Chinese Journal of Pharmacovigilance ›› 2021, Vol. 18 ›› Issue (10): 969-974.
DOI: 10.19803/j.1672-8629.2021.10.16

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Efficacy and Safety of Batroxobin in the Treatment of Sudden Hearing Loss: a Meta-analysis

GONG Li1,2,3, SU Shuping4, TIAN Xiaojiang5, TANG Xuewen6, JI Huanhuan2, MENG Long7, JIA Yuntao2*   

  1. 1School of Pharmacy, Chongqing Medical University, Chongqing 400016, China;
    2Department of Pharmacy, Children's Hospital of Chongqing Medical University/Ministry of Education Key Laboratory of Child Development and Disorders/China International Science and Technology Cooperation Base of Child Development and Critical Disorders/Chongqing Key Laboratory of Pediatrics/National Clinical Research Center for Child Health and Disorders, Chongqing 400014, China;
    3Chongqing Key Laboratory of Translational Research for Cancer Metastasis and Individualized Treatment, Chongqing University Cancer Hospital, Chongqing 40030, China;
    4Department of Otolaryngology, Children's Hospital of Chongqing Medical University, Chongqing 400014, China;
    5Chongqing Maternal and Child Health Hospital, Chongqing 400021, China;
    6Taimei Technology, Shanghai 200233, China;
    7Department of Pharmacy, The First Affiliated Hospital of Chongqing Medical University, Chongqing 400016, China
  • Received:2020-01-13 Online:2021-10-15 Published:2021-10-27

Abstract: Objective To systematically review the efficacy and safety of batroxobin in the treatment of sudden hearing loss in order to provide evidence-based data for clinical medication. Methods Such databases as Pubmed, Embase, Cochrane Library, ClinicalTrials.gov, CNKI, Wanfang data, and Weipu were searched for randomized controlled trials of sudden hearing loss, and related literature was searched for manually. The data was screened and retrieved according to the inclusion and exclusion criteria. The quality of the enrolled literature was assessed by the quality assessment standard from Cochrane Handbook 5.0, with the cure rate, effective rate and incidence of adverse reactions as evaluation indexes. Software of RevMan 5.0 was used for the meta-analysis and subgroup analysis. Results A total of 25 randomized controlled trials were enrolled, involving 2 458 patients. Meta-analysis results suggested that the therapeutic effect in the batroxobin group was better than in the control with statistically significant difference. Only 4 randomized controlled trials reported adverse reactions that manifested themselves as a decrease of fibrinogen, dizziness, nausea, purpura, and a mild increase of transaminase. Conclusion Meta-analysis results show that batroxobin can be used alone or in combination with other drugs for the treatment of sudden hearing loss. But whether it can be used as a first-line drug needs to be confirmed by more rigorous and scientific clinical trials.

Key words: batroxobin, sudden hearing loss, Meta-analysis, safety

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