重组人生长激素冷却给药的药代动力学。点击2,一种新的无针装置,与使用传统注射器和针头的皮下给药相比。

Chris Brearley, Anthony Priestley, James Leighton-Scott, Michel Christen
{"title":"重组人生长激素冷却给药的药代动力学。点击2,一种新的无针装置,与使用传统注射器和针头的皮下给药相比。","authors":"Chris Brearley,&nbsp;Anthony Priestley,&nbsp;James Leighton-Scott,&nbsp;Michel Christen","doi":"10.1186/1472-6904-7-10","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Growth hormone (GH) is used to treat growth hormone deficiency (GHD, adult and paediatric), short bowel syndrome in patients on a specialized diet, HIV-associated wasting and, in children, growth failure due to a number of disorders including Turner's syndrome and chronic renal failure, and in children born small for gestational age. Different brands and generic forms of recombinant human growth hormone (r-hGH) are approved for varying indications in different countries. New ways of administering GH are required because the use of a needle and syringe or a device where a patient still has to insert the needle manually into the skin on a daily basis can lead to low adherence and sub-optimal treatment outcomes. The objective of this study was to assess the relative bioavailability of r-hGH (Saizen, Merck Serono) administered by a new needle-free device, cool.click 2, and a standard needle and syringe.</p><p><strong>Methods: </strong>The study was performed with 38 healthy volunteers who underwent pituitary somatotrope cell down-regulation using somatostatin, according to a randomized, two-period, two-sequence crossover design. Following subcutaneous administration of r-hGH using cool.click 2 or needle and syringe, pharmacokinetic parameters were analysed by non-compartmental methods. Bioequivalence was assessed based on log-transformed AUC and C(max) values.</p><p><strong>Results: </strong>The 90% confidence intervals for test/reference mean ratio of the plasma pharmacokinetic variables Cmax and AUC(0-inf) were 103.7-118.3 and 97.1-110.0, respectively, which is within the accepted bioequivalence range of 80-125%. r-hGH administered by cool.click 2 is, therefore, bioequivalent to administration by needle and syringe with respect to the rate and extent of GH exposure. Treatment using cool.click 2 was found to be well tolerated. With cool.click 2 the tmax was less (3.0 hours) than for needle and syringe delivery (4.5 hours), p = 0.002 (Friedman test), although this is unlikely to have any clinical implications.</p><p><strong>Conclusion: </strong>These results demonstrate that cool.click 2 delivers subcutaneous r-hGH exposure that is bioequivalent to the conventional mode of injection. The new device has the additional advantage of being needle-free, and should help to increase patient adherence and achieve good therapeutic outcomes from r-hGH treatment.</p>","PeriodicalId":9196,"journal":{"name":"BMC Clinical Pharmacology","volume":"7 ","pages":"10"},"PeriodicalIF":0.0000,"publicationDate":"2007-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1186/1472-6904-7-10","citationCount":"4","resultStr":"{\"title\":\"Pharmacokinetics of recombinant human growth hormone administered by cool.click 2, a new needle-free device, compared with subcutaneous administration using a conventional syringe and needle.\",\"authors\":\"Chris Brearley,&nbsp;Anthony Priestley,&nbsp;James Leighton-Scott,&nbsp;Michel Christen\",\"doi\":\"10.1186/1472-6904-7-10\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Growth hormone (GH) is used to treat growth hormone deficiency (GHD, adult and paediatric), short bowel syndrome in patients on a specialized diet, HIV-associated wasting and, in children, growth failure due to a number of disorders including Turner's syndrome and chronic renal failure, and in children born small for gestational age. Different brands and generic forms of recombinant human growth hormone (r-hGH) are approved for varying indications in different countries. New ways of administering GH are required because the use of a needle and syringe or a device where a patient still has to insert the needle manually into the skin on a daily basis can lead to low adherence and sub-optimal treatment outcomes. The objective of this study was to assess the relative bioavailability of r-hGH (Saizen, Merck Serono) administered by a new needle-free device, cool.click 2, and a standard needle and syringe.</p><p><strong>Methods: </strong>The study was performed with 38 healthy volunteers who underwent pituitary somatotrope cell down-regulation using somatostatin, according to a randomized, two-period, two-sequence crossover design. Following subcutaneous administration of r-hGH using cool.click 2 or needle and syringe, pharmacokinetic parameters were analysed by non-compartmental methods. Bioequivalence was assessed based on log-transformed AUC and C(max) values.</p><p><strong>Results: </strong>The 90% confidence intervals for test/reference mean ratio of the plasma pharmacokinetic variables Cmax and AUC(0-inf) were 103.7-118.3 and 97.1-110.0, respectively, which is within the accepted bioequivalence range of 80-125%. r-hGH administered by cool.click 2 is, therefore, bioequivalent to administration by needle and syringe with respect to the rate and extent of GH exposure. Treatment using cool.click 2 was found to be well tolerated. With cool.click 2 the tmax was less (3.0 hours) than for needle and syringe delivery (4.5 hours), p = 0.002 (Friedman test), although this is unlikely to have any clinical implications.</p><p><strong>Conclusion: </strong>These results demonstrate that cool.click 2 delivers subcutaneous r-hGH exposure that is bioequivalent to the conventional mode of injection. The new device has the additional advantage of being needle-free, and should help to increase patient adherence and achieve good therapeutic outcomes from r-hGH treatment.</p>\",\"PeriodicalId\":9196,\"journal\":{\"name\":\"BMC Clinical Pharmacology\",\"volume\":\"7 \",\"pages\":\"10\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2007-10-08\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://sci-hub-pdf.com/10.1186/1472-6904-7-10\",\"citationCount\":\"4\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"BMC Clinical Pharmacology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1186/1472-6904-7-10\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"BMC Clinical Pharmacology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1186/1472-6904-7-10","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 4

