Atkins Susan, Detke Holland C, McDonnell David P, Case Michael G, Wang Shufang
Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, USA.
BMC Psychiatry. 2014 Jan 14;14:7. doi: 10.1186/1471-244X-14-7.
Depot antipsychotic injections are an important tool for the management of patients with schizophrenia who have difficulty with adherence to oral medication. However, pain and discomfort at the injection site can be a potential impediment to the use of these long-acting formulations. We report here the results of a pooled analysis of injection site-related adverse events (AEs) collected during treatment with the olanzapine long-acting injection (olanzapine LAI).
Unsolicited injection site-related AEs were pooled from 7 olanzapine LAI clinical trials conducted in patients between March 2001 and December 2010. All patients had a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) or Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of schizophrenia or schizoaffective disorder and were between the ages of 18 and 75. Doses ranged from 45 to 405 mg olanzapine LAI, and injection intervals were 2, 3, or 4 weeks. Events were evaluated for severity, timing, possible risk factors, and outcome. A criterion of p < .05 for statistical significance was used for all tests.
A total of 1752 patients received at least 1 olanzapine LAI injection. Of these, 92 patients (5.3%) reported at least 1 injection site-related AE, with "pain" being the most common type (2.9%). Most events were mild (81.4%) and the median duration was 3 days. Four patients (0.2%) discontinued due to injection site-related AEs. Dose volume and body mass index did not appear to affect the probability of injection site-related AEs. However, patients who experienced a post-injection delirium/sedation syndrome event (n = 37) were more likely to have or have had an injection site-related AE at some time during the study. Incidence of injection site-related AEs appeared to decrease over time. In 94.2% of the injection site-related AEs, no specific treatment or concomitant medication was reported; in 9 cases, patients received pharmacologic treatment for reaction, mass, abscess, rash, or pain.
Injection site-related AEs with olanzapine LAI were generally mild. The incidence and nature of these injection site-related AEs were generally similar to those occurring during treatment with other injectable antipsychotics.
ClinicalTrials.gov ID; URL: NCT00094640, NCT00088478, NCT00088491, NCT00088465, and NCT00320489.
长效抗精神病药物注射剂是治疗难以坚持口服药物治疗的精神分裂症患者的重要工具。然而，注射部位的疼痛和不适可能会阻碍这些长效制剂的使用。我们在此报告对使用奥氮平长效注射剂（奥氮平LAI）治疗期间收集的注射部位相关不良事件（AE）进行汇总分析的结果。
汇总2001年3月至2010年12月期间在7项奥氮平LAI临床试验中主动报告的注射部位相关AE。所有患者均符合《精神障碍诊断与统计手册》第四版（DSM-IV）或第四版修订本（DSM-IV-TR）中精神分裂症或分裂情感性障碍的诊断标准，年龄在18至75岁之间。奥氮平LAI剂量范围为45至405mg，注射间隔为2、3或4周。对事件的严重程度、发生时间、可能的危险因素和结局进行评估。所有检验均采用p < 0.05作为统计学显著性标准。
共有1752例患者接受了至少1次奥氮平LAI注射。其中，92例患者（5.3%）报告了至少1次注射部位相关AE，最常见的类型是“疼痛”（2.9%）。大多数事件为轻度（81.4%），中位持续时间为3天。4例患者（0.2%）因注射部位相关AE停药。剂量体积和体重指数似乎不影响注射部位相关AE的发生概率。然而，经历过注射后谵妄/镇静综合征事件的患者（n = 37）在研究期间的某个时间更有可能发生或已经发生过注射部位相关AE。注射部位相关AE的发生率似乎随时间下降。在94.2%的注射部位相关AE中，未报告具体治疗或伴随用药情况；9例患者因反应、肿块、脓肿、皮疹或疼痛接受了药物治疗。
奥氮平LAI的注射部位相关AE一般较轻。这些注射部位相关AE的发生率和性质与其他注射用抗精神病药物治疗期间发生的情况总体相似。
ClinicalTrials.gov标识符；网址：NCT00094640、NCT00088478、NCT00088491、NCT00088465和NCT00320489。
