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5 result(s) for "静脉给药"
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應用根本原因分析於提升嬰兒連續性靜脈給藥安全之改善專案
背景 2010年嬰兒加護單位因連續性靜脈給藥劑量錯誤,導致嬰兒傷害事件。經品管小組運用根本原因分析法,歸納出藥物不良事件之原因,包括:醫師處方開立程序不正確及內容不完整、護理師執行連續性靜脈給藥步驟不完整、確認醫囑的流程複雜、手抄醫囑於治療單不僅耗時且易抄錯、護理師專業認知不足等組織系統方面的缺失。目的 期能達成護理師執行連續性靜脈給藥步驟完整率為100%,給藥異常事件為0件。解決方案 改善策略包含:簡化確認醫囑流程、制定醫師處方規範、制定標準化連續性靜脈給藥步驟、規範連續性靜脈給藥劑量之配製藥量,與建制高警訊藥物雙人核對機制。除循序建立上述之改善措施外,同時提供單位護理師相關教育訓練,以落實方案執行。結果 經計畫至執行後,評值改善策略之成效,發現給藥步驟完整率提升至99%,醫師處方開立正確率提升為96%;評值期間無藥物不良事件發生。結論 本專案建立之系統性安全給藥機制,可增進醫護照護團隊間溝通與合作,進而提升嬰兒給藥安全及品質。
Pharmacokinetics and disposition of monoterpene glycosides derived from Paeonia lactiflora roots (Chishao) after intravenous dosing of antiseptic XueBiJing injection in human subjects and rats
Aim: Monoterpene glycosides derived from Paeonia lactiflora roots (Chishao) are believed to be pharmacologically important for the antiseptic herbal injection XueBiJing. This study was designed to characterize the pharmacokinetics and disposition of monoterpene glycosides. Methods: Systemic exposure to Chishao monoterpene glycosides was assessed in human subjects receiving an intravenous infusion and multiple infusions of XueBiJing injection, followed by assessment of the pharmacokinetics of the major circulating compounds. Supportive rat studies were also performed. Membrane permeability and plasma-protein binding were assessed in vitro. Results: A total of 18 monoterpene glycosides were detected in XueBiJing injection (content levels, 0.001-2.47 mmol/L), and paeoniflorin accounted for 85.5% of the total dose of monoterpene glycosides detected. In human subjects, unchanged paeoniflorin exhibited considerable levels of systemic exposure with elimination half-lives of 1.2-1.3 h; no significant metabolite was detected. Oxypaeoniflorin and albiflorin exhibited low exposure levels, and the remaining minor monoterpene glycosides were negligible or undetected. Glomerular-filtration-based renal excretion was the major elimination pathway of paeoniflorin, which was poorly bound to plasma protein. In rats, the systemic exposure level of paeoniflorJn increased proportionally as the dose was increased. Rat lung, heart and liver exposure levels of paeoniflorin were lower than the plasma level, with the exception of the kidney level, which was 4.3-fold greater than the plasma level; brain penetration was limited by the poor membrane permeability. Conclusion: Due to its significant systemic exposure and appropriate pharmacokinetic profile, as well as previously reported antiseptic properties, paeoniflorin is a promising XueBiJing constituent of therapeutic importance.
Population Pharmacokinetics of High-dose Methotrexate After Intravenous Administration in Chinese Osteosarcoma Patients from a Single Institution
Background: High-dose methotrexate (HD-MTX) with folinic acid (leucovorin) rescue is the gold standard therapy in the treatment of osteosarcoma. The plasma concentration of MTX is closely related to efficacy and toxicity. There are large individual differences. Many authors have described the pharmacokinetic (PK) profile of MTX regarding osteosarcoma under a variety of circumstances. However, no data concerning Chinese osteosarcoma patient PKs using the nonlinear mixed effects models (NONMEM) have been previously reported. The goals of this study were to establish the population pharmacokinetics (PPK) of HD-MTX treatment in Chinese osteosarcoma patients, and to explore the influence of patient covariates and between-occasion variability on drug disposition. Methods: An intravenous HD-MTX solution (10 g/m 2 ) was given 274 times to 148 osteosarcoma patients. MTX plasma concentrations were measured at 0, 6, 12, 24, 48 and 72 h after commencement of the infusion, and the fluorescence polarization immunoassay was used to determine MTX plasma concentrations. The PPK model and parameters were estimated using NONMEM software. The effects of fixed-effect factors were evaluated, and the final regression model was obtained. Results: The following population parameters were obtained using a two-compartment model: CL1 (clearance of central compartment): (CL1 ) = CL1TV × [1 - θ CL 1- MTXNUM × MTXNUM] × [1 - θ CL 1- CrCl1 × (CrCl1 - 1.89)] × e ηCL 1i (L/h). V1 (central volume): (V1 )i = V1TV × e ηV 1i (L). CL2 (clearance of peripheral compartment): (CL2 )i = CL2TV × [1 - θCL 2 - BODY AREA × (body area - 1.62)] × e ηCL 2i (L/h). V2 (peripheral compartment): (V2 )i = V2TV × [1 - θ V 2-bodyarea × (bodyarea-1.62)] × e ηV 2i (L). The PPK parameters (RSD%) were CL1, V1, CL2 and V2 with values of 6.20 L/h (8.48%), 19.6 L (extremely small), 0.0172 L/h (50.9%) and 0.515 L (39.1%), respectively. Creatinine clearance and the number of methotrexate chemotherapy cycles before MTX infusion had a significant effect on the CL1, and body surface area had a significant effect on the CL2 and the V2 (P < 0. 01). Conclusions: A good fit was derived for the PPK. The model could be used to provide guidance for MTX treatment and reduce adverse effects.
