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目的:探讨阿立哌唑治疗抗精神病药相关高催乳素血症(AIH)的有效性和安全性。方法:检索国内外有关数据库(截至2020年11月29日),收集阿立哌唑治疗AIH的随机对照试验(RCT),试验组在原抗精神病药治疗基础上加用阿立哌唑,对照组加用或不加用安慰剂,结局指标包括血清催乳素复常率、血清催乳素水平和主要不良事件发生率。采用RevMan 5.4软件进行meta分析,计数资料的效应量采用风险比(n RR)及其95%置信区间(n CI)表示,计量资料的效应量采用标准化均数差(n SMD)及其95n %CI表示。n 结果:共23项RCT纳入分析,包括患者1 530例,试验组816例,对照组714例。meta分析结果显示,疗程(4~24周)结束时试验组患者血清催乳素复常率高于对照组,差异有统计学意义[73.5%(150/204)比4.1%(8/194),n RR=16.58,95n %CI:8.61~31.93,n P<0.001]。按阿立哌唑剂量分5 mg/d组和10 mg/d组进行分析,结果显示疗程结束时2个试验组患者血清催乳素水平均低于相应的对照组,差异有统计学意义[n SMD=n -1.25,95n %CI:n -1.66~n -0.84,n P<0.001;n SMD=1.93,95n %CI:n -2.38~n -1.48,n P<0.001]。试验组与对照组患者试验期间总体不良事件、锥体外系反应、失眠、嗜睡和体重增加发生率差异均无统计学意义[26.5%(103/388)比24.1%(94/390),n RR=1.10,95n %CI:0.90~1.36,n P=0.35;26.0%(53/204)比34.0%(70/206),n RR=0.77,95n %CI:0.58~1.02,n P=0.06;8.4%(31/368)比9.9%(37/372),n RR=0.86,95n %CI:0.56~1.33,n P=0.50;5.6%(19/340)比4.7%(16/342),n RR=1.16,95n %CI:0.64~2.12,n P=0.63;0比7.9%(7/89),n RR=0.18,95n %CI:0.03~0.99),n P=0.05]。n 结论:阿立哌唑治疗AIH安全有效,但长期疗效与安全性尚待探索。“,”Objective:To explore the efficacy and safety of aripiprazole in the treatment of antipsychotic-induced hyperprolactinemia (AIH).Methods:Randomized controlled trials (RCTs) of aripiprazole in treating AIH were collected by searching relevant databases at home and abroad (up to November 29, 2020). Patients in the trial group was treated with aripiprazole on the base antipsychotic drugs, and those in the control group was treated with or without additional placebo. Outcome indicators included serum prolactin normalization rate, serum prolactin level, and the incidence of major adverse events. Meta-analysis was performed using RevMan 5.4 software. The effect size of counting data was risk ratio (n RR) and its 95% confidence interval (n CI), and the effect size of measurement data was standardized mean difference (n SMD) and its 95n %CI.n Results:A total of 23 RCTs were entered in the analysis, including 1 530 patients, 816 patients in the trial group and 714 patients in the control group. The meta-analysis results showed that the normalization rate of serum prolactin in the trial group was higher than that in the control group at the end of the treatment course (4-24 weeks) [73.5% (150/204) n vs. 4.1% (8/194), n RR=16.58, 95n %CI: 8.61-31.93, n P<0.001]. According to the dose of aripiprazole, the patients were divided into 5 mg/d and 10 mg/d subgroups. The analysis results showed that the serum prolactin levels in patients in the 2 trial subgroups were lower than those in their corresponding control groups at the end of the treatment, and the differences were statistically significant [n SMD=n -1.25, 95n %CI: n -1.66-n -0.84, n P<0.001;n SMD=1.93, 95n %CI: n -2.38-n -1.48, n P<0.001]. There were no significant differences in the incidence of overall adverse events, extrapyramidal reactions, insomnia, somnolence, and weight gain in patients between the trial and control groups during the trial [26.5% (103/388)n vs. 24.1% (94/390), n RR=1.10, 95n %CI: 0.90-1.36, n P=0.35; 26.0% (53/204) n vs. 34.0% (70/206), n RR=0.77, 95n %CI: 0.58-1.02, n P=0.06; 8.4% (31/368) n vs. 9.9% (37/372), n RR=0.86, 95n %CI: 0.56-1.33, n P=0.50; 5.6% (19/340) n vs. 4.7% (16/342), n RR=1.16, 95n %CI: 0.64-2.12, n P=0.63; 0 n vs. 7.9% (7/89), n RR=0.18, 95n %CI: 0.03-0.99), n P=0.05].n Conclusion:Aripiprazole is safe and effective in the treatment of AIH, but the long-term efficacy and safety need to be explored.