复元生肌颗粒与力如太治疗肌萎缩侧索硬化症的随机对照临床研究

目的：观察复元生肌颗粒治疗肌萎缩侧索硬化症的临床疗效及不良反应。方法：125例肌萎缩侧索硬化症患者,男74例,女51例,年龄18~79岁,平均年龄为（55±13）岁,进行了随机、对照研究,对照组为目前公认可延缓ALS进展的西药力如太。结果 （：1）与目前唯一能延缓ALS患者生存期3~5个月的西药力如太相比,两组在延缓ALS功能量表下降趋势方面,无显著统计学差异（P〉0.05）。（2）两组治疗前后血、尿常规、肝肾功能均无显著变化（P〉0.05）。（3）两组均未发现药物相关性异常恶心、呕吐、胃纳减退、腹胀、腹泻等胃肠道症状和皮肤过敏等情况。结论：复元生肌颗粒延缓ALS功能量表积分进展的效果与力如太相当。

Randomized Controlled Clinical Trial on Fuyuan Shengfi Granule and Riluzole for Treatment of Amyotrophic Lateral Sclerosis

Objective： To investigate the therapeutic efficacy and adverse-events of Fuyuan Shengji granule in patients with amyotrophie lateral sclerosis （ ALS ）, Methods ： One hundred and twenty-five patients with ALS with an average age of （ 55 -- 13 ）years old （ranging from 18-79 ）were investigated in this randomized, controlled study.Riluzole, which is the only drug that can slowdown the progression of this disease, was used in the control group. Results： （ 1 ）Fuyuan Shengji granule had the similar efficacy to improve the ALS Norris Scale score compared with riluzole.There was no significant difference between tile two groups （ P〉0.05 ）. （ 2 ） There were no noticeable changes in blood/urine routine examination and liver- kidney function by blood testing （ P〉0.05 ）. （ 3 ） No obvious adverse-events of gastrointestinal tract and skin irritation were found in both groups. Conclusion ： Fuyuan .Shengji granule is as effective as riluzole for the treatment of ALS as measured by ALS Norris Scale score.