Randomised trial of isoniazid versus rifampicin and pyrazinamide for prevention of tuberculosis in HIV-1 infection
Tuberculosis is a common complication of HIV-1 infection, especially in developing countries. Practical and effective chemoprophylaxis regimens for HIV-1-related tuberculosis are needed. Our aim was to test the efficacy of isoniazid versus rifampicin with pyrazinamide for prevention of tuberculosis...
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| Veröffentlicht in: | The Lancet (British edition) 1998-03, Vol.351 (9105), p.786-792 |
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| creator | Halsey, Neal A Coberly, Jacqueline S Desormeaux, Julio Losikoff, Phyllis Atkinson, Joan Moulton, Lawrence H Contave, Mireil Johnson, Michael Davis, Homer Geiter, Lawrence Johnson, Erica Huebner, Robin Boulos, Reginald Chaisson, Richard E |
| description | Tuberculosis is a common complication of HIV-1 infection, especially in developing countries. Practical and effective chemoprophylaxis regimens for HIV-1-related tuberculosis are needed. Our aim was to test the efficacy of isoniazid versus rifampicin with pyrazinamide for prevention of tuberculosis in HIV-1-positive individuals.
We compared the efficacy of 6 months of isoniazid with 2 months of rifampicin and pyrazinamide for prevention of tuberculosis in HIV-1-seropositive individuals. Eligible participants were aged 16–77 years, HIV-1 seropositive, had a positive purified-protein derivative (PPD) skin test reaction of at least 5 mm, and had a normal chest radiograph. Participants were randomly assigned partially supervised twice weekly isoniazid for 24 weeks or twice weekly rifampicin and pyrazinamide for 8 weeks. Participants were followed up for up to 4 years for the development of tuberculosis and survival.
Tuberculosis developed in 14 (3·8%) of 370 participants assigned isoniazid and 19 (5·0%) of 380 participants assigned rifampicin and pyrazinamide (Cox model rate ratio 1·3 [95% CI 0·7–2·7]). The Kaplan-Meier estimate of the risk of tuberculosis during the first 10 months after entry was 3·7% among participants who received rifampicin and pyrazinamide compared with 1·0% (p=0·03) among participants who received isoniazid, and 5·4% versus 5·1%, respectively (p=0·9) at 36 months after entry. Higher rates of tuberculosis were observed in people with baseline CD4 percentages (of total lymphocytes) of less than 20 (rate ratio 4·0 [95% CI 1·8–9·0]). There were no significant differences in total mortality at any time.
Twice-weekly isoniazid preventive therapy for 6 months or rifampicin and pyrazinamide for 2 months provided similar overall protection against tuberculosis in HIV-1-infected, PPD-positive adults. The better protection among recipients of isoniazid during the first 10 months was most likely secondary to the longer duration of chemoprophylaxis. Preventive therapy for HIV-1-seropositive, PPD-positive individuals could be practical in developing countries with a once weekly clinic visit, but optimum duration of chemoprophylaxis has not been determined. |
| doi_str_mv | 10.1016/S0140-6736(97)06532-X |
| format | Article |
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We compared the efficacy of 6 months of isoniazid with 2 months of rifampicin and pyrazinamide for prevention of tuberculosis in HIV-1-seropositive individuals. Eligible participants were aged 16–77 years, HIV-1 seropositive, had a positive purified-protein derivative (PPD) skin test reaction of at least 5 mm, and had a normal chest radiograph. Participants were randomly assigned partially supervised twice weekly isoniazid for 24 weeks or twice weekly rifampicin and pyrazinamide for 8 weeks. Participants were followed up for up to 4 years for the development of tuberculosis and survival.
Tuberculosis developed in 14 (3·8%) of 370 participants assigned isoniazid and 19 (5·0%) of 380 participants assigned rifampicin and pyrazinamide (Cox model rate ratio 1·3 [95% CI 0·7–2·7]). The Kaplan-Meier estimate of the risk of tuberculosis during the first 10 months after entry was 3·7% among participants who received rifampicin and pyrazinamide compared with 1·0% (p=0·03) among participants who received isoniazid, and 5·4% versus 5·1%, respectively (p=0·9) at 36 months after entry. Higher rates of tuberculosis were observed in people with baseline CD4 percentages (of total lymphocytes) of less than 20 (rate ratio 4·0 [95% CI 1·8–9·0]). There were no significant differences in total mortality at any time.
