大剂量附子治疗晚期恶性肿瘤的安全性评价及用药规律分析

Safety Evaluation of Large-dose Processed Radix Aconiti Lateralis in Treating Advanced Malignant Tumor and Analysis of Its Medication Regularity

目的评价大剂量附子在晚期恶性肿瘤中使用的安全性并分析附子的用药规律。方法收集2017年1月至2018年12月期间浙江省立同德医院肿瘤内科收治的晚期恶性肿瘤住院患者16例,提取其含大剂量附子的处方106张、共计378帖,回顾性分析患者用药前后心脏功能、肝肾功能、骨髓功能相关指标。运用聚类方法分析附子用药规律。结果配对t检验分析显示15 g、30 g、45 g、60 g附子用药后,患者的ALT、AST、TB、DB、IB、Scr、UREA、CK-MB、LDH、WBC、Hgb、PLT等相关指标均未发生明显异常,心电图、心超等检查未见明显异常。通过聚类热图分析得到了核心组合“附子-太子参-当归”等10个组合。结论含有大剂量附子的方药并未对晚期恶性肿瘤患者的心脏功能、肝肾功能、骨髓功能带来明显副作用,具有较好的安全性。

Objective To investigate the safety of large-dose processed Radix Aconiti Lateralis in treating advanced malignant tumor and to analyze the medication regularity for processed Radix Aconiti Lateralis.Methods The clinical data of 16 patients with advanced malignant tumors admitted to the Oncology Department of Tongde Hospital of Zhejiang Province from January 2017 to December 2018 were collected.A total of 106 recipes and 378 dosages containing large-dose processed Radix Aconiti Lateralis were included.A retrospective analysis of the indicators associated with the heart function,liver and kidney function and bone marrow function before and after intervention of large-dose processed Radix Aconiti Lateralis was carried out,and cluster analysis was used for the exploration of the medication regularity for processed Radix Aconiti Lateralis.Results The paired t test showed that no obvious abnormalities were found in the indicators of ALT,AST,TB,DB,IB,Scr,UREA,CKMB,LDH,WBC,Hgb,PLT in the patients after the intervention with 15 g,30 g,45 g,60 g of processed Radix Aconiti Lateralis,and the results of inspection of ECG,echocardiography were normal.The heat map showed by cluster analysis presented 10 core herbal combinations such as the combination of processed RadixAconiti Lateralis,Radix Pseudostellariae,and Radix Angelicae Sinensis. Conclusion The prescription containedlarge dose of processed Radix Aconiti Lateralis which used in treating advanced malignant tumors has no sideeffecton heart function,liver and kidney function and bone marrow function,indicating that the medication hasgood clinical safety.