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运用PDCA结合高效液相色谱法评估并提高儿科输液剂量的准确性:一项来自中国的质量改进研究

Evaluating and improving the accuracy of pediatric infusion dose using PDCA combined with HPLC: a quality improvement study from China.

作者信息

Jiang Dan, Cui Min, Fang Baoxia, Chen Fuchao

机构信息

Sinopharm Dongfeng General Hospital, Hubei University of Medicine, Shiyan, Hubei, 442008, China.

School of Pharmaceutical Sciences, Hubei University of Medicine, Shiyan, Hubei, 442000, China.

出版信息

J Pharm Health Care Sci. 2025 Jun 13;11(1):49. doi: 10.1186/s40780-025-00457-y.

Abstract

BACKGROUND

Accurate formulation of an intravenous infusion is critical in ensuring its smooth implementation. However, in clinical practice, owing to the diverse reasons for drug preparation, some patients cannot obtain safe and accurate medications, especially in pediatric infusion rooms. Pediatric patients often experience adverse reactions as the dosage administered does not meet the requirements or exceeds the recommended dose.

METHODS

Finished product infusion of potassium sodium dehydroandrographolide succinate (PSDS) was used as the study drug. Drug residue samples from the finished product infusion bags were collected randomly in the pediatric infusion room and clinical wards before (from October 2022 to December 2022) and after (from May 2023 to July 2023) the plan-do-check-action (PDCA) cycle intervention. High-performance liquid chromatography (HPLC) was used to determine the drug content. Comparisons of the changes in the proportion of the drug in the infusion were made based on the monitoring results.

RESULTS

After PDCA cycle intervention, the qualified rates of whole, non-whole, and overall infusions increased from 92.95%, 82.68%, and 86.59% to 97.56%, 95.12%, and 96.10% (P < 0.05), respectively. The accuracy and uniformity of the infusion preparations significantly improved.

CONCLUSIONS

The combination of HPLC and PDCA cycle management can effectively improve the quality of pediatric infusion preparations and enhance their effectiveness.

摘要

背景

准确配制静脉输液对于确保其顺利实施至关重要。然而,在临床实践中,由于药物配制的原因多种多样,一些患者无法获得安全准确的药物,尤其是在儿科输液室。儿科患者常因给药剂量不符合要求或超过推荐剂量而出现不良反应。

方法

以成品痰热清注射液为研究药物。在计划-执行-检查-处理(PDCA)循环干预前后(2022年10月至2022年12月为干预前,2023年5月至2023年7月为干预后),在儿科输液室和临床病房随机采集成品输液袋中的药物残留样本。采用高效液相色谱法(HPLC)测定药物含量。根据监测结果对输液中药物比例的变化进行比较。

结果

PDCA循环干预后,全量、半量及总量输液的合格率分别从92.95%、82.68%和86.59%提高到97.56%、95.12%和96.10%(P<0.05)。输液制剂的准确性和均匀性显著提高。

结论

HPLC与PDCA循环管理相结合可有效提高儿科输液制剂质量,增强其有效性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cb25/12166566/3f3dfa2ea69b/40780_2025_457_Fig1_HTML.jpg

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