基于真实世界数据的注射用紫杉醇(白蛋白结合型)药学监护路径研究

Pharmaceutical Care Pathways of Nanoparticle Albumin Bound Paclitaxel Based on Real-World Data

目的:建立注射用紫杉醇(白蛋白结合型)(nab-PTX)药学监护路径,为临床合理用药提供参考。方法:对2020年1月至2023年6月该院使用过nab-PTX的患者资料进行回顾性分析,评价用药合理性。以nab-PTX的药品说明书为基础,以循证医学为依据,结合该院nab-PTX使用的真实世界数据等,建立nab-PTX在肿瘤患者真实世界人群中合理用药的药学监护路径。结果:本研究纳入279例使用过nab-PTX的患者数据。分析结果显示,42例转移性乳腺癌患者符合nab-PTX的药品说明书适应证;超说明书适应证用药的共237例(占84.9%),其中有循证医学证据的超说明书适应证用药有209例(包括宫颈癌、胰腺癌、胃癌、非小细胞肺癌、鼻咽癌、卵巢癌或输卵管癌、食管癌、子宫内膜癌、胆管癌),评价为用药合理,而部分超说明书用药(口腔癌、纵隔恶性肿瘤、骨肿瘤、软组织恶性肿瘤、前列腺癌、十二指肠恶性肿瘤等)循证医学证据不足,评价为不合理用药。患者使用nab-PTX最常见的不良反应为骨髓抑制和周围神经病变,与药品说明书相符。在此基础上,从化疗前、化疗中、化疗后及随访等多方面建立了nab-PTX药学监护路径。结论:nab-PTX超说明书用药普遍存在,应加强对nab-PTX应用的管理,通过制定住院患者nab-PTX药学监护路径,可以提高药师的工作效率,保障肿瘤患者合理用药。

OBJECTIVE:To establish the pharmaceutical care pathways of nanoparticle albumin bound paclitaxel(nab-PTX),so as to provide reference for clinical rational drug use.METHODS:Data of patients who used nab-PTX from Jan.2020 to Jun.2023 in the hospital were retrospectively analyzed and evaluated.The pharmaceutical care pathways of rational use of nab-PTX was established based on the instructions of nab-PTX,evidence-based medicine,and the real-world data of nab-PTX use in the hospital.RESULTS:Data analysis of 279 patients included in this study showed that 42 cases of metastatic breast were in line with the drug indications of nab-PTX,and 237 cases(84.9%)were off-label.There were 209 off-label cases with evidence-based medical evidence(including cervical cancer,pancreatic cancer,stomach cancer,non-small cell lung cancer,nasopharyngeal cancer,ovarian cancer or fallopian tube cancer,esophageal cancer,endometrial cancer,and cholangiocarcinoma),which were evaluated as rational drug use.However,some off-label cases(oral cancer,mediastinal tumor,bone carcinoma,soft-tissue carcinoma,prostatic cancer,and malignant duodenal neoplasm)were evaluated as irrational due to insufficient evidence-based medical evidence.The most common adverse drug reactions of nab-PTX were myelosuppression and peripheral neuropathy,which were consistent with the drug instructions.The pharmaceutical care pathways of nab-PTX were established from various aspects,including pre-chemotherapy,chemotherapy,post-chemotherapy and follow-up.CONCLUSIONS:Off-label drug use of nab-PTX is common,and the management for application of nab-PTX should be strengthened.The development of pharmaceutical care pathways of nab-PTX can improve the work efficiency of pharmacists and ensure the safe and rational drug use of cancer patients.