目的 探讨蛤蚧治痨丸联合2HRZE/4HR方案治疗初治肺结核的临床疗效。方法 纳入2021年4月—2024年12月保定市人民医院收治的82例初治肺结核患者，按随机数字表法分为对照组和治疗组，每组各41例。对照组给予2HRZE/4HR方案治疗，异烟肼片0.3 g/次，利福平胶囊0.45 g/次，吡嗪酰胺片1.5 g/次，盐酸乙胺丁醇片0.75 g/次，1次/d，连续治疗2个月，随后继续服用异烟肼片和利福平胶囊4个月，1次/d。在对照组基础上，治疗组口服蛤蚧治痨丸，1丸/次，2次/d。两组疗程均为6个月。观察两组患者临床疗效，比较治疗前后两组患者典型表现缓解时间，痰涂片转阴率，空洞闭合率，病灶显著吸收率，肺结核病患者生存质量测定量表（PTBS）和简式抑郁–焦虑–压力量表（DASS-21）评分，及血清基质金属蛋白酶抑制剂-1（TIMP-1）、正五聚蛋白3（PTX3）、白细胞介素-8（IL-8）和可溶性白介素-2受体（sIL-2R）。结果 治疗后，治疗组总有效率（90.24%）明显高于对照组（73.17%，P＜0.05）。治疗后，治疗组各项典型表现（咳嗽、咯血等）的缓解时间明显短于对照组（P＜0.05）。治疗后，治疗组痰涂片转阴率、空洞闭合率、病灶显著吸收率明显高于对照组（P＜0.05）。治疗后，两组PTBS评分增加，而DASS-21评分减少（P＜0.05），且治疗组评分明显好于对照组（P＜0.05）。治疗后，两组血清TIMP-1、PTX3、IL-8和sIL-2R水平均显著下降（P＜0.05），且治疗组血清水平显著低于对照组（P＜0.05）。结论 蛤蚧治痨丸联合2HRZE/4HR方案治疗初治肺结核，能有效调节患者机体免疫炎症状态，对抗肺纤维化，促进痰菌转阴、空洞闭合、病灶吸收及临床表现减轻，利于患者生活质量和不良情绪体验好转。

Objective To investigate the clinical efficacy of Gejie Zhilao Pills combined with 2HRZE/4HR regimen in treatment of newly diagnosed pulmonary tuberculosis. Methods Patients (82 cases) with newly diagnosed pulmonary tuberculosis in Baoding People's Hospital from April 2021 to December 2024 were divided into control and treatment group by random number table method, and each group had 41 cases. Patients in the control group were administered with 2HRZE/4HR regimen, 0.3 g/time of Isoniazid Tablets, 0.45 g/time of Rifampicin Capsules, 1.5 g/time of Pyrazinamide Tablets, 0.75 g/time of Ethambutol Hydrochloride Tablets, once daily for 2 months, they were treated with Isoniazid Tablets and Rifampicin Capsules for 4 months, once daily. Patients in the treatment group were po administered with Gejie Zhilao Pills on the basis of the control group, 1 pill/time, twice daily. Patients in two groups were treated for 6 months. After treatment, the clinical evaluations were evaluated, and the typical performance relief time, sputum smear negative conversion rate, cavity closure rate, and significant lesion absorption rate, the scores of PTBS and DASS-21, and the serum levels of TIMP-1, PTX3, IL-8, and sIL-2R in two groups before and after treatment were compared. Results After treatment, the total effective rate in the treatment group (90.24%) was significantly higher than that in the control group (73.17%, P < 0.05). After treatment, the relief time of typical manifestations (cough, hemoptysis, etc.) in the treatment group was significantly earlier than that in the control group (P < 0.05). After treatment, the sputum smear negative rate, cavity closure rate, and significant focus absorption rate in the treatment group were significantly higher than those in the control group (P < 0.05). After treatment, PTBS scores were increased in two groups, while DASS-21 scores were decreased (P < 0.05), and the scores in the treatment group were significantly better than those in the control group (P < 0.05). After treatment, the serum levels of TIMP-1, PTX3, IL-8 and sIL-2R in two groups were decreased significantly (P < 0.05), and the serum levels in the treatment group were significantly lower than those in the control group (P < 0.05). Conclusion The combination of Gejie Zhilao Pills and 2HRZE/4HR regimen for the initial treatment of pulmonary tuberculosis can effectively regulate the patient’s immune inflammatory state, combat pulmonary fibrosis, promote sputum conversion, cavity closure, lesion absorption, and reduce clinical manifestations, which is beneficial for improving the patient’s quality of life and negative emotional experience.

R978.7

保定市科技计划项目（2341ZF132）