增量氯吡格雷对中重度脑动脉狭窄CYP2C19中间代谢型脑梗死预后影响的临床观察

Clinical observation of the effect of dual antiplatelet therapy with conventional dose and incremental clopidogrel on prognosis of intermediate metabolic cerebral infarction in patients with moderate to severe cerebral artery stenosis

目的:探讨增加氯吡格雷剂量的双联抗血小板与常规剂量氯吡格雷的双联抗血小板治疗对中重度脑动脉狭窄CYP2C19中间代谢型脑梗死患者预后的影响。方法:以2017年1月至2017年9月收治的中重度脑动脉狭窄且为CYP2C19中间代谢型的脑梗死患者98例为研究对象,随机分为对照组与观察组各49例。对照组采用阿司匹林联合常规氯吡格雷剂量的双抗治疗90 d,观察组采用阿司匹林联合增加氯吡格雷剂量的双联抗血小板治疗90 d,两组其他治疗方案相同,所有患者出院后追踪随访12个月。比较2组患者卒中复发率、出血事件发生率、脑卒中量表(NIHSS)评分及日常生活能力量表(ADL)评分。结果:随访3个月、6个月及12个月时,观察组卒中复发率分别为0.00%、4.08%及8.16%,明显低于对照组的12.24%、18.37%及22.45%,差异具有显著性(P<0.05);随访3个月、6个月及12个月时,观察组出血事件发生率分别为10.20%、14.29%及20.41,与对照组的8.16%、16.33%及18.37%相比无明显区别,差异不具有显著性(P>0.05);治疗前2组ADL及NIHSS量表评分无明显差异(P>0.05),出院后随访3个月、6个月及12个月时,观察组NIHSS评分明显低于对照组,ADL评分明显高于对照组,差异均具有显著性(P<0.05)。结论:中重度脑动脉狭窄且CYP2C19中间代谢型脑梗死患者采用增加氯吡格雷剂量的双联抗血小板二级预防治疗能患者降低卒中复发率且不增加出血事件发生,同时对患者神经功能改善效果优于常规剂量氯吡格雷的双联抗血小板治疗,值得临床参考借鉴。

OBJECTIVE To detect the adverse drug reactions(ADR) signals of valproic acid in American Adverse Event Reporting System(AERS) and analyze the influencing factors of adverse reactions, so as to provide references for clinical rational drug use. METHODS The reports collected from the first quarter of 2017 to the fourth quarter of 2017 in AERS database were extracted and analyzed by reporting odds ratio(ROR). The related signals of adverse reactions of blood, metabolism, digestion and skin system induced by valproic acid were excavated. RESULTS 110 reports of adverse drug reactions were reported, among which the number of reports and signals of hematological adverse drug reactions were the most. Statistical analysis showed a statistically significant distribution of hematological ADRs relative to other systemic ADRs in age(P<0.05) and gender(P<0.05), and no statistically significant distribution was detected in dose of medication(P>0.05) and combination(P>0.05). Children, especially female patients, were more sensitive to hematological adverse reactions. CONCLUSION The detection and analysis of safety signals and influencing factors of valproic acid indicate that attention should be paid to the influence of age and gender on hematological adverse reactions, and it is necessary to carry out further signal evaluation and verification, so as to provide the basis for clinical safe medication.