本文關(guān)鍵詞：基于貝葉斯網(wǎng)狀Meta分析的丹參類注射劑治療心腦血管疾病臨床評(píng)價(jià)研究　出處：《北京中醫(yī)藥大學(xué)》2017年碩士論文　論文類型：學(xué)位論文

  更多相關(guān)文章： 丹參類注射劑 急性腦梗死 不穩(wěn)定型心絞痛 網(wǎng)狀Meta分析 安全性 療效 系統(tǒng)評(píng)價(jià)

【摘要】：研究背景據(jù)世衛(wèi)組織統(tǒng)計(jì),心腦血管疾病的發(fā)病率逐年升高,已成為導(dǎo)致人類死亡的首要原因。近年來,中藥注射劑在心腦血管疾病中發(fā)揮了不可替代的作用,特別是丹參類注射劑,具有較好的經(jīng)濟(jì)效益和社會(huì)效益。臨床實(shí)踐中,醫(yī)務(wù)工作者經(jīng)常需要從丹參類注射劑中選擇出療效較好的品種,然而丹參類注射劑間缺乏直接對(duì)比的隨機(jī)試驗(yàn),且經(jīng)典Meta分析因其局限性無法實(shí)現(xiàn)多品種間的綜合比較分析。故而,探索應(yīng)用新的研究方法綜合評(píng)價(jià)不同品種丹參類注射劑治療心腦血管疾病的療效,具有重要學(xué)術(shù)意義和臨床價(jià)值。正基于此,本研究以急性腦梗死、不穩(wěn)定型心絞痛為切入點(diǎn),應(yīng)用Meta分析、網(wǎng)狀Meta分析等方法,對(duì)丹參類注射劑的有效性和安全性開展橫向綜合評(píng)價(jià),促進(jìn)臨床合理用藥。研究目的運(yùn)用網(wǎng)狀Meta分析方法評(píng)價(jià)丹參類注射劑治療急性腦梗死、不穩(wěn)定型心絞痛的有效性和安全性。研究方法1.網(wǎng)狀Meta分析基于貝葉斯理論,運(yùn)用WinBUGS軟件對(duì)數(shù)據(jù)進(jìn)行分析,運(yùn)用Stata13.0軟件對(duì)結(jié)果進(jìn)行可視化,繪制曲線下面積圖,預(yù)測治療措施療效排序。計(jì)算不一致因子(IF)及其95%CI評(píng)價(jià)一致性。2.Meta分析全面、系統(tǒng)檢索國內(nèi)外中、英文數(shù)據(jù)庫,收集相關(guān)的臨床隨機(jī)對(duì)照試驗(yàn)(RCTs)。質(zhì)量評(píng)價(jià)采用偏倚風(fēng)險(xiǎn)評(píng)價(jià)工具。運(yùn)用RevMan軟件、Stata軟件進(jìn)行數(shù)據(jù)分析。3.文獻(xiàn)研究法采用文獻(xiàn)研究的方法對(duì)檢索到的文獻(xiàn)資料進(jìn)行統(tǒng)計(jì)分析,包括對(duì)丹參類注射劑基本功效、適應(yīng)癥、安全性和對(duì)已發(fā)表的丹參類注射劑系統(tǒng)評(píng)價(jià)現(xiàn)狀進(jìn)行統(tǒng)計(jì)分析。研究結(jié)果(1)丹參類注射劑治療急性腦梗死研究結(jié)果對(duì)于急性腦梗死,共檢索到10007篇文獻(xiàn),經(jīng)篩查后,最終納入157個(gè)RCT,15570例受試者,所有研究都是二臂RCT,所有患者均診斷為急性腦梗死。納入干預(yù)措施包括丹參注射劑、復(fù)方丹參注射劑、丹紅注射劑、丹參川芎嗪注射劑、丹參酮ⅡA磺酸鈉注射劑、丹參多酚酸鹽注射劑、丹參多酚酸注射劑、冠心寧注射劑。所有研究均提及"隨機(jī)分組",29個(gè)研究通過"隨機(jī)數(shù)字表"產(chǎn)生隨機(jī)序列,11個(gè)研究提及盲法,2個(gè)研究有不完整結(jié)局,其他研究均無失訪或撤出病例。所有納入研究未獲得提前發(fā)布的試驗(yàn)方案,可能存在選擇性報(bào)告。133個(gè)研究報(bào)告了臨床療效總有效率,112個(gè)研究報(bào)告了神經(jīng)功能缺損,31個(gè)研究報(bào)告了日常生活活動(dòng)能力評(píng)分,24個(gè)研究報(bào)告了全血高切黏度,24個(gè)研究報(bào)告了全血低切黏度,25個(gè)研究報(bào)告了血漿黏度,27個(gè)研究報(bào)告了纖維蛋白原。Meta分析結(jié)果顯示:對(duì)于急性腦梗死患者,丹參類注射劑能提高臨床療效總有效率,改善神經(jīng)功能缺損、提高日常生活活動(dòng)能力。網(wǎng)狀Meta分析結(jié)果顯示:在提高臨床療效總有效率方面,冠心寧注射劑排序最佳,但因納入數(shù)量僅有1項(xiàng),研究結(jié)果無法確證;在改善神經(jīng)功能缺損、日常生活活動(dòng)能力、全血低切黏度、全血高切黏度方面,丹參酮ⅡA磺酸鈉注射劑效果排序最佳;在降低血漿黏度方面,丹紅注射劑效果排序最佳;在降低纖維蛋白原方面,丹參多酚酸注射劑效果排序最佳。25個(gè)研究共報(bào)道70例不良反應(yīng)/不良事件。主要表現(xiàn)為頭痛、頭暈、皮膚瘙癢、惡心、嘔吐、皮疹、滴注側(cè)肢體皮膚紅腫等。(2)丹參類注射劑治療不穩(wěn)定型心絞痛研究結(jié)果對(duì)于不穩(wěn)定型心絞痛,共檢索到3966篇文獻(xiàn),經(jīng)篩查后,最終納入172 RCTs,16306例受試者,所有納入研究都是二臂研究,所有患者均診斷為不穩(wěn)定型心絞痛。納入干預(yù)措施包括丹參注射劑、復(fù)方丹參注射劑、丹紅注射劑、丹參川芎嗪注射劑、丹參酮ⅡA磺酸鈉注射劑、丹參多酚酸鹽注射劑、丹參多酚酸注射劑、冠心寧注射劑。所有研究均提及"隨機(jī)分組",20個(gè)研究通過"隨機(jī)數(shù)字表"產(chǎn)生隨機(jī)序列,7個(gè)研究采用盲法,均未提及分配隱藏,所有研究均無失訪或撤出病例。所有納入研究未獲得提前發(fā)布的試驗(yàn)方案,可能存在選擇性報(bào)告。5個(gè)研究報(bào)告了心血管事件,8個(gè)研究報(bào)告了硝酸甘油用量,18個(gè)研究報(bào)告了心絞痛發(fā)作頻率,15個(gè)研究報(bào)告了心絞痛發(fā)作持續(xù)時(shí)間,172個(gè)研究報(bào)告了心絞痛療效,108個(gè)研究報(bào)告了心電圖療效,32個(gè)研究報(bào)告了總膽固醇,31個(gè)研究報(bào)告了甘油三酯,23個(gè)研究報(bào)告了高密度脂蛋白,27個(gè)研究報(bào)告了低密度脂蛋白。Meta分析結(jié)果顯示:丹參類注射劑治療不穩(wěn)定型心絞痛在提高心絞痛療效、心電圖療效,減少心血管事件、硝酸甘油用量、心絞痛發(fā)作頻率、心絞痛發(fā)作持續(xù)時(shí)間、改善血脂方面有一定的療效。因原始研究大多數(shù)未提及心血管事件、硝酸甘油用量、心絞痛發(fā)作頻率、心絞痛發(fā)作持續(xù)時(shí)間,無法構(gòu)建證據(jù)網(wǎng)絡(luò),故僅對(duì)心絞痛療效、心電圖療效、血脂指標(biāo)進(jìn)行網(wǎng)狀Meta分析。