目的 探讨利肺胶囊联合2HRZE/4HR方案治疗初治肺结核的临床疗效。方法 选取2021年1月-2023年1月商丘市结核病防治所收治的94例初治肺结核患者，按随机数字表法将所有患者分为对照组和治疗组，每组各47例。对照组给予2HRZE/4HR方案治疗，口服异烟肼片0.3 g/次，吡嗪酰胺片1.5 g/次；利福平胶囊，体质量≥ 50 kg，0.6 g/d，体质量<50 kg，0.45 g/d；盐酸乙胺丁醇片0.75 g/次；均1次/d，共2个月；后继续使用异烟肼片、利福平胶囊，剂量同前，1次/d，共4个月。治疗组在对照组基础上口服利肺胶囊，2粒/次，3次/d。两组疗程均为6个月。比较两组临床疗效及痰涂片转阴率、病灶显著吸收率、空洞闭合率。比较治疗前后两组慢性病患者生命质量测定量表体系之肺结核量表（QLICD-PT）评分及外周血T淋巴细胞亚群和血清糖类抗原125（CA125）、白细胞介素-17（IL-17）水平。结果 治疗后，治疗组总有效率为89.36%，显著高于对照组的72.34%（P<0.05）。治疗后，治疗组痰涂片转阴率、病灶显著吸收率、空洞闭合率分别为94.87%、63.83%、60.00%，均显著高于对照组的77.50%、42.55%、34.38%（P<0.05）。治疗后，两组QLICD-PT中生理功能评分、心理功能评分、社会功能评分、共性模块评分、特异模块评分、总评分均较治疗前显著升高（P<0.05）；治疗后，治疗组QLICD-PT评分均显著高于对照组（P<0.05）。治疗后，两组外周血CD4⁺水平、CD4⁺/CD8⁺比值均显著升高，外周血CD8⁺及血清CA125、IL-17水平均显著降低（P<0.05）；治疗后，治疗组外周血T淋巴细胞亚群和血清CA125、IL-17水平改善优于对照组（P<0.05）。结论 利肺胶囊联合2HRZE4HR方案治疗初治肺结核具有较好的临床疗效，能促进痰菌转阴、病灶吸收与空洞闭合，调节机体免疫状态及炎症反应，利于生命质量改善，值得临床推广应用。

Objective To explore the clinical efficacy of Lifei Capsule combined with 2HRZE/4HR regimen in treatment of primary pulmonary tuberculosis. Methods A total of 94 newly treated tuberculosis patients admitted to Shangqiu Tuberculosis Prevention and Control Institute from January 2021 to January 2023 were selected and divided into control group and treatment group according to random number table method, with 47 cases in each group. Patients in the control group were given 2HRZE/4HR regimen, and they were po administered with Isoniazid Tablets 0.3 g/time, Pyrazinamide Tablets 1.5 g/time; Rifampicin Capsules, body weight ≥ 50 kg, 0.6 g/d, body weight < 50 kg, 0.45 g/d; Ethambutol Hydrochloride Tablets, 0.75 g/time; once daily for 2 months. After that, Isoniazid Tablets and Rifampicin Capsules were continued to be used, the dose was the same as before, once daily for 4 months. Patients in the treatment group were po administered with Lifei Capsules on the basis of the control group, 2 grains/time, three times daily. Patients in two groups were treated for 6 months. After treatment, the clinical efficacy, sputum smear negative conversion rate, significant lesion absorption rate, and cavity closure rate of two groups were evaluated. The tuberculosis scale (QLICD-PT) score of chronic disease quality of life measurement scale system, T lymphocyte subsets in peripheral blood and serum carbohydrate antigen 125 (CA125) and interleukin-17 (IL-17) levels of two groups before and after treatment were compared. Results After treatment, the total effective rate of the treatment group was 89.36%, which was significantly higher than that of the control group (72.34%) (P < 0.05). After treatment, the sputum smear negative conversion rate, significant absorption rate and cavity closure rate in the treatment group were 94.87%, 63.83% and 60.00%, respectively, which were significantly higher than 77.50%, 42.55% and 34.38% in the control group (P< 0.05). After treatment, the physiological function score, psychological function score, social function score, common module score, specific module score and total score of QLICD-PT in two groups were significantly higher than those before treatment (P < 0.05). After treatment, QLICD-PT scores in the treatment group were significantly higher than those in the control group (P < 0.05). After treatment, peripheral blood CD4⁺ level and CD4⁺/CD8⁺ were significantly increased, peripheral blood CD8⁺, serum CA125 and IL-17 levels were significantly decreased in both groups (P < 0.05). After treatment, T lymphocyte subsets in peripheral blood and serum CA125 and IL-17 levels in the treatment group were better than those in the control group (P < 0.05). Conclusion Lifei Capsules combined with 2HRZE/4HR regimen has a good clinical effect in treatment of primary pulmonary tuberculosis, and can promote sputum to negative, lesion absorption and cavity closure, regulate the immune state and inflammatory response of the body, and is beneficial to the improvement of life quality, which is worthy of clinical application.

R974

商丘市科技攻关项目（203053）