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Rev Man 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。
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.
作者
龚莉
苏述平
田晓江
唐学文
季欢欢
蒙龙
贾运涛
GONG Li;SU Shuping;TIAN Xiaojiang;TANG Xuewen;JI Huanhuan;MENG Long;JIA Yuntao(School of Pharmacy,Chongqing Medical University,Chongqing 400016,China;Department 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;Chongqing Key Laboratory of Translational Research for Cancer Metastasis and Individualized Treatment,Chongqing University Cancer Hospital,Chongqing 40030,China;Department of Otolaryngology,Children's Hospital of Chongqing Medical University,Chongqing 400014,China;Chongqing Maternal and Child Health Hospital,Chongqing 400021,China;Taimei Technology,Shanghai 200233,China;Department of Pharmacy,The First Affiliated Hospital of Chongqing Medical University,Chongqing 400016,China)
出处
《中国药物警戒》
2021年第10期969-974,共6页
Chinese Journal of Pharmacovigilance
基金
重庆市卫计委医学科研项目(2016ZDXM017)。
作者简介
龚莉,女,硕士,药师,临床药学;通信作者:贾运涛,男,主任药师,临床药学。E-mail:jiayuntaomail@hospital.cqmu.edu.cn。
