唑吡坦对变异型心绞痛伴自述失眠患者临床疗效、预后及安全性的影响

Effect of Zolpidem on Clinical Efficacy, Prognosis and Safety in Patients with Variant Angina Pectoris and Self-reported Insomnia

关键词:  唑吡坦  变异型心绞痛  自述失眠  炎症因子  SF-36

Key words:  zolpidem  variant angina  self-report insomnia  inflammatory factors  SF-36

摘要:

目的 探讨唑吡坦对变异型心绞痛（variant angina pectoris，VAP）伴自述失眠（self-reported insomnia，SRI）患者临床疗效、预后和安全性的影响。方法 将98例VAP伴SRI患者随机分为对照组（常规治疗+安慰剂）和试验组（常规治疗+唑吡坦），每组各49例。试验组在VAP常规治疗基础上给予唑吡坦5~10 mg，每晚睡前口服；对照组则给予同等样式安慰剂。治疗30 d后，对比2组治疗前后匹兹堡睡眠质量指数（Pittsburgh sleep quality index，PSQI）评分和SF-36生活质量评分，观察其肿瘤坏死因子α（tumor necrosis factor α，TNF-α）、白细胞介素10（interleukin 10，IL-10）、脂蛋白相关磷脂酶A2（lipoprotein associated phospholipase A2，Lp-PLA₂）水平变化，比较心绞痛发作频率、持续时间、硝酸甘油片消耗量，并评价治疗过程中心血管事件和不良反应发生情况。结果 治疗30 d后2组PSQI评分和SF-36评分均有所改善（P<0.05），试验组优于对照组（P<0.05）。2组炎症因子TNF-α、Lp-PLA₂水平均降低（P<0.05），IL-10均升高（P<0.05），试验组比对照组变化明显（P<0.05）。同时2组心血管事件均减少，试验组减少更显著（P<0.05）。对照组和试验组药物不良反应总发生率分别为6.12%和8.16%，无统计学差异。结论 唑吡坦可明显提高VAP伴SRI患者的睡眠质量和生活质量，减轻其血管炎症反应，改善VAP治疗效果和心血管事件发生率，且不增加不良反应总发生率。

Abstract:

OBJECTIVE To explore the effect of zolpidem on the clinical efficacy, prognosis and safety of patients with variant angina pectoris(VAP) and self-reported insomnia(SRI). METHODS Ninety-eight patients with VAP and SRI were randomly divided into the control group(conventional treatment and placebo) and experimental group(conventional treatment with zolpidem), 49 patients in each group. The experimental group was given zolpidem 5-10 mg orally before bedtime on the basis of routine treatment of VAP. The control group was given the same type of placebo. After treatment for 30 d, the Pittsburgh sleep quality index(PSQI) scores and SF-36 life quality scores were compared, the tumor necrosis factor a(TNF-a), interleukin 10(IL-10), and lipoprotein associated phospholipase A2(Lp-PLA₂) levels were observed, the frequency and duration of VAP and nitroglycerin consumption between two groups before and after treatment were compared, and the occurrence of cardiovascular events and adverse reactions during treatment were also evaluated. RESULTS After treatment for 30 d, the PSQI scores and SF-36 scores were improved in both groups(P<0.05) while the experimental group showed better than the control group(P<0.05). The levels of TNF-α and Lp-PLA₂ were decreased in both groups(P<0.05) and the levels of IL-10 were increased(P<0.05), and the experimental group showed more changes than the control group(P<0.05). Meanwhile, cardiovascular events were reduced in both groups, and more significant in the experimental group(P<0.05). The total incidence of drug adverse reactions in the control group and the experimental group were 6.12% and 8.16%, respectively, with no statistical difference between two groups(P>0.05). CONCLUSION Zolpidem can significantly improve the sleep and life quality of patients with VAP and SRI, reduce their vascular inflammation, and improve the treatment effect of VAP and the incidence of cardiovascular events, without increasing the overall incidence of adverse reactions.