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临床条件下患者教育对泊沙康唑口服混悬液血药浓度和疗效的影响。

Impact of patient education on plasma concentrations and effectiveness of posaconazole oral suspension under clinical conditions.

机构信息

Department of Anesthesiology, Heidelberg University Hospital, Heidelberg, Germany.

Department of Internal Medicine V, Heidelberg University Hospital, Heidelberg, Germany.

出版信息

Basic Clin Pharmacol Toxicol. 2019 Jan;124(1):56-61. doi: 10.1111/bcpt.13093. Epub 2018 Aug 2.

Abstract

Posaconazole prophylaxis is recommended for patients with acute myeloid leukaemia during induction chemotherapy. Although a tablet formulation with better oral bioavailability is available, some patients have to rely on the oral suspension in clinical routine. Therefore, effectiveness of posaconazole oral suspension under real-life clinical conditions and impact of patient education about the correct intake on its plasma concentrations were assessed in this study. Altogether 96 patients receiving 160 cycles of induction chemotherapy were retrospectively (40 patients) and prospectively (56 patients) analysed. Patients were assigned into two groups for each chemotherapy cycle according to the application of antifungal prophylaxis (A: posaconazole oral suspension, 200 mg three times a day ≥7 days; B: intake <7 days, fluconazole or no prophylaxis). Antifungal prophylaxis and therapy were analysed for each cycle. Additionally, plasma concentrations were determined from prospectively included subjects of group A who were intensively educated to perform a correct drug intake. Systemic antifungal therapy was statistically started less often in group A (26% vs 53%; P = 0.002). Posaconazole prophylaxis was associated with a lower risk of proven invasive fungal infection (P = 0.003). Median plasma concentration apparently increased between the first and second time of determination effected by an initial intensive on-site patient education. The clinical effectiveness of posaconazole oral suspension was confirmed. A detailed patient education at the beginning of the treatment with posaconazole oral suspensions seems to be of primary importance for efficient plasma concentrations.

摘要

泊沙康唑预防疗法被推荐用于接受诱导化疗的急性髓系白血病患者。尽管已有生物利用度更好的片剂制剂,但一些患者在临床常规中仍需依赖口服混悬剂。因此,本研究评估了泊沙康唑口服混悬剂在真实临床环境下的有效性,以及患者接受正确用药教育对其血药浓度的影响。共有 96 例接受 160 个诱导化疗周期的患者接受了回顾性(40 例)和前瞻性(56 例)分析。根据抗真菌预防应用情况,将每个化疗周期的患者分为两组(A:泊沙康唑口服混悬剂,200 mg,每日三次,≥7 天;B:<7 天,氟康唑或无预防)。对每个周期的抗真菌预防和治疗进行分析。此外,对接受强化用药教育的 A 组前瞻性纳入的患者进行了血药浓度检测。A 组的全身抗真菌治疗的统计学开始时间较少(26% vs 53%;P = 0.002)。泊沙康唑预防与确诊侵袭性真菌感染的风险降低相关(P = 0.003)。通过最初的现场患者强化教育,首次和第二次测定之间的中位血药浓度明显增加。泊沙康唑口服混悬剂的临床疗效得到了证实。在开始使用泊沙康唑口服混悬剂时,对患者进行详细的教育似乎对有效的血药浓度至关重要。

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