中药治疗膝骨关节炎临床疗效和安全性的系统评价  

Systematic review on the clinical curative effects and safety of traditional chinese medicine in the treatment of knee osteoarthritis

作　　者：唐萌芽 翁祝承 邵利芳 

机构地区：[1]浙江省富阳市中医骨伤医院,浙江富阳311400

出　　处：《中医正骨》2014年第1期43-48,共6页The Journal of Traditional Chinese Orthopedics and Traumatology

摘　　要：目的:系统评价中药治疗膝骨关节炎的临床疗效和安全性。方法:运用计算机检索中国知网、万方数据库、维普数据库2000年1月至2012年9月收录的国内公开发表的中药治疗膝骨关节炎的临床研究文献,并进行Meta分析。结果:共检索出590篇相关文献,通过筛选最终有32篇文献纳入研究,涉及2 950例患者。纳入文献Jadad评分普遍不高,最高分为2分;32篇文献均说明了基线资料具有可比性;3篇文献采用随机数字表进行分组,3篇文献按就诊顺序随机分组,其余各篇随机方法未说明;各篇均未描述随机分配方案的隐藏方法;1篇文献采用单盲,1篇文献采用双盲,其余各篇均未描述盲法;各篇均未描述病例失访或退出情况。对32篇文献进行合并分析显示,治疗组和对照组的有效率分别为64.01%和43.96%,治疗组的临床疗效优于对照组(Z=6.850,P=0.000),比数比=2.35,95%可信区间为1.84~3.01。20篇文献提及对用药安全性的观察,其中15篇文献记录了患者用药后不良反应发生情况。治疗组不良反应发生率低于对照组(Z=8.870,P=0.000),比数比=0.14,95%可信区间为0.09~0.21。纳入疗效分析的32篇文献及纳入安全性评价的15篇文献的漏斗图均呈倒漏斗形,图形两侧分布均匀,提示纳入文献发表性偏倚不明显。结论:中药治疗膝骨关节炎疗效优于非甾类消炎药,且不良反应较少。但由于纳入的文献在方法学上存在问题,Meta分析得出的结论有一定的局限性,中药治疗膝骨关节炎的疗效和安全性还需要大样本、多中心、随机双盲的临床对照试验来进一步验证。Objective ： To review systematically the clinical curative effects and safety of traditional chinese medicine in the treatment of knee osteoarthritis（KOA）. Methods：All the clinical research articles about traditional Chinese medicine for KOA included from January 2000 to September 2012 were retrieved from China national knowledge internet, Wanfang Database and Vip Database through computer, and then a recta-analysis was conducted. Results：Search terms yielded 590 articles and 32 articles （2 950 patients）were included in the final analysis. The Jadad scores of included articles were not high in general, and the highest score was two points. Comparable baseline data were demonstrated in all of the 32 articles. The random digits table was used for grouping in three articles, and randomization was performed ac- cording to the visit sequence in 3 articles, and the method of randomization was not mentioned in the other article. The hiding method for randomization was not described in all of the articles. Single blind was used in one article, double-blind was used in another article, and the blind method were not mentioned in other articles. The cases lost to follow-up and the cases dropped out of the study were not described in each article. Data from 32 articles were pooled and analyzed, and the resuhs showed that the effective rate of treatment group and control group were 64.01 v/o and 43.96% respectively, and the treatment group surpassed the control group in clinical curative effect（ Z = 6. 850, P = 0. 000;odd ratio,2.35 ;95% Confidence Interval 1.84 to 3.01 ）. Observztions on the safety of medication were mentioned in 20 arti- cles, 15 of which recorded the adverse drug reaction. The incidence rate of adverse reaction of treatment group was lower than that of control group（ Z = 8. 870 ,P = 0. 000;odd ratio 0.14;95% Confidence Interval 0.09 to 0.21 ）. Funnel plots were inverted and symmetrical in 32 articles which involved the curative effect analysis and in 15 articles which involved the saf

关 键 词：骨关节炎 膝 中草药 消炎药 非甾类 Meta分析 

分 类 号：R274.9[医药卫生—中西医结合]