健脾益气法治疗肌萎缩侧索硬化症的随机开放临床试验

Open Randomized Clinical Trial on Spleen-strengthening and Qi-replenishing Method in Treating Amyotrophic Lateral Sclerosis

目的:观察加味四君子汤治疗肌萎缩侧索硬化症(ALS)的疗效和安全性。方法:将48例ALS患者随机分为治疗组(n=24)和对照组(n=24),在常规药物治疗基础上治疗组给予加味四君子汤口服,对照组给予利鲁唑口服,治疗周期为6个月。分别于治疗前及治疗后3个月、6个月进行ALS功能量表(ALSFRS)评价,并观察两组患者对药物的依从性及治疗期间的不良反应。结果:治疗后3个月、6个月,两组患者及两组中以四肢为首发症状者的ALSFRS评分均呈下降趋势,且治疗后6个月,两组患者及两组中以四肢为首发症状者的评分与治疗前比较,差异均有统计学意义(P<0.05);治疗后6个月,治疗组中以四肢为首发症状者的ALSFRS评分变化率明显低于对照组(P<0.01)。治疗过程中,治疗组患者的药物依从性较好,未发生明显的不良反应;对照组脱落5例,包括死亡2例,因不良反应或经济原因退出3例。结论:健脾益气法在延缓ALS尤其是以四肢为首发症状者的病情进展方面较西药利鲁唑具有一定的优势,且副反应少,价格便宜。

Objective： To investigate the effects and safety of ＂Jiawei Sijunzi Decoction＂ in treating amyotrophic lateral sclerosis（ALS）.Methods： Forty-eight patients with ALS were randomly divided into treatment group（n=24） and control group（n=24）.On the basis of routine treatment,the treatment group was treated by ＂Jiawei Sijunzi Decoction＂ and the control group was treated by riluzole,with a course of six months.Before treatment,and three and six months after treatment,the ALS functional rating scale（ALSFRS） was evaluated,and the compliance and side effects of the additional treatment were observed.Results： Three and six months after treatment,the scores of ALSFRS in both groups presented declining trend,and six months after treatment,the scores of ALSFRS in both groups were obviously decreased compared with before treatment（P＆lt;0.05）.The change rates of ALSFRS scores of patients with initial symptoms from limbs in treatment group were lower than those in control group（P＆lt;0.01）.In the course of treatment,the treatment group presented better compliance,and there were no severe side effects occurring in treatment group;five cases were loss in control group including two died cases and three cases dropping out because of side effects or financial reason.Conclusion： Compared with riluzole,spleen-strengthening and qi-replenishing method has some advantages in delaying the development of ALS,especially for the patients with initial symptoms from limbs,with less side effects and low price.