本文選題：鹽酸馬尼地平 + 苯磺酸氨氯地平　； 參考：《新鄉(xiāng)醫(yī)學(xué)院》2016年碩士論文

【摘要】：背景近年來(lái),隨著我國(guó)居民生活水平的改善及現(xiàn)代工作壓力的增大,原發(fā)性高血壓的發(fā)病有年輕化的趨勢(shì)且發(fā)病率逐年增高,發(fā)現(xiàn)和干預(yù)高血壓的發(fā)生發(fā)展過(guò)程及預(yù)防其并發(fā)癥的出現(xiàn),已經(jīng)成為醫(yī)務(wù)工作者臨床研究的重點(diǎn)項(xiàng)目之一。鹽酸馬尼地平為二氫吡啶類鈣離子拮抗劑,于1990年在日本上市,是對(duì)L型和T型鈣通道都有阻滯作用的長(zhǎng)效二氫吡啶類鈣離子拮抗劑。國(guó)內(nèi)于2012年由許昌恒生制藥有限公司仿制并上市銷售,商品名稱為舒平喜。在臨床上,有部分高血壓患者應(yīng)用舒平喜進(jìn)行疾病的治療,降壓療效達(dá)不到預(yù)期治療效果,基于此,我們?cè)谂R床上進(jìn)行了鹽酸馬尼地平片(舒平喜)對(duì)原發(fā)性高血壓的療效及安全性研究,目前該方面的文獻(xiàn)報(bào)道較為少見。目的觀察鹽酸馬尼片地平治療原發(fā)性高血壓的療效及安全性,為臨床高血壓的治療提供參考。方法將2014年1月—2015年6月在許昌市中心醫(yī)院門診及住院患者264例納入研究對(duì)象,這些患者均患有高血壓病,其疾病診斷均符合《2010年中國(guó)高血壓防治指南》,所有患者均為原發(fā)性高血壓,分級(jí)為1級(jí)、2級(jí)和3級(jí)。將264例患者隨機(jī)分為A和B兩組,A組采用鹽酸馬尼地平片降血壓治療,B組采用苯磺酸氨氯地平片降血壓治療,其中鹽酸馬尼地平片起始給藥劑量均為5 mg,一天一次,口服給藥,依據(jù)患者治療情況可適當(dāng)增加劑量,一天最大給藥劑量為20 mg;B組患者初始劑量為5 mg,一天一次,口服給藥,依據(jù)患者治療情況適當(dāng)增加劑量,一天最大給藥劑量為10 mg。分別于治療前及治療后3、7、10、14天后以收縮壓和舒張壓的降低程度評(píng)價(jià)治療的有效性,記錄兩組患者治療期間所發(fā)生的不良反應(yīng),用于評(píng)定治療的安全性。采用SPSS19.0統(tǒng)計(jì)軟件對(duì)研究數(shù)據(jù)進(jìn)行統(tǒng)計(jì)分析。其中計(jì)量資料,均進(jìn)行正態(tài)性檢驗(yàn),對(duì)符合正態(tài)分布的資料以均數(shù)±標(biāo)準(zhǔn)差(喁±s)表示,兩組間比較采用獨(dú)立樣本t檢驗(yàn)。計(jì)數(shù)資料比較采用卡方檢驗(yàn);檢驗(yàn)顯著性水平a為0.05。結(jié)果1、有效性評(píng)價(jià)結(jié)果:(1)治療三天和七天后,A組患者收縮壓(SBP)、舒張壓(DBP)的平均值均高于B組,兩組差異均有統(tǒng)計(jì)學(xué)意義(P0.05);(2)治療十天后,A組SBP、DBP的平均值高于B組,其中兩組SBP差異有統(tǒng)計(jì)學(xué)意義(P0.05);(3)治療十四天后,A組患者SBP、DBP的平均值均高于B組,兩組差異無(wú)統(tǒng)計(jì)學(xué)意義(P0.05)。(4)治療十四天后,A組治療有效率為82.8%,B組治療有效率為88.9%,A組有效率低于B組,兩組差異無(wú)統(tǒng)計(jì)學(xué)意義(P0.05)。2、安全性評(píng)價(jià)結(jié)果:兩組患者在治療期間,實(shí)驗(yàn)室檢查指標(biāo)與治療前相比均未發(fā)現(xiàn)明顯異常,患者在治療期間所發(fā)生的不良反應(yīng)有惡心、口干、頭暈、心悸、腹脹、便秘、水腫、肝功能異常等均較為輕微,不良反應(yīng)發(fā)生率兩組相比,差異無(wú)統(tǒng)計(jì)學(xué)意義(P0.05)。結(jié)論鹽酸馬尼地平片治療原發(fā)性高血壓臨床起效較慢,但降壓效果平穩(wěn)安全有效,具有良好耐受性、無(wú)嚴(yán)重不良反應(yīng)發(fā)生的特點(diǎn),值得臨床推廣使用。
[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 鹵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.
【學(xué)位授予單位】：新鄉(xiāng)醫(yī)學(xué)院
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2016
【分類號(hào)】：R544.1

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