三伏天服用真武汤防治慢性阻塞性肺疾病的随机对照研究
A Randomized Controlled Study on the Prevention and Treatment of Chronic Obstructive Pulmonary Disease by Taking Zhenwu Decoction in Sanfutian

目的：研究三伏天服用真武汤防治慢性阻塞性肺疾病的临床疗效。方法：采用前瞻性、平行组设计、大样本、双盲、分层区组随机对照研究的方法，入组患者均为慢阻肺“ABCD”评估中的D组患者共236人，随机分为治疗组和对照组，各118例，两组患者的基础治疗为戒烟、呼吸肌锻炼、三联药物吸入(布地奈德福莫特罗粉吸入剂160/4.5 μg，1吸，一日2次；噻托溴铵粉吸入剂18 μg，1吸，一日1次)，疗程为1年(2020-07-16~2021-07-16)，治疗组在基础治疗上增加冬病夏治内治法，即三伏天服用真武汤，疗程为40天(2020-07-16~2020-08-24)，对照组在基础治疗上增加三伏天服用安慰剂中药汤剂，疗程为40天(2020-07-16~2020-08-24)，观察统计两组患者治疗开始后1年内中到重度急性加重率；治疗1年后FEV1谷值反应；CAT评分、SGRQ评分的变化；应急药物使用数量。结论：对照组中到重度急性加重率高于治疗组，差异有统计学意义(P < 0.05)。两种治疗方法均能改善CAT评分、SGRQ评分，差异有统计学意义(P < 0.05)；治疗组更能改善CAT评分、SGRQ评分，差异有统计学意义(P < 0.05)；两种治疗方法均不能改善FEV1 (P > 0.05)。治疗组使用应急药物数量少于对照组，差异有统计学意义(P < 0.05)。两组不良反应发生率无明显差别(P > 0.05)。结论：三伏天服用真武汤防治慢性阻塞性肺疾病安全有效。
Objective: To study the clinical efficacy of taking Zhenwu Decoction in the prevention and treatment of chronic obstructive pulmonary disease during the dog days. Methods: A prospective, parallel group design, large-sample, double-blind, stratified block randomized controlled study method was used. The enrolled patients were all 236 patients in group D in the COD “ABCD” assessment, and they were randomly divided into the treatment group and the control group, each with 118 cases. The basic treatment of the two groups of patients is smoking cessation, breathing muscle exercise, triple drug inhalation (budesonide formoterol powder inhalation 160/4.5 μg, 1 inhalation, 2 times a day; Tiotropium bromide powder inhalation 18 μg, 1 inhalation, once a day), the course of treatment is 1 year (2020-07-16~2021-07-16), the treatment group adds winter disease and summer treatment to the basic treatment, that is, take Zhenwu Decoction on dog days for 40 days (2020-07-16~2020-08-24), and the control group will take placebo traditional Chinese medicine decoction on dog days (2020-07-16~2020-08-24) to observe and count the moderate to severe acute exacerbation rates of the two groups of patients within 1 year after the start of treatment; FEV1 trough response after 1 year of treatment; changes in CAT score and SGRQ score; and the number of emergency medications used. Conclusion: The rate of moderate to severe acute exacerbation in the control group was higher than that in the treatment group, and the difference was statistically significant (P < 0.05). The two treatment methods can improve the CAT score and SGRQ score, the difference is statistically significant (P < 0.05); the treatment group can improve the CAT score and SGRQ score, the difference is statistically significant (P < 0.05); none of them could improve FEV1 (P > 0.05). The number of emergency drugs used in the treatment group was less than that in