目的 评估清咳平喘颗粒治疗慢性阻塞性肺疾病急性加重期（acute exacerbation of chronic obstructive pulmonary disease，AECOPD）痰热壅肺证患者的疗效和安全性。方法 纳入60例来自广东省中医院门诊及住院的AECOPD痰热壅肺证患者，采用中央随机分配系统将患者随机分成试验组和对照组，每组各30例。在西医常规治疗的基础上，试验组口服清咳平喘颗粒，对照组口服清咳平喘颗粒安慰剂，疗程14 d。观察两组的临床疗效。比较两组患者治疗前后咳嗽和咳痰评估问卷（cough and sputum assessment questionnaire，CASA-Q）、改良版英国医学研究委员会呼吸困难问卷（modified medical research council，mMRC）、临床慢性阻塞性肺疾病（chronic obstructive pulmonary disease，COPD）问卷（clinical COPD questionnaire，CCQ）、慢阻肺评估测试（COPD assessment test，CAT）评分及白细胞计数的变化。结果 治疗后，试验组咳嗽总有效率为75.00%，高于对照组的60.71%；试验组咳痰总有效率为64.29%，高于对照组的53.57%，但组间差异均无统计学意义（P>0.05）。试验组治疗前后CASA-Q的咳嗽症状评分差值显著高于对照组（P<0.05），而咳嗽影响、咳痰症状和咳痰影响评分的差值试验组均高于对照组，但组间差异无统计学意义（P>0.05）；治疗后，两组mMRC评分均显著降低（P<0.05），且试验组的mMRC评分明显低于对照组（P<0.05）；治疗后，两组CCQ和CAT评分较治疗前均明显降低（P<0.05），试验组CCQ和CAT评分均低于对照组，但组间差异无统计学意义（P>0.05）；两组治疗后的白细胞计数差异无统计学意义（P>0.05）。治疗期间两组不良事件的发生率无统计学差异（P>0.05），无严重不良事件发生。结论 在西医常规治疗基础上联合清咳平喘颗粒口服能够减轻AECOPD患者的咳嗽症状，并能降低患者的mMRC评分，改善呼吸困难症状，且安全性较好。

Objective To evaluate the efficacy and safety of Qingke Pingchuan Granules (清咳平喘颗粒) in the treatment of acute exacerbation of chronic obstructive pulmonary disease (AECOPD) with phlegm-heat obstructing lung syndrome. Methods A total of 60 patients with phlegm-heat obstructing lung syndrome of AECOPD from outpatients and inpatients of Guangdong Hospital of Chinese Medicine were included. The patients were randomly divided into experimental group and control group by central random distribution system, with 30 cases in each group. Based on conventional western medicine treatment, the experimental group was given Qingke Pingchuan Granules, and the control group was given Qingke Pingchuan Granules placebo. The course of treatment was 14 d. The clinical effect of the two groups was observed. The changes of cough and sputum assessment questionnaire (CASA-Q), modified medical research council (mMRC), clinical chronic obstructive pulmonary disease (COPD) questionnaire (CCQ), COPD assessment test (CAT) and white blood cell (WBC) count before and after treatment were compared between the two groups. Results After treatment, the total effective rate of cough in the experimental group was 75.00%, which was higher than that of the control group (60.71%). The total effective rate of sputum in experimental group was 64.29%, which was higher than that in control group (53.57%), but there was no statistical significance between groups (P > 0.05). The difference of CASA-Q cough symptom score before and after treatment in the experimental group was significantly higher than that in the control group (P < 0.05), and the difference of cough influence, sputum symptom and sputum influence score in the experimental group was higher than that in the control group, but there was no significant difference between the two groups (P > 0.05). After treatment, the mMRC score of both groups was significantly decreased (P < 0.05), and the mMRC score of experimental group was significantly lower than that of control group (P < 0.05). After treatment, CCQ and CAT scores in both groups were significantly lower than before treatment (P < 0.05), and CCQ and CAT scores in experimental groups were lower than those in the control group, but there was no statistical significance between two groups (P > 0.05). There was no significant difference in WBC count between the two groups after treatment (P > 0.05). There was no significant difference in the incidence of adverse events between the two groups during treatment (P > 0.05), and no serious adverse events occurred. Conclusion Conventional western medicine treatment combined with oral Qingke Pingchuan Granules can alleviate the cough symptoms of AECOPD patients, and can reduce the mMRC score of patients, and improve the symptoms of dyspnea, with good safety.

R285.64

国家自然科学基金资助项目（82074343）；广州市科技计划项目（202002020042）；广东省中医院中医药科学技术研究专项（YN2018QL07）；广东省中医院周仲瑛学术经验传承工作室（中医二院[2014]89号）