Holohan T V
U.S. Department of Health and Human Services, Public Health Service, Agency for Health Care Policy and Research, Rockville, MD, USA.
Health Technol Assess (Rockv). 1995 Aug(4):1-53.
Simultaneous pancreas-kidney (SPK) or pancreas-after-kidney (PAK) transplantation has been advocated as an alternative to kidney transplant alone (KTA) for type 1 diabetics with end-stage renal disease. Advocates of combined transplant assert that the procedure reduces, prevents, or mitigates secondary complications of diabetes and improves the quality of life (QOL) of recipients. The combined procedures may be accomplished with a relatively low mortality, but the morbidity significantly exceeds that of KTA. The published data did not provide unambiguous support for the contention that SPK or PAK improved or ameliorated the secondary diabetic complications of retinopathy, neuropathy, and nephropathy, and it cannot be reasonably concluded that such benefit is likely to result. The majority of studies of QOL subsequent to combined transplant had significant methodologic deficiencies which made generalizations problematic. Notwithstanding, improvements in objective measures, such as return to employment or school, reduction in medical care requirements, days spent in hospital, social or physical activity, etc, have not been demonstrated for combined transplant; improvements in subjective measures were inconsistently reported. The United Network for Organ Sharing (UNOS) registry indicated that SPK represents 83 percent, and PAK about 8 percent of all pancreas transplants in the United States. Pancreas graft survival data are limited; UNOS reported 3-year survival rates of approximately 65 percent following SPK, and 35 percent after PAK. Renal graft survival following SPK appears comparable to that reported for most cadaver KTA. However, selection of SPK in lieu of KTA with a living-related donor or HLA-matched cadaver kidney may result in significant reduction in expected renal graft survival, in the range of 40-70 percent to as much as 350 percent. A cost-effectiveness analysis (CEA) model compared SPK with KTA and continued insulin therapy. The model employed a wide range of reported charges/payments, and postulated that SPK would provide significant improvements in quality of life. Sensitivity analyses indicated that SPK was equal in cost effectiveness to KTA only in patients who incurred very high annual costs for the treatment of hyper- or hypoglycemia. The literature does not indicate that such patients comprise the majority of SPK recipients. Additional evidence is necessary to unequivocally demonstrate the risks, costs, and ultimate benefits of combined transplant. Such information should include detailed and unambiguous patient selection criteria, prospective comparative studies of the effects of SPK/PAK upon secondary complications and quality of life, and accurate cost data for the transplant procedures and required followup care.
对于终末期肾病的1型糖尿病患者，胰肾联合移植（SPK）或肾后胰腺移植（PAK）已被提倡作为单纯肾移植（KTA）的替代方案。联合移植的支持者称，该手术可减少、预防或减轻糖尿病的继发性并发症，并提高受者的生活质量（QOL）。联合手术的死亡率可能相对较低，但发病率显著高于KTA。已发表的数据并未明确支持SPK或PAK能改善或减轻糖尿病视网膜病变、神经病变和肾病等继发性并发症的观点，也无法合理得出可能会产生此类益处的结论。联合移植术后生活质量的大多数研究存在重大方法学缺陷，这使得进行概括存在问题。尽管如此，联合移植在客观指标方面，如恢复工作或上学、减少医疗护理需求、住院天数、社交或体育活动等方面的改善尚未得到证实；主观指标方面的改善报告也不一致。器官共享联合网络（UNOS）登记处显示，在美国，SPK占所有胰腺移植的83%，PAK约占8%。胰腺移植物存活数据有限；UNOS报告称，SPK术后3年存活率约为65%，PAK术后为35%。SPK术后肾移植物存活率似乎与大多数尸体肾KTA报告的存活率相当。然而，选择SPK而非与活体亲属供肾或HLA匹配尸体肾进行KTA，可能会导致预期肾移植物存活率显著降低，降低幅度在40%-70%至高达350%之间。一项成本效益分析（CEA）模型将SPK与KTA及持续胰岛素治疗进行了比较。该模型采用了广泛报道的费用/支付情况，并假定SPK将显著改善生活质量。敏感性分析表明，仅在因治疗高血糖或低血糖而年度费用非常高的患者中，SPK的成本效益才与KTA相当。文献并未表明此类患者占SPK受者的大多数。需要更多证据来明确证明联合移植的风险、成本和最终益处。此类信息应包括详细且明确的患者选择标准、SPK/PAK对继发性并发症和生活质量影响的前瞻性比较研究，以及移植手术和所需后续护理的准确成本数据。
