Evidence on antipsychotic drug treatment for schizophrenia from Western and Chinese trials: building a joint database and applying network meta-analyses

根据《世界卫生报告》，精神分裂症是最令人衰弱的疾病之一。这给患者、家属和社会带来了巨大的负担。多种抗精神病药物可用于其治疗，其多种副作用差异很大，但可能也有疗效。这些药物已在数百项随机对照试验中进行了比较。这些高数字使得特殊的统计技术-所谓的网络荟萃分析-有必要综合数据，并得出有关这些化合物的相对影响的客观结论。网络荟萃分析还允许产生关于哪种药物是最好的药物，第二好的药物等等的层次结构。中国和德国合作伙伴在精神分裂症循证医学领域合作多年，他们都担任科克伦精神分裂症组的编辑。因此，两人都是循证医学的方法学专家。此外，德国合作伙伴还建立了一个初步的精神分裂症研究荟萃分析。然而，这个数据库需要更新，并扩大到新的药物和纳入更多的结果。中国的研究目前约占该领域随机试验的25%，但迄今尚未纳入。这一差距是一个主要的限制，因为它是基于证据的医学的基本原则，所有的试验都包括无论其起源。造成这种不幸局面的原因是大多数中国研究没有被Pubmed等国际数据库收集，翻译问题和研究质量的差异。因此，要将中国研究纳入大规模荟萃分析，与经验丰富的中国团队合作是必要的。因此，该提案的目的是提供一个数据库的西方和中国的随机抗精神病药物试验已提取的荟萃分析。为此，上海团队将接受慕尼黑团队的培训，学习如何选择研究、评估研究质量和提取数据。这种标准化对于使其结果与德国小组的结果相比较至关重要。上海团队将评估中国研究的质量，包括与作者的直接联系。我们预计将纳入约900项关于约30种抗精神病药物的研究。最后，将计算多种疗效和副作用结局（包括短期和长期治疗）的综合网络荟萃分析。将建立多种抗精神病药物的等级，这将告知临床医生，患者和政策制定者这些药物的影响。

Schizophrenia ranks among the most debilitating disorders according to the World Health Report. It leads to a dramatic burden for patients, relatives and society. Multiple antipsychotic drugs are available for its treatment which differ enormously in their multiple side-effects, but probably also efficacy. These agents have been compared in hundreds of randomised-controlled trials. These high numbers make special statistical techniques – so- called network meta-analyses – necessary to synthesize the data and to come up with objective conclusions about the relative effects of these compounds. Network meta-analysis also allows to produce hierarchies about which is the best drug, the second best and so on in a specific outcome. The Chinese and the German partner have collaborated in the area of evidence-based medicine in schizophrenia for many years, and they both serve as editors to the Cochrane Schizophrenia Group. Thus, both are methodological experts in evidence-based medicine. Moreover, the German partner has set up a preliminary meta-analytic of schizophrenia studies. However, this database needs to be updated, and expanded to new drugs and the inclusion of further outcomes. Studies from China which currently produces approximately 25% of the randomised trials in this area have to date not been included. This gap is a major limitation, because it is fundamental in evidence-based medicine that all trials are included irrespectively of their origin. Reasons for this unfortunate situation are that most Chinese studies are not collected by international databases such as Pubmed, translation problems and differences in study quality. To include Chinese studies in large scale meta-analyses collaboration with an experienced Chinese team is therefore necessary. The aim of the proposal therefore is to provide a database of Western and Chinese randomised antipsychotic drug trials which have been extracted for meta-analysis. The team in Shanghai will be trained for this purpose by the Munich team in its exact methods as to how to select studies, evaluate their quality and extract the data. Such a standardization is essential for making its results comparable with those of the German team. The Shanghai team will assess the quality of the Chinese studies including direct contact with their authors. We expect that approximately 900 studies on approximately 30 antipsychotics will be included. Finally, comprehensive network meta-analyses on multiple efficacy and side- effect outcomes, including short-term and long-term treatment will be calculated. Hierarchies of the multiple antipsychotic drugs will be established which will inform clinicians, patients and policy makers on the effects of these drugs.