{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,11]],"date-time":"2026-10-11T13:39:51Z","timestamp":1791725991589,"version":"4.3.4"},"reference-count":30,"publisher":"Oxford University Press (OUP)","issue":"9","license":[{"start":{"date-parts":[[2020,8,26]],"date-time":"2020-08-26T00:00:00Z","timestamp":1598400000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"funder":[{"DOI":"10.13039\/501100001322","name":"South African Medical Research Council","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100001322","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,11,2]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Liver injury is a common complication of anti-tuberculosis therapy. N-acetylcysteine (NAC) used in patients with paracetamol toxicity with limited evidence of benefit in liver injury due to other causes.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>We conducted a randomized, double-blind, placebo-controlled trial to assess the efficacy of intravenous NAC in hospitalized adult patients with anti-tuberculosis drug\u2013induced liver injury (AT-DILI). The primary endpoint was time for serum alanine aminotransferase (ALT) to fall below 100 U\/L. Secondary endpoints included length of hospital stay, in-hospital mortality, and adverse events.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Fifty-three participants were randomized to NAC and 49 to placebo. Mean age was 38 (SD\u00b110) years, 58 (57%) were female, 89 (87%) were HIV positive. Median (IQR) serum ALT and bilirubin at presentation were 462 (266\u2013790) U\/L and 56 (25\u2013100) \u03bcmol\/L, respectively. Median time to ALT &amp;lt;100 U\/L was 7.5 (6\u201311) days in the NAC arm and 8 (5\u201313) days in the placebo arm. Median time to hospital discharge was shorter in the NAC arm (9 [6\u201315] days) than in the placebo arm (18 [10\u201325] days) (HR, 1.73; 95% CI, 1.13\u20132.65). Mortality was 14% overall and did not differ by study arm. The study infusion was stopped early due to an adverse reaction in 5 participants receiving NAC (nausea and vomiting [3], anaphylaxis [1], pain at drip site [1]).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>NAC did not shorten time to ALT &amp;lt;100 U\/L in participants with AT-DILI, but significantly reduced length of hospital stay. NAC should be considered in management of AT-DILI.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Clinical Trials Registration<\/jats:title>\n                  <jats:p>South African National Clinical Trials Registry (SANCTR: DOH-27-0414-4719).<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/cid\/ciaa1255","type":"journal-article","created":{"date-parts":[[2020,8,21]],"date-time":"2020-08-21T19:15:36Z","timestamp":1598037336000},"page":"e3377-e3383","source":"Crossref","is-referenced-by-count":46,"title":["A Randomized Controlled Trial of Intravenous N-Acetylcysteine in the Management of Anti-tuberculosis Drug\u2013Induced Liver Injury"],"prefix":"10.1093","volume":"73","author":[{"given":"Muhammed Shiraz","family":"Moosa","sequence":"first","affiliation":[{"name":"Department of Medicine, University of Cape Town, Cape Town, South Africa"},{"name":"Department of Medicine, New Somerset Hospital, Cape Town, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3080-6606","authenticated-orcid":false,"given":"Gary","family":"Maartens","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hannah","family":"Gunter","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shaazia","family":"Allie","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohamed F","family":"Chughlay","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mashiko","family":"Setshedi","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Department of Medicine, University of Cape Town, Cape Town, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sean","family":"Wasserman","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases and HIV Medicine, Department of Medicine, University of Cape Town, Cape Town, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David F","family":"Stead","sequence":"additional","affiliation":[{"name":"Department of Medicine, University of Cape Town, Cape Town, South Africa"},{"name":"Department of Medicine, New Somerset Hospital, Cape Town, South 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