Tenback Diederik E, van Harten Peter N, Slooff Cees J, Belger Mark A, van Os Jim
Psychiatric Centre Altrecht, Den Dolder, The Netherlands.
J Clin Psychiatry. 2005 Sep;66(9):1130-3.
To compare the incidence and persistence of tardive dyskinesia between patients diagnosed with schizophrenia (ICD-10 and/or DSM-IV) who were treated with second-generation antipsychotics and first-generation antipsychotics in routine clinical practice.
The European Schizophrenia Outpatient Health Outcomes (SOHO) study is a 3-year, prospective, observational study. Each country had a start date for patient enrollment before October 2000. All enrollment was completed by June 30, 2001. A simple, global measure of tardive dyskinesia was rated by participating clinicians. For the current analysis, data at baseline, 3 months, and 6 months were analyzed using a generalized estimating equation model.
Second-generation antipsychotics conferred a lower risk for tardive dyskinesia at 6 months than first-generation antipsychotics (0.9% vs. 3.8%, odds ratio [OR] = 0.29, 95% confidence interval [CI] = 0.18 to 0.46). In addition, patients with tardive dyskinesia at baseline who were receiving second-generation antipsychotics were less likely than patients receiving first-generation antipsychotics to have tardive dyskinesia symptoms at 6 months (43.6% vs. 60.8%, OR = 0.50, 95% CI = 0.30 to 0.85). A sensitivity analysis suggested no bias related to pharmaceutical industry financial support.
The results suggest that the relative advantage of second-generation antipsychotics in terms of lower rates of incidence and persistence of tardive dyskinesia, observed in technical randomized controlled trials, generalizes to routine clinical care.
比较在常规临床实践中,使用第二代抗精神病药物和第一代抗精神病药物治疗的精神分裂症(国际疾病分类第十版[ICD - 10]和/或精神疾病诊断与统计手册第四版[DSM - IV])患者中迟发性运动障碍的发生率和持续情况。
欧洲精神分裂症门诊健康结局(SOHO)研究是一项为期3年的前瞻性观察性研究。每个国家在2000年10月之前有患者入组的起始日期。所有入组工作于2001年6月30日完成。参与研究的临床医生对迟发性运动障碍进行简单的整体评估。对于当前分析,使用广义估计方程模型分析基线、3个月和6个月时的数据。
与第一代抗精神病药物相比,第二代抗精神病药物在6个月时导致迟发性运动障碍的风险更低(0.9%对3.8%,优势比[OR]=0.29,95%置信区间[CI]=0.18至0.46)。此外,基线时患有迟发性运动障碍且接受第二代抗精神病药物治疗的患者在6个月时出现迟发性运动障碍症状的可能性低于接受第一代抗精神病药物治疗的患者(43.6%对60.8%,OR = 0.50,95%CI = 0.30至0.85)。敏感性分析表明不存在与制药行业资金支持相关的偏差。
结果表明,在技术随机对照试验中观察到的第二代抗精神病药物在迟发性运动障碍发生率和持续率较低方面的相对优势,在常规临床护理中同样适用。