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《规范》及指导原则适用于食品药品监管部门对第三类医疗器械批发/零售经营企业经营许可（含变更和延续）的现场核查，第二类医疗器械批发/零售经营企业经营备案后的现场核查，以及医疗器械经营企业的各类监督检查 Diabetic Nephropathy Diabetic nephropathy is the leading cause of chronic renal failure in the industrialised world. It is also one of the most significant long-term complications in terms of morbidity and mortality for individual patients with diabetes. Diabetes is responsible for 30-40% of all end-stage renal disease (ESRD) cases in the United States. Although both type 1 diabetes mellitus (insulin-dependent diabetes mellitus [IDDM]) and type 2 diabetes mellitus (non–insulin-dependent diabetes mellitus [NIDDM]) lead to ESRD, the great majority of patients are those with NIDDM. The glomeruli and kidneys are typically normal or increased in size initially, thus distinguishing diabetic nephropathy from most other forms of chronic renal insufficiency, wherein renal size is reduced (except renal amyloidosis and polycystic kidney disease). Signs and Symptoms Approximately 25% to 40% of patients with DM 1 ultimately develop diabetic nephropathy (DN), which progresses through five predictable stages. Stage 1 (very early diabetes) Increased demand upon the kidneys is indicated by an above-normal glomerular filtration rate (GFR). Hyperglycemia leads to increased kidney filtration (see later) This is due to osmotic load and to toxic effects of high sugar levels on kidney cells Increased Glomerular Filtration Rate (GFR) with enlarged kidneys Stage 2 (developing diabetes) Clinically silent phase with continued hyper filtration and hypertrophy The GFR remains elevated or has returned to normal, but glomerular damage has progressed to significant microalbuminuria (small but above-normal level of the protein albumin in the urine). Significant microalbuminuria will progress to end-stage renal disease (ESRD). Therefore, all diabetes patients should be screened for microalbuminuria on a routine basis. Stage 3 (overt, or dipstick-positive diabetes) Glom