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1.
Background
Evidence from developing countries regarding the association between gender inequity and intimate partner violence (IPV) victimization in women has been suggestive but inconclusive. Using nationally representative population-based data from Bangladesh, we examined the association between multidimensional aspects of gender inequity and the risk of IPV.Methods
We used data from the 2007 Bangladesh Demographic Health Survey. The analyses were based on the responses of 4,467 married women. The main explanatory variable was gender inequity, which reflects the multidimensional aspects of women''s autonomy and the relationship inequality between women and their partner. The experience of physical and/or sexual IPV was the main outcome variable of interest.Results
Over 53% of married Bangladeshi women experienced physical and/or sexual violence from their husbands. In the adjusted models, women who had a higher level of autonomy (adjusted odds ratio [AOR] 0.48; 99% confidence interval [CI] 0.37–0.61), a particularly high level of economic-decision-making autonomy (AOR 0.12; 99% CI 0.08–0.17), and a higher level of non-supportive attitudes towards wife beating or raping (AOR 0.61; 99% CI 0.47–0.83) were less likely to report having experienced IPV. Education level, age at marriage, and occupational discrepancy between spouses were also found to be significant predictors of IPV.Conclusions
In conclusion, dimensions of gender inequities were significant predictors of IPV among married women in Bangladesh. An investigation of the causal link between multidimensional aspects of gender inequity and IPV will be critical to developing interventions to reduce the risk of IPV and should be considered a public health research priority. 相似文献2.
Weihai Zhan Alla V. Shaboltas Roman V. Skochilov Tatiana V. Krasnoselskikh Nadia Abdala 《PloS one》2013,8(7)
Objectives
To examine correlates of perpetration and victimization of intimate partner violence (IPV) under and not under the influence of a substance, we conducted a study among women in Russia.Methods
In 2011, a cross-sectional survey was conducted among patients receiving services at a clinic for sexually transmitted infections in St. Petersburg, Russia. Multinomial logistic regression was used for analysis.Results
Of 299 women, 104 (34.8%) and 113 (37.8%) reported a history of IPV perpetration and victimization, respectively. Nearly half (47.1%) of perpetrators and 61.1% of victims reported that the latest IPV event (perpetration and victimization, respectively) was experienced under the influence of a substance. Factors independently associated with IPV victimization under the influence of a substance were alcohol misuse and a higher number of lifetime sex partners, whereas only experience of childhood abuse (emotional and physical abuse) was independently associated with IPV victimization that did not occur under the influence of a substance. Childhood physical abuse, lower age of first sex, sensation seeking, and alcohol misuse were independently associated with IPV perpetration under the influence of a substance, while only childhood abuse (emotional and physical abuse) was independently associated with IPV perpetration that did not occur under the influence of a substance.Conclusions
IPV under and not under the influence of a substance had different correlates (e.g., alcohol misuse and sensation seeking). Despite the strong association between substance use and IPV, experience of childhood abuse is an important predictor of IPV perpetration and victimization in Russia, above and beyond substance use. 相似文献3.
Objectives
To compare the impact of scheduling caesarean section prior to versus after 39 completed weeks of gestation on the occurrence of unscheduled caesarean section and rescheduling of the procedure.Methods
Secondary analysis from a multicentre randomised open-label trial including singleton pregnant women with a healthy foetus and a reliable due date. Women were allocated by computerized telephone randomisation to planned caesarean section at 38 weeks and three days or 39 weeks and three days. The outcomes were unscheduled deliveries with provided reasons, such as spontaneous labour onset or supervening complications, and any changes in the scheduled delivery date. Statistical analyses were according to intention-to-treat using Fisher’s exact test.Results
From March 2009 to June 2011 1,274 women were included. Median difference in gestational age at delivery was six days. Compared to the 38 weeks group, the women in the 39 weeks group were more likely to have an unscheduled caesarean section (15.2% vs. 9.3%; RR 1.64, 95% CI 1.21; 2.22), to deliver between 6 pm and 8 am (10 % vs. 6%; RR 1.68, 95% CI 1.14; 2.47), or to have the procedure rescheduled (36.7% vs. 23%; RR 1.6, 95% CI 1.34;1.90).Conclusions
Scheduling caesarean section after 39 weeks leads to a 60% increase in unscheduled caesarean sections and a 70% increase in delivery outside regular work hours as compared to scheduling of the procedure prior to 39 weeks.Trial Registration
www.clinicaltrials.gov NCT00835003 http://www.clinicaltrials.gov/ct2/show/NCT00835003?term=NCT00835003&rank=1 相似文献4.
