抗精神病药所致高催乳素血症的阿立哌唑辅助治疗与安慰剂对照的随机对照试验的荟萃分析。

Adjunctive aripiprazole versus placebo for antipsychotic-induced hyperprolactinemia: meta-analysis of randomized controlled trials.

机构信息

Beijing Key Lab of Mental Disorders, Beijing Anding Hospital, Capital Medical University, Beijing, China.

出版信息

PLoS One. 2013 Aug 1;8(8):e70179. doi: 10.1371/journal.pone.0070179. Print 2013.

OBJECTIVE

To compare the safety and efficacy of adjunctive aripiprazole versus placebo for antipsychotic-induced hyperprolactinemia.

POPULATION

adult patients presenting with antipsychotic-induced hyperprolactinemia diagnosed by prolactin level with or without prolactin-related symptoms.

INTERVENTIONS

adjunctive aripiprazole vs. adjunctive placebo.

OUTCOME MEASURES

adverse events and efficacy of treatment.

STUDIES

randomized controlled trials.

RESULTS

Five randomized controlled trials with a total of 639 patients (326 adjunctive aripiprazole, 313 adjunctive placebo) met the inclusion criteria. Adjunctive aripiprazole was associated with a 79.11% (125/158) prolactin level normalization rate. Meta-analysis of insomnia, headache, sedation, psychiatric disorder, extrapyramidal symptom, dry mouth, and fatigue showed no significant differences in the adjunctive aripiprazole treatment group compared with the placebo group (risk difference (Mantel-Haenszel, random or fixed) -0.05 to 0.04 (95% confidence interval -0.13 to 0.16); I(2) =0% to 68%, P=0.20 to 0.70). However, sedation, insomnia, and headache were more frequent when the adjunctive aripiprazole dose was higher than 15 mg/day. Meta-analysis of the prolactin level normalization indicated adjunctive aripiprazole was superior to placebo (risk difference (Mantel-Haenszel, random) 0.76 (95% confidence interval 0.67 to 0.85); I(2) =43%, P<0.00001). The subgroup analysis confirmed that the subjects who received adjunctive aripiprazole 5 mg/day showed a degree of prolactin normalization similar to that of all participants. No significant differences between groups in discontinuation and improvements of psychiatric symptoms.

CONCLUSION

Adjunctive aripiprazole is both safe and effective as a reasonable choice treatment for patients with antipsychotic-induced hyperprolactinemia. The appropriate dose of adjunctive aripiprazole may be 5 mg/day.

目的

比较辅助阿立哌唑与安慰剂治疗抗精神病药引起的高催乳素血症的安全性和疗效。

人群

出现催乳素水平升高伴有或不伴有催乳素相关症状的抗精神病药引起的高催乳素血症的成年患者。

干预措施

辅助阿立哌唑与辅助安慰剂。

结局指标

不良反应和治疗效果。

研究类型

随机对照试验。

结果

共纳入了 5 项随机对照试验，总计 639 例患者（辅助阿立哌唑组 326 例，辅助安慰剂组 313 例）符合纳入标准。辅助阿立哌唑组催乳素水平正常率为 79.11%（125/158）。Meta 分析显示，在辅助阿立哌唑治疗组与安慰剂组之间，失眠、头痛、镇静、精神障碍、锥体外系症状、口干和疲劳的发生率无显著差异（风险差异（Mantel-Haenszel，随机或固定）-0.05 至 0.04（95%置信区间-0.13 至 0.16）；I²=0% 至 68%，P=0.20 至 0.70）。然而，当辅助阿立哌唑剂量高于 15 mg/天时，镇静、失眠和头痛的发生更为频繁。催乳素水平正常化的 Meta 分析表明，辅助阿立哌唑优于安慰剂（风险差异（Mantel-Haenszel，随机）0.76（95%置信区间 0.67 至 0.85）；I²=43%，P<0.00001）。亚组分析证实，接受辅助阿立哌唑 5 mg/天的患者显示出与所有参与者相似的催乳素正常化程度。两组之间停药和精神症状改善无显著差异。