鱼油脂肪乳治疗重症胰腺炎的随机双盲对照试验

Randomized and Double-blind Controlled Trial of Fish-oil-based Lipid Emulsion Infusion for Treatment of Severe Pancreatitis

目的:探讨鱼油脂肪乳肠外辅助治疗重症胰腺炎的临床疗效。方法:选取60名重症胰腺炎(SAP)患者进行随机、双盲对照的临床试验。对照组(n=30)给予常规治疗,研究组(n=30)将结构脂肪乳替换为鱼油脂肪乳,余治疗方案相同。主要观察并比较两组患者实验室检查指标,临床病情严重度。同时观察并比较两组患者ICU及总平均住院日。结果:对照组在第5 d白介素-6(IL-6)(P=0.038)及肿瘤坏死因子-α(TNF-α)(P=0.019)水平明显降低,研究组在第5 d IL-6(P=0.018)及TNF-α(P=0.011)水平显著降低。对照组在第5 d降钙素原(PCT)(P=0.032)水平下降明显,研究组在第3 d PCT(P=0.018)水平即明显降低。对照组在第5 d CD4+的比率(P=0.033)和CD4+/CD8+比值(P=0.021)明显升高,研究组在第5 d CD4+的比率(P=0.017)和CD4+/CD8+比值(P=0.007)明显升高。研究组急性生理学与慢性健康状况评分(APACHEⅡ)减分率在第3 d(P=0.004)、第5 d(P=0.022)和第7 d(P=0.035)显著降低,APACHE Ⅲ评分(P=0.021)和简化急性生理学评分(SAPS Ⅱ) Ⅱ(P=0.017)减分率在第7 d显著降低。而平均重症监护病房(ICU)天数、平均住院天数比较差异无统计学意义(P>0.05)。结论:鱼油脂肪乳剂辅助治疗SAP是安全的,有助于减轻机体炎症反应和改善SAP的预后。

Objective:To explore the clinical benefits to patients with severe pancreatitis of receiving parenteral fish-oil-based lipid emulsion as adjuvant treatment. Methods:A randomized and double-blind controlled clinical trial was conducted in 60 patients with severe pancreatitis(SAP). The control group(n=30) received routine treatments, while the study group(n=30) replaced the structural fat emulsion with fish-oil-based lipid emulsion. The rest of the treatments were the same. Observation and comparison of laboratory cytokine indicators and clinical assessment of the two groups were done. At the same time, ICU and the total average hospital stay of two groups were compared and observed. Results:The levels of interleukin-6(IL-6)(P=0.038) and tumor necrosis factor-α(TNF--α)(P=0.019) in the control group decreased significantly on the 5 th day, while the levels of IL-6(P=0.018)and TNF--α(P=0.011) in the study group decreased significantly on the 5 th day. The level of procalcitonin(PCT)(P=0.032) in the control group decreased significantly on the 5 th day, and the level of PCT(P=0.018) in the study group decreased significantly on the 3 rd day. In the control group, the ratio of CD4+(P=0.033) and the ratio to CD4+/CD8+(P=0.021) increased significantly on the 5 th day, while in the study group, the ratio of CD4+(P=0.017) and the ratio of CD4+/CD8+(P=0.007) increased significantly on the 5 th day. The study group showed a significant score reduction for acute physiology and chronic health score(APACHE Ⅱ)on the 3 rd day(P=0.004), the 5 th day(P=0.022) and the 7 th day(P=0.035), and for APACHE Ⅲ score(P=0.021) and simplified acute physiology score(SAPS Ⅱ) Ⅱ(P=0.017) on the 7 th day. However, length of intensive care unit(ICU) and hospital stay showed no significant difference with the groups compared(P>0.05). Conclusion:Treatment with fish-oil-based lipid emulsion for patients with SAP is safe and helpful for rapid reduction of clinical severity of the disease.