目的 观察补肺活血胶囊联合化疗治疗利福平敏感复治肺结核的临床疗效及预后风险因素分析。方法 152例符合标准的利福平敏感的复治肺结核（阴阳两虚型）患者随机分为试验组和对照组，每组各76例。试验组采用补肺活血胶囊联合标准化疗方案[2HRZS(L)E/6HRE]，对照组单用标准化疗方案。观察两组在治疗2个月、5个月和疗程结束时的痰菌转阴、病灶吸收及空洞闭合情况，比较两组的总有效率和临床症状改善情况，以及治疗前后免疫功能指标；通过多因素回归分析评价预后的风险因素。结果 试验过程中脱落16例（两组各8例）。试验组的总有效率为78.95%，显著高于对照组的64.47%（P＜0.05）；疗程结束后，试验组的胸部X线病灶吸收显效率（80.88%）显著高于对照组的64.71%（P＜0.05），临床症状改善显著快于对照组（P＜0.05）。治疗后两组患者的CD3⁺水平和CD4⁺/CD8⁺值显著升高（P＜0.05），CD8⁺水平显著降低（P＜0.05）；治疗后，试验组患者CD4⁺/CD8⁺值显著高于对照组（P＜0.05）。治疗期间试验组不良反应发生率明显低于对照组（P＜0.05）。治疗前患者为多耐药以及CD8⁺水平是治疗成功的独立危险因素，治疗前CD4⁺水平以及使用补肺活血胶囊辅助治疗是治疗成功的独立保护因素。结论 使用补肺活血胶囊辅助治疗利福平敏感的复治肺结核（阴阳两虚型）患者，可提高治疗成功率、加速病灶吸收、促进症状改善、改善细胞免疫、减少不良反应发生率，是更为优化的复治肺结核治疗方案。

Objective To evaluate the efficacy and prognostic risk factors of Bufei Huoxue Capsule (补肺活血胶囊) combined with chemotherapy in the treatment of rifampicin-susceptible retreated patients with pulmonary tuberculosis. Methods A total of 152 rifampicin-susceptible retreated patients with pulmonary tuberculosis (yin and yang deficiency type) were randomly divided into treatment group and control group, with 76 cases in each group. The treatment group was treated with Bufei Huoxue Capsule combined with standard chemotherapy regimen [2HRZS(L)E/6HRE], and the control group was treated with standard chemotherapy regimen alone. The sputum negative conversion, lesion absorption and cavity closure of the two groups were observed at two months, five months and the end of treatment. The total effective rate and improvement of clinical symptoms, as well as immune function indexes before and after treatment were compared between the two groups. The risk factors of prognosis were evaluated by multivariate regression analysis. Results A total of 16 cases dropped out (8 cases in each group) during the experiment. The total effective rate in treatment group was 78.95%, which was higher than 64.47% in the control group (P< 0.05). At the end of treatment, the absorption efficiency of lesions in chest X-ray in treatment group (80.88%) was higher than that in the control group (64.71%) (P < 0.05), and the clinical symptoms were improved faster than that in the control group (P < 0.05). After treatment, CD3⁺ level and CD4⁺/CD8⁺ value were significantly increased (P < 0.05), and CD8⁺ level was significantly decreased (P < 0.05) in two group. After treatment, CD4⁺/CD8⁺ in treatment group was significantly higher than that in control group (P< 0.05). The incidence of adverse reactions in treatment group was significantly lower than that in control group (P < 0.05). Pre-treatment multi-drug resistance and CD8⁺ level were independent risk factors for treatment success, while pre-treatment CD4⁺ level and the use of Bufei Huoxue Capsule as adjuvant therapy were independent protective factors for treatment success. Conclusion The use of Bufei Huoxu Capsule in the adjuvant treatment of rifampicin-susceptible retreated patients with pulmonary tuberculosis (yin and yang deficiency type) can improve the success rate of treatment, accelerate lesion absorption, promote symptom improvement, improve cellular immunity, reduce the incidence of adverse reactions, and is a more optimized retreated pulmonary tuberculosis treatment plan.

R285.64