本文選題：參附注射液 + 膿毒癥休克��； 參考：《山東中醫(yī)藥大學(xué)》2017年碩士論文

【摘要】：目的:運用Meta-分析(Meta-analysis)的方法對目前國內(nèi)外已公開發(fā)表的有關(guān)參附注射液治療膿毒癥休克患者早期液體復(fù)蘇臨床療效的相關(guān)研究進行綜合定量分析,以希望對以后臨床治療膿毒癥休克患者有效治療方案提供科學(xué)依據(jù)。方法:(1)根據(jù)系統(tǒng)評價的要求制定全面、合理的檢索策略;(2)根據(jù)系統(tǒng)評價的要求制定嚴格的納入標準、排除標準,相關(guān)文獻研究中應(yīng)包擴研究對象的特征、干預(yù)措施、研究的相關(guān)結(jié)局指標等;(3)根據(jù)系統(tǒng)評價的要求按照隨機對照試驗的質(zhì)量評價標準對所有納入研究的文獻進行風(fēng)險偏倚評估;(4)對納入文獻進行數(shù)據(jù)提取,應(yīng)用國際Cochrane協(xié)作網(wǎng)制作的Review Manager 5.3軟件,根據(jù)文獻結(jié)果指標的數(shù)據(jù)類型確定分析方法,進行相應(yīng)的Meta分析。(5)發(fā)表性偏倚采用倒漏斗圖(funnel plot)表示。結(jié)果:本次研究共納入15篇文獻,入組患者共計1088人。Meta分析結(jié)果顯示:(1)以24小時尿量為觀察指標,加用參附注射液治療膿毒癥休克患者早期液體復(fù)蘇臨床療效24小時尿量的合并效應(yīng)量檢驗:MD=0.46,95%CI為[0.20,0.72],統(tǒng)計學(xué)顯著性檢驗:Z=3.49,P=0.0005,差異具有顯著統(tǒng)計學(xué)意義;(2)以24h Sc VO2為觀察指標,加用參附注射液治療膿毒癥休克患者早期液體復(fù)蘇臨床療效24h Sc VO2的合并效應(yīng)量檢驗:MD=4.61,95%CI為[2.67,6.55],統(tǒng)計學(xué)顯著性檢驗:Z=4.66,P0.00001,差異具有顯著統(tǒng)計學(xué)意義;(3)以24h MAP為觀察指標,加用參附注射液治療膿毒癥休克患者早期液體復(fù)蘇臨床療效24h MAP的合并效應(yīng)量檢驗:MD=6.62,95%CI為[2.10,11.13],統(tǒng)計學(xué)顯著性檢驗:Z=2.87,P=0.004,差異具有顯著統(tǒng)計學(xué)意義;(4)以24h Lac為觀察指標,加用參附注射液治療膿毒癥休克患者早期液體復(fù)蘇臨床療效24h Lac的合并效應(yīng)量檢驗:MD=-0.72,其95%CI為[-1.10,-0.33],統(tǒng)計學(xué)顯著性檢驗:Z=3.67,P=0.0002,差異具有顯著統(tǒng)計學(xué)意義;(5)以3d APACHEII評分為觀察指標,加用參附注射液治療膿毒癥休克患者早期液體復(fù)蘇臨床療效3d APACHEII評分的合并效應(yīng)量檢驗:MD=-2.52,95%CI為[-3.56,-1.49],統(tǒng)計學(xué)顯著性檢驗:Z=4.76,P0.00001,差異具有顯著統(tǒng)計學(xué)意義;(6)以28d死亡率為觀察指標,加用參附注射液治療膿毒癥休克患者早期液體復(fù)蘇臨床療效28d死亡率的合并效應(yīng)量檢驗:RR=0.84,95%CI為[0.70,1.00],統(tǒng)計學(xué)顯著性檢驗:Z=1.94,P=0.05,差異具有統(tǒng)計學(xué)意義。結(jié)論:(1)通過對參附注射液治療膿毒癥休克患者早期液體復(fù)蘇臨床療效文獻的Meta-分析,表明參附注射液治療膿毒癥休克患者早期液復(fù)蘇臨床療效在改善24h尿量、MAP、ScVO_2、Lac,3d APACHEII評分以及28d死亡率等方面確有療效,且優(yōu)于西醫(yī)標準治療的對照組;(2)有關(guān)參附注射液治療膿毒癥休克患者早期液體復(fù)蘇臨床療效文獻質(zhì)量有待提高,特別是在對樣本量的估計、臨床試驗設(shè)計隨機方案、盲法處理等方面;(3)目前發(fā)表文獻很少提及藥物不良反應(yīng),不能為臨床用藥提供可靠的安全性證據(jù)。
[Abstract]:Objective: to analyze the clinical effect of Shenfu injection on early fluid resuscitation in septic shock patients with septic shock. In order to provide scientific basis for clinical treatment of septic shock patients. Methods 1) according to the requirement of system evaluation, a comprehensive and reasonable retrieval strategy was formulated. According to the requirements of system evaluation, strict inclusion criteria were formulated, exclusion criteria were excluded, and the characteristics of research objects and intervention measures should be expanded in relevant literature studies. According to the requirements of systematic evaluation, risk bias assessment of all the literature included in the study was carried out according to the quality evaluation criteria of the randomized controlled trial. Using the Review Manager 5.3 software made by the international Cochrane cooperation network, according to the method of determining the data type of the result index of the literature, the corresponding Meta analysis. 