Haardt M J, Selam J L, Slama G, Bethoux J P, Dorange C, Mace B, Ramaniche M L, Bruzzo F
Department of Diabetology, INSERM Unit 341, Hotel-Dieu Hospital, Paris, France.
Diabetes Care. 1994 Aug;17(8):847-51. doi: 10.2337/diacare.17.8.847.
To investigate if intraperitoneal (IP) insulin infusion via programmable implantable pumps is a potential alternative to subcutaneous (SC) insulin via multiple injections.
We compared the cost-benefits of the two methods using a randomized, prospective, 6-month, crossover design in 10 adult type I diabetic patients.
When judged on the last month of IP versus SC periods in the nine patients who completed the study, metabolic data showed better glycemic control (HbA1c: 7.2 +/- 0.2 IP vs. 8.5 +/- 0.7% SC, mean +/- SE, P = 0.02), reduced glycemic fluctuations (SD of capillary glucose values: 3.4 +/- 0.2 IP vs. 4.6 +/- 0.2 mM SC, P < 0.01), and fewer mild hypoglycemic events (5.7 +/- 2.0 IP vs. 10.0 +/- 3.1 events/month SC, P = 0.02). Quality of life, judged by Diabetes Control and Complications Trial questionnaires, was unaffected by pump therapy. Direct costs, including pump acquisition, implantation, and follow-up, were 2.6-fold higher with IP than with SC delivery.
The implantable pump is more effective in the short term, equally accepted, but more costly than multiple injections and should be limited to patients with unsatisfactory glycemic control despite intensive diabetes management with SC insulin. In addition, longer-term, larger-scale, and comparative evaluation is required.
研究通过可编程植入式泵进行腹腔内(IP)胰岛素输注是否是皮下(SC)多次注射胰岛素的一种潜在替代方法。
我们采用随机、前瞻性、为期6个月的交叉设计,对10名成年1型糖尿病患者比较了这两种方法的成本效益。
在完成研究的9名患者中,根据IP期与SC期的最后一个月判断,代谢数据显示血糖控制更佳(糖化血红蛋白:IP组为7.2±0.2,SC组为8.5±0.7%,均值±标准误,P = 0.02),血糖波动减少(毛细血管血糖值标准差:IP组为3.4±0.2,SC组为4.6±0.2 mM,P < 0.01),轻度低血糖事件更少(IP组为5.7±2.0,SC组为10.0±3.1次/月,P = 0.02)。根据糖尿病控制与并发症试验问卷判断,生活质量不受泵治疗的影响。直接成本,包括泵的购置、植入和随访,IP组比SC组高2.6倍。
植入式泵在短期内更有效,接受程度相同,但比多次注射成本更高,应仅限于尽管使用SC胰岛素进行强化糖尿病管理但血糖控制仍不理想的患者。此外,还需要进行长期、大规模的比较评估。