PDF(Pubmed)
Abstract：
UNASSIGNED: This study analyzed the effectiveness of methylprednisolone in improving jaundice, bilirubin levels, liver function tests, and inflammatory biomarkers in infants with cholestasis.
UNASSIGNED: The randomized, actively controlled, parallel-group trial (ISRCTN45080388 registry) was conducted from November 2022 to May 2023 in Dr. Soetomo General Academic Hospital, Surabaya, Indonesia, on infants with cholestasis. The ethics committee of Dr. Soetomo General Academic Hospital, Surabaya approved the study protocol. Infants 14 days to 3 months old, with cholestasis followed by acholic stool, dark urine, and hepatomegaly were included in the trial. Participants were randomly assigned to methylprednisolone 2 mg/kg/day twice daily or to placebo twice daily for two weeks. Ursodeoxycholic acid (10 mg/kg) was administered to all patients thrice daily. Clinical examination and laboratory measurements (direct and total bilirubin, Aspartate aminotransferase (AST), Alanine transaminase (ALT), Gamma-glutamyl transferase (GGT), and inflammatory biomarker) were performed at baseline and after 2-week treatment. Measurement of inflammatory biomarkers (IL-2, IL-4, IL-6, IL-10, IFN-γ, TGF-β, and ANCA) was performed using enzyme-linked immunoassays. Data distribution was checked for normality. Analysis was carried out using SPSS ver. 21 with p significant <0.05.
UNASSIGNED: In total, 40 participants were randomized to methylprednisolone (n = 20; mean age 8.39 ± 3.11 weeks) and placebo (n = 18; 2 drop out; mean age 8.98 ± 2.80 weeks) groups. At baseline, the methylprednisolone treatment and placebo groups significantly differed in gender (p = 0.02) but not in clinical, laboratory examination, or inflammatory biomarker levels. The methylprednisolone group had direct bilirubin 8.36 ± 4.84 mg/dL; total bilirubin 10.40 (2.70-33.25) mg/dL; AST 187.05 (42.00-911.00) U/L; ALT 170.43 ± 134.43 U/L; IL-2 171.29 (73.70-378.57) ng/L; IL-4 119.57 ± 59.69 ng/L; IL-6 71.74 ± 29.83 ng/L; IL-10 138.15 ± 70.62 ng/L; IFN-γ 42.54 ± 12.17 ng/L; TGF-β 316.58 (163.68-606.16) ng/L; ANCA 1.70 (0.66-3.25) ng/L. After two weeks of treatment, direct bilirubin, total bilirubin, AST, IL-10, and IFN-γ levels were significantly lower in the methylprednisolone group (p < 0.05) than those in the placebo group. No serious adverse events were reported.
UNASSIGNED: Methylprednisolone was efficacious in reducing 2-week bilirubin levels. These results support the hypothesis that the immunological process is involved in cholestasis. Further studies with larger sample sizes are needed to confirm the bile duct anti-inflammatory effect of methylprednisolone in cholestasis as an opportunity for new therapies to prevent the immunopathological process of cholestasis to biliary atresia.
UNASSIGNED: The randomized, actively controlled, parallel-group trial (ISRCTN45080388 registry) was conducted from November 2022 to May 2023 in Dr. Soetomo General Academic Hospital, Surabaya, Indonesia, on infants with cholestasis. The ethics committee of Dr. Soetomo General Academic Hospital, Surabaya approved the study protocol. Infants 14 days to 3 months old, with cholestasis followed by acholic stool, dark urine, and hepatomegaly were included in the trial. Participants were randomly assigned to methylprednisolone 2 mg/kg/day twice daily or to placebo twice daily for two weeks. Ursodeoxycholic acid (10 mg/kg) was administered to all patients thrice daily. Clinical examination and laboratory measurements (direct and total bilirubin, Aspartate aminotransferase (AST), Alanine transaminase (ALT), Gamma-glutamyl transferase (GGT), and inflammatory biomarker) were performed at baseline and after 2-week treatment. Measurement of inflammatory biomarkers (IL-2, IL-4, IL-6, IL-10, IFN-γ, TGF-β, and ANCA) was performed using enzyme-linked immunoassays. Data distribution was checked for normality. Analysis was carried out using SPSS ver. 21 with p significant <0.05.
UNASSIGNED: In total, 40 participants were randomized to methylprednisolone (n = 20; mean age 8.39 ± 3.11 weeks) and placebo (n = 18; 2 drop out; mean age 8.98 ± 2.80 weeks) groups. At baseline, the methylprednisolone treatment and placebo groups significantly differed in gender (p = 0.02) but not in clinical, laboratory examination, or inflammatory biomarker levels. The methylprednisolone group had direct bilirubin 8.36 ± 4.84 mg/dL; total bilirubin 10.40 (2.70-33.25) mg/dL; AST 187.05 (42.00-911.00) U/L; ALT 170.43 ± 134.43 U/L; IL-2 171.29 (73.70-378.57) ng/L; IL-4 119.57 ± 59.69 ng/L; IL-6 71.74 ± 29.83 ng/L; IL-10 138.15 ± 70.62 ng/L; IFN-γ 42.54 ± 12.17 ng/L; TGF-β 316.58 (163.68-606.16) ng/L; ANCA 1.70 (0.66-3.25) ng/L. After two weeks of treatment, direct bilirubin, total bilirubin, AST, IL-10, and IFN-γ levels were significantly lower in the methylprednisolone group (p < 0.05) than those in the placebo group. No serious adverse events were reported.
