Rheumatoid arthritis combined with wrist inflammation treated with <italic style="font-style: italic">Luofushan</italic> Rheumatism Plaster: a randomized, double-blind, placebo-controlled, multicenter clinical trial

SONG Mengge; JIANG Quan; JIAO Juan; WANG Bei; GU Wen; CHENG Yongjing; WANG Qian; TAO Qingwen; JIN Di’er; LIU Xiaoping; ZHENG Xinchun; LIU Jia; HUANG Qingchun; ZHAO Yue; LIN Changsong

doi:10.3969/j.issn.1006-2157.2023.10.015

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Rheumatoid arthritis combined with wrist inflammation treated with Luofushan Rheumatism Plaster: a randomized, double-blind, placebo-controlled, multicenter clinical trial

Clinical Studies | 更新时间：2023-11-06

- Rheumatoid arthritis combined with wrist inflammation treated with Luofushan Rheumatism Plaster: a randomized, double-blind, placebo-controlled, multicenter clinical trial
- Journal of Beijing University of Traditional Chinese Medicine Vol. 46, Issue 10, Pages: 1431-1442(2023)
- 作者机构：
  
  1.中国中医科学院广安门医院　北京　100053
  2.首都医科大学附属北京中医医院
  3.北京医院
  4.中日友好医院
  5.北京中医药大学东方医院
  6.上海光华中西医结合医院
  7.广东省中医院
  8.广州中医药大学第一附属医院
- 作者简介：
  
  Prof. JIANG Quan, Ph.D., Chief Physician, Doctoral Supervisor. Guang’anmen Hospital, China Academy of Chinese Medical Sciences, No. 5, Beixiange Road, Xicheng District, Beijing 100053. E-mail: doctorjq@126.com
- 基金信息：
  
  National Natural Science Foundation of China(82230121);National Natural Science Foundation of China(2018YFC1705200);Scientific and Technological Innovation Project of China Academy of Chinese Medical Sciences(CI2021A01501)
- DOI：10.3969/j.issn.1006-2157.2023.10.015
  CLC： R259.322
- Received：23 February 2023，
  
  Published Online：29 August 2023，
  
  Published：30 October 2023
- 稿件说明：
移动端阅览
SONG Mengge, JIANG Quan, JIAO Juan, et al. Rheumatoid arthritis combined with wrist inflammation treated with Luofushan Rheumatism Plaster: a randomized, double-blind, placebo-controlled, multicenter clinical trial[J]. Journal of beijing university of traditional chinese medicine, 2023, 46(10): 1431-1442.
DOI：

SONG Mengge, JIANG Quan, JIAO Juan, et al. Rheumatoid arthritis combined with wrist inflammation treated with Luofushan Rheumatism Plaster: a randomized, double-blind, placebo-controlled, multicenter clinical trial[J]. Journal of beijing university of traditional chinese medicine, 2023, 46(10): 1431-1442. DOI： 10.3969/j.issn.1006-2157.2023.10.015.

摘要

目的

评价罗浮山风湿膏药治疗类风湿关节炎(rheumatoid arthritis，RA)腕关节炎的临床疗效和安全性。

方法

采用多中心、区组随机、双盲、安慰剂对照临床试验方法，收集8家医院RA合并腕关节腱鞘炎和(或)滑膜炎患者180例，按照1∶1比例区组随机法分为罗浮山组90例、对照组90例。两组均给予改善病情抗风湿药物(DMARDs)等基础治疗，罗浮山组予罗浮山风湿膏药，对照组予罗浮山风湿膏药模拟剂，核心试验疗程4周，继而于其中3家医院进行扩展试验(受试者自愿选择继续接受罗浮山风湿膏药治疗4周)。于治疗前和治疗4、8周后进行评价，腕关节局部症状评价包括疼痛视觉模拟评分(VAS)、腕关节肿胀程度、晨僵持续时间，双腕关节半定量超声评价包括腱鞘炎、滑膜炎、滑膜增生，疾病整体评价包括28处关节活动度评估(DAS28)－C反应蛋白(CRP)评分、健康评定问卷残疾指数(HAQ-DI)、中国类风湿关节炎患者报告的疾病活动度指数(CPRI-RA)、炎性指标红细胞沉降率(ESR)水平，记录试验期间皮肤刺激性评价及不良事件发生情况。有效性评价采用符合方案数据集(PPS)、安全性指标以安全性分析数据集(SS)进行分析。

