1 Discipline of Psychiatry, School of Medicine, The University of Adelaide, Adelaide, SA, Australia.
2 Department of Psychiatry, College of Medicine, University of Lagos, Lagos, Nigeria.
Aust N Z J Psychiatry. 2019 Jun;53(6):509-527. doi: 10.1177/0004867419837358. Epub 2019 Apr 8.
Impairment in psychosocial function is common in schizophrenia. Long-acting injectable atypical antipsychotics are thought to enhance psychosocial function by boosting adherence. However, no systematic review has examined the effects of long-acting injectable atypical antipsychotics on psychosocial function in clinical trials.
We searched major databases including Medline/PubMed, PsychINFO, EMBASE, CINAHL, Scopus, Web of Science, Cochrane Central Register of Controlled Trials and Clinical Trial Registries for randomised controlled trials that compared long-acting injectable atypical antipsychotics to placebo, oral antipsychotic medications or long-acting injectable atypical antipsychotics for all years till 2018, with no language limits. We performed a systematic review of findings on change in psychosocial function and its predictors in the included reports. Data on change in psychosocial functioning were meta-analysed using a random-effects model.
A total of 26 studies were included in systematic review, and 19 studies with 8616 adults, 68.1% males were meta-analysed. Long-acting injectable atypical antipsychotics were superior to placebo (standardised mean difference = 0.39; 95% confidence interval = [0.32, 0.47]; p < 0.001; I = 0%; 9 studies) and oral antipsychotic medications (standardised mean difference = 0.16; 95% confidence interval = [0.01, 0.31]; p = 0.04; I = 77%; 10 studies) for improved psychosocial function and superiority was maintained in short- and long trials. Poor psychosocial function was predicted by longer treatment duration, severe symptoms, poor cognition and poor insight. Functioning was assessed by either a single or a combination of measures, but was not the primary outcome in most studies. Other sources of bias include poor blinding and reporting of randomisation.
Long-acting injectable atypical antipsychotics are beneficial for recovery of psychosocial function in comparison with placebo, but the magnitude of superiority over oral antipsychotic treatment was small. Severe psychopathology at baseline predicted poor psychosocial function. Future effectiveness trials in which post-randomisation involvement is kept to a minimum, and psychosocial function is included as primary outcome a priori, are needed to capture the real-world impact of long-acting injectable atypical antipsychotics and to address methodological biases.
精神分裂症患者的社会心理功能受损较为常见。长效注射用非典型抗精神病药被认为可以通过提高治疗依从性来增强社会心理功能。然而，目前尚无系统评价检查临床试验中长效注射用非典型抗精神病药对社会心理功能的影响。
我们检索了 Medline/PubMed、PsychINFO、EMBASE、CINAHL、Scopus、Web of Science、Cochrane 对照试验中心注册库和临床试验注册库等主要数据库，以获取截至 2018 年的所有年份中，长效注射用非典型抗精神病药与安慰剂、口服抗精神病药物或长效注射用非典型抗精神病药比较的随机对照试验，无语言限制。我们对纳入报告中社会心理功能变化及其预测因素的研究结果进行了系统评价。使用随机效应模型对社会心理功能变化的数据进行了荟萃分析。
共纳入 26 项系统评价研究，19 项研究共纳入 8616 名成年人，其中 68.1%为男性，进行了荟萃分析。长效注射用非典型抗精神病药优于安慰剂（标准化均数差=0.39；95%置信区间=0.32，0.47；p<0.001；I=0%；9 项研究）和口服抗精神病药物（标准化均数差=0.16；95%置信区间=0.01，0.31；p=0.04；I=77%；10 项研究），改善社会心理功能，且在短期和长期试验中均保持优势。社会心理功能不良的预测因素为治疗时间较长、症状严重、认知功能较差和洞察力较差。功能评估采用单一或多种措施进行，但大多数研究均不是主要结局。其他偏倚来源包括盲法和随机分组报告不佳。
长效注射用非典型抗精神病药在改善社会心理功能方面优于安慰剂，但与口服抗精神病药物治疗相比，其优势幅度较小。基线时严重的精神病理学预示着社会心理功能不良。未来需要开展有效性试验，尽量减少随机分组后参与度，并将社会心理功能作为预先设定的主要结局，以评估长效注射用非典型抗精神病药的实际影响，并解决方法学偏倚问题。
