Medicine
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一项临床试验,评估基于橄榄油的三腔袋的亲子营养的安全性、有效性和交付
Chapters
Summary September 20th, 2019
Please note that all translations are automatically generated.
Click here for the English version.
在这里,我们提出了一个协议,用于比较橄榄油基3CB和大豆油基CoB配方在需要肠外营养的成年人的功效、安全性和交付。结果表明,与大豆配方相比,以橄榄油为基础的3CB是非劣质的,耐受性好。
Transcript
该协议为未来多个中心、室室袋提供了模板。该方案具有平衡性和有效性,即临床可操作性,为今后的研究提供实用模型。这种方法可以作为研究父母管理和医疗营养的参考,特别是三室袋。
奇怪是很难设计和实现。引用类似的协议可能是首次进入此字段的某人的快捷方式。本研究的部分设计实现可以通过文本清楚地呈现。
为了确保每个治疗的正确剂量,并保持处方的一致性,给每个研究网站一个表,其中包含不同重量的确切PM成分。通过控制泵通过外围静脉导管为每位参与者进行治疗。如果无法通过外设 IV 进行输液或不可取,则通过外设插入的中央导管或中央 IV 线路注入研究处理。
在第一小时内逐渐将流量提高至每小时 50 至 100 毫升,并在至少 5 天和 14 天内提供 12 至 22 小时的治疗。第1天至第5天,只进行研究治疗。为了评估主要疗效结果测量,血清前白蛋白水平,在第5天,从外周四研究参与者的反向附属物以及评估时间表中指明的时间点获取2至3毫升外周外静脉血样。
将血液在4摄氏度下储存长达4小时,然后将样品转移到中央实验室,以分析疗效参数。要评估尿液输出的主要疗效结果测量,请根据第5天收集尿液6小时,并按照评估时间表进行收集。在将样品储存在 4 摄氏度之前,记录适用处理日收集的体积。
然后将尿液收集中的等分转移到中央实验室,用于分析功效参数。对于治疗的安全性评估,调查参与者的任何不良或严重不良事件,并进行重要体征评估和身体检查。然后按照时间表执行任何其他实验室评估。
第6天,直到研究期结束,开始在研究治疗中添加液体口服营养,以满足计算的每日营养需求。一旦患者接受所计算的每日营养需求的至少80%,或在完成第14天研究治疗时,停止研究治疗;以先到者为准。完成或终止治疗后,按照时间表为学员执行适当的治疗结束程序。
在这项具有代表性的研究中,共有62%的患者接受了一次平均持续时间为3小时的高复杂手术。在2组进行年龄"性别"无手术""中等复杂手术"和高复杂度手术的分组分析时,也观察到了类似的趋势。研究发现,总体感染率较低,对照组患者的感染率明显高于测试组。
研究中最常见的感染是肺部感染,其次是切口和伤口感染。研究治疗的准备时间也明显低于所有评估日对照组。首先,在研究设计之前,我们应考虑临床安全性和可行性。
另一点是,最大限度地减少不同边的差异对于新兴中心研究的构建协议设计非常重要。
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