| 引用本文:任似梦1，刘杰1，吴晓月1，金嘉悦2，王凡3，江浩4，陈意红5，韩宝瑾2，张文政1，苏学尧6，马军7，林洪生1.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[J].世界中医药,2022,(22):. |
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| 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 |
| 投稿时间：2022-06-29 |
| DOI：10.3969/j.issn.1673-7202.2022.22.012 |
| 中文关键词: 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 |
| English Keywords:Compound Kushen Injection Head and neck cancer Chemoradiotherapy Radiation-induced skin injury Radiation-induced oral mucositis |
| 基金项目: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） |
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| 中文摘要: |
| 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。 |
| English Summary: |
| 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. |
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