首页|白芍总苷治疗原发性干燥综合征的疗效及安全性Meta分析

白芍总苷治疗原发性干燥综合征的疗效及安全性Meta分析

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[目的]系统评价白芍总苷(TGP)治疗原发性干燥综合征(pSS)的疗效及安全性.[方法]计算机检索中国知网(CNKI)、维普数据库(VIP)、中国生物医学文献数据库(CBM)、万方数据库(Wanfang)、PubMed、EMBASE、Cochrane(截至 2022年10月29日),收集TGP治疗pSS的随机对照试验(RCTs).2 名评价人员独立筛选文献、录入数据并进行文献质量评价,采用RevMan 5.4 软件进行Meta分析.[结果]共检索到 368篇文献,筛选后纳入 10项RCTs,包括受试者 874 例.Meta分析显示,单用TGP治疗pSS时在Schirmer试验[MD=1.31,95%CI(0.74,1.88),P<0.000 01]、唾液流率[MD=0.12,95%CI(0.02,0.21),P=0.02]和红细胞沉降率(ESR)[MD=-7.30,95%CI(-16.64,1.24),P=0.000 4]方面疗效显著,TGP联用西药时在Schirmer试验[MD=1.10,95%CI(0.36,3.17),P=0.01]、唾液流率[MD=-6.96,95%CI(-8.34,-5.57),P<0.000 01]、ESR[MD=-9.87,95%CI(-12.64,-7.10),P<0.00001]、类风湿因子(RF)[MD=-9.95,95%CI(-13.45,-6.45),P<0.000 01)、C反应蛋白(CRP)[MD=-1.76,95%CI(-2.92,-0.60),P=0.003)、免疫球蛋白G(IgG)[MD=-3.19,95%CI(-4.22,-2.17),P<0.000 01)、IgA[MD=-0.97,95%CI(-1.36,-0.58),P<0.000 01)和IgM[MD=-0.44,95%CI(-0.72,-0.16),P=0.002)方面疗效显著,有效率均显著提高,且不良反应较少,差异均具有统计学意义(P<0.05).[结论]当前研究证据表明,TGP对于pSS患者在改善外分泌功能(Schirmer试验和唾液流率),降低炎症指数(ESR、RF和CRP)和免疫球蛋白(IgG、IgA和IgM)方面疗效显著,改善血清γ球蛋白、ESSPRI等指标均具有一定优势,同时其不良反应少且症状较轻,安全性较好.但受纳入研究样本量、方法学质量、结局指标等限制,该结论有待更多高质量研究进行验证.
Meta-analysis of efficacy and safety of primary Sj?gren's syndrome treated by total glucosides of paeony
[Objective]To systematically evaluate the efficacy and safety of primary Sjögren's syndrome(pSS)treated by total glucosides of paeony(TGP).[Methods]Databases of CNKI,VIP,CBM,Wanfang,PubMed,EMBASE,and Cochrane were searched(from inception to October 29,2022)to screen the randomized controlled trials(RCTs)of TGP for pSS.Two authors independently screened the literature,extracted data,and performed literature quality evaluation,and Meta-analysis was performed using RevMan 5.4 software.[Results]A total of 368 literatures were retrieved,and 10 RCTs were included after the screening,including 874 subjects.The Meta-analysis showed that the treatment of pSS with TGP alone was more effective in the Schirmer's test[MD=1.31,95%CI(0.74,1.88),P<0.00001],salivary flow rate[MD=0.12,95%CI(0.02,0.21),P=0.02],and erythrocyte sedimentation rate(ESR)[MD=-7.30,95%CI(-16.64,1.24),P=0.000 4].When TGP in combination with Western medicine,and efficacy in the Schirmer's test[MD=1.10,95%CI(0.36,3.17),P=0.01],salivary flow rate[MD=-6.96,95%CI(-8.34,-5.57),P<0.000 01],ESR[MD=-9.87,95%CI(-12.64,-7.10),P<0.000 01],rheumatoid factor(RF)[MD=-9.95,95%CI(-13.45,-6.45),P<0.000 01],C-reactive protein(CRP)[MD=-1.76,95%CI(-2.92,-0.60),P=0.003],immunoglobulin G(IgG)[MD=-3.19,95%CI(-4.22,-2.17),P<0.000 01],IgA[MD=-0.97,95%CI(-1.36,-0.58),P<0.000 01]and IgM[MD=-0.44,95%CI(-0.72,-0.16),P=0.002]were significantly more efficacious,with significantly higher efficiency and fewer adverse effects,all with statistically significant differences(P<0.05).[Conclusion]The current research evidence suggests that TGP is effective in improving exocrine function(Schirmer's test and salivary flow rate),reducing inflammatory indices(ESR,RF and CRP)and immunoglobulins(IgG,IgA and IgM)in pSS patients,improving serum gamma globulin,ESSPRI and other indices,while having fewer and less symptomatic adverse effects and the safety is better.However,due to the limitations of the sample size,methodological quality,and outcome indicators of the included studies,this conclusion needs to be validated by more high-quality studies.

systematic reviewtotal glucosides of paeonyprimary Sjögren's syndromerandomized controlled trial

卫博文、刘维、张淑敏、王爱华、林芳芳、丁久力、戚浩

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天津中医药大学第一附属医院风湿免疫科,天津 300193

国家中医针灸临床医学研究中心,天津 300193

系统评价 白芍总苷 原发性干燥综合征 随机对照试验

中医药传承与创新"百千万"人才工程(岐黄工程)岐黄学者项目全国名老中医药专家传承工作室建设项目&&

20210602-19750222020MZ319-350601

2024

天津中医药
天津市中医药大学,天津中西医结合学会,天津中医药学会

天津中医药

CSTPCD
影响因子:0.998
ISSN:1672-1519
年,卷(期):2024.41(4)
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