本文選題：纈沙坦氨氯地平 + 纈沙坦氫氯噻嗪復方片��； 參考：《青島大學》2017年碩士論文

【摘要】：目的:探討纈沙坦氨氯地平(倍博特)治療高血壓患者的有效性和安全性,并分析該藥物對高血壓患者血壓晝夜節(jié)律性變化的影響。方法:本研究采用隨機抽簽法選取觀察對象,從2015年12月-2016年9月在青島大學附屬醫(yī)院心內(nèi)科門診以及住院治療的高血壓患者中選取符合標準的200例患者納入研究領(lǐng)域,采取隨機分組法將患者分為2組,每組100例。治療組患者采用纈沙坦氨氯地平(倍博特)治療,對照組患者采用纈沙坦氫氯噻嗪復方片(復代文)治療。根據(jù)患者ms DBP(平均坐位舒張壓)、ms SBP(平均坐位收縮壓)的下降幅度及治療有效標準評價降壓療效;根據(jù)患者的臨床癥狀、體征、實驗室生化指標評價藥物安全性。根據(jù)血壓變異性指征和平均血壓計算患者血壓晝夜規(guī)律。血壓變異性指征:24h SBP(24小時平均收縮壓)、24h DBP(24小時平均舒張壓)、(d SBP)白天平均收縮壓、d DBP(白天平均舒張壓)、n SBP(夜間平均收縮壓)、n DBP(夜間平均舒張壓)。對患者隨訪4個月,記錄MACE事件。結(jié)果:(1)基線資料比較:兩組患者的基線資料比較,差異無統(tǒng)計學意義(p0.05)。患者基線資料包括性別、年齡、BMI(身體質(zhì)量指數(shù))、飲酒史、吸煙史、高血壓家族史、冠心病史、病程;實驗室生化指標包括TG(甘油三酯)、LDL-C(低密度脂蛋白膽固醇)、HDL-C(高密度脂蛋白膽固醇)、TC(總膽固醇)、UA(尿酸)、FPG(空腹血糖)。(2)降壓療效:兩組患者治療前ms DBP和ms SBP水平比較,差異無統(tǒng)計學意義(p0.05);治療8周后,治療組ms DBP和ms SBP下降幅度大于對照組,兩組數(shù)據(jù)比較,差異有統(tǒng)計學意義(p0.05);(3)兩組患者治療前24h SBP、24h DBP、d SBP、d DBP、n SBP、n DBP比較,差異無統(tǒng)計學意義(p0.05)。治療后第4、8周兩組患者24h SBP、24h DBP、d SBP、d DBP、n SBP、n DBP與治療前比較,均有所下降;治療組與對照組治療后4周的n SBP比較,差異有統(tǒng)計學意義(p0.05),其余數(shù)據(jù)治療后4周比較,差異無統(tǒng)計學意義(p0.05);治療后8周,治療組的n SBP和n DBP與對照組比較,差異有統(tǒng)計學意義(p0.05)。(4)血壓變異性比較:治療組和對照組治療前24h SBPV、24h DBPV、d SBPV、d DBPV、n SBPV、n DBPV水平比較,差異無統(tǒng)計學意義(p0.05);治療后,兩組24h SBPV、24h DBPV、d SBPV、d DBPV、n SBPV、n DBPV水平均有所下降;治療組在治療后的第4周,24h DBPV、d DBPV、n DBPV就已有明顯降低,與對照組比較,差異有統(tǒng)計學意義(p0.05);治療后第8周,兩組24h SBPV、24h DBPV、d SBPV、d DBPV、n SBPV、n DBPV明顯下降,且治療組下降較對照組明顯,兩組比較,差異有統(tǒng)計學意義(p0.05)。(5)兩組患者治療后,一氧化氮水平較治療前顯著上升,而內(nèi)皮素水平較治療前明顯下降,與治療前比較,差異有統(tǒng)計學意義(p0.05);與對照組比較,治療組一氧化氮水平和內(nèi)皮素水平的上升/下降幅度更大,兩組數(shù)據(jù)比較,差異有統(tǒng)計學意義(p0.05)。(6)治療組MACE事件發(fā)生率雖然低于對照組,但兩組MACE事件的發(fā)生率比較,無統(tǒng)計學意義(p0.05)。(7)安全性分析:兩組患者治療期間并未發(fā)生嚴重不良事件,兩組不良反應率比較,差異無統(tǒng)計學意義(p0.05)。結(jié)論:(1)與纈沙坦氫氯噻嗪復方片治療高血壓比較,纈沙坦氨氯地平片治療高血壓的降壓效果更理想。(2)纈沙坦氨氯地平片與纈沙坦氫氯噻嗪復方片比較,前者在降低高血壓患者夜間血壓水平上更突出。(3)纈沙坦氨氯地平片與纈沙坦氫氯噻嗪復方片均能降低高血壓患者血壓變異性,但前者能更進一步降低血壓變異性,尤其是以舒張壓變異性最為突出。(4)纈沙坦氨氯地平片與纈沙坦氫氯噻嗪復方片比較,前者在改善血管內(nèi)皮功能方面更突出,其改善血壓變異性的機制可能是通過改善血管內(nèi)皮功能實現(xiàn)。(5)纈沙坦氨氯地平片在降低高血壓患者心血管事件方面無顯著療效。(6)纈沙坦氫氯噻嗪復方片和纈沙坦氨氯地平片治療高血壓的不良反應低,患者均可耐受。
[Abstract]:Objective: To investigate the efficacy and safety of valsartan amlodipine (Abbott) in the treatment of hypertensive patients, and to analyze the effect of the drug on the circadian rhythm of blood pressure in patients with hypertension. Methods: This study selected the object of observation by random drawing, and was in the Department of Cardiology, Affiliated Hospital of Qiingdao University, December 2015, and lived in the Department of Cardiology, -2016 year, December 2015. Among the patients with high blood pressure in the hospital, 200 patients were selected in accordance with the standard. The patients were divided into 2 groups by random grouping method, 100 cases in each group. The patients in the treatment group were treated with valsartan amlodipine (plibot), and the patients in the control group were treated with Valsartan hydrochlorothiazide tablets (complex). According to the patient's MS DBP (average sitting position) Zhang Ya), the decrease of MS SBP (average sitting systolic pressure) and the effective standard of treatment to evaluate the effect of hypotension; evaluate the drug safety according to the patient's clinical symptoms, signs and laboratory biochemical indexes. According to the blood pressure variability index and mean blood pressure, the circadian rhythm of blood pressure is calculated. The blood pressure variability indication: 24h SBP (24 hour mean systolic pressure), 2 4h DBP (24 hour mean diastolic pressure), (D SBP) average daytime systolic pressure, D DBP (daytime diastolic pressure), n SBP (mean night systolic pressure), n DBP (mean night diastolic pressure). The patients were followed up for 4 months, and MACE events were recorded. Results: (1) baseline data comparison: the baseline data of the two groups were not statistically significant (P0.05). Materials include sex, age, BMI (body mass index), history of drinking, history