目的 评估注射用母牛分枝杆菌联合含贝达喹啉方案治疗耐多药肺结核（MDR-PTB）患者的有效性与安全性，从而为优化MDR-PTB的临床综合治疗方案提供参考依据。方法 选取2023年4月—2025年3月沧州市第三医院收治的100例MDR-PTB患者，按照开展的干预方式不同分为对照组和治疗组，每组各50例。对照组采用常规治疗联合富马酸贝达喹啉片，治疗组在对照组治疗方案基础上联合注射用母牛分枝杆菌，两组均连续治疗24周。对比两组临床疗效、痰菌转阴、病灶吸收与空洞改善情况、免疫指标。结果 治疗后，治疗组治疗总有效率明显高于对照组（94.00% vs 78.00%，P＜0.05），痰菌转阴成功例数与痰涂片/培养阴转率均高于对照组（P＜0.05），治疗组总吸收率与总改善率均高于对照组（P＜0.05）。治疗后，两组CD4⁺、CD3⁺、CD4⁺/CD8⁺表达均较治疗前升高（P＜0.05），而CD8⁺表达均较治疗前下降（P＜0.05），且治疗后治疗组CD4⁺、CD3⁺、CD4⁺/CD8⁺表达均高于对照组，CD8⁺表达低于对照组（P＜0.05）。结论 在MDR-PTB患者的治疗中，常规标准化疗法联合注射用母牛分枝杆菌与贝达喹啉的方案显示出明确的协同增效作用。该联合策略能更有效地促进肺部病灶吸收与空洞改善，显著提升痰菌阴转率，并对机体免疫功能产生积极调节作用，且总体安全性可控，未显著增加治疗相关不良反应。

Objective To evaluate the efficacy and safety of Mycobacterium vaccae for injection combined with a bedaquiline-containing regimen in patients with multidrug-resistant pulmonary tuberculosis (MDR-PTB), so as to provide a reference for optimizing the comprehensive clinical treatment regimen for MDR-PTB. Methods A total of 100 patients with MDR-PTB admitted to the Third Hospital of Cangzhou from April 2023 to March 2025 were enrolled and divided into a control group and a treatment group according to different interventions, with 50 cases in each group. The control group received conventional treatment combined with Bedaquiline Fumarate Tablets. On the basis of the control regimen, the treatment group was additionally administered Mycobacterium vaccae for injection. Both groups received continuous treatment for 24 weeks. Clinical efficacy, sputum bacteriological conversion, lesion absorption, cavity improvement, and immune indicators were compared between the two groups. Results After treatment, the total effective rate of the treatment group was significantly higher than that of the control group (94.00% vs 78.00%, P < 0.05). The success cases of sputum conversion and the negative conversion rates of sputum smear and culture in the treatment group were all higher than those in the control group (P < 0.05). The total lesion absorption rate and total cavity improvement rate in the treatment group were also higher than those in the control group (P < 0.05). After treatment, the expression levels of CD3⁺, CD4⁺ and the CD4⁺/CD8⁺ ratio in both groups were increased compared with baseline (P < 0.05), while the expression level of CD8⁺ was decreased (P < 0.05). Moreover, the treatment group exhibited higher levels of CD3⁺, CD4⁺ and CD4⁺/CD8⁺ and a lower CD8⁺ level than the control group (P < 0.05). Conclusion In the treatment of patients with MDR-PTB, the regimen of conventional standardized therapy combined with Mycobacterium vaccae for injection and bedaquiline shows a clear synergistic effect. This combined strategy can more effectively promote pulmonary lesion absorption and cavity improvement, significantly increase the sputum bacteriological negative conversion rate, and exert a positive regulatory effect on immune function. The overall safety is controllable, with no significant increase in treatment-related adverse reactions.

R978.3

河北省中医药管理局科研立项项目（2023272）