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1 CTD mg 0.4mg 0.6mg 0.8mg 1.0mg 1.2mg 1.4mg 1.6mg 1.8mg 2.0mg 12mg
2
3 2.5 Page GH AGHD AGHD IGF-I AGHD AGHD AGHD gold standard Cut-off GH AGHD AGHD IGF-I IGFBP QOL...43
4 2.5 Page QOL QOL-AGHDA SF GH
5 2.5 Page
6 Page 6 ACTH ADH AGHD AGHDA BIA BMI CT DEXA FDA FSH GCP GH GHD GT GT/GT HbA 1C HDL hgh ISE ISS KIGS KIMS IGF-I IGF-II IGFBP-3 IU LDL LH MRI P Adrenocorticotropic hormone Antidiuretic hormone Adult growth hormone deficiency Quality of life assessment of GHD in adults QOL Bioelectrical impedence analysis Body mass index kg / m 2 Computerized tomography Dual energy X-ray absorption X Food and Drug Administration Follicle-stimulating hormone Good Clinical Practice Growth hormone Growth hormone deficiency GT 076 Hemoglobin A 1C A 1C High-density lipoprotein Human growh hormone Integrated summary of efficacy FDA Integrated summary of safety FDA Pfizer International Growth Database 1987 Kabi International Growth Survey Pfizer International Metabolic Database 1994 Kabi International Metabolic Survey Insulin-like growth factor-i I Insulin-like growth factor-ii II Insulin-like growth factor blinding protein-3 3 International unit Low-density lipoprotein Luteinizing hormone Magnetic resonance imaging 075
7 Page 7 P/GT QOL SD SDS SF-36 T3 T4 TSH WHO-ART 075 P 076 Quality of life Standard deviation Standard deviation Score SD / SD Short Form 36 QOL Triiodothyronine 3, 5, 3 L- T4 5 Thyroxin Thyroxin-stimulating hormone WHO Adverse Reaction Terminology WHO
8 2.5.1 Page GH GH 1 1 GH 191 GH GHRH GH GH I IGF-I 1 GH IGF-I IGF-I
9 2.5.1 Page GH Na K P AGHD GH GH AGHD: Adult Growth Hormone Deficiency 2 AGHD LDL-
10 2.5.1 Page 10 2 AGHD GH <3µg/L ng/ml IGF-I LDL GH TSH ACTH ADH GH GH n=498 GH GH n=365 GH GH 2 2 GH GH 3 3 GH 2.9% GH 8% 11.8% GH
11 2.5.1 Page 11 3 Rosén GH GH Bülow GHD AGHD
12 2.5.1 Page GH 1800 AGHD 5 AGHD KIMS 5 AGHD GH GH GH AGHD child onset; CO adult onset; AO GH MRI GH, GH GH GH GHD GH GH GH 10 ng/ml AGHD GH GH GH 3 ng/ml GH AGHD GH AGHD IGF-I Hu AGHD bioelectrical impedance analysis BIA AGHD p< % 52.9% p<0.005, GH AGHD % %
13 2.5.1 Page 13 3 AGHD AGHD ( ) a (kg) c e e BMI (kg/m 2 ) c d d / (%) c e e / (%) c e e / (%) c d e / (%) e / (%) b e d a SEM b p<0.025 c p<0.005 d p<0.025 e p< AGHD %% % * p<0.025 ** p<0.005 IGF-I % % IGF-I %% 6 7 IGF-I
14 2.5.1 Page 14 6 AGHD % IGF-I y= x r =0.51 p<0.005 AGHD 7 AGHD % IGF-I y= x r = 0.62 p< AGHD AGHD The Growth Hormone Research Society GRS AGHD GRS FDA 4 2
15 2.5.1 Page 15 AGHD GH AGHD IGF-I 5 AGHD AGHD 2 4 GRS ABC 参加者氏名 Dr.Andrea Attanasio Dr.Kenneth Attie Dr.Rob Baxter Dr.Bengt-Ake Bengtsson Dr.Allan Black Dr.Sandra Blethen Dr.Lena Carlsson Dr.Filipe Casaneuva Dr.John Chipman Dr.Jens Sandahl Christiansen Dr.David Clemmons Dr.Ross Cuneo Mr.Dirk De Rijdt Dr.Ezio Ghigo Dr.Mark Hartman Ms.Elizabeth Hernberg-Stahl Dr.Raymond Hintz Dr.Ken Ho Garvan Dr. David Hoffman Dr.Minoru Irie Dr.Jens Otto Jorgensen Ms.Anne-Marie Kappelgaard Dr.Zvi Laron Dr. Saul Malozowski Dr.David Russel-Jones Dr.Steve Shalet Dr.Pierre Sizonenko Dr.Peter H. Sonksen Dr.Christian Strasburger Dr.Kazue Takano Dr.Michael Thorner 施設 Lilly Research Center (England) Genentech, Inc. (USA) Kollings Institute of Research (Australia) Sahlgrenska University (Sweden) Therapeutic Goods Administration (Australia) Genentech, Inc. (USA) Sahlgrenska University (Sweden) Santiago