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

张红智; 司马旦旦; JoanaSchroder; 郑宣璐; 王明哲; 潘卫东

doi:10.16306/j.1008-861x.2021.04.004

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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

临床研究 | 更新时间：2022-09-09

- 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
- Effects of Wenshen Jianpi Recipe hot compress in the treatment of amyotrophic lateral sclerosis: A randomized controlled clinical trial
- 上海中医药大学学报 2021年35卷第4期页码：25-28
- 作者机构：
  
  1.上海中医药大学附属曙光医院神经内科（上海　201203）
- 作者简介：
  
  张红智，男，硕士，主治医师，主要从事中西医结合治疗神经内科疾病临床研究
  潘卫东，主任医师，硕士生导师；E-mail：panwd@medmail.com.cn
- 基金信息：
  
  国家自然科学基金资助项目(81373619)
- DOI：10.16306/j.1008-861x.2021.04.004
  中图分类号：
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张红智, 司马旦旦, JoanaSchroder, 等. 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[J]. 上海中医药大学学报, 2021,35(4):25-28.

ZHANG Hongzhi, SIMA Dandan, JOANA Schroder, et al. Effects of Wenshen Jianpi Recipe hot compress in the treatment of amyotrophic lateral sclerosis: A randomized controlled clinical trial[J]. Academic Journal of Shanghai University of Traditional Chinese Medicine, 2021,35(4):25-28.
张红智, 司马旦旦, JoanaSchroder, 等. 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[J]. 上海中医药大学学报, 2021,35(4):25-28. DOI： 10.16306/j.1008-861x.2021.04.004.

ZHANG Hongzhi, SIMA Dandan, JOANA Schroder, et al. Effects of Wenshen Jianpi Recipe hot compress in the treatment of amyotrophic lateral sclerosis: A randomized controlled clinical trial[J]. Academic Journal of Shanghai University of Traditional Chinese Medicine, 2021,35(4):25-28. DOI： 10.16306/j.1008-861x.2021.04.004.

摘要

目的：,2,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：,2,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：,2,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：,2,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。

Abstract

Objective:,2,To observe the efficacy and safety of Wenshen Jianpi Recipe hot compress in the treatment of amyotrophic lateral sclerosis(ALS) .,Methods:,2,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:,2,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:,2,As an adjuvant treatment method, Wenshen Jianpi Recipe hot compress may delay the development of ALS symptoms to a certain degree, with good safety.

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

Keywords

amyotrophic lateral sclerosisWenshen Jianpi Recipe hot compressintegrated traditional Chinese and western medicinerandomized controlled trial

references

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许文杰，任洪丽，支惠萍.补肾健脾疏肝法治疗肌萎缩侧索硬化症临床疗效观察[J].上海中医药大学学报，2011，25(5)：46-49.

潘卫东，苏小静，王骏，等.健脾益气法治疗肌萎缩侧索硬化症的随机开放临床试验[J].上海中医药大学学报，2013，27(3)：38-41.

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