对客观观察功效和安全汉语药(厘米) 化合物 Zhuye Shigao 小粒(, CZSG ) 在在癌症的尖锐导致放射的食道炎(ARIE ) 上病人们。方法在一使失明,使随机化, Kangfuxin 答案(, KFX )-controlled, 单个中心的临床的试用,有肺的 120 个病人,食管或 mediastinal 癌症有希望地被注册并且把组(60 个盒子) 和控制组(60 个盒子) 分到治疗旁边随机数桌子方法。都并发的接待的病人或顺序的放射疗法(2 Gy 每天, 5 次每星期,为 4 星期) 并且被对待 4 个星期自从放射治疗。在治疗组的病人口头上地被给 12 mg CZSG,三次每天,当在控制组的病人口头上地被给 10 mL KFX 时,三次每日。主要指示物被观察,包括食道炎的发生和等级,出现和持续时间的时间。次要的指示物地位(KPS ) 从开始在 4 个星期期间放大的厘米症状,重量和 Karnofsky 性能的变化,每周一次记录了。血平淡的检查和 hepatorenal 功能第 4 个星期在第二 and 被检测。结果 ARIE 的发生和等级显著地在治疗被减少组与控制相比组(P < 0.05 ) 。CZSG 看起来显著地推迟 ARIE 出现的时间并且与 KFX 相比减少持续时间(P < 0.05 ) 。厘米症状, KPS 和重量的分数在治疗显著地被改进组与控制相比组(P < 0.05 ) 。没有血常规和 hepatorenal 功能在两个组的反常或明显的副作用。血红素被改进并且嗜中性并且 interleukin 6 与以前相比在 4 星期的处理以后在两个组被减少处理(P < 0.05 ) ,并且二之间没有重要差别组(P > 0.05 ) 。结论 CZSG 罐头减少发生和等级 ARIE,推迟出现的时间,减少持续时间并且减轻 ARIE 的损坏。它在 ARIE 的预防和痊愈安全、有效。
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