Pharmacy Department, Norfolk and Suffolk NHS Foundation Trust, Norwich, UK.
Research Department, Norfolk and Suffolk NHS Foundation Trust, Norwich, UK.
Bipolar Disord. 2018 Dec;20(8):687-696. doi: 10.1111/bdi.12707. Epub 2018 Nov 11.
Non-adherence is a significant problem in bipolar disorder. Second-generation antipsychotics (SGA) long-acting injections (LAIs) may improve adherence in bipolar disorder and may prevent relapses. However, the evidence is limited and conflicting.
The objective of this study was to evaluate efficacy and safety of SGA LAIs in bipolar disorder.
Systematic review and meta-analysis of randomised controlled trials (RCTs) (≥6 months duration) investigating safety and efficacy of SGA LAIs for bipolar disorder. We searched Pubmed, Embase, CINAHL, Cochrane, PsycINFO, LiLACS, www.clinicaltrials.gov up to October 2016. We also contacted the manufacturers of SGA LAIs. Primary efficacy and safety outcomes were relapse rate and all-cause discontinuation respectively.
Total of seven RCTs (n = 1192) were included. SGA LAIs show superiority over placebo for study-defined relapse rate (RR = 0.58, 95% CI = 0.49-0.68, P < 0.00001) and all-cause discontinuation (RR = 0.72, 95% CI = 0.64-0.82, P < 0.00001). However, no significant difference was found between SGA LAIs and oral active control for relapse rate (RR = 0.92, P = 0.79) and all-cause discontinuation (RR = 1.2, P = 0.31). In terms of secondary outcomes, SGA LAIs performed better than placebo in relapse to mania/hypomania, young mania rating scales (YMRS), clinical global impression-severity (CGI-S), montgomery-asberg depression rating scale (MADRS). There was no significant difference between SGA LAIs and oral active control regarding relapse to mania/hypomania, YMRS, CGI-S, extra-pyramidal side effects (EPSEs), weight gain. However, the active control performed better than SGA LAIs in relapse to depression, MADRS, and prolactin-related AEs.
Current evidence is very limited to support the use of SGA LAIs (compared to oral medication) in bipolar disorder. Further high-quality studies, particularly comparing SGA LAIs with active control, are warranted.
在双相情感障碍中，不遵医嘱是一个严重的问题。第二代抗精神病药（SGA）长效注射剂（LAI）可能会改善双相情感障碍患者的依从性，并预防复发。然而，证据有限且存在冲突。
本研究旨在评估 SGA LAI 在双相情感障碍中的疗效和安全性。
系统检索了 Pubmed、Embase、CINAHL、Cochrane、PsycINFO、LiLACS、www.clinicaltrials.gov 等数据库，检索时间截至 2016 年 10 月，还联系了 SGA LAI 制造商，以评估 SGA LAI 治疗双相情感障碍的安全性和疗效。我们纳入了评估 SGA LAI 治疗双相情感障碍的随机对照试验（RCT）（≥6 个月），主要疗效和安全性结局分别为复发率和全因停药率。
共纳入了 7 项 RCT（n=1192）。SGA LAI 组在研究定义的复发率（RR=0.58，95%CI=0.49-0.68，P<0.00001）和全因停药率（RR=0.72，95%CI=0.64-0.82，P<0.00001）方面优于安慰剂组。然而，SGA LAI 组与口服活性对照组在复发率（RR=0.92，P=0.79）和全因停药率（RR=1.2，P=0.31）方面无显著差异。在次要结局方面，SGA LAI 组在躁狂/轻躁狂复发、Young 躁狂评定量表（YMRS）、临床总体印象严重程度（CGI-S）、蒙哥马利-阿斯伯格抑郁评定量表（MADRS）方面优于安慰剂组。SGA LAI 组与口服活性对照组在躁狂/轻躁狂复发、YMRS、CGI-S、锥体外系不良反应（EPS）、体重增加方面无显著差异。然而，活性对照组在抑郁复发、MADRS 和与催乳素相关的不良事件（AE）方面优于 SGA LAI 组。
目前的证据非常有限，无法支持 SGA LAI（与口服药物相比）在双相情感障碍中的应用。需要进一步开展高质量的研究，特别是比较 SGA LAI 与活性对照药物的研究。
