【摘要】 目的评价中药健脾益肺Ⅱ号对慢性阻塞性肺疾病(COPD)稳定期的疗效和安全性。方法选取COPD稳定期患者263例,将病例按2∶1比例随机分为治疗组178例和对照组85例,两组分别予健脾益肺Ⅱ号和安慰剂,疗程2个月,随访4个月。观察治疗前、治疗后及随访后两组患者6分钟步行距离、生存质量评分(SGRQ)、肺功能、BODE指数、中医证候评分变化及不良反应。结果治疗组患者治疗后和随访后与治疗前比较6分钟步行距离明显增加(P<0.01);两组患者治疗后、随访后SGRQ总分、中医证候评分与本组治疗前比较差异均有统计学意义(P<0.01),且在治疗后两组间比较差异有统计学意义(P<0.05);中医证候疗效治疗组优于对照组(P<0.01);两组患者肺功能、BODE指数、安全性指标差异无统计学意义(P>0.05)。结论健脾益肺Ⅱ号治疗COPD稳定期患者疗效确切,可提高患者生存质量,增加运动耐量,改善症状,安全性好。更多还原

【Abstract】 Objective To evaluate the efficacy and safety of Jianpi YifeiⅡ (granules of strengthening the spleen and improving the lung)in the treatment of chronic obstructive pulmonary disease(COPD)in the stable stage.Methods Totally 263 COPD patients in the stable stage were randomized into treatment group of 178cases and control group of 85cases.They were given Jianpi YifeiⅡand placebo respectively for 2months and followed up for 4months.Six-minutes walking distance,score of the St.George’s Respiratory Questionnaire(SGRQ),pulmonary functions,BODE index,TCM syndrome score,and adverse reaction were observed.Results After treatment and follow-up,six-minutes walking distance of the treatment group was significantly increased(P<0.01).The total SGRQ score and TCM syndrome score of both groups were statistically different(P<0.01)in the in-group comparison as well as in the between-group comparison(P<0.05).The efficacy of TCM syndrome in the treatment group was better than that in the control group(P<0.01).The pulmonary functions,BODE index, and safety of both groups were without statistical difference(P>0.05).Conclusion Jianpi YifeiⅡis effective in the treatment of COPD patients in stable stage,improving the quality of life,increasing exercise tolerance,and relieving symptoms, with a safe result.更多还原