網(wǎng)狀Meta分析結(jié)果顯示:在提高心絞痛療效方面,丹參酮ⅡA磺酸鈉注射劑效果排序最佳;在提高心電圖療效方面,丹參酮ⅡA磺酸鈉注射劑效果排序最佳;在改善TC方面,丹參多酚酸鹽注射劑效果排序最佳;在改善TG方面,丹紅注射劑效果排序最佳;在改善HDL-C方面,丹參注射劑效果排序最佳;在改善LDL-C方面,丹參多酚酸鹽注射劑效果排序最佳。32個(gè)研究共報(bào)道117例不良反應(yīng)/不良事件。主要表現(xiàn)為頭痛、頭暈、腹痛、惡心、嘔吐、皮膚瘙癢、皮膚點(diǎn)片狀出血點(diǎn)等。研究結(jié)論在西醫(yī)常規(guī)治療的基礎(chǔ)上,聯(lián)合使用丹參類注射劑可以提高急性腦梗死、不穩(wěn)定型心絞痛的治療效果。網(wǎng)狀Meta分析結(jié)果提示冠心寧注射劑在提高急性腦梗死患者臨床療效方面較好,丹參酮ⅡA磺酸鈉注射劑在改善急性腦梗死患者神經(jīng)功能缺損、日常生活活動(dòng)能力、全面低切黏度、全血高切黏度方面效果較好,在提高不穩(wěn)定型心絞痛患者的心絞痛療效和心電圖療效方面較好;丹紅注射劑在降低急性腦梗死患者血漿黏度、改善不穩(wěn)定型心絞痛患者甘油三酯方面較好;丹參多酚酸鹽注射劑在改善不穩(wěn)定型心絞痛患者總膽固醇、低密度脂蛋白方面較好;丹參多酚酸注射劑在降低急性腦梗死患者纖維蛋白原方面效果較好。對(duì)于丹參類注射劑的安全性,因納入研究安全性不一,不能得出明確的結(jié)論,仍需進(jìn)一步探討。今后應(yīng)開展更多設(shè)計(jì)嚴(yán)謹(jǐn)?shù)碾S機(jī)雙盲對(duì)照試驗(yàn)對(duì)丹參類注射劑的療效與安全性作進(jìn)一步評(píng)價(jià)。
[Abstract]:According to the research background of the World Health Organization statistics, cardiovascular disease incidence increased year by year, has become the leading cause of human death. In recent years, Chinese medicine injection has played an irreplaceable role in cardiovascular diseases, especially Danshen injection, with good economic and social benefits. In clinical practice, medical workers often need to choose a good effect from the varieties of Radix Salviae miltiorrhizae injection, Salvia miltiorrhiza injection but lack of randomized trials directly comparing, and the classic Meta analysis can not be achieved due to the limitation of multi varieties comparative analysis. Therefore, to explore the effect of application of new research methods of comprehensive evaluation of different varieties of Radix Salviae Miltiorrhizae Injection in treatment of cardiovascular and cerebrovascular the disease, has important academic significance and clinical value. Based on this, in this study, acute cerebral infarction, unstable angina as the starting point, the application of Meta Network analysis, Meta analysis and other methods, to carry out comprehensive evaluation of transverse efficacy and safety of Salvia miltiorrhiza injection, promote clinical rational drug use. Research using Meta mesh analysis method for evaluation of Danshen injection in treatment of acute cerebral infarction, efficacy and safety of unstable angina pectoris. Methods 1. Meta mesh based on Bayesian theory and use WinBUGS to analyze the data, using Stata13.0 software to visualize the results, draw the area under the curve graph, prediction of treatment efficacy. Sort of inconsistent calculation factor (IF) and 95% CI evaluation of consistency of.2.Meta comprehensive analysis, retrieval system at home and abroad, English database, collection of Clinical RCTs (RCTs). Quality evaluation using bias risk assessment tool. Using RevMan software, data analysis methods.3. literature research by literature research by Stata software Statistical analysis of the retrieved documents, including the basic effect of Radix Salviae miltiorrhizae injection, indications, safety and statistical analysis of Radix Salviae Miltiorrhizae Injection status evaluation system. The research results have been published (1) Danshen