盐酸马尼地平片治疗原发性高血压的疗效及安全性研究

发布时间：2018-06-03 18:42

本文选题：盐酸马尼地平 + 苯磺酸氨氯地平　；参考：《新乡医学院》2016年硕士论文

【摘要】：背景近年来,随着我国居民生活水平的改善及现代工作压力的增大,原发性高血压的发病有年轻化的趋势且发病率逐年增高,发现和干预高血压的发生发展过程及预防其并发症的出现,已经成为医务工作者临床研究的重点项目之一。盐酸马尼地平为二氢吡啶类钙离子拮抗剂,于1990年在日本上市,是对L型和T型钙通道都有阻滞作用的长效二氢吡啶类钙离子拮抗剂。国内于2012年由许昌恒生制药有限公司仿制并上市销售,商品名称为舒平喜。在临床上,有部分高血压患者应用舒平喜进行疾病的治疗,降压疗效达不到预期治疗效果,基于此,我们在临床上进行了盐酸马尼地平片(舒平喜)对原发性高血压的疗效及安全性研究,目前该方面的文献报道较为少见。目的观察盐酸马尼片地平治疗原发性高血压的疗效及安全性,为临床高血压的治疗提供参考。方法将2014年1月—2015年6月在许昌市中心医院门诊及住院患者264例纳入研究对象,这些患者均患有高血压病,其疾病诊断均符合《2010年中国高血压防治指南》,所有患者均为原发性高血压,分级为1级、2级和3级。将264例患者随机分为A和B两组,A组采用盐酸马尼地平片降血压治疗,B组采用苯磺酸氨氯地平片降血压治疗,其中盐酸马尼地平片起始给药剂量均为5 mg,一天一次,口服给药,依据患者治疗情况可适当增加剂量,一天最大给药剂量为20 mg;B组患者初始剂量为5 mg,一天一次,口服给药,依据患者治疗情况适当增加剂量,一天最大给药剂量为10 mg。分别于治疗前及治疗后3、7、10、14天后以收缩压和舒张压的降低程度评价治疗的有效性,记录两组患者治疗期间所发生的不良反应,用于评定治疗的安全性。采用SPSS19.0统计软件对研究数据进行统计分析。其中计量资料,均进行正态性检验,对符合正态分布的资料以均数±标准差(喁±s)表示,两组间比较采用独立样本t检验。计数资料比较采用卡方检验;检验显著性水平a为0.05。结果1、有效性评价结果:(1)治疗三天和七天后,A组患者收缩压(SBP)、舒张压(DBP)的平均值均高于B组,两组差异均有统计学意义(P0.05);(2)治疗十天后,A组SBP、DBP的平均值高于B组,其中两组SBP差异有统计学意义(P0.05);(3)治疗十四天后,A组患者SBP、DBP的平均值均高于B组,两组差异无统计学意义(P0.05)。(4)治疗十四天后,A组治疗有效率为82.8%,B组治疗有效率为88.9%,A组有效率低于B组,两组差异无统计学意义(P0.05)。2、安全性评价结果:两组患者在治疗期间,实验室检查指标与治疗前相比均未发现明显异常,患者在治疗期间所发生的不良反应有恶心、口干、头晕、心悸、腹胀、便秘、水肿、肝功能异常等均较为轻微,不良反应发生率两组相比,差异无统计学意义(P0.05)。结论盐酸马尼地平片治疗原发性高血压临床起效较慢,但降压效果平稳安全有效,具有良好耐受性、无严重不良反应发生的特点,值得临床推广使用。
[Abstract]:Background in recent years, with the improvement of living standard and the increase of modern work pressure, the incidence of essential hypertension has a tendency of younger and the incidence is increasing year by year. The discovery and intervention of hypertension and prevention of its complications have become one of the most important items in the clinical research of medical workers. Manidipine hydrochloride, a dihydropyridine calcium ion antagonist, was launched in Japan in 1990. Manidipine hydrochloride is a long-acting dihydropyridine calcium ion antagonist that blocks both L-type and T-type calcium channels. In 2012 by Xu Chang Hang Seng Pharmaceutical Co., Ltd. imitation and listed for sale, the commodity name is Shu Pingxi. Clinically, some patients with hypertension have been treated with Shupingxi for diseases. The antihypertensive effect is not up to the expected therapeutic effect. Based on this, We have studied the efficacy and safety of Manidipine Hydrochloride tablets (Shu Pingxi) in the treatment of essential hypertension. Objective to observe the efficacy and safety of mannitine hydrochloride in the treatment of essential hypertension. Methods from January 2014 to June 2015, 264 outpatients and inpatients in Xuchang Central Hospital were included in the study. The diagnosis of the disease was in accordance with the Chinese guidelines for the Prevention and treatment of Hypertension in 2010. All the patients were essential hypertension with grade 1, grade 2 and grade 3. 264 patients were randomly divided into two groups: group A and group B were treated with Manidipine hydrochloride for lowering blood pressure. Group B was treated with amlodipine benzenesulfonic acid tablets. The initial dose of Manidipine hydrochloride was 5 mg, once a day, orally. According to the treatment condition of the patients, the dosage can be increased appropriately. The initial dose of 20 mg / day group B is 5 mg, once a day, oral administration. According to the treatment condition of the patients, the dosage can be increased appropriately, and the maximum dose per day is 10 mg / day. The efficacy of the treatment was evaluated before and after treatment by the degree of systolic blood pressure and diastolic blood pressure. Adverse reactions occurred during the treatment were recorded and used to evaluate the safety of the treatment. The research data were analyzed by SPSS19.0 software. Among them, the measured data were tested by normality, the data in accordance with normal distribution were expressed as mean 卤standard deviation, and the independent sample t test was used to compare the data between the two groups. The count data were compared by chi-square test, the significant level a was 0.05. Results 1. The results of effectiveness evaluation showed that the mean values of systolic blood pressure (SBP) and diastolic blood pressure (DBP) in group A were higher than those in group B three and seven days after treatment, and the difference between the two groups was statistically significant (P 0.05). After 10 days of treatment, the mean value of SBPfU DBP in group A was higher than that in group B. After 14 days of treatment, the mean value of SBP in group A was higher than that in group B. After 14 days of treatment, the effective rate of treatment in group A was 82.8%. The effective rate of group A was 88.9%. The effective rate of group A was lower than that of group B, and there was no significant difference between the two groups. There was no obvious abnormality in laboratory examination. The adverse reactions occurred during the treatment were nausea, dry mouth, dizziness, palpitation, abdominal distension, constipation, edema, abnormal liver function, etc. There was no significant difference in the incidence of adverse reactions between the two groups (P 0.05). Conclusion Manidipine hydrochloride has a slow clinical effect in the treatment of essential hypertension, but the effect of lowering blood pressure is stable, safe and effective, with good tolerance and no serious adverse reactions, so it is worthy of clinical popularization.
【学位授予单位】：新乡医学院
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：R544.1

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