Twice-weekly isoniazid preventive therapy for 6 months or rifampicin and pyrazinamide for 2 months provided similar overall protection against tuberculosis in HIV-1-infected, PPD-positive adults. The better protection among recipients of isoniazid during the first 10 months was most likely secondary to the longer duration of chemoprophylaxis. Preventive therapy for HIV-1-seropositive, PPD-positive individuals could be practical in developing countries with a once weekly clinic visit, but optimum duration of chemoprophylaxis has not been determined.</description><identifier>ISSN: 0140-6736</identifier><identifier>EISSN: 1474-547X</identifier><identifier>DOI: 10.1016/S0140-6736(97)06532-X</identifier><identifier>PMID: 9519950</identifier><identifier>CODEN: LANCAO</identifier><language>eng</language><publisher>London: Elsevier Ltd</publisher><subject>Adult ; AIDS-Related Opportunistic Infections - epidemiology ; AIDS-Related Opportunistic Infections - prevention & control ; AIDS/HIV ; Antitubercular Agents - therapeutic use ; Bacterial diseases ; Bacterial endocarditis, myocarditis and pericarditis. Bacterial diseases of the aorta, limb vessels and lymphatic vessels ; Biological and medical sciences ; Developing countries ; Drug Administration Schedule ; Drug therapy ; Female ; Follow-Up Studies ; HIV ; HIV Infections - complications ; HIV-1 ; Human bacterial diseases ; Human immunodeficiency virus ; Humans ; Infectious diseases ; Isoniazid - therapeutic use ; LDCs ; Lymphocytes ; Male ; Medical sciences ; Prevention ; Preventive medicine ; Prospective Studies ; Pyrazinamide - therapeutic use ; Rifampin - therapeutic use ; Time Factors ; Tuberculosis ; Tuberculosis, Pulmonary - epidemiology ; Tuberculosis, Pulmonary - prevention & control</subject><ispartof>The Lancet (British edition), 1998-03, Vol.351 (9105), p.786-792</ispartof><rights>1998 Elsevier Ltd</rights><rights>1998 INIST-CNRS</rights><rights>Copyright Lancet Ltd. Mar 14, 1998</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c463t-6e6a044839b66fcc0fb3d5569a6efd51dffaf09fa26293f4653e8aeb438b12533</citedby><cites>FETCH-LOGICAL-c463t-6e6a044839b66fcc0fb3d5569a6efd51dffaf09fa26293f4653e8aeb438b12533</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/199009592?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>314,780,784,3549,27923,27924,45994,64384,64386,64388,72340</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=2171409$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/9519950$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Halsey, Neal A</creatorcontrib><creatorcontrib>Coberly, Jacqueline S</creatorcontrib><creatorcontrib>Desormeaux, Julio</creatorcontrib><creatorcontrib>Losikoff, Phyllis</creatorcontrib><creatorcontrib>Atkinson, Joan</creatorcontrib><creatorcontrib>Moulton, Lawrence H</creatorcontrib><creatorcontrib>Contave, Mireil</creatorcontrib><creatorcontrib>Johnson, Michael</creatorcontrib><creatorcontrib>Davis, Homer</creatorcontrib><creatorcontrib>Geiter, Lawrence</creatorcontrib><creatorcontrib>Johnson, Erica</creatorcontrib><creatorcontrib>Huebner, Robin</creatorcontrib><creatorcontrib>Boulos, Reginald</creatorcontrib><creatorcontrib>Chaisson, Richard E</creatorcontrib><title>Randomised trial of isoniazid versus rifampicin and pyrazinamide for prevention of tuberculosis in HIV-1 infection</title><title>The Lancet (British edition)</title><addtitle>Lancet</addtitle><description>Tuberculosis is a common complication of HIV-1 infection, especially in developing countries. Practical and effective chemoprophylaxis regimens for HIV-1-related tuberculosis are needed. Our aim was to test the efficacy of isoniazid versus rifampicin with pyrazinamide for prevention of tuberculosis in HIV-1-positive individuals.
