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激光扁桃体切除术与扁桃体切除术的长期疗效和成本效益:一项随机临床试验的二次分析

Long-Term Efficacy and Cost-Effectiveness of Laser Tonsillotomy vs Tonsillectomy: A Secondary Analysis of a Randomized Clinical Trial.

作者信息

Wong Chung Justin Emile Raoul Edouard, van den Hout Wilbert Bernhard, van Helmond Noud, van Benthem Peter Paul Germain, Blom Hendrikus Maria

机构信息

Department of Otolaryngology Head and Neck Surgery, Hagaziekenhuis, The Hague, the Netherlands.

Department of Otolaryngology Head and Neck Surgery, Leiden University Medical Centre, Leiden, the Netherlands.

出版信息

JAMA Netw Open. 2025 Apr 1;8(4):e254858. doi: 10.1001/jamanetworkopen.2025.4858.

DOI:10.1001/jamanetworkopen.2025.4858
PMID:40299386
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12042055/
Abstract

IMPORTANCE

The current treatment for adult tonsil disease, tonsillectomy (TE), may involve a burdensome recovery.

OBJECTIVE

To evaluate long-term efficacy (1- and 2-year efficacy) and cost-effectiveness of carbon dioxide (CO2) laser tonsillotomy (TO) vs TE.

DESIGN, SETTING, AND PARTICIPANTS: A prespecified secondary analysis of a randomized clinical trial was conducted in 5 Dutch hospitals. Participants included adults with persistent tonsil-related symptoms enrolled from January 25, 2018, to December 17, 2019. Data analysis was performed from January 5, 2025, to April 9, 2025.

INTERVENTIONS

Tonsillectomy under general anesthesia vs CO2 laser TO under local anesthesia.

MAIN OUTCOMES AND MEASURES

Intention-to-treat analysis on primary (persistent symptoms, defined as an answer of yes to the question of whether symptoms were still present, reported at 1 and 2 years) and secondary (symptom severity, patient satisfaction, quality-adjusted life-years [QALYs], and cost-effectiveness) outcomes.

RESULTS

In total, 98 patients were assigned to TO and 101 to TE; 98 were analyzed per group. The TO and TE groups were similar (69 [70%] vs 67 [68%] female; mean [SD] age, 29 [10] vs 30 [8] years). The most common symptom was sore throat with fever (34% vs 34%), with a baseline mean (SD) severity score of 57 (19) vs 59 (17) mm. At 1 year, 51.8% of patients assigned to TO had persistent symptoms vs 25.2% assigned to TE (odds ratio [OR], 3.2; 95% CI, 1.6-6.4; P < .001); at 2 years, 45.2% vs 19.7% had persistent symptoms (OR, 3.4; 95% CI, 1.7-6.7; P < .001). Symptom severity decreased significantly in both groups but was lower after TE at 1 year (14.8 vs 23.0 mm; mean difference, -8.1 mm; 95% CI, -14.8 to -1.5 mm; P = .02) and 2 years (10.8 vs 19.6 mm; mean difference, -8.8 mm; 95% CI, -14.7 to -2.9 mm; P = .001). Patient satisfaction was similar between groups; mean VAS scores were 79.0 (95% CI, 72.2-85.9) mm for TE and 69.3 (95% CI, 63.4-75.3) mm for TO at 1 year and 64.1 (95% CI, 55.7-72.5) mm and 64.4 (95% CI, 56.9-71.8) mm at 2 years. Similar proportions of participants would recommend the procedure at 1 year (79% TE vs 76% TO) and 2 years (71%, both). Both TE and TO demonstrated high cumulative QALYs at 2 years (EuroQol 5 Dimension: mean, 1.89 vs 1.84; mean difference, 0.05, P = .06; EuroQol Visual Analogue Scale: mean, 1.83 vs 1.81, mean difference, 0.02; P = .38). Tonsillotomy had lower overall costs ($869 vs $2363 for TE), with societal cost savings of $1925 (P = .001), and a 71% probability of cost-effectiveness at $25 907 per QALY (85%-93% in sensitivity analyses).

