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辛伐他汀片联合硫酸氢氯吡格雷片治疗不稳定型心绞痛的临床研究 被引量:30

Clinical trial of simvastatin tablet combined with clopidogrel bisulfate tablet in the treatment of unstable angina pectoris
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摘要 目的观察辛伐他汀联合硫酸氢氯吡格雷治疗不稳定型心绞痛(UAP)的临床疗效和安全性。方法将107例UAP患者随机分为试验组53例和对照组54例。2组患者均予以常规治疗。对照组予以口服辛伐他汀40 mg qd;试验组患者在对照组的基础上予以硫酸氢氯吡格雷片,首次口服300 mg,维持量75 mg qd。试验组和对照组疗程均为6个月。比较2组患者治疗后总有效率、血流动力学及血清趋化因子Fractalkine和血清单核细胞趋化蛋白-1(MCP-1)水平、生活质量评分和药物不良反应。结果治疗后,试验组和对照组的总有效率分别为90.57%(48例/53例)和74.07%(40例/54例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的纤维蛋白原分别为(3.96±0.63),(4.52±0.64)g·L^(-1),血浆黏度分别为(1.66±0.21),(1.81±0.23)m Pa·s,红细胞聚集指数分别为2.89±0.41,3.84±0.39,红细胞沉降率分别为(23.13±7.35),(25.05±7.01)mm·h-1,血小板聚集率指标分别为(38.79±2.87)%,(42.79±3.17)%,Fractalkine分别为(34.74±5.82),(40.42±6.13)ng·L^(-1),MCP-1分别为(43.16±5.61),(48.89±6.29)ng·L^(-1),差异均有统计学意义(均P<0.05)。2组患者发生的药物不良反应有肝转氨酶升高﹑胃肠道反应和皮肤紫癜,试验组和对照组的药物不良反应率分别为9.43%(5例/53例)和9.25%(5例/54例),差异无统计学意义(P>0.05)。结论辛伐他汀联合硫酸氢氯吡格雷能够有效改善UAP患者血流动力学,降低Fractalkine和MCP-1水平,且安全性较好。 Objective To observe the clinical efficacy and safety profile of simvastatin combined with clopidogrel bisulfate in the treatment of unstable angina pectoris(UAP).Methods A total of 107 UAP patients were randomly divided into treatment group(n = 53) and control group(n = 54).Both groups were given conventional treatment.The control group received oral administration of simvastatin 40 mg once daily,while the treatment group received oral administration of clopidogrel bisulfate(initiated with a single 300 mg loading dose and then continued at 75 mg once a day) on the basis of control group.The total effective rate,hemorheology,the level of Fractalkine,monocyte chemoattractant protein-1(MCP-1),quality of life scores(QOL) and adverse drug reactions were compared between the two groups after 6-month treatment.Results The total effective rates of the treatment group and the control group were 90.57%(48 cases/53 cases) and74.07%(40 cases/54 cases) respectively,the difference was statistically significant(P 〈 0.05).After treatment,the fibrinogen level in the treatment group and the control group were(3.96 ± 0.63),(4.52 ± 0.64) g ·L-1,the plasma viscosity were(1.66 ± 0.21),(1.81 ± 0.23) m Pa·s,the erythrocyte aggregation indices were 2.89 ± 0.41,3.84 ± 0.39,the erythrocyte sedimentation rates were respectively(23.13 ± 7.35),(25.05 ± 7.01) mm·h-1,the platelet aggregation rates were respectively(38.79 ± 2.87) %,(42.79 ± 3.17) %,the Fractalkine were(34.74 ± 5.82),(40.42 ± 6.13)ng·L-1,the MCP-1 were(43.16 ± 5.61),(48.89 ± 6.29) ng·L-1,respectively,and the differences between the treatment group and the control group were statistically significant(P 〈 0.05).The drug adverse reactions of the two groups were elevated liver transaminase,gastrointestinal reaction and skin purpura,the adverse drug reactions in the treatment group and the control group were 9.43%(5 cases/53 cases) and 9.25%(5 cases/54 cases),respectively,with no statistically significant difference(P 〉 0.05).Conclusion Simvastatin combined with clopidogrel bisulfate could effectively improve the hemorheology and reduce the level of Fractalkine and MCP-1 in UAP patients,with satisfying safety profile.
出处 《中国临床药理学杂志》 CAS CSCD 北大核心 2017年第22期2222-2225,共4页 The Chinese Journal of Clinical Pharmacology
基金 苏州市科教兴卫青年课题基金资助项目(KJXW2014001)
关键词 辛伐他汀 硫酸氢氯吡格雷 不稳定型心绞痛 血流动力学 simvastatin clopidogrel bisulfate unstable angina pectoris hemorheology
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