前列腺素E1脂微球载体注射液治疗病毒性肝炎的有效性和安全性评价

目的系统评价前列腺素E1脂微球载体注射液治疗病毒性肝炎的有效性和安全性。方法采用Cochrane系统评价方法,计算机检索MEDLINE、EMbase、Cochrane图书馆临床对照试验数据库(CENTRAL)和CNKI等数据库,检索时间从1978年到2007年。纳入在治疗病毒性肝炎中,以前列腺素E1脂微球载体注射液为试验组,其他药物或空白治疗为对照组的随机对照试验。由2名研究者独立评价纳入研究的方法学质量,并采用RevMan 4.2.7软件对相关数据进行Meta分析。结果共纳入包括1218例患者的14个研究,研究质量均为C级。其中1个研究为前列腺素E1脂微球载体注射液与脉安定注射液对比,1个研究为前列腺素E1脂微球载体注射液与门冬氨酸钾镁对比,其余12个研究为前列腺素E1脂微球载体注射液与空白对照比较。Meta分析结果显示:前列腺素E1脂微球载体注射液在总有效率上明显优于空白对照组[RR1.45,95%CI(1.29,1.63)],但在用药后注射部位静脉血管潮红疼痛发生率也高于空白对照组[RR7.70,95%CI(2.57,23.07)],其余副反应发生率前列腺素E1脂微球载体注射液虽高于空白对照,但差异无统计学意义;前列腺素E1脂微球载体注射液在死亡率上低于空白对照组[RR0.66,95%CI(0.53,0.83)]。因各文献数据存在临床异质性,故无法判断前列腺素E1脂微球载体注射液在肝功能恢复上是否优于空白对照组。前列腺素E1脂微球载体注射液与脉安定注射液治疗后总有效率的差异无统计学意义(P>0.05);但前列腺素E1脂微球载体注射液在总有效率上优于门冬氨酸钾镁[RR1.54,95%CI(1.14,2.08)]。结论现有研究结果显示,与空白对照组相比,前列腺素E1脂微球载体注射液可明显提高病毒性肝炎治疗后总有效率,并降低死亡率,但其副反应发生率高于空白对照组;对前列腺素E1脂微球载体注射液是否有助于肝功能恢复,尚无肯定结论。前列腺素E1脂微球载体注射液治疗病毒性肝炎的疗效与安全性和脉安定注射液无明显差别,而优于门冬氨酸钾镁,但其证据强度很弱。

Effectiveness and Safety of Lipo-prostaglandin E1 Injection for Viral Hepatitis: A Systematic Review

Objective To evaluate the effectiveness and safety of Lipo-prostaglandin E1 injection in treating viral hepatitis.Methods We searched MEDLINE ,EMBASE , The Cochrane Library and CNKI from 1978 to June 2007. We identified randomized controlled trials of Kai Shi injection versus other medicines or blank control in treating viral hepatitis. The quality of included trials was evaluated independently by two reviewers. Meta-analyses were performed with The Cochrane Collaboration's RevMan 4.2.7 software. Results Fourteen studies involving 1 218 patients were included , one of these compared Lipo-prostaglandin E1 injection versus Mai Anding injection ,one compared Lipo-prostaglandin E1 injection versus potassium-magnesium aspartate injection, and the other 12 compared Lipo-prostaglandin E1 injection versus blank control. All included studies were assessed in terms of randomization ,allocation concealment and bl inding; and all were graded C(poor quality). Meta-analyses showed that ,the total effective rate was significantly higher in the Lipo-prostaglandin E1 injection group[RR 1.45 ,95%CI (1.29 ,1.63)] and the mortality was lower[RR 0.66 ,95%CI (0.53 ,0.83)] compared with the blank control group ,but the incidence of phlebitis was significantly higher [RR 7.70 ,95%CI (2.57 ,23.07)]. There was no significant difference between Mai Anding injection and Lipo-prostaglandin E1 injection in the total effective rate ,but Lipo-prostaglandin E1 injection was more effective in improving patients' liver functions. Compared with potassium-magnesium aspartate injection ,the total effective rate was significantly higher in the Lipo-prostaglandin E1 injection group[RR1.54 , 95%CI (1.14 ,2.08)]. Conclusion The evidence currently available shows that the effectiveness and safety of Lipo-prostaglandin E1 injection are not significantly different from those of Mai Anding injection for patients with viral hepatitis. Compared with potassium-magnesium aspartate injection ,Lipo-prostaglandin E1 injection could significantly improve the total effective rate ,but since we only include 1 relevant randomized trials ,the strength of this evidence is weak. When compared with the blank control ,Lipo-prostaglandin E1 injection significantly improved the total effective rate ,decreased mortality but increased the incidence of side effects and the existing evidence is insufficiant to show whether Lipo-prostaglandin E1 injection improves patients' liver functions.