CONCLUSIONS AND RELEVANCE

The findings of this trial suggest that both CO2 laser TO and TE under general anesthesia significantly reduced long-term symptoms, with greater reduction after TE. TO had lower cost and similar patient satisfaction. Based on these findings, CO2-laser TO appears to be a safe, effective, and cost-effective method for long-term relief of tonsil-related problems with excellent patient satisfaction.

TRIAL REGISTRATION

trialregister.nl Identifier: NL 6866.

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dda7/12042055/4b3dad6ce18d/jamanetwopen-e254858-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dda7/12042055/4114a95de4cf/jamanetwopen-e254858-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dda7/12042055/e85b832d3f75/jamanetwopen-e254858-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dda7/12042055/4b3dad6ce18d/jamanetwopen-e254858-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dda7/12042055/4114a95de4cf/jamanetwopen-e254858-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dda7/12042055/e85b832d3f75/jamanetwopen-e254858-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dda7/12042055/4b3dad6ce18d/jamanetwopen-e254858-g003.jpg
摘要

重要性

目前成人扁桃体疾病的治疗方法扁桃体切除术(TE),恢复过程可能较为繁重。

目的

评估二氧化碳(CO₂)激光扁桃体切开术(TO)与TE相比的长期疗效(1年和2年疗效)和成本效益。

设计、设置和参与者:在5家荷兰医院对一项随机临床试验进行了预先指定的二次分析。参与者包括2018年1月25日至2019年12月17日入组的有持续性扁桃体相关症状的成年人。数据分析于2025年1月5日至2025年4月9日进行。

干预措施

全身麻醉下的扁桃体切除术与局部麻醉下的CO₂激光TO。

主要结局和测量指标

对主要结局(持续性症状,定义为在1年和2年时对症状是否仍然存在的问题回答为是)和次要结局(症状严重程度、患者满意度、质量调整生命年[QALY]和成本效益)进行意向性分析。

结果

总共98例患者被分配到TO组,101例被分配到TE组;每组分析98例。TO组和TE组相似(女性分别为69例[70%]和67例[68%];平均[标准差]年龄,29[10]岁和30[8]岁)。最常见的症状是咽痛伴发热(34%对34%),基线平均(标准差)严重程度评分分别为57(19)和59(17)mm。1年时,分配到TO组的患者中有51.8%有持续性症状,而分配到TE组的为25.2%(优势比[OR],3.2;95%置信区间,1.6 - 6.4;P <.001);2年时,分别为45.2%和19.7%有持续性症状(OR,3.4;95%置信区间,1.7 - 6.7;P <.001)。两组症状严重程度均显著降低,但TE组在1年时更低(14.8对23.0 mm;平均差值, - 8.1 mm;95%置信区间, - 14.8至 - 1.5 mm;P = 0.02),2年时也是如此(10.8对19.6 mm;平均差值, - 8.8 mm;95%置信区间, - 14.7至 - 2.9 mm;P = 0.001)。两组患者满意度相似;TE组1年时平均视觉模拟量表(VAS)评分为79.0(95%置信区间,72.2 - 85.9)mm,TO组为69.3(95%置信区间,63.4 - 75.3)mm,2年时分别为64.1(95%置信区间,55.7 - 72.5)mm和64.4(95%置信区间,56.9 - 71.8)mm。相似比例的参与者在1年时(TE组79%对TO组76%)和2年时(均为71%)会推荐该手术。TE和TO在2年时均显示出较高的累积QALY(欧洲五维健康量表:平均值,1.89对1.84;平均差值,0.05,P = 0.06;欧洲视觉模拟量表:平均值,1.83对1.81,平均差值,0.02;P = 0.38)。扁桃体切开术的总体成本较低(TO为869美元,TE为2363美元),社会成本节省1925美元(P = 0.001),每QALY成本效益概率为71%(敏感性分析中为85% - 93%),成本效益阈值为每QALY 25907美元。

结论与相关性

该试验结果表明,CO₂激光TO和全身麻醉下的TE均能显著减轻长期症状,TE减轻得更多。TO成本更低,患者满意度相似。基于这些发现,CO₂激光TO似乎是一种安全、有效且具有成本效益的方法,可长期缓解扁桃体相关问题,患者满意度高。

试验注册

trialregister.nl标识符:NL 6866。

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