机构地区:[1]中国人民解放军总医院第五医学中心肝病研究所,北京100039 [2]中国人民解放军总医院第一医学中心神经外科,北京100853 [3]北京赛德维康医药研究院,北京100039 [4]江苏省内皮细胞靶向性心血管药物创制工程研究中心,江苏徐州221116 [5]中国人民解放军总医院第二医学中心急诊科,北京100853
出 处:《中华老年多器官疾病杂志》2024年第6期411-415,共5页Chinese Journal of Multiple Organ Diseases in the Elderly
基 金:国家重大新药创制科技重大专项(2010ZX09401-307,2008ZXJ09004-018,2009ZX09301-002)。
摘 要:目的研究苯磺酸氨氯地平治疗轻中度原发性高血压患者的降压达标率。方法研究数据来源一项前瞻性自身对照试验,选取符合纳排标准的轻中度原发性高血压患者进行苯磺酸氨氯地平片单药治疗,剂量为5 mg,疗程共8周。分析降压有效性和安全性,计算分别以140/90 mmHg(1 mmHg=0.133 kPa)和130/80mmHg为目标值时降压达标率并做年龄亚组分析。采用SAS 9.3和Graphpad Prism 9.5.1软件进行数据分析。根据数据类型,组间比较分别采用t检验、Fisher精确概率法检验及χ^(2)检验。结果研究共纳入患者120例,治疗前后收缩压和舒张压下降幅度分别为(16.7±12.9)mmHg和(12.9±7.5)mmHg,降压显效率为72.5%(87/120),总有效率为91.7%(110/120)。苯磺酸氨氯地平片治疗前后血压下降有统计学意义(P<0.05),与文献报道结果一致。以140/90 mmHg和130/80 mmHg为降压目标值,苯磺酸氨氯地平8周末达标率分别为51.6%(49/95)和5.0%(6/119),差异有统计学意义(P<0.05)。中低龄组和高龄组患者治疗8周末强化降压达标率分别为4.1%(4/98)和9.5%(2/21)。治疗周期不良事件发生率为15.8%(19/120),不良反应发生率为3.3%(4/120)。结论苯磺酸氨氯地平治疗轻中度原发性高血压患者安全有效,强化降压目标值130/80 mmHg为标准,其达标率仅5%。提示临床常用抗高血压药物单药治疗难以实现强化降压目标。Objective To investigate standard-reaching rate of blood pressure reduction in patients with mild to moderate primary hypertension after treatment of amlodipine besylate.Methods Based on the data from a prospective self-controlled trial,the patients with mild to moderate primary hypertension who met our inclusion criteria were enrolled and then treated with a single drug therapy of amlodipine besylate tablet with 5 mg dose for 8 weeks.The efficacy and safety of amlodipine besylate tablet were evaluated,and the standard-reaching rate of blood pressure reduction was calculated with 140/90 and 130/80 mmHg(1 mmHg=0.133 kPa)as blood pressure targets,respectively,and for the patients of different ages.SPSS statistics SAS 9.3 and Graphpad Prism 9.5.1 were used for statistical analysis.Intergroup comparison was performed using student′s t test,Fisher′s exact probability test or Chi-square test depending on data type.Results For the 120 patients included in this study,the decline in systolic(SBP)and diastolic blood pressure(DBP)was(16.7±12.9)and(12.9±7.5)mmHg,respectively,after treatment,with an effective rate of 72.5%(87/120),and an overall effective rate of 91.7%(110/120).Statistical significance was observed in the decrease in blood pressure before and after treatment of amlodipine besylate tablet(P<0.05),which was consistent with literature reports.With 140/90 and 130/80 mmHg as blood pressure targets,the standard-reaching rate was 51.6%(49/95)and 5.0%(6/119),respectively after 8 weeks of treatment(P<0.05).Subgroup analysis showed that the rate was 4.1%(4/98)and 9.5%(2/21),respectively in the younger and older age groups.The incidence of adverse events and adverse reactions was 15.8%(19/120)and 3.3%(4/120),respectively during the treatment period.Conclusion Amlodipine besylate is safe and effective in treatment of mild to moderate primary hypertension.However,when taking the intensified blood pressure reduction target of 130/80 mmHg as the standard,the achievement rate is only 5%.This suggests that monotherapy w
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