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1.
Pascale Rialland Simon Authier Martin Guillot Jér?me R. E. del Castillo Daphnée Veilleux-Lemieux Diane Frank Dominique Gauvin Eric Troncy 《PloS one》2012,7(11)
In the context of translational research, there is growing interest in studying surgical orthopedic pain management approaches that are common to humans and dogs. The validity of postoperative pain assessment methods is uncertain with regards to responsiveness and the potential interference of analgesia. The hypothesis was that video analysis (as a reference), electrodermal activity, and two subjective pain scales (VAS and 4A-VET) would detect different levels of pain intensity in dogs after a standardized trochleoplasty procedure. In this prospective, blinded, randomized study, postoperative pain was assessed in 25 healthy dogs during a 48-hour time frame (T). Pain was managed with placebo (Group 1, n = 10), preemptive and multimodal analgesia (Group 2, n = 5), or preemptive analgesia consisting in oral tramadol (Group 3, n = 10). Changes over time among groups were analyzed using generalized estimating equations. Multivariate regression tested the significance of relationships between pain scales and video analysis. Video analysis identified that one orthopedic behavior, namely ‘Walking with full weight bearing’ of the operated leg, decreased more in Group 1 at T24 (indicative of pain), whereas three behaviors indicative of sedation decreased in Group 2 at T24 (all p<0.004). Electrodermal activity was higher in Group 1 than in Groups 2 and 3 until T1 (p<0.0003). The VAS was not responsive. 4A-VET showed divergent results as its orthopedic component (4A-VETleg) detected lower pain in Group 2 until T12 (p<0.0009), but its interactive component (4A-VETbeh) was increased in Group 2 from T12 to T48 (p<0.001). Concurrent validity established that 4A-VETleg scores the painful orthopedic condition accurately and that pain assessment through 4A-VETbeh and VAS was severely biased by the sedative side-effect of the analgesics. Finally, the video analysis offered a concise template for assessment in dogs with acute orthopedic pain. However, subjective pain quantification methods and electrodermal activity need further investigation. 相似文献
2.
目的:探究股神经阻滞(femoral nerve block,FNB)和收肌管阻滞(adductor canal block,ACB)对全膝关节置换术(total knee arthroplasty,TKA)后下肢静脉血栓形成的影响。方法:将2019年3月-2019年4月拟在全身麻醉下行全膝关节置换术的40例患者随机分为FNB组和ACB组,所有患者均给予超声引导下单次注射,术后均给予标准化抗凝治疗。术后评估两组患者不同时间节点的疼痛评分、股四头肌肌力及术后下肢静脉血栓形成情况。结果:两组患者术后2、6、12、24、48、72 h患肢术区局部疼痛的VAS评分差异无统计学意义(P0.05)。ACB组患者术后2、6、12、24、48 h股四头肌肌力均明显高于FNB组(P0.05),术后72 h两组患者股四头肌肌力无明显差异(P0.05)。ACB组在术后患者首次直腿抬高时间(4.5±4.6)h,显著低于FNB组在术后患者首次直腿抬高时间(25.6±12.6)h,两组对比差异有统计学意义(P0.05)。术后72 h给予两组患者复查双下肢血管超声,复查结果显示,FNB组19例患者中共有2例出现下肢静脉血栓,均为肌间隙静脉血栓形成;ACB组20例患者中无患者出现下肢静脉血栓形成,差异无有统计学意义(P0.05)。结论:FNB与ACB在全膝关节置换术后镇痛方面无明显差异,但ACB组较好的保留患者术后早期股四头肌肌力,对于术后功能锻炼和快速康复有较积极的作用,两种神经阻滞方式对患者VTE风险的影响相同。 相似文献
3.
