目的 探讨清气化痰丸联合茶碱缓释片治疗慢性阻塞性肺疾病稳定期的临床效果。方法 选取2016年5月—2019年5月驻马店市中心医院收治的134例稳定期慢性阻塞性肺疾病患者，随机分成对照组（n=67）和治疗组（n=67）。对照组口服茶碱缓释片，1片/次，2次/d，于早晚整片用温开水送服。治疗组在对照组基础上口服清气化痰丸，6 g/次，2次/d。两组均连续治疗8周。观察两组临床疗效，比较两组改良版英国医学研究委员会呼吸问卷（mMRC）、咳嗽和咳痰的评估问卷（CASA-Q）、慢性阻塞性肺疾病患者自我评估测试（CAT）问卷]评分、6 min步行距离（6MWD）、肺功能参数[第1秒用力呼气容积（FEV₁）与用力肺活量比值（FEV₁/FVC）、一氧化碳弥散量（D_LCO）占预计值百分比（DLCO占预计值%）、FEV₁占预计值百分比（FEV₁占预计值%）、呼气峰值流量（PEF）]、呼出气一氧化氮（FeNO）水平及血清炎症指标[白三烯（LT）B4、基质金属蛋白酶（MMP）-9、C反应蛋白（CRP）]水平变化。结果 治疗后，治疗组总有效率是95.5%较对照组的85.1%显著提高（P<0.05）。治疗后，两组mMRC、CAT问卷评分均显著低于治疗前，而CASA-Q评分则均显著升高，6MWD均显著延长（P<0.05）；且治疗后，治疗组患者以上各项指标（mMRC、CASA-Q、CAT问卷评分及6MWD）的改善效果均显著优于对照组（P<0.05）。治疗后，两组患者FEV₁/FVC、D_LCO占预计值%、FEV₁占预计值%、PEF值均显著高于治疗前（P<0.05）；但治疗组肺功能指标改善更显著（P<0.05）。与治疗前相比，两组治疗后FeNO、LTB₄、MMP-9、CRP水平均显著下降（P<0.05）；但治疗组炎症相关指标降低更显著（P<0.05）。结论 清气化痰丸联合茶碱缓释片治疗慢性阻塞性肺疾病稳定期有助于缓解患者呼吸道症状，提高健康状况及运动耐力，改善肺功能，降低气道及全身炎症反应程度，值得临床推广应用。

Objective To investigate the clinical effect of Qingqi Huatan Pills combined with Theophylline Sustained-release Tablets in treatment of stable chronic obstructive pulmonary disease. Methods A total of 134 patients with stable COPD admitted to Zhumadian Central Hospital from May 2016 to May 2019 were randomly divided into control group (n=67) and treatment group (n=67). Patients in the control group were po administered with Theophylline Sustained-release Tablets with warm water in morning and evening, 1 tablet/time, twice daily. Patients in the treatment group were po administered with Qingqi Huatan Pills on the basis of the control group, 6 g/time, twice daily. Patients in two groups were treated for 8 weeks. After treatment, the clinical efficacy was evaluated. The changes of modified British Medical Research Council Respiration Questionnaire (mMRC), Cough and Sputum Assessment Questionnaire (CASA-Q), Chronic Obstructive Pulmonary Disease Patients Self-Assessment Test (CAT) Questionnaire] score, 6 min walking distance (6MWD), pulmonary function parameters [forced expiratory volume in the first second (FEV₁) to forced vital capacity ratio (FEV₁/FVC), Carbon monoxide dispersion (D_LCO) as a percentage of the predicted value (D_LCO as a percentage of the predicted value), FEV₁ as a percentage of the predicted value (FEV₁ as a percentage of the predicted value), peak expiratory flow (PEF)] value, exhaled nitric oxide (FeNO) concentration and changes in serum inflammatory indexes [leukotriene (LT) B4, matrix metalloproteinase (MMP)-9, C-reactive protein (CRP)] levels in two groups were compared. Results After treatment, the total effective rate of the treatment group was 95.5%, which was significantly higher than that of the control group (85.1%, P<0.05). After treatment, mMRC and CAT scores in both groups were significantly lower than before treatment, while CASA-Q scores were significantly increased, and 6MWD scores were significantly prolonged (P<0.05). After treatment, the improvement effect of the above indexes (mMRC, CASA-Q, CAT score and 6MWD) in the treatment group was significantly better than that in the control group (P<0.05). After treatment, FEV₁/FVC, D_LCO%, FEV₁%, and PEF value in two groups were significantly higher than those before treatment (P<0.05). However, the improvement of pulmonary function indexes in the treatment group was more significant (P<0.05). Compared with before treatment, the levels of FeNO, LTB4, MMP-9, and CRP in both groups were significantly decreased after treatment (P<0.05). However, inflammation related indexes in the treatment group decreased more significantly (P<0.05). Conclusion Qingqi Huatan Pills combined with Theophylline Sustained-release Tablets can help to relieve the patient's respiratory symptoms in treatment of stable chronic obstructive pulmonary disease, and is worthy of clinical promotion and application to improve health status and exercise endurance, also can improve lung function and reduce the degree of airway and systemic inflammatory response, which is worthy of clinical promotion and application.

R974

河南省卫计委科研项目（201702811）