Vasudev Akshya, Macritchie Karine, Rao Sanjay Nk, Geddes John, Young Allan H
University of Western Ontario, London Health Sciences Centre, Victoria Hospital, 800 Commissioners Road East, PO BOX 5010, London, Ontario, Canada.
Cochrane Database Syst Rev. 2011 Dec 7;2011(12):CD005173. doi: 10.1002/14651858.CD005173.pub3.
Tiagabine, an anticonvulsant, has been reported to have efficacy in prophylactic treatment of bipolar disorder in case reports and in case series.
To assess the efficacy and acceptability of tiagabine, relative to placebo, and other agents in the prevention or attenuation, or both, of episodes of bipolar disorder in adults. The efficacy and acceptability of tiagabine were considered in terms of mood symptoms, mortality, general health, social functioning, adverse effects and overall acceptability to participants.
The Cochrane Collaboration Depression, Anxiety and Neurosis review group's specialised registers (CCDANCTR-Studies and CCDANCTR-References) were searched to 1 October 2011. These registers contains relevant randomised controlled trials from: The Cochrane Library (all years to date), EMBASE, (1974 to date) MEDLINE (1950 to date) and PsycINFO (1967 to date). Reference lists of relevant papers and major textbooks of affective disorder were examined. Authors, other experts in the field and pharmaceutical companies were contacted for knowledge of suitable published or unpublished trials. Specialist journals and conference proceedings were handsearched.
Randomised controlled trials of tiagabine versus placebo, alternative mood stabilisers or antipsychotics, for the maintenance treatment of bipolar disorder in adults, male and female, aged 18 to 74 years.
Data were to be extracted from the original reports of included studies independently by two authors. The main outcomes to be assessed were:(1) the efficacy of tiagabine treatment in preventing or attenuating further episodes of bipolar disorder, including its efficacy in rapid cycling disorder; (2) the acceptability of tiagabine treatment to participants; (3) the prevalence of side effects; and (4) mortality, if any, on tiagabine treatment.Outcomes concerning relapse or recurrence were to be analysed excluding data from studies using discontinuation protocols, which were to be analysed separately. Subgroup analyses were to be performed to examine the effects of tiagabine treatment in rapid cycling bipolar disorder and previous mood stabiliser non-responders. Data were to be analysed using Review Manager 5.
No randomised controlled trials of tiagabine in the maintenance treatment of bipolar disorder were found.
AUTHORS' CONCLUSIONS: There is an insufficient methodologically rigorous evidence base to draw any conclusions regarding the use of tiagabine in the maintenance treatment of bipolar disorder. There is a need for randomised controlled trials examining the therapeutic potential of this agent in bipolar disorder. There have been some reports of syncope or seizures, or both, when tiagabine has been used for the acute treatment of mania. It needs to be established if such adverse effects occur in the maintenance phase as well.
据病例报告和病例系列报道，抗惊厥药噻加宾在双相情感障碍的预防性治疗中具有疗效。
评估噻加宾相对于安慰剂及其他药物在预防或减轻或同时预防和减轻成人双相情感障碍发作方面的疗效和可接受性。从情绪症状、死亡率、总体健康状况、社会功能、不良反应以及参与者的总体可接受性等方面考量噻加宾的疗效和可接受性。
检索至2011年10月1日的Cochrane协作抑郁、焦虑与神经症综述组的专门注册库（CCDANCTR-研究和CCDANCTR-参考文献）。这些注册库包含来自以下数据库的相关随机对照试验：Cochrane图书馆（截至目前的所有年份）、EMBASE（1974年至今）、MEDLINE（1950年至今）和PsycINFO（1967年至今）。查阅了相关论文的参考文献列表以及情感障碍的主要教科书。联系了作者、该领域的其他专家以及制药公司以获取有关合适的已发表或未发表试验的信息。手工检索了专业期刊和会议论文集。
噻加宾与安慰剂、其他心境稳定剂或抗精神病药物对比，用于18至74岁成年男女双相情感障碍维持治疗的随机对照试验。
由两名作者独立从纳入研究的原始报告中提取数据。待评估的主要结局包括：（1）噻加宾治疗在预防或减轻双相情感障碍进一步发作方面的疗效，包括其在快速循环型障碍中的疗效；（2）噻加宾治疗对参与者的可接受性；（3）副作用的发生率；（4）噻加宾治疗时的死亡率（如有）。关于复发或再发的结局分析将排除采用停药方案的研究数据，这些数据将单独分析。进行亚组分析以检验噻加宾治疗在快速循环型双相情感障碍和既往对心境稳定剂无反应者中的效果。使用Review Manager 5进行数据分析。
未找到关于噻加宾用于双相情感障碍维持治疗的随机对照试验。
缺乏方法学严谨的证据基础，无法就噻加宾用于双相情感障碍维持治疗得出任何结论。需要进行随机对照试验来检验该药物在双相情感障碍中的治疗潜力。有一些报告称，噻加宾用于躁狂急性治疗时出现了晕厥或癫痫发作，或两者皆有。还需确定在维持治疗阶段是否也会出现此类不良反应。
