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己酮可可碱联合泼尼松龙与单用己酮可可碱治疗重度酒精性肝炎的随机对照临床试验

Pentoxifylline Plus Prednisolone versus Pentoxifylline Only for Severe Alcoholic Hepatitis: A Randomized Controlled Clinical Trial.

作者信息

De Bk, Mandal Sk, Sau D, Mani S, Chatterjee S, Mondal Ss, Bhattacharya K, Sil K, Bhattacharya R

机构信息

Department of Medicine, Medical College, Kolkata, West Bengal, India.

出版信息

Ann Med Health Sci Res. 2014 Sep;4(5):810-6. doi: 10.4103/2141-9248.141562.

DOI:10.4103/2141-9248.141562
PMID:25328799
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4199180/
Abstract

BACKGROUND

Prednisolone and pentoxifylline (PTX) have been shown to be individually useful in severe alcoholic hepatitis with Maddrey discriminant function (MDF) score ≥32. Previous report suggests that PTX is probably superior to prednisolone alone. However the efficacy of PTX and prednisolone combination over PTX alone in the management of acute alcoholic hepatitis (MDF score ≥32) is yet unrevealed.

AIM

The present study was initiated to find out the efficacy of combined pentoxifylline and prednisolone versus PTX alone in acute alcoholic hepatitis in respect of short and intermediate term outcomes.

SUBJECTS AND METHODS

A total of 124 patients with severe alcoholic hepatitis (MDF score ≥ 32) initially were evaluated. 62 patients who fulfilled the inclusion and exclusion criteria were randomized and divided into 2 groups. Group 1 received PTX only, whereas Group 2 received PTX plus Prednisolone. The total duration of follow-up was 12 months. Student's t-test, Chi-square test, the Kaplan-Meier methods were used for statistical analysis.

RESULTS

A total of 60 patients, 30 in each group were available for final analysis. In Group-1, 6 patients expired at the end of 1 year (5 within 3 months and another after 3 months). In Group 2, 10 patients expired at the end of 1 year (9 within 3 months and another after 3 months). Though survival probability is higher among Group 1 patients but the difference is not statistically significant.

CONCLUSION

The combination of PTX plus Prednisolone yields no additional benefit in terms of mortality and morbidity from that of PTX monotherapy.

摘要

背景

泼尼松龙和己酮可可碱(PTX)已被证明单独用于治疗Maddrey判别函数(MDF)评分≥32的严重酒精性肝炎时均有效。先前的报告表明,PTX可能优于单独使用泼尼松龙。然而,PTX与泼尼松龙联合使用在治疗急性酒精性肝炎(MDF评分≥32)方面相对于单独使用PTX的疗效尚未明确。

目的

本研究旨在探讨己酮可可碱与泼尼松龙联合使用相对于单独使用PTX治疗急性酒精性肝炎的短期和中期疗效。

对象与方法

最初对124例严重酒精性肝炎(MDF评分≥32)患者进行了评估。将62例符合纳入和排除标准的患者随机分为2组。第1组仅接受PTX治疗,而第2组接受PTX加泼尼松龙治疗。随访总时长为12个月。采用学生t检验、卡方检验和Kaplan-Meier方法进行统计分析。

结果

共有60例患者可供最终分析,每组各30例。在第1组中,1年结束时6例患者死亡(3个月内5例,3个月后1例)。在第2组中,1年结束时10例患者死亡(3个月内9例,3个月后1例)。虽然第1组患者的生存概率较高,但差异无统计学意义。

结论

PTX加泼尼松龙联合使用在死亡率和发病率方面相对于PTX单药治疗没有额外益处。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d0d9/4199180/bc6abaab110b/AMHSR-4-810-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d0d9/4199180/2834e0864a30/AMHSR-4-810-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d0d9/4199180/bc6abaab110b/AMHSR-4-810-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d0d9/4199180/2834e0864a30/AMHSR-4-810-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d0d9/4199180/bc6abaab110b/AMHSR-4-810-g003.jpg

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