injection in treatment of acute cerebral infarction results in acute cerebral infarction and 10007 literatures were retrieved and screened after a total of 157 RCT, 15570 subjects, all two arm RCT, all patients were diagnosed with acute cerebral infarction. Included interventions including Danshen injection, compound Danshen injection, Danhong injection, Danshen ligustrazine injection of sodium tanshinone A sulfonate injection, salvianolate injection, Salvia miltiorrhiza polyphenol acid injection, injection of Guanxinning. All studies are mentioned "randomized", 29 research through the "random number table" to generate random sequence, 11 studies mentioned blind method, 2 Research Incomplete ending, other studies were not lost or withdraw cases. All included studies did not obtain the test plan released in advance, there may be a selective report.133 study reported the total curative rate, 112 research reports of neurologic impairment, 31 Research Report ADL score, 24 research report the whole blood viscosity, 24 studies reported low blood viscosity, plasma viscosity in 25 studies, 27 studies reported the fibrinogen.Meta analysis results showed that: for patients with acute cerebral infarction, Danshen injection can improve the clinical curative effect of the total efficiency, improve neurological function, improve the ability of daily life net. Meta analysis results showed that: in improving clinical curative effect the total efficiency, but the best sort of Guanxinning Injection, into the number of only 1, the results can not be confirmed in the improvement of God; The function defect and activities of daily living, low blood viscosity, high blood viscosity, tanshinone II A sodium sulfonate injection in reducing the effect of ranking the best; plasma viscosity, the effect of Danhong injection in the best order; decrease fibrinogen, Danshen phenolic acid injection effect of multi sort optimal.25 studies were reported adverse 70 cases of adverse reaction / event. The main manifestations are headache, dizziness, skin itching, nausea, vomiting, rash, drip limbs skin redness. (2) Danshen injection in treatment of unstable angina pectoris results for unstable angina, a total of 3966 articles were retrieved, after screening, the final in 172 RCTs, 16306 subjects, all included in the study are two arm study, all patients were diagnosed with unstable angina pectoris. Included interventions including Danshen injection, compound Danshen injection, Danhong injection, Salvia miltiorrhiza Ligustrazine injection of sodium tanshinone A sulfonate injection of salvianolate injection, salvianolate injection, injection of Guanxinning. All studies are mentioned "randomized", 20 research through the "random number table" to generate random sequence, 7 studies using blind method, were not mentioned allocation concealment, all of all lost or withdrawn. All cases included in the study did not obtain the test plan released in advance, there may be a selective report.5 study reported cardiovascular events, 8 studies reported on the dosage of nitroglycerin, 18 studies