{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T01:45:10Z","timestamp":1791942310026,"version":"4.3.4"},"reference-count":37,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2018,10,20]],"date-time":"2018-10-20T00:00:00Z","timestamp":1539993600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Sun Yat-Sen University Clinical Research 5010 Program","award":["2010001"],"award-info":[{"award-number":["2010001"]}]},{"name":"The Science and Technology Planning Project of Guangdong Province, China","award":["2014A020221008"],"award-info":[{"award-number":["2014A020221008"]}]},{"name":"The Science and Technology Planning Project of Guangzhou, China","award":["201604020128"],"award-info":[{"award-number":["201604020128"]}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["American J Hematol"],"published-print":{"date-parts":[[2018,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Intravenous arsenic trioxide (ATO) has been adopted as the first\u2010line treatment for acute promyelocytic leukemia (APL). Another arsenic compound named the Realgar\u2010\n                    <jats:italic>Indigo naturalis<\/jats:italic>\n                    formula (RIF), an oral traditional Chinese medicine containing As\n                    <jats:sub>4<\/jats:sub>\n                    S\n                    <jats:sub>4<\/jats:sub>\n                    , has been shown to be highly effective in treating adult APL. In the treatment of pediatric APL, the safety and efficacy of RIF remains to be confirmed. This randomized, multicenter, and noninferiority trial was conducted to determine whether intravenous ATO can be substituted by oral RIF in the treatment of pediatric APL. From September 2011 to January 2017, among 92 patients who were 16\u2009years old or younger with newly diagnosed PML\u2010RARa positive APL, 82 met eligible criteria and were randomly assigned to ATO (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u200942) or RIF (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u200940) group. The remaining 10 patients did not fulfilled eligible criteria because five did not accept randomization, four died and one had hemiplegia prior to arsenic randomization due to intracranial hemorrhage or cerebral thrombosis. Induction and consolidation treatment contained ATO or RIF, all\u2010trans\u2010retinoic acid and low intensity chemotherapy. End points included event\u2010free survival (EFS), adverse events and hospital days. After a median 3\u2010year follow\u2010up, the estimated 5\u2010year EFS was 100% in both groups, and adverse events were mild. However, patients in the RIF group had significantly less hospital stay than those in the ATO group. This interim analysis shows that oral RIF is as effective and safe as intravenous ATO for the treatment of pediatric APL, with the advantage of reducing hospital stay. Final trial analysis will reveal mature outcome data.\n                  <\/jats:p>","DOI":"10.1002\/ajh.25271","type":"journal-article","created":{"date-parts":[[2018,8,30]],"date-time":"2018-08-30T12:47:39Z","timestamp":1535633259000},"page":"1467-1473","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":64,"title":["Multicenter randomized trial of arsenic trioxide and Realgar\u2010\n                    <i>Indigo naturalis<\/i>\n                    formula in pediatric patients with acute promyelocytic leukemia: Interim results of the SCCLG\u2010APL clinical study"],"prefix":"10.1002","volume":"93","author":[{"given":"Ming\u2010Hua","family":"Yang","sequence":"first","affiliation":[{"name":"Department of Pediatrics Xiangya Hospital, Central South University  Changsha Hunan China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wu\u2010Qing","family":"Wan","sequence":"additional","affiliation":[{"name":"Department of Pediatrics Second Xiangya Hospital, Central South University  Hunan China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jie\u2010Si","family":"Luo","sequence":"additional","affiliation":[{"name":"Department of Pediatrics First Affiliated Hospital, Sun Yat\u2010Sen University  Guangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Min\u2010Cui","family":"Zheng","sequence":"additional","affiliation":[{"name":"Department of Hematology Hunan Childdren's Hospital  Changsha Hunan China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ke","family":"Huang","sequence":"additional","affiliation":[{"name":"Department of Pediatrics Sun Yat\u2010Sen Memorial Hospital, Sun Yat\u2010Sen University  Guangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Li\u2010Hua","family":"Yang","sequence":"additional","affiliation":[{"name":"Department of Pediatrics Zhujiang Hospital, Southern Medical University  Guangzhou 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