促红细胞生成素治疗脑梗死疗效及安全性的系统评价

发布时间：2018-03-04 18:31

本文选题：促红细胞生成素　切入点：脑梗死　出处：《广西医科大学》2014年硕士论文　论文类型：学位论文

【摘要】：背景和目的：脑梗死是人类致残和致死的主要疾病之一，目前缺乏有效的特异性治疗措施。在体内或体外多种动物模型都证实促红细胞生成素（erythropoietin，EPO）对不同的致伤因子导致的脑损伤均有神经保护作用。EPO应用于脑梗死动物模型实验研究已得到广泛的开展，并证实EPO能有效减少脑梗死面积，改善预后。但其临床试验研究仍处于起步阶段，，EPO治疗脑梗死的临床疗效及安全性尚存在争议。本系统评价为国内外首次采用cochrane系统评价的方法，评价EPO治疗脑梗死的疗效及安全性，为临床应用提供参考。方法：用Cochrane系统评价方法，检索Cochrane library、Pubmed、Embase、中国生物医学文献数据库、维普中文科技期刊数据库、中国知网、万方数据库，检索时间截止至2014年3月。由两名评价员独立筛选促红细胞生成素治疗脑梗死的安慰剂随机对照试验（Random Control Trials，RCTs），提取资料并评价文献质量。采用急性期DWI及FLAIR提示脑梗死面积变化情况、治疗后1个月的神经功能缺损的改善、日常生活能力、残疾程度、不良反应及治疗后3个月神经功能缺损的改善和死亡率作为结局指标，共同评价EPO治疗脑梗死的疗效及安全性。统计软件采用Cochrane协作网提供的RevMan5.2，用I2统计量描述研究间异质性，采用比值比（OddsRatio，OR）、均数差（weighted mean difference，WMD）或者标准化均数差(standardized mean difference，SMD)及其95%的可信区间（confidenceinterval，CI）作为合并统计量进行统计分析。结果：共检索到相关文献119篇，符合本系统评价的文献纳入标准共6篇，1002例患者。Meta分析结果显示，EPO能有效减少急性期DWI和FLAIR提示脑梗死的面积（分别为P=0.05，WMD=-12.11，95%CI=-24.20~-0.02和P=0.03，WMD=-13.45，95%CI=-25.67~-1.23）；但治疗后1个月，EPO并未能有效改善神经功能缺损（P=0.07，SMD=-0.88，95%CI=-1.83~0.07）、提高日常生活能力（P=0.62，WMD=-1.76，95%CI=-8.69~5.16）和改善残疾程度（P=0.40，WMD=0.14，95%CI=-0.19~0.46）,敏感性分析结果前后保持一致。此外，EPO还显著提高了血细胞压积的水平（P＜0.00001，WMD=1.42，95%CI=0.93~1.90）。治疗后3个月，EPO对改善神经功能缺损仍未证明有效（P=0.99，SMD=-0.00，95%CI=-0.32~0.32），而死亡的风险较对照组明显增加（P=0.01，OR=1.98，95%CI=1.18~3.34）。结论: EPO联合常规治疗脑梗死可以在一定程度上减少急性期的脑梗死面积，但尚不足以改善短期内神经功能缺损、提高日常生活能力和改善残疾程度。此外，EPO治疗脑梗死有显著增加病死率和潜在的红细胞增多的风险。因此，EPO治疗脑梗死的有效性及安全性有待更大量的随机对照试验进一步研究印证。
[Abstract]:Background and objective: cerebral infarction is one of the major diseases that cause disability and death in human beings. In vivo or in vitro, erythropoietin erythropoietin (EPO) has neuroprotective effect on brain injury induced by different injury factors. EPO is used in animal models of cerebral infarction. Type A experimental research has been widely carried out, It is proved that EPO can effectively reduce the area of cerebral infarction. However, the clinical efficacy and safety of EPO in the treatment of cerebral infarction are still in the initial stage. The evaluation of this system is the first time that cochrane system is used in the evaluation of cerebral infarction at home and abroad. To evaluate the efficacy and safety of EPO in the treatment of cerebral infarction. Methods: Cochrane system was used to search the database of Cochrane library.Pubmedmedus Embase, Chinese biomedical literature database, Weipu Chinese science and technology journal database, China Zhiwang database and Wanfang database. The search time was up to March 2014. Random Control trialsl RCTs were screened by two evaluators independently for the treatment of cerebral infarction. The data were extracted and the quality of the literature was evaluated. The brain was indicated by DWI and FLAIR in the acute phase. Changes in infarct area, One month after treatment, the improvement of neurological function deficit, the ability of daily living, the degree of disability, the adverse reaction, the improvement of nerve function defect at 3 months after treatment and the mortality rate were taken as the outcome indicators. To evaluate the efficacy and safety of EPO in the treatment of cerebral infarction, the statistical software was used to describe the heterogeneity between the two groups with the help of RevMan5.2provided by the Cochrane Cooperative Network, and I2 statistics were used to describe the heterogeneity between the two groups. OddsRatio OR, weighted mean difference or standardized mean difference (SD) and its confidence interval confidence intervalation (95%) were used for statistical analysis. Results: a total of 119 literatures were retrieved. The results of Meta-analysis showed that EPO could effectively reduce the area of cerebral infarction indicated by DWI and FLAIR in acute stage (P < 0.05) WMD-12.1195 ~ (95) CI-24.20 ~ (-0.02) and P ~ (0.03) WMD-13.459 ~ (95) CI-25.67 ~ (-1.23), but no effective improvement was found one month after treatment. P0.07 SMD-0.8895 CI-1.830.07, P0.62WMD-1.76-95CI-8.695.16) and improvement of the degree of disability P0.40mWMD0.1495CI-0.190.466.EPO also significantly increased the level of hematocrit (P < 0.00001WMD1.4295CI0.931.90). The defect was not proved to be effective. The risk of death was significantly higher than that of the control group. The risk of death was 1.98 / 95CI1.180.32 / 0.34. Conclusion: EPO combined with conventional therapy can reduce the area of acute cerebral infarction to some extent, but it is not sufficient to improve the neurological deficit in the short term. In addition, EPO treatment of cerebral infarction has a significant increase in mortality and potential risk of polycythemia. Therefore, the efficacy and safety of EPO in the treatment of cerebral infarction need to be more randomized. Further research was carried out according to the experiment.
【学位授予单位】：广西医科大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：R743.33

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