Background
Intimate partner violence (IPV) is a serious global public health issue. Acceptance of wife beating is known to be associated with IPV, but few studies have analysed the acceptance of wife beating from both women and men’s points of view. The objective of this study was to examine whether acceptance of wife beating among couples is associated with lifetime and past one-year physical IPV perpetration towards wives in Nepal.Methods
A cross-sectional study was conducted from August to September 2011, with 717 randomly selected couples with wives aged 18 to 49 years old from the Kirtipur municipality and Bhaktapur district of Nepal. Wives’ and husbands’ acceptance of wife beating was measured by six scale items, while physical IPV experience among wives was measured by seven physical assault scale items. To assess the association between acceptance of wife beating and physical IPV, multiple logistic regression analysis was used.Results
Nearly 30% of wives and husbands indicated that beating of wives is acceptable under certain circumstances. Statistically, no significant difference was detected between wives’ and husbands’ level of acceptance of wife beating. However, husbands’ acceptance of wife beating was positively associated with lifetime and past one-year perpetration of physical IPV, whereas wives’ acceptance of wife beating was neither associated with lifetime nor past one-year victimization of physical IPV. The positive association for husbands remained even after controlling for their partner’s factors.Conclusions
Acceptance of wife beating is an important risk factor, which must be considered to prevent perpetration of physical IPV towards wives in Nepal. Future studies should include men to better understand the structure and dynamics of IPV in Nepal, and prevention programs should also target men to change their attitudes or to identify which couples are at more risk of physical IPV occurring toward wives. 相似文献5.
Pengfei He Qi Han Jiajia Liu Dongjuan Liu Xin Zhao Ting Hu Lu Jiang Hongxia Dan Xin Zeng Jing Li Jiayi Wang Qianming Chen 《PloS one》2013,8(12)
Background
The possible association between HIF-1α C1772T polymorphism and cancer risk has been studied extensively. However, the results were controversial. In order to get a more precise conclusion of this association, a meta-analysis was performed.Methods
A total of 10186 cases and 10926 controls in 37 case-control studies were included in this meta-analysis. Allele and genotypic differences between cases and controls were evaluated. Subgroup analysis by cancer site, ethnicity, source of controls and gender was performed.Results
The T allele of HIF-1α gene C1772T was significantly associated with increased cancer risk in three genetic models: TT+CT vs.CC (dominant model OR=1.23, 95%CI=1.03-1.47), TT vs. CT+CC (recessive model OR=2.51, 95%CI=1.54-4.09), TT vs. CC (homozygote comparison OR=2.02, 95%CI=1.21-3.39).In subgroup analysis, the frequency of the T variant was found to be significantly increased in cervical cancer, pancreatic cancer, head and neck cancer, renal cell carcinoma, Asian and female subgroups.Conclusions
Our meta-analysis suggests that the substitution of C allele with T at HIF-1α gene C1772T polymorphism is a risk factor of cancer, especially for cervical, head and neck cancer, pancreatic cancer and renal cell carcinoma. It is also a risk factor of cancer in Asian group as well as in female group. 相似文献6.
Background
Lifetime victimization experiences, including child sexual abuse (CSA), child physical abuse (CPA), adult sexual assault (ASA), and adult physical assault (APA), are associated with health problems.Purpose
To examine relationships between cumulative victimization and physical health among heterosexual and lesbian women and determine whether these relationships differ by sexual identity.Methods
Large samples of heterosexual (n = 482) and lesbian women (n = 394) were interviewed. Questions included lifetime victimization experiences and physical health problems.Results
Compared to women who reported no childhood victimization, those who reported experiencing both CSA and CPA were 44% more likely to report health problems and women who experienced all four types of victimization (CSA, CPA, APA, ASA) were nearly 240% as likely to report physical health problems. Interaction analyses revealed the association between victimization and physical health did not differ by sexual identity.Conclusions
Although lesbians were more likely to report all types of victimization, results suggest that victimization conferred increased physical health risks regardless of sexual identity. 相似文献7.
