目的 通过开展清咳平喘颗粒治疗慢性阻塞性肺疾病急性加重（acute exacerbation of chronic obstructive pulmonary disease，AECOPD）（痰热郁肺证）的临床研究，观察其对AECOPD临床症状的改善情况及炎症指标的调节作用，评价清咳平喘颗粒治疗AECOPD（痰热郁肺证）的有效性和安全性。方法 采用前瞻性、随机、平行、对照的临床研究设计，将2022年3月—2023年4月就诊于河北省中医院呼吸科病房的痰热郁肺证AECOPD患者100例，使用随机数字表法分成对照组、试验组各50例。对照组给予常规西医对症治疗，试验组在常规治疗基础上给予清咳平喘颗粒治疗，疗程14 d。观察两组的临床疗效，比较两组患者慢阻肺评估测试（COPD assessment test，CAT）评分、改良版英国医学研究委员会呼吸困难问卷（modified medical research council，mMRC）评分和中医证候量表评分，血气指标、6 min步行试验（6 min walking test，6MWT）距离、血清白细胞介素-6（interleukin-6，IL-6）和降钙素原（procalcitonin，PCT）水平、实际住院天数及不良反应发生情况。结果 试验组总有效率（97.92%）高于对照组的93.62%，但差异不具有显著性（P＞0.05）。治疗后，两组中医证候积分和CAT、mMRC评分均较治疗前降低（P＜0.05），且试验组中医证候积分和CAT、mMRC评分较对照组下降更明显（P＜0.05）。治疗后，两组血二氧化碳分压（pCO₂）较治疗前明显降低，血氧分压（pO₂）、6MWT较治疗前明显升高（P＜0.05）；且试验组pCO₂、pO₂、6MWT较对照组明显改善（P＜0.05）。治疗后，两组血清PCT、IL-6水平均较治疗前明显降低（P＜0.05）；与对照组比较，试验组治疗第1周末血清PCT、IL-6水平差异不明显（P＞0.05），治疗第2周末，试验组血清PCT、IL-6水平下降更明显（P＜0.05）。两组比较试验组实际住院天数明显短于对照组（P＜0.05）。在不良反应方面，观察期间，两组均未发现明显的严重不良反应，安全性良好。结论 清咳平喘颗粒可有效改善AECOPD（痰热郁肺证）的临床症状及各项试验指标，且具有较好的安全性，值得在临床进一步研究推广。

Objective To observe the improvement of clinical symptoms and the regulation of inflammatory factors of acute exacerbation of chronic obstructive pulmonary disease (AECOPD), then to evaluate the clinical efficacy and safety of Qingke Pingchuan Granules (清咳平喘颗粒) in the treatment of AECOPD (phlegm heat stagnation lung syndrome) through clinical study. Methods Using a prospective, randomized, parallel, and controlled clinical study design, a total of 100 AECOPD patients with phlegm heat stagnation lung syndrome who were admitted to the respiratory ward of Hebei Hospital of Traditional Chinese Medicine from March 2022 to April 2023 were randomly divided into control group and experimental group method with 50 patients in each group using a random number table method. The control group received symptomatic treatment with conventional Western medicine. On the basis of routine treatment, patients in the experimental group were treated with Qingke Pingchuan Granules for two weeks. The clinical efficacy of the two groups was observed, and the scores of COPD assessment test (CAT), modified medical research council (mMRC) and traditional Chinese medicin (TCM) syndrome scale score, blood gas index, 6 min walking test (6MWT) distance, serum interleukin-6 (IL-6) and procalcitonin (PCT) level, real hospitalization duration and occurrence of adverse reactions were compared between the two groups. Results The total effective rate of experimental group (97.92%) was higher than that of control group (93.62%), but the difference was not significant (P > 0.05).. After treatment, TCM syndrome, CAT and mMRC scores in both groups were lower than before treatment (P < 0.05), and TCM syndrome, CAT and mMRC scores in experimental group were more significantly lower than those in control group (P < 0.05). After treatment, blood carbon dioxide partial pressure (pCO₂) was significantly decreased, partial pressure of blood oxygen (pO₂) and 6MWT were significantly increased (P < 0.05). pCO₂, pO₂ and 6MWT in experimental group were significantly improved compared with control group (P < 0.05). After treatment, serum PCT and IL-6 levels in both groups were significantly decreased compared with those before treatment (P < 0.05). Compared with the control group, the serum PCT and IL-6 levels of experimental group had no significant difference at the first weekend of treatment (P > 0.05), but the serum PCT and IL-6 levels of experimental group decreased more significantly at the second weekend of treatment (P < 0.05). The actual hospitalization days of the experimental group were significantly shorter than that of the control group (P < 0.05). In terms of adverse reactions, no obvious serious adverse reactions were found in both groups during the observation period, and the safety was good. Conclusion Qingke Pingchuan Granules can effectively improve the clinical symptoms and various experimental indicators of AECOPD (phlegm heat lung syndrome), and has good safety, which is worth further research and promotion in clinical practice.

R285.64

河北省中医药管理局科研计划项目（2021079）；河北省中医药管理局科研计划项目（2019029）