Which Is Safer, Chinese Medicine or Western Medicine?Comparative Analysis Based on Chinese Spontaneous Reporting Database

Jian-xiang WEI; Zhi-qiang LU; Guan-zhong FENG; Yun-xia ZHU

doi:10.1007/s11655-021-3340-7

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Which Is Safer, Chinese Medicine or Western Medicine?Comparative Analysis Based on Chinese Spontaneous Reporting Database

Original Article | Updated：2022-02-22

- Which Is Safer, Chinese Medicine or Western Medicine?Comparative Analysis Based on Chinese Spontaneous Reporting Database
- Which Is Safer, Chinese Medicine or Western Medicine?Comparative Analysis Based on Chinese Spontaneous Reporting Database
- Chinese Journal of Integrative Medicine 2022年28卷第2期页码：138-144
- Affiliations：
  
  1.School of Management, Nanjing University of Posts and Telecommunications, Nanjing (210003), China
  2.School of Internet of Things, Nanjing University of Posts and Telecommunications, Nanjing (210003), China
- Author bio：
  
  Associate Prof. WEI Jian-xiang, E-mail:jxwei@njupt.edu.cn
- Funds：
  
  the Major Project of Philosophy and Social Science Research in Jiangsu Universities(2020SJZDA102);the Postgraduate Research & Practice Innovation Program of Jiangsu Province(SJCX20_0223)
- DOI：10.1007/s11655-021-3340-7
  中图分类号：
- 纸质出版日期：2022-02-01，
  
  网络出版日期：2021-10-01，
  
  录用日期：2021-01-08
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Jian-xiang WEI, Zhi-qiang LU, Guan-zhong FENG, 等. Which Is Safer, Chinese Medicine or Western Medicine?Comparative Analysis Based on Chinese Spontaneous Reporting Database[J]. Chinese Journal of Integrative Medicine, 2022,28(2):138-144.

Jian-xiang WEI, Zhi-qiang LU, Guan-zhong FENG, et al. Which Is Safer, Chinese Medicine or Western Medicine?Comparative Analysis Based on Chinese Spontaneous Reporting Database[J]. Chinese Journal of Integrative Medicine, 2022,28(2):138-144.
Jian-xiang WEI, Zhi-qiang LU, Guan-zhong FENG, 等. Which Is Safer, Chinese Medicine or Western Medicine?Comparative Analysis Based on Chinese Spontaneous Reporting Database[J]. Chinese Journal of Integrative Medicine, 2022,28(2):138-144. DOI： 10.1007/s11655-021-3340-7.

Jian-xiang WEI, Zhi-qiang LU, Guan-zhong FENG, et al. Which Is Safer, Chinese Medicine or Western Medicine?Comparative Analysis Based on Chinese Spontaneous Reporting Database[J]. Chinese Journal of Integrative Medicine, 2022,28(2):138-144. DOI： 10.1007/s11655-021-3340-7.

摘要

目的:

基于中国自发报告数据库比较中药和西药之间的安全性差异.

方法:

以2010年至2011年中国自发报告数据库中中药和西药引起的不良事件报告为研究数据. 构建了以下评价指标: 严重不良事件比例 (PSE) 、平均不良事件数 (ANA) 和不良事件覆盖率 (CRA) . 进一步的安全性比较还包括报告不良事件最多的药物

报告数量最多的不良事件

以及5种感兴趣的严重不良事件 (包括死亡、过敏性休克、昏迷、呼吸困难和肝功能异常) .

结果:

西药的PSE、ANA和CRA分别是中药的1.09、8.23和2.35倍. 最严重不良事件的前10名药物主要是中药注射剂和西药抗生素. 两者不良事件报告数量最多的是皮疹、瘙痒、恶心、头晕和呕吐

在过敏性休克和昏迷中的比例两者相似

而对于肝功能异常和死亡

西药的比例则分别是中药的5.47倍和3.00倍.

结论:

基于中国自发报告数据库

从药物不良反应的视角

中药在平均水平上比西药更加安全.

Abstract

Objective:

To compare the safety differences between Chinese medicine (CM) and Western medicine (WM) based on Chinese Spontaneous Reporting Database (CSRD).

Methods:

Reports of adverse events (AEs) caused by CM and WM in the CSRD between 2010 and 2011 were selected. The following assessment indicators were constructed: the proportion of serious AEs (PSE)

the average number of AEs (ANA)

and the coverage rate of AEs (CRA). Further comparisons were also conducted

including the drugs with the most reported serious AEs

the AEs with the biggest report number

and the 5 serious AEs of interest (including death

anaphylactic shock

coma

dyspnea and abnormal liver function).

Results:

The PSE

ANA and CRA of WM were 1.09

8.23 and 2.35 times higher than those of CM

respectively. The top 10 drugs with the most serious AEs were mainly injections for CM and antibiotics for WM. The AEs with the most reports were rash

pruritus

nausea

dizziness and vomiting for both CM and WM. The proportions of CM and WM in anaphylactic shock and coma were similar. For abnormal liver function and death

the proportions of WM were 5.47 and 3.00 times higher than those of CM

respectively.

Conclusion:

Based on CSRD

CM was safer than WM at the average level from the perspective of adverse drug reactions.

关键词

Keywords

Chinese medicineWestern medicinedata analysisadverse drug reactiondrug safety

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