Objective
To investigate the effectiveness of educational poster on improving secondary school students'' knowledge of emergency management of dental trauma.Methods
A cluster randomised controlled trial was conducted. 16 schools with total 671 secondary students who can read Chinese or English were randomised into intervention (poster, 8 schools, 364 students) and control groups (8 schools, 305 students) at the school level. Baseline knowledge of dental trauma was obtained by a questionnaire. Poster containing information of dental trauma management was displayed in a classroom for 2 weeks in each school in the intervention group whereas in the control group there was no display of such posters. Students of both groups completed the same questionnarie after 2 weeks.Results
Two-week display of posters improved the knowledge score by 1.25 (p-value = 0.0407) on average.Conclusion
Educational poster on dental trauma management significantly improved the level of knowledge of secondary school students in Hong Kong.Trial Registration
HKClinicalTrial.com HKCTR-1343 ClinicalTrials.gov NCT01809457 相似文献8.
Joop P. W. van den Bergh Marian E. Bouts Eveline van der Veer Robert Y. van der Velde Marcel J. W. Janssen Piet P. Geusens Bjorn Winkens Nico J. J. Oldenhof Tineke A. C. M. van Geel 《PloS one》2013,8(10)
Introduction
An increasing number of generic alendronate formulations have become available. Although expected to have the same tolerability and efficacy, head-to head comparison of generic and brand alendronate was never performed. Therefore, we compared the tolerability and efficacy of generic and brand alendronate.Methods
In a randomized double-blinded single centre cross-over study in 37 postmenopausal women (mean age 65.4±6.4 years) with osteoporosis were treated with generic and branded alendronate during 24 (2x12) weeks. Tolerance was evaluated by the Gastro intestinal Symptom Rating Scale (GSRS) and self-reported side effects. Efficacy was assessed by serum bone turnover markers, carboxy terminal telopeptide (CTX) and procollagen type I N-terminal propeptide (PINP). No wash out period was allowed (ethical reasons). Because of possible carry over effect only data of the first 12 weeks were analyzed using linear mixed models.Results
There were no significant differences in overall tolerance (GSRS) between treatment groups. However, for subscale abdominal pain, patients using generic had a significantly higher mean GSRS score at week 4 (estimated mean difference (B): 0.40; 95%CI: 0.05 to 0.74, p = 0.024). The level of bone turnover markers significantly decreased over 12 weeks of follow-up for generic and branded alendronate (p < 0.001). Mean level of CTX was significantly lower with branded at week 4 (B: 121.3; 95%CI: 52.0 to 190.5), but not at week 12 (B: 53.6; 95%CI:-3.7 to 110.9). No significant differences were found for PINP at week 4 or 12.Conclusions
Bone turnover markers were significantly reduced with branded and generic alendronate. With branded, CTX was significantly lower at 4 weeks. Generic caused significantly higher abdominal pain scores in the first 4 weeks of treatment. Therefore, generic alendronate may not have the same tolerability and efficacy as branded alendronate in the first weeks after starting treatment in patients with a recent fracture.Trial Registration
Dutch Trial Register NTR number 1867 http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1867 相似文献9.
