Deleterious Effect of Prednisolone in HBsAg-positive Chronic Active Hepatitis

To study the efficacy of corticosteroids in chronic active hepatitis (CAH) positive for hepatitis B surface antigen (HBsAg), we pair-randomized 51 patients to receive either 15 to 20 mg of prednisolone per day or a placebo. After initial remission, the maintenance dosage of prednisolone was 10 mg pe...

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Veröffentlicht in:The New England journal of medicine 1981-02, Vol.304 (7), p.380-386
Hauptverfasser: Lam, Kui Chun, Lai, Ching Lung, Ng, R. P, Trepo, Christian, Wu, P. C
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container_issue 7
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container_title The New England journal of medicine
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creator Lam, Kui Chun
Lai, Ching Lung
Ng, R. P
Trepo, Christian
Wu, P. C
description To study the efficacy of corticosteroids in chronic active hepatitis (CAH) positive for hepatitis B surface antigen (HBsAg), we pair-randomized 51 patients to receive either 15 to 20 mg of prednisolone per day or a placebo. After initial remission, the maintenance dosage of prednisolone was 10 mg per day, and the patients were prospectively followed for up to 3 1/2 years. Prednisolone decreased serum bilirubin (P
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P ; Trepo, Christian ; Wu, P. C</creator><creatorcontrib>Lam, Kui Chun ; Lai, Ching Lung ; Ng, R. P ; Trepo, Christian ; Wu, P. C</creatorcontrib><description><![CDATA[To study the efficacy of corticosteroids in chronic active hepatitis (CAH) positive for hepatitis B surface antigen (HBsAg), we pair-randomized 51 patients to receive either 15 to 20 mg of prednisolone per day or a placebo. After initial remission, the maintenance dosage of prednisolone was 10 mg per day, and the patients were prospectively followed for up to 3 1/2 years. Prednisolone decreased serum bilirubin (P<0.05) and globulin (P<0.01) at three months; it delayed other biochemical remission occurring after the second month of medication (P<0.001); it hastened biochemical relapse (P<0.0001); and it increased the frequency of complications (P<0.0001) and the death rate (P<0.01). We conclude that prednisolone has an overall harmful effect in patients with HBsAg-positive CAH. (N Engl J Med. 1981; 304:380–6.) THE beneficial effects of corticosteroids in chronic active hepatitis (CAH) have been so well established in Australia, 1 England, 2 and America 3 that this group of drugs has become the mainstay of treatment for CAH. The conclusions are so strong that withholding corticosteroids from these patients has been considered unethical. 2 However, the cases in these series have usually been negative for hepatitis B surface antigen (HBsAg). In HBsAg-positive cases, the response to prednisolone has recently been found to be less satisfactory than that in HBsAg-negative cases. 4 Whether corticosteroids are effective at all in HBsAg-positive disease is still open to question. 5 There is . . .]]></description><identifier>ISSN: 0028-4793</identifier><identifier>EISSN: 1533-4406</identifier><identifier>DOI: 10.1056/NEJM198102123040702</identifier><identifier>PMID: 7005678</identifier><language>eng</language><publisher>United States: Massachusetts Medical Society</publisher><subject>Adult ; Alanine Transaminase - blood ; Aspartate Aminotransferases - blood ; Bilirubin - blood ; Biopsy ; Chronic Disease ; Clinical Trials as Topic ; Corticosteroids ; Diabetes ; Drug dosages ; Endoscopy ; Female ; Hepatitis ; Hepatitis - drug therapy ; Hepatitis B - drug therapy ; Hepatitis B Surface Antigens - analysis ; Hospitals ; Humans ; Laboratories ; Male ; Middle Aged ; Patients ; Prednisolone - adverse effects ; Prednisolone - therapeutic use ; Prospective Studies ; Random Allocation ; Remission, Spontaneous ; Serum Globulins - analysis ; Tuberculosis ; Urine</subject><ispartof>The New England journal of medicine, 1981-02, Vol.304 (7), p.380-386</ispartof><rights>Copyright Massachusetts Medical Society Feb 12, 1981</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c467t-a728c7d5c836d8fb020c867e11f1491c0ed729a41a49feccf82a78fbd817618d2</citedby><cites>FETCH-LOGICAL-c467t-a728c7d5c836d8fb020c867e11f1491c0ed729a41a49feccf82a78fbd817618d2</cites></display><links><openurl>$$Topenurl_article</openurl><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>776</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/7005678$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Lam, Kui Chun</creatorcontrib><creatorcontrib>Lai, Ching Lung</creatorcontrib><creatorcontrib>Ng, R. P</creatorcontrib><creatorcontrib>Trepo, Christian</creatorcontrib><creatorcontrib>Wu, P. C</creatorcontrib><title>Deleterious Effect of Prednisolone in HBsAg-positive Chronic Active Hepatitis</title><title>The New England journal of medicine</title><addtitle>N Engl J Med</addtitle><description><![CDATA[To study the efficacy of corticosteroids in chronic active hepatitis (CAH) positive for hepatitis B surface antigen (HBsAg), we pair-randomized 51 patients to receive either 15 to 20 mg of prednisolone per day or a placebo. After initial remission, the maintenance dosage of prednisolone was 10 mg per day, and the patients were prospectively followed for up to 3 1/2 years. Prednisolone decreased serum bilirubin (P<0.05) and globulin (P<0.01) at three months; it delayed other biochemical remission occurring after the second month of medication (P<0.001); it hastened biochemical relapse (P<0.0001); and it increased the frequency of complications (P<0.0001) and the death rate (P<0.01). 