中药联合硫酸羟氯喹治疗干燥综合征疗效和安全性的Meta分析

Meta analysis of efficacy and safety of traditional Chinese medicine combined with hydroxychloroquine sulfate in the treatment of Sjogren's syndrome

目的:系统评价中药联合硫酸羟氯喹(HCQ)治疗干燥综合征(Sjögren'ssyndrome,SS)的疗效与安全性。方法:2名研究者通过计算机检索知网、万方、维普、中国生物医学文献数据库、PubMed、Webof Science和TheCochraneLibrary数据库(检索年限为建库至2020年10月份)并独立筛选文献,提取资料进行偏倚风险评估后,使用RevMan 5.3软件进行Meta分析。结果:共纳入19篇文献,涉及1185例患者,其中治疗组617例,对照组568例。合并数据分析显示:中药联合硫酸羟氯喹治疗干燥综合征的总有效率较单用硫酸羟氯喹更高[RR=1.34,95%CI(1.24,1.44),P<0.00001],在改善唾液腺[SMD=0.66,95%CI(0.47,0.85),P<0.00001]、泪液分泌功能[MD=2.56,95%CI(1.29,3.83),P<0.0001]以及降低C反应蛋白(CRP)[MD=−3.53,95%CI(−3.93,−3.14),P<0.00001]、红细胞沉降率(ESR)[MD=−5.80,95%CI(−8.48,−3.13),P<0.00001]方面优于对照组,差异具有统计学意义。但两组在降低免疫球蛋白G及不良反应发生率方面,差异无统计学意义。结论:中药联合硫酸羟氯喹治疗SS在总有效率、改善唾液腺、泪液分泌功能以及降低CRP、ESR方面优于对照组,并且未观察到显著的不良反应率上升,但由于纳入研究的样本量较少,质量不高,结论有待更大样本、更高质量的随机对照试验进行验证。

Objective:To systematically evaluate the efficacy and safety of traditional Chinese medicine combined with hydroxychloroquine sulfate in the treatment of Sjogren’s syndrome(SS). Methods:Two researchers searched the databases of Chinese National Knowledge Infrastructure,Wanfang Database,Weipu Database,Chinese Biomedical Literature Database,PubMed Database,Web of science Database and The Cochrane Library Database(the retrieval period is from the establishment of the database to October 2020) and screened the literatures independently. The data were extracted for bias risk assessment,and then meta-analysis was performed using Revman 5.3 software. Results:A total of 19 articles involving 1 185 patients were included,including 617 cases in the treatment group and 568 cases in the control group. Combined data analysis showed that the total effective rate of traditional Chinese medicine combined with hydroxychloroquine sulfate in the treatment of Sjogren’s syndrome was significantly higher than that of hydroxychloroquine sulfate alone[RR=1.34,95%CI(1.24,1.44),P<0.000 01].The improvement of salivary gland[SMD=0.66,95%CI(0.47,0.85),P<0.000 01],tear secretion function[MD=2.56,95%CI(1.29,3.83),P<0.000 1]and reducing CRP[MD=-3.53,95%CI(-3.93,-3.14),P<0.000 01],ESR[MD=-5.80,95%CI(-8.48,-3.13),P<0.000 01]were better than those of the control group. However,there was no significant difference in the reduction of IgG and the incidence of adverse reactions between the two groups. Conclusion:Traditional Chinese medicine combined with hydroxychloroquine sulfate in the treatment of SS is superior to the control group in total effective rate,improvement of salivary gland and tear secretion function,and reduction of CRP and ESR,and we didn’t see the significantly increase on the adverse event.However,due to the small sample size and low quality of the included studies,the conclusion needs to be verified by larger sample and higher quality randomized controlled trials.