新风胶囊降低强直性脊柱炎患者终点事件发生风险的队列研究

方妍妍; 刘健; 忻凌; 李旭; 齐亚军; 丁香; 从承志; 黄旦

doi:10.3969/j.issn.1006-2157.2023.05.003

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新风胶囊降低强直性脊柱炎患者终点事件发生风险的队列研究

“中医药防治风湿病”专题 | 更新时间：2023-06-05

- 新风胶囊降低强直性脊柱炎患者终点事件发生风险的队列研究
- Xinfeng Capsule reduces the risk of endpoint events in patients with ankylosing spondylitis: a cohort study
- 北京中医药大学学报 2023年46卷第5期页码：607-616
- 作者机构：
  
  1.安徽中医药大学第一附属医院　合肥　230031
  2.新安医学教育部重点实验室
  3.现代中医内科应用基础与开发研究安徽省重点实验室
- 作者简介：
  
  方妍妍，女，在读博士生
  # 刘健，男，教授，主任医师，博士生导师，主要研究方向：中医药防治风湿病，E-mail: liujianahzy@126.com
- 基金信息：
  
  国家自然科学基金项目(82104817);现代中医内科应用基础与开发研究安徽省重点实验室(2016080503B041);安徽省中医药领军人才项目(中医药发展秘〔2018〕23号);新安医学教育部重点实验室(2020xayx08);安徽省卫生健康委科研项目(AHWJ2021b036);现代中医内科应用基础与开发研究安徽省重点实验室2021年度开放基金(2021AKLMCM003)
- DOI：10.3969/j.issn.1006-2157.2023.05.003
  中图分类号： R255.6
- 纸质出版日期：2023-05-30，
  
  网络出版日期：2023-04-26，
  
  收稿日期：2023-01-29，
- 稿件说明：
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方妍妍, 刘健, 忻凌, 等. 新风胶囊降低强直性脊柱炎患者终点事件发生风险的队列研究[J]. 北京中医药大学学报, 2023,46(5):607-616.

FANG Yanyan, LIU Jian, XIN Ling, et al. Xinfeng Capsule reduces the risk of endpoint events in patients with ankylosing spondylitis: a cohort study[J]. Journal of Beijing University of Traditional Chinese Medicine, 2023,46(5):607-616.
方妍妍, 刘健, 忻凌, 等. 新风胶囊降低强直性脊柱炎患者终点事件发生风险的队列研究[J]. 北京中医药大学学报, 2023,46(5):607-616. DOI： 10.3969/j.issn.1006-2157.2023.05.003.

FANG Yanyan, LIU Jian, XIN Ling, et al. Xinfeng Capsule reduces the risk of endpoint events in patients with ankylosing spondylitis: a cohort study[J]. Journal of Beijing University of Traditional Chinese Medicine, 2023,46(5):607-616. DOI： 10.3969/j.issn.1006-2157.2023.05.003.

摘要

目的

评价中药复方新风胶囊是否与强直性脊柱炎(AS)患者的终点事件(再入院、关节外表现和手术治疗)有关。

方法

回顾性收集2012年6月—2022年6月在安徽中医药大学第一附属医院风湿免疫科出院的1 621例AS患者的临床数据。按是否服用新风胶囊将患者分为新风胶囊组及非新风胶囊组。采用倾向性评分匹配方法来匹配基线数据。以随机行走模型评价规范化西药联合新风胶囊对免疫炎症指标改善情况的影响。关联规则分析新风胶囊与AS临床免疫炎症指标改善的关联度。进行多变量(包括新风胶囊、性别、年龄、原发性高血压、糖尿病、高脂血症、骨质疏松症、肝功能不全和慢性乙型肝炎)COX分析，确定再入院、关节外表现和手术治疗的风险。

结果

最终有1 455例AS患者被纳入该研究。经过倾向性评分匹配，新风胶囊使用者的基线数据与非新风胶囊使用者的基线数据一致，每组203例。回顾性数据挖掘结果显示，新风胶囊可明显降低AS患者的临床免疫炎症指标；随机行走模型结果提示，规范化西药联合新风胶囊治疗与免疫炎症指标的改善长程关联；关联规则分析结果显示，新风胶囊与免疫炎症指标的改善呈强关联。与非新风胶囊使用者相比，新风胶囊使用者总终点事件的预后更优(

＝ 11.678，

＝0.65，95%

＝0.500～0.810，

0.01)。高暴露组(

＝0.504，95%

＝0.357～0.711)和中暴露组(

＝0.576，95%

＝0.380～0.873)的终点事件发生风险明显低于非暴露组。

结论

中药复方新风胶囊与AS较低的终点事件(再入院、关节外表现及手术治疗)有关，可能是AS终点事件的保护因素，并且长期暴露于新风胶囊可能明显减少终点事件的发生。

Abstract

Objective

We aimed to evaluate whether the Chinese medicine compound

Xinfeng

Capsule (XFC) is associated with the incidence of endpoint events (readmission

extra-articular lesions

and surgical treatment) in patients with ankylosing spondylitis (AS).

Methods

Clinical data were retrospectively collected from 1 621 AS patients discharged from the Department of Rheumatology and Immunology of the First Affiliated Hospital of Anhui University of Chinese Medicine between June 2012 and June 2022. XFC users and non-XFC users were defined as the XFC group and non-XFC group

respectively. Propensity score matching was used to match baseline data. A random walk model was used to evaluate the effects of western drugs combined with XFC treatment on the improvement of immunoinflammatory indexes. Association rules were used to analyze the association between XFC and improvement of clinical immunoinflammatory indexes in AS. Multivariate COX analysis including XFC

gender

age

hypertension

diabetes

hyperlipidemia

osteoporosis

hepatic insufficiency

and chronic hepatitis B was performed to determine the risk of readmission

extra-articular lesions

and surgical treatment.

Results

A total of 1 455 patients with AS were included. After propensity score matching

baseline data for XFC users were consistent with those for non-XFC users

with 203 cases in each group. Retrospective data mining showed that XFC significantly reduced clinical immunoinflammatory markers in patients with AS

and random walk result suggested that XFC treatment was associated with long-term improvement in immunoinflammatory markers. The result of association rule analysis showed that XFC was strongly associated with the improvement of immune inflammatory markers. The prognosis of the overall endpoint events was better in XFC users compared to non-XFC users (

=11.678

=0.65

95%

=0.500-0.810

0.01). The risk of endpoint events was significantly lower in XFC users with high exposure intensity (

=0.504

95%

=0.357-0.711) and moderate exposure intensity (

=0.576

95%

=0.380-0.873) than in non-XFC users.

Conclusion

The herbal compound XFC is associated with a lower incidence of endpoint events (readmission

extra-articular lesions

and surgical treatment) in AS; long-term exposure to XFC may significantly reduce the occurrence of endpoint events.

关键词

强直性脊柱炎回顾性队列研究新风胶囊终点事件

Keywords

ankylosing spondylitisretrospective cohort studyXinfeng Capsuleendpoint events

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