中药治疗干燥综合征随机对照试验的系统评价和meta分析

背景：中药被广泛地应用于干燥综合征的治疗,但对其疗效和安全性尚缺乏系统的评价。目的：评价中药治疗干燥综合征的有效性和安全性。检索策略：检索电子数据库PubMed、Cochrane图书馆（2010年第3期）、中国知网数据库、重庆维普中文科技期刊数据库、中国生物医学文献数据库网络版、万方数据和中国中医药期刊文献数据库。所有数据库检索时间从建库截止至2010年10月15日。纳入标准：纳入比较中药与西药或安慰剂治疗干燥综合征的随机对照试验。对于中药联用西药与单纯使用西药比较的随机对照试验也予以纳入。资料提取与分析：由两名系统评价员独立提取资料,采用Cochrane协作网的质量评价标准进行文献质量评价。采用RevMan5.0.17软件进行meta分析,检验异质性,并根据异质性结果选择相应的效应模型。结局的效应指标为相对危险度（risk ratio,RR）或均数差,均以95%可信区间（confidence interval,CI）表示。结果：共计纳入52项随机对照试验,涉及3886例干燥综合征患者。所纳入的文献质量普遍偏低。在临床症状总体改善方面,中药与西药对比（RR：1.36;95%CI：1.24~1.49）、中药联合西药与单纯使用西药对比（RR：1.38;95%CI：1.30~1.46）,试验组疗效优于对照组,差异有统计学意义;在泪腺功能改善方面,中药与西药对比（RR：2.12;95%CI：1.06~3.18）、中药联合西药与单纯使用西药对比（RR：1.90;95%CI：0.99~2.81）,试验组疗效优于对照组;在实验室指标检测方面,中药改善血沉的疗效优于对照组（中药与西药对比RR：-9.63;95%CI：-15.73~-3.52。中药联合西药与单纯使用西药对比RR：-8.42;95%CI：-14.71~-2.13）;其他指标（C反应蛋白、类风湿因子、IgG、IgA、IgM）的改善,两组未见显著差异。中药组的不良反应主要表现为腹泻等胃肠道症状,但西药对照组的不良反应高于中药组。结论：中药治疗干燥综合征具有改善症状的疗效。但由于纳入研究的质量不高,仍需要多中心、大样本及双盲的随机对照试验加以验证。

Systematic review and meta-analysis of randomized controlled trials of Chinese herbal medicine in the treatment of Sj(o)gren's syndrome

Background：Chinese herbal medicine（CHM）has been widely used in the treatment of Sjgren＇s syndrome.However,there remains no systematic review to assess the effectiveness and safety of CHM.Objective：To assess the effectiveness and safety of CHM in the treatment of Sjgren＇s syndrome.Search strategy：Literature was searched from PubMed,the Cochrane Library（Issue 3,2010）,the China National Knowledge Infrastructure Database,the Chongqing VIP Chinese Science and Technology Periodical Database,the Chinese Biomedical Literature Database（SinoMed）,Wanfang Data and the Traditional Chinese Medical Periodical Literature Database.The time limitation ran from the commencement of each database to October 15,2010.Inclusion criteria：Randomized controlled trials（RCTs）testing CHM alone or in combination with Western medicine（WM）against WM or placebo used alone were included.Data extraction and analysis：Two authors collected data independently.The assessment of methodological quality was based on the Cochrane handbook and the data were analyzed by using RevMan 5.0.17 software.Heterogeneity of the included studies was tested and use of statistical model was based on the heterogeneity.The efficacy measure was relative risk（RR）or mean difference with a 95% confidence interval（CI）.Results：A total of 52 RCTs involving 3 886 patients were included.The included trials were all of low quality.CHM was superior in improving clinical symptoms to WM,with statistical significance between the groups（RR：1.36;95% CI：1.24-1.49）;CHM plus WM was better than WM used alone（RR：1.38;95% CI：1.30-1.46）.CHM improved lacrimal gland function more effectively than WM,with statistical significance between the groups（RR：2.12;95% CI：1.06-3.18）;CHM plus WM was better than WM used alone（RR：1.90;95% CI：0.99-2.81）.CHM was superior to WM in the improvement of erythrocyte sedimentation rate（RR：-9.63;95% CI：-15.73--3.52）,and CHM plus WM was also more effective than WM used alone（RR：-8.42;95% CI：-14.71--2.13）.However,there was no statistical difference between groups in other immune index（C-reactive protein,rheumatoid factor,IgG,IgA and IgM）.The reported adverse effects of CHM were mainly gastrointestinal symptoms,such as diarrhea.The incidence of adverse effects of WM was higher than that of CHM.Conclusion：CHM appears to improve the symptoms of Sjgren＇s syndrome.However,due to the low quality of included studies,further well-designed multicenter and large-scale RCTs are still needed to evaluate the beneficial effects of CHM.