研究揭示GHB檢測作為美國篩查未診斷糖尿病的高效方法

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2000年的研究利用GHB(糖化血紅蛋白,又稱HbA1c)來篩查美國人口中未診斷的糖尿病。結果顯示,使用GHB高靈敏度(83.4%)和特異性(84.4%)篩查未診斷糖尿病。此研究證實,GHB是一種與空腹血糖測量相比的便捷而有效的篩查方法,特別是在高風險人群中。

Use of GHB (HBA1C) in screening for undiagnosed diabetes in the U.S. population

在美國人口中使用糖化血紅蛋白 (HbA1c) 篩查未診斷的糖尿病

Rohlfing CL, Little RR, Wiedmeyer HM, et al. Use of GHb (HbA1c) in screening for undiagnosed diabetes in the U.S. population [published correction appears in Diabetes Care 2000 Jun;23(6):876]. Diabetes Care. 2000;23(2):187-191. doi:10.2337/diacare.23.2.187

https://pubmed.ncbi.nlm.nih.gov/10868829/#:~:text=Results%3A%20GHb%20demonstrated%20high%20sensitivity,SD%20above%20the%20normal%20mean.

Abstract

To evaluate the use of GHb as a screening test for undiagnosed diabetes (fasting plasma glucose > or =7.0 mmol/l) in a representative sample of the U.S. population. The Third National Health and Nutrition Examination Survey included national samples of non-Hispanic whites, non-Hispanic blacks, and Mexican Americans aged > or =20 years. Of these subjects, 7,832 participated in a morning examination session, of which 1,273 were excluded because of a previous diagnosis of diabetes, missing data, or fasting time of <8 h before examination. Venous blood was obtained to measure fasting plasma glucose and GHb in the remaining 6,559 subjects. Receiver operating characteristic curve analysis was used to examine the sensitivity and specificity of GHb for detecting diabetes at increasing GHb cutoff levels. GHb demonstrated high sensitivity (83.4%) and specificity (84.4%) for detecting undiagnosed diabetes at a GHb cutoff of 1 SD above the normal mean. Moderate sensitivity (63.2%) and very high specificity (97.4%) were evident at a GHb cutoff of 2 SD above the normal mean. Sensitivity at this level ranged from 58.6% in the non-Hispanic white population to 83.6% in the Mexican-American population; specificity ranged from 93.0% in the nonHispanic black population to 98.3% in the non-Hispanic white population. GHb is a highly specific and convenient alternative to fasting plasma glucose for diabetes screening. A GHb value of 2 SD above the normal mean could identify a high proportion of individuals with undiagnosed diabetes who are at risk for developing diabetes complications.

摘要

為評估在美國人口中使用糖化血紅蛋白 (GHb) 作為篩查未診斷糖尿病(空腹血漿葡萄糖 ≥ 7.0 mmol/l)的方法,第三次全國健康與營養調查包括年齡 ≥ 20 歲的非西班牙裔白人、非西班牙裔黑人和墨西哥裔美國人的全國樣本。在這些受試者中,7,832 人參加了上午的檢查,其中 1,273 人因之前被診斷為糖尿病、數據缺失或檢查前空腹時間少於 8 小時而被排除。剩餘 6,559 名受試者的靜脈血被用來測量空腹血漿葡萄糖和 GHb。使用受試者操作特徵曲線分析來檢查不同 GHb 截止水平下 GHb 檢測糖尿病的敏感性和特異性。在 GHb 截止值為正常平均值高於 1 個標準差時,GHb 檢測未診斷糖尿病顯示出高敏感性(83.4%)和高特異性(84.4%)。在 GHb 截止值為正常平均值高於 2 個標準差時,顯示出中等敏感性(63.2%)和非常高的特異性(97.4%)。在這一水平上的敏感性從非西班牙裔白人群體的 58.6% 到墨西哥裔美國人群體的 83.6% 不等;特異性從非西班牙裔黑人群體的 93.0% 到非西班牙裔白人群體的 98.3% 不等。GHb 是一種高度特異且方便的糖尿病篩查替代方法。GHb 值高於正常平均值 2 個標準差可以識別出大量未診斷糖尿病且有發展糖尿病併發症風險的個體。

