益活化痰方治疗慢性阻塞性肺疾病稳定期气虚血瘀痰阻证的临床研究

Efficacy and safety of Yi Huo Hua Tan granule in the treatment of stable chronic obstructive pulmonary disease(syndrome of Qi deficiency with phlegm and blood stagnation)

目的观察益活化痰方治疗慢性阻塞性肺疾病稳定期气虚血瘀痰阻证的有效性和安全性。方法选择2016年8月—2017年3月于四川大学华西医院中西医结合科门诊就诊的慢性阻塞性肺疾病稳定期气虚血瘀痰阻证患者。采用随机数字表方法,将纳入患者随机分为试验组和对照组。对照组给予西医常规治疗,试验组在西医常规治疗基础上加用益活化痰方,两组疗程均为60 d。比较两组患者的中医临床证候疗效、中医证候积分、慢性阻塞性肺疾病评估测试评分、改良版英国医学研究委员会呼吸困难量表评分、6 min步行距离、远期疗效指标、肺功能指标、血清和诱导痰上清炎症指标和安全性指标。结果共纳入患者69例。其中,试验组34例,对照组35例。使用益活化痰方治疗2个月后,试验组中医证候疗效总有效率高于对照组(44.1%vs.8.6%,P=0.001)。两组随访2、4个月比较,差异均有统计学意义(P<0.05)。治疗2个月后,试验组中医证候评分、慢性阻塞性肺疾病评估测试评分、改良版英国医学研究委员会呼吸困难量表评分、年急性加重次数、年急性加重住院次数和年急性加重总住院日均低于对照组(P<0.05)。而6 min步行距离,用力肺活量,1 s用力呼气量,1 s用力呼气量/预计值,血清和诱导痰上清中白细胞介素(interleukin,IL)-6、IL-1β、IL-10浓度在治疗后组间比较,差异均无统计学意义(P>0.05)。治疗前后患者的血常规,肝、肾功能,心电图和大、小便常规均无明显异常。结论益活化痰方可以改善慢性阻塞性肺疾病稳定期(气虚血瘀痰阻证)患者的临床症状,提高生活质量,且安全可靠,值得临床推广。

Objective To study the efficacy and safety of Yi Huo Hua Tan granule in the treatment of stable chronic obstructive pulmonary disease(COPD)patients with a traditional Chinese medicine(TCM)syndrome of Qi deficiency with phlegm and blood stagnation.Methods The stable COPD patients with a TCM syndrome of Qi deficiency with phlegm and blood stagnation who visited the outpatient in the Department of Integrated Traditional and Western Medicine,West China Hospital of Sichuan University between August 2016 and March 2017 were selected.The patients were randomly divided into an experimental group and a control group using a random number table method.Patients in both groups received conventional western medicine,with Yi Huo Hua Tan granule being additionally prescribed in patients in the experimental group.The treatment during was 60 days.The TCM effective rate,TCM syndrome score,COPD Assessment Test(CAT)score,modified Medical Research Council Dyspnea Scale,six minutes walking distance,long-term prognostic indicators,lung function indicators,inflammatory cytokines in serum and induced sputum supernatant were compared between groups.The safety of Yi Huo Hua Tan granule was also observed.Results A total of 69 patients were included,including 34 patients in the experimental group and 35 patients in the control group.After treatment of Yi Huo Hua Tan granule for 2 months,the total effective rate of TCM syndrome was 44.1% and 8.6% in the experimental group and the control group,respectively(P=0.001).There were statistically significant differences at 2 months and 4 months of follow-up visits between groups(P<0.05).After 2 months treatment,TCM syndrome score,CAT score,modified Medical Research Council score,number of acute exacerbations per year,hospitalization per year,and total length of hospital stay per year in the experimental group were lower than those in the control group(P<0.05).The six minutes walking distance,forced vital capacity,forced expiratory volume in one second,forced expiratory volume in one second/predicted value,serum,and the concentrations of interleukin(IL)-6,IL-1β,and IL-10 in induced sputum supernatant between the two groups showed no statistically significant difference(P>0.05).There was no significant change in blood routine,liver and kidney function,electrocardiogram,or urine and urine routine of the patients in the two groups.Conclusion Yi Huo Hua Tan granule improves the clinical symptoms and quality of life in patients with stable COPD,with a good safety.