复方卡力孜然酊治疗白癜风的系统评价和试验序贯分析  

Meta-analysis and Trial Sequential Analysis of Compound Kali Cumin Tincture in the Treatment of Vitiligo

作　　者：许孟月 左永杰 郭菲 刘朝霞 李鹏英 李斌 丰靓 刘红霞 康晓静[4] Xu Mengyue;Zuo Yongjie;Guo Fei;Liu Zhaoxia;Li Pengying;Li Bin;Feng Liang;Liu Hongxia;Kang Xiaojing(The Fourth Clinical Medical College,Xinjiang Medical University,Urumqi 830011,the Xinjiang Uygur Autonomous Region,China;Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine,Shanghai 200437,the Xinjiang Uygur Autonomous Region,China;Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine,Urumqi 830000,the Xinjiang Uygur Autonomous Region,China;People's Hospital of Xinjiang Uygur Autonomous Region,Urumqi 830000,the Xinjiang Uygur Autonomous Region,China)

机构地区：[1]新疆医科大学第四临床医学院,新疆维吾尔自治区乌鲁木齐830011 [2]上海中医药大学附属岳阳中西医结合医院,上海200437 [3]新疆维吾尔自治区中医医院,新疆维吾尔自治区乌鲁木齐830000 [4]新疆维吾尔自治区人民医院,新疆维吾尔自治区乌鲁木齐830000

出　　处：《中国中西医结合皮肤性病学杂志》2023年第3期235-246,共12页Chinese Journal of Dermatovenereology of Integrated Traditional and Western Medicine

基　　金：新疆维吾尔自治区重点研发计划项目(编号:2021B03001-2)。

摘　　要：目的系统评价复方卡力孜然酊治疗白癜风的临床疗效。方法检索PubMed、Embase、Web of Science、中国知网(CNKI)、维普(VIP)、万方数据库(Wanfang Database)、中国生物医学文献数据库(CBMdisc),收集自建库至2022年1月有关复方卡力孜然酊治疗白癜风的随机对照试验(RCT)。2名独立研究者根据Cochrane系统评价方法筛选文献,并对纳入研究进行质量评价及提取有效数据。采用RevMan 5.3软件和Stata 15.0对所得数据进行Meta分析,以TSA 0.9.5.10 Beta软件进行试验序贯分析(TSA)。结果共纳入31项研究,患者总计3210例,其中试验组1626例,对照组1584例。Meta分析结果显示:试验组患者总有效率[相对危险度(RR)=1.56,95%置信区间(95%CI)为(1.47,1.65),P<0.00001]优于对照组,以干预措施、疗程进行亚组分析,结果显示,单一应用复方卡力孜然酊或联合窄谱中波紫外线(NB-UVB)、308 nm准分子激光都有良好疗效,对不同部位的皮损也有良好疗效,TSA结果进一步肯定了复方卡力孜然酊治疗白癜风的临床疗效。复方卡力孜然酊可降低试验组皮肤病生活质量指数(DLQI)评分[均数差(MD)=-4.24,95%CI(-9.31,0.82),P=0.10],无严重不良反应[RR=1.20,95%CI(1.00,1.45),P=0.05],但是DLQI评分、不良事件发生率差异均无统计学意义。结论复方卡力孜然酊可提高白癜风的临床疗效,本结论仍需大样本和高质量的文献进一步验证。Objective In order to systematically evaluate the clinical efficacy and safety of compound Kali cumin tincture in the treatment of vitiligo.Methods The databases of PubMed,Web of Science,Embase,CNKI,VIP,Wanfang Database,and CBMdisc were searched fully for collecting the relevant randomized controlled researches from the inceptions of these databases until January 2022.Two independent investigators screened the literature based on the Cochrane systematic review method,evaluated the quality of the included studies,and extracted valid data.Meta-analysis was operated on the obtained data with RevMan 5.3 and Stata 15.0,and trial sequential analysis(TSA)was operated with TSA 0.9.5.10 Beta.Results A total of 31 studies were included,with 3210 patients.There were 1626 cases in experimental group while 1584 cases in control group.The results of meta-analysis revealed that the total effective rate of patients in the experimental group[RR=1.56,95%CI(1.47,1.65),P<0.00001]was better than that in the control group.Subgroup analysis was conducted with intervention measures and courses of treatment,and the results showed that a single application of compound Kali cumin tincture or combined with narrow band ultra violet B light(NB-UVB),308 nm excimer laser had good curative effect,and also had good curative effect on skin lesions in different parts.The results of TSA confirmed additionally the clinical efficacy of compound Kali cumin tincture in the treatment of vitiligo.Compound Kai cumin tincture could reduced dermatology life quality index(DLQI)score of experimental group[MD=-4.24,95%CI(-9.31,0.82),P=0.10],and there were no serious adverse reactions[RR=1.20,95%CI(1.00,1.45),P=0.05].However,DLQI score and incidence of adverse events were not statistically significant.Conclusion Compound Kali cumin tincture can improve the clinical efficacy of vitiligo.This conclusion still needs to be further verified by large samples and high-quality literature.

关 键 词：白癜风 复方卡力孜然酊 随机对照试验 系统评价 试验序贯分析 GRADE评价 

分 类 号：R758.41[医药卫生—皮肤病学与性病学]