背景:左乙拉西坦(LEV)和丙戊酸(VPA)是我们机构常规用于预防创伤后癫痫(PTS)的两种抗癫痫药物(AED)。在我们的实践中,VPA用于对行为激动和头痛的有益影响,但它也与异常肝功能测试(LFTs)有关。两种药物都可能与血小板减少症有关。在PTS预防的背景下,比较LEV和VPA的不良反应概况和停药率的文献较少。我们进行了质量改进(QI)分析,以确定LEV和VPA对我们机构的创伤性脑损伤(TBI)患者的安全性。特别是,我们的QI分析包括计算因不良反应而停药或改变药物治疗方案的比率.
方法:我们的QI分析集中于在我们机构接受6年TBI治疗的患者。我们记录了使用的AED,如果由于血小板减少而停用或转换AED,行为激动,头痛,或升高的LFTs(包括天冬氨酸转氨酶或丙氨酸转氨酶值升高)。我们还记录了早期PTS的发生率,定义为TBI后七天内的癫痫发作。
结果:我们的QI分析包括平均年龄约49岁的患者,其中男性占75%。平均格拉斯哥昏迷量表(GCS)评分为12.88分,其中73.11%的患者患有轻度GCS。三种主要的损伤机制是跌倒,攻击,和机动车碰撞。TBI的三种主要类型是外伤性蛛网膜下腔出血,硬膜下血肿,还有脑挫裂伤.在没有癫痫发作史的患者中,我们发现早期PTS发生率为7.28%。对于使用LEV和VPA的患者,0.11%(1/898)和3.85%(4/104)因血小板减少而停药或改药(p<0.001),分别。对于LEV上的患者,4.01%(36/898)和1.78%(16/898)因行为激动和头痛而停药或改变。分别。对于服用VPA的患者,2.88%(3/104)因肝脏毒性而停药或改药。总的来说,LEV和VPA的患者分别为5.90%和6.73%(p>0.5),分别,由于不良反应,他们的用药方案发生了变化。
结论:我们的患者早期PTS的发生率在文献报道的范围内。在PTS预防的情况下,由于不良事件导致的LEV和VPA停药率较低。两种药物的总体停药率相似。由于血小板减少,VPA比LEV更频繁地停药。但停药在这两种情况下都不常见。LEV与行为激动和头痛有关,这使得VPA成为患有这些症状的患者的理想选择。
BACKGROUND: Levetiracetam (LEV) and valproic acid (VPA) are two anti-epileptic drugs (AEDs) routinely used for post-traumatic seizure (PTS) prophylaxis at our institution. In our practice, VPA is used for its beneficial effects on behavioral agitation and headaches, but it is also associated with abnormal liver function tests (LFTs). Both medications may be associated with thrombocytopenia. There is less literature comparing the adverse effect profiles and discontinuation rates of LEV and VPA in the context of PTS prophylaxis. We conducted a quality improvement (QI) analysis to determine the safety of LEV and VPA for traumatic brain injury (TBI) patients at our institution. In particular, our QI analysis involved calculating the rates of discontinuation or change of drug regimen due to the adverse effects.
METHODS: Our QI analysis focused on patients treated for TBI at our institution during a six-year period. We recorded the AED used and if the AED was discontinued or switched due to thrombocytopenia, behavioral agitation, headaches, or elevated LFTs (including elevated aspartate aminotransferase or alanine aminotransferase values). We also recorded the incidence of early PTS, defined as seizures within seven days of the TBI.
RESULTS: Our QI analysis included patients with a mean age of approximately 49 years with nearly 75% males. The mean Glasgow Coma Scale (GCS) score was 12.88, with 73.11% of patients having a mild GCS. The three leading injury mechanisms were fall, assault, and motor vehicle collision. The three leading types of TBI were traumatic subarachnoid hemorrhage, subdural hematoma, and cerebral contusion. Among patients with no prior history of seizures, we found an early PTS incidence of 7.28%. For patients administered LEV and VPA, 0.11% (1/898) and 3.85% (4/104) had the medication discontinued or changed because of thrombocytopenia (p < 0.001), respectively. For patients on LEV, 4.01% (36/898) and 1.78% (16/898) had the medication discontinued or changed because of behavioral agitation and headaches, respectively. For patients on VPA, 2.88% (3/104) had the medication discontinued or changed because of hepatotoxicity. In total, 5.90% versus 6.73% (p > 0.5) of patients on LEV and VPA, respectively, had their medication regimens changed due to the adverse effects.
CONCLUSIONS: The incidence of early PTS in our patients is within the range of what has been reported in the literature. The rate of discontinuation of LEV and VPA on account of adverse events is low in the context of PTS prophylaxis. Both medications had similar overall rates of discontinuation. VPA was discontinued more frequently than LEV due to thrombocytopenia, but discontinuation was not common in either case. LEV is associated with behavioral agitation and headaches, which makes VPA a desirable alternative for patients suffering from these symptoms.