中国药物警戒 ›› 2021, Vol. 18 ›› Issue (10): 969-974.
DOI: 10.19803/j.1672-8629.2021.10.16

• 安全与合理用药 • 上一篇    下一篇

巴曲酶治疗突发性聋的疗效及安全性的Meta分析

龚莉1,2,3, 苏述平4, 田晓江5, 唐学文6, 季欢欢2, 蒙龙7, 贾运涛2,*   

  1. 1重庆医科大学药学院,重庆 400016;
    2重庆医科大学附属儿童医院药学部,儿童发育疾病研究教育部重点实验室,儿童发育重大疾病国家国际科技合作基地,儿科学重庆市重点实验室,国家儿童健康与疾病临床医学研究中心,重庆 400014;
    3重庆大学附属肿瘤医院,肿瘤转移与个体化诊治转化研究重庆市重点实验室;
    4重庆医科大学附属儿童医院耳鼻喉科,重庆 400014;
    5重庆市妇幼保健院,重庆 400021;
    6嘉兴太美医疗科技有限公司,上海 200233;
    7重庆医科大学附属第一医院药学部,重庆 400016
  • 收稿日期:2020-01-13 出版日期:2021-10-15 发布日期:2021-10-27
  • 通讯作者: *贾运涛,男,主任药师,临床药学。E-mail：jiayuntaomail@hospital.cqmu.edu.cn
  • 作者简介:龚莉,女,硕士,药师,临床药学。
  • 基金资助:
    重庆市卫计委医学科研项目（2016ZDXM017）

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

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摘要： 目的 系统评价巴曲酶治疗突发性聋的有效性和安全性,为临床药物的选择提供循证证据。方法 检索Pubmed、Embase、Cochrane Library、Clinical Trials.gov、中国知网、万方数据、维普网,并人工检索相关领域文献,检索时间从建库至2019年10月31日,查找巴曲酶治疗突发性聋的随机对照试验,按照纳入排除标准对文献进行筛选、提取资料,并根据Cochrane Handbook 5.0的质量评价标准对纳入文献的方法学进行质量评价,以痊愈、总有效性、不良反应为评价指标,采用RevMan 5.0软件进行Meta分析,并进行单用和联用、不同疾病程度的亚组分析。结果 共纳入25项随机对照研究,合计2 458例患者。Meta分析结果显示：①巴曲酶组与对照组相比,痊愈和总有效性总体合并效应量,以及单用和联用、不同疾病程度的亚组分析效应量均优于对照组,差异均具有统计学意义;②所纳入文献中只有4篇报道不良反应,主要表现为纤维蛋白原降低、头晕、恶心、紫癜、轻度转氨酶升高。结论 Meta分析结果显示,巴曲酶可单用或联用治疗突发性耳聋,但是否能作为一线药物尚需设计更严格更科学的临床试验证实。

关键词: 巴曲酶, 突发性聋, Meta分析, 安全性

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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