基于循证药学评价强力定眩片(胶囊)联合倍他司汀治疗眩晕的有效性和安全性  

Efficacy and Safety of Qiangli Dingxuan Tablets(Capsules)Combined with Betastine in the Treatment of Vertigo Based on Evidence-Based Pharmacy

作　　者：郑子恢[1] 张碧华[1] 张白歌 原涵[1] 马琳[1] 李文英[1] 邹定[1] 金鹏飞[1] ZHENG Zihui;ZHANG Bihua;ZHANG Baige;YUAN Han;MA Lin;LI Wenying;ZOU Ding;JIN Pengfei(Dept.of Pharmacy,Beijing Hospital,National Center of Gerontology,Institute of Geriatric Medicine,Chinese Academy of Medical Science,Beijing Key Laboratory of Assessment of Clinical Drugs Risk and Individual Application(Beijing Hospital),Beijing 100730,China)

机构地区：[1]北京医院药学部,国家老年医学中心,中国医学科学院老年医学研究院,北京市药物临床风险与个体化应用评价重点实验室(北京医院),北京100730

出　　处：《中国医院用药评价与分析》2021年第9期1084-1090,1096,共8页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：中央保健专项基金项目(No.B2009B032)。

摘　　要：目的:基于循证药学,评价强力定眩片(胶囊)联合倍他司汀治疗眩晕的有效性和安全性。方法:计算机检索Embase、PubMed、the Cochrane Library、万方数据库、中国知网和中国生物医学文献数据库,纳入强力定眩片(胶囊)联合倍他司汀治疗眩晕的随机对照试验[研究组方案为强力定眩片(胶囊)联合倍他司汀治疗,对照组为单独使用倍他司汀治疗],检索时间为建库至2021年6月。由2名研究者提取资料、选取文献并评价纳入文献的偏倚风险后,采用Rev Man 5.4软件进行荟萃分析(Meta分析)。结果:共纳入11项随机对照试验,包括956例患者(研究组478例患者,对照组478例患者)。Meta分析结果显示,有效性方面,研究组患者的总有效率(OR=5.19,95%CI=3.33~8.10,P<0.00001)、显效率(OR=2.09,95%CI=1.57~2.78,P<0.00001)、痊愈率(OR=3.75,95%CI=1.86~7.55,P=0.0002)、眩晕症状评分(MD=-4.40,95%CI=-4.82~-3.98,P<0.00001)、眩晕障碍量表评分(MD=-10.57,95%CI=-11.92~-9.22,P<0.00001)、血浆黏度(MD=-0.25,95%CI=-0.32~-0.17,P<0.00001)、左椎动脉血流速度(MD=4.56,95%CI=3.38~5.74,P<0.00001)、右椎动脉血流速度(MD=4.37,95%CI=3.85~4.90,P<0.00001)、基底动脉血流速度(MD=3.49,95%CI=2.68~4.31,P<0.00001)、内皮素1水平(MD=-29.72,95%CI=-31.29~-28.15,P<0.00001)、降钙素基因相关肽水平(MD=6.21,95%CI=5.43~6.99,P<0.00001)和内皮素1/降钙素基因相关肽比值(OR=-2.01,95%CI=-2.38~-1.63,P<0.00001)均显著优于对照组,差异均有统计学意义;安全性方面,两组患者不良反应发生率比较,差异无统计学意义(OR=0.59,95%CI=0.14~2.53,P=0.47>0.05)。结论:现有证据表明,强力定眩片(胶囊)联合倍他司汀治疗眩晕安全、有效,较单独使用倍他司汀有显著优势。因纳入的研究数量和质量的限制,上述结论有待今后更多高质量随机对照试验予以验证。OBJECTIVE:To evaluate the efficacy and safety of Qiangli Dingxuan tablets(capsules)combined with betastine in the treatment of vertigo based on evidence-based pharmacy.METHODS:Embase,PubMed,the Cochrane Library,Wanfang database,CNKI and CBM were retrieved to collect the randomized controlled trial of Qiangli Dingxuan tablets(capsules)combined with betastine in the treatment of vertigo[the study group was given Qiangli Dingxuan tablets(capsules)combined with betastine,while the control group received betastine alone].The retrieval time was from the establishment of the database to Jun.2021.After two researchers extracted data,selected literature and evaluated the risk of bias in the included literature,Meta-analysis was performed by using RevMan 5.4 software.RESULTS:Totally 11 randomized controlled trials were collected,including 956 patients(478 cases in the experimental group and 478 cases in the control group).Meta-analysis results showed that the total effective rate(OR=5.19,95%CI=3.33-8.10,P<0.00001)and significant rate(OR=2.09,95%CI=1.57-2.78,P<0.00001),recovery rate(OR=3.75,95%CI=1.86-7.55,P=0.0002),vertigo symptom score(MD=-4.40,95%CI=-4.82--3.98,P<0.00001),dizziness handicap inventory score(MD=-10.57,95%CI=-11.92--9.22,P<0.00001),plasma viscosity(MD=-0.25,95%CI=-0.32--0.17,P<0.00001),left vertebral artery blood flow velocity(MD=4.56,95%CI=3.38-5.74,P<0.00001),right vertebral artery blood flow velocity(MD=4.37,95%CI=3.85-4.90,P<0.00001),basilar artery blood flow velocity(MD=3.49,95%CI=2.68-4.31,P<0.00001),endothelin-1 level(MD=-29.72,95%CI=-31.29--28.15,P<0.00001),calcitonin gene-related peptide level(MD=6.21,95%CI=5.43-6.99,P<0.00001)and ratio of endothelin 1/calcitonin gene-related peptide(OR=-2.01,95%CI=-2.38--1.63,P<0.00001)in the study group were significantly better than those in the control group,the differences were statistically significant.There was no significant difference in the incidence of adverse drug reactions between two groups(OR=0.59,95%CI=0.14-2.53,P=0.47>0.05).CONCLUSIONS:Existing evi

关 键 词：强力定眩片(胶囊) 倍他司汀 眩晕 Meta分析 随机对照试验 

分 类 号：R932[医药卫生—生药学]