【摘要】 目的 評價九味柔肝顆粒治療慢性乙肝肝纖維化的療效和安全性。 方法 根據納入與排除標準，選取2007年2-8月入院的慢性乙肝肝纖維化（氣滯血瘀兼濕熱未凈證）患者96例，按3∶1隨機分為兩組進行隨機雙盲雙模擬對照試驗。試驗組72例，口服九味柔肝顆粒， 2次/d，每次10 g；陽性對照藥鱉甲軟肝片組（對照組）24例，口服鱉甲軟肝片，4片/次，3次/d；兩組療程均為6個月。 結果 試驗組完成治療66例，對照組完成21例。符合方案數據分析（PPS）結果顯示，試驗組治療后中醫證侯積分及B超積分分別下降了0.50±1.04和8.61±3.62，對照組分別下降了0.32±1.01和8.63±3.15，均較治療前顯著下降（P lt;0.05），兩組比較無統計學意義（P gt;0.05）。在血清肝纖維化四項指標方面，試驗組除LN外，其余指標治療后均較治療前明顯下降（P lt;0.05），對照組中僅PⅢP有顯著下降（P lt;0.05），其余指標下降不明顯，兩組比較無統計學意義（P gt;0.05）。兩組患者治療期間均未觀察到明顯不良反應，不良反應發生率分別為5.56%和4.17%。 結論 九味柔肝顆粒能明顯改善慢性肝炎肝纖維化患者的癥狀和部分肝纖維化指標，其療效與鱉甲軟肝片相當，安全性良好。
【Abstract】 Objective To assess the safety and therapeutic effect of Jiuweirougan grandule on chronic hepatitis B with hepatic fibrosis. Methods A double-blind, double dummy and randomized controlled method was adopted. Ninety-six patients from February to August 2007 selected by including and excluding criteria were distributed randomly in accordance with the 3∶1 ratio into the test group (n=72, treated with Jiuweirougan 10 g, two times per day) and the control group (n=24, treated with Biejiaruangan 4 tablets, three times per day). The period of treatment for both groups lasted for half a year. Results A total of 66 cases in the test group and 21 cases in the control group completed the experiment. The results of per-protocol population (PPS) suggested that the accumulated score of B ultrasound and symptom decreased 0.50±1.04 and 8.61±3.62 in the test group and 0.32±1.01 and 8.63±3.15 in the control group, respectively. The score decreased remarkably compared with pre-treatment(P lt;0.05). There was no significant difference between the two groups (P gt;0.05). For serum liver fibrotic parameters, all parameters except laminin (LN) in the test group decreased remarkably compared with pre-treatment(P lt;0.05). But in the control group, besides type Ⅲ procollagen (PCⅢ) decreased remarkably(P lt;0.05), other parameters showed no obvious changes. There was no significant difference between the two groups (P gt;0.05). At the same time, no obvious adverse effect was found in the two groups. The incidence of adverse reactions was 5.56% and 4.17% respectively. Conclusion Jiuweirougan granule may improve the syndrome and part of fibrotic index of chronic hepatitis B with fibrosis, and the effect is equal to that of Biejiaruangan with good security.
引用本文： 王麗春,雷秉鈞,劉麗,劉 聰,張瑞明,李廷謙,唐紅. 九味柔肝顆粒治療慢性乙肝肝纖維化的隨機雙盲對照研究. 華西醫學, 2010, 25(10): 1801-1804. doi: 復制