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10409例丹红注射液上市后医院集中监测安全性研究

[Study on 10 409 cases of post-marketing safety Danhong injection centralized monitoring of hospital].

作者信息

Li Xuelin, Tang Jinfa, Meng Fei, Li Chunxiao, Xie Yanming

机构信息

The First Affiliated Hospital of Henan College of Pharmacy, Zhengzhou 450000, China.

出版信息

Zhongguo Zhong Yao Za Zhi. 2011 Oct;36(20):2783-5.

PMID:22292364
Abstract

OBJECTIVE

To study Danhong injection adverse reactions (ADR) incidence, nature and clinical performance, provide the basis for the clinical safety of drugs.

METHOD

Multi-center, a large sample of hospitals focused on monitoring method.

RESULT

Danhong injection ADR for the rapid onset and ease the quick recovery, the rate was 0. 682% , the newly discovered ADR constipation, sweating, tinnitus, irritability, joint disease, erythema, venous pain, phlebitis, local numbness, pain, weakness, gastrointestinal ulcer bleeding, vasospasm, cyanosis.

CONCLUSION

Danhong injection adverse reactions are type A adverse reactions occasionally, centralized monitoring of hospital medicine injection method is to carry out post-marketing safety re-evaluation of appropriate methods.

摘要

目的

研究丹红注射液不良反应(ADR)的发生率、性质及临床表现,为临床用药安全性提供依据。

方法

采用多中心、大样本医院集中监测方法。

结果

丹红注射液不良反应起病迅速且缓解快,发生率为0.682%,新发现的ADR有便秘、出汗、耳鸣、烦躁、关节不适、红斑、静脉疼痛、静脉炎、局部麻木、疼痛、乏力、消化道溃疡出血、血管痉挛、发绀。

结论

丹红注射液不良反应偶见A型不良反应,医院集中监测药品注射方法是开展上市后安全性再评价的适宜方法。

相似文献

1
[Study on 10 409 cases of post-marketing safety Danhong injection centralized monitoring of hospital].10409例丹红注射液上市后医院集中监测安全性研究
Zhongguo Zhong Yao Za Zhi. 2011 Oct;36(20):2783-5.
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[Comparative study on four kinds of assessment methods of post-marketing safety of Danhong injection].丹红注射液上市后安全性四种评估方法的比较研究
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引用本文的文献

1
Post-marketing safety surveillance and re-evaluation of Xueshuantong injection.血栓通注射液上市后安全性监测与再评价。
BMC Complement Altern Med. 2018 Oct 16;18(1):277. doi: 10.1186/s12906-018-2329-z.
2
Evaluating the effects of Danhong injection in treatment of acute ischemic stroke: study protocol for a multicenter randomized controlled trial.评价丹红注射液治疗急性缺血性脑卒中的效果:一项多中心随机对照试验的研究方案
Trials. 2015 Dec 9;16:561. doi: 10.1186/s13063-015-1076-4.
3
Pretreatment with Danhong injection protects the brain against ischemia-reperfusion injury.
丹红注射液预处理对脑缺血再灌注损伤的保护作用。
Neural Regen Res. 2014 Aug 1;9(15):1453-9. doi: 10.4103/1673-5374.139462.
4
Quantitative profiling of polar metabolites in herbal medicine injections for multivariate statistical evaluation based on independence principal component analysis.基于独立主成分分析的中药注射剂中极性代谢物定量分析及多元统计评价
PLoS One. 2014 Aug 26;9(8):e105412. doi: 10.1371/journal.pone.0105412. eCollection 2014.