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

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...

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Autores principales:	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
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Pulmonary tuberculosis Multidrug-resistant Chemotherapeutic drug Chinese herbs Randomized controlled trial Infectious and parasitic diseases RC109-216 Public aspects of medicine RA1-1270
Acceso en línea:	https://doaj.org/article/6b979a62edda4d03970ab6f5f01b528b
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spelling	oai:doaj.org-article:6b979a62edda4d03970ab6f5f01b528b2021-11-08T10:59:18ZEfficacy of integrating short-course chemotherapy with Chinese herbs to treat multi-drug resistant pulmonary tuberculosis in China: a study protocol10.1186/s40249-021-00913-52049-9957https://doaj.org/article/6b979a62edda4d03970ab6f5f01b528b2021-11-01T00:00:00Zhttps://doi.org/10.1186/s40249-021-00913-5https://doaj.org/toc/2049-9957Abstract 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). Graphical AbstractShun-Xian ZhangLei QiuCui LiWei ZhouLi-Ming TianHui-Yong ZhangZi-Feng MaXian-Wei WuXing HuangYu-Wei JiangShao-Yan ZhangZhen-Hui LuBMCarticlePulmonary tuberculosisMultidrug-resistantChemotherapeutic drugChinese herbsRandomized controlled trialInfectious and parasitic diseasesRC109-216Public aspects of medicineRA1-1270ENInfectious Diseases of Poverty, Vol 10, Iss 1, Pp 1-16 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Pulmonary tuberculosis Multidrug-resistant Chemotherapeutic drug Chinese herbs Randomized controlled trial Infectious and parasitic diseases RC109-216 Public aspects of medicine RA1-1270
spellingShingle	Pulmonary tuberculosis Multidrug-resistant Chemotherapeutic drug Chinese herbs Randomized controlled trial Infectious and parasitic diseases RC109-216 Public aspects of medicine RA1-1270 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 Efficacy of integrating short-course chemotherapy with Chinese herbs to treat multi-drug resistant pulmonary tuberculosis in China: a study protocol
description	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). Graphical Abstract
format	article
author	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
author_facet	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
author_sort	Shun-Xian Zhang
title	Efficacy of integrating short-course chemotherapy with Chinese herbs to treat multi-drug resistant pulmonary tuberculosis in China: a study protocol
title_short	Efficacy of integrating short-course chemotherapy with Chinese herbs to treat multi-drug resistant pulmonary tuberculosis in China: a study protocol
title_full	Efficacy of integrating short-course chemotherapy with Chinese herbs to treat multi-drug resistant pulmonary tuberculosis in China: a study protocol
title_fullStr	Efficacy of integrating short-course chemotherapy with Chinese herbs to treat multi-drug resistant pulmonary tuberculosis in China: a study protocol
title_full_unstemmed	Efficacy of integrating short-course chemotherapy with Chinese herbs to treat multi-drug resistant pulmonary tuberculosis in China: a study protocol
title_sort	efficacy of integrating short-course chemotherapy with chinese herbs to treat multi-drug resistant pulmonary tuberculosis in china: a study protocol
publisher	BMC
publishDate	2021
url	https://doaj.org/article/6b979a62edda4d03970ab6f5f01b528b
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Efficacy of integrating short-course chemotherapy with Chinese herbs to treat multi-drug resistant pulmonary tuberculosis in China: a study protocol

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