Efficacy of integrating short-course chemotherapy with Chinese herbs to treat multi-drug resistant pulmonary tuberculosis in China: a study protocol.

IF 4.8 1区医学 Q1 INFECTIOUS DISEASES Infectious Diseases of Poverty Pub Date : 2021-11-06 DOI:10.1186/s40249-021-00913-5

Shun-Xian Zhang, Lei Qiu, Cui Li, Wei Zhou, Li-Ming Tian, Hui-Yong Zhang, Zi-Feng Ma, Xian-Wei Wu, Xing Huang, Yu-Wei Jiang, Shao-Yan Zhang, Zhen-Hui Lu

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引用次数: 3

Abstract

Background: Tuberculosis (TB) caused Mycobacterium tuberculosis (M.tb) is one of infectious disease that lead a large number of morbidity and mortality all over the world. Although no reliable evidence has been found, it is considered that combining chemotherapeutic drugs with Chinese herbs can significantly improves the cure rate and the clinical therapeutic effect.

Methods: Multi-drug resistant pulmonary tuberculosis (MDR-PTB, n = 258) patients with Qi-yin deficiency syndrome will be randomly assigned into a treatment group (n = 172) or control/placebo group (n = 86). The treatment group will receive the chemotherapeutic drugs combined with Chinese herbs granules (1 + 3 granules), while the control group will receive the chemotherapeutic drugs combined with Chinese herbs placebo (1 + 3 placebo granules). In addition, MDR-PTB (n = 312) patients with Yin deficiency lung heat syndrome will be randomly assigned to a treatment (n = 208) or control/placebo (n = 104) group. The treatment group will receive the chemotherapeutic regimen combined with Chinese herbs granules (2 + 4 granules), while the control group will receive the chemotherapeutic drugs and Chinese herbs placebo (2 + 4 placebo granules). The primary outcome is cure rate, the secondary outcomes included time to sputum culture conversion, lesion absorption rate and cavity closure rate. BACTEC™ MGIT™ automated mycobacterial detection system will be used to evaluate the M.tb infection and drug resistance. Chi-square test and Cox regression will be conducted with SAS 9.4 Statistical software to analyze the data.

Discussion: The treatment cycle for MDR-PTB using standardized modern medicine could cause lengthy substantial side effects. Chinese herbs have been used for many years to treat MDR-PTB, but are without high-quality evidence. Hence, it is unknown whether Chinese herbs enhances the clinical therapeutic effect of synthetic drugs for treating MDR-PTB. Therefore, this study will be conducted to evaluate the clinical therapeutic effect of combining Chinese herbs and chemotherapeutic drugs to treat MDR-PTB cases. It will assist in screening new therapeutic drugs and establishing treatment plan that aims to improve the clinical therapeutic effect for MDR-PTB patients.

Trial registration: This trial was registered at ClinicalTrials.gov (ChiCTR1900027720) on 24 November 2019 (prospective registered).

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中国短期化疗结合中药治疗多重耐药肺结核的疗效研究方案。

背景:结核分枝杆菌(Mycobacterium Tuberculosis, M.tb)是世界范围内发病率和死亡率较高的传染病之一。虽然尚未找到可靠的证据，但认为化疗药物与中药联合治疗可显著提高治愈率和临床治疗效果。方法:将多药耐药肺结核(MDR-PTB, n = 258)气阴虚证患者随机分为治疗组(n = 172)和对照组/安慰剂组(n = 86)。治疗组给予化疗药物联合中药颗粒(1 + 3颗粒)，对照组给予化疗药物联合中药安慰剂(1 + 3安慰剂颗粒)。此外，耐多药肺结核阴虚肺热证患者(n = 312)将被随机分配到治疗组(n = 208)或对照组/安慰剂组(n = 104)。治疗组采用化疗药物联合中药颗粒(2 + 4颗粒)方案，对照组采用化疗药物联合中药安慰剂(2 + 4安慰剂颗粒)方案。主要观察指标为治愈率，次要观察指标为痰培养转化时间、病灶吸收率及腔体闭合率。BACTEC™MGIT™分枝杆菌自动检测系统将用于评估M.tb感染和耐药性。采用SAS 9.4统计软件进行卡方检验和Cox回归分析。讨论:使用标准化现代医学的耐多药肺结核的治疗周期可能会导致漫长的实质性副作用。中草药用于治疗耐多药肺结核已有多年，但缺乏高质量的证据。因此，中药是否能提高合成药物治疗耐多药肺结核的临床疗效尚不清楚。因此，本研究将对中药联合化疗药物治疗耐多药肺结核的临床疗效进行评价。它将有助于筛选新的治疗药物和制定治疗计划，旨在提高耐多药肺结核患者的临床治疗效果。试验注册:该试验于2019年11月24日在ClinicalTrials.gov (ChiCTR1900027720)注册(前瞻性注册)。

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来源期刊

Infectious Diseases of Poverty Medicine-Public Health, Environmental and Occupational Health

CiteScore

16.70

自引率

1.20%

发文量

368

审稿时长

13 weeks

期刊介绍： Infectious Diseases of Poverty is a peer-reviewed, open access journal that focuses on essential public health questions related to infectious diseases of poverty. It covers a wide range of topics and methods, including the biology of pathogens and vectors, diagnosis and detection, treatment and case management, epidemiology and modeling, zoonotic hosts and animal reservoirs, control strategies and implementation, new technologies, and their application. The journal also explores the impact of transdisciplinary or multisectoral approaches on health systems, ecohealth, environmental management, and innovative technologies. It aims to provide a platform for the exchange of research and ideas that can contribute to the improvement of public health in resource-limited settings. In summary, Infectious Diseases of Poverty aims to address the urgent challenges posed by infectious diseases in impoverished populations. By publishing high-quality research in various areas, the journal seeks to advance our understanding of these diseases and contribute to the development of effective strategies for prevention, diagnosis, and treatment.