UNASSIGNED: Methylprednisolone was efficacious in reducing 2-week bilirubin levels. These results support the hypothesis that the immunological process is involved in cholestasis. Further studies with larger sample sizes are needed to confirm the bile duct anti-inflammatory effect of methylprednisolone in cholestasis as an opportunity for new therapies to prevent the immunopathological process of cholestasis to biliary atresia.
摘要：
■这项研究分析了甲基强的松龙改善黄疸的有效性，胆红素水平，肝功能检查,和婴儿胆汁淤积的炎症生物标志物。
■随机化，主动控制,平行组试验（ISRCTN45080388注册）于2022年11月至2023年5月在Soetomo综合学术医院进行，泗水,印度尼西亚,婴儿胆汁淤积。Soetomo博士综合学术医院伦理委员会，泗水批准了研究方案。14天至3个月大的婴儿，胆汁淤积，其次是大便，深色尿液,和肝肿大纳入试验.参与者被随机分配给甲基强的松龙2mg/kg/天，每天两次，或安慰剂，每天两次，持续两周。所有患者每日三次服用熊去氧胆酸（10mg/kg）。临床检查和实验室测量（直接和总胆红素，天冬氨酸转氨酶(AST),丙氨酸转氨酶(ALT),γ-谷氨酰转移酶（GGT），和炎症生物标志物）在基线和治疗2周后进行。炎症生物标志物的测量（IL-2，IL-4，IL-6，IL-10，IFN-γ，TGF-β,和ANCA）使用酶联免疫测定法进行。检查数据分布是否正常。使用SPSSver进行分析。21,p显著<0.05。
■总共，40名参与者被随机分为甲基强的松龙（n=20；平均年龄8.39±3.11周）和安慰剂（n=18；2退出；平均年龄8.98±2.80周）组。在基线,甲基强的松龙治疗组和安慰剂组在性别上有显著差异(p=0.02),但在临床上没有显著差异,实验室检查,或炎性生物标志物水平。甲基强的松龙组直接胆红素8.36±4.84mg/dL;总胆红素10.40(2.70-33.25)mg/dL;AST187.05(42.00-911.00)U/L;ALT170.43±134.43U/L;IL-2171.29(73.70-378.57)ng/L;IL-4119.57±59.69L/IFN0.66ng/L;经过两周的治疗,直接胆红素,总胆红素,AST,甲基强的松龙组的IL-10和IFN-γ水平显著低于安慰剂组(p<0.05)。未报告严重不良事件。
■甲基强的松龙可有效降低2周胆红素水平。这些结果支持免疫过程参与胆汁淤积的假设。需要更大样本量的进一步研究来确认甲基强的松龙在胆汁淤积中的胆管抗炎作用，这是新疗法预防胆汁淤积到胆道闭锁的免疫病理学过程的机会。
■随机化，主动控制,平行组试验（ISRCTN45080388注册）于2022年11月至2023年5月在Soetomo综合学术医院进行，泗水,印度尼西亚,婴儿胆汁淤积。Soetomo博士综合学术医院伦理委员会，泗水批准了研究方案。14天至3个月大的婴儿，胆汁淤积，其次是大便，深色尿液,和肝肿大纳入试验.参与者被随机分配给甲基强的松龙2mg/kg/天，每天两次，或安慰剂，每天两次，持续两周。所有患者每日三次服用熊去氧胆酸（10mg/kg）。临床检查和实验室测量（直接和总胆红素，天冬氨酸转氨酶(AST),丙氨酸转氨酶(ALT),γ-谷氨酰转移酶（GGT），和炎症生物标志物）在基线和治疗2周后进行。炎症生物标志物的测量（IL-2，IL-4，IL-6，IL-10，IFN-γ，TGF-β,和ANCA）使用酶联免疫测定法进行。检查数据分布是否正常。使用SPSSver进行分析。21,p显著<0.05。
■总共，40名参与者被随机分为甲基强的松龙（n=20；平均年龄8.39±3.11周）和安慰剂（n=18；2退出；平均年龄8.98±2.80周）组。在基线,甲基强的松龙治疗组和安慰剂组在性别上有显著差异(p=0.02),但在临床上没有显著差异,实验室检查,或炎性生物标志物水平。甲基强的松龙组直接胆红素8.36±4.84mg/dL;总胆红素10.40(2.70-33.25)mg/dL;AST187.05(42.00-911.00)U/L;ALT170.43±134.43U/L;IL-2171.29(73.70-378.57)ng/L;IL-4119.57±59.69L/IFN0.66ng/L;经过两周的治疗,直接胆红素,总胆红素,AST,甲基强的松龙组的IL-10和IFN-γ水平显著低于安慰剂组(p<0.05)。未报告严重不良事件。
■甲基强的松龙可有效降低2周胆红素水平。这些结果支持免疫过程参与胆汁淤积的假设。需要更大样本量的进一步研究来确认甲基强的松龙在胆汁淤积中的胆管抗炎作用，这是新疗法预防胆汁淤积到胆道闭锁的免疫病理学过程的机会。