Kate Bramham Carlos E. Poli-de-Figueiredo Paul T. Seed Annette L. Briley Lucilla Poston Andrew H. Shennan Lucy C. Chappell 《PloS one》2013,8(10)
Objectives
To evaluate occurrence of adverse maternal and perinatal outcomes with different thresholds of proteinuria (300-499mg and ≥500mg/24 hours) in pre-eclamptic women, comparing outcomes against women with chronic and gestational hypertension.Design
Secondary analysis of the Vitamins in Pre-Eclampsia Trial.Setting
25 UK hospitals in ten geographical areas.Population
946 women with pre-existing risk factors for pre-eclampsia.Methods
Women with pre-eclampsia and proteinuria 300-499mg/24h (PE300, referent group, n=60) or proteinuria ≥500 mg/24h (PE500, n=161) were compared with two groups of non-proteinuric women with chronic hypertension (CHT, n=615) or gestational hypertension (GH, n=110).Main Outcome Measures
Maternal: progression to severe hypertension. Perinatal: small for gestational age (SGA) <5th centile, gestation at delivery.Results
Severe hypertension occurred more frequently in PE500 (35%) and PE300 (27%) than CHT (5.9%; P≤0.01) and GH (10%; p≤0.001). Gestation at delivery was earlier in PE500 (33.2w) than PE300 (37.3w; P≤0.001), and later in CHT (38.3w; P≤0.05) and GH (39.1w; P≤0.001). SGA infants were more frequent in PE300 (32%) than in CHT (13.3%; P≤0.001) and GH (16.5%; P≤0.05). Women in PE500 were more likely to have a caesarean section than PE300 (78% vs. 48%; P≤0.001), and to receive magnesium sulphate (17% vs. 1.7%, P≤0.05).Conclusion
Women with PE300 have complication rates above those of women managed as out-patients (GH and CHT), meriting closer surveillance and confirming 300 mg/d as an appropriate threshold for determining in-patient management. Adverse perinatal outcomes are higher still in women with PE500. 相似文献10.
Introduction
Stories may be an effective tool to communicate with patients because of their ability to engage the reader. Our objective was to evaluate the effectiveness of story booklets compared to standard information sheets for parents of children attending the emergency department (ED) with a child with croup.Methods
Parents were randomized to receive story booklets (n=208) or standard information sheets (n=205) during their ED visit. The primary outcome was change in anxiety between triage to ED discharge as measured by the State-Trait Anxiety Inventory. Follow-up telephone interviews were conducted at 1 and 3 days after discharge, then every other day until 9 days (or until resolution of symptoms), and at 1 year. Secondary outcomes included: expected future anxiety, event impact, parental knowledge, satisfaction, decision regret, healthcare utilization, time to symptom resolution.Results
There was no significant difference in the primary outcome of change in parental anxiety between recruitment and ED discharge (change of 5 points for the story group vs. 6 points for the comparison group, p=0.78). The story group showed significantly greater decision regret regarding their decision to go to the ED (p<0.001): 6.7% of the story group vs. 1.5% of the comparison group strongly disagreed with the statement “I would go for the same choice if I had to do it over again”. The story group reported shorter time to resolution of symptoms (mean 3.7 days story group vs. 4.0 days comparison group, median 3 days both groups; log rank test, p=0.04). No other outcomes were different between study groups.Conclusions
Stories about parent experiences managing a child with croup did not reduce parental anxiety. The story group showed significantly greater decision regret and quicker time to resolution of symptoms. Further research is needed to better understand whether stories can be effective in improving patient-important outcomes.Trial Registration
Current Controlled Trials, ISRCTN39642997 (http://www.controlled-trials.com/ISRCTN39642997) 相似文献11.