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In HBsAg-positive cases, the response to prednisolone has recently been found to be less satisfactory than that in HBsAg-negative cases. 4 Whether corticosteroids are effective at all in HBsAg-positive disease is still open to question. 5 There is . . .]]></description><subject>Adult</subject><subject>Alanine Transaminase - blood</subject><subject>Aspartate Aminotransferases - blood</subject><subject>Bilirubin - blood</subject><subject>Biopsy</subject><subject>Chronic Disease</subject><subject>Clinical Trials as Topic</subject><subject>Corticosteroids</subject><subject>Diabetes</subject><subject>Drug dosages</subject><subject>Endoscopy</subject><subject>Female</subject><subject>Hepatitis</subject><subject>Hepatitis - drug therapy</subject><subject>Hepatitis B - drug therapy</subject><subject>Hepatitis B Surface Antigens - analysis</subject><subject>Hospitals</subject><subject>Humans</subject><subject>Laboratories</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Patients</subject><subject>Prednisolone - adverse effects</subject><subject>Prednisolone - therapeutic use</subject><subject>Prospective Studies</subject><subject>Random Allocation</subject><subject>Remission, Spontaneous</subject><subject>Serum Globulins - analysis</subject><subject>Tuberculosis</subject><subject>Urine</subject><issn>0028-4793</issn><issn>1533-4406</issn><fulltext>false</fulltext><rsrctype>article</rsrctype><creationdate>1981</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BEC</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNp9UMFOwzAMjRBojMEXIKRKHFHBTrMmPY4xGGgDDnCuutSBTmszkhaJvydjEyeEL5b1np-fH2OnCJcIw_TqcfIwx0whcOQJCJDA91gfh0kSCwHpPusDcBULmSWH7Mj7JYRCkfVYT0IQkKrP5je0opZcZTsfTYwh3UbWRM-OyqbydmUbiqomml770Vu8tr5qq0-Kxu_ONpWORvpnnNK6aAPij9mBKVaeTnZ9wF5vJy_jaTx7ursfj2axFqls40JypWU51CpJS2UWwEGrVBKiCfZQA5WSZ4XAQmTBkTaKFzLwSoUyRVXyATvf6q6d_ejIt_nSdq4JJ3NUcvNkCCSwki1LO-u9I5OvXVUX7itHyDcJ5n8kGLbOdtrdoqbyd2cXWcAvtnhd-7yhZf2v2jdHdXa_</recordid><startdate>19810212</startdate><enddate>19810212</enddate><creator>Lam, Kui Chun</creator><creator>Lai, Ching Lung</creator><creator>Ng, R. 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P</au><au>Trepo, Christian</au><au>Wu, P. C</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Deleterious Effect of Prednisolone in HBsAg-positive Chronic Active Hepatitis</atitle><jtitle>The New England journal of medicine</jtitle><addtitle>N Engl J Med</addtitle><date>1981-02-12</date><risdate>1981</risdate><volume>304</volume><issue>7</issue><spage>380</spage><epage>386</epage><pages>380-386</pages><issn>0028-4793</issn><eissn>1533-4406</eissn><abstract><![CDATA[To study the efficacy of corticosteroids in chronic active hepatitis (CAH) positive for hepatitis B surface antigen (HBsAg), we pair-randomized 51 patients to receive either 15 to 20 mg of prednisolone per day or a placebo. After initial remission, the maintenance dosage of prednisolone was 10 mg per day, and the patients were prospectively followed for up to 3 1/2 years. Prednisolone decreased serum bilirubin (P<0.05) and globulin (P<0.01) at three months; it delayed other biochemical remission occurring after the second month of medication (P<0.001); it hastened biochemical relapse (P<0.0001); and it increased the frequency of complications (P<0.0001) and the death rate (P<0.01). We conclude that prednisolone has an overall harmful effect in patients with HBsAg-positive CAH. (N Engl J Med. 1981; 304:380–6.) THE beneficial effects of corticosteroids in chronic active hepatitis (CAH) have been so well established in Australia, 1 England, 2 and America 3 that this group of drugs has become the mainstay of treatment for CAH. The conclusions are so strong that withholding corticosteroids from these patients has been considered unethical. 2 However, the cases in these series have usually been negative for hepatitis B surface antigen (HBsAg). In HBsAg-positive cases, the response to prednisolone has recently been found to be less satisfactory than that in HBsAg-negative cases. 4 Whether corticosteroids are effective at all in HBsAg-positive disease is still open to question. 5 There is . . .]]></abstract><cop>United States</cop><pub>Massachusetts Medical Society</pub><pmid>7005678</pmid><doi>10.1056/NEJM198102123040702</doi><tpages>7</tpages></addata></record>
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subjects Adult
Alanine Transaminase - blood
Aspartate Aminotransferases - blood
Bilirubin - blood
Biopsy
Chronic Disease
Clinical Trials as Topic
Corticosteroids
Diabetes
Drug dosages
Endoscopy
Female
Hepatitis
Hepatitis - drug therapy
Hepatitis B - drug therapy
Hepatitis B Surface Antigens - analysis
Hospitals
Humans
Laboratories
Male
Middle Aged
Patients
Prednisolone - adverse effects
Prednisolone - therapeutic use
Prospective Studies
Random Allocation
Remission, Spontaneous
Serum Globulins - analysis
Tuberculosis
Urine
title Deleterious Effect of Prednisolone in HBsAg-positive Chronic Active Hepatitis
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