We compared the efficacy of 6 months of isoniazid with 2 months of rifampicin and pyrazinamide for prevention of tuberculosis in HIV-1-seropositive individuals. Eligible participants were aged 16–77 years, HIV-1 seropositive, had a positive purified-protein derivative (PPD) skin test reaction of at least 5 mm, and had a normal chest radiograph. Participants were randomly assigned partially supervised twice weekly isoniazid for 24 weeks or twice weekly rifampicin and pyrazinamide for 8 weeks. Participants were followed up for up to 4 years for the development of tuberculosis and survival.
Tuberculosis developed in 14 (3·8%) of 370 participants assigned isoniazid and 19 (5·0%) of 380 participants assigned rifampicin and pyrazinamide (Cox model rate ratio 1·3 [95% CI 0·7–2·7]). The Kaplan-Meier estimate of the risk of tuberculosis during the first 10 months after entry was 3·7% among participants who received rifampicin and pyrazinamide compared with 1·0% (p=0·03) among participants who received isoniazid, and 5·4% versus 5·1%, respectively (p=0·9) at 36 months after entry. Higher rates of tuberculosis were observed in people with baseline CD4 percentages (of total lymphocytes) of less than 20 (rate ratio 4·0 [95% CI 1·8–9·0]). There were no significant differences in total mortality at any time.
Twice-weekly isoniazid preventive therapy for 6 months or rifampicin and pyrazinamide for 2 months provided similar overall protection against tuberculosis in HIV-1-infected, PPD-positive adults. The better protection among recipients of isoniazid during the first 10 months was most likely secondary to the longer duration of chemoprophylaxis. Preventive therapy for HIV-1-seropositive, PPD-positive individuals could be practical in developing countries with a once weekly clinic visit, but optimum duration of chemoprophylaxis has not been determined.</description><subject>Adult</subject><subject>AIDS-Related Opportunistic Infections - epidemiology</subject><subject>AIDS-Related Opportunistic Infections - prevention & control</subject><subject>AIDS/HIV</subject><subject>Antitubercular Agents - therapeutic use</subject><subject>Bacterial diseases</subject><subject>Bacterial endocarditis, myocarditis and pericarditis. Bacterial diseases of the aorta, limb vessels and lymphatic vessels</subject><subject>Biological and medical sciences</subject><subject>Developing countries</subject><subject>Drug Administration Schedule</subject><subject>Drug therapy</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>HIV</subject><subject>HIV Infections - complications</subject><subject>HIV-1</subject><subject>Human bacterial diseases</subject><subject>Human immunodeficiency virus</subject><subject>Humans</subject><subject>Infectious diseases</subject><subject>Isoniazid - therapeutic use</subject><subject>LDCs</subject><subject>Lymphocytes</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Prevention</subject><subject>Preventive medicine</subject><subject>Prospective Studies</subject><subject>Pyrazinamide - therapeutic use</subject><subject>Rifampin - therapeutic use</subject><subject>Time Factors</subject><subject>Tuberculosis</subject><subject>Tuberculosis, Pulmonary - epidemiology</subject><subject>Tuberculosis, Pulmonary - prevention & control</subject><issn>0140-6736</issn><issn>1474-547X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>1998</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqFkd1rFDEUxYModVv9EwpBRPRhNJl8zOZJpFhbKAh-sW8hk9xAykwyJjML9a830132wRefEri_c7j3HIQuKXlPCZUfvhPKSSM7Jt-q7h2RgrXN7gnaUN7xRvBu9xRtTshzdF7KPSGESyLO0JkSVClBNih_M9GlMRRweM7BDDh5HEqKwfwJDu8hl6XgHLwZp2BDxBXH00Ou02jG4AD7lPGUYQ9xDimu8nnpIdtlSCUUXCU3t78aWj8e7Iq8QM-8GQq8PL4X6Of15x9XN83d1y-3V5_uGsslmxsJ0hDOt0z1Unprie-ZE0IqI8E7QZ33xhPlTStbxTyvAcDWQM_ZtqetYOwCvTn4Tjn9XqDMup5pYRhMhLQU3amOy23bVvDVP-B9WnKsu-maEiFKqBUSB8jmVEoGr6ccRpMfNCV6LUQ_FqLXtLXq9GMheld1l0fzpR_BnVTHBur89XFuijWDzybaUE5YS7vqqir28YBBTWwfIOtiA0QLLuQaq3Yp_GeRvx57qTE</recordid><startdate>19980314</startdate><enddate>19980314</enddate><creator>Halsey, Neal A</creator><creator>Coberly, Jacqueline S</creator><creator>Desormeaux, Julio</creator><creator>Losikoff, Phyllis</creator><creator>Atkinson, Joan</creator><creator>Moulton, Lawrence H</creator><creator>Contave, Mireil</creator><creator>Johnson, Michael</creator><creator>Davis, Homer</creator><creator>Geiter, Lawrence</creator><creator>Johnson, Erica</creator><creator>Huebner, Robin</creator><creator>Boulos, Reginald</creator><creator>Chaisson, Richard E</creator><general>Elsevier Ltd</general><general>Lancet</general><general>Elsevier Limited</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>0TT</scope><scope>0TZ</scope><scope>0U~</scope><scope>3V.