摘要
目的评价甲钴胺联合芪芍濡筋汤与放血疗法治疗奥沙利铂所致周围神经毒性(oxaliplatin-induced peripheral neuropathy,OIPN)的疗效与安全性。方法采用随机对照试验设计,将80例OIPN患者分为治疗组(40例,予甲钴胺片+芪芍濡筋汤+放血疗法)和对照组(40例,予甲钴胺片),疗程为21天。主要结局为治疗前后Levi神经毒性分级变化;次要结局包括神经毒性疗效、中医证候积分改善情况、卡氏功能状态评分(karnofsky performance status,KPS)及不良事件。结果治疗后,两组神经毒性Levi分级为0级、1级的占比均明显高于治疗前(P<0.05),且治疗组Levi分级改善明显优于对照组。治疗后治疗组神经毒性有效率为90%高于对照组67.5%,治疗组神经毒性疗效、中医证候积分及KPS评分改善情况均优于对照组(P<0.05)。两组均未发生≥3级治疗相关不良事件。结论甲钴胺联合芪芍濡筋汤与放血疗法能安全有效地缓解奥沙利铂所致神经毒性,改善患者生活质量,疗效优于单用甲钴胺。
Objective To evaluate the efficacy and safety of mecobalamin combined with Qishao Rujin Decoction and bloodletting therapy in treating oxaliplatin-induced peripheral neuropathy(OIPN).Methods A randomized controlled trial was conducted,dividing 80 patients with OIPN into a treatment group(40 cases,treated with mecobalamin tablets+Qishao Rujin Decoction+bloodletting therapy)and a control group(40 cases,treated with mecobalamin tablets alone).The treatment course was 21 days.The primary outcome was the change in Levi neurotoxicity grading before and after treatment;secondary outcomes included the efficacy of neurotoxicity,traditional Chinese medicine(TCM)syndrome scores,karnofsky performance status(KPS)scores,and adverse events.Results After treatment,the proportions of patients with grade 0 and 1 neurotoxicity according to Levi classification in both groups were significantly higher than those before treatment(P<0.05),and the Levi grade of the treatment group was significantly superior to that of the control group.The effective rate of neurotoxicity in the treatment group was 90%,which was higher than 67.5%in the control group.The improvement of neurotoxicity efficacy,TCM syndrome score,and KPS score in the treatment group was significantly greater than that in the control group(P<0.05).No treatment-related adverse events of grade 3 or higher were observed in either group.Conclusion Mecobalamin combined with Qishao Rujin Decoction and bloodletting therapy can safely and effectively alleviate oxaliplatin-induced neuropathy and improve patients’quality of life,demonstrating superior efficacy compared with monotherapy with mecobalamin.
作者
张春娟
李东华
李佳欣
芦明月
官欣
刘晗宇
陈禹铮
赵环茹
ZHANG Chunjuan;LI Donghua;LI Jiaxin;LU Mingyue;GUAN Xin;LIU Hanyu;CHEN Yuzheng;ZHAO Huanru(Department of Integrated Traditional Chinese and Western Medicine,Jiamusi Tumor Hospital,Jiamusi 154007 Heilongjiang,China)
出处
《中医肿瘤学杂志》
2025年第6期70-76,共7页
Journal of Oncology in Chinese Medicine
基金
黑龙江省卫生健康委科研课题(编号:20232121020433)。
关键词
甲钴胺
奥沙利铂
神经毒性
放血疗法
芪芍濡筋汤
mecobalamin
oxaliplatin
neurotoxicity
bloodletting therapy
Qishao Rujin Decoction
