摘要
目的 评价九味柔肝颗粒治疗慢性乙型肝炎肝纤维化 (气滞血瘀兼湿热未净证 )的疗效和安全性。方法 根据本研究的纳入与排除标准 ,选取慢性乙型肝炎肝纤维化 (气滞血瘀兼湿热未净证 )患者 4 6例 ,随机分为两组 ,进行随机双盲双模拟对照试验。试验组 2 3例 ,口服九味柔肝颗粒 ,每日 2次 ,每次 10 g ;阳性对照药鳖甲软肝片组 (对照组 ) 2 3例 ,口服鳖甲软肝片 ,每日 3次 ,每次 4片。疗程均为半年。结果 试验组完成治疗 2 1例 ,对照组完成 2 2例。就中医证候疗效而言 ,意向性治疗 (ITT)分析结果显示 ,试验组总有效率 82 6 1% ( 19/ 2 3) ,对照组总有效率 86 96 % ( 2 0 / 2 3) ;符合方案数据分析 (PP)结果显示 ,试验组总有效率 90 4 8% ( 19/ 2 1) ,对照组总有效率 86 36 % ( 19/ 2 2 ) ,两组中医证候疗效比较无统计学意义 (P >0 0 5 )。就肝纤维化的改善 (PP人群 )而言 ,试验组透明质酸 (HA)、Ⅲ型前胶原 (PCⅢ )、Ⅳ型胶原 (CⅣ )和层粘连蛋白 (LN)的总有效率分别为 2 8 5 7% ( 6 / 2 1)、2 3 81% ( 5 / 2 1)、2 8 5 7% ( 6 / 2 1)和 4 76 % ( 1/ 2 1) ;对照组HA、PCⅢ、CⅣ、和LN的总有效率分别为 36 37% ( 8/ 2 2 )、13 6 4 % ( 3/ 2 2 )、36 37% ( 8/ 2 2 )和 9 0 9% ( 2 / 2 2 ) ,两组肝纤?
Objective To assess the effectiveness and safety of Jiuweirougan granule in the treatment of chronic hepatitis with hepatic fibrosis. Methods 5 A double-blind, double dummy and randomized controlled method was adopted.Foryty-six patients were selected by using the inclusion and exclusion criteria and were randomizedly allocated to the treatment group (n3=23, Jiuweirougan 10 g, twice a day) and the control group (n=23, treated with Biejiaruangan 4 pills, three times a day). The duration of treatment for both groups lasted for 6 months.Results Two patients in the treatment group dropped out halfway through the study, while one patient in the control group was withdrawal for irregular treatment. Analysis according to intention-to-treat (ITT) and per-protocol (PP) was conducted. In the treatment group, the effective rates of TCM (Traditional Chinese Medicine) on the syndrome were 82.61% (19/23) (ITT) and 90.48% (19/21) (PP), while in the control group, there were 86.96% (20/23) (ITT) and 86.36% (19/20) (PP). There was no significant difference between the two groups (P3>0.05). The improvement rate of serum parameters in the treatment group such as hyaluronic acid (HA), type Ⅲ procollagen (PCⅢ), type Ⅳ collagewn (CⅣ) and laminin (LN) were 28.57% (6/21), 23.81% (5/21), 28.57% (6/21) and 4.76% (1/21), respectively, while in control group, the rates were 36.37% (8/22),13.64% (3/22), 36.37% (8/22) and 9.09% (2/22), respectively. No significant difference 1was seen between the two groups (3>0.05). ITT and PP analysis revealed similar results. No obvious adverse effects were noted. Conclusion Jiuweirougan granule may improve chronic hepatitis with fibrosis, and its effect is equal to that of Biejiaruangan. No obvious toxic-adverse effects were seen.
出处
《中国循证医学杂志》
CSCD
2004年第11期778-782,793,共6页
Chinese Journal of Evidence-based Medicine
关键词
九味柔肝颗粒
慢性肝炎肝纤维化
随机双盲对照试验
Jiuweirougan granule
Chronic hepatitis with hepatic fibrosis
Double-blind randomized controlled trial