Importance
Patients with a hip fracture lose more than 50% knee-extension strength in the fractured limb within one week of surgery. Hence, immediate progressive strength training following hip fracture surgery may be rational, but the feasibility unknown.Objective
To examine the feasibility of in-hospital progressive strength training implemented in the acute ward following hip fracture surgery, based on pre-specified criteria for feasibility.Design, Setting and Patients
A prospective cohort study conducted in an acute orthopedic hip fracture unit at a university hospital. A consecutive sample of 36 patients, 18 with a cervical and 18 with a trochanteric hip fracture (27 women and 9 men, mean (SD) age of 79.4 (8.3) years) were included between June and December 2012.Intervention
A daily (on weekdays) program of progressive knee-extension strength training for the fractured limb, using ankle weight cuffs in 3 sets of 10 repetition maximum loadings.Main outcomes and Measures
The primary outcome was the change in training load (kg) during the knee-extension strength training. The secondary outcomes were changes in hip fracture-related pain and maximal isometric knee-extension strength.Results
The strength training was commenced at a mean of 2.4 (0.7) days after surgery. The training loads (kilograms lifted) increased from 1.6 (0.8) to 4.3 (1.7) kg over 4.3 (2.2) training sessions (P<.001). The maximal isometric knee-extension strength of the fractured limb increased from 0.37 (0.2) to 0.61 (0.3) Nm/kg (P<.001), while the average strength deficit in the fractured limb decreased from 50% to 32% (% non-fractured, P<.001). Only 3 of 212 sessions were not performed because of severe hip fracture-related pain.Conclusion and Relevance
Progressive knee-extension strength training of the fractured limb commenced in the acute ward seems feasible, and may reduce strength asymmetry between limbs without hip pain interfering. The clinical efficacy needs confirmation in a randomized controlled design.Trial Registration
ClinicalTrials.gov ID: NCT01616030 相似文献12.
Jamila Mejdoubi Silvia C. C. M. van den Heijkant Frank J. M. van Leerdam Martijn W. Heymans Alfons Crijnen Remy A. Hirasing 《PloS one》2015,10(4)
Background
Child maltreatment is a great public health concern that has long-term mental and physical health consequences and can result in death. We studied the effect of a nurse home visiting program on child maltreatment among young disadvantaged families in the Netherlands. This study is the first to investigate the effects of this program outside of the United States.Methods
We conducted a single blind, parallel-group, randomized controlled trial that compared usual care with the nurse home visitation program, which began during pregnancy and continued until the children’s second birthdays, in 460 disadvantaged women who were pregnant for the first time and <26 years of age. The primary outcome was the existence of a report about the child from a child protecting services agency (CPS reports). Secondary outcome measures included home environment and child behavior.Results
Two hundred twenty-three participants were assigned to the control group, and 237 were assigned to the intervention group. Three years after birth, 19% of the children in the control group had a CPS report. The 11 percent of children in the intervention group with CPS files was significantly lower (relative risk 0.91, p-value 0.04). At 24 months, the intervention group scored significantly better on the IT-HOME. At 24 months after birth, the children in the intervention group exhibited a significant improvement in internalizing behavior (relative risk 0.56, p-value 0.04) but no evidence of a difference from the control group in externalizing behavior (relative risk 0.71, p-value 0.12).Conclusion
The number of CPS reports for the intervention group was significantly lower than that of the control group. Additionally, the long-term home environments were improved and internalizing behaviors of the children were lower in the intervention group.Trial Registration
Dutch Trial Register NTR854 相似文献13.
Maria Egede Johansen Jens-Ulrik Jensen Morten Heiberg Bestle Lars Hein Anne ?berg Lauritsen Hamid Tousi Kim Michael Larsen Jesper L?ken Thomas Mohr Katrin Thormar P?r I. Johansson Alessandro Cozzi-Lepri Jens D. Lundgren 《PloS one》2013,8(11)
Background
Antimicrobial-induced thrombocytopenia is frequently described in the literature among critically ill patients. Several antimicrobials have been implicated, although experimental evidence to demonstrate causality is limited. We report, using a randomized trial, the potential of antimicrobials to induce thrombocytopenia.Methods
