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温肾健脾热敷贴治疗肌萎缩侧索硬化症的随机对照临床试验 被引量:1

Effects of Wenshen Jianpi Recipe hot compress in the treatment of amyotrophic lateral sclerosis: A randomized controlled clinical trial
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摘要 目的:观察温肾健脾热敷贴治疗肌萎缩侧索硬化症(ALS)的疗效和安全性。方法:纳入69例ALS患者,随机分为治疗组35例和对照组34例。两组患者均采用常规治疗,在此基础上治疗组患者给予温肾健脾热敷贴,治疗周期为4个月。比较两组患者治疗前后的ALS中西医结合治疗症状量表(ALS-SSIT)、ALS功能量表(ALS-FRS)评分,评价热敷贴治疗的安全性。结果:试验过程中,治疗组3例患者被剔除,对照组4例患者被剔除,最终治疗组32例、对照组30例纳入统计分析。治疗后,两组患者的ALS-SSIT评分均升高(P<0.05),而治疗组患者的评分低于对照组(P<0.05)。治疗后,两组患者的ALS-FRS评分均降低(P<0.05),而治疗组患者的评分高于对照组(P<0.05)。治疗过程中,因温肾健脾热敷贴引起皮肤瘙痒者7例,其中2例中断治疗、5例未中断治疗,未见其他不良反应发生。结论:温肾健脾热敷贴作为一种辅助治疗手段,可能在一定程度上延缓ALS症状进展,且安全性较好。 Objective: To observe the efficacy and safety of Wenshen Jianpi Recipe hot compress in the treatment of amyotrophic lateral sclerosis(ALS). Methods: Sixty-nine patients with ALS were selected and randomly divided into the treatment group(n=35) and control group(n=34). The patients in both groups were treated with conventional medicine, and the patients in the treatment group were treated with Wenshen Jianpi Recipe hot compress based on above. The treatment course was 4 months. Before and after treatment, the scores of ALS symptom scale in integrative treatment(ALS-SSIT) and ALS functional rating scale(ALS-FRS) were compared between the two groups, and the safety of treatment was evaluated. Results: In the course of trial, 3 patients in the treatment group and 4 patients in the control group were excluded. Finally 32 cases in the treatment group and 30 cases in the control group were included for the statistical analysis. After treatment, the ALS-SSIT scores in the two groups were increased(P<0.05), while the score of the treatment group was lower than that of the control group(P<0.05). After treatment, the ALS-FRS scores in the two groups were decreased(P<0.05), while the score of the treatment group was higher than that of the control group(P<0.05). In the course of treatment, skin itching caused by Wenshen Jianpi Recipe hot compress was observed in 7 cases. Among, 2 cases discontinued the therapy and 5 cases continued the therapy. Other adverse reactions were not found. Conclusion: As an adjuvant treatment method, Wenshen Jianpi Recipe hot compress may delay the development of ALS symptoms to a certain degree, with good safety.
作者 张红智 司马旦旦 Joana Schroder 郑宣璐 王明哲 潘卫东 ZHANG Hongzhi;SIMA Dandan;JOANA Schroder;ZHENG Xuanlu;WANG Mingzhe;PAN Weidong(Department of Neurology,Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China)
出处 《上海中医药大学学报》 CAS 2021年第4期25-28,共4页 Academic Journal of Shanghai University of Traditional Chinese Medicine
基金 国家自然科学基金面上项目(81373619)。
关键词 肌萎缩侧索硬化症 温肾健脾热敷贴 中西医结合 随机对照试验 amyotrophic lateral sclerosis Wenshen Jianpi Recipe hot compress integrated traditional Chinese and western medicine randomized controlled trial
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