盐酸氟西汀分散片联合阿普唑仑片治疗脑梗死恢复期患者的临床研究

Clinical trial of fluoxetine hydrochloride dispersible tablets combined with alprazolam tablets in the treatment of patients with cerebral infarction at recovery stage

目的观察盐酸氟西汀分散片联合阿普唑仑片治疗脑梗死恢复期患者的临床疗效及安全性。方法将80例脑梗死恢复期患者随机分为对照组和试验组,每组40例。对照组给予阿普唑仑0.8 mg·d^(-1),早晚各一次,口服;试验组在对照组治疗的基础上,给予盐酸氟西汀分散片20 mg·d^(-1),早餐后服用,口服。2组患者均治疗8周。比较2组患者的临床疗效、血浆纤维蛋白原、匹兹堡睡眠质量指数量表(PSQI)评分,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为95.00%(38例/40例)和80.00%(32例/40例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的血浆纤维蛋白原分别为(2.18±0.43)和(3.85±0.51)g·L^(-1),PSQI总分分别为(6.68±1.48)和(12.26±2.86)分,差异均有统计学意义(均P<0.05)。试验组的药物不良反应主要有头晕、恶心、乏力和口干,对照组的药物不良反应主要有头晕、头痛、恶心和口干。试验组和对照组的总药物不良反应发生率均为12.50%,差异无统计学意义(P>0.05)。结论盐酸氟西汀分散片联合阿普唑仑片治疗脑梗死恢复期患者的临床疗效确切,其可有效降低患者血浆纤维蛋白原水平,改善睡眠障碍,且不增加药物不良反应的发生率。

Objective To observe the clinical efficacy and safety of fluoxetine hydrochloride dispersible tablets combined with alprazolam tablets in the treatment of patients with cerebral infarction at recovery stage.Methods A total of 80 patients with cerebral infarction at recovery stage were randomly divided into control group and treatment group with 40 cases per group.The control group was treated with alprazolam 0.8 mg·d^(-1),once in the morning and evening,orally.On the basis of control group,the treatment group was given fluoxetine hydrochloride dispersible tablets 20 mg·d^(-1),after breakfast,orally.Two groups were treated for 8 weeks.The clinical efficacy,plasma fibrinogen,Pittsburgh sleep quality index(PSQI)score and adverse drug reactions were compared between two groups.Results After treatment,the total effective rates of treatment and control groups were 95.00%(38 cases/40 cases)and 80.00%(32 cases/40 cases)with significant difference(P<0.05).After treatment,the levels of plasma fibrinogenin the treatment and control groups were(2.18±0.43)and(3.85±0.51)g·L^(-1),the total scores of PSQI were(6.68±1.48)and(12.26±2.86)point,the differences were statistically significant(all P<0.05).The main adverse drug reactions of treatment group were dizziness,nausea,fatigue and dry mouth,while those in the control group were dizziness,headache,nausea and dry mouth.The total incidences of adverse drug reactions in the treatment and control groups were 12.50%without significant difference(P>0.05).Conclusion Fluoxetine hydrochloride dispersible tablets combined with alprazolam tablets have a definitive clinical efficacy in the treatment of convalescent patients with cerebral infarction,which can effectively reduce the level of plasma fibrinogen and improve sleep disorders,without increasing the incidence of adverse drug reactions.