參考文獻

1lock EV, Bennett PH, Savage PJ, Webner CJ,H o w a rd BV, Rushford NB, Miller M:Bimodality of glycosylated hemoglobin dis-tribution in Pima Indians: relationship tofasting hyperglycemia. Diabetes 28:984–989,1979
2. Orchard TJ, Daneman D, Becker DJ, KullerLH, LaPorte RE, Drash AL, Wagener D: Gly-cosylated hemoglobin: a screening test fordiabetes mellitus? Prev Med 11:595–601,1982
3. Modan M, Halkin H, Karasik A, Lusky A:Effectiveness of glycosylated hemoglobin,fasting plasma glucose, and a single postload plasma glucose level in populationscreening for glucose intolerance. Am J Epi –demiol 119:431–444, 1984
4. Albutt EC, Nattrass M, Northam BE: Glu-cose tolerance test and glycosylated hemo-globin measurement for diagnosis ofdiabetes mellitus: an assessment of the cri-teria of the WHO Expert Committee onDiabetes Mellitus 1980. Ann Clin Biochem22:67–73, 1985
5. Guillausseau PJ, Charles MA, Paolaggi F,Timsit J, Chanson P, Peynet J, Godard V,Eschwege E, Rousselet F, Lubetzki J: Com-parison of HbA1 and fructosamine in diag-nosis of glucose-tolerance abnormalities.Diabetes Care 13:898–900, 1990
6. Gerken KL, Van Lente F: Effectiveness ofscreening for diabetes. Arch Pathol Lab Med114:201–203, 1990
7. Mulkerin EC, Arnold JD, Dewar R, SykesD, Rees A, Pathy MSJ: Glycosylated haemo-globin in the diagnosis of diabetes mellitusin elderly people. Age Ageing 21:175–177,1992
8. Kilpatrick ES, Maylor PW, Keevil BG: Bio-logical variation of glycated hemoglobin:implications for diabetes screening andmonitoring. Diabetes Care 21:261–264,1998
9. Dix D, Cohen P, Kingsley S, Senkbeil J, Sex-ton K: Glycohemoglobin and glucose toler-ance tests compared as indicators ofborderline diabetes. Clin Chem 25:877–879,1979
10. Dods RF, Bolmey C: Glycosylated hemo-globin assay and oral glucose tolerance testcompared for detection of diabetes melli-tus. Clin Chem 25:764–768, 1979
11. Dunn PJ, Coile RA, Soeldner JS, Gleason RE:Reproducibility of hemoglobin A1c and sen-sitivity to various degrees of glucose intoler-ance. Ann Intern Med 91:390–396, 1979
12. Clipson KL, Kansal PC, Poon M-C, BoshellBR: Hemoglobin A1 in the diagnosis ofchemical diabetes mellitus. Horm Metab Res13:129–131, 1982
13. Kesson CM, Youn RE, Talwar D, WhitelawJWW, Robb DA: Glycosylated hemoglobinin the diagnosis of non-insulin dependentdiabetes mellitus. Ann Clin Biochem 22:74–78, 1985
14. Verrillo A, De Teresa A, Golia R, NunziataV: The relationship between glycosylatedhaemoglobin levels and various degrees ofglucose intolerance. Diabetologia 24:391–393, 1983
15. Nomura Y, Nanjo K, Kawa A, Miyano M,Okai K, Kimura S, Furuta K, Miyamura K,Panelo A, Fernando R: Reliability of HbA1assay in the mass survey for diabetes melli-tus, with special reference to the preserva-tion and transportation of blood samples.Tohoku J Exp Med 141 (Suppl.):S77–S84,
1983
16. Ferrell RE, Hanis CL, Aguilar L, Tulloch B,Garcia C, Schull WJ: Glycosylated hemo-globin determination from capillary bloodsamples: utility in an epidemiologic surveyof diabetes. Am J Epidemiol 119:159–166,1984
17. Lester E, Frazer AD, Shepherd CA,Woodroffe FJ: Glycosylated haemoglobin asan alternative to the glucose tolerance testfor the diagnosis of diabetes mellitus. AnnClin Biochem 22:74–78, 1985
18. Tsuji I, Nakamoto K, Hasegawa T, Hisas-hige A, Inawashiro H, Fukao A, HisamichiS: Receiver operating characteristic analysison fasting plasma glucose, HbA1c, andfructosamine on diabetes screening. Dia –betes Care14:1075–1077, 1991
19. Hanson RL, Nelson RG, McCance DR,Beart JA, Charles MA, Pettitt DJ, KnowlerWC: Comparison of screening tests fornon-insulin dependent diabetes mellitus.Arch Intern Med 153:2133–2140, 1994
20. McCance DR, Hanson RL, Charles MA,Jacobsson LTH, Pettitt DJ, Bennett PH,Knowler WC: Comparison of tests for gly-cated haemoglobin and fasting and twohour plasma glucose concentrations asdiagnostic methods for diabetes. BMJ308:1323–1328, 1994
