壮医药线点灸疗法治疗寻常型银屑病的多中心随机对照试验

Yu-zhou PANG; Jing TANG; Qing-huai ZHANG; Feng-zhen LIANG; Gang FANG; Chen ZHAO; Hong-cai SHANG; Li-ying WANG; Yan-ping WANG

doi:10.1007/s11655-021-3489-5

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壮医药线点灸疗法治疗寻常型银屑病的多中心随机对照试验

Original Article | Updated：2022-03-18

- 壮医药线点灸疗法治疗寻常型银屑病的多中心随机对照试验
- Treatment of Psoriasis Vulgaris with Medicated Thread Moxibustion of Zhuang Medicine: A Multicenter Randomized, Parallel Controlled Trial
- Chinese Journal of Integrative Medicine 2022年28卷第3期页码：208-214
- Affiliations：
  
  1.School of Zhuang Medicine, Guangxi University of Chinese Medicine, Nanning (530001), China
  2.Department of Zhuang Medicine Acupuncture, Guangxi International Hospital of Zhuang Medicine Affiliated to Guangxi University of Chinese Medicine,Nanning (530201), China
  3.Graduate School of Guangxi University of Chinese Medicine, Nanning (530001), China
  4.School of Chinese Medicine, Hong Kong Baptist University,Hong Kong (999077), China
  5.Key Laboratory of Chinese Internal Medicine of Ministry of Education, Beijing University of Chinese Medicine, Beijing (100000), China
  6.Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing (100700), China
- Author bio：
  
  Prof. PANG Yu-zhou, E-mail:2017pangyuzhou@sina.com;
  Prof. WANG Yan-ping,E-mail:wangyanping4816@163.com
- Funds：
  
  the Scientific Research Special Fund of Traditional Chinese Medicine Industry(201507006)
- DOI：10.1007/s11655-021-3489-5
  中图分类号：
- 纸质出版日期：2022-03-01，
  
  网络出版日期：2021-12-12，
  
  录用日期：2020-08-25
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Yu-zhou PANG, Jing TANG, Qing-huai ZHANG, 等. 壮医药线点灸疗法治疗寻常型银屑病的多中心随机对照试验[J]. Chinese Journal of Integrative Medicine, 2022,28(3):208-214.

Yu-zhou PANG, Jing TANG, Qing-huai ZHANG, et al. Treatment of Psoriasis Vulgaris with Medicated Thread Moxibustion of Zhuang Medicine: A Multicenter Randomized, Parallel Controlled Trial[J]. Chinese Journal of Integrative Medicine, 2022,28(3):208-214.
Yu-zhou PANG, Jing TANG, Qing-huai ZHANG, 等. 壮医药线点灸疗法治疗寻常型银屑病的多中心随机对照试验[J]. Chinese Journal of Integrative Medicine, 2022,28(3):208-214. DOI： 10.1007/s11655-021-3489-5.

Yu-zhou PANG, Jing TANG, Qing-huai ZHANG, et al. Treatment of Psoriasis Vulgaris with Medicated Thread Moxibustion of Zhuang Medicine: A Multicenter Randomized, Parallel Controlled Trial[J]. Chinese Journal of Integrative Medicine, 2022,28(3):208-214. DOI： 10.1007/s11655-021-3489-5.

摘要

目的:

探讨壮医药线点灸(ZMTM)治疗寻常型银屑病的疗效和安全性.

方法:

本试验设计为多中心随机对照临床试验

收集2015年6月至2018年5月期间共241例寻常型银屑病患者

随机分为对照组 (120例) 和治疗组 (121例) . 对照组给予西药匹多莫德分散片、复合维生素B片、复方鱼肝油氧化锌软膏治疗; 治疗组给予西药联合ZMTM治疗; 两组均连续治疗30天

并于治疗后30天进行随访. 主要疗效指标是患者治疗前后皮损面积和严重程度 (PASI)

次要疗效指标是瘙痒、皮肤病生活质量指数量表(DLQI)、汉密顿焦虑量表(HAMA)评分及PASI应答率.

结果:

本次试验有5例脱落病例

最终纳入236例

每组各118例. 治疗第30天

两组患者的PASI评分均低于基线(P<0.01)

治疗组的PASI评分低于对照组(P<0.01); 两组治疗后瘙痒评分、DLQI、HAMA评分均低于基线

且治疗组低于对照组(P<0.01); PASI 50和75的应答率显著高于对照组[81.4% (96/118) 、43.2% (51/118) 和41.5% (49/118) 、11.0% (13/118)

P<0.05]. 随访期间

治疗组的PASI、瘙痒评分、DLQI、HAMA评分低于对照组(P<0.01). 治疗组PASI50和75的应答率均高于对照组(P<0.05). 两组患者均无明显的不良反应.

结论:

ZMTM联合西药治疗寻常型银屑病疗效较好

无明显不良反应.

Abstract

Objective:

To explore the efficacy and safety of Zhuang medicine medicated thread moxibustion (ZMTM) on psoriasis vulgaris.

Methods:

A multicenter

randomized

parallel controlled clinical trial was designed. A total of 241 outpatients with psoriasis vulgaris were randomly divided into a control group (120 cases) and a treatment group (121 cases) using a central block randomization from June 2015 to May 2018. The control group was treated with Western medicines alone including pidotimod dispersible tablets

vitamin B compound tablets

and compound cod liver oil-zinc oxide ointment. The treatment group was treated with ZMTM every 2 days combined with Western medicines. The two groups received continuous intervention for 30 days. The primary outcome was Psoriasis Area and Severity Index (PASI)

and the secondary outcomes included Itch Rating Scale

Dermatology Quality of Life Index (DLQI)

Hamilton Anxiety Rating Scale (HAMA)

as well as PASI response rate. Meanwhile

adverse events were evaluated during the whole clinical trial. Follow-up was carried out 30 days after treatment.

Results:

There were 5 cases of shedding in this trial. In intention-to-treat analysis

236 cases were included and each group contained 118 cases. On the 30th and 60th days

PASI scores of patients in each group were significantly lower than that at baseline (

0.01) and the PASI score reduction of the treatment group was greater than that of the control group (

0.01). Itch Rating Scale

DLQI

and HAMA scale were decreased in both groups after treatment

and the treatment group showed a better therapeutic effect (

0.01). The response rates of PASI 50 and 75 were significantly higher than those in the control group [81.4% (96/118)

43.2% (51/118) vs. 41.5% (49/118)

11.0% (13/118)

respectively

0.05]. During follow-up

the improvements in scores of PASI

Itch Rating Scale

DLQI

and HAMA of the treatment group were significantly greater than those of the control group (

0.01). The response rates of PASI 50 and 75 in the treatment group were significantly higher than those in the control group

respectively (both

0.05). No obvious adverse reaction was found in either group.

Conclusion:

ZMTM combined with Western medicines showed a better therapeutic effect in the treatment of psoriasis vulgaris without obvious adverse reaction. (Trial Registration No. ChiCTR-IOR-16008159)

关键词

Keywords

psoriasis vulgarisZhuang medicated thread moxibustiontraditional medicinemulticenter randomized controlled trial

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