摘要

背景:生长激素(GH)用于治疗生长激素缺乏症(GHD,成人和儿童),特殊饮食患者的短肠综合征,艾滋病毒相关的消瘦和儿童,由于许多疾病(包括特纳综合征和慢性肾衰竭)引起的生长衰竭,以及出生时小于胎龄的儿童。不同品牌和通用形式的重组人类生长激素(r-hGH)在不同的国家被批准用于不同的适应症。由于使用针头和注射器或患者每天仍需手动将针头插入皮肤的装置可能导致低依从性和次优治疗结果,因此需要新的GH管理方法。本研究的目的是评估r-hGH (Saizen,默克雪兰诺)的相对生物利用度,通过一种新的无针装置给药,cool。点击2,一个标准的针头和注射器。方法:采用随机、两期、两序列交叉设计,对38名接受生长抑素下调垂体生长激素细胞的健康志愿者进行研究。皮下注射r-hGH后使用凉液。点击2针和注射器,采用非室室法分析药动学参数。生物等效性评价基于对数转换的AUC和C(max)值。结果:血浆药代动力学变量Cmax和AUC(0-inf)的试验/参考均值比值的90%置信区间分别为103.7 ~ 118.3和97.1 ~ 110.0,在公认的80 ~ 125%的生物等效性范围内。r-hGH用凉液给药。因此,就生长激素暴露的速率和程度而言,点击2与用针和注射器给药具有生物等效性。处理时使用凉水。Click 2的耐受性良好。与酷。点击2,tmax(3.0小时)少于针头和注射器输送(4.5小时),p = 0.002 (Friedman检验),尽管这不太可能有任何临床意义。结论:这些结果证明了酷。点击2提供皮下r-hGH暴露,与传统的注射方式生物等效。这种新装置还有一个额外的优点,那就是不需要针头,应该有助于提高患者的依从性,并从r-hGH治疗中获得良好的治疗效果。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

摘要图片

查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
Pharmacokinetics of recombinant human growth hormone administered by cool.click 2, a new needle-free device, compared with subcutaneous administration using a conventional syringe and needle.

Background: Growth hormone (GH) is used to treat growth hormone deficiency (GHD, adult and paediatric), short bowel syndrome in patients on a specialized diet, HIV-associated wasting and, in children, growth failure due to a number of disorders including Turner's syndrome and chronic renal failure, and in children born small for gestational age. Different brands and generic forms of recombinant human growth hormone (r-hGH) are approved for varying indications in different countries. New ways of administering GH are required because the use of a needle and syringe or a device where a patient still has to insert the needle manually into the skin on a daily basis can lead to low adherence and sub-optimal treatment outcomes. The objective of this study was to assess the relative bioavailability of r-hGH (Saizen, Merck Serono) administered by a new needle-free device, cool.click 2, and a standard needle and syringe.

Methods: The study was performed with 38 healthy volunteers who underwent pituitary somatotrope cell down-regulation using somatostatin, according to a randomized, two-period, two-sequence crossover design. Following subcutaneous administration of r-hGH using cool.click 2 or needle and syringe, pharmacokinetic parameters were analysed by non-compartmental methods. Bioequivalence was assessed based on log-transformed AUC and C(max) values.

Results: The 90% confidence intervals for test/reference mean ratio of the plasma pharmacokinetic variables Cmax and AUC(0-inf) were 103.7-118.3 and 97.1-110.0, respectively, which is within the accepted bioequivalence range of 80-125%. r-hGH administered by cool.click 2 is, therefore, bioequivalent to administration by needle and syringe with respect to the rate and extent of GH exposure. Treatment using cool.click 2 was found to be well tolerated. With cool.click 2 the tmax was less (3.0 hours) than for needle and syringe delivery (4.5 hours), p = 0.002 (Friedman test), although this is unlikely to have any clinical implications.

Conclusion: These results demonstrate that cool.click 2 delivers subcutaneous r-hGH exposure that is bioequivalent to the conventional mode of injection. The new device has the additional advantage of being needle-free, and should help to increase patient adherence and achieve good therapeutic outcomes from r-hGH treatment.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
自引率
0.00%
发文量
0
期刊最新文献
Statin therapy in critical illness: an international survey of intensive care physicians' opinions, attitudes and practice. Correction: Adverse drug reactions to antiretroviral therapy (ARVs): incidence, type and risk factors in Nigeria Data for drugs available through low-cost prescription drug programs are available through pharmacy benefit manager and claims data. Population prevalence of high dose paracetamol in dispensed paracetamol/opioid prescription combinations: an observational study. Adherence to medication for the treatment of psychosis: rates and risk factors in an Ethiopian population.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1