Zaninotto G, Vergadoro V, Annese V, Costantini M, Costantino M, Molena D, Rizzetto C, Epifani M, Ruol A, Nicoletti L, Ancona E
Department of Medical and Surgical Sciences (Clinica Chirurgica 4), University of Padova School of Medicine, Via Giustiniani 2, 35128 Padova, Italy.
Surg Endosc. 2004 Apr;18(4):691-5. doi: 10.1007/s00464-003-8910-6. Epub 2004 Mar 19.
The treatment of esophageal achalasia is still controversial: current therapies are palliative and aim to relieve dysphagia by disrupting or relaxing the lower esophageal sphincter muscle fibers with botulinum toxin. The aim of this study was to compare the clinical and economic results of two such treatments: laparoscopic myotomy and botulinum toxin injection.
A total of 37 patients with esophageal achalasia were randomly assigned to receive laparoscopic myotomy (20) or two Botox injections 1 month apart (17). All patients were treated at the same hospital and were part of a larger multicenter study. Symptom score, lower esophageal sphincter pressure, and esophageal diameter at barium swallow were compared. The economic analysis was performed considering only the direct costs (cost per treatment and cost effectiveness, i.e., cost per patient healed).
Mortality and morbidity were nil in both groups. The actuarial probability of being asymptomatic at 2 years was 90% for surgery and 34% for Botox (p < 0.05). The initial cost was lower for Botox (1,245 Euros) than for surgery (3,555 Euros), but when cost effectiveness at 2 years was considered, this difference nearly disappeared: Botox 3,364 Euros, surgery 3,950 Euros.
Botox is still the least costly treatment, but the minimal difference in the longer term does not justify its use, given that surgery is a risk-free, definitive treatment.
食管贲门失弛缓症的治疗仍存在争议:目前的治疗方法是姑息性的,旨在通过肉毒杆菌毒素破坏或松弛食管下括约肌肌纤维来缓解吞咽困难。本研究的目的是比较两种此类治疗方法的临床和经济结果:腹腔镜肌切开术和肉毒杆菌毒素注射。
总共37例食管贲门失弛缓症患者被随机分配接受腹腔镜肌切开术(20例)或每隔1个月注射两次肉毒杆菌毒素(17例)。所有患者均在同一家医院接受治疗,并且是一项更大的多中心研究的一部分。比较了症状评分、食管下括约肌压力以及钡餐检查时的食管直径。经济分析仅考虑直接成本(每次治疗的成本和成本效益,即每位治愈患者的成本)。
两组的死亡率和发病率均为零。手术组2年无症状的精算概率为90%,肉毒杆菌毒素注射组为34%(p < 0.05)。肉毒杆菌毒素注射的初始成本(1245欧元)低于手术(3555欧元),但考虑到2年的成本效益时,这种差异几乎消失:肉毒杆菌毒素注射为3364欧元,手术为3950欧元。
肉毒杆菌毒素注射仍然是成本最低的治疗方法,但从长远来看差异极小,鉴于手术是一种无风险的确定性治疗方法,因此不值得使用。