The Clinical Study Of Compound Zhuye Shigao Granule In Prevention And Treatment On Radiation-Induced Esophagitis

Objective To observe the efficacy and safety of the Chinese medicine Compound Zhuye Shigao Granule (????????,CZSG) on acute radiation-induced esophagitis(RIE) in cancer patients.Methods In a randomized, Kangfuxin Solution (????,KFX)-controlled,single-centre clinical trial, 120 patients with lung, esophagus 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 (2Gy per day, 5 times per week) and were treated since the radiation therapy until the end. 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 included throat-drying,dysphagia, vomiting, retrosternal pain, and limb weakness, weight and Karnofsky Performance Status (KPS) Scale, recorded once a week; Blood routine examination and hepatorenal function were detected once every two weeks, from the beginning until the end of radiotheraphy.Results The incidence and grade of RIE were significantly decreased in treatment group compared with the control group (P<0.05). CZSG appeared to significantly delay the time of RIE occurrence and reduce the duration compared with KFX (P<0.05).The incidence rate of esophagitis of grade land grade 2 were 39.7%, 13.8%in the treatment group, without esophagitis of grade3,4; the incidence rate of esophagitis of grade1, grade2,grade3in the control group were 35.1%, 31.5%, 8.7%, no grade 4, the difference was statistically significant (P<0.01); the occur time in the treatment group was( 19.08d� 2.03d)than (10.84d�1.82d) in the control group, which was significantly delayed (P<0.05), the duration was shortened that (15.63d�2.12d)in the treatment group than (23.05d�2.45d)in the control group(P<0.05).The CM symptoms included throat-drying, dysphagia and vomiting 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 (P>0.05).Conclusions CZSG can decrease the incidence and grade of RIE, delay the time of occurrence, reduce duration and alleviate the damage of RIE. It is safe and effective in the prevention and treatment of RIE.