目的 探討利肺膠囊聯(lián)合2HRZE/4HR方案治療初治肺結(jié)核的臨床療效。方法 選取2021年1月-2023年1月商丘市結(jié)核病防治所收治的94例初治肺結(jié)核患者，按隨機(jī)數(shù)字表法將所有患者分為對(duì)照組和治療組，每組各47例。對(duì)照組給予2HRZE/4HR方案治療，口服異煙肼片0.3 g/次，吡嗪酰胺片1.5 g/次；利福平膠囊，體質(zhì)量≥ 50 kg，0.6 g/d，體質(zhì)量<50 kg，0.45 g/d；鹽酸乙胺丁醇片0.75 g/次；均1次/d，共2個(gè)月；后繼續(xù)使用異煙肼片、利福平膠囊，劑量同前，1次/d，共4個(gè)月。治療組在對(duì)照組基礎(chǔ)上口服利肺膠囊，2粒/次，3次/d。兩組療程均為6個(gè)月。比較兩組臨床療效及痰涂片轉(zhuǎn)陰率、病灶顯著吸收率、空洞閉合率。比較治療前后兩組慢性病患者生命質(zhì)量測(cè)定量表體系之肺結(jié)核量表（QLICD-PT）評(píng)分及外周血T淋巴細(xì)胞亞群和血清糖類抗原125（CA125）、白細(xì)胞介素-17（IL-17）水平。結(jié)果 治療后，治療組總有效率為89.36%，顯著高于對(duì)照組的72.34%（P<0.05）。治療后，治療組痰涂片轉(zhuǎn)陰率、病灶顯著吸收率、空洞閉合率分別為94.87%、63.83%、60.00%，均顯著高于對(duì)照組的77.50%、42.55%、34.38%（P<0.05）。治療后，兩組QLICD-PT中生理功能評(píng)分、心理功能評(píng)分、社會(huì)功能評(píng)分、共性模塊評(píng)分、特異模塊評(píng)分、總評(píng)分均較治療前顯著升高（P<0.05）；治療后，治療組QLICD-PT評(píng)分均顯著高于對(duì)照組（P<0.05）。治療后，兩組外周血CD4⁺水平、CD4⁺/CD8⁺比值均顯著升高，外周血CD8⁺及血清CA125、IL-17水平均顯著降低（P<0.05）；治療后，治療組外周血T淋巴細(xì)胞亞群和血清CA125、IL-17水平改善優(yōu)于對(duì)照組（P<0.05）。結(jié)論 利肺膠囊聯(lián)合2HRZE4HR方案治療初治肺結(jié)核具有較好的臨床療效，能促進(jìn)痰菌轉(zhuǎn)陰、病灶吸收與空洞閉合，調(diào)節(jié)機(jī)體免疫狀態(tài)及炎癥反應(yīng)，利于生命質(zhì)量改善，值得臨床推廣應(yīng)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

商丘市科技攻關(guān)項(xiàng)目（203053）