Quraishi S, David A
Department of Psychological Medicine, Guy's, King's and St. Thomas' College School of Medicine, 103 Denmark Hill, London, UK, SE5 8AF.
Cochrane Database Syst Rev. 2000(2):CD001717. doi: 10.1002/14651858.CD001717.
Anti-psychotic drugs are usually given orally but compliance with medication given by this route may be difficult to quantify. The development of depot injections in the 1960s gave rise to extensive use of depots as a means of long-term maintenance treatment. Perphenazine decanoate and enanthate are depot antipsychotics that belong to the phenothiazine family and have a piperazine ethanol side chain.
To assess the effects of depot perphenazine decanoate and enanthate versus placebo, oral anti-psychotics and other depot antipsychotic preparations for people with schizophrenia in terms of clinical, social and economic outcomes.
Biological Abstracts (1982-1998), the Cochrane Library (Issue 2, 1998), the Cochrane Schizophrenia Group's Register (June 1998), EMBASE (1980-1998), MEDLINE (1966-1998), and PsycLIT (1974-1998) were searched. References of all identified trials were also inspected for more studies and industry contacted.
Randomised clinical trials focusing on people with schizophrenia where depot perphenazine decanoate and enanthate, oral anti-psychotics or other depot preparations were compared.
Studies were reliably selected, quality rated and data extracted. For dichotomous data Peto odds ratios (OR) with the 95% confidence intervals (CI) were estimated. Where possible, the number needed to treat statistic (NNT) was calculated. Analysis was by intention-to-treat.
One study of six months duration, compared perphenazine enanthate to clopenthixol decanoate. There was no differences between the two for outcomes of global improvement, relapse and leaving the study early. More people in the perphenazine enanthate group required anticholinergic drugs than those allocated to clopenthixol decanoate (OR 3.6 CI 1.2-10, NNT 10). A single study (n=64, duration six weeks) compared perphenazine enanthate and its longer acting decanoate ester. Data on relapse and leaving the study early failed to show convincing differences. The enanthate group, however, experienced more movement disorders (OR 0.2 CI 0.06-0.7) than those allocated the decanoate ester of the same drug (NNT 4.0) and required more anticholinergic drugs (OR 0.2 CI 0.08-0.7, NNT 3.7).
REVIEWER'S CONCLUSIONS: Depot perphenazine is in clinical use in the Nordic countries, Belgium, Portugal and the Netherlands. At a conservative estimate a quarter of a million people suffer from schizophrenia in those countries and could be treated with depot perphenazine. The total number of participants in the two trials with useful data is 236. Neither study observes the effect of oral versus depot antipsychotic drugs. Until well conducted and reported randomised trials are undertaken clinicians will be in doubt as to the effects of perphenazine depots and people with schizophrenia should exercise their own judgement or ask to be randomised.
抗精神病药物通常口服给药,但通过这种途径给药的依从性可能难以量化。20世纪60年代长效注射剂的研发使得长效注射剂作为长期维持治疗手段得到广泛应用。癸酸奋乃静和庚酸奋乃静是属于吩噻嗪类且具有哌嗪乙醇侧链的长效抗精神病药物。
从临床、社会和经济结果方面评估癸酸奋乃静和庚酸奋乃静长效注射剂与安慰剂、口服抗精神病药物及其他长效抗精神病制剂相比,对精神分裂症患者的疗效。
检索了《生物学文摘》(1982 - 1998年)、《考克兰图书馆》(1998年第2期)、考克兰精神分裂症研究组登记库(1998年6月)、《荷兰医学文摘数据库》(1980 - 1998年)、《医学索引》(1966 - 1998年)和《心理学文摘》(1974 - 1998年)。还查阅了所有已识别试验的参考文献以寻找更多研究,并与制药行业联系。
聚焦于精神分裂症患者的随机临床试验,比较了癸酸奋乃静和庚酸奋乃静长效注射剂、口服抗精神病药物或其他长效制剂。
可靠地选择研究、对质量进行评分并提取数据。对于二分法数据,估计了带有95%置信区间(CI)的Peto比值比(OR)。尽可能计算治疗所需人数(NNT)统计量。分析采用意向性分析。
一项为期6个月的研究比较了庚酸奋乃静与癸酸氯哌噻吨。在总体改善、复发和提前退出研究的结果方面,两者之间没有差异。与分配到癸酸氯哌噻吨组的人相比,庚酸奋乃静组更多人需要抗胆碱能药物(OR 3.6,CI 1.2 - 10,NNT 10)。一项单一研究(n = 64,为期6周)比较了庚酸奋乃静及其长效的癸酸酯。关于复发和提前退出研究的数据未显示出令人信服的差异。然而,庚酸奋乃静组比分配到同一药物癸酸酯组的人出现更多运动障碍(OR 0.2,CI 0.06 - 0.7)(NNT 4.0),且需要更多抗胆碱能药物(OR 0.2,CI 0.08 - 0.7,NNT 3.7)。
长效奋乃静在北欧国家、比利时、葡萄牙和荷兰临床使用。据保守估计,这些国家有25万人患有精神分裂症,可用长效奋乃静治疗。两项有有用数据的试验的参与者总数为236人。两项研究均未观察到口服与长效抗精神病药物的效果差异。在进行良好且报告规范的随机试验之前,临床医生会对奋乃静长效注射剂的效果存疑,精神分裂症患者应自行判断或要求进行随机分组。