加味四君子方辅治肌萎缩侧索硬化症脾虚证的临床效果与安全性评价

发布时间：2018-08-12 15:36

【摘要】：目的评价加味四君子方在改善肌萎缩侧索硬化症(amyotrophic lateral sclerosis,ALS)脾虚证患者生活功能及延缓ALS疾病进展中的价值。方法采用随机、双盲、安慰剂对照的临床试验设计方案,将2013年1月—2015年12月上海中医药大学附属曙光医院50例ALS脾虚证患者均分为加味四君子方组和安慰剂组。加味四君子方组在西药治疗基础上加用加味四君子方;安慰剂组在西药治疗基础上加用安慰剂。两组均服药9个月。观察比较两组治疗前和治疗后3、6、9个月及停药后3个月时,ALS功能评分量表(ALSFRS-r)评分和ALS中医脾虚症状评分及治疗期间不良反应发生情况。结果经广义估计方程分析,两组治疗后ALSFRS-r评分、中医脾虚症状评分比较差异均有统计学意义(Waldχ~2=594.155,P0.05;Waldχ~2=452.196,P0.05),特别是在中医脾虚症状方面,加味四君子方组能有效延迟相关症状的恶化。对ALSFRS-r中精细动作、粗大运动评分的时间级别分析结果显示,两组间比较差异有统计学意义(Waldχ~2=166.976,P0.05;Waldχ~2=97.015,P0.05);但对延髓症状、呼吸症状评分的时间级别分析结果显示,两组间比较差异无统计学意义(Waldχ~2=0.007,P0.05;Waldχ~2=1.918,P0.05)。且两组治疗期间无严重不良反应事件发生。结论加味四君子方可以延缓ALS脾虚证患者神经功能恶化,对粗大动作、精细动作功能有良好的疗效。
[Abstract]:Objective to evaluate the value of modified Sijunzi recipe in improving the life function of patients with spleen deficiency syndrome of amyotrophic lateral sclerosis (amyotrophic lateral sclerosis) and delaying the progression of ALS disease. Methods A randomized, double-blind, placebo-controlled clinical trial was used to divide 50 patients with ALS spleen deficiency syndrome in Shuguang Hospital affiliated to Shanghai University of traditional Chinese Medicine from January 2013 to December 2015. All patients were divided into modified Sijunzi recipe group and placebo group. Jiawei Sijunzi prescription group added modified Sijunzi recipe on the basis of western medicine, and placebo group added placebo on western medicine treatment. Both groups took medicine for 9 months. Objective: to observe and compare the scores of ALSFRS-r and ALS's spleen deficiency symptom and the occurrence of adverse reactions during the treatment between the two groups before treatment and 3 months, 9 months after treatment and 3 months after withdrawal. Results after treatment, there were significant differences in ALSFRS-r score and TCM spleen deficiency symptom score between the two groups (Wald 蠂 ~ (2 +) ~ (2) 594.155) (P ~ (0.05) (P ~ (0.05) (P < 0.05). Especially in the aspect of TCM spleen deficiency symptoms, Jiawei Sijunzi prescription group could effectively delay the deterioration of related symptoms. The results of time level analysis of fine movement and coarse motor score in ALSFRS-r showed that there was a significant difference between the two groups (Wald 蠂 ~ (2) 166.976) (P < 0.05), but the time level analysis of medulla oblongata symptom and respiratory symptom score showed that there was a significant difference between the two groups (P < 0.05), but the results of time level analysis of medulla oblongata symptom and respiratory symptom score showed that there was a significant difference between the two groups (P < 0.05). There was no significant difference between the two groups (Wald 蠂 ~ (2) 0.007) (P < 0.05). There were no serious adverse events during treatment in both groups. Conclusion the modified Sijunzi prescription can delay the deterioration of nerve function in patients with ALS spleen deficiency syndrome, and has good curative effect on coarse and fine motion function.
【作者单位】：上海中医药大学附属曙光医院神经内科;
【基金】：上海市卫生计生委三年行动计划(2014-2016)(ZY3-CCCX-3-3030)
【分类号】：R277.7

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