目的 观察补肺活血胶囊联合2HRZE/4HR方案治疗初治老年肺结核（肺阴亏虚兼血瘀证）的临床疗效及对外周血T细胞亚群的影响。方法 选取符合标准的206例初治老年肺结核患者（肺阴亏虚兼血瘀证）为研究对象，随机分为对照组和观察组，每组103例。对照组采用2HRZE/4HR方案治疗，观察组在对照组的基础上联合补肺活血胶囊治疗，两组持续治疗6个月，在疗程结束时比较两组的总有效率，并对比两组痰菌转阴率、病灶吸收有效率、中医证候评分以及治疗前后外周血T淋巴细胞亚群（CD3⁺、CD4⁺、CD8⁺、CD4⁺/CD8⁺）水平变化及不良反应发生情况。结果 治疗过程中脱落22例（两组各11例）。观察组的治疗总有效率为93.48%，高于对照组的83.69%，差异有统计学意义（P＜0.05）。治疗后，两组痰菌转阴率无统计学差异（P＞0.05）；观察组病灶吸收有效率为90.22%，对照组为75.00%，两组比较差异有统计学意义（P＜0.05）治疗后，两组中医证候评分均较治疗前降低（P＜0.05），且观察组中医证候评分低于对照组（P＜0.05）。治疗后，两组CD3⁺、CD4⁺、CD4⁺/CD8⁺水平均较治疗前升高，CD8⁺水平较治疗前降低（P＜0.05），且观察组CD3⁺、CD4⁺、CD4⁺/CD8⁺水平均高于对照组，CD8⁺水平低于对照组（P＜0.05）；两组不良反应发生率比较，差异无统计学意义。结论 补肺活血胶囊联合2HRZE/4HR方案治疗初治老年肺结核患者的效果优于单纯2HRZE/4HR方案治疗，可改善患者临床症状，促进肺部病灶吸收，提高患者免疫力和临床疗效，证实中西医结合治疗肺结核效果显著。

Objective To observe the clinical efficacy of Bufei Huoxue Capsule (补肺活血胶囊) combined with the 2HRZE/4HR regimen in treating elderly patients with newly diagnosed pulmonary tuberculosis (PTB) presenting with deficiency of lung-yin and blood stasis syndrome, and to assess its impact on peripheral blood T-cell subsets. Methods A total of 206 eligible elderly patients with newly diagnosed PTB (deficiency of lung-yin and blood stasis syndrome) were enrolled and randomly divided into the control group (n = 103) and the observation group (n = 103). The control group received the standard 2HRZE/4HR anti-tuberculosis regimen, while the observation group received Bufei Huoxue Capsule plus the 2HRZE/4HR regimen. Both groups were treated continuously for six months. At the end of the treatment course, the following outcomes were compared: total effective rate, sputum smear conversion rate, lesion absorption effective rate, traditional Chinese medicine (TCM) symptom scores, changes in peripheral blood T-lymphocyte subsets (CD3⁺、CD4⁺、CD8⁺、CD4⁺/CD8⁺ ratio) before and after treatment, and incidence of adverse reactions. Results A total of 22 patients discontinued the study (11 per group). The observation group exhibited a significantly higher overall response rate (93.48% vs 83.69%, P < 0.05). After treatment, sputum smear conversion rates showed no significant difference between groups (P > 0.05). The lesion absorption effective rate of the observation group was significantly higher in the observation group (90.22% vs 75.00%, P < 0.05). Both groups showed reduced TCM symptom scores post-treatment (P < 0.05), with lower scores in the observation group (P < 0.05). After treatment, the levels of CD3⁺, CD4⁺, and CD4⁺/CD8⁺ in both groups increased compared with those before treatment, and the level of CD8⁺ decreased compared with that before treatment (P < 0.05). Moreover, the levels of CD3⁺, CD4⁺, and CD4⁺/CD8⁺ in the observation group were higher than those in the control group, and the level of CD8⁺ was lower than that in the control group (P < 0.05). No significant difference in adverse reaction incidence was observed between groups. Conclusion The efficacy of Bufei Huoxue Capsule combined with the 2HRZE/4HR regimen demonstrates superior efficacy over the 2HRZE/4HR regimen alone in treating elderly patients with newly diagnosed PTB. The integrated approach alleviates clinical symptoms, promotes lesion absorption, enhances immune function, and improves overall clinical outcomes, supporting the significant therapeutic value of combining traditional Chinese and Western medicine for PTB management.

R285.64

河南省医学科技攻关项目（LHGJ20230113）