Abstract:
In Japan, a pituitary-extracted human GH (phGH), Crescormon®, was approved for the treatment of pituitary dwarfism in 1975. The Study Group of Pituitary Dysfunction was organized by the Ministry of Health and Welfare (MHW) in 1973 and prepared the \"Diagnostic Handbook: Pituitary Dwarfism\" guidelines in 1974. Eligibility assessments for phGH treatment were conducted by the research group on pituitary dwarfism (later the Foundation for Growth Science [FGS] GH Treatment Eligibility Assessment Committee); however, there were 200-300 patients on the waiting list. GH treatment has been financially supported by the Grant-in-Aid Program for Chronic Diseases in Childhood, MHW, since 1974. In 1984, phGH was discontinued in the United States due to reports of the onset of Creutzfeldt-Jakob disease in patients treated with phGH. Japan approved the use of methionyl hGH in 1986 and recombinant hGH in 1988. As a result, the phGH disappeared from the market. The role of the Eligibility Assessment Committee of the FGS shifted to the provision of second opinions about diagnoses and treatment appropriateness. Since then, the indications for GH treatment of pediatric growth disorders have expanded to include other pediatric growth disorders such as Turner syndrome, achondroplasia/hypochondroplasia, etc.
摘要:
在日本,垂体提取的人GH(PHGH),Crescormon®,1975年被批准用于治疗垂体侏儒症。垂体功能障碍研究小组由卫生和福利部(MHW)于1973年组织,并于1974年编写了“诊断手册:垂体侏儒症”指南。phGH治疗的资格评估是由垂体侏儒症研究小组(后来的生长科学基金会[FGS]GH治疗资格评估委员会)进行的;然而,等待名单上有200-300名患者。GH治疗得到了儿童慢性病补助计划的财政支持,MHW,自1974年。1984年,由于有报道称在接受phGH治疗的患者中出现了Creutzfeldt-Jakob病,因此在美国停用了phGH。日本于1986年批准使用甲硫氨酰hGH,并于1988年批准使用重组hGH。因此,PHGH从市场上消失了。FGS资格评估委员会的作用转移到提供有关诊断和治疗适当性的第二意见。从那以后,GH治疗儿科生长障碍的适应症已经扩展到包括其他儿科生长障碍,如特纳综合征,软骨发育不全/软骨发育不全,等。