消银颗粒联合常规疗法治疗寻常型银屑病的系统评价与Meta分析  

A Meta-analysis of Xiaoyin Granules Plus Conventional Therapies in the Treatment of Psoriasis Vulgaris

作　　者：欧阳奕瑜 喻靖傑 官科汶 卢传坚[1,2,3] OUYANG Yiyu;YU Jingjie;GUAN Kewen;LU Chuanjian(The Second Clinical Medical School of Guangzhou University of Chinese Medicine,Guangzhou 510120 Guangdong,China;The Second Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangdong Provincial Hospital of traditional Chinese Medicine and Guangdong Provincial Academy of Chinese Medical Sciences,Guangzhou 510120 Guangdong,China;State Key Laboratory of Dampness Syndrome of Chinese Medicine,Guangdong-Hong Kong-Macao Joint Lab on Chinese Medicine and Immune Disease Research and Guangdong Provincial Key Laboratory of Clinical Research on Chinese Medicine Syndrome,Guangzhou 510120 Guangdong,China)

机构地区：[1]广州中医药大学第二临床医学院,广东广州510120 [2]广州中医药大学第二附属医院,广东省中医院,广东省中医药科学院,广东广州510120 [3]省部共建中医湿证国家重点实验室,粤港澳中医药与免疫疾病研究联合实验室,广东省中医证候临床研究重点实验室,广东广州510120

出　　处：《中药新药与临床药理》2023年第3期420-427,共8页Traditional Chinese Drug Research and Clinical Pharmacology

基　　金：广东省重点领域研发计划项目(2020B1111100005);广东省中医院临床研究专项(1010专项)(YN10101909);广东省中医院拔尖人才计划科研专项(BJ2022KY17);广东省基础与应用基础研究基金项目(2019A1515111094);2020广东省科技创新战略专项资金(粤港澳联合实验室)项目(2020B1212030006)。

摘　　要：目的系统评价消银颗粒联合常规疗法治疗寻常型银屑病的临床疗效及安全性。方法计算机检索中国知网(CNKI)、万方数据库(Wanfang)、中国生物医学文献数据库(CBM)、维普数据库(VIP)、PubMed及Cochrane library等中、英文数据库中关于消银颗粒联合常规疗法治疗寻常型银屑病的随机对照试验(RCT),检索时间为建库至2022年1月。2名研究员对检索出的文献进行筛选及提取有效数据,根据Cochrane推荐的评估工具RoB 2对文献质量进行偏倚风险评估,采用RevMan 5.4对数据进行Meta分析,利用Stata 12软件进行敏感性分析并对纳入研究≥10项的结局指标以Egger’s test检测发表偏倚,最后使用GRADE评价系统进行证据质量评价。结果纳入10篇文献,涉及1230例患者。系统评价及Meta分析结果显示,与对照组相比,消银颗粒联合常规疗法可提高银屑病面积与严重程度指数(PASI)评分与基线相比改善达到90%及以上的应答率(PASI90应答率)[RR=1.88,95%CI(1.54,2.28),P<0.00001],且不会增加不同类型不良事件发生率。仅1项RCT提示联合消银颗粒可提高生活质量评分,2项RCT提及临床复发率,但报告不充分。敏感性分析及发表偏倚结果提示主要结局指标(PASI90应答率)结果可靠稳定,纳入文献不存在发表偏倚。GRADE证据评价结果显示PASI90应答率为中等质量证据,生活质量评分为极低质量证据,不良事件发生率为低质量证据。结论消银颗粒联合常规疗法治疗寻常型银屑病临床疗效较好、安全性较高。由于本系统评价纳入的研究方法学质量较低,对于结果的解释仍需谨慎,消银颗粒治疗寻常型银屑病的有效性仍需更多设计严谨的多中心、高质量的随机双盲试验加以验证。Objective To systematically evaluate the clinical efficacy and safety of Xiaoyin Granules plus conventional therapies in the treatment of psoriasis vulgaris.Methods Randomized controlled trial(RCT)of Xiaoyin Granules combined with conventional therapy in the treatment of psoriasis vulgaris were searched from nine English and Chinese databases,including PubMed,Embase,Cochrane Library,CNKI,VIP,CBM and Wanfang,etc.The retrieval time was from database inception to January 2022. Two investigators screened the retrieved citations and extracted valid data independently,then evaluated risk of bias assessment of outcome indicators by using the RoB2tool recommended by Cochrane. Revman 5.4 software was used to perform Meta-analysis in the included studies,Stata12 software was adopted to perform sensitivity analysis and publication bias was assessed for the outcome indicators with number of studies≥ 10 by Egger's test. The quality of evidence for outcome indicators was evaluated according to GRADE standard.Results Ten RCTs were included in this study,involving a total of 1 230 patients. The results of the systematic review and Meta-analysis showed that,compared with the control group,Xiaoyin Granules plus conventional therapies could increase the psoriasis area and severity index(PASI)with 90 response rate[RR=1.88,95% CI(1.54, 2.28), P<0.000 01], and the occurrence of adverse events did not increase. Only one RCT indicated that Xiaoyin Granules plus conventional therapies could improve the patient's quality of life. Though clinical relapse rate was mentioned in two RCTs, the reports were insufficiently represented. Test of sensitivity analysis and publication bias suggested that the results of PASI90 response rate were stable and credible,and there was no publication bias. The results of GRADE evidence showed that the quality of evidence for PASI90 response rate was medium,the quality of evidence for quality of life was extremely low and the quality of evidence for adverse events was low.Conclusion XiaoyinGranules plus con

关 键 词：消银颗粒 银屑病 系统评价 META分析 GRADE评价 

分 类 号：R285.6[医药卫生—中药学]