【摘要】：目的1.觀察陰虛陽(yáng)亢型高血壓病伴失眠患者運(yùn)用舒樂(lè)降壓顆粒聯(lián)合西藥治療的臨床療效。2.初步評(píng)價(jià)舒樂(lè)降壓顆粒的有效性及其安全性。方法選擇符合納入標(biāo)準(zhǔn)的福建中醫(yī)藥大學(xué)附屬人民醫(yī)院門診及住院患者60例并簽署知情同意書。將60例患者根據(jù)就診順序進(jìn)行編號(hào),然后由電腦產(chǎn)生隨機(jī)數(shù)字,按順序給每一例患者分配一個(gè)3位數(shù)的隨機(jī)數(shù)字,再將病例號(hào)根據(jù)對(duì)應(yīng)隨機(jī)數(shù)字的大小按從小到大的順序排列編號(hào)分為試驗(yàn)組和對(duì)照組。①試驗(yàn)組予舒樂(lè)降壓顆粒1袋bid(早、晚飯后開(kāi)水沖服)+佐匹克隆(齊魯制藥H10980162每片3.75mg)3.75mgqd+氨氯地平(蘇州東瑞制藥H20020390每片5mg)5mgqd,14日血壓未達(dá)標(biāo)者加替米沙坦(勃林格殷格翰制藥H20090089每片80mg)80mg qd,治療4周。②對(duì)照組給藥方案:佐匹克隆(同上)3.75mgqd+氨氯地平(同上)5mgqd,14日血壓未達(dá)標(biāo)者加替米沙坦(同上)80mgqd,治療4周。兩組分別于試驗(yàn)前,試驗(yàn)后第2、4周觀察血壓、血常規(guī)、尿常規(guī)、血脂全套、肝功、腎功,常規(guī)心電圖、進(jìn)行中醫(yī)辨證、SPIEGEL睡眠量表評(píng)分。搜集并整理治療前后的病例報(bào)告表及處理相關(guān)數(shù)據(jù)。結(jié)果1.治療后試驗(yàn)組和對(duì)照組血壓較治療前均明顯降低,但試驗(yàn)組與對(duì)照組有統(tǒng)計(jì)學(xué)差異(P0.05)。2.治療后試驗(yàn)組和對(duì)照組睡眠較治療前均有改善,但試驗(yàn)組與對(duì)照組有統(tǒng)計(jì)學(xué)差異(P0.05)。3.兩組治療后證候均有改善,但試驗(yàn)組與對(duì)照組有統(tǒng)計(jì)學(xué)差異(P0.05)。4.兩組病人在治療中對(duì)照組出現(xiàn)1例不良反應(yīng),對(duì)該例停藥、隨訪并剔除處理,兩組在治療期間血常規(guī)、尿常規(guī)、血脂全套、肝功、腎功、常規(guī)心電圖未見(jiàn)明顯異常。結(jié)論1.通過(guò)治療前后對(duì)比,兩組均能降低血壓水平、改善睡眠及中醫(yī)證候,但試驗(yàn)組明顯優(yōu)于對(duì)照組。說(shuō)明舒樂(lè)降壓顆粒治療高血壓病伴失眠有一定的療效。舒樂(lè)降壓顆粒合常規(guī)西藥治療高血壓病伴失眠可試著用于臨床中。2.在整個(gè)課題實(shí)施過(guò)程中試驗(yàn)組患者均未見(jiàn)明顯不適,且血常規(guī)、尿常規(guī)、血脂全套、肝功、腎功、常規(guī)心電圖未見(jiàn)明顯異常,表明舒樂(lè)降壓顆粒未見(jiàn)明顯副作用。
[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.
【學(xué)位授予單位】：福建中醫(yī)藥大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2017
【分類號(hào)】：R544.1;R740

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