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展开更多
Objective： To investigate the effect of Modified Zhuye Shigao Decoction （加味竹叶石膏汤, MZSD） and its components on preventing radiation esophagitis of rats. Me,otis： One hundred Wistar rats were randomly divided...Objective： To investigate the effect of Modified Zhuye Shigao Decoction （加味竹叶石膏汤, MZSD） and its components on preventing radiation esophagitis of rats. Me,otis： One hundred Wistar rats were randomly divided into 5 groups, including the control group, radiation model group, MZSD group, Zhuye Shigao Decoction （竹叶石膏汤, ZSD） group, and added ingredients group, 20 rats in each group. The model of radiation esophagitis of rat was established by once local radiation of 40 Gy （330 Mu/min） with a high energy linear accelerator. The administration of Chinese medicine was continued for 14 days from 7 days before radiation application in the three treatment groups. On the 7th and 14th day, the serum was isolated and the levels of inflammatory cytokines tumor necrosis factor （TNF-α）, interleukin 1 β （IL-1 β） and IL-8 were tested. The pathological slices of esophagus were obtained, and the pathological changes were observed. During the whole process, weight and food intake were recorded each day. Resale： On the 7th day after radiation, the esophagus of rats in the MZSD group was almost intact, and the pathological injury score was significantly lower than that of the radiation model group, ZSD group and added ingredients group （P〈0.01）. Compared with the control group, the body weight and food intake of rats in the radiation model group were significantly decreased, and the levels of TNF-α, IL-1 β and IL-8 were significantly increased （P〈0.05 or P〈0.01）, while the MZSD group showed a significant increase in body weight and food intake, and a significant decrease in the levels of TNF- α, IL-1 β and IL-8 compared with the radiation model group, ZSD group and added ingredients group （P〈0.05 or P〈0.01）. Conclusion： MZSD prevents the development of radiation esophagitis probably by inhibiting the generation and release of the inflammatory cytokines TNF- α, IL-1βand iL-8.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
基金Supported by the National Natural Science Foundation of China(No.81173195)Capital Medical Development Fund,China(No.SF-2009-Ⅲ-45)
文摘Objective： To investigate the effect of Modified Zhuye Shigao Decoction （加味竹叶石膏汤, MZSD） and its components on preventing radiation esophagitis of rats. Me,otis： One hundred Wistar rats were randomly divided into 5 groups, including the control group, radiation model group, MZSD group, Zhuye Shigao Decoction （竹叶石膏汤, ZSD） group, and added ingredients group, 20 rats in each group. The model of radiation esophagitis of rat was established by once local radiation of 40 Gy （330 Mu/min） with a high energy linear accelerator. The administration of Chinese medicine was continued for 14 days from 7 days before radiation application in the three treatment groups. On the 7th and 14th day, the serum was isolated and the levels of inflammatory cytokines tumor necrosis factor （TNF-α）, interleukin 1 β （IL-1 β） and IL-8 were tested. The pathological slices of esophagus were obtained, and the pathological changes were observed. During the whole process, weight and food intake were recorded each day. Resale： On the 7th day after radiation, the esophagus of rats in the MZSD group was almost intact, and the pathological injury score was significantly lower than that of the radiation model group, ZSD group and added ingredients group （P〈0.01）. Compared with the control group, the body weight and food intake of rats in the radiation model group were significantly decreased, and the levels of TNF-α, IL-1 β and IL-8 were significantly increased （P〈0.05 or P〈0.01）, while the MZSD group showed a significant increase in body weight and food intake, and a significant decrease in the levels of TNF- α, IL-1 β and IL-8 compared with the radiation model group, ZSD group and added ingredients group （P〈0.05 or P〈0.01）. Conclusion： MZSD prevents the development of radiation esophagitis probably by inhibiting the generation and release of the inflammatory cytokines TNF- α, IL-1βand iL-8.
