High-dose intravenous vitamin C reduce C-reactive protein levels, fluid retention, and APACHE II scores in patients with moderately severe acute pancreatitis: a prospective, randomized, double-blinded, placebo-controlled study.
Bing Zhao, Wenwu Sun, Yihui Wang, Li Ma, Menglu Gui, Jiaoyan Li, Xianxian Yu, Xing Qi, Ning Ning, Silei Sun, Mengjiao Li, Yi Yao, Tongtian Ni, Juan He, Zhitao Yang, Ying Chen, Huiqiu Sheng, Meihua Shen, Jian Li, Jun Huang, Enqiang Mao
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引用次数: 0
Abstract
Background: The aim of this study was to investigate whether high-dose intravenous vitamin C (HDIVC) could decrease the mortality rate within 28 days among patients moderately severe acute pancreatitis (MSAP) and severe acute pancreatitis (SAP).
Methods: In this randomized, placebo-controlled trial, patients diagnosed with predicted MSAP or SAP within 72 h of symptom onset were enrolled to receive either a vitamin C infusion (200 mg/kg/24 h) or a matched placebo for 7 days. The primary outcome was 28-day mortality.
Results: 212 adults including 155 MSAP and 57 SAP were enrolled from September 2019 to June 2023. The trial was terminated prematurely due to a lower than expected 28-day mortality rate which showed no difference between the HDIVC and Control group (3/109 vs. 4/103, unadjusted OR: 0.70, 95% CI, 0.15-3.21, p = 0.647). Among patients with MSAP, the HDIVC group exhibited a more pronounced reduction in C-reactive protein levels compared to the Control group (Day0 to Day3, median 72 mg/L vs. 46 mg/L, p = 0.003; Day0 to Day7, median 168 mg/L vs. 121 mg/L, p = 0.013); The volume of fluid retention was lower in the HDIVC group compared to the Control group (Day0-Day1, median 676.5 ml vs. 1130 ml, P = 0.04; Day0-Day2, median 511 ml vs. 1290 ml, P = 0.02; Day0-Day3, median 692 ml vs. 1534 ml, P = 0.04). The APACHE II scores reduction from Day0 to Day7 was significantly greater in the HDIVC group in APACHE II scores (median change of 3 vs. 2, P = 0.01). No significant difference was observed among patients with SAP.
Conclusion: HDIVC did not significantly reduce 28-day mortality in MSAP and SAP patients. While it showed potential benefits in reducing CRP, fluid retention, and APACHE II scores in MSAP patients, these effects may not be directly related to the study drug, and no similar changes were observed in SAP patients.
Trial registration: ChiCTR.org.cn, ChiCTR1900022022. Registered March 21 2019, https//www.chictr.org.cn/showproj.html?proj=37,106 .
背景：本研究的目的是探讨高剂量静脉注射维生素C （HDIVC）是否能降低中重度急性胰腺炎（MSAP）和重度急性胰腺炎（SAP）患者28天内的死亡率。方法：在这项随机、安慰剂对照试验中，在症状出现72小时内被诊断为预测MSAP或SAP的患者入组，接受维生素C输注（200mg /kg/24小时）或匹配的安慰剂7天。主要终点为28天死亡率。结果：2019年9月至2023年6月，共有212名成人入组，其中MSAP 155人，SAP 57人。由于低于预期的28天死亡率，试验提前终止，HDIVC组和对照组之间没有差异（3/109比4/103，未经调整的OR: 0.70, 95% CI, 0.15-3.21, p = 0.647）。在MSAP患者中，与对照组相比，HDIVC组的c反应蛋白水平下降更为明显(第0天至第3天，中位数为72 mg/L vs. 46 mg/L, p = 0.003；第0天至第7天，中位数168 mg/L vs. 121 mg/L, p = 0.013)；与对照组相比，HDIVC组液体潴留量较低(Day0-Day1，中位数676.5 ml vs 1130 ml, P = 0.04；Day0-Day2，中位数511 ml vs. 1290 ml, P = 0.02；第0天至第3天，中位数692 ml vs. 1534 ml, P = 0.04)。HDIVC组APACHE II评分从第0天到第7天的下降幅度明显大于HDIVC组（中位数变化为3比2，P = 0.01）。结论：HDIVC对MSAP和SAP患者28天死亡率无显著降低作用。虽然它在降低MSAP患者的CRP、体液潴积和APACHE II评分方面显示出潜在的益处，但这些效果可能与研究药物没有直接关系，并且在SAP患者中没有观察到类似的变化。试验注册：ChiCTR.org.cn, ChiCTR1900022022。2019年3月21日注册，https//www.chictr.org.cn/showproj.html?proj=37,106。
期刊介绍：
Annals of Intensive Care is an online peer-reviewed journal that publishes high-quality review articles and original research papers in the field of intensive care medicine. It targets critical care providers including attending physicians, fellows, residents, nurses, and physiotherapists, who aim to enhance their knowledge and provide optimal care for their patients. The journal's articles are included in various prestigious databases such as CAS, Current contents, DOAJ, Embase, Journal Citation Reports/Science Edition, OCLC, PubMed, PubMed Central, Science Citation Index Expanded, SCOPUS, and Summon by Serial Solutions.
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