【摘要】：背景:高血壓分為原發(fā)性和繼發(fā)性,其中原發(fā)性高血壓占整個(gè)高血壓中的90%。高血壓早期直接致病因素為交感神經(jīng)系統(tǒng)活性增加,因此及早阻斷交感活性,減少去甲腎上腺素的釋放是治療高血壓主要機(jī)制之一,這樣可及時(shí)有效的控制血壓,減少并發(fā)癥,減輕社會(huì)經(jīng)濟(jì)負(fù)擔(dān),提高高血壓患者的生活質(zhì)量。β受體阻滯劑能夠抑制交感神經(jīng)活性,對(duì)高血壓的治療有一定的效果。卡維地洛是第3代β受體阻滯劑的一種新產(chǎn)品,藥理學(xué)作用比第1、2代受體阻滯劑更廣,對(duì)α1、β1、β2受體都有阻滯作用,并具有調(diào)節(jié)兒茶酚胺對(duì)心臟、末梢血管和腎臟的不利影響,逆轉(zhuǎn)血管緊張素和受體改變等的聯(lián)合調(diào)節(jié)作用,而沒(méi)有單純擴(kuò)血管或β受體阻滯帶來(lái)的副反應(yīng),其降壓效果肯定及副作用少對(duì)高血壓患者來(lái)說(shuō)無(wú)疑是一個(gè)重要的理想治療藥物,具有良好的臨床應(yīng)用前景。目的:以琥珀酸美托洛爾緩釋片為對(duì)照,評(píng)價(jià)硫酸卡維地洛緩釋膠囊治療輕、中度原發(fā)性高血壓的有效性和安全性;通過(guò)動(dòng)態(tài)血壓開(kāi)放研究觀察硫酸卡維地洛緩釋膠囊對(duì)受試者24小時(shí)血壓的控制效果。方法:對(duì)診斷為輕、中度高血壓患者,進(jìn)行嚴(yán)格篩選后入組進(jìn)行硫酸卡維地洛緩釋膠囊治療輕、中度原發(fā)性高血壓的隨機(jī)、雙盲、陽(yáng)性藥物平行對(duì)照、多中心的臨床試驗(yàn)。主要分為兩項(xiàng):一項(xiàng)為多中心、隨機(jī)、雙盲雙模擬、陽(yáng)性藥物平行對(duì)照臨床研究,另一項(xiàng)為單臂、開(kāi)放、多中心動(dòng)態(tài)血壓臨床研究。分別在給藥前和給藥后進(jìn)行血生化、血常規(guī)、尿常規(guī)及、十二導(dǎo)聯(lián)體表心電圖檢查及測(cè)量血壓,結(jié)束時(shí)對(duì)有效完整病例進(jìn)行有效性及安全性評(píng)估。結(jié)果:在主要及次要觀察指標(biāo)方面硫酸卡維地洛及美托洛爾組均表現(xiàn)出較好的臨床療效,即表現(xiàn)在至第八周時(shí)對(duì)照組與用藥組相比舒張壓降低了12.96±6.55mm Hg,差異有統(tǒng)計(jì)學(xué)意義;試驗(yàn)組與用藥前相比減少了12.24±5.82mm Hg,差異有統(tǒng)計(jì)學(xué)意義。即表現(xiàn)在至第八周時(shí)對(duì)照組與用藥組相比收縮壓降低了17.13±11.22mm Hg,差異有統(tǒng)計(jì)學(xué)意義;試驗(yàn)組與用藥前相比減少了16.92±11.07mm Hg,差異有統(tǒng)計(jì)學(xué)意義。經(jīng)統(tǒng)計(jì)兩組組內(nèi)差異有統(tǒng)計(jì)學(xué)意義(P0.05),但卡維地洛組與美托洛爾組組間治療后療效無(wú)統(tǒng)計(jì)學(xué)意義(P0.05)。所有入選患者,安全性檢查后我們進(jìn)行統(tǒng)計(jì)分析,未能發(fā)現(xiàn)兩組藥物對(duì)肝功能、腎功能、尿酸、血糖、血脂、白細(xì)胞及中性粒細(xì)胞有明顯影響。結(jié)論:硫酸卡維地洛治療原發(fā)性輕、中度高血壓相當(dāng)美托洛爾而言療效相當(dāng),但其不良反應(yīng)明顯減少,治療原發(fā)性輕、中度高血壓是有效和安全的。
[Abstract]:Background: hypertension is divided into primary and secondary, of which essential hypertension accounts for 90% of the total hypertension. The direct cause of hypertension is the increase of sympathetic nervous system activity. Therefore, blocking sympathetic activity early and reducing the release of norepinephrine is one of the main mechanisms in the treatment of hypertension, which can effectively control blood pressure and reduce complications. The 尾 -receptor blocker can inhibit sympathetic nerve activity and has certain effect on the treatment of hypertension. Carvedilol is a new product of the third generation of 尾 -blockers. Its pharmacological effect is wider than that of the first and second generation of 尾 -blockers. It blocks 偽 _ 1, 尾 _ 1 and 尾 _ 2 receptors and regulates the adverse effects of catecholamine on heart, peripheral blood vessels and kidneys. Reversing the combined effects of angiotensin and receptor changes without the side effects caused by simple vasodilation or 尾 -receptor block, its antihypertensive effect and less side effects are undoubtedly an important ideal therapeutic drug for patients with hypertension. It has a good prospect of clinical application. Objective: to evaluate the efficacy and safety of carvedilol sulfate sustained-release capsule in the treatment of mild and moderate essential hypertension. The control effect of Carvedilol sulfate sustained release capsule on 24 hours blood pressure was observed by ambulatory blood pressure opening study. Methods: the patients with mild and moderate hypertension were selected strictly and then treated with Carvedilol sulfate sustained release capsule. The clinical trials were randomized, double-blind, positive drug parallel control and multicenter clinical trial. It is mainly divided into two items: one is a multicenter, randomized, double-blind, double-mimic, positive drug parallel controlled clinical study, the other is a single-arm, open, multi-center clinical study of ambulatory blood pressure. Before and after administration, blood biochemistry, blood routine, urine routine and 12-lead surface electrocardiogram were examined and blood pressure was measured. The efficacy and safety of effective and complete cases were evaluated at the end of the study. Results: carvedilol sulfate and metoprolol groups showed better clinical efficacy in the main and secondary indexes, that is, the diastolic blood pressure decreased 12.96 鹵6.55mm Hg, between the control group and the medication group at the eighth week. The experimental group decreased 12.24 鹵5.82mm Hg, compared with before treatment. That is to say, the systolic blood pressure decreased 17.13 鹵11.22mm Hg, in the control group and 16.92 鹵11.07mm Hg, in the experimental group at the eighth week. The difference between the two groups was statistically significant (P0.05), but there was no significant difference after treatment between carvedilol group and metoprolol group (P0.05). In all the patients, after safety examination, we did not find that the two groups of drugs on liver function, renal function, uric acid, blood sugar, blood lipid, white blood cells and neutrophils have a significant effect on the liver function, renal function, blood sugar, blood lipid, leukocyte and neutrophil. Conclusion: carvedilol sulfate is effective and safe in the treatment of primary mild and moderate hypertension.
【學(xué)位授予單位】：華中科技大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2016
【分類(lèi)號(hào)】：R544.11

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