A Prospective Study on Adverse Reactions of Cefazolin Sodium Pentahydrate for Injection

doi:10.19803/j.1672-8629.2021.12.16

Chinese Journal of Pharmacovigilance ›› 2021, Vol. 18 ›› Issue (12): 1171-1175.
DOI: 10.19803/j.1672-8629.2021.12.16

A Prospective Study on Adverse Reactions of Cefazolin Sodium Pentahydrate for Injection

LI Jin^1,2, LANG Gang, WEI Li⁴, QIN Zhengbi⁵, SUN Yinxiang⁶, LU Xiaoqin⁷, CHEN Zhigao⁸, LI Yunmei⁹, LI Meijun², DENG Jianxiong^2,*

¹Pharmacy Department, Guangzhou United Family Hospital, Guangzhou Guangdong 510335, China;
²Guangdong Provincial Pharmacological Society, Guangzhou Guangdong, 510080, China;
³China Resources Sanjiu Medical & Pharmaceutical CO., LTD., Shenzhen Guangdong 518049, China;
⁴Department of Pharmacy, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou Guangdong 510120, China;
⁵Department of Pharmacy, Affiliated Hospital of Hubei University for Nationalities, Enshi Hubei 445099, China;
⁶Department of Pharmacy, Zhuhai People's Hospital, Zhuhai Guangdong 519070, China;
⁷Department of Research and Education, Chongqing Ninth People's Hospital, Chongqing 400799, China;
⁸Department of Pharmacy, Jiangyin Hospital Affiliated to Medical College of Southeast University, Jiangyin Jiangsu 214400, China;
⁹Department of Pharmacy, Dongguan Hospital of Traditional Chinese Medicine, Dongguan Guangdong 523127, China

Received:2021-03-10 Online:2021-12-15 Published:2021-12-16

Abstract

Abstract: Objective To evaluate prospectively the adverse reactions of cefazolin sodium pentahydrate for injection and evaluate its safety by means of the Chinese Hospital Pharmacovigilance System (CHPS). Methods From March 1, 2018 to October 31, 2018, the data on 3 641 valid hospitalized patients was collected prospectively via the CHPS from six tertiary hospitals, and the post-marketing safety analysis of cefazolin sodium for injection was performed. Results The rate of adverse drug reactions (ADR) was 4.35‰. There were no serious ADR, and most of the ADR occurred within 24 hours of the administration. The drug was discontinued after the occurrence of ADR. Some patients received treatment after the discontinuation of this drug. All the patients were cured or improved after treatment. Conclusion The incidence of ADR (4.35‰) of cefazolin sodium pentahydrate for injection is significantly different from that of ADR (1.1%) in the instructions for amorphous cefazolin sodium. Probably due to the chelating structure of unstable cefazolin sodium pentahydrate, the sulfur-containing groups in the tunnel-shaped cavity protective molecules composed of cefazolin molecules will not easily fall off and can avoid contact with rubber plugs, thus improving stability, decreaseing catabolites and reducing adverse reactions.

Key words: cefazolin sodium pentahydrate, adverse drug reaction, prospective, safety study

CLC Number:

R994.11

LI Jin, LANG Gang, WEI Li, QIN Zhengbi, SUN Yinxiang, LU Xiaoqin, CHEN Zhigao, LI Yunmei, LI Meijun, DENG Jianxiong. A Prospective Study on Adverse Reactions of Cefazolin Sodium Pentahydrate for Injection[J]. Chinese Journal of Pharmacovigilance, 2021, 18(12): 1171-1175.

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A Prospective Study on Adverse Reactions of Cefazolin Sodium Pentahydrate for Injection

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