Objective
A retrospective analysis of early postoperative pain in the first and second knee in staged bilateral total knee arthroplasty (TKA) to provide a clinical evidence for the change of analgesic strategy.Methods
From January 2009 to January 2013, 87 cases which meet the inclusion criterion were retrospectively reviewed. In stage TKA, the postoperative pain in the first and second knee at 24h, 48h, 72h after operation were compared using the visual analogue scale (VAS) score in the rest and maximum knee flexion position. The difference in pain scores (ΔVAS) was also compared between the second and first knee at different time intervals (less than 6 months, 6-12 months, more than 12 months).Results
The VAS scores in the second knee were significantly higher than those in the first knee at 24h, 48h after surgery, but with no difference at 72h. The ΔVAS in the group of less than 6 months was significantly higher than of those more than 6 months, and there was no difference in ΔVAS between group of 6-12 months and group of more than 12 months.Conclusions
Patient receiving staged bilateral TKA experiences greater postoperative pain within 48h after operation in the second knee than in the first knee, which can provide a clinical evidence to enhance the analgesic strategy in the second operation of the staged bilateral TKA. And for the management of postoperative pain in staged bilateral TKA, it’s better to recommend that the interval between two operations should be more than 6 months, which may reduce the postoperative pain in the second knee, improve patient satisfaction, and speed up patient‘s rehabilitation process. 相似文献4.
Thomas M. Kessler Livio Mordasini Christian Weisstanner Peter Jüni Bruno R. da Costa Roland Wiest George N. Thalmann 《PloS one》2014,9(12)
Objective
To assess the efficacy and safety of sono-electro-magnetic therapy compared to placebo in men with refractory CPPS.Patients and Methods
In a randomized, placebo-controlled, double-blind single center trial, we assessed the effect of sono-electro-magnetic therapy in men with treatment refractory CPPS. Sixty male patients were randomly assigned to treatment with either sono-electro-magnetic (n = 30) or placebo therapy (n = 30) for 12 weeks. The primary outcome was a change in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) from baseline to 12 weeks.Results
The 12-week difference between sono-electro-magnetic and placebo therapy in changes of the NIH-CPSI total score was −3.1 points (95% CI −6.8 to 0.6, p = 0.11). In secondary comparisons of NIH-CPSI sub-scores, we found differences between groups most pronounced for the quality-of-life sub-score (difference at 12 weeks −1.6, 95% CI −2.8 to −0.4, p = 0.015). In stratified analyses, the benefit of sono-electro-magnetic therapy appeared more pronounced among patients who had a symptom duration of 12 months or less (difference in NIH-CPSI total score −8.3, 95% CI −14.5 to 2.6) than in patients with a longer symptom duration (−0.8, 95% CI −4.6 to 3.1; p for interaction = 0.023).Conclusions
Sono-electro-magnetic therapy did not result in a significant improvement of symptoms in the overall cohort of treatment refractory CPPS patients compared to placebo treatment. Subgroup analysis indicates, however, that patients with a symptom-duration of 12 months or less may benefit from sono-electro-magnetic therapy, warranting larger randomized controlled trials in this subpopulation.Trial Registration
ClinicalTrials.gov NCT00688506 相似文献5.
Véronique Morel Dominique Joly Christine Villatte Claude Dubray Xavier Durando Laurence Daulhac Catherine Coudert Delphine Roux Bruno Pereira Gisèle Pickering 《PloS one》2016,11(4)
BackgroundNeuropathic pain following surgical treatment for breast cancer with or without chemotherapy is a clinical burden and patients frequently report cognitive, emotional and quality of life impairment. A preclinical study recently showed that memantine administered before surgery may prevent neuropathic pain development and cognitive dysfunction. With a translational approach, a clinical trial has been carried out to evaluate whether memantine administered before and after mastectomy could prevent the development of neuropathic pain, the impairment of cognition and quality of life.MethodA randomized, pilot clinical trial included 40 women undergoing mastectomy in the Oncology Department, University Hospital, Clermont-Ferrand, France. Memantine (5 to 20 mg/day; n = 20) or placebo (n = 20) was administered for four weeks starting two weeks before surgery. The primary endpoint was pain intensity measured on a (0–10) numerical rating scale at three months post-mastectomy.ResultsData analyses were performed using mixed models and the tests were two-sided, with a type I error set at α = 0.05. Compared with placebo, patients receiving memantine showed at three months a significant difference in post-mastectomy pain intensity, less rescue analgesia and a better emotional state. An improvement of pain symptoms induced by cancer chemotherapy was also reported.ConclusionsThis study shows for the first time the beneficial effect of memantine to prevent post-mastectomy pain development and to diminish chemotherapy-induced pain symptoms. The lesser analgesic consumption and better well-being of patients for at least six months after treatment suggests that memantine could be an interesting therapeutic option to diminish the burden of breast cancer therapy.