</scope><scope>7QL</scope><scope>7QP</scope><scope>7RV</scope><scope>7TK</scope><scope>7U7</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88A</scope><scope>88C</scope><scope>88E</scope><scope>88G</scope><scope>88I</scope><scope>8AF</scope><scope>8AO</scope><scope>8C1</scope><scope>8C2</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AEUYN</scope><scope>AFKRA</scope><scope>AN0</scope><scope>ASE</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BEC</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>C1K</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FPQ</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>H94</scope><scope>HCIFZ</scope><scope>K6X</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>KB~</scope><scope>LK8</scope><scope>M0R</scope><scope>M0S</scope><scope>M0T</scope><scope>M1P</scope><scope>M2M</scope><scope>M2O</scope><scope>M2P</scope><scope>M7N</scope><scope>M7P</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PSYQQ</scope><scope>Q9U</scope><scope>S0X</scope><scope>7X8</scope></search><sort><creationdate>19980314</creationdate><title>Randomised trial of isoniazid versus rifampicin and pyrazinamide for prevention of tuberculosis in HIV-1 infection</title><author>Halsey, Neal A ; Coberly, Jacqueline S ; Desormeaux, Julio ; Losikoff, Phyllis ; Atkinson, Joan ; Moulton, Lawrence H ; Contave, Mireil ; Johnson, Michael ; Davis, Homer ; Geiter, Lawrence ; Johnson, Erica ; Huebner, Robin ; Boulos, Reginald ; Chaisson, Richard E</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c463t-6e6a044839b66fcc0fb3d5569a6efd51dffaf09fa26293f4653e8aeb438b12533</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>1998</creationdate><topic>Adult</topic><topic>AIDS-Related Opportunistic Infections - epidemiology</topic><topic>AIDS-Related Opportunistic Infections - prevention & control</topic><topic>AIDS/HIV</topic><topic>Antitubercular Agents - therapeutic use</topic><topic>Bacterial diseases</topic><topic>Bacterial endocarditis, myocarditis and pericarditis. Bacterial diseases of the aorta, limb vessels and lymphatic vessels</topic><topic>Biological and medical sciences</topic><topic>Developing countries</topic><topic>Drug Administration Schedule</topic><topic>Drug therapy</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>HIV</topic><topic>HIV Infections - complications</topic><topic>HIV-1</topic><topic>Human bacterial diseases</topic><topic>Human immunodeficiency virus</topic><topic>Humans</topic><topic>Infectious diseases</topic><topic>Isoniazid - therapeutic use</topic><topic>LDCs</topic><topic>Lymphocytes</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Prevention</topic><topic>Preventive medicine</topic><topic>Prospective Studies</topic><topic>Pyrazinamide - therapeutic use</topic><topic>Rifampin - therapeutic use</topic><topic>Time Factors</topic><topic>Tuberculosis</topic><topic>Tuberculosis, Pulmonary - epidemiology</topic><topic>Tuberculosis, Pulmonary - prevention & 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edition)</jtitle><addtitle>Lancet</addtitle><date>1998-03-14</date><risdate>1998</risdate><volume>351</volume><issue>9105</issue><spage>786</spage><epage>792</epage><pages>786-792</pages><issn>0140-6736</issn><eissn>1474-547X</eissn><coden>LANCAO</coden><abstract>Tuberculosis is a common complication of HIV-1 infection, especially in developing countries. Practical and effective chemoprophylaxis regimens for HIV-1-related tuberculosis are needed. Our aim was to test the efficacy of isoniazid versus rifampicin with pyrazinamide for prevention of tuberculosis in HIV-1-positive individuals.
