百地滋阴丸和参芪益肺丸辅助治疗敏感肺结核患者有效性和安全性:一项全国随机对照多中心临床研究

Efficacy and safety of Baidiziyin Pill and Shenqiyifei Pill in adjuvant treatment of susceptible pulmonary tuberculosis patients: a national randomized controlled multicenter clinical study

背景:结核病多伴有咳嗽、咳痰、乏力、纳差、消瘦等症状,且一线抗结核药物治疗方案常伴肝肾损伤等不良反应。百地滋阴丸和参芪益肺丸具有减轻结核病症状、抗炎、增强细胞免疫功能和保肝的作用。目前尚无百地滋阴丸和参芪益肺丸辅助一线抗结核治疗方案的研究。方法:本研究采用多中心随机对照临床试验,以新发敏感肺结核患者作为研究对象,随机分为试验组和对照组,两组均接受标准一线抗结核治疗方案,同时,试验组增加百地滋阴丸和参芪益肺丸辅助治疗,旨在通过对比两组患者的症状缓解情况,评估百地滋阴丸和参芪益肺丸作为辅助治疗药物,对接受一线抗结核治疗的新发敏感肺结核患者症状缓解及药物不良反应减轻的效果。讨论:尽管本研究未对两种药物的独立影响作用及长期治疗效应进行分析,但本研究期望通过优化新发敏感肺结核治疗方案以减轻结核病呼吸道和全身症状,以及抗结核化疗不良反应,改善肺结核患者生活质量,以期为临床医生提供更多的有关中药辅助治疗结核病的思路和策略。

Background:Tuberculosis frequently manifests with symptoms including cough,sputum production,fatigue,anorexia,and weight loss.The first-line treatment regimens are often associated with adverse effects,notably hepatotoxicity and nephrotoxicity.Baidiziyin Pill and Shenqiyifei Pill exhibit properties that alleviate tuberculosis symptoms,possess anti-inflammatory effects,enhance cellular immune function,and offer hepatoprotective benefits.To date,no studies have investigated the application of Baidiziyin Pill and Shenqiyifei Pill as adjunctive therapies in conjunction with first-line anti-tuberculosis treatment.Methods:This study utilizes a multicenter randomized controlled trial design,focusing on patients newly diagnosed as susceptible pulmonary tuberculosis.Participants were randomly assigned to either an experimental group or a control group.Both groups received the standard first-line anti-tuberculosis treatment regimen,while the experimental group additionally received Baidiziyin Pill and Shenqiyifei Pill as adjunctive therapies.The primary objective is to compare symptom relief between the two groups,thereby evaluating the efficacy of Baidiziyin Pill and Shenqiyifei Pill in alleviating symptoms and mitigating adverse effects in patients undergoing first-line anti-tuberculosis treatment.Discussion:While this study does not evaluate the independent effects of the two drugs or their long-term therapeutic outcomes,it aims to optimize the treatment protocol for newly diagnosed pulmonary tuberculosis.The goal is to alleviate both respiratory and systemic symptoms associated with tuberculosis,as well as the adverse reactions resulting from anti-tuberculosis chemotherapy,ultimately improving the quality of life for affected patients.This research aspires to offer clinicians enhanced insights and strategies for the adjunctive use of traditional Chinese medicine in the treatment of tuberculosis.