Objective： To observe the efficacy and safety of the Chinese medicine（CM） Compound Zhuye Shigao Granule（复方竹叶石膏颗粒, CZSG） on acute radiation-induced esophagitis（ARIE） in cancer patients. Methods： In a bl...Objective： To observe the efficacy and safety of the Chinese medicine（CM） Compound Zhuye Shigao Granule（复方竹叶石膏颗粒, CZSG） on acute radiation-induced esophagitis（ARIE） in cancer patients. Methods： In a blinded, randomized, Kangfuxin Solution（康复新液, KFX）-controlled, single-centre clinical trial, 120 patients with lung, esophagus or mediastinal cancer were prospectively enrolled and assigned to the treatment group（60 cases） and control group（60 cases） by the random number table method. All patients received concurrent or sequential radiotherapy（2 Gy per day, 5 times per week, for 4 weeks） and were treated for 4 weeks since the radiation therapy. Patients in the treatment group were given 12 mg CZSG orally, thrice daily, while patients in the control group were given 10 m L KFX orally, thrice daily. The major indicators were observed, including the incidence and grade of esophagitis, time of occurrence and duration. Minor indicators were changes of CM symptoms, weight and Karnofsky Performance Status（KPS） Scale during 4 weeks from the beginning, recorded once a week. Blood routine examination and hepatorenal function were detected at the 2nd and 4th weeks. Results： The incidence and grade of ARIE were significantly decreased in the treatment group compared with the control group（P〈0.05）. CZSG appeared to significantly delay the time of ARIE occurrence and reduce the duration compared with KFX（P〈0.05）. The scores of CM symptoms, KPS and weight were improved significantly in the treatment group compared with the control group（P〈0.05）. There were no blood routine and hepatorenal function abnormal or obvious side-effects in both groups. Hemoglobin was improved and neutrophil and interleukin 6 were decreased in both groups after 4-week treatment compared with before treatment（P〈0.05）, and there was no significant difference between the two groups（P〉0.05）. Conclusions： CZSG can decrease the incidence and grade of ARIE, delay the time of occurrence, reduce duration and alleviate the damage of ARIE. It is safe and effective in the prevention and cure of ARIE.展开更多
目的观察低剂量丝裂霉素C(M M C)对胸部癌症患者放疗中的降低放射损伤作用。方法100例胸部癌症患者中,食管癌54例、肺癌46例,随机分为研究组和对照组各50例,研究组于常规放疗过程中同时用低剂量M M C0.002m g/kg,每周1次,共5￣7次;对照...目的观察低剂量丝裂霉素C(M M C)对胸部癌症患者放疗中的降低放射损伤作用。方法100例胸部癌症患者中,食管癌54例、肺癌46例,随机分为研究组和对照组各50例,研究组于常规放疗过程中同时用低剂量M M C0.002m g/kg,每周1次,共5￣7次;对照组只接受常规放疗。结果100例全部完成治疗,研究组、对照组急性放射性食管炎发生率分别为30%,48%(χ2=3.897,P=0.048);研究组、对照组急性放射性肺炎发生率分别为4%,16%(χ2=4.001,P=0.045);血液毒性反应研究组、对照组分别为50%,48%(χ2=0.208,P=0.648)。研究组有效率(C R+PR)(84%)明显高于对照组(68%)(χ2=4.089,P=0.043)。结论低剂量M M C配合胸部癌症放疗,明显减轻了急性放射性食管炎及肺炎的发生,无明显的血液毒性反应,同时提高了肿瘤的放疗效果。展开更多
基金Supported by the National Natural Science Foundation of China(No.81373543)Clinical Research Support Fund of the PLA General Hospital(No.2013FC-ZHCG-1002)
文摘Objective： To observe the efficacy and safety of the Chinese medicine（CM） Compound Zhuye Shigao Granule（复方竹叶石膏颗粒, CZSG） on acute radiation-induced esophagitis（ARIE） in cancer patients. Methods： In a blinded, randomized, Kangfuxin Solution（康复新液, KFX）-controlled, single-centre clinical trial, 120 patients with lung, esophagus or mediastinal cancer were prospectively enrolled and assigned to the treatment group（60 cases） and control group（60 cases） by the random number table method. All patients received concurrent or sequential radiotherapy（2 Gy per day, 5 times per week, for 4 weeks） and were treated for 4 weeks since the radiation therapy. Patients in the treatment group were given 12 mg CZSG orally, thrice daily, while patients in the control group were given 10 m L KFX orally, thrice daily. The major indicators were observed, including the incidence and grade of esophagitis, time of occurrence and duration. Minor indicators were changes of CM symptoms, weight and Karnofsky Performance Status（KPS） Scale during 4 weeks from the beginning, recorded once a week. Blood routine examination and hepatorenal function were detected at the 2nd and 4th weeks. Results： The incidence and grade of ARIE were significantly decreased in the treatment group compared with the control group（P〈0.05）. CZSG appeared to significantly delay the time of ARIE occurrence and reduce the duration compared with KFX（P〈0.05）. The scores of CM symptoms, KPS and weight were improved significantly in the treatment group compared with the control group（P〈0.05）. There were no blood routine and hepatorenal function abnormal or obvious side-effects in both groups. Hemoglobin was improved and neutrophil and interleukin 6 were decreased in both groups after 4-week treatment compared with before treatment（P〈0.05）, and there was no significant difference between the two groups（P〉0.05）. Conclusions： CZSG can decrease the incidence and grade of ARIE, delay the time of occurrence, reduce duration and alleviate the damage of ARIE. It is safe and effective in the prevention and cure of ARIE.
文摘目的观察低剂量丝裂霉素C(M M C)对胸部癌症患者放疗中的降低放射损伤作用。方法100例胸部癌症患者中,食管癌54例、肺癌46例,随机分为研究组和对照组各50例,研究组于常规放疗过程中同时用低剂量M M C0.002m g/kg,每周1次,共5￣7次;对照组只接受常规放疗。结果100例全部完成治疗,研究组、对照组急性放射性食管炎发生率分别为30%,48%(χ2=3.897,P=0.048);研究组、对照组急性放射性肺炎发生率分别为4%,16%(χ2=4.001,P=0.045);血液毒性反应研究组、对照组分别为50%,48%(χ2=0.208,P=0.648)。研究组有效率(C R+PR)(84%)明显高于对照组(68%)(χ2=4.089,P=0.043)。结论低剂量M M C配合胸部癌症放疗,明显减轻了急性放射性食管炎及肺炎的发生,无明显的血液毒性反应,同时提高了肿瘤的放疗效果。