reported the frequency of angina attack, 15 studies reported on the duration of angina pectoris, 172 Research Report angina pectoris, 108 research report the EKG, 32 studies reported total cholesterol, 31 studies reported in 23 studies of triglycerides, high density lipoprotein, 27 studies reported low Density lipoprotein.Meta analysis results showed that Danshen injection in treatment of unstable angina pectoris in improving angina pectoris, ECG curative effect, reduce cardiovascular events, the dosage of nitroglycerin, angina frequency, duration of angina pectoris have certain curative effect, improve blood pressure. Because of the original study did not mention the most cardiovascular events, nitrate glycerol, angina frequency, duration of angina pectoris, unable to construct evidence network, so only on angina pectoris, ECG, blood lipid indexes were analyzed. The mesh network Meta Meta analysis results showed that: in the aspect of improving the efficacy of angina pectoris, sodium tanshinone A sulfonate injection effect in improving the ranking best; electrocardiogram effect of sodium tanshinone A sulfonate injection effect in improving the ranking best; TC, salvianolate injection effect in improving TG ranking the best; Dan. The effect of injection of red ranking best; in the improvement of HDL-C, ranking the best effect of Danshen injection in improving; LDL-C, salvianolate injection effect.32 studies were the best sort of reports of adverse reactions / 117 cases of adverse events. The main manifestations are headache, dizziness, abdominal pain, nausea, vomiting, skin itching, skin patchy bleeding the conclusion of the study. On the basis of conventional treatment, the combined use of Danshen injection can improve the acute cerebral infarction, unstable angina treatment. Meta analysis showed that the Guanxinning Injection mesh to improve the good clinical curative effect in patients with acute cerebral infarction, tanshinone II A sodium sulfonate injection in improving nerve function of acute cerebral infarction patients with defect. The activities of daily living, overall low shear viscosity, whole blood viscosity has better effect in improving the patients with unstable angina pectoris angina Curative effect and electrocardiogram efficacy; Danhong injection in reducing plasma viscosity in patients with acute cerebral infarction, improve unstable angina patients better triglyceride; salvianolate injection unstable angina in patients with total cholesterol, low density lipoprotein is better; salvianolic acid injection on acute cerebral infarction patients better reduce the fiber protein the original effect. For the safety of Danshen injection, because safety is not included in the study, no clear conclusion, still need further discussion. We should carry out more rigorous randomized double-blind design for further evaluation of control efficacy and safety test of Radix Salviae miltiorrhizae injection.

【學(xué)位授予單位】：北京中醫(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)】：R259

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