Randomized trial allocated patients to antimicrobial treatment according to standard- of-care (SOC group) or drug-escalation in case of procalcitonin increases (high-exposure group). Patients were followed until death or day 28. Thrombocytopenia defined as absolute (platelet count ≤100x109/L) or relative (≥20% decrease in platelet count). Analyses were performed in the two randomized groups and as a merged cohort.Results
Of the 1147 patients with platelet data available, 18% had absolute thrombocytopenia within the first 24 hours after admission to intensive care unit and additional 17% developed this complication during follow-up; 57% developed relative thrombocytopenia during follow-up. Absolute and relative thrombocytopenia day 1-4 was associated with increased mortality (HR: 1.67 [95% CI: 1.30 to 2.14]; 1.71 [95% CI: 1.30 to 2.30], P<0.0001, respectively). Patients in the high-exposure group received more antimicrobials including piperacillin/tazobactam, meropenem and ciprofloxacin compared with the SOC group, whereas cefuroxime was used more frequently in the SOC group (p<0.05). Risk of absolute and relative thrombocytopenia (RR: 0.9 [0.7-1.3], p=0.7439; 1.2 [1.0-1.4], p=0.06; respectively), as well as absolute platelet count (daily difference, high-exposure vs. SOC -1.7 [-3.8-0.5], p=0.14) was comparable between groups. In observational analyses, use of ciprofloxacin and piperacillin/tazobactam predicted risk of relative thrombocytopenia (vs. cefuroxime, RR: 2.08 [1.48-2.92]; 1.44 [1.10-1.89], respectively), however only ciprofloxacin were associated with a reduction in absolute platelet count (p=0.0005).Conclusion
High exposure to broad-spectrum antimicrobials does not result in a reduction in thrombocytopenia in critically ill patients. However, single use of ciprofloxacin, and less so piperacillin/tazobactam, may contribute to a lower platelet count.Trial Registration
ClinicalTrials.gov NCT00271752 http://clinicaltrials.gov/ct2/show/NCT00271752 相似文献14.
Marcello Bertotti Paul Watts Gopalakrishnan Netuveli Ge Yu Elena Schmidt Patrick Tobi Shahana Lais Adrian Renton 《PloS one》2013,8(12)
Objectives
To examine the extent to which individual and ecological-level cognitive and structural social capital are associated with common mental disorder (CMD), the role played by physical characteristics of the neighbourhood in moderating this association, and the longitudinal change of the association between ecological level cognitive and structural social capital and CMD.Design
Cross-sectional and longitudinal study of 40 disadvantaged London neighbourhoods. We used a contextual measure of the physical characteristics of each neighbourhood to examine how the neighbourhood moderates the association between types of social capital and mental disorder. We analysed the association between ecological-level measures of social capital and CMD longitudinally.Participants
4,214 adults aged 16-97 (44.4% men) were randomly selected from 40 disadvantaged London neighbourhoods.Main Outcome Measures
General Health Questionnaire (GHQ-12).Results
Structural rather than cognitive social capital was significantly associated with CMD after controlling for socio-demographic variables. However, the two measures of structural social capital used, social networks and civic participation, were negatively and positively associated with CMD respectively. ‘Social networks’ was negatively associated with CMD at both the individual and ecological levels. This result was maintained when contextual aspects of the physical environment (neighbourhood incivilities) were introduced into the model, suggesting that ‘social networks’ was independent from characteristics of the physical environment. When ecological-level longitudinal analysis was conducted, ‘social networks’ was not statistically significant after controlling for individual-level social capital at follow up.Conclusions
If we conceptually distinguish between cognitive and structural components as the quality and quantity of social capital respectively, the conclusion of this study is that the quantity rather than quality of social capital is important in relation to CMD at both the individual and ecological levels in disadvantaged urban areas. Thus, policy should support interventions that create and sustain social networks. One of these is explored in this article.Trial Registration
Controlled-Trials.com ISRCTN68175121 http://www.controlled-trials.com/ISRCTN68175121 相似文献15.