Trial Registration
Clinicaltrials.gov NCT01536314 相似文献6.
Marrigje F. Meijer Alexander L. Boerboom Martin Stevens Sjoerd K. Bulstra Inge H. F. Reininga 《PloS one》2014,9(9)
Introduction
A new low-dose X-ray device, called EOS, has been introduced for determining lower-limb alignment in 2D and 3D. Reliability has not yet been assessed when using EOS on lower limbs containing a knee prosthesis. Therefore purpose of this study was to determine intraobserver and interobserver reliability of EOS 2D and 3D knee prosthesis alignment measurements after revision total knee arthroplasty (rTKA).Methods
Forty anteroposterior and lateral images of 37 rTKA patients were included. Two observers independently performed measurements on these images twice. Varus/valgus angles were measured in 2D (VV2D) and 3D (VV3D). Intraclass correlation coefficients and the Bland and Altman method were used to determine reliability. T-tests were used to test potential differences.Results
Intraobserver and interobserver reliability were excellent for VV2D and VV3D. No significant difference or bias between the first and second measurements or the two observers was found. A significant mean and absolute difference of respectively 1.00° and 1.61° existed between 2D and 3D measurements.Conclusions
EOS provides reliable varus/valgus measurements in 2D and 3D for the alignment of the knee joint with a knee prosthesis. However, significant differences exist between varus/valgus measurements in 2D and 3D. 相似文献7.
Background
Dezocine is considered to be an alternative medication for managing postoperative pain. The aim of this study was to assess the efficacy and safety of this drug in this regard.Methods
Medline, EMBASE and the Cochrane Central Register of Control Trials (CENTRAL) were searched to identify all randomized controlled trials (RCTs) that compare dezocine with placebo or dezocine with morphine on postoperative pain. The data were extracted and pooled using Mantel-Haenszel random effects model. Heterogeneity was tested using the I 2 statistic with values >50% and Chi2 test with P ≤ 0.05 indicating obvious heterogeneity between the studies.Results
Seven trials evaluating 665 patients were included. The number of patients with at least 50% pain relief was increased (N = 234; RR 3.04, 95% CI 2.27 to 4.08) and physician (N = 465; RR 2.84, 95% CI 1.66 to 4.84) and patient satisfaction (N = 390; RR 2.81, 95% CI 1.85 to 4.26) were improved following the administration of dezocine compared with the placebo. The effects of dezocine were similar to those of morphine in terms of the number of patients reporting at least 50% pain relief within 2–6 h after surgery (N = 235; RR 1.29, 95% CI 1.15 to 1.46) and physician (N = 234; RR 1.18, 95% CI 0.93 to 1.49) and patient (N = 158; RR 1.33, 95% CI 0.93 to 1.92) satisfaction. While, the number of patients with at least 50% pain relief within 0–1 h after surgery increased following dezocine compared with morphine treatment (N = 79; RR 1.45, 95% CI 1.18 to 1.77). There was no difference in the incidence of postoperative nausea and vomiting (PONV) following dezocine treatment compared with the placebo (N = 391; RR 1.06, 95% CI 0.42 to 2.68) or morphine treatment (N = 235; RR 0.65, 95% CI 0.14 to 2.93).Conclusion
Dezocine is a promising analgesic for preventing postoperative pain, but further studies are required to evaluate its safety. 相似文献8.
