复方苦参注射液减少头颈肿瘤患者放射性损伤的临床研究  

Compound Kushen Injection Reduces the Incidence of Severe Radiation-induced Injury in Head and Neck Cancer Patients:A Clinical Trial

作　　者：任似梦 刘杰[1] 吴晓月 金嘉悦 王凡[3] 江浩[4] 陈意红[5] 韩宝瑾 张文政 苏学尧 马军[7] 林洪生[1] REN Simeng;LIU Jie;WU Xiaoyue;JIN Jiayue;WANG Fan;JIANG Hao;CHEN Yihong;HAN Baojin;ZHANG Wenzheng;SU Xueyao;MA Jun;LIN Hongsheng(Guang′anmen Hospital,China Academy of Chinese Medical Sciences,Beijing 100053,China;Beijing University of Chinese Medicine,Beijing 100029,China;The First Affiliated Hospital of Anhui Medical University,Hefei 230031,China;The First Affiliated Hospital of Bengbu Medical College,Bengbu 233000,China;The First Affiliated Hospital of Wannan Medical College,Wuhu 241000,China;Chongqing Medical University,Chongqing 400016,China;Anhui Provincial Hospital,Hefei 230001,China)

机构地区：[1]中国中医科学院广安门医院,北京100053 [2]北京中医药大学,北京100029 [3]安徽医科大学第一附属医院,合肥230031 [4]蚌埠医学院第一附属医院,蚌埠233000 [5]皖南医学院弋矶山医院,芜湖241000 [6]重庆医科大学,重庆400016 [7]安徽省立医院,合肥230001

出　　处：《世界中医药》2022年第22期3200-3205,共6页World Chinese Medicine

基　　金：国家中医药管理局中医药国际合作专项(GZYYGJ2017008);首都临床特色应用研究项目(Z181100001718175)。

摘　　要：目的:观察复方苦参注射液(CKI)对头颈肿瘤(HNC)患者放射性损伤的临床疗效和安全性。方法:采用随机对照、多中心研究方法,将患有头颈肿瘤的成年患者随机分为观察组和对照组,每组100例。观察组接受放疗或放化疗联合CKI治疗,对照组接受单纯放疗或放化疗治疗。主要疗效指标为放射性皮肤损伤和放射性口腔黏膜炎的发生率及严重度。次要疗效指标为生命质量及实体瘤疗效。使用不良事件通用术语标准4.0版评估安全性。结果:治疗结束时,观察组≥2级放射性皮肤损伤的发生率显著低于对照组,2组比较差异有统计学意义(P<0.05);观察组≥2级放射性口腔黏膜炎的发生率低于对照组,但差异无统计学意义(P>0.05)。治疗后,观察组躯体功能评分及社会功能评分恶化程度比对照组轻,疲劳、疼痛、便秘、经济困难及总体症状领域评分均优于对照组,2组比较差异均有统计学意义(均P<0.05)。2组治疗期间不良事件发生率比较,差异无统计学意义(P>0.05)。结论:CKI能减少头颈肿瘤患者放射性皮肤损伤的发生率及严重程度,改善患者的生命质量,安全性良好。Objective:To investigate the clinical effect of Compound Kushen Injection(CKI)on radiation-induced injury in head and neck cancer(HNC)patients and the safety.Methods:A multicenter open-label randomized controlled trial was conducted.Adults with HNC were randomized into the control group(n=100)and treatment group(n=100).The treatment group received CKI and radiotherapy(RT)/chemoradiotherapy(CRT)and the control group was treated by RT or CRT alone.The primary outcome indicators were the incidence and severity of radiation-induced skin injury and radiation-induced oral mucositis.Secondary outcome indicators were quality of life and efficacy on the solid tumor.The safety of CKI was evaluated with Common Terminology Criteria for Adverse Events(CTCAE)Version 4.0.Results:Compared with control group,the treatment group had low incidence of skin injury≥grade 2(P<0.05)and low incidence of oral mucositis≥grade 2(P>0.05).The treatment group showed a better change in physical functioning,social functioning,fatigue,pain,constipation,financial difficulty,and overall symptom scales compared with the control group from baseline to the end of RT(P<0.05).The incidence of adverse events showed no significant difference between the two groups(P<0.05).Conclusion:CKI has predominant efficacy in reducing the incidence and severity of radiation-induced skin injury,which can improve quality of life and is safe.

关 键 词：复方苦参注射液 头颈肿瘤 放化疗 放射性皮肤损伤 放射性口腔黏膜炎 

分 类 号：R273[医药卫生—中西医结合]