黄芪注射液治疗慢性心力衰竭急性失代偿患者随机对照试验

目的：评价黄芪注射液治疗气虚型慢性心力衰竭急性失代偿（DCHF）患者的疗效。方法：将118例气虚类（含气阴两虚及气阳虚）DCHF患者随机分为试验组60例,对照组58例,试验组予以黄芪注射液结合西医常规治疗,对照组予以西医常规治疗,观察7天,评价两组在超声心动图、心功能分级、临床表现等方面的变化。结果：（1）试验组全部受试者未发生不良事件和药物不良反应。提示黄芪注射液治疗慢性心力衰竭急性失代偿安全性好。（2）试验组对于LVEF（P=0.003）、呼吸困难程度（P=0.002）、心功能分级改善程度（P=0.044）和Tei指数（P=0.035）的改善优于对照组。疗效评价结果显示试验组疗效优于对照组,黄芪注射液结合西医常规药物治疗DCHF效果优于单纯西医常规药物治疗,黄芪注射液治疗DCHF有效。结论：（1）本试验比较黄芪注射液与5%葡萄糖注射液结合西医常规治疗对DCHF的疗效,结果显示黄芪注射液治疗DCHF有效,可以应用于DCHF及其他急性心力衰竭的治疗。（2）本试验比较黄芪注射液与5%葡萄糖注射液治疗DCHF的安全性,结果全部受试者未发生不良反应,提示黄芪注射液安全性好。

A Randomized Controlled Trial of Astragalus Injection in the Treatment of Patients with Acute Decompensated Chronic Heart Failure and Qi-Deficiency

Objective：To observe the clinical efficacy of Astragalus injection in treating acute decompensated chronic heart failure（DCHF）.Methods：118 cases with DCHF and Qi Deficiency were randomly assigned to receive conventional therapy（control group）or conventional therapy plus Astragalus injection（treatment group）.After 7 days observations,The therapeutic efficacy and adverse reactions were compared between the two groups.Results：（1）There was no adverse Event and adverse reactions to drug happened.（2）There were significant differences between 2 groups in LVEF（P=0.003）,dyspnea situation（P=0.002）,cardiac function grade improvement（P=0.044）and Tei index（P=0.035）.In treatment group showed better improvement than in control group.Conclusions：（1）In the examination,we compared Astragalus injection with 5% glucose injection in the security,the result was no Adverse Event happened,which showes that Astragalus injection has good security.（2）In this examination,we compared Astragalus injection with 5% glucose injection in the efect to DCHF,the result showed that Astragalus injection can effectively improve heart function in DCHF patients.