破格救心汤治疗严重心力衰竭安全性研究

摘要

目的 破格救心汤中破格重用超常规剂量的附子以治疗严重心力衰竭,本研究通过临床观察探讨其用药安全性.方法 采用前瞻性、同期、开放、对照试验设计,选择54例符合入选标准的严重心力衰竭患者分别进入常规治疗组和破格救心汤组,常规治疗组给予抗心衰标准治疗,破格救心汤组在此基础上加用破格救心汤,疗程2～3周.观察两组患者用药前后的生命体征、全血细胞分析、肝功能(谷丙转氨酶、谷草转氨酶)、肾功能(尿蛋白、尿素、肌酐),持续心电监测,判断不良事件,采集安全性数据.结果 破格救心汤组治疗过程中未出现附子中毒症状,治疗后复查血常规、肝肾功能无异常,治疗全程无异常心电波动,未出现严重不良反应.结论 破格救心汤治疗严重心力衰竭具有良好的安全性.%Objective Observation of clinical safety in patients with chronic cardiac insufficiency ( heart function grade HI-IV ) patients for heart failure treatment with the additional treatment of taking Poge Jiuxin Decoction. Methods This is a pioneering study. Over the same time period, using an open, non-randomized controlled trial design, 54 subjects who met the inclusion criteria were selected who were experiencing an acute exacerbation of their chronic heart failure condition. They were divided into the treatmentrngroup or the control group. The control group was given standard conventional therapy for 2—3weeks; the treatment group was given Poge Jiuxin Decoction in addition to standard conventional therapy. Safety information data were taken. Results Our clinical research shows that blood cell analysis and the liver and kidney function are normal, no abnormal ECG fluctuations, no significant adverse events in the 34 cases taking Poge Jiuxin Decoction. Conclusion In congestive heart failure, Poge Jiuxin Decoction is safe.