The Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital), Guangzhou, China.
Clinics of Chinese Medicine, The First Clinical Medical College of Guangzhou University of Chinese Medicine, Guangzhou, China.
J Psychiatr Res. 2018 Aug;103:244-251. doi: 10.1016/j.jpsychires.2018.06.005. Epub 2018 Jun 5.
Lurasidone, an azapirone derivative, is a novel second generation antipsychotic with potent binding affinity for dopamine D2, serotonin 5-HT, 5-HT 5-HT and noradrenaline alpha receptors. This updated meta-analysis of randomized controlled trials (RCTs) examined the short-term efficacy and tolerability of lurasidone in the treatment of acute schizophrenia.
Double-blinded RCTs reporting on the short-term effects of lurasidone were included. Standardized mean difference (SMD) with their 95% confidence interval (CI), and number needed to harm (NNH) were computed.
The meta-analysis had 8 RCTs with 16 active arms that included 2373 patients with acute schizophrenia who were randomized to either lurasidone (20-160 mg/day; n = 1570) or placebo (n = 803) groups. Lurasidone was superior to placebo with regard to change in total psychopathology [SMD: -0.34, (95%CI: -0.48, -0.20), P<0.00001], positive symptoms [SMD: -0.47, (95%CI: -0.57, -0.36), P<0.00001], negative symptoms [SMD:-0.34, (95%CI: -0.45, -0.22), P<0.00001], and general psychopathology [SMD: -0.36, (95%CI: -0.48, -0.24), P<0.00001]. Results were consistent for total psychopathology in 11 out of the 13 subgroups. Lurasidone resulted in higher weight gain [SMD: 0.15, (95% CI: 0.06, 0.24), P = 0.001] and BMI [SMD: 0.17, (95%CI: 0.07, 0.28), P = 0.002] than placebo, but the differences were not clinically significant. Lurasidone group had less frequent inefficacy (NNH = 14) and discontinuation due to any reason (NNH = 17), but was associated with more frequent vomiting, akathisia, dystonia, parkinsonism, somnolence, dizziness, sedation, nausea, and weight gain of ≥7% of the initial weight (NNH = 11-50).
This meta-analysis of 8 short-term studies supported the efficacy and safety of lurasidone in the acute phase of schizophrenia, particularly at the higher dose range of 80 mg/day.
鲁拉西酮是一种氮杂螺环酮衍生物，是一种新型的第二代抗精神病药物，对多巴胺 D2、5-羟色胺 5-HT2A、5-HT2C 和去甲肾上腺素 α 受体具有很强的结合亲和力。这项更新的随机对照试验 (RCT) 的荟萃分析研究了鲁拉西酮在治疗急性精神分裂症中的短期疗效和耐受性。
纳入了报告鲁拉西酮短期疗效的双盲 RCT。计算了标准化均数差 (SMD)及其 95%置信区间 (CI)和需要治疗的人数 (NNH)。
荟萃分析纳入了 8 项 RCT，共 16 个活性臂，包括 2373 例急性精神分裂症患者，他们被随机分配至鲁拉西酮（20-160mg/天；n=1570）或安慰剂（n=803）组。与安慰剂相比，鲁拉西酮在总精神病学变化方面更具优势[SMD：-0.34，（95%CI：-0.48，-0.20），P<0.00001]，阳性症状[SMD：-0.47，（95%CI：-0.57，-0.36），P<0.00001]，阴性症状[SMD：-0.34，（95%CI：-0.45，-0.22），P<0.00001]和一般精神病学[SMD：-0.36，（95%CI：-0.48，-0.24），P<0.00001]。在 13 个亚组中的 11 个中，结果在总精神病学方面是一致的。鲁拉西酮导致体重增加[SMD：0.15，（95%CI：0.06，0.24），P=0.001]和 BMI [SMD：0.17，（95%CI：0.07，0.28），P=0.002]高于安慰剂，但差异无临床意义。鲁拉西酮组无效发生率（NNH=14）和因任何原因停药率（NNH=17）较低，但呕吐、静坐不能、肌张力障碍、帕金森病、嗜睡、头晕、镇静、恶心和体重增加≥初始体重的 7%（NNH=11-50）的发生率较高。
这项对 8 项短期研究的荟萃分析支持了鲁拉西酮在精神分裂症急性期的疗效和安全性，尤其是在 80mg/天的较高剂量范围内。