Joakim M. Bischoff Thomas K. Ringsted Marian Petersen Claudia Sommer Nurcan ü?eyler Mads U. Werner 《PloS one》2014,9(10)
Background
Persistent pain after inguinal herniorrhaphy is a disabling condition with a lack of evidence-based pharmacological treatment options. This randomized placebo-controlled trial investigated the efficacy of a capsaicin 8% cutaneous patch in the treatment of severe persistent inguinal postherniorrhaphy pain.Methods
Forty-six patients with persistent inguinal postherniorrhaphy pain were randomized to receive either a capsaicin 8% patch or a placebo patch. Pain intensity (Numerical Rating Scale [NRS 0–10]) was evaluated under standardized conditions (at rest, during movement, and during pressure) at baseline and at 1, 2 and 3 months after patch application. Skin punch biopsies for intraepidermal nerve fiber density (IENFD) measurements were taken at baseline and 1 month after patch application. Quantitative sensory testing was performed at baseline and at 1, 2, and 3 months after patch application. The primary outcome was comparisons of summed pain intensity differences (SPIDs) between capsaicin and placebo treatments at 1, 2 and 3 months after patch application (significance level P<0.01).Results
The maximum difference in SPID, between capsaicin and placebo treatments, was observed at 1 month after patch application, but the pain reduction was not significant (NRS, mean difference [95% CI]: 5.0 [0.09 to 9.9]; P = 0.046). No differences in SPID between treatments were observed at 2 and 3 months after patch application. Changes in IENFD on the pain side, from baseline to 1 month after patch application, did not differ between capsaicin and placebo treatment: 1.9 [−0.1 to 3.9] and 0.6 [−1.2 to 2.5] fibers/mm, respectively (P = 0.32). No significant changes in sensory function, sleep quality or psychological factors were associated with capsaicin patch treatment.Conclusions
The study did not demonstrate significant differences in pain relief between capsaicin and placebo treatment, although a trend toward pain improvement in capsaicin treated patients was observed 1 month after patch application.Trial Registration
Clinicaltrialsregister.eu 2012-001540-22 ClinicalTrials.gov NCT01699854 相似文献9.
ObjectiveSeveral studies investigated the association between bisphosphonate use and the risk of implant revision after total hip or knee arthroplasty (THA or TKA); However, the findings were inconsistent. We performed this meta-analysis to evaluate the overall relative risk of such an event.MethodsWe searched the PubMed, EMBASE and Cochrane library databases to identify relevant publications on April 22, 2015. To calculate the pooled risk ratios (RRs) with 95% confidential intervals (CIs), a fixed- or random-effects model was applied based on the heterogeneity across studies.ResultsThree cohort studies and one case-control study were included in this meta-analysis. Compared with the bisphosphonate nonusers, the patients who used bisphosphonates for a long period of time had a significantly decreased risk of implant revision after THA/TKA (summary adjusted RR = 0.48, 95% CI: 0.38–0.61), and the summary adjusted RRs for the users who underwent THA and those who underwent TKA were 0.47 (95% CI: 0.36–0.61) and 0.45 (95% CI: 0.21–0.95), respectively.ConclusionsLong-term use of bisphosphonates is correlated with a significantly decreased risk of implant revision after THA/TKA. However, due to limited number of the included studies, the findings of the present study should be treated with caution. More well-designed studies are required to further confirm our findings. 相似文献
10.
Pascal H. Vuilleumier Marie Besson Jules Desmeules Lars Arendt-Nielsen Michele Curatolo 《PloS one》2013,8(3)
Background and Aims
Compounds that act on GABA-receptors produce anti-hyperalgesia in animal models, but little is known on their effects in humans. The aim of this study was to explore the potential usefulness of GABA-agonism for the control of pain in humans. Two agonists at the benzodiazepine-binding site of GABAA-receptors (clobazam and clonazepam) were studied using multiple experimental pain tests. Positive results would support further investigation of GABA agonism for the control of clinical pain.Methods
In a randomized double-blind crossover design, 16 healthy male volunteers received clobazam 20 mg, clonazepam 1 mg and tolterodine 1 mg (active placebo). The area of static hyperalgesia after intradermal capsaicin injection was the primary endpoint. Secondary endpoints were: area of dynamic hyperalgesia, response to von Frey hair stimulation, pressure pain thresholds, conditioned pain modulation, cutaneous and intramuscular electrical pain thresholds (1, 5 and 20 repeated stimulation), and pain during cuff algometry.Results
For the primary endpoint, an increase in the area of static hyperalgesia was observed after administration of placebo (p<0.001), but not after clobazam and clonazepam. Results suggestive for an anti-hyperalgesic effect of the benzodiazepines were obtained with all three intramuscular pain models and with cuff algometry. No effect could be detected with the other pain models employed.Conclusions
Collectively, the results are suggestive for a possible anti-hyperalgesic effect of drugs acting at the GABAA-receptors in humans, particularly in models of secondary hyperalgesia and deep pain. The findings are not conclusive, but support further clinical research on pain modulation by GABAergic drugs. Because of the partial results, future research should focus on compounds acting selectively on subunits of the GABA complex, which may allow the achievement of higher receptor occupancy than unselective drugs. Our data also provide information on the most suitable experimental models for future investigation of GABAergic compounds.Trial Registration
ClinicalTrials.gov NCT01011036 相似文献11.
