Chinese Journal of Pharmacovigilance ›› 2022, Vol. 19 ›› Issue (5): 537-540.
DOI: 10.19803/j.1672-8629.2022.05.13

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Adverse drug reactions of cefoperazone sodium and sulbactam sodium in children

LI Yan, SUN Chong, LYU Meng, ZHOU Yuxue, MA Shuli*   

  1. Department of Pharmacy, Children's Hospital Affiliated to Zhengzhou University/Henan Children's Hospital/Zhengzhou Children's Hospital, Zhengzhou Henan 450000, China
  • Received:2020-06-30 Online:2022-05-15 Published:2022-05-18

Abstract: Objective To analyze the characteristics of adverse drug reactions (ADR) of cefoperazone sodium and sulbactam sodium in children, and to provide data for clinical decision-making. Methods ADR reports of cefoperazone sodium and sulbactam sodium in children in Henan Pediatric Medical Alliance between 2014 and 2018 were collected. The gender, age distribution, types of ADR and involved systems and organs were analyzed. Results A total of 877 reports were collected, 536 of which involved males and 341 involved females. There were 50 reports related to the neonatal group (5.70%), 126 the 1-12-month-old group (14.37%), 319 the 1-3-year-old group (36.37%), 208 the pre-school age group (23.72%), 95 the school-age group (10.83%), and 79 related to the adolescent group (9.01%). The peak of ADR occurred between the day of administration and the third day. There were 83 reports (0.95%) on serious cases, and the proportion of severe ADR in the pre-school age group was the highest (3.42%). The clinical manifestations of ADR in children were mainly skin lesions (65.90%) and digestive system lesions (20.07%), and hematological system lesions were rarely reported (0.98%). Severe ADR included severe skin rash, convulsions and epilepsy. Conclusion There is something unique about ADR of cefoperazone sodium and sulbactam sodium in children, which is worthy of attention in clinic.

Key words: cefoperazone sodium and sulbactam sodium, adverse drug reaction, children

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