De Compostela university (Spain) Lilly Research Laboratories (USA) Aarhus Kommunehospital (Denmark) University of North Carolina (USA) Princess Alexandra Hospital (Australia) Pharmacia & Upjohn (Belgium) University of Turin (Italy) University of Virginia (USA) Pharmacia & Upjohn (Sweden) Stanford University Medical Center (USA) Institute of Medical Research (Australia) Garvan Institute of Medical Research (Australia) Toho University (Japan) Aarhus Kommunehospital (Denmark) Novo Nordisk A/S (Denmark) Children's Medical Center of Israel (Israel) FDA (USA) St.Thomas' Hospital (England) Christie Hospital (England) University of Geneva (Switzerland) St.Thomas' Hospital (England) Innenstandt University Hospital (Germany) Tokyo Woman's Medical College (Japan) University of Virginia Health Sciences Center (USA)
16 2.5.1 Page 16 5 AGHD GH GHRH GH GH 3ng/mL GH GH mg/ 1 1.0mg/ GHD 1 1 GH IGF-I IGF-I GH 1 2 Bio-impedance Dual X-ray Absorptiometry DEXA 1 AGHD GH GH 2 GH AGHD gold standard GH 8 1 GH GH
17 2.5.1 Page 睡眠 35 血中 GH (ng/ml) 時間 8 24 GH GH GH GH GH L-DOPAGHRP-2 AGHD AGHD gold standard GH GH GH 5 ng/ml AGHD growth hormone releasing hormone GHRH GH GH AGHD GH IGF-I IGF-I IGF-I GH IGF-I GH GH GH Cut-off Cut-off 1998
18 2.5.1 Page 18 Hoffmann GHD BMI Body Mass Index GH GH peak GH GH 24 h integrated GH concentration IGHC IGF-I IGFBP-3 4 peak GH AGHD GH < ng/ml 0.5 ng/ml ng/ml 16.3 ng/ml peak GH AGHD AGHD AGHD 6 AGHD SE SE / 20/ /7 23 cm kg BMI kg/m peak GH Ng/mL * * < IGHC ng/ml * < * < IGF-I ng/ml * * < IGFBP-3 µg/ml * * * p<0.001 IGHC GH
19 2.5.1 Page 19 B A Peak GH ng/ml IGHC ng/ml S S 0 n = 21 n = 25 C IGF-I ng/ml D IGFBP-3 μg/ml S n = 23 n = 35 n = 20 n = 31 S GH 0.2 S: 測定感度, GH:0.2ng/mL, ng/ml IGF-I 25 IGF-I:25ng/mL, ng/ml n n: 被験者数 n = 21 n = 29 9 ( ) peak GH A IGHC B IGF-I C IGFBP-3 D A Peak GH ng/ml B IGHC ng/ml S S S: 測定感度 S Age (yr) C IGF-I ng/ml S 0 D IGFBP-3 μg/ml Age (yr) 10 peak GH A IGHC B IGF-I C IGFBP-3 D peak GH 24 GH IGHC IGF-I
20 2.5.1 Page 20 IGFBP-3 7 peak GH GH 5 ng/ml GH AGHD 100 IGHC GH IGHC 0.4 ng/ml 0.2 ng/ml IGHC <0.2 ng/ml IGF-I IGF-I Cut-off IGF-I IGFBP peak GH 24 GH IGHC IGF-I IGFBP-3 95% % % peak GH ng/ml < IGHC ng/ml <0.4 a) <0.2 a) <0.2 b) <0.2 b) IGF-I ng/ml <187 a) <180 a) <84 c) <55 c) IGFBP-3 ng/ml <4.1 a) <2.0 c) a) b) c) Ho AGHD GH 1997 Port Stephens Growth Hormone Research Society GRS GH GH Cut-off 5 ng/ml GH AGHD GH GH 3 ng/ml AGHD
21 2.5.1 Page GH GH GH 3 ng/ml GH 5 ng/ml GHD Cut-off GH 5 ng/ml GHD GH GH 3 ng/ml GH GH GH GH Cut-off 5 ng/ml 3 ng/ml GH TSH ACTH LH FSH ADH GH 60 AGHD AGHD GH QOL AGHD AGHD AGHD AGHD GH GH AGHD GH 8 9
22 2.5.1 Page 22 8 GH 1 Na K P 9 GH Williams textbook of Endocrinology 10 th edition QOL GH GH IGF-I IGF-BP3 TSH ACTH GH IGF-I LDL HDL T 3
23 2.5.1 Page ACE GHD GH GHD GH GH GH GH AGHD QOL GH AGHD GH AGHD GH AGHD AGHD GH 3 ng/ml GH GH AGHD AGHD AGHD GHD GH AGHD AGHD 1997
24
25
26
27
28 2.5.2 Page
29 2.5.3 Page
5.3mg () 1 2SD 2 1.5SD 17 15 2 4 4 3 ( ) 瘙 3 嘔 気 嘔 吐 腹 痛 消 化 不 良 便 秘 4 24 p * p ** IGF-I (ng/ml) 77.12±60.19 238.97±143.60 161.85±113.30 [124.08, 199.63] (p
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Contents 1. 2 2. 3 3. 7 4. 9 5. 14 6. 15 7. 17 8. 19 9. 21 1. growth hormone deficiency : GHD10,00015,000 2 2. 03 1GH T3T4 1 GHRHGHIH -CIGF-1 -CIGF-1 3 1 GHRH GHIH GH TSH LHFSH -C IGF-1 -C IGF-1 T3T4 4
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