Jørgensen J O, Møller J, Jensen F S, Jørgensen J T, Christiansen J S
Second University Clinic of Internal Medicine, Aarhus Kommunehospital, Denmark.
Pharmacol Toxicol. 1989 Aug;65(2):96-9. doi: 10.1111/j.1600-0773.1989.tb01135.x.
We have evaluated the pharmacokinetics, reliability and patient tolerability of a newly developed injection pen for cartridged growth hormone (GH). The cartridge contains 25 IU GH in 2 ml solvents. The pen, which is basically a needle, syringe and vial in one piece, is operated by a turning movement and allows doses from 0.25-4 IU. Nine GH deficient patients were hospitalized twice for overnight bloodsampling following subcutaneous injections (at 8 p.m.) of GH: i.e. when using traditional syringe and vial and after 6 weeks of use of the pen. Serum GH antibodies were measured immediately prior to, and 3 and 6 months following pen treatment. GH containers were collected regularly from the patients for chemical analysis. A questionnaire was completed during and at the end of the study. The absorption rate and bioavailability of GH tended to be higher with syringe and vial (2 P = 0.07) but there were no differences in the profiles of IGF-I, insulin, glucagon or pertinent metabolic parameters following the 2 injection modes. No GH antibodies occurred during 6 months of pen treatment. The content of polymeric GH was lower in the cartridges (2 P less than 0.001). Seven of the patients reported less injection pain when using the injection pen, which they all strongly preferred and wished to continue using. We conclude that the GH injection pen is a reliable tool which seems to be more convenient for the patients.
我们评估了一种新开发的用于预装生长激素(GH)的注射笔的药代动力学、可靠性和患者耐受性。笔芯在2毫升溶剂中含有25国际单位的生长激素。该注射笔基本上是一体的针头、注射器和药瓶,通过旋转操作,可提供0.25 - 4国际单位的剂量。9名生长激素缺乏患者住院两次,分别在皮下注射生长激素(晚上8点)后进行过夜采血,即一次使用传统注射器和药瓶时,另一次在使用该注射笔6周后。在笔治疗前、治疗后3个月和6个月立即测量血清生长激素抗体。定期从患者处收集生长激素容器进行化学分析。在研究期间和结束时完成一份问卷。生长激素的吸收率和生物利用度在使用注射器和药瓶时往往更高(P = 0.07),但两种注射方式后胰岛素样生长因子-I、胰岛素、胰高血糖素或相关代谢参数的曲线没有差异。在笔治疗的6个月期间未出现生长激素抗体。笔芯中聚合生长激素的含量较低(P小于0.001)。7名患者报告使用注射笔时注射疼痛较轻,他们都强烈偏好并希望继续使用。我们得出结论,生长激素注射笔是一种可靠的工具,对患者来说似乎更方便。