Antipsychotic and mood stabilizer efficacy and tolerability in pediatric and adult patients with bipolar I mania: a comparative analysis of acute, randomized, placebo-controlled trials
Antipsychotic and mood stabilizer efficacy and tolerability in pediatric and adult patients with bipolar I mania: a comparative analysis of acute, randomized, placebo-controlled trials
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DOI：
10.1111/j.1399-5618.2010.00798.x
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发表时间：
2010-03-01
影响因子：
5.4
通讯作者：
DelBello, Melissa P.
中科院分区：
文献类型：
--
作者：
Correll, Christoph U.;Sheridan, Eva M.;DelBello, Melissa P.
目的：比较抗精神病药和心境稳定剂（MS）在青年和成人双相躁狂症患者中的疗效和耐受性。（18岁以下）或成人（>= 18岁）;（ii）双相I型障碍;（iii）双盲、随机、安慰剂对照试验（DB-RPCT）;（iv）< 12周治疗;和（v）可计算的效应量（ES）和/或治疗/伤害所需的数量（NNT/NNH）+/-95%置信区间（CI）。非重叠的95%CI确定显着groupdifferentiation.Results：我们确定了9 DB-RPCT的青年（n = 1，609），5评估第二代抗精神病药（SGAs）（n = 1，140）和4评估MS（n = 469）。我们还确定了23例成人DB-RPCT（n = 6，501），14例包括SGA（n = 3，297），5例使用氟哌啶醇作为活性对照（n = 580），11例包括MS（n = 2，581）。在青年（ES = 0.65，CI：0.53-0.78 vs 0.24，CI：0.06-0.41）和成人（ES = 0.48，CI：0.41-0.55 vs 0.24，CI：0.17-0.31）中，SGA组的青年躁狂评定量表评分改善显著高于MS组。在排除托吡酯研究后，仅在青年中SGAs的ES大于MS（ES = 0.65，CI：0.53-0.78 vs 0.20，CI：0.02-0.39），但在成人中则不然（ES = 0.48，CI：0.41-0.55 vs 0.46，CI：0.37-0.55）。然而，在成人中，即使没有托吡酯，SGAs在临床总体免疫功能评分方面的ES也显著大于MS（ES = 0.75，CI：0.68-0.82 vs 0.24，CI：0.07-0.41）。与安慰剂组相比，药物组和年龄组之间的应答率、缓解率和因任何原因停药的发生率相似，但排除托吡酯后，在成人中，SGA缓解的NNT比MS更有利。在青年中，SGAs比MS引起更多的体重增加（ES = 0.53，CI：0.41-0.66 vs 0.10，CI：-0.12-0.33），但在成人中则不然（ES = 0.13，CI：0.05-0.22 vs 0.00，CI：-0.08-0.08）。然而，排除托吡酯后，两个年龄组的结果是异质性的，没有显著性。然而，青年人与SGA相关的体重增加明显大于成年人。在年轻人中，SGA相关的嗜睡大于MS（NNH = 4.7，CI：3.9-6.0 vs 9.5，CI：6.3-23.5），并且比成人更可能（NNH = 7.1，CI：6.1-8.8）。相反，年轻人经历了较少静坐不能与SGAs比成人（NNH = 20.4，CI：14.1-36.5与10.2，CI：8.1-13.7），可能是由于较低的剂量/较慢titration.Conclusions：在治疗躁狂症，可能更大的短期疗效与安慰剂相比，SGAs与MS需要对增加的不良事件进行平衡，特别是在青年。
Objective:To compare antipsychotic and mood stabilizer (MS) efficacy and tolerability in youth and adults with bipolar mania.Methods:Medline/PubMed search for studies including: (i) youth (< 18 years) or adults (>= 18 years); (ii) bipolar I disorder; (iii) double-blind, randomized, placebo-controlled trial (DB-RPCT); (iv) < 12 weeks of treatment; and (v) calculable effect sizes (ES) and/or numbers needed to treat/harm (NNT/NNH) +/- 95% confidence intervals (CI). Non-overlapping 95% CIs determined significant group differences.Results:We identified nine DB-RPCTs in youth (n = 1,609), 5 evaluating second-generation antipsychotics (SGAs) (n = 1,140) and 4 evaluating MSs (n = 469). We also identified 23 DB-RPCTs in adults (n = 6,501), 14 including SGAs (n = 3,297), 5 using haloperidol as an active comparator (n = 580), and 11 including MSs (n = 2,581). Young Mania Rating Scale scores improved significantly more with SGAs than MSs in youth (ES = 0.65, CI: 0.53-0.78 versus 0.24, CI: 0.06-0.41) and adults (ES = 0.48, CI: 0.41-0.55 versus 0.24, CI: 0.17-0.31). After excluding topiramate studies, SGAs had larger ES than MSs only in youth (ES = 0.65, CI: 0.53-0.78 versus 0.20, CI: 0.02-0.39), but not adults (ES = 0.48, CI: 0.41-0.55 versus 0.46, CI: 0.37-0.55). However, in adults SGAs had significantly larger ES regarding Clinical Global Impressions scores than MSs, even without topiramate (ES = 0.75, CI: 0.68-0.82 versus 0.24, CI: 0.07-0.41). Rates of response, remission, and discontinuation due to any reason compared to placebo were similar between medication and age groups, except for more favorable NNTs for remission with SGAs than MSs in adults after excluding topiramate. SGAs caused more weight gain than MSs in youth (ES = 0.53, CI: 0.41-0.66 versus 0.10, CI: -0.12-0.33), but not in adults (ES = 0.13, CI: 0.05-0.22 versus 0.00, CI: -0.08-0.08). However, results were heterogeneous and not significant in either age group after excluding topiramate. Nevertheless, SGA-related weight gain was significantly greater in youth than adults. In youth, SGA-related somnolence was greater than with MSs (NNH = 4.7, CI: 3.9-6.0 versus 9.5, CI: 6.3-23.5), and more likely than in adults (NNH = 7.1, CI: 6.1-8.8). Conversely, youth experienced less akathisia with SGAs than adults (NNH = 20.4, CI: 14.1-36.5 versus 10.2, CI: 8.1-13.7), likely due to lower doses/slower titration.Conclusions:In treating mania, potentially greater short-term efficacy compared to placebo with SGAs versus MS needs to be balanced against increased adverse events, especially in youth.