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药剂科自制毛果芸香碱滴眼液:解决囊性纤维化患者汗测试中 Pilogel® 盘短缺的有效方法。

Pharmacy compounded pilocarpine: An adequate solution to overcome shortage of pilogel® discs for sweat testing in patients with cystic fibrosis.

机构信息

Department of Clinical Pharmacy and Pharmacology, University Medical Centre Groningen, University of Groningen, Groningen, the Netherlands.

Department of Clinical Pharmacy and Pharmacology, University Medical Centre Groningen, University of Groningen, Groningen, the Netherlands.

出版信息

J Cyst Fibros. 2024 Jan;23(1):126-131. doi: 10.1016/j.jcf.2023.09.014. Epub 2023 Sep 27.

Abstract

To respond to shortage of pilocarpine discs due to CE-licensing problems a pharmacy compounded pilocarpine HCL solution was developed and validated for use in CF diagnosis. The aim of this study was to compare the results from a pharmacy compounded pilocarpine HCL solution versus Pilogel® discs for the measurements of sweat chloride concentrations. Ten pediatric and adult patients with CF underwent a sweat test using both Pilogel® discs and pilocarpine HCL solution. The average difference between both methods was -3.25 mmol/L (95% Limits of Agreement: -7.19 [95% CI: -9.19;-5.19] and 0.69 [95% CI: -1.31;2.69] mmol/L. Passing-Bablok regression showed that zero was enclosed with the 95% CI of the calculated intercept (0.15 [95% CI: -1.70;1.42] mmol/L). These data show a good agreement in chloride concentrations obtained using the two pilocarpine products. Therefore, the pharmacy compounded pilocarpine HCL solution can be used as an alternative for Pilogel® discs during times of shortage.

摘要

为应对因 CE 认证问题导致的毛果芸香碱片短缺,一家药店配制了盐酸毛果芸香碱溶液,并对其在 CF 诊断中的应用进行了验证。本研究旨在比较药店配制的盐酸毛果芸香碱溶液与 Pilogel®片在测量汗液氯化物浓度方面的结果。10 名儿科和成年 CF 患者同时使用 Pilogel®片和盐酸毛果芸香碱溶液进行了汗液测试。两种方法的平均差异为-3.25mmol/L(95%可信区间:-7.19 [95% CI:-9.19;-5.19] 和 0.69 [95% CI:-1.31;2.69] mmol/L。Passing-Bablok 回归显示,计算出的截距 95%可信区间内包含零(0.15 [95% CI:-1.70;1.42] mmol/L)。这些数据表明,使用两种毛果芸香碱产品获得的氯化物浓度具有良好的一致性。因此,在 Pilogel®片短缺期间,药店配制的盐酸毛果芸香碱溶液可以作为替代产品。

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