5) the published bias is expressed by funnel plot (inverted funnel plot). Results: a total of 15 articles were included in this study. A total of 1088 patients were included. The results of meta-analysis showed that the urine volume of 24 hours was taken as the observation index. Combined effects of Shenfu injection on early fluid resuscitation in patients with septic shock the combined effect of 24 hours urine volume test was [0.20 鹵0.72] (CI = 0.20 鹵0.72), and the difference was statistically significant (P < 0.05). The 24 h SC VO2 was used as the index of observation. Clinical efficacy of early fluid resuscitation in septic shock patients with Shenfu injection the combined effect of 24 h SC VO2 in patients with septic shock; the combined effect of SC VO2 was [2.67 鹵6.55], and the difference was significant (P 0.00001). The 24 h MAP was taken as the index of observation. Clinical efficacy of early fluid resuscitation in septic shock patients treated with Shenfu injection the combined effect quantity test of 24 hours MAP was [2.10 鹵11.13], statistical significance test showed that the difference was significant (P < 0.05). The 24 h Lac was taken as the index of observation. The combined effect of Shenfu injection on early fluid resuscitation in septic shock patients after 24 hours of clinical efficacy; the combined effect of 95%CI was [-1.10 ~ (-0.33)], the 95%CI was [-1.10 ~ (-0.33)], and the statistical significance was: (1) the difference was statistically significant (P < 0.05). The APACHEII score of 3 days was taken as the index of observation, and the difference was significant (P < 0.05), and the 95%CI was [-1.10 ~ (-0.33)], and the difference was statistically significant. The combined effects of Shenfu injection on early fluid resuscitation in patients with septic shock the combined effect dose test of 3-day APACHEII score was [-3.56 ~ (-1.49)], and the statistical significance was: "10 ~ (-) -2.52 ~ (95) CI = [-3.56] ~ (-1.49), and the difference was statistically significant (P ~ (0.00001). The 28d mortality rate was taken as the index of observation. Combined effects of Shenfu injection on early fluid resuscitation in patients with septic shock the combined effect dose test of 28d mortality test showed that the CI was 0.701.00 [0.701.00], and the difference was statistically significant (P < 0.05). Conclusion 1) Meta-analysis of the clinical efficacy of Shenfu injection in the treatment of septic shock patients with early fluid resuscitation. The results showed that Shenfu injection was effective in improving 24 h urine volume of patients with septic shock and improving the 3-day APACHEII score and 28d mortality. The quality of literature on the clinical efficacy of Shenfu injection in the treatment of septic shock patients with early fluid resuscitation needs to be improved, especially in the estimation of sample size and the randomized design of clinical trials. At present, there is little mention of adverse drug reactions in the literature published, which can not provide reliable evidence of safety for clinical use of drugs.
【學(xué)位授予單位】：山東中醫(yī)藥大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2017
【分類號】：R459.7

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