多烯磷脂酰胆碱(易善复)治疗酒精性肝病和脂肪肝的系统评价

Polyunsaturated phosphatidylcholine (Essentiale) for alcoholic/fatty liver:A systematic review

目的 评价多烯磷脂酰胆碱 (易善复 )治疗酒精性肝病 脂肪肝的疗效与安全性。方法 应用国际Cochrane协作网的系统评价方法 ,对关于易善复与安慰剂 不治疗相比较治疗酒精性肝病 脂肪肝的随机对照试验进行系统评价。结果 共检索出 1694篇文献。经评估后 6个随机对照试验包含 662例患者符合纳入标准。 6篇文献都没有报道和易善复相关的不良反应。 1个试验 ,10 4例患者的研究表明 ,易善复有降低酒精性肝病患者早期死亡率的趋势 (2 2 .6%对3 9.2 % ;相对危险度 0 .5 0 ,95 %可信区间 0 .3 2～ 1.0 6,P =0 .0 7)。 4个试验 ,14 6例患者的Meta 分析显示 ,易善复治疗酒精性肝病或脂肪肝的有效率为 83 .5 % ,对照组的有效率为 41.7% ,差异具有统计学意义 (相对危险度 2 .2 0 ,95 %可信区间1.0 8～ 4.5 0 ,异质性检验P =0 .0 3 )。 3个试验的Meta 分析显示 ,易善复有防止酒精性肝病 脂肪肝患者病理组织学恶化的趋势 ,但是 ,并不能改善患者的组织学。结论 易善复治疗酒精性肝病 脂肪肝是安全的 ,它可以提高酒精性肝病 脂肪肝患者治疗的有效率 ,改善患者的临床症状和体征。

Objective To evaluate the efficacy and safety of Polyunsaturated phosphatidylcholine (PPC) for alcoholic/fatty liver. Methods Randomized controlled trials comparing PPC versus placebo/no treatment for alcoholic/fatty liver were identified by electronic and manual searches. No blinding、language and publishing were applied. The methodological quality of trials was assessed in four aspect: generation of the allocation sequence、allocation concealment、blinding and follow-up. Two reviewers independently assessed the methodological quality and extracted data on patients、methods、interventions and outcomes. All the data was analyzed by the software of RevMan 4.2 supplied by the Cochrane Collaboration.Results Six trials involving 662 patients were included. The methodological quality was high in six randomized controlled trials. No serious adverse events were reported. One study involving 102 patients concerned for mortality. The results indicated that PPC can reduce the early mortality ((22.6%) vs (39.2%), relative risk, RR (0.50), 95% confidence interval, CI(0.32)～(1.06),P=(0.007)). Four studies involving 146 patients concerned for efficacy. The combined results showed that PPC had positive effect on alcoholic/fatty liver((83.5%) vs (41.7%), RR(2.20); 95% CI(1.08)～(4.50)). Three articles including 546 patients reported the result of biopsy. The combined results showed that the drug had no effect on histology improving. But the drug has the trend for preventing histology warnsening.Conclusion PPC treatment is effective for alcoholic/fatty liver and improve the clinic symptoms and singns. It has the positive tendency of reducing mortality and prevent histology worsening for alcoholic /fatty liver.