Yuen Andrew S C, Chen Boqing, Chan Adrienne Y L, Hayes Joseph F, Osborn David P J, Besag Frank M C, Lau Wallis C Y, Wong Ian C K, Wei Li, Man Kenneth K C
Research Department of Practice and Policy, School of Pharmacy, University College London, London, UK.
Centre for Medicines Optimisation Research and Education, University College London Hospitals NHS Foundation Trust, London, UK.
BMJ. 2025 Apr 30;389:e081627. doi: 10.1136/bmj-2024-081627.
To estimate the effect of gabapentinoid treatment on self-harm.
A population based self-controlled case series study.
UK Clinical Practice Research Datalink Aurum database linked to the Hospital Episode Statistics and Office for National Statistics databases.
10 002 adults (aged ≥18 years), with gabapentinoid prescriptions, who had an incident event of self-harm between 1 January 2000 and 31 December 2020. Individual censoring occurred on the date of epilepsy, substance misuse, or cancer diagnosis.
Crude incidence rates of self-harm in different risk periods: 90 days before gabapentinoid treatment, gabapentinoid treatment period, 14 days after treatment periods, and reference periods were calculated. Conditional Poisson regression derived the incidence rate ratio and 95% confidence intervals (CIs) to evaluate the risk of self-harm in different risk periods, compared with reference period for each individual.
1 503 597 individuals received gabapentinoid prescriptions and 10 002 individuals were included in the analysis. The incidence rate of self-harm per 100 person years was 16.79 (95% CI 16.65 to 16.92) in the 90 days before treatment period, 9.66 (9.62 to 9.70) in the treatment period, 29.60 (29.09 to 30.11) in the 14 days after treatment period, and 6.75 (6.74 to 6.77) in the reference period. The results yielded an increased risk of self-harm during the 90 day period before treatment, with an adjusted incidence rate ratio of 1.69 (95% CI 1.55 to 1.85). The spline based analysis showed that the risk of self-harm declined gradually around the time of treatment initiation and returned to reference level during the treatment period (adjusted incidence rate ratio 1.06 (0.98 to 1.13)). Adjusted incidence rate ratio for self-harm increased within 14 days after treatment cessation (3.02 (2.53 to 3.60)). The findings remained consistent throughout a series of subgroups and sensitivity analyses.
The association between gabapentinoids and risk of self-harm seems to be multifaceted: an elevated risk of self-harm is present before initiation of gabapentinoid treatment, which persists during the initial phase of the treatment period, and rises again shortly after treatment discontinuation. These findings do not support a direct effect of gabapentinoid treatment on self-harm but underscore the necessity for close patient monitoring of self-harm throughout the gabapentinoid treatment journey.
评估加巴喷丁类药物治疗对自我伤害行为的影响。
一项基于人群的自我对照病例系列研究。
英国临床实践研究数据链金数据数据库,与医院事件统计数据库和国家统计局数据库相关联。
10002名成年人(年龄≥18岁),有使用加巴喷丁类药物的处方记录,在2000年1月1日至2020年12月31日期间发生过自我伤害事件。个体审查在癫痫、药物滥用或癌症诊断日期进行。
计算不同风险期的自我伤害行为粗发病率:加巴喷丁类药物治疗前90天、加巴喷丁类药物治疗期、治疗期后14天以及参照期。采用条件泊松回归得出发病率比和95%置信区间(CI),以评估不同风险期与每个个体参照期相比的自我伤害行为风险。
1503597人接受了加巴喷丁类药物处方,10002人纳入分析。治疗前90天每100人年的自我伤害行为发病率为16.79(95%CI 16.65至16.92),治疗期为9.66(9.62至9.70),治疗期后14天为29.60(29.09至30.11),参照期为6.75(6.74至6.77)。结果显示治疗前90天自我伤害行为风险增加,调整后的发病率比为1.69(95%CI 1.55至1.85)。基于样条的分析表明,自我伤害行为风险在治疗开始时逐渐下降,并在治疗期间恢复到参照水平(调整后的发病率比1.06(0.98至1.13))。治疗停止后14天内自我伤害行为的调整发病率比增加(3.02(2.53至3.60))。在一系列亚组分析和敏感性分析中,研究结果保持一致。
加巴喷丁类药物与自我伤害行为风险之间的关联似乎是多方面的:在加巴喷丁类药物治疗开始前存在自我伤害行为风险升高,在治疗初期持续存在,并在治疗停止后不久再次上升。这些发现不支持加巴喷丁类药物治疗对自我伤害行为有直接影响,但强调在整个加巴喷丁类药物治疗过程中密切监测患者自我伤害行为的必要性。