中国临床药学杂志

目的 基于真实世界数据，对白蛋白结合型紫杉醇超说明书用药情况进行综合评价，为白蛋白结合型紫杉醇的临床应用及超说明书用药的管理提供参考。方法 收集2021年1月1日至2023年12月31日白蛋白结合型紫杉醇超说明书用药的161例住院病例相关信息，分析白蛋白结合型紫杉醇超说明书用药的病种、循证证据水平和强度、药物疗效及安全性。结果 161例病例中，转移性胰腺癌60例（占37.27%）、铂耐药的复发性卵巢癌58例（占36.02%）、局部晚期或转移性的非小细胞肺癌43例（占26.71%），超说明书用药循证证据水平均较高（ClassⅡa或ClassⅡb），证据强度均为Category B。超说明书用药的科室主要有肿瘤科（占86.34%）。转移性胰腺癌、铂耐药的复发性卵巢癌和局部晚期或转移性的非小细胞肺癌的治疗有效率分别为90.57%、84.62%和75.76%，复发率分别为8.33%、15.91%和4.00%。不良反应主要累及血液系统（占53.42%）。结论 白蛋白结合型紫杉醇的超说明书用药主要集中在转移性胰腺癌、铂耐药的复发性卵巢癌和局部晚期或转移性的非小细胞肺癌，临床治疗有效率较高，但仍需警惕血液系统的不良反应风险，临床用药期间应全程监测全血细胞及淋巴细胞。药学部门需进一步加大白蛋白结合型紫杉醇超说明书用药的监管力度，在超说明书用药过程中加强临床药学监护和用药追踪，以提高临床疗效，保障用药安全。

AIM To comprehensively evaluate the off-label use of nab-paclitaxel(nab-PTX) based on real-worlddata, and provide a reference for the clinical application and off-label drug use management of nab-PTX. METHODSData of 161 hospitalized patients receiving off-label use of nab-PTX from January 1st, 2021 to December 31st, 2023were collected and analyzed. The analysis focused on the types of diseases, level and strength of clinical evidence,efficacy, and safety of off-label use of nab-PTX. RESULTS Among the 161 cases analyzed, the off-label use of nab-PTXwas predominantly observed in the following malignancies: metastatic pancreatic adenocarcinoma(60 cases, 37.27%),platinum-resistant recurrent ovarian cancer(58 cases, 36.02%), and locally advanced or metastatic non-small cell lungcancer(NSCLC)(43 cases, 26.71%). The level of evidence-based evidence for the off-label use of nab-PTX in these caseswas all relatively high(Class Ⅱ a or Class Ⅱ b), and the strength of evidence was Category B. The departments whereoff-label use of nab-PTX occurred were mainly the department of oncology(86.34%). The treatment response rates formetastatic pancreatic cancer, platinum-resistant recurrent ovarian cancer, and locally advanced or metastatic non-smallcell lung cancer were 90.57%, 84.62%, and 75.76% respectively, and the recurrence rates were 8.33%, 15.91%, and 4.00%respectively. Adverse reactions mainly affected the hematological system(53.42%). CONCLUSION The off-label use ofnab-PTX is predominantly observed in metastatic pancreatic adenocarcinoma, platinum-resistant recurrent ovarian cancer,and locally advanced or metastatic NSCLC. The efficacy of the off-label use of nab-PTX in patients is relatively high, butit is still necessary to pay attention to the risk of hematological injury. Complete blood counts and lymphocyte level shouldbe monitored throughout clinical medication administration. The pharmacy department needs to further strengthen thesupervision of off-label use of nab-PTX, enhancing clinical pharmaceutical care and medication tracking during off-labeluse to improve clinical efficacy and ensure medication safety.