普瑞巴林的不良事件概要:随机对照试验的系统性回顾和荟萃分析。
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Zaccara G, Gangemi P, Perucca P L》
普瑞巴林的不良事件概要:随机对照试验的系统性回顾和荟萃分析。
Epilepsia。2011年4月;52 (4):826 - 36。doi: 10.1111 / j.1528-1167.2010.02966.x。Epub 2011年2月14。
- PubMed ID
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21320112 (在PubMed]
- 文摘
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目的:尽管广泛使用抗癫痫药物(AED)在不同的神经和精神障碍,没有研究系统地回顾了所有可用的随机对照试验(相关的)的一个给定的AED充分揭示其耐受性。我们旨在识别紧急治疗的不良事件(AEs)与普瑞巴林通过所有可用的相关的系统回顾和荟萃分析。我们也评估之间的关系严重的AEs和普瑞巴林,调查是否与AEs显示剂量反应关系。方法:我们搜查了MEDL必威国际appINE和EMBASE,和Cochrane中央为相关的2010年2月。额外的研究确定了从在线临床参考检索论文列表和数据库。我们选择安慰剂对照、双盲治疗效果的相关调查与成人与任何条件。研究必须包括至少20 /胳膊,有至少4周时间。AEs协会进行了评估与普瑞巴林同义词识别/排除后,罕见的AEs, nonassessable AEs由于方法学的局限性。我们使用相对风险(RRs)评估协会(99%的置信区间(CIs))或严重的AEs (CIs) 95%与普瑞巴林和风险差异(CIs) RDs, 95%调查与AEs的剂量反应关系。主要结论:38相关的被包含在我们的研究中。 Of 39 AEs, 20 (51%) were significantly associated with pregabalin (dizziness, vertigo, incoordination, balance disorder, ataxia, diplopia, blurred vision, amblyopia, tremor, somnolence, confusional state, disturbance in attention, thinking abnormal, euphoria, asthenia, fatigue, edema, peripheral edema, dry mouth, constipation). The highest RRs were found for cognition/coordination AEs. There was no significant association between serious AEs and pregabalin. There was a selective dose-response pattern in the onset of pregabalin AEs, with certain AEs appearing at lower doses than others. SIGNIFICANCE: Individuals starting treatment with pregabalin are at increased risk for several AEs, particularly those affecting cognition/coordination. Pregabalin AEs appear according to a selective dose-response pattern, possibly reflecting the severity of dysfunction of distinct anatomic structures. These findings may aid clinicians in providing better patient management, and support the value of including in meta-analyses of AED tolerability profiles RCTs performed in different conditions.
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