4.4 Article Retracted Publication

被撤回的出版物: Dexamethasone for the Prevention of Recurrent Laryngeal Nerve Palsy and Other Complications After Thyroid Surgery A Randomized Double-Blind Placebo-Controlled Trial (Publication with Expression of Concern. See vol. 143, pg. 869, 2017) (Retracted article. See vol. 144, pg. 1089, 2018)

Journal

JAMA OTOLARYNGOLOGY-HEAD & NECK SURGERY
Volume 139, Issue 5, Pages 471-478

Publisher

AMER MEDICAL ASSOC
DOI: 10.1001/jamaoto.2013.2821

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Importance: Recurrent laryngeal nerve dysfunction and hypoparathyroidism are well-recognized, important complications of thyroid surgery. The duration of convalescence after noncomplicated thyroid operation may depend on several factors, of which pain and fatigue are the most important. Nausea and vomiting occur mainly on the day of operation. Glucocorticoids are well known for their analgesic, anti-inflammatory, immune-modulating and antiemetic effects. However, there is little information in the literature on the use of steroids in thyroid surgery, and the information that is available is conflicting. Objective: To investigate whether preoperative dexamethasone could improve surgical outcome in patients undergoing thyroid surgery. Design: A randomized double-blind placebo-controlled trial. A 30-day follow-up for morbidity was performed in all cases. Setting: All patients were hospitalized in a public hospital. Participants: From June 2008 through August 2011, 328 patients were randomized to receive either intravenous dexamethasone, 8 mg, administered 90 minutes before skin incision, or saline solution (placebo). Interventions: Intravenous dexamethasone, 8 mg. Main Outcomes and Measures: The primary end points were temporary or permanent recurrent laryngeal nerve palsy. Transient and definitive hypoparathy-roidism, pain and fatigue scores, nausea, and the number of vomiting episodes were also registered. Preoperatively and at several times during the first 24 postoperative hours, we measured C-reactive protein, interleukin 6, and interleukin 1 beta levels. Results: In the dexamethasone group, the rate of temporary recurrent laryngeal nerve palsy (4.9%) was significantly lower compared with the placebo group (8.4%) (P=.04). Also, postoperative transient biochemical hypoparathyroidism occurred more frequently in the placebo group (37.0%) than in the dexamethasone group (12.8%). Dexamethasone use significantly reduced postoperative levels of C-reactive protein (P=.01) and interleukin 6 and interleukin 1 beta (P=.02), fatigue (P=.01), and overall pain during the first 24 postoperative hours (P=.04), as well as the total analgesic (ketorolac tromethamine) requirement (P=.04). Dexamethasone use also reduced nausea and vomiting on the day of operation (P=.045). Conclusions and Relevance: Preoperative administration of dexamethasone, 8 mg, reduced postoperative temporary recurrent laryngeal nerve palsy and hypoparathyroidism rates and reduced pain, fatigue, nausea, and vomiting after thyroid surgery. However, these data require further analysis in randomized prospective studies.

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