目的 探讨回生甘露丸联合乙胺吡嗪利福异烟片治疗初期肺结核的安全性与有效性。方法 选取2017年3月—2020年3月在河南省胸科医院诊治的91例初期肺结核患者，根据入组顺序分成对照组（45例）和治疗组（46例）。对照组饭前1 h顿服乙胺吡嗪利福异烟片，体质量30～37 kg者2片/d，体质量38～54 kg者3片/d，体质量55～70 kg者4片/d，体质量71 kg以上者5片/d；治疗组在对照组基础上口服回生甘露丸，4丸/次，2次/d。两组患者治疗6个月。观察两组患者临床疗效，比较治疗前后两组患者痰涂片转阴率和空洞消失率，QLICD-PT评分和ARS评分，血清肿瘤坏死因子-α（TNF-α）、白细胞介素-1β（IL-1β）和糖类抗原125（CA125）水平及不良反应情况。结果 治疗后，治疗组治疗初期肺结核总有效率为89.13%，明显高于对照组的62.22%（P<0.05）。治疗后，治疗组痰涂片转阴率和空洞消失率明显高于对照组（97.78%vs 84.78%、69.57%vs 46.67%，P<0.05）。治疗后，两组患者QLICD-PT评分明显升高，而ARS评分明显降低（P<0.05），且治疗组QLICD-PT评分和ARS评分明显优于对照组（P<0.05）。治疗后，两组血清TNF-α、IL-1β、CA125水平显著降低（P<0.05），且治疗组明显低于对照组（P<0.05）。治疗期间，治疗组患者不良反应发生率明显低于对照组（10.87%vs 33.33%，P<0.05）。结论 回生甘露丸联合乙胺吡嗪利福异烟片治疗初期肺结核安全有效，可改善治疗依从性和生存质量，调节血清因子水平。

Objective To investigate the safety and efficacy of Huisheng Ganlu Pills combined with ethambutol in treatment of initial pulmonary tuberculosis. Methods Patients (91 cases) with initial pulmonary tuberculosis in Henan Chest Hospital from March 2017 to March 2020 were divided into control (45 cases) and treatment (46 cases) groups according to the order of inclusion. Patients in the control group were po administered with Ethambutol Hydrochloride, Pyrazinamide, Rifampicin and Isoniazid Tablets 1 h before meal, 2 tablets/d for patients weighing 30-37 kg, 3 tablets/d for patients weighing 38-54 kg, 4 tablets/d for patients weighing 55-70 kg, 5 tablets/d for patients weighing more than 71 kg. Patients in the treatment group were po administered with Huisheng Ganlu Pills, 4 pills/time, twice daily. Patients in two groups were treated for 6 months. After treatment, the clinical efficacy was evaluated, the negative conversion rate of sputum smear and disappearance rate of cavity, QLICD-PT score and ARS score, levels of serum TNF-α, IL-1β, and CA125, and adverse reactions in two groups before and after treatment were compared. Results After treatment, the clinical effective rate of pulmonary tuberculosis in the treatment group was 89.13%, which was significantly higher than 62.22% in the control group (P < 0.05). After treatment, the sputum smear negative rate and cavity disappearance rate in the treatment group were significantly higher than those in the control group (97.78% vs 84.78%, 69.57% vs 46.67%, P < 0.05). After treatment, the QLICD-PT scores in two groups were significantly increased, while the ARS score were significantly decreased (P < 0.05), and the QLICD-PT score and ARS score in the treatment group were significantly better than those in the control group (P < 0.05). After treatment, the levels of serum TNF-α, IL-1β and CA125 in two groups were significantly decreased (P < 0.05), and which in the treatment group were significantly lower than those in the control group (P < 0.05). During the treatment, the incidence of adverse reactions in the treatment group was significantly lower than that in the control group (10.87% vs 33.33%, P < 0.05). Conclusion Huisheng Ganlu Pills combined with ethambutol in treatment of initial pulmonary tuberculosis is safe and effective, which can improve treatment compliance and quality of life, and regulate the level of serum factors.

R974

河南省医学科技攻关计划项目（2018020544）