参附注射液对脓毒症休克患者早期液体复苏临床疗效的Meta-分析及临床研究

发布时间：2018-05-17 03:04

本文选题：参附注射液 + 脓毒症休克　；参考：《山东中医药大学》2017年硕士论文

【摘要】：目的:运用Meta-分析(Meta-analysis)的方法对目前国内外已公开发表的有关参附注射液治疗脓毒症休克患者早期液体复苏临床疗效的相关研究进行综合定量分析,以希望对以后临床治疗脓毒症休克患者有效治疗方案提供科学依据。方法:(1)根据系统评价的要求制定全面、合理的检索策略;(2)根据系统评价的要求制定严格的纳入标准、排除标准,相关文献研究中应包扩研究对象的特征、干预措施、研究的相关结局指标等;(3)根据系统评价的要求按照随机对照试验的质量评价标准对所有纳入研究的文献进行风险偏倚评估;(4)对纳入文献进行数据提取,应用国际Cochrane协作网制作的Review Manager 5.3软件,根据文献结果指标的数据类型确定分析方法,进行相应的Meta分析。(5)发表性偏倚采用倒漏斗图(funnel plot)表示。结果:本次研究共纳入15篇文献,入组患者共计1088人。Meta分析结果显示:(1)以24小时尿量为观察指标,加用参附注射液治疗脓毒症休克患者早期液体复苏临床疗效24小时尿量的合并效应量检验:MD=0.46,95%CI为[0.20,0.72],统计学显著性检验:Z=3.49,P=0.0005,差异具有显著统计学意义;(2)以24h Sc VO2为观察指标,加用参附注射液治疗脓毒症休克患者早期液体复苏临床疗效24h Sc VO2的合并效应量检验:MD=4.61,95%CI为[2.67,6.55],统计学显著性检验:Z=4.66,P0.00001,差异具有显著统计学意义;(3)以24h MAP为观察指标,加用参附注射液治疗脓毒症休克患者早期液体复苏临床疗效24h MAP的合并效应量检验:MD=6.62,95%CI为[2.10,11.13],统计学显著性检验:Z=2.87,P=0.004,差异具有显著统计学意义;(4)以24h Lac为观察指标,加用参附注射液治疗脓毒症休克患者早期液体复苏临床疗效24h Lac的合并效应量检验:MD=-0.72,其95%CI为[-1.10,-0.33],统计学显著性检验:Z=3.67,P=0.0002,差异具有显著统计学意义;(5)以3d APACHEII评分为观察指标,加用参附注射液治疗脓毒症休克患者早期液体复苏临床疗效3d APACHEII评分的合并效应量检验:MD=-2.52,95%CI为[-3.56,-1.49],统计学显著性检验:Z=4.76,P0.00001,差异具有显著统计学意义;(6)以28d死亡率为观察指标,加用参附注射液治疗脓毒症休克患者早期液体复苏临床疗效28d死亡率的合并效应量检验:RR=0.84,95%CI为[0.70,1.00],统计学显著性检验:Z=1.94,P=0.05,差异具有统计学意义。结论:(1)通过对参附注射液治疗脓毒症休克患者早期液体复苏临床疗效文献的Meta-分析,表明参附注射液治疗脓毒症休克患者早期液复苏临床疗效在改善24h尿量、MAP、ScVO_2、Lac,3d APACHEII评分以及28d死亡率等方面确有疗效,且优于西医标准治疗的对照组;(2)有关参附注射液治疗脓毒症休克患者早期液体复苏临床疗效文献质量有待提高,特别是在对样本量的估计、临床试验设计随机方案、盲法处理等方面;(3)目前发表文献很少提及药物不良反应,不能为临床用药提供可靠的安全性证据。
[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 卤0.72] (CI = 0.20 卤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 卤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 卤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.
【学位授予单位】：山东中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R459.7

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