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目的观察复元生肌颗粒治疗肌萎缩侧索硬化症(ALS)的临床疗效。方法 58例ALS患者分为治疗组和对照组,对照组予利鲁唑治疗,治疗组在利鲁唑的基础上加用复元生肌颗粒。分别于治疗前及治疗后2、4、6个月进行改良Norris评分评定,治疗前及治疗后6个月对ALS患者进行肺功能检查,并随访患者18个月。结果两组患者在治疗第6个月时,改良Norris评分变化值组间差异有统计学意义(P<0.05),但用力肺活量(FVC)变化值的组间差异无统计学意义(P>0.05)。生存分析显示,在随访第18个月时治疗组与对照组累积生存率分别为80.0%和71.4%,差异无统计学意义(P>0.05)。结论复元生肌颗粒在延缓ALS患者延髓及肢体功能进展方面可能有一定作用,但在改善患者肺功能、延长生存时间方面有待于进一步证实。
Objective To observe the clinical efficacy of Fuyuan Shengji granule in the treatment of amyotrophic lateral sclerosis (ALS). Methods 58 patients with ALS were divided into treatment group and control group. The control group was treated with riluzole. The treatment group was treated with riluzole on the basis of riluzole. The improved Norris score was assessed before treatment and at 2, 4 and 6 months after treatment. The pulmonary function tests of ALS patients were performed before treatment and 6 months after treatment, and the patients were followed up for 18 months. Results There was a significant difference between the two groups in the 6th month of treatment (P <0.05), but there was no significant difference between the groups in the change of forced vital capacity (FVC) (P> 0.05 ). Survival analysis showed that the cumulative survival rates of the treatment group and the control group were 80.0% and 71.4% respectively at the 18th month of follow-up, with no significant difference (P> 0.05). Conclusion Fuyuan Shengji granule may play a role in retarding the development of medulla oblongata and limbs in patients with ALS, but it needs to be further confirmed in improving lung function and prolonging the survival time of patients.