Zhao Mingjun, Qin Bin, Mao Yage, Wang Hailing, Wang Aiqin, Wang Chuansheng
Department of Pharmacy, The Second Affiliated Hospital of Xinxiang Medical University (Henan Mental Hospital), Xinxiang, Henan, People's Republic of China.
Department of Neurology, Liuzhou General Hospital, Liuzhou, Guangxi, People's Republic of China.
Neuropsychiatr Dis Treat. 2022 Aug 11;18:1705-1713. doi: 10.2147/NDT.S374577. eCollection 2022.
The purpose of this meta-analysis was to compare the efficacy and safety profile of low-dose brexpiprazole (<2 mg/d) compared to placebo and standard-dose brexpiprazole (2-4 mg/d).
We identified relevant studies pertaining to the specific purpose of our meta-analysis by searching PubMed, Web of Science, Embase, Cochrane library, and PsycINFO using the search terms "schizophrenia" or "schizophrenic" AND "brexpiprazole" or "REXULTI". We systematically reviewed all randomized controlled trials (RCTs) comparing low-dose brexpiprazole with placebo. Primary efficacy outcomes were the PANSS total score change and response rate. Primary safety outcomes were total treatment discontinuation rate, and total serious adverse events (SAEs). Risk ratios (RR) and standardized mean differences (SMDs) were pooled implementing a random effect model.
Four RCTs (2178 patients) were included for effect assessment of low-dose brexpiprazole treatment on the patients with acute schizophrenia. Low-dose brexpiprazole was not superior to placebo (SMD = -0.11, 95% CI = -0.23, 0.02, P = 0.10, I = 0%), and significantly inferior to standard-dose brexpiprazole (SMD = 0.15, 95% CI = 0.03, 0.26, P = 0.01, I = 0%) for PANSS total score change. Low-dose brexpiprazole did not result in significant difference for response rate when compared to placebo and standard-dose brexpiprazole (RR = 1.16, 95% CI = 0.95, 1.41, P = 0.14, I = 25%; RR = 0.92, 95% CI = 0.76, 1.12, P = 0.40, I = 38%, respectively). For ratio of total discontinuation, low-dose brexpiprazole did not exhibit significant difference when compared to placebo (RR = 0.95, 95% CI = 0.81, 1.11, P = 0.53, I = 0%) and standard-dose brexpiprazole group (RR = 1.11, 95% CI = 0.95, 1.29, P = 0.19, I = 0%). Total SAEs in low-dose brexpiprazole group did not differ significantly from placebo and standard-dose brexpiprazole group (RR = 0.96, 95% CI = 0.52, 1.80, P = 0.90, I = 0%; RR = 1.29, 95% CI = 0.65, 2.57, P = 0.47, I = 26%, respectively).
The results indicated that low-dose brexpiprazole may be not superior for improving the efficacy and safety for acute schizophrenia compared to placebo and standard-dose brexpiprazole, and may cause additional risk of increasing body weight. Therefore, using low-dose brexpiprazole in acute schizophrenia patients may be not recommended.
本荟萃分析的目的是比较低剂量布瑞哌唑（<2毫克/天）与安慰剂及标准剂量布瑞哌唑（2 - 4毫克/天）的疗效和安全性。
我们通过在PubMed、科学网、Embase、Cochrane图书馆和PsycINFO中使用搜索词“精神分裂症”或“精神分裂症患者”以及“布瑞哌唑”或“REXULTI”来检索与我们荟萃分析特定目的相关的研究。我们系统回顾了所有比较低剂量布瑞哌唑与安慰剂的随机对照试验（RCT）。主要疗效指标为阳性和阴性症状量表（PANSS）总分变化及缓解率。主要安全性指标为总治疗中断率和严重不良事件（SAE）总数。采用随机效应模型合并风险比（RR）和标准化均数差（SMD）。
纳入四项RCT（共2178例患者）以评估低剂量布瑞哌唑治疗急性精神分裂症患者的效果。低剂量布瑞哌唑在PANSS总分变化方面不优于安慰剂（SMD = -0.11，95%置信区间 = -0.23，0.02，P = 0.10，I² = 0%），且显著劣于标准剂量布瑞哌唑（SMD = 0.15，95%置信区间 = 0.03，0.26，P = 0.01，I² = 0%）。与安慰剂和标准剂量布瑞哌唑相比，低剂量布瑞哌唑在缓解率方面无显著差异（RR分别为1.16，95%置信区间 = 0.95，1.41，P = 0.14，I² = 25%；RR = 0.92，95%置信区间 = 0.76，1.12，P = 0.40，I² = 38%）。在总中断率方面，低剂量布瑞哌唑与安慰剂（RR = 0.95，95%置信区间 = 0.81，1.11，P = 0.53，I² = 0%）及标准剂量布瑞哌唑组（RR = 1.11，95%置信区间 = 0.95，1.29，P = 0.19，I² = 0%）相比无显著差异。低剂量布瑞哌唑组的SAE总数与安慰剂和标准剂量布瑞哌唑组相比无显著差异（RR分别为0.96，95%置信区间 = 0.52，1.80，P = 0.90，I² = 0%；RR = 1.29，95%置信区间 = 0.65，2.57，P = 0.47，I² = 26%）。
结果表明，与安慰剂和标准剂量布瑞哌唑相比，低剂量布瑞哌唑在改善急性精神分裂症的疗效和安全性方面可能并不优越，且可能增加体重的额外风险。因此，不建议在急性精神分裂症患者中使用低剂量布瑞哌唑。
