中西医结合治疗肉芽肿性乳腺炎患者的临床疗效及安全性系统评价和GRADE证据级别评价

Clinical Efficacy and Safety of Integrated Traditional Chinese and Western Medicine in the Treatment of Granulomatous Mastitis: A Systematic Review and GRADE Profile

目的 系统评价中西医结合治疗肉芽肿性乳腺炎的有效性和安全性。方法 全面检索中文科技期刊全文数据库(VIP)、万方数据库、中国期刊全文数据库(CNKI)、中国生物医学数据库(SinoMed)、The Cochrane Library、PubMed、EMbase、Clinical Trail gov数据库,收集中西医结合治疗肉芽肿性乳腺炎的随机对照试验(Randomized controlled trial,RCT),检索时间为各数据库建库至2021年12月31日,根据预先制定的纳入和排除标准筛选文献,并进行提取资料和质量评估,采用RevMan 5.3软件进行Meta分析,运用GRADE(Grading of Recommendations,Assessment,Development and Evaluation,GRADE)系统对关键结局指标的证据质量进行分级。结果 检索出中英文文献共1892篇,最终纳入9项RCT研究,累计受试者652例,其中试验组340例,对照组312例。Meta分析结果显示:与对照组比较,试验组(中西医结合治疗组)可明显提高肉芽肿性乳腺炎患者的临床疗效[OR=4.19,95%CI(2.60,6.77),P<0.001],试验组287例,对照组259例,采用固定效应模型,低质量证据;降低复发率[OR=0.22,95%CI(0.12,0.41),P<0.001],试验组171例,对照组157例,采用固定效应模型,低质量证据;改善中医证候学积分[MD=-4.01,95%CI(-7.02,-0.99),P=0.009],试验组74例,对照组60例,采用随机效应模型,极低质量证据。两组患者在住院时间的差别无统计学意义。9项研究中有5项研究提及了不良反应,其中1项研究明确提及无不良反应,4项研究报道了18例不良反应事件,以皮疹、头晕和轻微消化道症状为主,无严重不良反应,其余4项研究未对安全性做出说明。结论 中西医结合治疗肉芽肿性乳腺炎能明显提高临床有效率和改善中医证候学评分,降低复发率,具有良好的临床安全性。

Objective To systematically evaluate the efficacy and safety of integrated traditional Chinese and western medicine in the treatment of granulomatous mastitis.Methods The databases, such as VIP,Wanfang Data, CNKI,SinoMed, The Cochrane Library, PubMed, Embase, and Clinical Trail gov, were searched comprehensively for randomized controlled trials(RCTs)of integrated traditional Chinese and western medicine in the treatment of granulomatous mastitis from database inception to December 2021.The research articles were screened according to the pre-set inclusion and exclusion criteria.The data were extracted and the quality was evaluated.Meta-analysis was performed using RevMan 5.3 software.The evidence quality of key outcome indicators was graded using the Grading of Recommendations, Assessment, Development, and Evaluation(GRADE)system.Results A total of 1 892 Chinese and English articles were retrieved, and nine RCTs were finally included.A total of 652 subjects were involved, including 340 in the experimental group and 312 in the control group.Meta-analysis showed that compared with the control group, the experimental group(integrated traditional Chinese and western medicine treatment group)could significantly improve the clinical efficacy of patients with granulomatous mastitis[OR=4.19,95% CI(2.60,6.77),P<0.001,287 cases in the experimental group and 259 cases inthe control group, FEM,low-quality evidence],reduce the recurrence rate[OR=0.22,95% CI(0.12,0.41),P<0.001,171 cases in the experimental group and 157 cases in the control group, FEM,low-quality evidence],and improve the TCM syndrome score[MD=-4.01,95% CI(-7.02,-0.99),P=0.009,74 cases in the experimental group and 60 cases in the control group, REM,very low-quality evidence].There was no significant difference in hospital stay between the two groups.Among nine RCTs, five mentioned adverse reactions.To be specific, one RCT explicitly mentioned no adverse reactions, four reported 18 cases of adverse reactions, mainly rash, dizziness, and mild gastrointestinal symptoms, and four did not explain the safety.Conclusion Integrated traditional Chinese and western medicine in the treatment of granulomatous mastitis can significantly improve the clinical efficiency and TCM syndrome score and reduce the recurrence rate, with good clinical safety.