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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)
纸质出版日期:2021,
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郑子恢, 张碧华, 张白歌, 等. 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[J]. 中国医院用药评价与分析, 2021,21(9):1084-1090.
Efficacy and Safety of Qiangli Dingxuan Tablets( Capsules) Combined with Betastine in the Treatment of Vertigo Based on Evidence-Based Pharmacy[J]. 2021,21(9):1084-1090.
郑子恢, 张碧华, 张白歌, 等. 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[J]. 中国医院用药评价与分析, 2021,21(9):1084-1090. DOI: 10.14009/j.issn.1672-2124.2021.09.016.
Efficacy and Safety of Qiangli Dingxuan Tablets( Capsules) Combined with Betastine in the Treatment of Vertigo Based on Evidence-Based Pharmacy[J]. 2021,21(9):1084-1090. DOI: 10.14009/j.issn.1672-2124.2021.09.016.
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 <0.000 01)、显效率(OR=2.09
95%CI=1.57~2.78
P<0.000 01)、痊愈率(OR=3.75
95%CI=1.86~7.55
P=0.000 2)、眩晕症状评分(MD=-4.40
95%CI=-4.82~-3.98
P<0.000 01)、眩晕障碍量表评分(MD=-10.57
95%CI=-11.92~-9.22
P<0.000 01)、血浆黏度(MD=-0.25
95%CI=-0.32~-0.17
P<0.000 01)、左椎动脉血流速度(MD=4.56
95%CI=3.38~5.74
P<0.000 01)、右椎动脉血流速度(MD=4.37
95%CI=3.85~4.90
P<0.000 01)、基底动脉血流速度(MD=3.49
95%CI=2.68~4.31
P<0.000 01)、内皮素1水平(MD=-29.72
95%CI=-31.29~-28.15
P<0.000 01)、降钙素基因相关肽水平(MD=6.21
95%CI=5.43~6.99
P<0.000 01)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<0.000 01)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. 000 01) and significant rate( OR = 2. 09
95%CI= 1. 57-2. 78
P<0. 000 01)
recovery rate( OR = 3. 75
95%CI = 1. 86-7. 55
P = 0. 000 2)
vertigo symptom score( MD =-4. 40
95% CI =-4. 82--3. 98
P<0. 000 01)
dizziness handicap inventory score( MD =-10. 57
95% CI =-11. 92--9. 22
P < 0. 000 01)
plasma viscosity( MD =-0. 25
95%CI =-0. 32--0. 17
P<0. 000 01)
left vertebral artery blood flow velocity( MD =4. 56
95%CI = 3. 38-5. 74
P<0. 000 01)
right vertebral artery blood flow velocity( MD = 4. 37
95%CI = 3. 85-4. 90
P<0. 000 01)
basilar artery blood flow velocity( MD = 3. 49
95%CI = 2. 68-4. 31
P<0. 000 01)
endothelin-1 level( MD=-29. 72
95%CI=-31. 29--28. 15
P<0. 000 01)
calcitonin gene-related peptide level( MD= 6. 21
95%CI =5. 43-6. 99
P< 0. 000 01) and ratio of endothelin 1/calcitonin gene-related peptide( OR =-2. 01
95% CI =-2. 38--1. 63
P<0. 000 01) 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 evidence shows that Qiangli Dingxuan tablets( capsules) combined with betastine are safe and effective in the treatment of vertigo
which has significant advantages over betahistine alone. Due to the limitations of the quantity and quality of the included literature
the conclusions need to be verified by more high-quality randomized controlled trials in the future.
强力定眩片(胶囊)倍他司汀眩晕Meta分析随机对照试验
Qiangli Dingxuan tablets(capsules)BetahistineVertigoMeta-analysisRandomized controlled trial
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