复方苦参注射液防治急性放射性食管炎随机对照研究

A Randomized Controlled Clinical Study on Prevention and Treatment for Acute Radiation Esophagitis by Compound Kushen Injection

目的观察复方苦参注射液防治食管癌急性放射性食管炎的作用。方法将筛选入组的82例食管癌患者随机分为治疗组和对照组,各41例。治疗组放疗同步联合使用复方苦参注射液,对照组放疗同步使用康复新液。观察2组患者放射性食管炎发生时间、级别,以及止痛药物用量。结果 2组病例均出现不同程度的食管急性放疗反应。治疗组患者较高级别(RTOG分级Ⅲ级及以上)急性放射性食管炎的发生率为7.3%(3/41),低于对照组的31.7%(13/41),差异有统计学意义(P<0.05);治疗组止痛药物芬太尼透皮贴剂的用量低于对照组(P<0.001)。结论复方苦参注射液能有效减轻食管癌患者急性放疗反应,降低高级别食管炎的发生率,减少放疗期间镇痛药的用量,辅助放疗顺利完成。

Objective To investigate the prevention and treatment effects of Compound Kushen Injection on acute radiation esophagitis. Methods Eighty-two eligible patients with esophageal cancer were randomly divided into the treatment group （41 cases） and the control group （41 cases）. All the patients received radiotherapy. Throughout the course of radiotherapy, patients in the treatment group received Compound Kushen Injection, and patients in the control group received Kangfuxin Liquid. Occurrence time and level of radiation esophagitis, and dosage of painkillers were observed. Results Different degrees of acute esophageal toxicity were observed in the two groups. The occurrence rate of high level （degree III and degree IV） acute radiation esophagitis was 7.3%（3/41） in the treatment group, and 31.7%（13/41） in the control group. There was significant difference between the two groups （P〈0.05）. The dosage of the analgesic drug （Fentanyl Transdermal System） in the treatment group was far less than the controlled group （P〈0.001）. Conclusion Compound Kushen Injection could decrease the incidence rate of acute radiation esophagitis, and reduce the high-level esophagitis and the dosage of the analgesic drug, which can help the completion of radiation.