermore, other variables with a high HR were age over 74 years (HR = 3.20; 95% CI = 2.13–4.81), a history of Hypertension (HR = 2.02; 95% CI = 1.42–2.89), Myocardial Infarction (HR= 1.72; 95% IC= 1.25–2.37), Dyslipidemia (HR = 1.68; 95% CI 1.30–2.17), duration of diabetes mellitus ≥ 10 years (HR = 1.46; 95% CI = 1.14-1.88) and Systolic Blood Pressure >149 mmHg (HR = 1.52; 95% CI = 1.02–2.24).Conclusions
After a five-year follow-up, the cumulative incidence of CKD is concordant with rates described in Spain and other countries. Albuminuria ≥ 300 mg/g and age over 74 years were the risk factors more strongly associated with developing CKD (Stage 3-5). Blood Pressure, lipid and albuminuria control could reduce CKD incidence of CKD in patients with T2DM. 相似文献20.
Chen-Yi Wu Hsiao-Yun Hu Lok-Hi Chow Yiing-Jenq Chou Nicole Huang Pei-Ning Wang Chung-Pin Li 《PloS one》2015,10(6)