白芍总苷胶囊治疗干燥综合征的有效性与安全性Meta分析

Efficacy and Safety of Total Glucosides of Paeony in Treatment of Patients with Sjogren Syndrome:A Meta-analysis

目的系统评价白芍总苷胶囊治疗干燥综合征的有效性和安全性。方法计算机检索Cochrane图书馆、Pub Med、EMBASE、中国生物医学文献数据库(CBM)、维普中文科技期刊全文数据库(VIP)、中国知网(CNKI)、万方数据库,均从建库日期检索至2015年9月30日,纳入白芍总苷胶囊治疗干燥综合征的随机对照试验(RCT),由2名评价员独立提取资料,并对其方法学质量进行评价。对符合纳入标准的研究采用Rev Man 5.3版软件进行Meta分析。结果共纳入10项研究,干燥综合征患者573例,根据对照组的药品类别进行亚组分析。(1)泪液分泌功能:白芍总苷胶囊组泪液分泌功能优于空白对照组[MD=2.41,95%CI(0.08,4.74)],劣于中药方剂组[MD=-2.55,95%CI(-3.88,-1.22);(2)唾液流量:白芍总苷胶囊组唾液流量劣于空白对照组[SMD=-0.87,95%CI(-1.20,-0.54)]。(3)类风湿因子(RF):白芍总苷胶囊组RF优于中药方剂组[SMD=0.44,95%CI(0.06,0.82)],优于中成药组[SMD=0.74,95%CI(0.36,1.12)],劣于空白对照组[SMD=-2.23,95%CI(-2.79,-1.67);(4)C反应蛋白(CRP):白芍总苷胶囊组CRP优于中成药组[MD=4.51,95%CI(1.75,7.26)];(5)免疫球蛋白Ig G:白芍总苷胶囊组Ig G优于中成药组[MD=2.73,95%CI(1.63,3.84)],劣于空白对照组[MD=-3.90,95%CI(-5.67,-2.13);(6)红细胞沉降率(ESR):白芍总苷胶囊组ESR优于中药方剂组[MD=12.73,95%CI(3.62,21.84)]、中成药组[MD=7.82,95%CI(5.39,10.24)],劣于空白对照组[MD=-7.13,95%CI(-12.70,-1.56)、其他西药[MD=-12.19,95%CI(-24.19,-0.19)];(7)安全性:纳入的8个研究报道不良反应,涉及41例患者,Meta分析结果显示白芍总苷不良反应发生率高于对照组[OR=3.23,95%CI(1.60,6.50)]。结论研究显示白芍总苷胶囊治疗干燥综合征改善CRP的作用明显,且安全性较好。但在改善唾液流量、泪液分泌功能、免疫球蛋白Ig G、ESR、RF方面作用不明显。纳入研究间存在异质性和发生偏倚的高度风险,需谨慎看待结果。

Objective Objective To evaluate the effects and safety of total glucosides of paeony（ TGP） in the treatment of patients with Sjogren syndrome. Methods The Cochrane Library,Pub Med,EMBASE,CBM,VIP,CNKI,Wanfang databases were searched from their establishments up to September 30,2015. We used the method recommended by the Cochrane collaboration to perform a meta-analysis of randomized controlled trails（ RCTs） of total glucosides of peony in the treatment of patients with Sjogren syndrome. Two reviewers analyzed these data independently. The Cochrane Collaboration＇s software Rev Man5. 3 was used for meta-analysis. Results A total of 573 patients in 10 studies were finally included,and were divided into different subgroups. The results of subgroup-analysis showed that：（1）Schimer test： TGP group had a higher effective rate than the blank control group [MD = 2. 41,95% CI（ 0. 08,4. 74） ],lower effective rate than Chinese herbal medicine [MD =-2. 55,95%CI（-3. 88,-1. 22）;（2） Salivary flow： TGP group had a lower effective rate than the control group [SMD =-0. 87,95% CI（-1. 20,-0. 54） ].（3）Rheumatic factors（ RF） ： TGP group had a higher effective rate than Chinese herbal medicine [SMD =0. 44,95% CI（ 0. 06,0. 82） ]and Chinese patent drug [SMD = 0. 74,95% CI（ 0. 36,1. 12） ],lower effective rate than the blank control group [SMD = 2. 23,95% CI（-2. 79,-1. 67）;（4） C-reactive protein（ CRP） ： TGP group had a higher effective rate than the control group [MD = 4. 51,95% CI（ 1. 75,7. 26） ];（5）Ig G： TGP group had a higher effective rate than Chinese patent drug group [MD = 2. 73,95% CI（ 1. 63,3. 84） ],lower effective rate than the blank control group [MD =-3. 90,95% CI（-5. 67,-2. 13）,but no statistical difference was noted when compared with Chinese herbal medicine and Western medicine groups;（6） ESR： TGP group had a higher effective rate than Chinese herbal medicine group [MD = 12. 73,95% CI（ 3. 62,21. 84） ] and Chinese patent drug group [MD = 7. 82,95% CI（ 5. 39,10. 24） ],lower effective rate than the blank control group[MD =-7. 13,95% CI（-12. 70,-1. 56） and Western medicine group [MD =-12. 19,95% CI（-24. 19,-0. 19） ];（7）Safety： 8 studies reported adverse effects in 41 patients. TGP group had a higher adverse reaction rate than the control group[OR = 3. 23,95% CI（ 1. 60,6. 50） ]. Conclusion Current evidence demonstrates that TGP can effectively improve CRP,but its effects on Salivary flow,Schimer test,IgG,ESR,RF were not significant. However,the heterogeneity and high risk of bias in the reports involved in this study limits the reliability of this conclusion.