Bryant J, Clegg A J, Sidhu M K, Brodin H, Royle P, Davidson P
Southampton Health Technology Assessments Centre, Wessex Institute for Health Research and Development, Southampton, UK.
Health Technol Assess. 2004 Feb;8(7):iii, 1-54. doi: 10.3310/hta8070.
This systematic review examines the clinical and cost-effectiveness of the Sugarbaker procedure for treating pseudomyxoma peritonei (PMP) and the costs of the procedure in the UK.
Electronic databases, bibliographies of related papers and experts in the field were used as sources for English language studies available up to September 2002.
Evidence of the clinical effectiveness of the Sugarbaker procedure for PMP was synthesised through a narrative review with full tabulation of results of all included studies. The economic modelling used a Monte-Carlo simulation model populated with UK price data to estimate likely UK costs.
Five retrospective case-series reports assessing the Sugarbaker procedure met the inclusion criteria for the review, although they were found to be of poor quality when judged against standard criteria for assessing methodological standard. There appears to be some benefit for people with PMP who undergo treatment with the Sugarbaker procedure. Commonly reported complications of the Sugarbaker procedure were anastomotic leaks, fistula formation, wound infection, small bowel perforations/obstructions and pancreatitis. One costing study of poor methodological quality and set in the USA was found. This study, together with UK unit price data and expert advice, was used to populate a Monte-Carlo simulation model to estimate the marginal cost of operating a service to provide treatment for PMP using the Sugarbaker technique rather than standard treatment. The results of the Monte-Carlo simulation model showed that the cost for one patient over a maximum of 5 years would be about 9700 British pounds, with a standard deviation of about 1300 British pounds (although costs incurred in setting up the specific service or training the staff were not included). The US study showed a ten-fold higher cost. The Monte-Carlo analysis showed that the variation around the mean was not very high. The most likely factor influencing the variation of the costs was the length of procedure. No sensitivity analysis could be done of the alternative treatment.
The economic results should be seen as merely an example of the likely marginal costs of the Sugarbaker procedure, as more information about the current alternative is required. Trained and experienced staff are required to implement the procedure and inevitably time and cost will be involved in developing the appropriate teams. Although the procedure requires some specialist equipment and maintenance, such as smoke evacuators, these should have limited effect on setting up the service. PMP is a relatively rare condition with approximately 50 new cases per year in the UK and the impact of an increase in the demand for services should be limited. Evidence is needed for the effectiveness of maximal cytoreductive surgery compared with surgical debulking, using different intraoperative intraperitoneal chemotherapy strategies, and for the effectiveness of treatments in patients who have residual disease following maximal efforts at cytoreduction. Further research involving high-quality prospective cohort studies with economic evaluations would be valuable.
本系统评价旨在探讨Sugarbaker手术治疗腹膜假黏液瘤（PMP）的临床疗效和成本效益，以及该手术在英国的费用。
截至2002年9月，电子数据库、相关论文的参考文献以及该领域的专家被用作英语研究的资料来源。
通过叙述性综述对Sugarbaker手术治疗PMP的临床疗效证据进行综合，并完整列出所有纳入研究的结果。经济模型采用填充了英国价格数据的蒙特卡洛模拟模型来估计英国可能的成本。
五项评估Sugarbaker手术的回顾性病例系列报告符合本综述的纳入标准，不过根据评估方法标准判断，这些报告质量较差。接受Sugarbaker手术治疗的PMP患者似乎有一定益处。Sugarbaker手术常见的并发症有吻合口漏、瘘管形成、伤口感染、小肠穿孔/梗阻和胰腺炎。发现一项方法学质量较差且在美国开展的成本研究。该研究与英国单位价格数据及专家建议一起，被用于填充蒙特卡洛模拟模型，以估计采用Sugarbaker技术而非标准治疗为PMP患者提供治疗服务的边际成本。蒙特卡洛模拟模型的结果显示，一名患者最长5年的费用约为9700英镑，标准差约为1300英镑（不过未包括设立特定服务或培训工作人员所产生的成本）。美国的研究显示成本高出10倍。蒙特卡洛分析表明，均值周围的变异不是很高。影响成本变异的最可能因素是手术时长。无法对替代治疗进行敏感性分析。
由于需要更多关于当前替代治疗的信息，经济结果应仅被视为Sugarbaker手术可能的边际成本的一个示例。实施该手术需要训练有素且经验丰富的工作人员，组建合适的团队必然会涉及时间和成本。尽管该手术需要一些专业设备及维护，如烟雾抽吸器，但这些对设立服务的影响应有限。PMP是一种相对罕见的疾病，在英国每年约有50例新发病例，服务需求增加的影响应该有限。需要证据来证明与减瘤手术相比，采用不同术中腹腔内化疗策略的最大程度细胞减灭术的有效性，以及在最大程度细胞减灭努力后仍有残留疾病的患者中治疗的有效性。涉及高质量前瞻性队列研究及经济评估的进一步研究将很有价值。
