摘要
目的评价扶正化瘀胶囊预防肝硬化患者食管静脉曲张破裂出血的临床疗效。方法采用随机、对照、双盲、多中心、前瞻性临床研究，181例肝硬化患者，根据食管静脉曲张程度、有无出血史分为3组：食管静脉曲张轻度大组、食管静脉曲张中／重度大组、预防再出血大组。食管静脉曲张轻度大组患者随机分配接受扶正化瘀胶囊和安慰剂治疗；食管静脉曲张中／重度大组患者随机分配接受扶正化瘀胶囊、普萘洛尔联用安慰剂、扶正化瘀胶囊联用普萘洛尔治疗；预防再出血大组患者随机分配接受普萘洛尔联用安慰剂、扶正化瘀胶囊联用普萘洛尔治疗。治疗观察2年后，随访患者至发生终点事件或至2009年2月。主要终点为食管静脉曲张破裂出血，次要终点为任何原因导致的死亡、原发性肝癌、肝移植。用Kaplan-Meier法分析各大组内各组食管静脉曲张破裂出血发生率、生存率的差异。结果经中位时间为50个月的随访，食管静脉轻度曲张患者中，扶正化瘀胶囊组累积出血率显著低于安慰剂组（3．4％对比23．7％），差异有统计学意义（x^2=4．829，P=0．028）。食管静脉中／重度曲张患者中，扶正化瘀胶囊联用普萘洛尔组（联用组）累积出血率显著低于普萘洛尔组（15．2％对比43．6％），差异有统计学意义（x^2=6．166，尸：0．013）；扶正化瘀胶囊组与普萘洛尔组、联用组与扶正化瘀胶囊组之间的累积出血率比较，尸值均大于＞0．05，差异无统计学意义。预防再出血患者中，扶正化瘀胶囊联用普萘洛尔组和普萘洛尔组的再出血中位时间分别为（40．00±17．92）个月和（7．00±2．3）个月，两组间累积再出血率比较（44．4％对比24．2％），x^2=4．433，P=0．035，差异有统计学意义。结论扶正化瘀胶囊能降低肝硬化食管静脉轻度曲张患者累积出血概率；不论是否
Objective To evaluate the efficacy of Fuzhenghuayu capsule for the prevention of oesophageal variceal bleeding in patients with liver cirrhosis. Methods A multicentre randomized placebo-controlled trial was conducted. A total of 181 liver cirrhosis patients were enrolled in the study and randomly assigned to different groups according to the level of oesophageal variceal bleeding. Patients with light oesophageal varices received Fuzhenghuayu capsule or a placebo. Patients with medium to heavy oesophageal varicesreceived either Fuzhenghuayu capsule alone, Fuzhenghuayu capsule plus propranolol, or propranolol plus a placebo. Patients with a history of oesophageal variceal bleeding received either Fuzhenghuayu capsule plus propranolol, propranolol alone, or a placebo. For all patients, the treatment lasted 2 years. The primary end point of the study was oesophageal variceal bleeding. The secondary end points were liver cancer, death by any cause, and liver transplantation. Risk of bleeding and survival were statistically assessed. Results The median follow-up time was 50 months. The patients with small oesophageal varices who were treated with Fuzhenghuayu capsule showed a significantly higher cumulative probability of bleeding than their counterparts treated with the placebo （3.4% vs. 23.7%,Z2 = 4.829,P= 0.028）. The patients with medium to heavy oesophageal varices and no history of oesophageal variceal bleeding who were treated with Fuzhenghuayu capsule plus propranolol showed a remarkably higher cumulative probability of bleeding than their counterparts treated with propranolol alone （15.2% vs. 43.6%,x^2 = 6.166, P = 0.013）. There were no significant differences between the patients treated with Fuzhenghuayu capsule alone and those treated with propranolol alone （P = 0.147） or the patients treated with Fuzhenghuayu capsule plus propranolol and those treated with Fuzhenghuayu capsule alone （P = 0.147）. The patients with history of oesophageal variceal bleeding who were treated with Fuzhenghuayu cap
出处
《中华肝脏病杂志》
CAS
CSCD
北大核心
2014年第8期594-599,共6页
Chinese Journal of Hepatology
基金
上海市教育委员会重点学科（第五期）建设项目（J50307）,上海市高校创新团队建设项目（第一期）
国家中医药管理局中医肝胆病重点学科（2010sh）
关键词
肝硬化
食管和胃静脉曲张
出血
普萘洛尔
扶正化瘀胶囊
Liver cirrhosis
Esophageal and gastric varices
Hemorrhage
Propranolol
FuzhengHuayu capsule
