破血逐瘀中药对急性脑出血血肿影响的前瞻性随机双盲对照研究

Effect of Chinese Drugs for Breaking Blood Expelling Stasis on Acute Cerebral Hemorrhage: a Prospective Randomized Double-blind Controlled Study

目的研究高血压脑出血患者发病6 h之内使用破血逐瘀中药的安全性,观察其是否可导致血肿扩大。方法采用前瞻性随机双盲对照临床研究。将128例来自2013年10月—2015年3月8个研究中心6 h内脑出血患者(最终76例纳入分析)按简单随机抽样方法分为A、B、C 3组,A组予破血逐瘀中药全方(26例),B组予去破血逐瘀药物方(在A组基础上去掉水蛭、虻虫,25例),C组予安慰剂(25例),各组均持续给药10天。观察患者发病24 h血肿扩大率、不良反应和不良事件的发生。为保证试验的安全性,本次为一级揭盲的中期分析。结果 A组血肿扩大率为11.5%(3/26),B组血肿扩大率为16.0%(4/25),C组血肿扩大率为20.0%(5/25),各组间比较,差异无统计学意义(χ2=0.823,P=0.682)。76例患者发生不良反应和不良事件7例,其中A组出现1例急性心肌梗死,1例胸闷、心慌,2例腹泻;B组则无不良反应和不良事件发生;C组出现3例腹泻。结论中期一级揭盲未见6 h之内使用破血中药导致血肿扩大。

Objective To study the safety of using Ch stasis （ CDBBES） in hypertension patients with intracerebral whether they would result in hematoma enlargement. Methods inese drugs for breaking blood expelling hemorrhage within 6 h, and to observe A prospective randomized double-blind controlled clinical study was employed. Totally 128 cerebral hemorrhage patients within 6 h were recruited from 8 research centers from October 2013 to March 2015, and finally 76 of them were included. These patients were assigned to 3 groups by simple random sampling, group A, B, and C. Patients in group A （26 cases） took whole CDBBES recipe （containing leeches and equivalent insects）. Those in group B （25 cases） took CDBBES recipe （removing leech and gradfly）. Those in group C （25 cases） took place- bos. Medication lasted for 10 successive days. The hematoma enlargement rate within 24 h, the occur- rence of adverse reactions and adverse events were observed. To guarantee the safety of this trial, an interim analysis of first level unblinding was used. Results The hematoma enlargement rate was 11.5% （3/26） in group A, 16.0% （4/25） in group B, and 20.0% （5/25） in group C. There was no statistical difference in the hematoma enlargement rate among the 3 groups （χ^2 =0. 823, P =0. 682）. Adverse reactions and adverse events occurred in 7 cases, 1 patient with acute myocardial infarction, 1 with chest oppression and palpitation, 2 with diarrhea in group A. No patient had adverse reaction or adverse event in group B. And diarrhea occurred in 3 patients of group C. Conclusion The interim analysis of first level unblinding showed that hematoma enlargement within 6 h was not resulted from using CDBBES.