舒乐降压颗粒联合西药治疗高血压病伴失眠的初步观察

发布时间：2018-09-06 17:00

【摘要】：目的1.观察阴虚阳亢型高血压病伴失眠患者运用舒乐降压颗粒联合西药治疗的临床疗效。2.初步评价舒乐降压颗粒的有效性及其安全性。方法选择符合纳入标准的福建中医药大学附属人民医院门诊及住院患者60例并签署知情同意书。将60例患者根据就诊顺序进行编号,然后由电脑产生随机数字,按顺序给每一例患者分配一个3位数的随机数字,再将病例号根据对应随机数字的大小按从小到大的顺序排列编号分为试验组和对照组。①试验组予舒乐降压颗粒1袋bid(早、晚饭后开水冲服)+佐匹克隆(齐鲁制药H10980162每片3.75mg)3.75mgqd+氨氯地平(苏州东瑞制药H20020390每片5mg)5mgqd,14日血压未达标者加替米沙坦(勃林格殷格翰制药H20090089每片80mg)80mg qd,治疗4周。②对照组给药方案:佐匹克隆(同上)3.75mgqd+氨氯地平(同上)5mgqd,14日血压未达标者加替米沙坦(同上)80mgqd,治疗4周。两组分别于试验前,试验后第2、4周观察血压、血常规、尿常规、血脂全套、肝功、肾功,常规心电图、进行中医辨证、SPIEGEL睡眠量表评分。搜集并整理治疗前后的病例报告表及处理相关数据。结果1.治疗后试验组和对照组血压较治疗前均明显降低,但试验组与对照组有统计学差异(P0.05)。2.治疗后试验组和对照组睡眠较治疗前均有改善,但试验组与对照组有统计学差异(P0.05)。3.两组治疗后证候均有改善,但试验组与对照组有统计学差异(P0.05)。4.两组病人在治疗中对照组出现1例不良反应,对该例停药、随访并剔除处理,两组在治疗期间血常规、尿常规、血脂全套、肝功、肾功、常规心电图未见明显异常。结论1.通过治疗前后对比,两组均能降低血压水平、改善睡眠及中医证候,但试验组明显优于对照组。说明舒乐降压颗粒治疗高血压病伴失眠有一定的疗效。舒乐降压颗粒合常规西药治疗高血压病伴失眠可试着用于临床中。2.在整个课题实施过程中试验组患者均未见明显不适,且血常规、尿常规、血脂全套、肝功、肾功、常规心电图未见明显异常,表明舒乐降压颗粒未见明显副作用。
[Abstract]:Objective 1. To observe the clinical curative effect of Shule Jiangya granule combined with western medicine in patients with hyperactivity of yin and yang combined with insomnia. To evaluate the efficacy and safety of Shule Jiangya granules. Methods Sixty outpatients and inpatients in the people's Hospital affiliated to Fujian University of traditional Chinese Medicine were selected and signed informed consent. 60 patients were numbered according to the order of visit, and then random numbers were generated by computer, and each patient was assigned a random number of 3 digits in the order. According to the size of the corresponding random numbers, the case numbers were then divided into experimental group and control group according to the order from small to large. 1 bag of bid was given to the experimental group and control group. Zopicron (Qilu H10980162 / 3.75mg) 3.75mgqd amlodipine (Suzhou Dongrui H20020390 / 5mg) 5 mg QD, gatimisartan (Bollinger Ingerham H20090089 per 80mg) 80mg qd, treatment for 4 weeks Group A: zopicron (ibid.) 3.75mgqd amlodipine (ibid.) 5 mg QD, gatimisartan 80 mg QD for 4 weeks. Blood pressure, blood routine, urine routine, blood lipids, liver function, kidney function, routine electrocardiogram (ECG) and SPIEGEL sleep scale score were observed before and 2 weeks after the trial. Collect and arrange the case report form before and after treatment and deal with related data. Result 1. After treatment, the blood pressure of the experimental group and the control group were significantly lower than that of the control group, but there was a statistical difference between the experimental group and the control group (P0.05). After treatment, the sleep of the experimental group and the control group were improved, but there was a statistical difference between the experimental group and the control group (P0.05). After treatment, the syndromes of the two groups improved, but there was a statistical difference between the experimental group and the control group (P0.05). 4. One case of adverse reaction appeared in the control group in the treatment group. The patients were stopped the drug, followed up and eliminated. The blood routine, urine routine, blood lipid, liver function, renal function, routine electrocardiogram were not obviously abnormal in the two groups during the treatment period. Conclusion 1. By comparison before and after treatment, both groups can lower blood pressure, improve sleep and TCM syndrome, but the experimental group is better than the control group. It shows that Shule Jiangya granule has certain curative effect on hypertension with insomnia. Shule Jiangya granule combined with conventional western medicine in the treatment of hypertension with insomnia can be used in clinical. 2. 2. No obvious discomfort was found in the test group during the whole course of implementation, and blood routine, urine routine, blood lipids, liver function, renal function, routine electrocardiogram were not abnormal, which indicated that Shule Jiangya granule had no obvious side effects.
【学位授予单位】：福建中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R544.1;R740

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