苯磺酸氨氯地平叶酸片治疗H型高血压的临床价值

发布时间：2017-12-27 14:15

本文关键词：苯磺酸氨氯地平叶酸片治疗H型高血压的临床价值　出处：《安徽医科大学》2017年硕士论文　论文类型：学位论文

【摘要】：目的:采用口服苯磺酸氨氯地平叶酸片治疗伴有血浆同型半胱氨酸(Homocystine HCY)升高的轻、中度原发性高血患者,观察药物降血压的同时降低血浆同型半胱氨酸作用的有效性。方法:在安庆社区选择轻、中度原发性高血压患者,同时检测其血浆同型半胱氨酸浓度,将浓度大于10μmol/L的患者纳入试验,这类患者所患的高血压称之为H型高血压。试验采用的新药通过国家食品药品监督局批准,研究获得伦理委员会批准,所有患者在入组前均签署知情同意书。之后将最终入选的120例I级、II级原发性H型高血压患者,随机分为3组:A组:服用苯磺酸氨氯地平叶酸片(5mg/0.4mg)40例;B组:服用苯磺酸氨氯地平叶酸片(5mg/0.8mg)40例;C组:单独服用苯磺酸氨氯地平片(5mg)40例。每组患者在接受药物治疗的同时服用安慰剂进行阴性对照,即每组患者共服用三种药物,A组患者在服用药物的同时服用与B、C组药物相对应的安慰剂,B组服用与A、C组药物相对应的安慰剂,C组服用与A、B组药物相对应的安慰剂。安慰剂与相对应药物外观、颜色、形状、气味、包装完全相同。每日服药一次,连续治疗8周。在入组前测量所有患者的血压、血浆同型半胱氨酸、血清叶酸,并在治疗的第2、4、6、8周进行随访,记录血压、血浆同型半胱氨酸、心率,并记录不良事件。结果:最终一共115例患者进入随机试验,苯磺酸氨氯地平叶酸片(5mg/0.4mg)组、苯磺酸氨氯地平叶酸片(5mg/0.8mg)组及苯磺酸氨氯地平片(5mg)组降压同时降同型半胱氨酸的有效率分别为23.08%、26.32%、5.26%。两种配比的苯磺酸氨氯地平叶酸片组降压同时降血浆同型半管那有效性均显著优于苯磺酸氨氯地平组。A、B、C三组降压有效率分别为51.28%、55.26%、47.36%,降压效果三组之间无明显统计学差异。而三组在降低血浆同型半胱氨酸上存在明显差异,有效率分别为25.64%、34.21%、7.89%。两种配比的苯磺酸氨氯地平叶酸片在降血浆同型半胱氨酸上明显优于氨氯地平,而苯磺酸氨氯地平叶酸片(叶酸高剂量组)降血浆同型半胱氨酸效果优于叶酸低剂量组。结论:采用苯磺酸氨氯地平叶酸片治疗伴血浆同型半胱氨酸升高的原发型轻、中度高血压患者,复方制剂在降压方面不仅不低于氨氯地平单药效果,而且可以同时降低血浆同型半胱氨酸,同时降低两种心脑血管疾病危险因素,大大提高H型高血压患者的预后,为治疗H型高血压提供新选择。
[Abstract]:Objective: To observe the efficacy of amlodipine besylate in the treatment of mild and moderate primary high blood plasma with elevated plasma Homocystine HCY level, and observe the effect of drug lowering blood pressure and reducing plasma homocysteine in the treatment of Folic Acid Tablets. Methods: in Anqing community, mild and moderate essential hypertension patients were selected, and plasma homocysteine concentration was detected at the same time. Patients with a concentration of more than 10 mu mol/L were included in the trial. Hypertension in these patients was called H hypertension. The new drug was approved by the State Food and drug administration, and approved by the ethics committee. All patients signed the informed consent before entering the group. 120 cases of grade I, II grade of primary hypertension patients with type H after the final selection, were randomly divided into 3 groups: group A: Amlodipine Besylate Folic Acid Tablets (5mg/0.4mg) 40 cases; group B: Amlodipine Besylate Folic Acid Tablets (5mg/0.8mg) 40 cases; group C: taking Amlodipine Besylate Tablets alone (5mg) in 40 cases. Patients in each group received drug treatment and placebo for the negative control, i.e. each patients were taking three drugs, A group of patients taking drugs at the same time taking with B and C groups corresponding to the placebo group B took A and C group and placebo group taking drugs, C and A, should be relative to the B group of drug placebo. The placebo was exactly the same as the appearance, color, shape, smell and packaging of the corresponding drug. Take the medicine once a day for 8 weeks. Blood pressure, plasma homocysteine and serum folic acid were measured before admission. The patients were followed up for second, fourth, sixth and 8 weeks after treatment. Blood pressure, plasma homocysteine and heart rate were recorded, and adverse events were recorded. Results: a total of 115 patients were entered in randomized trials, amlodipine besylate Folic Acid Tablets (5mg/0.4mg) group, amlodipine group and Folic Acid Tablets (5mg/0.8mg) Amlodipine Besylate Tablets (5mg) group the blood pressure and homocysteine lowering the efficiency were 23.08%, 26.32%, 5.26%. The efficacy of two kinds of amlodipine benzoate Folic Acid Tablets group was significantly better than that of amlodipine sulfonic acid group. The three groups of A, B and C were 51.28%, 55.26% and 47.36% respectively. There was no significant difference between the three groups. There were significant differences between the three groups in reducing plasma homocysteine, and the effective rates were 25.64%, 34.21% and 7.89%, respectively. The two proportions of Folic Acid Tablets, amlodipine besylate, were superior to amlodipine in lowering plasma homocysteine, while amlodipine besylate in Folic Acid Tablets group was superior to folate in low dose group. Conclusion: the amlodipine treatment with Folic Acid Tablets plasma homocysteine primary mild and moderate hypertension, antihypertensive compound preparation in respect not only lower than amlodipine monotherapy effect, but also can reduce the plasma homocysteine, while reducing the two kinds of risk factors of cardiovascular disease and improve prognosis of patients H type hypertension, providing new options for the treatment of H type hypertension.
【学位授予单位】：安徽医科大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R544.1

【参考文献】