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特发性贲门失弛缓症患者治疗策略的卫生经济学评估:一项比较气囊扩张术与腹腔镜贲门肌切开术的随机试验结果

Health economic evaluation of therapeutic strategies in patients with idiopathic achalasia: results of a randomized trial comparing pneumatic dilatation with laparoscopic cardiomyotomy.

作者信息

Kostic S, Johnsson E, Kjellin A, Ruth M, Lönroth H, Andersson M, Lundell L

机构信息

Department of General Surgery, Borås Central Hospital, Borås, Sweden.

出版信息

Surg Endosc. 2007 Jul;21(7):1184-9. doi: 10.1007/s00464-007-9310-0. Epub 2007 May 19.

DOI:10.1007/s00464-007-9310-0
PMID:17514399
Abstract

BACKGROUND

We have prospectively collected information concerning the costs incurred during the management of patients allocated to either forceful dilatation or to an immediate laparoscopic operation because of newly diagnosed achalasia.

METHODS

Fifty-one patients with newly diagnosed achalasia were randomized to either pneumatic dilatation to a diameter of 30-40 mm or to a laparoscopic myotomy to which was added a posterior partial fundoplication. Follow-ups were scheduled at 1, 3, 6, and 12 months after inclusion. At each follow-up visit a study nurse interviewed the patients regarding symptoms and their quality of life (QoL) and a health economic questionnaire was completed. In the latter questionnaire, patients were asked to report the presence and character of contacts with the healthcare system since the last visit.

RESULTS

In the dilatation group six patients (23%), including the patient who was operated on because of perforation, were classified as failures during the first 12 months of follow-up compared to one (4%) in the myotomy group (p = 0.047). Five of those classified as failures in the dilatation group subsequently had a surgical myotomy and the sixth patient was treated with repeated dilatations. The patient classified as failure in the myotomy group was treated with endoscopic dilatation. The initial treatment cost and the total costs were significantly higher for laparoscopic myotomy compared to a pneumatic dilatation-based strategy (p = 0.0002 and p = 0.0019, respectively). When the total costs were subdivided into the different resources used, we found that the single largest cost item for pneumatic dilatation was that for hospital stay and that for laparoscopic myotomy was the actual operative treatment (operating room time). The cost-effectiveness analysis, relating to the actual treatment failures, revealed that the cost to avoid one treatment failure (incremental cost-effectiveness ratio) amounted to 9239 euros.

CONCLUSION

The current prospective, controlled clinical trial shows that despite a higher level of clinical efficacy of laparoscopic myotomy to prevent treatment failure in newly diagnosed achalasia, the cost effectiveness of pneumatic dilatation is superior, at least when a reasonable time horizon is applied.

摘要

背景

我们前瞻性地收集了因新诊断的贲门失弛缓症而接受强力扩张或立即进行腹腔镜手术治疗的患者的相关费用信息。

方法

51例新诊断的贲门失弛缓症患者被随机分为两组,一组接受直径为30 - 40毫米的气囊扩张术,另一组接受腹腔镜肌切开术并附加后部分胃底折叠术。纳入研究后,分别在1、3、6和12个月安排随访。每次随访时,研究护士就症状及其生活质量(QoL)对患者进行访谈,并完成一份健康经济问卷。在该问卷中,患者被要求报告自上次随访以来与医疗保健系统接触的情况及性质。

结果

在扩张组中,6例患者(23%),包括因穿孔而接受手术的患者,在随访的前12个月被归类为治疗失败,而肌切开术组为1例(4%)(p = 0.047)。扩张组中被归类为治疗失败的患者有5例随后接受了手术肌切开术,第6例患者接受了反复扩张治疗。肌切开术组中被归类为治疗失败的患者接受了内镜扩张治疗。与基于气囊扩张术的策略相比,腹腔镜肌切开术的初始治疗成本和总成本显著更高(分别为p = 0.0002和p = 0.0019)。当将总成本细分为所使用的不同资源时,我们发现气囊扩张术的最大单项成本是住院费用,而腹腔镜肌切开术的最大单项成本是实际手术治疗(手术室时间)。针对实际治疗失败的成本效益分析显示,避免一次治疗失败的成本(增量成本效益比)为9239欧元。

结论

当前的前瞻性对照临床试验表明,尽管腹腔镜肌切开术在预防新诊断的贲门失弛缓症治疗失败方面具有更高的临床疗效,但至少在应用合理的时间范围时,气囊扩张术的成本效益更优。

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