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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。
The purpose of breaking the heart to save soup Extraordinary conventional doses of aconite in the treatment of severe heart failure, the study through clinical observation of its drug safety. Methods Fifty-four patients with severe heart failure who met the inclusion criteria were enrolled in the conventional treatment group and the Jiangejiuxin Decoction group respectively. The conventional treatment group was given anti-heart failure standard treatment, On this basis plus broken save heart soup, treatment 2 to 3 weeks. The vital signs, whole blood cells, hepatic function (alanine aminotransferase, aspartate aminotransferase) and renal function (urine protein, urea and creatinine) before and after treatment were observed in both groups. The ECG was monitored continuously to judge the adverse events and the safety data were collected. Results The treatment of broken heart Xin Tang group did not appear symptoms of aconitine poisoning, blood routine examination after treatment, no abnormal liver and kidney function, the whole course of treatment without abnormal ECG fluctuations, no serious adverse reactions. Conclusion Dangerous Heart Soup treatment of severe heart failure has good safety.