Patel Parvati B, Patel Tejas K
Department of Pharmacology, GMERS Medical College, Gotri, Gujarat, India.
Eur J Rheumatol. 2017 Mar;4(1):11-18. doi: 10.5152/eurjrheum.2017.160080. Epub 2017 Mar 1.
To analyze the effects on pain, function, and safety of aceclofenac compared with other nonsteroidal anti-inflammatory drugs (NSAIDs) or pain relief medications in patients with osteoarthritis.
Two investigators independently searched the database. We included randomized controlled trials evaluating efficacy and/or safety of aceclofenac compared with control interventions (NSAIDs or acetaminophen) in patients with osteoarthritis. We did not include placebo, opioid analgesics, NSAID combinations, and topical analgesics for the control groups. We summarized the efficacy data as standardized mean differences (SMD) with 95% confidence intervals (CI) and safety outcomes as risk ratios (RR) with 95% CI using the inverse variance random effect model. We assessed the heterogeneity by the I test. We used the GRADE approach to evaluate the quality of the evidence for all outcome parameters.
We included 9 trials (8 double blind and 1 single blind) that evaluated pain (7 trials), function (8 trials) and safety (7 trials). We observed no significant difference in pain reduction between aceclofenac and control interventions [SMD: -0.30 (-0.62, 0.01); I=88%; GRADE evidence- low]. Aceclofenac was more beneficial than control interventions in improving physical function [SMD: -0.27 (-0.50, -0.03); I=88%; GRADE evidence- low]. We observed less gastrointestinal adverse events for aceclofenac than in control interventions [RR 0.69 (95% CI: 0.57, 0.83); I=12%; GRADE evidence- moderate]. We observed no difference in overall adverse events occurrence and dropout rate between aceclofenac and control interventions.
We observed that aceclofenac was beneficial over control analgesics for function improvement and to minimize gastrointestinal adverse events. Our findings could be biased due to the heterogeneity of the sample, the fact that the trials were small and methodological issues.
分析与其他非甾体抗炎药（NSAIDs）或止痛药物相比，醋氯芬酸对骨关节炎患者疼痛、功能及安全性的影响。
两名研究者独立检索数据库。我们纳入了评估醋氯芬酸与对照干预措施（NSAIDs或对乙酰氨基酚）相比，在骨关节炎患者中的疗效和/或安全性的随机对照试验。对照组未纳入安慰剂、阿片类镇痛药、NSAIDs联合用药及局部用镇痛药。我们使用逆方差随机效应模型将疗效数据汇总为标准化均数差（SMD）及95%置信区间（CI），将安全性结果汇总为风险比（RR）及95%CI。我们通过I²检验评估异质性。我们采用GRADE方法评估所有结局参数的证据质量。
我们纳入了9项试验（8项双盲试验和1项单盲试验），这些试验评估了疼痛（7项试验）、功能（8项试验）和安全性（7项试验）。我们观察到醋氯芬酸与对照干预措施在减轻疼痛方面无显著差异[SMD：-0.30（-0.62，0.01）；I² = 88%；GRADE证据等级 - 低]。在改善身体功能方面，醋氯芬酸比对照干预措施更有益[SMD：-0.27（-0.50，-0.03）；I² = 88%；GRADE证据等级 - 低]。我们观察到醋氯芬酸组的胃肠道不良事件少于对照干预措施组[RR 0.69（95%CI：0.57，0.83）；I² = 12%；GRADE证据等级 - 中等]。我们观察到醋氯芬酸与对照干预措施在总体不良事件发生率和退出率方面无差异。
我们观察到，与对照镇痛药相比，醋氯芬酸在改善功能和减少胃肠道不良事件方面有益。由于样本的异质性、试验规模较小以及方法学问题，我们的研究结果可能存在偏差。
