發(fā)布時間：2018-03-27 07:33

  本文選題：冠心病　切入點：雷諾嗪　出處：《山東大學(xué)》2017年碩士論文

【摘要】：背景:雷諾嗪是一類以降低缺血細(xì)胞內(nèi)鈉離子負(fù)荷以及繼發(fā)的鈣離子負(fù)荷為核心機制,進而遏制細(xì)胞內(nèi)鈣超載及其所伴隨的一系列病理生理不良事件,從而實現(xiàn)抗心肌缺血目的的新藥。近年來有關(guān)該藥治療各類冠心病的臨床試驗增多,但尚未達成較一致的共識。目的:本研究旨在借助系統(tǒng)綜述及Meta分析的方式,通過著眼于雷諾嗪在冠心病治療中的有效性及安全性,對該藥的抗心肌缺血療效以及病人服藥后的耐受性予以粗略評價。方法:使用計算機檢索系統(tǒng),按照預(yù)定的檢索策略,通過PubMed,Embase,Cochrane Library等英文數(shù)據(jù)庫以及CNKI(中國知網(wǎng))、萬方等中文數(shù)據(jù)庫,對各庫建庫以來至2016年7月份為止收錄的中英文論文進行檢索和篩選,逐層剔除無關(guān)或低質(zhì)量研究后,選取符合納入標(biāo)準(zhǔn)的研究文獻。在對各臨床試驗方法學(xué)的科學(xué)性進行仔細(xì)評估定級后,將有效可靠的數(shù)據(jù)進行提取、整合,并根據(jù)資料類型選取合適的合并效應(yīng)指標(biāo),包括均數(shù)差(mean differences,MDs)、危險比(risk ratios,RRs)、風(fēng)險比(hazard ratios,HRs)、危險差(risk difference,RD)以及 NNH(number needed to harm,發(fā)生一例不良反應(yīng)所需要治療的病例數(shù))等,之后借助于RevMan 5.3軟件對其進行統(tǒng)計、分析,以期得到科學(xué)的統(tǒng)計學(xué)結(jié)論。最后再結(jié)合相關(guān)基礎(chǔ)研究成果及雷諾嗪的其他臨床領(lǐng)域使用背景,對該藥的作用機制、臨床價值和用藥風(fēng)險進行詳細(xì)討論,以期得到科學(xué)的臨床結(jié)論。結(jié)果:本研究共納入了 17個隨機對照臨床試驗(Randomized controlled trials,RCTs)進行定性分析,并對其中14個隨機對照臨床試驗共計12429名患者的效應(yīng)指標(biāo)進行了 Meta分析。有效性方面,相比于對照組而言,雷諾嗪組顯著地改善了患者靜息指標(biāo),即心絞痛發(fā)作狀態(tài)(包括每周心絞痛發(fā)作頻率、每周硝酸甘油使用量、心絞痛每次發(fā)作持續(xù)時間);活動指標(biāo),即運動踏板試驗表現(xiàn)(包括每次運動持續(xù)時間、誘發(fā)心絞痛發(fā)作所需運動時間、誘發(fā)心電圖ST段壓低1mm所需運動時間);以及主觀指標(biāo),即西雅圖心絞痛量表評分(包括心絞痛頻率、治療滿意度和生活質(zhì)量等維度)。安全性方面,相比對照組而言,雷諾嗪并未增加全因死亡率在內(nèi)的各類心血管事件再發(fā)率;相反地,雷諾嗪組有減少短期內(nèi)心梗發(fā)作率的趨勢。該藥未發(fā)現(xiàn)誘發(fā)惡性心律失常的作用,其不良反應(yīng)主要有便秘、惡心、頭暈、乏力和暈厥,以往文獻提及的頭痛尚不足以認(rèn)定為雷諾嗪不良反應(yīng)。另外,該藥對血流動力學(xué)參數(shù)的影響較小。結(jié)論:雷諾嗪具有較好的耐受性和良好的抗心肌缺血療效。同時,雷諾嗪的使用并不影響甚或可以改善冠心病患者的臨床結(jié)局。
[Abstract]:Background: ranolazine is a kind of mechanism which focuses on reducing the intracellular sodium load and the secondary calcium load of ischemic cells, and thus inhibits intracellular calcium overload and a series of pathophysiological adverse events associated with it. In recent years, the clinical trials of this drug for the treatment of various kinds of coronary heart disease have increased, but no consensus has been reached. Objective: the purpose of this study is to use systematic review and Meta analysis. By focusing on the efficacy and safety of ranolazine in the treatment of coronary heart disease, the effect of the drug on myocardial ischemia and the patient's tolerance after taking medicine were roughly evaluated. By means of the English database of PubMedine Embase Cochrane Library and the Chinese database CNKI, the Chinese and English papers collected since the establishment of each database until July 2016 were searched and screened, and the irrelevant or low-quality studies were eliminated layer by layer. After carefully evaluating the scientific nature of each clinical trial methodology, the valid and reliable data were extracted, integrated, and the appropriate combined effect indexes were selected according to the data types. These include mean difference in mean value, risk ratio, risk ratio, risk ratio, NNH(number needed to harmfulness, and the number of cases where an adverse reaction needs to be treated. After that, RevMan 5.3 software was used to analyze the risk. Finally, the mechanism, clinical value and risk of the drug were discussed in detail, combining with the related basic research results and other clinical application background of ranolazine. Results: a total of 17 randomized controlled trialsof RCTs were included in this study. Meta analysis was performed on 12429 patients in 14 randomized controlled clinical trials. Compared with the control group, Renolonazine group significantly improved the resting index of the patients. That is, angina pectoris attack state (including weekly angina pectoris attack frequency, weekly nitroglycerin usage, angina pectoris duration per attack, activity indicators, that is, exercise pedal test performance (including each exercise duration, The exercise time needed to induce angina pectoris attack, St segment depression of 1mm induced electrocardiogram, and subjective index, the score of Seattle angina scale (including the frequency of angina pectoris), In terms of safety, treatment satisfaction and quality of life, ranolazine did not increase the recurrence rate of all cardiovascular events, including all-cause mortality, compared to the control group. Renolazine group showed a tendency to reduce the incidence of myocardial infarction in the short term. The drug had no effect on inducing malignant arrhythmias. The adverse effects were mainly constipation, nausea, dizziness, fatigue and syncope, the main adverse effects were constipation, nausea, dizziness, fatigue and syncope. The headache mentioned in the previous literature is not enough to be considered as an adverse reaction of ranolazine. In addition, the effect of the drug on hemodynamic parameters is small. Conclusion: ranolazine has good tolerance and good anti-myocardial ischemia effect. The use of ranolazine does not affect or even improve the clinical outcome of patients with coronary heart disease.
【學(xué)位授予單位】：山東大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2017
【分類號】：R541.4

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本文編號：1670602