We compared the efficacy of 6 months of isoniazid with 2 months of rifampicin and pyrazinamide for prevention of tuberculosis in HIV-1-seropositive individuals. Eligible participants were aged 16–77 years, HIV-1 seropositive, had a positive purified-protein derivative (PPD) skin test reaction of at least 5 mm, and had a normal chest radiograph. Participants were randomly assigned partially supervised twice weekly isoniazid for 24 weeks or twice weekly rifampicin and pyrazinamide for 8 weeks. Participants were followed up for up to 4 years for the development of tuberculosis and survival.
Tuberculosis developed in 14 (3·8%) of 370 participants assigned isoniazid and 19 (5·0%) of 380 participants assigned rifampicin and pyrazinamide (Cox model rate ratio 1·3 [95% CI 0·7–2·7]). The Kaplan-Meier estimate of the risk of tuberculosis during the first 10 months after entry was 3·7% among participants who received rifampicin and pyrazinamide compared with 1·0% (p=0·03) among participants who received isoniazid, and 5·4% versus 5·1%, respectively (p=0·9) at 36 months after entry. Higher rates of tuberculosis were observed in people with baseline CD4 percentages (of total lymphocytes) of less than 20 (rate ratio 4·0 [95% CI 1·8–9·0]). There were no significant differences in total mortality at any time.
Twice-weekly isoniazid preventive therapy for 6 months or rifampicin and pyrazinamide for 2 months provided similar overall protection against tuberculosis in HIV-1-infected, PPD-positive adults. The better protection among recipients of isoniazid during the first 10 months was most likely secondary to the longer duration of chemoprophylaxis. Preventive therapy for HIV-1-seropositive, PPD-positive individuals could be practical in developing countries with a once weekly clinic visit, but optimum duration of chemoprophylaxis has not been determined.</abstract><cop>London</cop><pub>Elsevier Ltd</pub><pmid>9519950</pmid><doi>10.1016/S0140-6736(97)06532-X</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0140-6736 |
| ispartof | The Lancet (British edition), 1998-03, Vol.351 (9105), p.786-792 |
| issn | 0140-6736 1474-547X |
| language | eng |
| recordid | cdi_proquest_miscellaneous_79746822 |
| source | Elsevier ScienceDirect Journals Complete - AutoHoldings; MEDLINE; Business Source Complete; ProQuest Central UK/Ireland |
| subjects | Adult AIDS-Related Opportunistic Infections - epidemiology AIDS-Related Opportunistic Infections - prevention & control AIDS/HIV Antitubercular Agents - therapeutic use Bacterial diseases Bacterial endocarditis, myocarditis and pericarditis. Bacterial diseases of the aorta, limb vessels and lymphatic vessels Biological and medical sciences Developing countries Drug Administration Schedule Drug therapy Female Follow-Up Studies HIV HIV Infections - complications HIV-1 Human bacterial diseases Human immunodeficiency virus Humans Infectious diseases Isoniazid - therapeutic use LDCs Lymphocytes Male Medical sciences Prevention Preventive medicine Prospective Studies Pyrazinamide - therapeutic use Rifampin - therapeutic use Time Factors Tuberculosis Tuberculosis, Pulmonary - epidemiology Tuberculosis, Pulmonary - prevention & control |
| title | Randomised trial of isoniazid versus rifampicin and pyrazinamide for prevention of tuberculosis in HIV-1 infection |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-08T08%3A30%3A23IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Randomised%20trial%20of%20isoniazid%20versus%20rifampicin%20and%20pyrazinamide%20for%20prevention%20of%20tuberculosis%20in%20HIV-1%20infection&rft.jtitle=The%20Lancet%20(British%20edition)&rft.au=Halsey,%20Neal%20A&rft.date=1998-03-14&rft.volume=351&rft.issue=9105&rft.spage=786&rft.epage=792&rft.pages=786-792&rft.issn=0140-6736&rft.eissn=1474-547X&rft.coden=LANCAO&rft_id=info:doi/10.1016/S0140-6736(97)06532-X&rft_dat=%3Cproquest_cross%3E27433199%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=199009592&rft_id=info:pmid/9519950&rft_els_id=S014067369706532X&rfr_iscdi=true |