PDF(Pubmed)
Abstract：
UNASSIGNED: In trials conducted in India, recombinant granulocyte colony stimulating factor (GCSF) improved survival in alcohol-associated hepatitis (AH). The aim of this trial was to determine the safety and efficacy of pegfilgrastim, a long-acting recombinant GCSF, in patients with AH in the United States.
UNASSIGNED: This prospective, randomized, open label trial conducted between March 2017 and March 2020 randomized patients with a clinical diagnosis of AH and a Maddrey discriminant function score ≥32 to standard of care (SOC) or SOC+pegfilgrastim (0.6 mg subcutaneously) on Day 1 and Day 8 (clinicaltrials.gov NCT02776059). SOC was 28 days of either pentoxifylline or prednisolone, as determined by the patient\'s primary physician. The second injection of pegfilgrastim was not administered if the white blood cell count exceeded 30,000/mm3 on Day 8. Primary outcome was survival at Day 90. Secondary outcomes included the incidence of acute kidney injury (AKI), hepatorenal syndrome (HRS), hepatic encephalopathy, or infections.
UNASSIGNED: The study was terminated early due to COVID19 pandemic. Eighteen patients were randomized to SOC and 16 to SOC+pegfilgrastim. All patients received prednisolone as SOC. Nine patients failed to receive a second dose of pegfilgrastin due to WBC > 30,000/mm3 on Day 8. Survival at 90 days was similar in both groups (SOC: 0.83 [95% confidence interval [CI]: 0.57-0.94] vs. pegfilgrastim: 0.73 [95% CI: 0.44-0.89]; p > 0.05; CI for difference: -0.18-0.38). The incidences of AKI, HRS, hepatic encephalopathy, and infections were similar in both treatment arms and there were no serious adverse events attributed to pegfilgrastim.
UNASSIGNED: This phase II trial found no survival benefit at 90 days among subjects with AH who received pegfilgrastim+prednisolone compared with subjects receiving prednisolone alone.
UNASSIGNED: was provided by the United States National Institutes of Health and National Institute on Alcohol Abuse and Alcoholism U01-AA021886 and U01-AA021884.
UNASSIGNED: This prospective, randomized, open label trial conducted between March 2017 and March 2020 randomized patients with a clinical diagnosis of AH and a Maddrey discriminant function score ≥32 to standard of care (SOC) or SOC+pegfilgrastim (0.6 mg subcutaneously) on Day 1 and Day 8 (clinicaltrials.gov NCT02776059). SOC was 28 days of either pentoxifylline or prednisolone, as determined by the patient\'s primary physician. The second injection of pegfilgrastim was not administered if the white blood cell count exceeded 30,000/mm3 on Day 8. Primary outcome was survival at Day 90. Secondary outcomes included the incidence of acute kidney injury (AKI), hepatorenal syndrome (HRS), hepatic encephalopathy, or infections.
UNASSIGNED: The study was terminated early due to COVID19 pandemic. Eighteen patients were randomized to SOC and 16 to SOC+pegfilgrastim. All patients received prednisolone as SOC. Nine patients failed to receive a second dose of pegfilgrastin due to WBC > 30,000/mm3 on Day 8. Survival at 90 days was similar in both groups (SOC: 0.83 [95% confidence interval [CI]: 0.57-0.94] vs. pegfilgrastim: 0.73 [95% CI: 0.44-0.89]; p > 0.05; CI for difference: -0.18-0.38). The incidences of AKI, HRS, hepatic encephalopathy, and infections were similar in both treatment arms and there were no serious adverse events attributed to pegfilgrastim.
UNASSIGNED: This phase II trial found no survival benefit at 90 days among subjects with AH who received pegfilgrastim+prednisolone compared with subjects receiving prednisolone alone.
UNASSIGNED: was provided by the United States National Institutes of Health and National Institute on Alcohol Abuse and Alcoholism U01-AA021886 and U01-AA021884.
摘要：
未经批准：在印度进行的试验中，重组粒细胞集落刺激因子（GCSF）可改善酒精相关性肝炎（AH）的生存率。该试验的目的是确定pegfilgrastim的安全性和有效性，长效重组GCSF，在美国AH患者中。
未经批准：此预期，随机化，在2017年3月至2020年3月之间进行的开放标签试验,在第1天和第8天,将临床诊断为AH且Maddrey判别函数评分≥32的患者随机分组至治疗标准(SOC)或SOC+pegfilgrastim(皮下0.6mg)(clinicaltrials.govNCT02776059).SOC为己酮可可碱或泼尼松龙28天，由患者的主治医生决定。如果在第8天白细胞计数超过30,000/mm3,则不施用pegfilgrastim的第二次注射。主要结果是在第90天的存活。次要结果包括急性肾损伤（AKI）的发生率，肝肾综合征（HRS），肝性脑病,或感染。
未经评估：由于COVID19大流行，该研究提前终止。18例患者随机接受SOC治疗，16例随机接受SOC+pegfilgrastim治疗。所有患者均接受泼尼松龙作为SOC。9名患者在第8天由于WBC>30,000/mm3而未能接受第二剂量的pegfilgrastin。两组90天的生存率相似（SOC：0.83[95％置信区间[CI]：0.57-0.94]vs.pegfilgrastim：0.73[95%CI：0.44-0.89]；p>0.05；差异CI：-0.18-0.38）。AKI的发生率，HRS,肝性脑病,两组治疗组的感染情况相似,且未出现因pegfilgrastim引起的严重不良事件.
UNASSIGNED：这项II期试验发现，与单独接受泼尼松龙的受试者相比，接受pegfilgrastim+泼尼松龙的AH受试者在90天没有生存益处。
UNASSIGNED：由美国国立卫生研究院和国家酗酒和酗酒研究所U01-AA021886和U01-AA021884提供。
未经批准：此预期，随机化，在2017年3月至2020年3月之间进行的开放标签试验,在第1天和第8天,将临床诊断为AH且Maddrey判别函数评分≥32的患者随机分组至治疗标准(SOC)或SOC+pegfilgrastim(皮下0.6mg)(clinicaltrials.govNCT02776059).SOC为己酮可可碱或泼尼松龙28天，由患者的主治医生决定。如果在第8天白细胞计数超过30,000/mm3,则不施用pegfilgrastim的第二次注射。主要结果是在第90天的存活。次要结果包括急性肾损伤（AKI）的发生率，肝肾综合征（HRS），肝性脑病,或感染。
未经评估：由于COVID19大流行，该研究提前终止。18例患者随机接受SOC治疗，16例随机接受SOC+pegfilgrastim治疗。所有患者均接受泼尼松龙作为SOC。9名患者在第8天由于WBC>30,000/mm3而未能接受第二剂量的pegfilgrastin。两组90天的生存率相似（SOC：0.83[95％置信区间[CI]：0.57-0.94]vs.pegfilgrastim：0.73[95%CI：0.44-0.89]；p>0.05；差异CI：-0.18-0.38）。AKI的发生率，HRS,肝性脑病,两组治疗组的感染情况相似,且未出现因pegfilgrastim引起的严重不良事件.
UNASSIGNED：这项II期试验发现，与单独接受泼尼松龙的受试者相比，接受pegfilgrastim+泼尼松龙的AH受试者在90天没有生存益处。
UNASSIGNED：由美国国立卫生研究院和国家酗酒和酗酒研究所U01-AA021886和U01-AA021884提供。
