Natural sequence of human growth hormone (r-hGH) prepared by Eli Lilly and Company using recombinant DNA technology has been used to treat 226 patients with growth hormone deficiency in the United States and Canada. The data from this multicenter study are sufficient to analyze for the efficacy of r-hGH in 156 of the patients, with a complete safety analysis of all patients. The patients had growth hormone deficiency as a growth rate <4cm/yr (5% for age by Tanner growth curves) and failure to

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... spond to two provocative stimuli for growth hormone release. The patients had no previous treatment with hGH or anabolic steroids. Other possible explanations for the growth failure or conditions that might interfere with the growth response were basis for exclusion from the study. The dosage of growth hormone was 0.06mg/kg given by intramuscular injection t. i. w. with a maximum dose of 8mg/wk. Other hormone deficiencies were treated in the usual fashion but cortisol replacement was limited to <10mg/m2. At the time of this report 156, 111 and 41 patients had completed 1, 3 and 6 months of therapy, respectively.