【摘要】 目的 观察富马酸贝达喹啉片在耐多药肺结核患者中的应用效果和安全性。方法 选取2020年1月至2021年12月河南省胸科医院收治的118例耐多药肺结核患者作为研究对象，按照随机数字表法分为观察组和对照组，各59例。对照组患者接受常规耐多药肺结核治疗方案，观察组在对照组的基础上接受富马酸贝达喹啉片治疗，服药24周。评价两组患者治疗后痰菌转阴情况和空洞闭合情况，检测血清免疫球蛋白(Ig)A、IgG、IgM等免疫功能指标，以及血清C反应蛋白(CRP)、白介素-6(IL-6)和干扰素-γ(IFN-γ)等细胞因子，记录治疗期间不良反应发生情况。结果 观察组患者的痰菌转阴率和空洞闭合率均高于对照组，差异有统计学意义(P<0.05)。两组患者治疗前IgA、IgG和IgM的免疫功能指标水平差异无统计学意义(P>0.05);治疗后两组血清IgA、IgG和IgM水平升高，且观察组患者水平高于对照组(P<0.05)。两组患者治疗前CRP、IL-6和IFN-γ水平差异无统计学意义(P>0.05);治疗后两组CRP、IL-6和IFN-γ水平降低，且观察组水平低于对照组(P<0.05)。两组不良反应差异无统计学意义(P>0.05)。结论 联合富马酸贝达喹啉片治疗方案能够改善耐多药肺结核患者免疫功能，降低体内炎症因子水平，促进痰菌转阴和空洞闭合，并且临床安全性较高。更多还原

【Abstract】 Objective To observe the application effect and safety of Bedaquiline Fumarate tablets in multidrug-resistant pulmonary tuberculosis patients.Methods A total of 118 patients with multidrug-resistant pulmonary tuberculosis admitted to Henan Chest Hospital from January 2020 to December 2021 were selected as the study subjects. They were randomly divided into observation group and control group, with 59 patients in each group. The control group patients received conventional treatment. The observation group received treatment with Bedaquiline Fumarate tablets for 24 weeks on the basis of the control group. The negative conversion of sputum bacteria and cavity closure after treatment in two groups of patients, and detect immune function indicators such as serum immunoglobulin(Ig) A, IgG, IgM, as well as serum C-reactive protein(CRP), interleukin-6(IL-6), and interferon-γ(IFN-γ) equivalent cytokines were evaluated. The occurrence of adverse reactions during treatment was recorded.Results The sputum bacteria conversion rate and cavity closure rate of the observation group patients were higher than those of the control group, and the difference was statistically significant(P<0.05). There was no statistically difference in the levels of immune function indicators of IgA, IgG, and IgM between the two groups of patients before treatment(P>0.05). After treatment, the serum levels of IgA, IgG, and IgM increased in both groups, and the levels in the observation group were higher than those in the control group(P<0.05). There was no statistically difference in levels of CRP, IL-6 and IFN-γ between the two groups of patients before treatment(P>0.05). After treatment, the levels of CRP, IL-6 and IFN-γ decreased in both groups, and the levels in the observation group were lower than those in the control group(P<0.05). There was no difference in adverse reactions between the two groups.Conclusion The combined treatment regimen of Bedaquiline Fumarate tablets can improve the immune function of multidrug-resistant pulmonary tuberculosis patients, reduce the levels of inflammatory factors in the body, promote sputum bacterial negative conversion and cavity closure, and have high clinical safety.更多还原