CHANGE试验:与单纯常规治疗相比,生活方式指导加护理协调加常规治疗在降低精神分裂症谱系障碍和腹部肥胖成年人心血管疾病风险方面并无优势。
The CHANGE trial: no superiority of lifestyle coaching plus care coordination plus treatment as usual compared to treatment as usual alone in reducing risk of cardiovascular disease in adults with schizophrenia spectrum disorders and abdominal obesity.
作者信息
Speyer Helene, Christian Brix Nørgaard Hans, Birk Merete, Karlsen Mette, Storch Jakobsen Ane, Pedersen Kamilla, Hjorthøj Carsten, Pisinger Charlotta, Gluud Christian, Mors Ole, Krogh Jesper, Nordentoft Merete
机构信息
Mental Health Centre Copenhagen, Copenhagen University Hospital, Copenhagen, Denmark.
Institute of Clinical Medicine, Faculty of Health Sciences, University of Copenhagen, Denmark.
出版信息
World Psychiatry. 2016 Jun;15(2):155-65. doi: 10.1002/wps.20318.
Life expectancy in patients with schizophrenia is reduced by 20 years for men and 15 years for women compared to the general population. About 60% of the excess mortality is due to physical illnesses, with cardiovascular disease being dominant. CHANGE was a randomized, parallel-group, superiority, multi-centre trial with blinded outcome assessment, testing the efficacy of an intervention aimed to improve cardiovascular risk profile and hereby potentially reduce mortality. A total of 428 patients with schizophrenia spectrum disorders and abdominal obesity were recruited and centrally randomized 1:1:1 to 12 months of lifestyle coaching plus care coordination plus treatment as usual (N=138), or care coordination plus treatment as usual (N=142), or treatment as usual alone (N=148). The primary outcome was 10-year risk of cardiovascular disease assessed post-treatment and standardized to age 60. At follow-up, the mean 10-year risk of cardiovascular disease was 8.4 ± 6.7% in the group receiving lifestyle coaching, 8.5 ± 7.5% in the care coordination group, and 8.0 ± 6.5% in the treatment as usual group (p=0.41). We found no intervention effects for any secondary or exploratory outcomes, including cardiorespiratory fitness, physical activity, weight, diet and smoking. In conclusion, the CHANGE trial did not support superiority of individual lifestyle coaching or care coordination compared to treatment as usual in reducing cardiovascular risk in patients with schizophrenia spectrum disorders and abdominal obesity.
与普通人群相比,精神分裂症患者的预期寿命男性缩短20年,女性缩短15年。约60%的额外死亡率归因于躯体疾病,其中心血管疾病最为突出。CHANGE是一项随机、平行组、优效性、多中心试验,采用盲法结局评估,旨在测试一种干预措施的疗效,该干预措施旨在改善心血管风险状况,从而有可能降低死亡率。共招募了428例精神分裂症谱系障碍和腹部肥胖患者,并将其中心随机分为1:1:1三组,分别接受为期12个月的生活方式指导加护理协调加常规治疗(N = 138),或护理协调加常规治疗(N = 142),或仅接受常规治疗(N = 148)。主要结局是治疗后评估的10年心血管疾病风险,并标准化至60岁。随访时,接受生活方式指导组的心血管疾病平均10年风险为8.4±6.7%,护理协调组为8.5±7.5%,常规治疗组为8.0±6.5%(p = 0.41)。我们未发现任何次要或探索性结局有干预效果,包括心肺适能、身体活动、体重、饮食和吸烟。总之,CHANGE试验不支持在降低精神分裂症谱系障碍和腹部肥胖患者心血管风险方面,个体生活方式指导或护理协调优于常规治疗。