Background
To assess the association of diabetes with postoperative limitation of activities of daily living (ADLs) after primary total knee arthroplasty (TKA).Methodology/Principal Findings
We used the prospectively collected data from the Mayo Clinic Total Joint Registry to assess the association of diabetes and diabetes with complications with moderate-severe ADL limitation 2- and 5-years after primary TKA. Multivariable logistic regression with general estimating equations adjusted for preoperative ADL limitation, comorbidity and demographic and clinical covariates. Odds ratio (OR) and 95% confidence interval (CI) are presented. 7,139 primary TKAs at 2-years and 4,234 at 5-years constituted the cohorts. In multivariable-adjusted analyses, diabetes was associated with higher odds of moderate-severe limitation at 2- and 5-years, 1.71 (95% CI: 1.26, 2.32; P = 0.001) and 1.66 (95% CI: 1.13, 2.46; P = 0.01). Respective ORs for patients with diabetes with complications were 2.73 (95% CI: 1.47, 5.07; P = 0.001) and 2.73 (95% CI: 1.21, 6.15; P = 0.016). Sensitivity analyses that adjusted for anxiety and depression or anxiety, depression and ipsilateral hip involvement showed minimal attenuation of magnitude of the association.Conclusions/Significance
In this large study of patients who underwent primary TKA, diabetes as well as its severity were independently associated with poorer functional outcome. Given the increasing rates of both diabetes as well as arthroplasty, more insight is needed into disease-related and treatment-related factors that underlie this higher risk of ADL limitation in patients with diabetes. Poor functional outcomes may be preventable by modifying the control of diabetes and associated comorbidity in pre- and post-arthroplasty periods. 相似文献12.
13.
Background
Total hip or knee arthroplasty is an elective procedure that is usually accompanied by substantial blood loss, which may lead to acute anemia. As a result, almost half of total joint arthroplasty patients receive allogeneic blood transfusions (ABT). Many studies have shown that post-operative auto-transfusion (PAT) significantly reduces the need for ABT, but other studies have questioned the efficacy of this method.Methods
The protocol for this trial and supporting CONSORT checklist are available as supporting information; see Checklist S1. To evaluate the efficacy of PAT, we conducted a Cochrane systematic review that combined all available data from randomized controlled trials. Data from the six included trials were pooled for analysis. We then calculated relative risks with 95% confidence intervals (CIs) for dichotomous outcomes and mean differences with 95% CIs for continuous outcomes.Findings and Conclusion
To our knowledge, this is the first meta-analysis to compare the clinical results between PAT and a control in joint replacement patients. This meta-analysis has proven that the use of a PAT reinfusion system reduced significantly the demand for ABT, the number of patients who require ABT and the cost of hospitalization after total knee and hip arthroplasty. This study, together with other previously published data, suggests that PAT drains are beneficial. Larger, sufficiently powered studies are necessary to evaluate the presumed reduction in the incidence of infection as well as DVT after joint arthroplasty with the use of PAT. 相似文献14.
15.
Akira Kogure Kazuhiko Kotani Shigehiko Katada Hiroshi Takagi Masahiro Kamikozuru Takashi Isaji Setsuo Hakata 《PloS one》2015,10(12)
Study design
cized, single-blind, controlled trial.Objective
To investigate the efficacy of the Arthrokinematic approach (AKA)-Hakata (H) method for chronic low back pain.Summary of Background Data
The AKA-H method is used to manually treat abnormalities of intra-articular movement.Methods
One hundred eighty-six patients with chronic nonspecific low back pain randomly received either the AKA-H method (AKA-H group) or the sham technique (S group) monthly for 6 months. Data were collected at baseline and once a month. Outcome measures were pain intensity (visual analogue scale [VAS]) and quality of life (the Roland-Morris Disability Questionnaire [RDQ] and Short Form SF-36 questionnaire [SF-36]).Results
At baseline, the VAS, RDQ, and SF-36 scores showed similar levels between the groups. After 6 months, the AKA-H group had more improvement in the VAS (42.8% improvement) and RDQ score (31.1% improvement) than the sham group (VAS: 10.4% improvement; RDQ: 9.8% improvement; both, P < 0.001). The respective scores for the SF-36 subscales (physical functioning, role physical, bodily pain, social functioning, general health perception, role emotional, and mental health) were also significantly more improved in the AKA-H group than in the sham group (all, P < 0.001). The scores for the physical, psychological, and social aspects of the SF-36 subscales showed similar improvement in the AKA-H group.Conclusion
The AKA-H method can be effective in managing chronic low back pain.Trial Registration
UMIN Clinical Trials Registry (UMIN-CTR) UMIN000006250. 相似文献16.
