芪参益气滴丸治疗冠心病稳定型心绞痛气虚血瘀证临床观察

Clinical Study of Qishen Yiqi Dropping Pills in the Treatment of Stable Angina Pectoris of Coronary Heart Disease with Syndrome of Qi Deficiency and Blood Stasis

目的观察芪参益气滴丸治疗冠心病稳定型心绞痛气虚血瘀证的有效性和安全性。方法选取2017年1月—2018年12月在常州市中医医院确诊为冠心病稳定型心绞痛,中医辨证为气虚血瘀型患者共60例,随机分成芪参益气组和常规治疗组各30例,常规芪参益气组予以标准常规治疗,芪参益气组在常规治疗组的基础上加服芪参益气滴丸,每次0.5 g,每日3次,治疗时间为8周,采用中医证候积分、中文简易疲乏量表(Brief Fatigue Inventory-Chinese version,BFI-C)、西雅图心绞痛量表(Seattle Angina Questionnair,SAQ)评价其疗效,运用血常规、肝肾功能等评价其安全性。结果治疗前2组中医证候积分、中文版简易疲乏量表积分、西雅图心绞痛量表积分无明显差异。治疗后常规治疗组中医证候积分、中文版简易疲乏量表积分、西雅图心绞痛量表积分治疗前后比较无明显变化,芪参益气组各项积分与治疗前比较有明显改善(P<0.05),而且2组前后差异变化比较有统计学意义(P<0.05)。结论芪参益气滴丸能明显改善冠心病稳定型心绞痛气虚血瘀证患者症状,提高生活质量,无明显不良反应。

Objective To evaluate the efficacy and safety of Qishen Yiqi dropping pills in the treatment of stable angina pectoris of coronary heart disease with syndrome of qi deficiency and blood stasis.Methods A randomized clinical trial was carried out in 60 patients with the syndrome of qi deficiency and blood stasis.Patients were randomly divided into two groups.The QSYQ group was treated with routine treatment and Qishen Yiqi dropping pills.The control group was treated with routine treatment.The efficacy of Qishen Yiqi dropping pills was evaluated,including score of TCM syndrome,score of BFI-C and score of SAQ.Safety indicators were observed such as the physical examination,adverse events and adverse reaction,hematuria,liver and kidney function.Results After 8-weeks treatment,the TCM syndrome score and the BFI-C score in QSYQ group were lower than that of the control group(P<0.05).The SAQ score in QSYQ group were significantly higher than control group(P<0.05).The incidence of adverse events was no significant difference between the two groups(P>0.05).Conclusion Qishen Yiqi dropping pills is effective and safe for the treatment of stable angina pectoris in patients with the syndrome of qi deficiency and blood stasis.