结果

在DMARDs等常规用药基础上联合罗浮山风湿膏药治疗4周可改善RA患者VAS评分(

0.05)、肿胀程度(

0.05)、晨僵持续时间(

0.05)，超声下腕关节腱鞘炎(

0.05)、滑膜炎(

0.05)，DAS28－CRP(

0.05)、HAQ-DI(

0.05)及CPRI-RA(

0.05)，但与对照组的差异无统计学意义(

0.05)。治疗8周后，罗浮山组降低VAS评分优于对照组，差异具有统计学意义(

0.05)；可改善超声下腕关节滑膜增生(

0.05)及ESR水平(

0.05)，但与对照组的差异无统计学意义(

0.05)；两组皮肤刺激性及不良事件发生率的差异无统计学意义(

0.05)。

结论

罗浮山风湿膏药治疗RA腕关节炎，止痛效果确切，对超声影像学评价、关节肿胀程度及ESR的改善有优效趋势，安全性高，具有临床长期使用价值。

Abstract

Objective

We aimed to evaluate the clinical efficacy and safety of

Luofushan

Rheumatic Plaster in the treatment of rheumatoid arthritis(RA) combined with wrist inflammation.

Methods

A multicenter

block-randomized

double-blind

placebo-controlled clinical trial was conducted including 180 patients with RA combined with wrist tenosynovitis and/or synovitis from eight hospitals who were randomly divided into the

Luofushan

group (90 cases) and the control group (90 cases). Patients in both groups were given basic treatment such as disease-modifying antirheumatic drugs (DMARDs). Patients in the

Luofushan

group were given

Luofushan

Rheumatic Plaster

while patients in the control group were given

Luofushan

Rheumatic Plaster simulant. The core trial duration was 4 weeks

and the extended trial was conducted in three centers (participants could voluntarily choose to continue to receive

Luofushan

Rheumatic Plaster for an additional 4 weeks). Follow-up of local symptoms of the wrist joint (VAS score

swelling degree

duration of morning stiffness)

bilateral wrist joint ultrasound (tenosynovitis

synovitis

synovial hyperplasia)

overall evaluation of disease (DAS28-CRP score

Health Assessment Questionnaire Disability Index [HAQ-DI]

and Chinese Patient-Reported Activity Index with Rheumatoid Arthritis [CPRI-RA]

)

and erythrocyte sedimentation rate(ESR)was conducted one or two times

and skin irritation and adverse events during the experiment were recorded. Effectiveness was analyzed using the per-protocol set

and the safety indicators were analyzed using the safety set.

Results

Compared to pre-treatment

adjuvant therapy with

Luofushan

Rheumatic Plaster for 4 weeks can improve the VAS score (

0.05)

the degree of swelling (

0.05)

morning stiffness duration (

0.05)

wrist tenosynovitis (

0.05)

synovitis (

0.05)

DAS28-CRP (

0.05)

HAQ-DI(

0.05)

and CPRI-RA(

0.05)

but there were no statistically significant difference compared to the control group. Compared to the control group

pain was alleviated in the

Luofushan

group after 8 weeks of treatment(

0.05). Compared to pre-treatment adjuvant therapy for 8 weeks can provide additional improvement in the synovial hyperplasia of the wrist joint (

0.05)

and the ESR level (

0.05)

but there were no statistically significant difference compared to the control group. There was no increase in the incidence of skin irritation and adverse events between the two groups (

0.05).

Conclusion

Luofushan

Rheumatic Plaster has a definite analgesic effect in the treatment of wrist rheumatoid arthritis

and it improves ultrasound imaging result

the degree of joint swelling

and ESR. Moreover

it is safe and suitable for long-term clinical use.

关键词

Keywords

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Rheumatoid arthritis combined with wrist inflammation treated with Luofushan Rheumatism Plaster: a randomized, double-blind, placebo-controlled, multicenter clinical trial

DOI：10.3969/j.issn.1006-2157.2023.10.015

摘要

Abstract

关键词

Keywords

references