of smoking, family history of hypertension, history of coronary heart disease, course of disease, laboratory biochemical indexes including TG (triglyceride), LDL-C (low density lipoprotein cholesterol), HDL-C (high density lipoprotein cholesterol), TC (total cholesterol), UA (uric acid), FPG (fasting blood glucose). (2) the curative effect of two groups of patients. There was no significant difference in the level of MS DBP and MS SBP before treatment (P0.05). After 8 weeks of treatment, the decrease of MS DBP and MS SBP in the treatment group was greater than that of the control group. The difference between the two groups was statistically significant (P0.05). (3) there was no statistically significant difference between the two groups before treatment. The difference was not statistically significant. Fourth, after treatment, 8 weeks of two groups, 24h SBP, 24h DBP, D SBP, D DBP, n SBP, n DBP were lower than before treatment. The difference was statistically significant between the treatment group and the control group at 4 weeks after treatment, and the difference was not statistically significant after 4 weeks of treatment. The difference between the treatment group and the control group after the treatment was compared with the control group at 8 weeks after treatment. (P0.05). (4) comparison of blood pressure variability: 24h SBPV, 24h DBPV, D SBPV, D DBPV, n SBPV before treatment in the treatment group and the control group. PV, n DBPV had been significantly reduced, and compared with the control group, the difference was statistically significant (P0.05). Eighth weeks after treatment, the two groups of 24h SBPV, 24h DBPV, D SBPV, D DBPV were significantly decreased, and the treatment group decreased significantly compared with the control group. (5) the level of nitric oxide was compared with the treatment of the two groups. Before the treatment, the level of endothelin was significantly lower than that before the treatment, and the difference was statistically significant (P0.05). Compared with the control group, the level of nitric oxide and endothelin in the treatment group increased significantly, and the difference between the two groups was statistically significant (P0.05). (6) the incidence of MACE events in the treatment group was lower than that in the treatment group. The control group, but the incidence of the two groups of MACE events was not statistically significant (P0.05). (7) safety analysis: the two groups of patients did not have serious adverse events during the treatment, there was no significant difference in the rate of adverse reaction between the two groups (P0.05). (1) compared with the Valsartan hydrochlorothiazide compound tablets for hypertension, Valsartan and Amlodipine Tablets Treatment of hypertension is more effective. (2) compared to Valsartan and Amlodipine Tablets and valsartan hydrochlorothiazide, the former is more prominent in reducing the night blood pressure in patients with hypertension. (3) both Valsartan and Amlodipine Tablets and valsartan hydrochlorothiazide can reduce the blood pressure variability in patients with high blood pressure, but the former can be further reduced. Hypotension variability, especially with diastolic pressure variability, (4) compared to Valsartan and Amlodipine Tablets and valsartan hydrochlorothiazide, the former is more prominent in improving vascular endothelial function, and the mechanism for improving blood pressure variability may be achieved by improving vascular endothelial function. (5) Valsartan and Amlodipine Tablets is reducing high blood pressure. There was no significant effect on cardiovascular events in patients. (6) the side effects of valsartan hydrochlorothiazide tablets and Valsartan and Amlodipine Tablets were low in the treatment of hypertension, and patients were well tolerated.
【學位授予單位】：青島大學
【學位級別】：碩士
【學位授予年份】：2017
【分類號】：R544.1

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