罗浮山风湿膏药治疗类风湿关节炎腕关节炎的多中心随机双盲对照临床研究
Rheumatoid arthritis combined with wrist inflammation treated with
Luofushan Rheumatism Plaster: a randomized, double-blind, placebo-controlled, multicenter clinical trial- 北京中医药大学学报 2023年46卷第10期 页码：1431-1442
- 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：
宋梦歌，女，在读博士生，住院医师
# 姜泉，女，博士，教授，主任医师，博士生导师，主要研究方向：中医药治疗风湿免疫病的临床与基础，E-mail：doctorjq@126.com
- 基金信息：国家自然科学基金项目(82230121);国家重点研发计划项目(2018YFC1705200);中国中医科学院科技创新工程重大攻关项目(CI2021A01501)
DOI：10.3969/j.issn.1006-2157.2023.10.015
中图分类号： R259.322纸质出版日期：2023-10-30，
网络出版日期：2023-08-29，
收稿日期：2023-02-23，
- 稿件说明：
移动端阅览
宋梦歌, 姜泉, 焦娟, 等. 罗浮山风湿膏药治疗类风湿关节炎腕关节炎的多中心随机双盲对照临床研究[J]. 北京中医药大学学报, 2023,46(10):1431-1442.
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.宋梦歌, 姜泉, 焦娟, 等. 罗浮山风湿膏药治疗类风湿关节炎腕关节炎的多中心随机双盲对照临床研究[J]. 北京中医药大学学报, 2023,46(10):1431-1442. DOI： 10.3969/j.issn.1006-2157.2023.10.015.
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
2
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
2
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
2
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(
P
<
0.05)、肿胀程度(
P
<
0.05)、晨僵持续时间(
P
<
0.05)，超声下腕关节腱鞘炎(
P
<
0.05)、滑膜炎(
P
<
0.05)，DAS28－CRP(
P
<
0.05)、HAQ-DI(
P
<
0.05)及CPRI-RA(
P
<
0.05)，但与对照组的差异无统计学意义(
P
>
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(
P
<
0.05)；可改善超声下腕关节滑膜增生(
P
<
0.05)及ESR水平(
P
<
0.05)，但与对照组的差异无统计学意义(
P
>
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(
P
>
0.05)。
结论
2
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
2
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
2
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
2
Compared to pre-treatment
adjuvant therapy with
Luofushan
Rheumatic Plaster for 4 weeks can improve the VAS score (
P
<
0.05)
the degree of swelling (
P
<
0.05)
morning stiffness duration (
P
<
0.05)
wrist tenosynovitis (
P
<
0.05)
synovitis (
P
<
0.05)
DAS28-CRP (
P
<
0.05)
HAQ-DI(
P
<
0.05)
and CPRI-RA(
P
<
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(
P
<
0.05). Compared to pre-treatment adjuvant therapy for 8 weeks can provide additional improvement in the synovial hyperplasia of the wrist joint (
P
<
0.05)
and the ESR level (
P
<
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 (
P
>
0.05).
Conclusion
2
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
类风湿关节炎腱鞘炎滑膜炎随机对照试验罗浮山风湿膏药
Keywords
rheumatoid arthritistenosynovitissynovitisrandomized controlled trialLuofushan Rheumatism Plaster
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