盐酸法舒地尔注射液治疗不稳定型心绞痛患者的临床研究  

Clinical trial of fasudil hydrochloride injection in the treatment of patients with unstable angina pectoris

作　　者：郑菊 吴雁鸣 尤华 庞翀 王彩虹 姚丹 王林全 ZHENG Ju;WU Yan-ming;YOU Hua;PANG Chong;WANG Cai-hong;YAO Dan;WANG Lin-quan(Department of Cardiology,Suzhou Ninth People’s Hospital,Suzhou 215200,Jiangsu Province,China)

机构地区：[1]苏州市第九人民医院心血管内科,江苏苏州215200

出　　处：《中国临床药理学杂志》2022年第12期1299-1302,1315,共5页The Chinese Journal of Clinical Pharmacology

基　　金：2019年院级科研立项基金资助项目(YY201933)。

摘　　要：目的观察盐酸法舒地尔注射液治疗不稳定型心绞痛(UAP)的临床疗效及安全性。方法将110例UAP患者随机分为对照组55例和试验组55例。对照组给予静脉泵注硝酸异山梨酯,初始剂量为1~2 mg·h^(-1),根据病情控制情况调整剂量,最大剂量不超过8~10 mg·h^(-1)+低分子肝素每次5000 U,bid,皮下注射+阿司匹林首次剂量300 mg,嚼服,之后调整为100 mg·d^(-1),顿服+氯比格雷首次剂量300 mg,嚼服,之后调整为75 mg·d^(-1),顿服+阿托伐他汀钙10~20 mg·d^(-1),顿服;试验组在对照组治疗的基础上,给予盐酸法舒地尔30 mg,bid,静脉滴注。2组患者均治疗14 d。比较2组患者的临床疗效,心功能,血清降钙素基因相关肽(CGRP)、基质金属蛋白酶-2(MMP-2)和MMP-9水平,以及药物不良反应的发生情况。结果试验过程中无病例脱落。治疗后,试验组和对照组的总有效率分别为94.55%(52例/55例)和81.82%(45例/55例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的左心室射血分数分别为(60.37±5.01)%和(52.47±4.92)%,CGRP分别为(55.15±7.80)和(40.15±5.54)pg·mL^(-1),MMP-2分别为(170.06±20.15)和(215.46±30.11)g·L^(-1),MMP-9分别为(165.54±25.03)和(220.17±27.84)g·L^(-1),差异均有统计学意义(均P<0.05)。试验组发生的药物不良反应以头晕和上腹部不适为主,对照组发生的药物不良反应以头晕为主。试验组和对照组的总药物不良反应发生率分别为5.45%和3.64%,差异无统计学意义(P>0.05)。结论盐酸法舒地尔注射液治疗UAP的临床疗效较好,其可显著提高患者血清CGRP水平,降低MMP水平,且不增加药物不良反应的发生率。Objective To observe the clinical efficacy and safety of fasudil hydrochloride injection in the treatment of patients with unstable angina pectoris(UAP).Methods A total of 110 patients with UAP were randomly divided into control and treatment groups with 55 cases per group.The control group was given intravenous infusion of isosorbide dinitrate,the initial dose was 1-2 mg·h^(-1),according to the control of the disease,the dosage was adjusted to a maximum of 8-10 mg·h^(-1)+low molecular weight heparin 5000 U per time,bid,subcutaneous injection+aspirin 300 mg for the first time,chewing,then adjusted to 100 mg·d^(-1),administered at draught+clopidogrel 300 mg for the first dose,administered at draught,then adjusted to 75 mg·d^(-1),oral+atorvastatin calcium 10-20 mg·d^(-1),administered at draught.On the basis of control group,the treatment group was given fasudil hydrochloride 30 mg,bid,intravenous drip.Two groups were treated for 14 days.The clinical efficacy,the levels of serum calcitonin gene-related peptide(CGRP),matrix metalloproteinase-2(MMP-2)and MMP-9,and adverse drug reactions were compared between two groups.Results No cases dropped out the trial.The total effective rates of treatment and control groups were 94.55%(52 cases/55 cases)and 81.82%(45 cases/55 cases)with significant difference(P<0.05).After treatment,left ventricular ejection fraction of the treatment and control groups were(60.37±5.01)%and(52.47±4.92)%,CGRP were(55.15±7.80)and(40.15±5.54)pg·mL^(-1),MMP-2 were(170.06±20.15)and(215.46±30.11)g·L^(-1),MMP-9 were(165.54±25.03)and(220.17±27.84)g·L^(-1),respectively.The differences were statistically significant(all P<0.05).The adverse drug reactions of treatment group were dizziness and upper abdominal discomfort,while those in the control group were dizziness.The incidences of total adverse drug reactions in the treatment and control groups were 5.45%and 3.64%without significant difference(P>0.05).Conclusion Fasudil hydrochloride injection has good clinical efficacy in the treatment

关 键 词：盐酸法舒地尔注射液 不稳定型心绞痛 安全性评价 

分 类 号：R972[医药卫生—药品]