目的:比较连续股神经阻滞(continuous femoral nerve block,CFNB)联合关节周围注射和单纯连续股神经阻滞对全膝关节置换(TKA)术后疼痛及早期功能康复的影响.方法:将2012年1月～2012年9月于我院初次行单侧全膝关节置换的40例患者随机分为CFNB联合关节周围注射组(n=20例)和CFNB治疗组(n=20例).观察和比较两组患者术后疼痛评分、CPM度数、被动屈伸活动度、围术期CRP水平及术后下肢深静脉血栓形成情况.结果:术后8h、12h,CFNB联合关节周围注射组的疼痛评分分别为2.45±0.2562和2.40±0.3026,明显低于CFNB组(5.25±0.3470和4.90±0.3692),差异均有统计学意义(P＜0.05);术后第2、3天,CFNB联合关节周围注射组的CPM锻炼度数(72.75± 2.750、89.00±2.283)分别明显高于CFNB组(57.95±1.724、79.00± 2.194),差异均有统计学意义(P＜0.05);两组患者术后膝关节被动活动度比较无统计学差异;CFNB联合关节周围注射组术后患者血清CRP水平低于CFNB组,均在术后第3天达到峰值,但组间比较均无统计学差异(P＞0.05);两组患者术后双下肢深静脉血栓形成情况比较无统计学差异.结论:连续股神经阻滞联合关节周围注射较单纯连续股神经阻滞可更加有效降低全膝关节置换术患者术后的疼痛评分,并促进早期功能康复. 相似文献
17.
Toshio Watanabe Toshihisa Takeuchi Osamu Handa Yasuhisa Sakata Tetsuya Tanigawa Masatsugu Shiba Yuji Naito Kazuhide Higuchi Kazuma Fujimoto Toshikazu Yoshikawa Tetsuo Arakawa 《PloS one》2015,10(4)
Background
Low-dose aspirin (LDA) frequently causes small bowel injury. While some drugs have been reported to be effective in treating LDA-induced small intestinal damage, most studies did not exclude patients with mild damage thought to be clinically insignificant.Aim
We conducted a multicenter, randomized, double-blind, placebo-controlled trial to assess the efficacy of a high dose of rebamipide, a gastroprotective drug, for LDA-induced moderate-to-severe enteropathy.Methods
We enrolled patients who received 100 mg of enteric-coated aspirin daily for more than 3 months and were found to have more than 3 mucosal breaks (i.e., erosions or ulcers) in the small intestine by capsule endoscopy. Eligible patients were assigned to receive either rebamipide 300 mg (triple dose) 3 times daily or placebo for 8 weeks in a 2:1 ratio. Capsule endoscopy was then repeated. The primary endpoint was the change in the number of mucosal breaks from baseline to 8 weeks. Secondary endpoints included the complete healing of mucosal breaks at 8 weeks and the change in Lewis score (an endoscopic score assessing damage severity) from baseline to 8 weeks.Results
The study was completed by 38 patients (rebamipide group: n = 25, placebo group: n = 13). After 8 weeks of treatment, rebamipide, but not placebo, significantly decreased the number of mucosal breaks (p = 0.046). While the difference was not significant (p = 0.13), the rate of complete mucosal break healing in the rebamipide group (32%, 8 of 25) tended to be higher than that in the placebo group (7.7%, 1 of 13). Rebamipide treatment significantly improved intestinal damage severity as assessed by the Lewis score (p = 0.02), whereas placebo did not. The triple dose of rebamipide was well tolerated.Conclusions
High-dose rebamipide is effective for the treatment of LDA-induced moderate-to-severe enteropathy.Trial Registration
UMIN Clinical Trials Registry UMIN000003463 相似文献18.