Effect of Intravenous Administration of Liposomal Prostaglandin E1 on Microcirculation in Patients with ST Elevation Myocardial Infarction Undergoing Primary Percutaneous Intervention
Background:Several studies have demonstrated that primary percutaneous coronary intervention (PCI) can result in reperfusion injury.This study aims to investigate the effectiveness of liposomal prostaglandin E l (Lipo-PGE1,Alprostadil,Beijing Tide Pharmaceutical Co.,Ltd.) for enhancing microcirculation in reperfusion injury.In addition,this study determined the optimal administration method for acute ST elevation myocardial infarction (STEMI) patients undergoing primary PCI.Methods:Totally,68 patients with STEMI were randomly assigned to two groups:intravenous administration ofLipo-PGE 1 (Group A),and no Lipo-PGE1 administration (Group B).The corrected thrombolysis in myocardial infarction (TIMI) frame count (cTFC) and myocardial blush grade (MBG) were calculated.Patients were followed up for 6 months.Major adverse cardiac events (MACE) were also measured.Results:There was no significant difference in the baseline characteristics between the two groups.The cTFC parameter in Group A was significantly lower than Group B (18.06 ± 2.06 vs.25.31 ± 2.59,P < 0.01).The ratio of final MBG grade-3 was significantly higher (P < 0.05) in Group A (87.9%) relative to Group B (65.7%).There was no significant difference between the two groups in final TIMI-3 flow and no-reflow.Patients were followed up for 6 months,and the occurrence of MACE in Group A was significantly lower than that in Group B (6.1% vs.25.9% respectively,P < 0.05).Conclusions:Myocardial microcirculation of reperfusion injury in patients with STEMI,after primary PCI,can be improved by administering Lipo-PGE1.
Pharmacokinetics and tolerance of dehydroandrographolide succinate injection after intravenous administration in healthy Chinese volunteers
Aim: Dehydroandrographolide succinate (DAS) is extracted from herbal medicine Andrographis paniculata (Burm f) Nees. DAS injection is used in China for the treatment of viral pneumonia and upper respiratory tract infections. The aim of this study is to investigate the pharmacokinetics and tolerance of DAS injection in healthy Chinese volunteers. Methods: This was a single-center, randomized, single-dose, three-way crossover design study. Nine eligible subjects were randomly divided into 3 groups, and each group sequentially received 80, 160, or 320 mg of DAS infusion according to a three-way Latin square design. Plasma and urine samples were collected and determined using an LC-MS/MS method. Safety and tolerability were determined via clinical evaluation and adverse event monitoring. Results: For the 80, 160, and 320 mg dose groups, the mean Cmax were 4.82, 12.85, and 26.90 mg/L, respectively, and the mean AUC0–12 were 6.18, 16.95, and 40.65 mg·L-1·h, respectively. DAS was rapidly cleared, with a mean Tmax of 0.94–1.0 h and a t1/2 of approximately 1.51–1.89 h. Approximately 10.1%–15.5% of the intravenous DAS dose was excreted unchanged in urine within 24 h in the 3 groups, and more than 90% of unchanged DAS was excreted between 0 and 4 h. The pharmacokinetic profile was similar between male and female subjects. No serious or unexpected adverse events were found during the study, but one mild adverse event (stomachache) was reported.Conclusion: This study shows that DAS has nonlinear pharmacokinetic characteristics. To guarantee the effective concentration, mul?tiple small doses are recommended in clinical regimens.