21. Little RR, England JD, Wiedmeyer HM,McKenzie EM, Pettitt DJ, Knowler WC,Goldstein DE: Relationship of glycosylatedhemoglobin to oral glucose tolerance:implications for diabetes screening. Dia –
betes 37:60–64, 1988
22. American Diabetes Association: Standardsof medical care for patients with diabetesmellitus (Position Statement). Diabetes Care22 (Suppl. 1):S32–S41, 1999
23. American Diabetes Association: Screeningfor type 2 diabetes (Position Statement).Diabetes Care 22 (Suppl. 1):S20–S23, 1999
24. Goldstein DE, Little RR: Bringing order tochaos: standardizing the hemoglobin A1cassay. Contemp Int Med 9:27–32, 1997
25. American Diabetes Association: Report ofthe Expert Committee on the Diagnosisand Classification of Diabetes Mellitus. Dia –betes Care 20:1183–1197, 1997
26. National Center for Health Statistics: Planand Operation of the Third National Healthan d N utrit i on E xa min atio n Sur v e y,1988–1994. Hyattsville, MD, National Cen-ter for Health Statistics, 1994 (Vital and
Health Statistics Ser. 1, no. 32)
27. Harris MI, Flegal KM, Cowie CC, Eber-hardt MS, Goldstein DE, Little RR, Wied-meyer HM, Byrd-Holt DD: Prevalence ofdiabetes, impaired fasting glucose, andimpaired glucose tolerance in U.S. adults:the Third National Health and NutritionExamination Survey, 1988–1994. DiabetesCare 21:518–524, 1998
28. National Center for Health Statistics: ThirdNational Health and Nutrition ExaminationSurvey, 1988–1994, Reference Manuals andReports: Manual for Medical Technicians andLaboratory Procedures Used for NHANES III(CD-ROM). Hyattsville, MD, Centers forDisease Control and Prevention, 1996
29. National Center for Health Statistics: ThirdNational Health and Nutrition ExaminationSurvey, 1988–1994, Reference Manuals andReports: Analytic and Reporting Guidelines(CD-ROM). Hyattsville, MD, Centers forDisease Control and Prevention, 1996
30. Beck JR, Shultz EK: The use of relative oper-ating characteristic (ROC) curves in test per-formance evaluation. Arch Pathol Lab Med110:13–20, 1986
31. World Health Organization: WHO ExpertCommittee on Diabetes Mellitus: Second Report.Geneva, World Health Organization, 1980(Tech. Rep. Ser., no. 646)
32. Voss EM, Cembrowski GS, Clasen BL,Spencer ML, Ainslie MB, Haig B: Evalua-tion of capillary collection system forHbA1c specimens. Diabetes Care 15:700–701, 1992
33. Little RR, Wiedmeyer HM, Huang DH,Goldstein DE, Parsons RG, Kowal R, John-ston M: A simple blood collection devicefor analysis of glycohemoglobin (GHB)(Abstract). Clin Chem 44 (Suppl. 6):A139,1998
34. Diabetes Control and Complications TrialResearch Group: The effect of intensivetreatment of diabetes on the developmentand progression of long term complica-tions in insulin-dependent diabetes melli-tus. N Engl J Med 329:977–986, 1993
35. U.K. Prospective Diabetes Study Group:Intensive blood-glucose control withsulphonylureas or insulin compared withconventional treatment and risk of compli-cations in patients with type 2 diabetes(UKPDS 33). Lancet 352:837–853, 1998
36. Klein R, Klein BEK, Moss SE: Relation ofglycemic control to diabetic microvascularcomplications in diabetes mellitus. ArchIntern Med 124:90–96, 1996
37. Orchard TJ, Forrest KYZ, Ellis D, BeckerDJ: Cumulative glycemic exposure andmicrovascular complications in insulin-dependent diabetes mellitus. Arch InternMed 157:1851–1856, 1997
38. Little RR, Myers GL, Nathan D, Steffes MW,Gunter EW, Messenger LJ, Parker KM, Rob-bins DC, Reed RG, Eckfeldt J, GoldsteinDE: Implementation of the National Gly-cohemoglobin Standardization Program(NGSP) in the U.S. (Abstract). Clin ChemLab Med 37 (Suppl. 186):M274, 1999
39. American Diabetes Association: Tests of gly-cemia in diabetes (Position Statement). Dia –betes Care 22 (Suppl. 1):S77–S79, 1999
40. Goldstein DE: Isn’t it time to retire the oralglucose tolerance test for diabetes screeningand diagnosis? Diabetes Care 21:1215–1216,1998