Nynke R. van den Broek Sarah A. White Mark Goodall Chikondi Ntonya Edith Kayira George Kafulafula James P. Neilson 《PLoS medicine》2009,6(12)
Background
Premature birth is the major cause of perinatal mortality and morbidity in both high- and low-income countries. The causes of preterm labour are multiple but infection is important. We have previously described an unusually high incidence of preterm birth (20%) in an ultrasound-dated, rural, pregnant population in Southern Malawi with high burdens of infective morbidity. We have now studied the impact of routine prophylaxis with azithromycin as directly observed, single-dose therapy at two gestational windows to try to decrease the incidence of preterm birth.Methods and Findings
We randomized 2,297 pregnant women attending three rural and one peri-urban health centres in Southern Malawi to a placebo-controlled trial of oral azithromycin (1 g) given at 16–24 and 28–32 wk gestation. Gestational age was determined by ultrasound before 24 wk. Women and their infants were followed up until 6 wk post delivery. The primary outcome was incidence of preterm delivery, defined as <37 wk. Secondary outcomes were mean gestational age at delivery, perinatal mortality, birthweight, maternal malaria, and anaemia. Analysis was by intention to treat. There were no significant differences in outcome between the azithromycin group (n = 1,096) and the placebo group (n = 1,087) in respect of preterm birth (16.8% versus 17.4%), odds ratio (OR) 0.96, 95% confidence interval (0.76–1.21); mean gestational age at delivery (38.5 versus 38.4 weeks), mean difference 0.16 (−0.08 to 0.40); mean birthweight (3.03 versus 2.99 kg), mean difference 0.04 (−0.005 to 0.08); perinatal deaths (4.3% versus 5.0%), OR 0.85 (0.53–1.38); or maternal malarial parasitaemia (11.5% versus 10.1%), OR 1.11 (0.84–1.49) and anaemia (44.1% versus 41.3%) at 28–32 weeks, OR 1.07 (0.88–1.30). Meta-analysis of the primary outcome results with seven other studies of routine antibiotic prophylaxis in pregnancy (>6,200 pregnancies) shows no effect on preterm birth (relative risk 1.02, 95% confidence interval 0.86–1.22).Conclusions
This study provides no support for the use of antibiotics as routine prophylaxis to prevent preterm birth in high risk populations; prevention of preterm birth requires alternative strategies.Trial registration
Current Controlled Trials ISRCTN84023116 Please see later in the article for the Editors'' Summary 相似文献19.
Objective
Minimally invasive midvastus approach (mini-midvastus) has been widely used in total knee arthroplasty (TKA). However, the clinical effects still remains controversial. This meta-analysis was based on randomized controlled trials (RCTs) aiming to quantitatively analyze the clinical efficacy of mini-midvastus versus standard parapatellar approach in TKA.Methods
This meta-analysis was performed according to the PRISMA guidelines. A literature search for the eligible RCTs was carried out in the databases of PubMed, the Cochrane library, EMBASE and Web of Science. Two independent reviewers independently completed the study selection, data extraction, and the assessment of methodological quality. Meta-analysis was conducted by the RevMan 5.2 software.Results
A total of 18 RCTs (937 patients with 1093 TKAs) published from 2007 to 2013 were included. The meta-analysis suggested that the mini-midvastus approach significantly improved knee range of motion (ROM) and decreased visual analog score (VAS) at postoperative 1–2 weeks (p<0.05), and there were no statistical differences in terms of knee society score (KSS) (6 weeks to 1 year), VAS (6 weeks to 6 months), ROM (6 weeks to 6 months), lateral retinacular release, blood loss, straight leg raise, hospital stay and postoperative complications between the mini-midvastus and standard parapatellar approach (p>0.05). However, the operative time was significantly longer when performing the mini-midvastus group than the parapartellar approach (p<0.05).Conclusion
This meta-analysis found that compared with the standard parapatellar approach, the mini-midvastus approach had early advantages in the VAS and ROM, but had the disadvantage in the operative time.Level of Evidence
Therapeutic study Level I. 相似文献20.
Emma del Carmen Macías-Cortés Lidia Llanes-González Leopoldo Aguilar-Faisal Juan Asbun-Bojalil 《PloS one》2015,10(3)