醋酸氯芬酸与双氯芬酸的胃肠道安全性和耐受性比较:膝骨关节炎患者的多中心、随机、双盲研究。

文章的细节

引用

复制到剪贴板

Pareek A, Chandurkar N

醋酸氯芬酸与双氯芬酸的胃肠道安全性和耐受性比较:膝骨关节炎患者的多中心、随机、双盲研究。

《当代医学与医学评论》2013年7月29(7):849-59。doi: 10.1185 / 03007995.2013.795139。Epub 2013年4月30日。

PubMed ID

23581533 (在PubMed

］

摘要

目的:比较醋酸氯芬酸与双氯芬酸治疗膝骨关节炎(OA)患者的胃肠道耐受性和疗效。方法:在这项随机、双盲、双假、多中心、比较研究中，7天安慰剂洗脱后，患者被随机分配接受乙酰氯芬酸100 mg b.i.d.或双氯芬酸50 mg t.i.d.，并随访6周。GI耐受性的评估基于预定义GI不良事件(AEs)的发生率和严重程度、患者服用胃保护药物(gpa)的数量以及因GI不良事件而退出研究。次要结果包括使用视觉模拟评分(VAS)评估疼痛强度、安大略西部和麦克马斯特大学(WOMAC)评分、疼痛缓解评分以及研究人员和患者对研究药物反应的总体评估。结果:共591例(醋酸氯芬酸组:297例;双氯芬酸组:294例)。消化不良GI ae的累积发生率(28.1% vs . 37.9%;P = 0.014)、腹痛(19% vs . 26.3%;p = 0.037)，预定义GI不良事件的总发生率(57.3% vs . 73.6%;p < 0.001)和报告胃肠道不良事件的患者数量(28.9% vs 36.5%; p = 0.053) were significantly less in the aceclofenac group compared to the diclofenac group throughout the study. All the AEs were mild to moderate in intensity. Fewer patients from the aceclofenac group required GPAs compared to the diclofenac group (28.17% versus 33.68%; p = 0.155). During first 7 days of therapy, >90% of patients from aceclofenac group did not require GPAs. There were no differences between the study groups in the various pain assessment scales when measured during the study period. CONCLUSION: Aceclofenac was better tolerated in terms of incidence and severity of GI AEs and GPA requirement and was as efficacious as diclofenac. The need for GPAs increased with the increase in duration of treatment with NSAIDs. Hence, it could be concluded that usual practice of co-prescription of GPAs with aceclofenac could be avoided to improve patient compliance and reduce cost of treatment. However, long term trials with endoscopic evaluation in the wider population are required to assess the GI tolerability of aceclofenac and diclofenac in detail.

引用本文的药库数据

药物

Aceclofenac