黄芪相关中药口服制剂辅助治疗肺结核增效减毒作用的Meta分析

Meta-analysis on Synergy and Attenuation of Astragalus Membranaceus Related Oral Preparations of Traditional Chinese Medicine in the Adjuvant Therapy for Pulmonary Tuberculosis

目的评价黄芪相关中药口服制剂辅助治疗肺结核的增效减毒作用,为中药口服制剂治疗肺结核提供科学依据。方法计算机检索中国生物医学文献数据库、中国知网、维普网、万方数据知识服务平台、Pub Med、EMBase、ISI、Cochrane Library等数据库中已发表文献及中国临床试验注册中心、美国临床试验注册中心中未发表文献,筛选有关黄芪相关中药口服制剂联合化疗治疗肺结核的随机对照试验,检索时间从建库至2016年9月。化疗组患者给予抗结核化疗方案治疗,黄芪联合化疗组患者给予抗结核化疗方案联合黄芪相关中药口服制剂治疗。采用Rev Man5.3软件进行Meta分析。结果共纳入20篇文献,包括4 098例肺结核患者。Meta分析结果显示,黄芪联合化疗组患者痰菌转阴率[相对危险度(RR)=1.35,95%可信区间(CI)(1.21,1.50)]、病灶吸收改善率[RR=1.21,95%CI(1.10,1.32)]、结核空洞缩小率[RR=1.19,95%CI(1.08,1.31)]及临床症状及体征改善率[RR=1.12,95%CI(1.07,1.16)]均高于化疗组(P<0.05);黄芪联合化疗组患者胃肠道反应发生率[RR=0.32,95%CI(0.24,0.43)]、肝功能损伤发生率[RR=0.35,95%CI(0.25,0.49)]及皮疹发生率[RR=0.31,95%CI(0.11,0.87)]均低于化疗组(P<0.05)。倒漏斗图提示,报道痰菌转阴率的文献可能存在发表偏倚,报道病灶吸收改善率和结核空洞缩小率的文献存在发表偏倚的可能性小。结论基于现有文献证据,黄芪相关中药口服制剂可提高肺结核患者痰菌转阴率、病灶吸收改善率、结核空洞缩小率、临床症状及体征改善率,降低胃肠道反应、肝功能损伤及皮疹发生率,其辅助治疗肺结核具有一定增效减毒作用。

Objective To evaluate the synergy and attenuation of astragalus membranaceus related oral preparations of traditional Chinese medicine in the adjuvant therapy for pulmonary tuberculosis, to provide scientific evidence for oral preparations of traditional Chinese medicine in treating pulmonary tuberculosis. Methods Computer was used to search RCTs about astragalus membranaceus related oral preparations of traditional Chinese medicine combined with chemotherapy in treatingpulmonary tuberculosis from crealeing database to September 2016, including published literatures in CBD, CNKI, VIP, Wanfanng Data, PubMed, EMBase, ISI and Cochrane library, unpublished literatures in Chinese Clinical Trial Registry and American Clinical Trial Registry, thereinto patients of control group received anti - tuberculosis chemotherapy regimens, while patients of test group received anti - tuberculosis chemotherapy regimens combined with astragalus membranaeeus related oral preparations of tradilional Chinese medicine. RevMan 5.3 software was used to carried out the Meta - analysis. Results A total of 20 literatures were involved, including 4 098 patients with pulmonary tuberculosis. Meta - analysis results showed that, sputum negative conversion rate [ RR = 1.35, 95% CI （ 1.21, 1.50） ], improvement rate of lesions absorption [ RR = 1.21, 95% CI （1. 10, 1.32） ], shrink ratio of tuberculous cavity [ RR = 1. 19, 95% CI （ 1.08, 1.31 ） ], improvement rate of clinical symptoms and signs [RR = 1.12, 95% CI （1.07, 1. 16）] of test group were statistically significantly higher than those of control group （ P 〈 0. 05 ） ; incidence of gastrointestinal reactions [ RR = 0. 32, 95% CI （0. 24, 0. 43 ） ], liver function damage [RR=0.35, 95%CI （0.25, 0.49）] and rash [RR=0.31, 95%CI （0.11, 0.87）] of test group was statistically significantly lower than that of control group, respectively （ P 〈 0. 05 ）. inverted funnel plot showed that, literatures reported sputum negative conversion rate may exist publication bias, while literatures reported improvement rate of lesions absorption and literatures reported shrink ratio of tuberculous cavity may not exist small possibility of publication bias. Conclusion According to existing literature evidence, astragalus membranaeeus related oral preparations of traditional Chinese medicine can improve the sputum negative conversion rate, improvement rate of lesions absorption, shrink ratio of tuberculous cavity and improvement rate of clinical symptoms and signs, reduce the incidence of gastrointestinal reactions, liver function damage and rash, has certain synergy and attenuation in the adjuvant therapy for pulmonary tuberculosis.