目的 探討回生甘露丸聯(lián)合乙胺吡嗪利福異煙片治療初期肺結核的安全性與有效性。方法 選取2017年3月—2020年3月在河南省胸科醫(yī)院診治的91例初期肺結核患者，根據入組順序分成對照組（45例）和治療組（46例）。對照組飯前1 h頓服乙胺吡嗪利福異煙片，體質量30～37 kg者2片/d，體質量38～54 kg者3片/d，體質量55～70 kg者4片/d，體質量71 kg以上者5片/d；治療組在對照組基礎上口服回生甘露丸，4丸/次，2次/d。兩組患者治療6個月。觀察兩組患者臨床療效，比較治療前后兩組患者痰涂片轉陰率和空洞消失率，QLICD-PT評分和ARS評分，血清腫瘤壞死因子-α（TNF-α）、白細胞介素-1β（IL-1β）和糖類抗原125（CA125）水平及不良反應情況。結果 治療后，治療組治療初期肺結核總有效率為89.13%，明顯高于對照組的62.22%（P<0.05）。治療后，治療組痰涂片轉陰率和空洞消失率明顯高于對照組（97.78%vs 84.78%、69.57%vs 46.67%，P<0.05）。治療后，兩組患者QLICD-PT評分明顯升高，而ARS評分明顯降低（P<0.05），且治療組QLICD-PT評分和ARS評分明顯優(yōu)于對照組（P<0.05）。治療后，兩組血清TNF-α、IL-1β、CA125水平顯著降低（P<0.05），且治療組明顯低于對照組（P<0.05）。治療期間，治療組患者不良反應發(fā)生率明顯低于對照組（10.87%vs 33.33%，P<0.05）。結論 回生甘露丸聯(lián)合乙胺吡嗪利福異煙片治療初期肺結核安全有效，可改善治療依從性和生存質量，調節(jié)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

河南省醫(yī)學科技攻關計劃項目（2018020544）