复方支链氨基酸颗粒剂治疗肝硬化低蛋白血症多中心临床观察

目的 观察口服复方支链氨基酸颗粒剂（商品名力维特，Livact)对肝硬化低蛋白血症的疗效和安全性。方法 上海地区6家医院共选择有低蛋白血症的肝硬化患者172例，其中治疗组120例，对照组52例，分别给予复方支链氨基酸颗粒剂和对照组药物复合氨基酸胶囊，治疗4周和9周后观察其临床太，血清总蛋白和白蛋白及Fisher比值的变化，评估其有效性和安全性。结果 复方支链氨基酸颗粒剂治疗组和对照组各项症状在治疗后均有显著改善（P＜0．05），其中复方支链氨基酸颗粒剂对疲劳感的改善情况优于对照组（P＝0．03）。复方支链氨基酸颗粒剂组在治疗4周和9周后，血清总蛋白和白蛋白均显著升高（P均为0．0001），Fisher比值复方支链氨基酸颗粒剂组治疗4周和9周后较前有显著改变（P分别为0．0005和0．0001），对照组则无明显变化（P＝0．75）。治疗过程中，复方支链氨基酸颗粒剂组和对照组的不良反应发生率为分别为7．50％和3．85％，程度均较轻。结论 复方支链氨基酸颗粒剂是治疗肝硬化低蛋白血症有效而安全的药物。

The efficacy and safety of a branched-chain amino acids granules in the treatment of cirrhotic hypoproteinemia--A multicenter, randomised, control study

Objective To investigate the efficacy and safety of a branched-chain oral amino acids granules (BCAA-G) on the cirrhotic hypoproteinemia. Methods 172 patients with cirrhotic hypoproteinemia from 6 hospitals in Shanghai area were studied. BCAA-G and control drug (amino acids capsule) were used respectively for 9 weeks. Symptoms、plasma protein、albumin and Fisher score were evaluated at 4 and 9 weeks to assess the efficacy and safety of BACC-G. Results After 4 and 9 weeks' therapy, symptoms of two groups improved (P＜ 0.05). Compared with the control group, fatigue was significantly improved (P = 0.03) in BCAA-G group. Plasma protein and albumin increased in BCAA-G group (P = 0.0001). The Fisher score in BCAA-G group improved after 4 weeks ( P = 0. 0005 ) and 9 weeks ( P = 0. 0001 ), while no marked change was found in the control group. The side effect rate was 7.50 % in the BCAA-G group and 3.85 % in the control group, respectively. Conclusion BCAA-G is effective and safe in the treatment of cirrhotic hypoproteinemia.