Jayaram M B, Hosalli P, Stroup S
NHS, Becklin Centre, Alma Street, Leeds, West Yorkshire, UK, LS9 7BE.
Cochrane Database Syst Rev. 2006 Apr 19(2):CD005237. doi: 10.1002/14651858.CD005237.pub2.
Antipsychotic medication is a mainstay of treatment for schizophrenia. Risperidone and olanzapine are popular choices among the new generation drugs.
To determine the clinical effects, safety and cost effectiveness of risperidone compared with olanzapine for treating schizophrenia.
We searched the Cochrane Schizophrenia Group's Register (Sept 2005) which is based on regular searches of, amongst others, BIOSIS, CENTRAL, CINAHL, EMBASE, MEDLINE and PsycINFO. References of all identified studies were inspected for further trials. We also contacted relevant pharmaceutical companies for additional information.
We included all clinical randomised trials comparing risperidone with olanzapine for schizophrenia and schizophrenia-like psychoses.
We extracted data independently. For homogenous dichotomous data we calculated random effects, relative risk (RR), 95% confidence intervals (CI) and, where appropriate, numbers needed to treat/harm (NNT/H) on an intention-to-treat basis. For continuous data, we calculated weighted mean differences (WMD).
We found no difference for the outcome of unchanged or worse in the short term (n=548, 2 RCTs, RR 1.00 CI 0.88 to 1.15). One study favoured olanzapine for the outcome of relapse/rehospitalisation by 12 months (n=279, 1 RCT, RR 2.16 CI 1.31 to 3.54, NNH 7 CI 3 to 25). Most mental state data showed the two drugs to be as effective as each other (n=552, 2 RCTs, RR 'no <20% decrease PANSS by eight weeks' 1.01 CI 0.87 to 1.16). Both drugs commonly cause adverse events: 75% given either drug experience an adverse event; 20% anticholinergic symptoms; both groups experienced insomnia although it was more frequent with risperidone (n=1588, 5 RCTs, RR 1.41 CI 1.15 to 1.72, NNH 15 CI 9 to 41); about 30% experienced sleepiness (n=1713, 6 RCTs, RR 0.92 CI 0.79 to 1.07). People given either drug often experienced some extrapyramidal symptoms (n=893, 3 RCTs, RR 1.18 CI 0.75 to 1.88); 25% of people using risperidone required medication to alleviate these symptoms (n=419, 2 RCTs, RR 1.76 CI 1.25 to 2.48, NNH 8 CI 4 to 25). People allocated to risperidone were less likely to gain weight compared with those given olanzapine and the weight gain was often considerable and of quick onset (n=984, 2 RCTs, RR gain more than 7% of their baseline weight in short term 0.47 CI 0.36 to 0.61, NNH 7 CI 6 to 10). Risperidone participants were less likely to leave the study due to metabolic side effects and weight gain compared with olanzapine (n=667, 1RCT, RR 0.19 CI 0.08 to 0.45). Patients on risperidone were more likely to experience abnormal ejaculation (n=370, 2 RCTs, RR 4.36 CI 1.38 to 13.76, NNH 20 CI 6 to 176). Both drugs are associated with high attrition rates; in the long term consistent findings show that 66% of those allocated risperidone left the study early compared with 56% given olanzapine (n=1440, 5 RCTs, RR 1.17 CI 1.08 to 1.27, NNH 11 CI 7 to 23).
AUTHORS' CONCLUSIONS: We know very little of the effects of these drugs regarding service outcomes, general functioning and behaviours, engagement with services and treatment satisfaction from evaluative studies. There was generally a high rate of attrition in the trials and there appears to be little to differentiate between risperidone and olanzapine except on issues of adverse effects. Both drugs are associated with a reduction in psychotic symptoms but both commonly cause unpleasant adverse effects.
抗精神病药物是治疗精神分裂症的主要手段。利培酮和奥氮平是新一代药物中常用的选择。
确定利培酮与奥氮平治疗精神分裂症的临床效果、安全性和成本效益。
我们检索了Cochrane精神分裂症研究组注册库(2005年9月),该注册库基于定期检索BIOSIS、CENTRAL、CINAHL、EMBASE、MEDLINE和PsycINFO等数据库。检查所有已识别研究的参考文献以寻找更多试验。我们还联系了相关制药公司以获取更多信息。
我们纳入了所有比较利培酮与奥氮平治疗精神分裂症及精神分裂症样精神病的临床随机试验。
我们独立提取数据。对于同质二分数据,我们在意向性分析基础上计算随机效应、相对风险(RR)、95%置信区间(CI),并在适当情况下计算治疗所需人数/伤害所需人数(NNT/H)。对于连续数据,我们计算加权平均差(WMD)。
我们发现短期内病情无变化或恶化的结果无差异(n = 548,2项随机对照试验,RR 1.00,CI 0.88至1.15)。一项研究表明,在12个月时奥氮平在复发/再住院结果方面更具优势(n = 279,1项随机对照试验,RR 2.16,CI 1.31至3.54,NNH 7,CI 3至25)。大多数精神状态数据显示两种药物效果相当(n = 552,2项随机对照试验,RR “八周内PANSS降低未达20%” 1.01,CI 0.87至1.16)。两种药物都常引起不良事件:服用任何一种药物的患者中有75%经历不良事件;20%出现抗胆碱能症状;两组都有失眠情况,不过利培酮组更常见(n = 1588,5项随机对照试验,RR 1.41,CI 1.15至1.72,NNH 15,CI 9至41);约30%经历嗜睡(n = 1713,6项随机对照试验,RR 0.92,CI 0.79至1.07)。服用任何一种药物的患者常出现一些锥体外系症状(n = 893,3项随机对照试验,RR 1.18,CI 0.75至1.88);25%使用利培酮的患者需要药物来缓解这些症状(n = 419,2项随机对照试验,RR 1.76,CI 1.25至2.48,NNH 8,CI 4至25)。与服用奥氮平的患者相比,服用利培酮的患者体重增加的可能性较小,且体重增加通常相当可观且起病迅速(n = 984,2项随机对照试验,RR短期内体重增加超过基线体重7% 0.47,CI 0.36至0.61,NNH 7,CI 6至10)。与奥氮平相比,服用利培酮的参与者因代谢副作用和体重增加而退出研究的可能性较小(n = 667,1项随机对照试验,RR 0.19,CI 0.08至0.45)。服用利培酮的患者更易出现射精异常(n = 370,2项随机对照试验,RR 4.36,CI 1.38至13.76,NNH 20,CI 6至176)。两种药物的脱落率都很高;长期一致的研究结果表明,分配服用利培酮的患者中有66%提前退出研究,而服用奥氮平的患者为56%(n = 1440,5项随机对照试验,RR 1.17,CI 1.08至1.27,NNH 11,CI 7至23)。
从评估研究来看,我们对这些药物在服务结果、总体功能和行为、与服务的接触以及治疗满意度方面的影响了解甚少。试验中总体脱落率较高,除了不良反应问题外,利培酮和奥氮平之间似乎没有什么差异。两种药物都能减轻精神症状,但都常引起令人不适的不良反应。