当归四逆颗粒预防奥沙利铂周围神经毒性双中心随机对照研究  

Double-center randomized controlled study on Danggui Sini Formula Granules in the prevention of oxaliplatin induced peripheral neuropathy

作　　者：陈曦[1] 邵襄 陈玉超[3] 李检阅 丁蓉[1] CHEN Xi;SHAO Xiang;CHEN Yuchao;LI Jianyue;DING Rong(Affiliated Hospital of Integrated Chinese and Western Medicine,Nanjing University of Chinese Medicine/Jiangsu Province Academy of Traditional Chinese Medicine,Nanjing 210028,China;Changshu Affiliated Hospital,Nanjing University of Chinese Medicine,Changshu 215516,China;Jiangsu Province Hospital of Chinese Medicine,Nanjing 210029,China)

机构地区：[1]南京中医药大学附属中西医结合医院/江苏省中医药研究院,南京210028 [2]南京中医药大学常熟附属医院,江苏常熟215516 [3]江苏省中医院,南京210029

出　　处：《吉林中医药》2025年第3期325-330,共6页Jilin Journal of Chinese Medicine

基　　金：江苏省中医药管理局科技课题(JD2022SZXMS02);江苏省干部保健科研课题(BJ23021);江苏省中医药研究院自主科研项目(BM2018024-2019010)。

摘　　要：目的观察当归四逆颗粒预防奥沙利铂周围神经毒性的临床疗效。方法选择采用含奥沙利铂方案治疗的结直肠癌患者69例,随机分为观察组(n=34)与对照组(n=35)。对照组联合当归四逆模拟颗粒,观察组联合当归四逆配方颗粒治疗。治疗每21天为1个周期,连续治疗4个周期。观察各周期急性神经毒性的发生率,评价第1周期第1天、每周期结束时对外周神经毒性分级、EORTC QLQ-CIPN20评分、KPS评分、安全性;4个周期化疗结束后进行评价临床疗效。结果观察组急性神经毒性发生率总体低于对照组,且在第3周期末、第4周期末时差异有统计学意义(P<0.05);患者发生外周感觉障碍的比例高于外周运动障碍,且外周运动障碍分级多为2级,随着化疗周期增加,外周感觉障碍和运动障碍的发生率和严重程度均有不同程度增长,第3周期或第3周期后观察组发生率低于对照组;第1周期、第4周期结束时观察组KPS评分高于对照组(P<0.01),其他各个时间点均无差异。2组疾病疗效及安全性评价等方面比较,差异无明显统计学意义。结论当归四逆颗粒可预防奥沙利铂急性周围神经毒性,减少奥沙利铂慢性周围神经毒性发生率,不影响临床疗效,安全性可控。Objective To observe the clinical efficacy of Danggui Sini Formula Granules in the prevention of oxaliplatin induced peripheral neuropathy.Methods A total of 69 patients were included in this study and randomly divided into an experimental group of 34 cases and a control group of 35 cases.All the patients were treated with a chemotherapy regimen containing oxaliplatin,with one cycle for 21 days and totaling four consecutive cycles.The control group was combined with Danggui Sini simulator,while the experimental group was combined with Danggui Sini Formula Granules.The incidence of acute neuropathy in each cycle was observed,and the peripheral neuropathy grading was evaluated by the EORTC QLQ-CIPN20 scores,KPS scores,and safety on thefirst day of thefirst cycle and at the end of each cycle,and the clinical efficacy evaluation was conducted after 4 cycles of chemotherapy.Results The overall incidence of acute neurotoxicity was lower in the experimental group than that in the control group,and there was a statistical difference at the end of the third and fourth cycles(P<0.05).The proportion of patients with peripheral sensory disorders was higher than that with peripheral motor disorders,and the grading of peripheral motor disorders was mostly level 2.With the increase of chemotherapy cycle,the incidence and severity of peripheral sensory and motor disorders were increased to varying degrees,while the incidence rate in the experimental group was lower,with the differences between the two groups manifested in the third cycle or after the third cycle.The KPS scores were higher in the experimental group than those in the control group at the end of thefirst and fourth cycles(P<0.01),while there was no difference at other time points.There was no significant difference in the efficacy and safety evaluation between the two groups.Conclusion Danggui Sini Formula Granules can prevent acute oxaliplatin induced peripheral neuropathy,reduce the incidence of chronic peripheral neuropathy,and does not affect clinical efficacy,

关 键 词：当归四逆颗粒 预防 奥沙利铂 神经毒性 临床研究 

分 类 号：R273[医药卫生—中西医结合]