title: Effects of GH assay standardization on evaluation of treatment outcomes for acromegaly in Japan.
abstract: In Japan, the growth hormone (GH) assay has been standardized since April 2005 through use of a uniform recombinant human GH (rhGH) standard.  Since then, GH values measured using the rhGH standard have been approximately 40% lower than previous values measured using kit standards based on the WHO standards for hGH of pituitary origin.  However, the Japanese criteria for evaluating treatment outcomes for acromegaly have remained the same: a nadir GH during a 75 g OGTT <1 µg/L is considered cured, 1≤GH<2.5µg/L is considered inadequately controlled, and ≥2.5 µg/L is considered poorly controlled, instead of these levels were lowered to 60%, i.e. from 1 to 0.6 µg/L for cured and from 2.5 to 1.5µg/L for inadequately controlled (termed as "newly proposed criteria" in this study).  We investigated the effects of standardization of the GH assay on the evaluation of post-surgical disease activity in 50 patients with acromegaly (M/F 19/31, 21-72 yr.).  Post-surgical nadir GH levels during OGTT were positively correlated with the IGF-I SD score 3 months after TSS.  Five of 6 patients whose post-surgical nadir GH levels ranged between 0.6 and 1 µg/L had normal serum IGF-I levels 3 months after TSS.  Rates of improvement in glucose metabolism did not differ when patients were classified based on the present criteria vs. the newly proposed criteria.  In conclusion, the current Japanese remission criteria for acromegaly still accurately reflect post-surgical disease activity in most patients, though long-term observation is still required.
authors: Department of Medicine II, Tokyo Women's Medical University, 8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan. izumif@endm.twmu.ac.jp
authors: Izumi
authors: I
authors: Fukuda
authors: Makiko
authors: M
authors: Kurimoto
authors: Satoshi
authors: S
authors: Tanaka
authors: Yu
authors: Y
authors: Yamakado
authors: Toko
authors: T
authors: Muraoka
authors: Kazue
authors: K
authors: Takano
authors: Naomi
authors: N
authors: Hizuka
mesh_terms: D000172:Acromegaly / Q000097:blood* / Q000601:surgery*; D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000032:analysis; D005260:Female; D005951:Glucose Tolerance Test; D019382:Human Growth Hormone / Q000097:blood*; D006801:Humans; D007124:Immunoenzyme Techniques / Q000379:methods; D007334:Insulin-Like Growth Factor I / Q000032:analysis / Q000378:metabolism; D007564:Japan; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000737:chemistry; D012189:Retrospective Studies; D018709:Statistics, Nonparametric; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D011994:Recombinant Proteins; D019382:Human Growth Hormone; D007334:Insulin-Like Growth Factor I