Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.
Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK; Ear, Nose, and Throat Department, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK. Electronic address: james.o'
Lancet. 2023 Jun 17;401(10393):2051-2059. doi: 10.1016/S0140-6736(23)00519-6. Epub 2023 May 17.
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 vs 220 in the conservative management group). 429 (95%) patients were included in the primary ITT analysis (224 vs 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] vs 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.
扁桃体切除术通常在患有急性扁桃体炎的成年人中进行，但证据很少。扁桃体切除术的减少与急性成人因扁桃体炎并发症住院的增加同时发生。我们旨在评估保守治疗与扁桃体切除术在复发性急性扁桃体炎患者中的临床效果和成本效益。
这是一项在英国 27 家医院进行的实用、多中心、开放性、随机对照试验。参与者为新转诊至二级保健耳鼻喉科诊所的 16 岁及以上复发性急性扁桃体炎患者。患者被随机分配（1:1）接受扁桃体切除术或保守治疗，采用可变长度的随机排列块进行随机分组。使用扁桃体结局量表 14 分（分类为轻度 0-35、中度 36-48 或重度 49-70）评估按招募中心和基线症状严重程度分层。扁桃体切除术组的患者在随机分组后 8 周内接受选择性手术切除腭扁桃体，保守治疗组的患者在 24 个月内接受标准非手术治疗。主要结局是随机分组后 24 个月内的咽痛天数，每周通过短信报告一次。主要分析在意向治疗（ITT）人群中进行。该研究在 ISRCTN 注册处注册，编号为 55284102。
2015 年 5 月 11 日至 2018 年 4 月 30 日，对 4165 名复发性急性扁桃体炎患者进行了资格评估，其中 3712 名患者被排除。453 名符合条件的参与者被随机分配（立即扁桃体切除术组 233 名 vs 保守治疗组 220 名）。429 名（95%）患者被纳入主要 ITT 分析（立即扁桃体切除术组 224 名 vs 保守治疗组 205 名）。参与者的中位年龄为 23 岁（IQR 19-30），其中 355 名（78%）为女性，97 名（21%）为男性。大多数参与者为白人（407 名[90%]）。与保守治疗组相比，立即扁桃体切除术组在 24 个月内的咽痛天数更少（中位数 23 天 [IQR 11-46] vs 30 天 [14-65]）。在调整了地点和基线严重程度后，立即扁桃体切除术组（n=224）与保守治疗组（n=205）总咽痛天数的发病率比为 0.53（95%CI 0.43-0.65；<0.0001）。231 名参与者中有 90 名（39%）发生了 191 次与扁桃体切除术相关的不良事件。最常见的不良事件是出血（44 名参与者中有 54 次[19%]）。研究期间无死亡。
与保守治疗相比，在复发性急性扁桃体炎的成年人中，立即进行扁桃体切除术在临床上是有效且具有成本效益的。
英国国家卫生研究院。
