出 处:《临床药物治疗杂志》2022年第2期76-81,共6页Clinical Medication Journal
基 金:北京大学人民医院研究与发展基金(科研)项目(RDY2019-39)。
摘 要:目的系统评价银杏叶提取物(GBE)序贯疗法治疗突发性聋(SSNHL)的有效性与安全性。方法计算机检索Embase、PubMed、Cochrane Library、万方、中国知网、维普数据库,收集从建库起至2021年10月31日发表的GBE序贯疗法治疗SSNHL的研究(研究组患者应用GBE序贯疗法,对照组患者采用常规治疗)。分别采用Cochrane风险评估工具和纽卡斯尔-渥太华量表评价纳入的随机对照试验(RCT)和临床对照试验(CCT)的质量,采用RevMan 5.4软件进行Meta分析。结果共纳入4项RCT,1项CCT,累计490例患者。基于RCT的Meta分析结果显示,研究组患者总有效率高于对照组,差异有统计学意义(RR=1.21,95%CI:1.08~1.36)。按治疗方案进行亚组分析,研究组中含有糖皮质激素的两组痊愈率差异无统计学意义(RR=1.38,95%CI:0.31~6.07),无糖皮激素的两组痊愈率差异有统计学意义,研究组痊愈率高于对照组(RR=1.41,95%CI:1.02~1.96)。两组不良反应的发生率差异无统计学意义(RR=0.58,95%CI:0.27~1.25)。无法合并的1项CCT采用描述性分析,结果显示研究组总有效率高于对照组(P<0.05),两组均未出现严重不良反应。结论GBE序贯疗法治疗SSNHL安全有效,可以提高总有效率。但由于纳入研究的样本量较少,部分研究质量较低,因此上述结果仍需高质量临床研究进一步证实。Objective To systematically evaluate the efficacy and safety of sequential therapy of Ginkgo biloba extract(GBE)in the treatment of sudden sensorineural hearing loss(SSNHL).Methods Embase,PubMed,Cochrane Library,Wanfang,CNKI and VIP databases were searched from the inception to October 31th,2021,and trials about sequential therapy of GBE for SSNHL were selected(the study group was treated with sequential therapy of GBE,while the control group received conventional regimen).The quality of randomized controlled trial(RCT)and controlled clinical trial(CCT)were evaluated by using bias risk evaluation tool recommended by Cochrane and Newcastle Ottawa scale,respectively.RevMan 5.4 software was used for Meta-analysis.Results A total of 4 RCTs and 1 CCT involving 490 patients were included.Meta-analysis of RCTs indicated that total effective rate in study group was significantly higher than that of control group(RR=1.21,95%CI:1.08-1.36).Sub-group analysis as per therapeutic regimen showed that there was no significant difference in clinical cure rate between the two groups(RR=1.38,95%CI:0.31-6.07)when corticosteroids were contained in the control group.However,clinical cure rate in study group was significantly higher than that of control group(RR=1.41,95%CI:1.02-1.96)when the treatment regimen did not contain corticosteroids.There was no significant difference in the incidence of drug adverse reactions between the two groups(RR=0.58,95%CI:0.27-1.25).Descriptive analysis was used in one CCT that could not be combined,the results showed that the total effective rate of study group was better than control group(P<0.05),no serious adverse reactions were observed in the two groups.Conclusions Sequential therapy of GBE can effectively improve the total effective rate of SSNHL and has a good safety profile.Due to the small sample size and low quality of the included literatures,the above results still need to be further verified by high-quality clinical studies.
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