Comparison of mania patients suitable for treatment trials versus clinical treatment.
Comparison of mania patients suitable for treatment trials versus clinical treatment.
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DOI：
10.1002/hup.952
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发表时间：
2008-08
影响因子：
1.7
通讯作者：
Centorrino, Franca
中科院分区：
文献类型：
--
作者：
Talamo, Alessandra;Baldessarini, Ross J.;Centorrino, Franca
随机对照试验（RCT）中的双相情感障碍（BPD）患者是否足以代表临床遇到的患者，以指导临床治疗实践，目前仍不确定。我们根据21项躁狂症随机对照试验报告的频率制定了纳入/排除标准，并将其应用于一项对因DSM-IV BPD躁狂/混合状态住院患者的初步研究，以比较符合与不符合排除标准的患者的特征和临床反应。从27个最初确定的纳入/排除标准按引用频率排序，我们得出了6个纳入因素和10个非冗余排除因素。在符合入选标准的67例连续患者中，15例（22.4%）潜在的“研究受试者”符合所有10项排除标准。其余52名“临床患者”在排除标准上有显著差异，包括更多的精神病合并症、药物滥用、非自愿住院、自杀企图或暴力，但在其他方面相似。两组患者对临床确定的住院治疗的反应相似，包括躁狂评分的改善。基于对住院躁狂患者的试点样本应用RCT报告的纳入/排除标准，那些可能被纳入现代RCT的患者与被排除的患者相似，最明显的是短期抗躁狂治疗反应。研究结果鼓励进一步比较纳入/排除RCT的受试者，以测试研究结果的潜在临床普遍性。初步研究的数量和暴露时间有限，无法测试“研究对象”和“临床患者”之间的微小差异。
It remains uncertain whether bipolar disorder (BPD) patients in randomized-controlled trials (RCTs) are sufficiently representative of clinically encountered patients as to guide clinical-therapeutic practice. We complied inclusion/exclusion criteria by frequency from reports of 21 RCTs for mania, and applied them in a pilot study of patients hospitalized for DSM-IV BPD manic/mixed states to compare characteristics and clinical responses of patients who did versus did not meet exclusion criteria. From 27 initially identified inclusion/exclusion criteria ranked by citation frequency, we derived six inclusion, and 10 non-redundant-exclusion factors. Of 67 consecutive patients meeting inclusion criteria, 15 (22.4%) potential “research subjects” met all 10 exclusion criteria. The remaining 52 “clinical patients” differed markedly on exclusion criteria, including more psychiatric co-morbidity, substance abuse, involuntary hospitalization, and suicide attempts or violence, but were otherwise similar. In both groups responses to clinically determined inpatient treatments were similar, including improvement in mania ratings. Based on applying reported inclusion/exclusion criteria for RCTs to a pilot sample of hospitalized-manic patients, those likely to be included in modern RCTs were similar to patients who would be excluded, most notably in short-term antimanic-treatment responses. The findings encourage further comparisons of subjects included/excluded from RCTs to test potential clinical generalizability of research findings. The pilot study is limited in numbers and exposure times with which to test for the minor differences between “research subjects” and “clinical patients.”
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影响因子：
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