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首页> 外文期刊>Pharmacology & Pharmacy >Evaluation Efficacy and Safety of Vortioxetine 20 mg/d versus Placebo for Treatment Major Depressive Disorder: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
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Evaluation Efficacy and Safety of Vortioxetine 20 mg/d versus Placebo for Treatment Major Depressive Disorder: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

机译：Vortioxetine 20 mg / d与安慰剂相比对治疗重度抑郁症的评估疗效和安全性：随机对照试验的系统评价和荟萃分析

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Major depressive disorder, a common debilitating illness, is one of the leading causes of disability and disease worldwide. Different drugs for the treatment of patients with major depression can be used. Vortioxetine for the treatment of major depressive disorder was approved by the Food and Drug Administration (FDA) in 2013. This study aimed to evaluation efficacy and safety Vortioxetine 20 mg/d compared placebo in major depressive disorder. To conduct this study, we searched Pub Med, Cochrane library, Scopus, and Central Register of Controlled Trials. This study by including randomized controlled trials (RCTs) that evaluated this study by including randomized controlled trials (RCTs) that evaluated Vortioxetine 20 mg/d in patients with major depressive disorder. Data analysis was conducted by standard mean different ratios (SMD) with 95% confidence intervals (CIs), P values and odds ratios (ORs) for adverse events with 95% confidence intervals (CIs) and P values; heterogeneity testing and sensitivity analysis was also performed in this study. We found that 4 articles met the inclusion criteria and were finally used for this meta-analysis. Results showed statistical significance in the MADRS (Montgomery-?sberg Depression Rating Scale), SMD = -4.75 with 95% CI [-6.84, -2.65] and P value < 0.00001), for Clinical Global Impression Scale-Improvement (CGI-I) SMD was -4.34 with 95% CI [-6.41, -2.27] and P value < 0.00001, and for Sheehan Disability Scale (SDS) SMD was -2.62 with 95% CI [-3.99, -1.25] and P value < 0.00001. The pooled analysis for safety demonstrated for diarrhea OR = 0.92 with 95% CI [0.46, 1.83] , P value = 0.09, for dry mouth OR = 1.74 with 95% CI [1.07, 2.83] , P value = 0.80, for dizziness OR = 1.62 with 95% CI [0.72, 3.66] , P value = 0.05, for fatigue OR = 1.17 with 95% CI [0.34, 4.08], P value = 0.07, for headache OR = 1.28 with 95% CI [0.91, 1.79], P value = 0.60 and for nausea OR = 4.78 with 95% CI [3.43, 6.67], P value = 0.61. Vortioxetine 20 mg/d versus placebo showed a significant difference for nausea and dry mouth, but no significant differences were observed for the four adverse effects. In several studies of the drug Vortioxetine 20 mg/d, the treatment of major depressive illness has been more effective for evaluating the effectiveness of this drug, which must be more clinical studies of sound.
机译：严重的抑郁症是一种常见的使人衰弱的疾病，是全球残疾和疾病的主要原因之一。可以使用用于治疗重度抑郁症患者的不同药物。 Vortioxetine用于治疗重度抑郁症的方法已于2013年获得美国食品药品监督管理局（FDA）批准。该研究旨在评估Vortioxetine 20 mg / d与安慰剂相比在重度抑郁症中的有效性和安全性。为了进行这项研究，我们搜索了Pub Med，Cochrane图书馆，Scopus和对照试验中心登记册。这项研究通过纳入随机对照试验（RCT）对本研究进行评估，该试验通过纳入随机对照试验（RCT）对严重抑郁症患者中的Vortioxetine 20 mg / d进行评估。通过具有95％置信区间（CIs），P值和95％置信区间（CIs）和P值的不良事件的比值比（OR）进行标准平均差异比（SMD）进行数据分析;在这项研究中还进行了异质性测试和敏感性分析。我们发现有4篇文章符合纳入标准，并最终用于该荟萃分析。结果显示，对于临床总体印象量表改进（CGI-S），MADRS（蒙哥马利-西斯伯格抑郁量表），SMD = -4.75，CI值为95％（-6.84，-2.65）和P值<0.00001）。 I）SMD为-4.34，CI为95％[-6.41，-2.27]，P值<0.00001，对于希恩·汉斯伤残量表（SDS），SMD为-2.62，CI为95％[-3.99，-1.25]和P值<0.00001。对安全性的汇总分析表明，对于口干而言，腹泻OR = 0.92时为95％[0.46，1.83]，P值= 0.09;对于95％CI为[1.07，2.83]，则为口干性腹泻= 1.74，P值= 0.80头晕OR = 1.62，95％CI [0.72，3.66]，P值= 0.05，疲劳度= 1.17 95％CI [0.34，4.08]，P值= 0.07，头痛OR = 1.28 95％ CI [0.91，1.79]，P值= 0.60，恶心OR = 4.78，95％CI [3.43，6.67]，P值= 0.61。与安慰剂相比，伏替西汀20 mg / d与恶心和口干表现出显着差异，但对四种不良反应没有观察到显着差异。在对Vortioxetine 20 mg / d进行的多项研究中，重度抑郁症的治疗对于评估该药的有效性更为有效，因此必须进行更完善的临床研究。

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