Multigenetic Pharmacogenomics–Guided Treatment vs Treatment As Usual Among Hospitalized Men With Schizophrenia

作者：Zhewei Kang, Ying Qin, Yutao Sun, Zhe Lu, Yaoyao Sun, Huan Chen, Xiaoyang Feng, Yuyanan Zhang, Hua Guo, Hao Yan, Weihua Yue · 发表于：JAMA Network Open · 年份：2023 · DOI：10.1001/jamanetworkopen.2023.35518 · 被引用次数：26 · 研究领域：Schizophrenia research and treatment、Pharmacogenetics and Drug Metabolism、Genetic Associations and Epidemiology

Importance: Limited evidence supports multigenetic pharmacogenomics-guided treatment (MPGT) in schizophrenia. Objective: To evaluate the clinical effectiveness of MPGT in schizophrenia in a randomized clinical trial (RCT). Design, Setting, and Participants: This RCT was conducted from March 2020 to March 2022. Male Chinese Han inpatients aged 18 to 60 years diagnosed with schizophrenia with a Positive and Negative Symptom Scale (PANSS) score of 60 or more from 2 selected study hospitals were included. Patients and raters were masked to MPGT or treatment as usual (TAU) randomization. Interventions: Participants were randomly assigned in a 1:1 ratio to receive either MPGT or TAU for 12 weeks. Main Outcomes and Measures: The primary efficacy outcome was the percentage change in PANSS total scores (range, 30 to 210) from baseline to week 6 analyzed by a modified intention-to-treat mixed model for repeated measures. The secondary outcome included response and symptomatic remission rates. Results: A total of 210 participants (mean [SD] age, 29.2 [8.8] years) were enrolled and analyzed, with 113 assigned to MPGT and 97 to TAU. Compared with those randomized to TAU, participants randomized to MPGT demonstrated a significantly higher percentage change in PANSS score (74.2% vs 64.9%; adjusted mean difference, 9.2 percentage points; 95% CI, 4.4-14.1 percentage points; P < .001) and a higher response rate (93 of 113 [82.3%] vs 63 of 97 [64.9%]; adjusted odds ratio, 2.48; 95% CI, 1.28-4.8...