Klaus Mross Heike Richly Richard Fischer Dirk Scharr Martin Büchert Angelika Stern Hendrik Gille Laurent P. Audoly Max E. Scheulen 《PloS one》2013,8(12)
Background
To report the nonrandomized first-in-human phase I trial of PRS-050, a novel, rationally engineered Anticalin based on human tear lipocalin that targets and antagonizes vascular endothelial growth factor A (VEGF-A).Methods
Patients with advanced solid tumors received PRS-050 at 0.1 mg/kg to 10 mg/kg by IV in successive dosing cohorts according to the 3+3 escalation scheme. The primary end point was safety.Results
Twenty-six patients were enrolled; 25 were evaluable. Two patients experienced dose-limiting toxicity, comprising grade (G) 3 hypertension and G3 pyrexia, respectively. The maximum tolerated dose was not reached. Most commonly reported treatment-emergent adverse events (AEs) included chills (52%; G3, 4%), fatigue (52%; G3, 4%), hypertension (44%; G3, 16%), and nausea (40%, all G1/2). No anti–PRS-050 antibodies following multiple administration of the drug were detected. PRS-050 showed dose-proportional pharmacokinetics (PK), with a terminal half-life of approximately 6 days. Free VEGF-A was detectable at baseline in 9/25 patients, becoming rapidly undetectable after PRS-050 infusion for up to 3 weeks. VEGF-A/PRS-050 complex was detectable for up to 3 weeks at all dose levels, including in patients without detectable baseline-free VEGF-A. We also detected a significant reduction in circulating matrix metalloproteinase 2, suggesting this end point could be a pharmacodynamic (PD) marker of the drug’s activity.Conclusions
PRS-050, a novel Anticalin with high affinity for VEGF-A, was well-tolerated when administered at the highest dose tested, 10 mg/kg. Based on target engagement and PK/PD data, the recommended phase II dose is 5 mg/kg every 2 weeks administered as a 120-minute infusion.Trial Registration
ClinicalTrials.gov NCT01141257 http://clinicaltrials.gov/ct2/show/NCT01141257 相似文献16.
Ai-Hsiang Chou Chia-Chyi Liu Jui-Yuan Chang Renee Jiang Yi-Chin Hsieh Amanda Tsao Chien-Long Wu Ju-Lan Huang Chang-Phone Fung Szu-Min Hsieh Ya-Fang Wang Jen-Ren Wang Mei-Hua Hu Jen-Ron Chiang Ih-Jen Su Pele Choi-Sing Chong 《PloS one》2013,8(11)
Background
Enterovirus 71 (EV71) has caused several epidemics of hand, foot and mouth diseases (HFMD) in Asia. No effective EV71 vaccine is available. A randomized and open-label phase I clinical study registered with ClinicalTrials.gov #NCT01268787, aims to evaluate the safety, reactogenicity and immunogenicity of a formalin-inactivated EV71 vaccine candidate (EV71vac) at 5- and 10-µg doses. In this study we report the cross-neutralizing antibody responses from each volunteer against different subgenotypes of EV71 and CVA16.Methods
Sixty eligible healthy adults were recruited and vaccinated. Blood samples were obtained on day 0, 21 and 42 and tested against B1, B4, B5, C2, C4A, C4B and CVA16 for cross-neutralizing antibody responses.Results
The immunogenicity of both 5- and 10- µg doses were found to be very similar. Approximately 45% of the participants had <8 pre-vaccination neutralization titers (Nt) against the B4 vaccine strain. After the first EV71vac immunization, 95% of vaccinees have >4-fold increase in Nt, but there was no further increase in Nt after the second dose. EV71vac induced very strong cross-neutralizing antibody responses in >85% of volunteers without pre-existing Nt against subgenotype B1, B5 and C4A. EV71vac elicited weak cross-neutralizing antibody responses (∼20% of participants) against a C4B and Coxsackie virus A16. Over 90% of vaccinated volunteers did not develop cross-neutralizing antibody responses (Nt<8) against a C2 strain. EV71vac can boost and significantly enhance the neutralizing antibody responses in volunteers who already had pre-vaccination antibodies against EV71 and/or CVA16.Conclusion
EV71vac is efficient in eliciting cross-neutralizing antibody responses against EV71 subgenotypes B1, B4, B5, and C4A, and provides the rationale for its evaluation in phase II clinical trials.Trial Registration
ClinicalTrials.gov __NCT01268787 相似文献17.
