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在一项德国非干预性研究中,双相情感障碍患者不同亚组的留存率较高且复发率较低。

Comparably high retention and low relapse rates in different subpopulations of bipolar patients in a German non-interventional study.

作者信息

Kraemer Susanne, Minarzyk Anette, Eppendorfer Steffen, Henneges Carsten, Hundemer Hans-Peter, Wilhelm Stefan, Grunze Heinz

出版信息

BMC Psychiatry. 2013 Jul 17;13:193. doi: 10.1186/1471-244X-13-193.

Abstract

BACKGROUND

Although a range of pharmacotherapeutical options are available for the treatment of bipolar disorder, patient non-adherence to prescribed treatment regimens and early treatment discontinuation remain among the primary obstacles to effective treatment. Therefore, this observational study assessed time on mood stabilizing medication and retention rates in patients with bipolar disorder (BD).

METHODS

In an 18-month, prospective, multicenter, non-interventional study conducted in Germany 761 outpatients (≥18 years) with BD and on maintenance therapy were documented. For analysis, patients were stratified by baseline medication: monotherapy olanzapine (OM, N = 186), lithium (LM, N = 152), anticonvulsants (N = 216), other mood stabilizing medication (OMS, N = 44); combination therapy olanzapine/lithium (N = 47), olanzapine/anticonvulsant (N = 68), other combinations (OC, N = 48). Continuation on medication was assessed as retention rates with 95% confidence intervals. Time to discontinuation and relapse-free time were calculated by Kaplan-Meier analysis. A relapse was defined as increase to CGI-BP >3, worsening of CGI-BP by ≥2 points, hospitalization or death related to BD. A Cox regression was calculated for the discontinuation of mood stabilizing therapy (reference: OM). Logistic regression models with stepwise forward selection were used to explore possible predictors of maintenance of treatment and relapse.

RESULTS

After 540 days (18 months), the overall retention rate of baseline medication was 87.7%, without notable differences between the cohorts. The overall mean time on mood stabilizing treatment was 444.7 days, with a range of 377.5 (OMS) to 481 (LM) by cohort. 74.0% of all patients were without relapse, with rates between the cohorts ranging from 58.4% (OC) to 80.2% (LM).

CONCLUSIONS

Retention rates exceeded controlled trial results in all treatment cohorts, in addition to other explanations possibly reflecting that the physicians were expertly adapting treatment regimens to the individual patient's disease characteristics and special needs.

摘要

背景

尽管有一系列药物治疗方案可用于双相情感障碍的治疗,但患者不遵守规定的治疗方案以及过早停药仍然是有效治疗的主要障碍。因此,这项观察性研究评估了双相情感障碍(BD)患者使用心境稳定剂的时间和留存率。

方法

在德国进行的一项为期18个月的前瞻性、多中心、非干预性研究中,记录了761名年龄≥18岁、正在接受维持治疗的BD门诊患者。为进行分析,患者按基线用药分层:单药治疗奥氮平(OM,N = 186)、锂盐(LM,N = 152)、抗惊厥药(N = 216)、其他心境稳定剂(OMS,N = 44);联合治疗奥氮平/锂盐(N = 47)、奥氮平/抗惊厥药(N = 68)、其他联合用药(OC,N = 48)。用药持续情况以留存率及95%置信区间进行评估。停药时间和无复发时间通过Kaplan-Meier分析计算得出。复发定义为临床总体印象-双相障碍量表(CGI-BP)评分增加至>3、CGI-BP评分恶化≥2分、因BD住院或死亡。计算心境稳定剂治疗停药情况的Cox回归(参照:OM)。采用逐步向前选择的逻辑回归模型探索治疗维持和复发的可能预测因素。

结果

540天(18个月)后,基线用药的总体留存率为87.7%,各队列之间无显著差异。心境稳定治疗的总体平均时间为444.7天,各队列范围为377.5天(OMS)至481天(LM)。所有患者中有74.0%无复发,各队列的复发率在58.4%(OC)至80.2%(LM)之间。

结论

所有治疗队列的留存率均超过对照试验结果,此外其他解释可能反映出医生能够根据个体患者的疾病特征和特殊需求巧妙地调整治疗方案。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/644b/3724595/2eb15ce4e6ba/1471-244X-13-193-1.jpg

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