University of Haifa, Israel.
Schizophr Res. 2013 Jan;143(1):60-4. doi: 10.1016/j.schres.2012.11.010. Epub 2012 Dec 4.
Evidence is lacking on remission in the presence of predominant negative symptoms.
To examine remission rates and their variation by antipsychotic medication in predominant negative symptoms.
Data were reanalyzed on patients (n=383) who had participated in two double blind randomized placebo-controlled clinical trials of predominant negative symptoms lasting to 84 and 360days. Symptom remission was defined with the Remission in Schizophrenia Working Group remission criteria of attaining and maintaining mild ratings on eight SANS items. Remission rates were examined to 90days, survival analysis computed to ascertain time to attain symptom remission, binary logistic models used to predict the remission rate and 2 persistent months of symptom remission, and ANCOVA used to predict percent time in remission.
Symptomatic remission rates were: 22.72% at any visit during 90days, and 3.66% lasting 2months. Kaplan-Meier and Cox survival models to adjust for baseline symptom severity showed that compared with the placebo group the amisulpride group attained significantly (p<.05) more remission sooner (HR=2.321, 95% CI=1.36, to 3.97, p<.05). ANCOVA showed that compared with placebo the amisulpride group spent significantly (p<.05) more percent time in remission (ES=.28). Specificity analysis showed that: across trials the negative symptom remission rate was 25.1%; and in one 360-day trial the six-month remission criteria were attained and maintained by 6.4% of participants.
Presented with predominant negative symptoms the Working Group Remission criteria appear not to be a pragmatic therapeutic objective. Modified remission symptom and time criteria may be an effective way to examine remission.
在主要阴性症状存在的情况下,缓解的证据不足。
研究主要阴性症状中抗精神病药物的缓解率及其变化。
对参加过两项主要阴性症状持续 84 和 360 天的双盲随机安慰剂对照临床试验的 383 名患者的数据进行了重新分析。采用缓解精神分裂症工作组缓解标准,即达到并维持 SANS 八项评分轻度,定义缓解。检查 90 天的缓解率,计算生存分析以确定达到症状缓解的时间,使用二元逻辑模型预测缓解率和 2 个持续的症状缓解月数,并使用 ANCOVA 预测缓解时间百分比。
症状缓解率为:90 天内任何就诊时的 22.72%,持续 2 个月的 3.66%。Kaplan-Meier 和 Cox 生存模型调整基线症状严重程度后显示,与安慰剂组相比,氨磺必利组更早(p<.05)获得显著(HR=2.321,95%CI=1.36,3.97,p<.05)缓解。ANCOVA 显示,与安慰剂相比,氨磺必利组有显著(p<.05)更多的缓解时间(ES=.28)。特异性分析显示:两项试验的阴性症状缓解率为 25.1%;在一项 360 天的试验中,6.4%的参与者达到并维持了六个月的缓解标准。
呈现出主要阴性症状时,工作组缓解标准似乎不是一个实际的治疗目标。修改后的缓解症状和时间标准可能是检查缓解的有效方法。