梅花针治疗白癜风疗效与安全性的meta分析及GRADE证据级别评价

Meta analysis and GRADE evidence level evaluation of therapeutic efficacy and safety of plum-blossom needle in treating vitiligo

目的采用系统评价与meta分析的方法,评价梅花针用于白癜风的疗效及安全性。方法系统检索美国国立医学图书馆(PubMed)、中国生物医学文献数据库、中国知网、万方数据库和维普数据库自建库起至2022年6月2日发表的梅花针治疗白癜风的相关随机对照试验。根据纳入和排除标准对文献进行筛选,对最终纳入文献进行数据资料提取,并应用RevMan 5.4软件进行数据分析,使用ROB工具对纳入试验进行方法学质量评价。采用证据推荐评估、开发与评价分级标准(GRADE)方法评估证据级别。结果最终纳入7项研究,涉及469例患者。meta分析结果显示,梅花针联合其他疗法(包括激光或紫外线照射、他克莫司软膏、复方卡力孜然酊等)在改善白斑皮损,包括缩小白斑皮损面积(MD=-1.11,95%CI:-1.92~-0.30,P=0.007)、提高白斑复色率(MD=18.09,95%CI:1.55~34.63,P=0.030)及增加白斑色素沉着积分(MD=0.92,95%CI:0.32~1.52,P=0.003),以及提高患者生活质量(MD=-7.48,95%CI:-8.04~-6.92,P<0.001)方面均优于其他疗法单独使用,差异有统计学意义。在安全性方面,梅花针联合其他疗法与其他疗法单独使用不良事件情况比较,差异无统计学意义(RR=1.20,95%CI:0.77~1.84,P=0.420)。结论低或非常低级别证据表明,梅花针联合其他疗法治疗白癜风,在改善白斑皮损及提高患者生活质量方面可增强疗效,且相对安全。

Objective To systematically evaluate the efficacy and safety of plum-blossom needle therapy for vitiligo by using the systematic review and meta analysis.Methods The randomized controlled trials(RCT)on plum-blossom needle for treating vitiligo were systematically retrieved from the databases of the PubMed,China Biological Medicine Database,CNKI,Wanfang Data and VIP database from the database establishment to June 2,2022.The literatures were screened according to the inclusion and exclusion criteria.The finally included literatures conducted the data extraction.The RevMan 5.4 software was used for conducting the data analysis.The methodological quality evaluation on the included trials was performed by the ROB tool.The GRADE method was used to assess the evidence level.Results A total of 7 trials involving 469 patients were finally included.The meta analysis results showed that the plum-blossom needle combined with other therapies(including laser or ultraviolet irradiation,tacrolimus ointment,compound Kaliziran tincture)was superior to the other therapies alone in the aspects of improving vitiligo skin lesion including reducing the of white spot skin lesion area(MD=-1.11,95%CI:-1.92 to-0.30,P=0.007),increasing the repigmentation rate of vitiliginous lesions(MD=18.09,95%CI:1.55 to 34.63,P=0.030)and enhancing the pigment deposition in vitiligo lesions(MD=0.92,95%CI:0.32 to 1.52,P=0.003),and improving the patients'quality of life(MD=-7.48,95%CI:-8.04 to-6.92,P<0.001),and the differences were statistically significant.In terms of safety,there was no statistically significant difference in adverse events between plum blossom acupuncture combined with other therapies and other therapies alone(RR=1.20,95%CI:0.77 to 1.84,P=0.420).Conclusion Low or very low evidence shows that plum-blossom needle combined with other therapies for treating vitiligo may enhance the effect in the aspects of improving the white spot skin lesions and quality of life in the patients with vitiligo,moreover which is relatively safe.