温络通治疗化疗或靶向治疗致周围神经病变的随机双盲对照研究

Bo DENG; Li-qun JIA; Dong-gui WAN; Bao-yi WANG; Zhi-qiang CHENG; Chao DENG

doi:10.1007/s11655-022-3575-y

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温络通治疗化疗或靶向治疗致周围神经病变的随机双盲对照研究

Original Article | Updated：2022-06-27

- 温络通治疗化疗或靶向治疗致周围神经病变的随机双盲对照研究
- Efficacy of Wen-Luo-Tong on Peripheral Neuropathy Induced by Chemotherapy or Target Therapy: A Randomized,Double-Blinded, Placebo-Controlled Trial
- Chinese Journal of Integrative Medicine 2022年28卷第7期页码：579-585
- Affiliations：
  
  1.Center of Science and Technology, China-Japan Friendship Hospital, Beijing (100029), China
  2.Integrative Oncology Department of Chinese Medicine and Western Medicine, China-Japan Friendship Hospital, Beijing (100029), China
- Author bio：
  
  Prof. JIA Li-qun, E-mail: liqun-jia@hotmail.com
- Funds：
  
  Capital's Funds for Health Improvement and Research(2018-2-40610)
- DOI：10.1007/s11655-022-3575-y
  中图分类号：
- 纸质出版日期：2022-07-01，
  
  网络出版日期：2022-05-18，
  
  录用日期：2021-10-13
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Bo DENG, Li-qun JIA, Dong-gui WAN, 等. 温络通治疗化疗或靶向治疗致周围神经病变的随机双盲对照研究[J]. Chinese Journal of Integrative Medicine, 2022,28(7):579-585.

Bo DENG, Li-qun JIA, Dong-gui WAN, et al. Efficacy of Wen-Luo-Tong on Peripheral Neuropathy Induced by Chemotherapy or Target Therapy: A Randomized,Double-Blinded, Placebo-Controlled Trial[J]. Chinese Journal of Integrative Medicine, 2022,28(7):579-585.
Bo DENG, Li-qun JIA, Dong-gui WAN, 等. 温络通治疗化疗或靶向治疗致周围神经病变的随机双盲对照研究[J]. Chinese Journal of Integrative Medicine, 2022,28(7):579-585. DOI： 10.1007/s11655-022-3575-y.

Bo DENG, Li-qun JIA, Dong-gui WAN, et al. Efficacy of Wen-Luo-Tong on Peripheral Neuropathy Induced by Chemotherapy or Target Therapy: A Randomized,Double-Blinded, Placebo-Controlled Trial[J]. Chinese Journal of Integrative Medicine, 2022,28(7):579-585. DOI： 10.1007/s11655-022-3575-y.

摘要

目的:

评价温络通 (WLT) 外用颗粒治疗化疗或靶向治疗所致周围神经病变 (PN) 的疗效.

方法:

本研究为随机、双盲、安慰剂对照试验. 2019年7月至2020年1月

收集中日友好医院就诊的化疗或靶向治疗所致周围神经病变患者共78例

随机分为温络通组 (39例) 及对照组 (39例)

分别给予WLT (浸泡手足) 或安慰剂治疗1周

两组均给与给予甲钴胺神经营养治疗. 主要终点是国家癌症研究所不良事件共同毒性标准 (NCI-CTCAE) 评估的PN等级. 次要终点包括客观评价指标触觉阈值和主观评价指标神经病变症状、周围神经病变生活质量调查问卷 (QLQ-CIPN20) 和生活质量调查问卷核心版 (QLQ-C30) 评估的患者生活质量.

结果:

治疗后WLT组NCI评分下降程度明显优于对照组 (1.00±0.29 vs 1.75±0.68

0.01) ; WLT组总有效率82.05%

明显高于对照组 (51.28%

0.01) . 与对照组相比

WLT组指尖阈值和神经病变症状评分下降程度明显优于对照组. 与对照组相比

WLT组生活质量QLQ-cipn20评分 (感觉神经、运动神经、自主神经和总分) 和QLQ-C30 (躯体领域、角色领域、情绪领域和整体健康) 均显著改善

明显优于对照组 (

0.01或

0.05) .

结论:

WLT外用可有效药治疗化疗或靶向治疗所致周围神经病变.

Abstract

Objective:

To evaluate the efficacy of Wen-Luo-Tong Granules (WLT) local administration in the treatment of patients with peripheral neuropathy (PN) induced by chemotherapy or target therapy.

Methods:

This study is a randomized

double-blinded

and placebo-controlled trial. Seventy-eight patients with PN induced by chemotherapy or target therapy were enrolled from China-Japan Friendship Hospital between July 2019 and January 2020. They were randomly assigned to WLT (39 cases) and control groups (39 cases) using a block randomization method. The WLT group received WLT (hand and foot bath) plus oral Mecobalamin for 1 week

while the control group received placebo plus oral Mecobalamin. The primary endpoint was PN grade evaluated by the National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE). The secondary endpoints included quantitative touch-detection threshold

neuropathy symptoms

Quality of Life Questionnaire- Chemotherapy Induced Peripheral Neuropathy (QLQ-CIPN20)

and Quality of Life Questionnaire-Core30 (QLQ-C30).

Results:

After treatment

the PN grade in the WLT group was significantly lower than that in the control group (1.00±0.29 vs. 1.75±0.68

0.01). The total effective rate in the WLT group was significantly higher than that in the control group (82.05% vs. 51.28%

0.01). Compared with the control group

the touchdetection thresholds at fingertips

neuropathy symptom score

QLQ-CIPN 20 (sensory scale

motor scale

autonomic scale

and sum score)

and QLQ-C30 (physical functioning

role functioning

emotional functioning

and global health) in the WLT group significantly improved after treatment (

0.01 or

0.05).

Conclusion:

WLT local administration was significantly effective in the treatment of patients with PN induced by chemotherapy or target therapy. (Trial registration No. ChiCTR1900023862)

关键词

Keywords

peripheral neuropathychemotherapytarget therapyChinese medicineWen-Luo-Tongrandomized controlled trial

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