Murasaka Toshiki, Ikemura Kenji, Enokiya Tomoyuki, Muraki Yuichi, Ikemura Mayumi, Terada Koji, Iwamoto Takuya, Okuda Masahiro
Konan Pharmacy, Tsu, Mie 514-0323 Japan.
Department of Clinical Pharmacy and Biopharmaceutics, Mie University Graduate School of Medicine, Tsu, Mie 514-8507 Japan.
J Pharm Health Care Sci. 2017 Nov 8;3:26. doi: 10.1186/s40780-017-0094-7. eCollection 2017.
A dry powder inhaled formulation is used for the anti-influenza drug laninamivir octanoate hydrate (laninamivir). Although two successive inhalations (puffs) are recommended to minimize residual amounts of active ingredients, previous reports suggest that pediatric patients with low peak inspiratory flow are unable to inhale the active ingredient adequately. In the present study, we prospectively investigated the appropriate number of repeated inhalations of laninamivir dry powder and factors influencing the residual amount of ingredients in pediatric patients with influenza.
The study enrolled 64 patients receiving laninamivir dry powder inhaler (Inavir®) between January and March 2016 at Tsu emergency medical center/pediatric clinic and dental clinic. All patients enrolled used a laninamivir dry powder inhaler in four repeated inhalations, as instructed by a pharmacist. The residual amount of laninamivir dry powder was calculated by measuring the device weight before and after each inhalation and a residual amount of >20% was defined as an unsuccessful inhalation.
The inadequate inhalation rate after two successive inhalations was 45%, and it decreased as number of inhalation repeats increased, reaching 23% after four successive inhalations. Peak inspiratory flow in patients with inadequate inhalation was significantly lower than that in patients with adequate inhalation, for all numbers of inhalation repeats analyzed. Receiver operating characteristic analyses indicated peak inspiratory flow cut-off values of 140, 120, 100, and 100 L/min at 1-4 successive inhalations, respectively.
The present findings suggest that a proportion of patients with low peak inspiratory flow were unable to inhale the active ingredient adequately when laninamivir dry powder inhaler was administered as two successive inhalations, as recommended in the instruction manual. Three or four repeated inhalations of laninamivir dry powder inhaler should be administered to pediatric patients with low peak inspiratory flow.
一种干粉吸入制剂用于抗流感药物八聚乙二醇化拉尼米韦(laninamivir)。尽管建议连续两次吸入(喷吸)以尽量减少活性成分的残留量,但先前的报告表明,吸气峰值流量较低的儿科患者无法充分吸入活性成分。在本研究中,我们前瞻性地调查了流感儿科患者重复吸入拉尼米韦干粉的合适次数以及影响成分残留量的因素。
该研究纳入了2016年1月至3月在津急救医疗中心/儿科诊所和牙科诊所接受拉尼米韦干粉吸入器(Inavir®)治疗的64例患者。所有纳入的患者均按照药剂师的指示,分四次重复吸入使用拉尼米韦干粉吸入器。通过测量每次吸入前后装置的重量来计算拉尼米韦干粉的残留量,残留量>20%被定义为吸入失败。
连续两次吸入后吸入不足率为45%,随着吸入重复次数的增加而降低,连续四次吸入后降至23%。在分析的所有吸入重复次数中,吸入不足患者的吸气峰值流量显著低于吸入充分患者。受试者工作特征分析表明,在连续1 - 4次吸入时,吸气峰值流量的截断值分别为140、120、100和100L/分钟。
本研究结果表明,当按照说明书建议将拉尼米韦干粉吸入器连续两次吸入给药时,一部分吸气峰值流量较低的患者无法充分吸入活性成分。对于吸气峰值流量较低的儿科患者,应给予三次或四次重复吸入拉尼米韦干粉吸入器。