Wang Li-Juan, Lu Jun-Zhang, Cai Bo-Ning, Li Ming-Wei, Qu Bao-Lin
Department of Chinese Medicine, Chinese PLA General Hospital, Beijing, 100853, China.
Department of Radiation Therapy, Chinese PLA General Hospital, Beijing, 100853, China.
Chin J Integr Med. 2017 Feb;23(2):98-104. doi: 10.1007/s11655-016-2652-5. Epub 2016 Dec 29.
To observe the efficacy and safety of the Chinese medicine (CM) Compound Zhuye Shigao Granule (, CZSG) on acute radiation-induced esophagitis (ARIE) in cancer patients.
In a blinded, randomized, Kangfuxin Solution (, 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 mL 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.
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).
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.
观察中药复方竹叶石膏颗粒（CZSG）对癌症患者急性放射性食管炎（ARIE）的疗效及安全性。
在一项单中心、双盲、随机、以康复新液（KFX）为对照的临床试验中，前瞻性纳入120例肺癌、食管癌或纵隔癌患者，采用随机数字表法将其分为治疗组（60例）和对照组（60例）。所有患者均接受同步或序贯放疗（每日2 Gy，每周5次，共4周），放疗开始后治疗4周。治疗组患者口服12 mg CZSG，每日3次，对照组患者口服10 mL KFX，每日3次。观察主要指标，包括食管炎的发生率和分级、发生时间及持续时间。次要指标为从开始起4周内中医症状、体重及卡氏功能状态（KPS）量表的变化，每周记录1次。在第2周和第4周检测血常规及肝肾功能。
与对照组相比，治疗组ARIE的发生率和分级显著降低（P<0.05）。与KFX相比，CZSG似乎能显著延迟ARIE的发生时间并缩短持续时间（P<0.05）。与对照组相比，治疗组中医症状评分、KPS评分及体重显著改善（P<0.05）。两组均未出现血常规及肝肾功能异常或明显副作用。与治疗前相比，两组治疗4周后血红蛋白升高，中性粒细胞及白细胞介素6降低（P<0.05），两组间差异无统计学意义（P>0.05）。
CZSG可降低ARIE的发生率和分级，延迟发生时间并缩短持续时间，减轻ARIE的损伤。其在ARIE的防治中安全有效。
