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Conservative management versus tonsillectomy in adults with recurrent acute tonsillitis in the UK (NATTINA): a multicentre, open-label, randomised controlled trial
The Lancet ( IF 98.4 ) Pub Date : 2023-05-17 , DOI: 10.1016/s0140-6736(23)00519-6
Janet A Wilson 1 , James O'Hara 2 , Tony Fouweather 1 , Tara Homer 1 , Deborah D Stocken 3 , Luke Vale 1 , Catherine Haighton 4 , Nikki Rousseau 3 , Rebecca Wilson 5 , Lorraine McSweeney 1 , Scott Wilkes 6 , Jill Morrison 7 , Kenneth MacKenzie 8 , Kim Ah-See 9 , Sean Carrie 10 , Claire Hopkins 11 , Nicola Howe 5 , Musheer Hussain 12 , Hisham Mehanna 13 , Christopher Raine 14 , Frank Sullivan 15 , Alexander von Wilamowitz-Moellendorff 5 , M Dawn Teare 1
Affiliation  

Tonsillectomy is regularly performed in adults with acute tonsillitis, but with scarce evidence. A reduction in tonsillectomies has coincided with an increase in acute adult hospitalisation for tonsillitis complications. We aimed to assess the clinical effectiveness and cost-effectiveness of conservative management versus tonsillectomy in patients with recurrent acute tonsillitis. This pragmatic multicentre, open-label, randomised controlled trial was conducted in 27 hospitals in the UK. Participants were adults aged 16 years or older who were newly referred to secondary care otolaryngology clinics with recurrent acute tonsillitis. Patients were randomly assigned (1:1) to receive tonsillectomy or conservative management using random permuted blocks of variable length. Stratification by recruiting centre and baseline symptom severity was assessed using the Tonsil Outcome Inventory-14 score (categories defined as mild 0–35, moderate 36–48, or severe 49–70). Participants in the tonsillectomy group received elective surgery to dissect the palatine tonsils within 8 weeks after random assignment and those in the conservative management group received standard non-surgical care during 24 months. The primary outcome was the number of sore throat days collected during 24 months after random assignment, reported once per week with a text message. The primary analysis was done in the intention-to-treat (ITT) population. This study is registered with the ISRCTN registry, 55284102. Between May 11, 2015, and April 30, 2018, 4165 participants with recurrent acute tonsillitis were assessed for eligibility and 3712 were excluded. 453 eligible participants were randomly assigned (233 in the immediate tonsillectomy group 220 in the conservative management group). 429 (95%) patients were included in the primary ITT analysis (224 205). The median age of participants was 23 years (IQR 19–30), with 355 (78%) females and 97 (21%) males. Most participants were White (407 [90%]). Participants in the immediate tonsillectomy group had fewer days of sore throat during 24 months than those in the conservative management group (median 23 days [IQR 11–46] 30 days [14–65]). After adjustment for site and baseline severity, the incident rate ratio of total sore throat days in the immediate tonsillectomy group (n=224) compared with the conservative management group (n=205) was 0·53 (95% CI 0·43 to 0·65; <0·0001). 191 adverse events in 90 (39%) of 231 participants were deemed related to tonsillectomy. The most common adverse event was bleeding (54 events in 44 [19%] participants). No deaths occurred during the study. Compared with conservative management, immediate tonsillectomy is clinically effective and cost-effective in adults with recurrent acute tonsillitis. National Institute for Health Research.

中文翻译:

英国复发性急性扁桃体炎成人的保守治疗与扁桃体切除术(NATTINA):一项多中心、开放标签、随机对照试验

患有急性扁桃体炎的成人经常进行扁桃体切除术,但证据很少。扁桃体切除术的减少与扁桃体炎并发症急性成人住院人数的增加同时发生。我们的目的是评估复发性急性扁桃体炎患者保守治疗与扁桃体切除术的临床效果和成本效益。这项务实的多中心、开放标签、随机对照试验在英国 27 家医院进行。参与者是 16 岁或以上的成年人,他们最近因复发性急性扁桃体炎转诊到二级护理耳鼻喉科诊所。患者被随机分配(1:1)接受扁桃体切除术或使用可变长度的随机排列块进行保守治疗。使用扁桃体结果清单 14 评分(类别定义为轻度 0-35、中度 36-48 或重度 49-70)按招募中心和基线症状严重程度进行分层。扁桃体切除术组的参与者在随机分配后 8 周内接受择期手术解剖腭扁桃体,而保守治疗组的参与者在 24 个月内接受标准的非手术护理。主要结果是随机分配后 24 个月内收集的喉咙痛天数,每周通过短信报告一次。主要分析是在意向治疗(ITT)人群中进行的。这项研究已在 ISRCTN 登记处注册,注册号为 55284102。2015 年 5 月 11 日至 2018 年 4 月 30 日期间,对 4165 名患有复发性急性扁桃体炎的参与者进行了资格评估,其中 3712 名被排除在外。453 名符合条件的参与者被随机分配(233 名参加立即扁桃体切除术组,220 名参加保守治疗组)。429 名 (95%) 患者被纳入主要 ITT 分析 (224 205)。参与者的中位年龄为 23 岁(IQR 19-30),其中 355 名(78%)女性和 97 名(21%)男性。大多数参与者是白人(407 名 [90%])。立即扁桃体切除术组的参与者在 24 个月内出现喉咙痛的天数比保守治疗组的参与者少(中位 23 天 [IQR 11–46] 30 天 [14–65])。调整部位和基线严重程度后,即刻扁桃体切除组(n=224)与保守治疗组(n=205)相比,咽痛总天数的发生率为 0·53(95% CI 0·43 至0·65;<0·0001)。231 名参与者中有 90 名(39%)发生了 191 起不良事件,被认为与扁桃体切除术有关。最常见的不良事件是出血(44 名 [19%] 参与者发生 54 起事件)。研究期间没有发生死亡。与保守治疗相比,对于患有复发性急性扁桃体炎的成人,立即扁桃体切除术具有临床效果和成本效益。国家健康研究所。
更新日期:2023-05-17
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