首页> 中文期刊> 《国际感染杂志(电子版)》 >A Retrospective, Multi-Center, Post-Marketing Observational Study to Evaluate the Effectiveness of Ademetionine 1,4-Butanedisulfonate Injection (Transmetil®) Treatment in Chinese Patients with Intrahepatic Cholestasis Caused by Viral Hepatitis

A Retrospective, Multi-Center, Post-Marketing Observational Study to Evaluate the Effectiveness of Ademetionine 1,4-Butanedisulfonate Injection (Transmetil®) Treatment in Chinese Patients with Intrahepatic Cholestasis Caused by Viral Hepatitis

         

摘要

Obejective Ademetionine 1,4-butanedisulfonate [S-adenosyl-L-methionine (SAMe)/Transmetil®, Abbott] has been available in China for more than 15 years, and it has been shown to reduce serum bilirubin and transaminase levels in patients with viral hepatitis (VH). However, no large-scale studies have focused on the impact of SAMe treatment regimen on reducing the serum total bilirubin (TBil) in VH patients with intrahepatic cholestasis (IHC). The main objective of this study was to evaluate the effectiveness of intravenous SAMe (Transmetil®) treatment in reducing the serum TBil by 50%. Methods This retrospective, multi-center, cross-sectional medical record review involved patients aged≥18 years. Records of 1 280 hospitalized VH patients at 16 sites diagnosed with IHC who had received intravenous SAMe 1 000 mg or 2 000 mg q.d. for at least 7 days from January 1, 2006 to June 30, 2009, were screened and 905 records were randomly selected. Results The safety set (SS) included 834 patients and the full analysis set included 826 patients. TBil levels after 14 days injection treatment were available for 763 patients. TBil decreased≥ 50%versus baseline after 14 days treatment in 288 (37.7%) patients (95%CI 34.3%, 41.2%). Twenty-nine non-serious adverse events (non-SAEs) were reported in 19 (2.3%) patients, and 29 SAEs were reported in 10 patients (1.2%). All adverse events (AEs) were considered unrelated to the drug. Conclusions This retrospective study shows that intravenous SAMe administration in VH patients with IHC is associated with signiifcant reduction of TBil levels in more than 30%of patients 14 days after treatment initiation.

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  • 来源
    《国际感染杂志(电子版)》 |2013年第2期|71-80|共10页
  • 作者单位

    Liver Diseases Center, Beijing Ditan Hospital, Capital Medical University, Beijing 100015, China;

    Fuzhou Infectious Disease Hospital, Fuzhou, Fujian Province 350025, China;

    Xuzhou Infectious Disease Hospital, Xuzhou, Jiangsu Province 221004, China;

    The First Afifliated Hospital of Jilin University, Changchun, Jilin Province 130021, China;

    Huaian Chuzhou Hospital, Chuzhou, Anhui Province 232052, China;

    China-Japan Friendship Hospital Afifliated Jilin University, Changchun, Jilin Province 130033, China;

    Yangzhou Third people’s Hospital, Yangzhou, Jiangsu Province 225002, China;

    The First Afifliated Hospital of Suzhou University, Suzhou, Jiangsu Province 215006, China;

    Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai 200025, China;

    Liver Diseases Center, Beijing Ditan Hospital, Capital Medical University, Beijing 100015, China;

    Liver Diseases Center, Beijing Ditan Hospital, Capital Medical University, Beijing 100015, China;

    YouAn Hospital, Capital Medical University, Beijing 100069, China;

    Shanghai Public Health Clinical Center, Shanghai 201508, China;

    Tianjin Infectious Disease Hospital, Tianjin 300192, China;

    Dalian Sixth People’s Hospital, Dalian, Liaoning Province 116031, China;

    Ningbo No.2 Hospital, Ningbo, Zhejiang Province 315010, China;

    The 302 Military Hospital of China, Beijing 100039, China;

    West China Hospital of Sichuan University, Chengdu, Sichuan Province 610041, China;

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