中药外治与西药治疗膝骨关节炎疗效及安全性Meta分析

目的:系统评价中药外治法治疗膝骨性关节炎的有效性与安全性.方法:计算机检索MEDLINE,CNKI及维普数据库(各数据库检索时间范围均从创库到2011年5月).收集所有以西药为对照的中药外治法治疗膝骨性关节炎的随机对照试验,筛选出符合纳入标准的文献,对其进行严格的质量评价,利用RevMan 5.1软件对纳入研究结果进行Meta分析.结果:共纳入25篇RCT,共2 159例(中药组共1 152例,阳性对照组共1 007例).共21篇文献纳入疗效分析,结果显示,中药组与西药组有效率分别为92.35％ (941/1 019),81.19％ (712/877),OR =2.882.16 ～3.83],对总效应假设检验结果Z=7.20(P＜0.000 01).中药外治法疗效优于西药对照组,共25篇文献纳入不良事件分析,不良事件发生率中药组为1.30％(15/1 152)、西药组为5.36％(54/1 007),OR =0.400.11～1.38],Z=1.46(P =0.15).中药外用与西药不良事件发生率无显著性差异.亚组分析显示:与外用西药相比,2组不良事件发生率相似1.87％(11/589)∶ 1.60％ (9/564)],Z=0.26 (P=0.80).而对于NSAIDS和COX-2抑制剂口服止痛药,中药组不良事件发生率较低1.07％ (4/375)∶15.46％ (45/291)],OR =0.110.01,0.87],Z=2.09 (P =0.04).结论:中药外治治疗膝骨性关节炎近期疗效优于西药,中药外治法的药物不良事件发生率与外用西药相当,而显著低于口服西药.但由于纳入的文献质量不高,仅以本研究Meta分析为基础,目前尚不能得出中药治疗膝关节骨性关节炎疗效的最终结论,有待于高质量临床研究的结果来证实.

Meta-analysis on efficacy and safety of external use of tradition Chinese medicines and western medicines in treating knee osteoarthritis

Objective: To assess the efficacy and safety of the external use of tradition Chinese medicine (TCM) in treating knee osteoarthritis. Method: By computer retrieval of MEDLINE,CNKI and VIP database on data from the establishment of database to May 2011,all of the randomized controlled trials on the external use of TCMs in treating knee osteoarthritis with western medicines as the control drugs were collected to screen out literatures in line with the inclusion standards. The quality of the included literatures was strictly assessed,and a meta-analysis was conducted by RevMan 5.1 software. Result: Totally 25 RCTs involving 2 159 patients were included 1 152 patients in the TCM group (TCMG),1007 patients in the western medicine group (WMG)],in which 21 articles were brought into the analysis on efficacy. The results of meta-analyses showed that the efficient rates of the TCMG and the WMG were 92.35% (941/1019) and 81.19% (712/877),respectively,OR=2.882.16-3.83],with a hypothesis testing on total effect of Z=7.20 (P< 0.000 01)], suggesting that the external use of TCMs had a better efficacy than the WMG. A total of 25 literatures were brought into the analysis on adverse effect. The adverse Effects Rate of the TCMG and the WMG were 1.30% (15/1 152) and 5.36% (54/1 007),respectively,OR=0.400.11-1.38],Z=1.46(P=0.15)],indicating no significant difference between them. The sub group analysis shows that compared with the external use of western medicines,the adverse effect rate of the two groups are similar,OR=1.120.48-2.58],Z=0.26 (P=0.80). But as for inhibitors NSAIDS and COX-2 for oral,the adverse effect rate of the TCMG was lower than that of the WMG (1.07% (4/375): 15.46% (45/291)],OR=0.11 0.01-0.87],Z=2.09 (P=0.04). Conclusion: The efficacy of the external use of TCMs in treating OA is better than that of western medicines. The adverse effect rates of the external use of TCMs is equivalent to that of western medicines,and significantly lower than that of oral western medicines. But because of the poor quality of the included literatures,the final conclusion for the efficacy of TCMs in treating knee osteoarthritis could not be reached only based on this Meta-analysis and remain to be proved with the results of high-quality clinical studies.