Ji-Juan Xing Xiu-Fen Liu Xiao-Ming Xiong Li Huang Cheng-Yi Lao Mei Yang Shan Gao Qiong-Yan Huang Wei Yang Yun-Feng Zhu Di-Hua Zhang 《PloS one》2015,10(9)
Objective
Combined spinal-epidural analgesia (CSEA) is sometimes used for difficult births, but whether it contributes to postpartum pelvic muscle disorder is unclear. This randomized controlled trial examined whether CSEA given during labor affects the electrophysiological index of postpartum pelvic floor muscle function.Methods
A consecutive sample of primiparous women who delivered vaginally at term were randomly assigned to a CSEA group (n = 143) and control group (n = 142) between June 2013 and June 2014. All were assessed 6–8 weeks later for electrophysiological function of pelvic floor muscle.Results
The two groups were similar in the degree of muscle strength, muscle fatigue, and pelvic dynamic pressure of pelvic floor muscle. The CSEA and control groups showed similar proportions of women with normal muscle strength (score ≥4) in type I pelvic fibers (23.1% vs. 14.1%, P = 0.051) and type II pelvic fibers (28.0% vs. 24.6%, P = 0.524). The groups also contained similar proportions of women who showed no fatigue in type I fibers (54.5% vs. 48.6%, P = 0.315) or type II fibers (88.8% vs. 87.3%, P = 0.699). Similarly low proportions of women in the CSEA group and control group showed normal pelvic dynamic pressure (11.2% vs. 7.7%, P = 0.321). However, women in the CSEA group spent significantly less time in labor than those in the control group (7.25 vs. 9.52 h, P <0.001).Conclusions
CSEA did not affect the risk of postpartum pelvic muscle disorder in this cohort of primiparous women who gave birth vaginally. A significant shorter duration of labour was observed in the CSEA-group.Trial Registration
ClinicalTrials.gov NCT02334150 相似文献18.
Background
Small trials with short term follow up suggest pharmacists’ interventions targeted at healthcare professionals can improve prescribing. In comparison with clinical guidance, contemporary statin prescribing is sub-optimal and achievement of cholesterol targets falls short of accepted standards, for patients with atherosclerotic vascular disease who are at highest absolute risk and who stand to obtain greatest benefit. We hypothesised that a pharmacist-led complex intervention delivered to doctors and nurses in primary care, would improve statin prescribing and achievement of cholesterol targets for incident and prevalent patients with vascular disease, beyond one year.Methods
We allocated general practices to a 12-month Statin Outreach Support (SOS) intervention or usual care. SOS was delivered by one of 11 pharmacists who had received additional training. SOS comprised academic detailing and practical support to identify patients with vascular disease who were not prescribed a statin at optimal dose or did not have cholesterol at target, followed by individualised recommendations for changes to management. The primary outcome was the proportion of patients achieving cholesterol targets. Secondary outcomes were: the proportion of patients prescribed simvastatin 40 mg with target cholesterol achieved; cholesterol levels; prescribing of simvastatin 40 mg; prescribing of any statin and the proportion of patients with cholesterol tested. Outcomes were assessed after an average of 1.7 years (range 1.4–2.2 years), and practice level simvastatin 40 mg prescribing was assessed after 10 years.Findings
We randomised 31 practices (72 General Practitioners (GPs), 40 nurses). Prior to randomisation a subset of eligible patients were identified to characterise practices; 40% had cholesterol levels below the target threshold. Improvements in data collection procedures allowed identification of all eligible patients (n = 7586) at follow up. Patients in practices allocated to SOS were significantly more likely to have cholesterol at target (69.5% vs 63.5%; OR 1.11, CI 1.00–1.23; p = 0.043) as a result of improved simvastatin prescribing. Subgroup analysis showed the primary outcome was achieved by prevalent but not incident patients. Statistically significant improvements occurred in all secondary outcomes for prevalent patients and all but one secondary outcome (the proportion of patients with cholesterol tested) for incident patients. SOS practices prescribed more simvastatin 40 mg than usual care practices, up to 10 years later.Interpretation
Through a combination of educational and organisational support, a general practice based pharmacist led collaborative intervention can improve statin prescribing and achievement of cholesterol targets in a high-risk primary care based population.Trial Registration
International Standard Randomised Controlled Trials Register ISRCTN61233866 相似文献19.
Cornelia C. H. Wielders Anneroos W. Boerman Barbara Schimmer René van den Brom Daan W. Notermans Wim van der Hoek Peter M. Schneeberger 《PloS one》2015,10(1)