| Objective:To observe the clinical efficacy of oral Qingjie prescription combined with western medicine enema in the treatment of patients with chronic radiation proctitis,and to evaluate the feasibility and safety of Qingjie prescription oral combined with western medicine enema.Methods: This study was a randomized controlled trial.Sixty patients with pelvic malignant tumor with chronic radiation proctitis after radiotherapy were included in this study.According to the time of patients entering the group,the patients were divided into control group(n = 30)and experimental group(n =30).The control group was given mesalazine 50 mg,gentamicin 80 000 U,dexamethasone 5mg,0.9% normal saline 100 ml enema,once a day,retained at least 1 hour after enema;the experimental group was treated with Qingjie decoction orally,1 dose a day,twice a day,a total of 300 ml,half an hour after breakfast and dinner.The patients in the two groups were treated continuously for 2 courses for 6 weeks.The changes of KPS score,clinical efficacy evaluation,serum laboratory index and Vienna colonoscopy score before and after treatment were observed in the baseline period and the 6th week,and the TCM symptom scores of the two groups were evaluated at the baseline period,the 3rd week and the 6th week.Blood routine,liver and kidney function were used as safety evaluation indicators to evaluate the safety of drugs.Through statistical analysis,to evaluate the clinical efficacy of oral Qingjie prescription combined with western medicine enema in the treatment of chronic radiation proctitis.Results: A total of 73 patients were recruited,60 patients met the inclusion criteria,and all the clinical trials were completed.There was no significant difference in general data between the control group and the experimental group(P > 0.05).The results showed that :(1)KPS scores of the experimental group and the control group were significantly improved compared with those before treatment,and the KPS score of the experimental group was significantly better than that of the control group.(2)TCM symptom score:At the 3rd and 6th week,the TCM symptom score of the experimental group and the control group was significantly lower than that of the baseline period,and the difference was statistically significant(P < 0.05),and the improvement of TCM symptom score of the experimental group was better than that of the control group(P < 0.05).The difference was statistically significant(P < 0.05).In the third week,the scores of abdominal pain,hematochezia,stool,acute afterweight and anorexia in the experimental group were significantly lower than those in the control group(P < 0.05).At the 6th week,the scores of stool character,acute afterweight,fatigue and anorexia in the experimental group were significantly lower than those in the control group(P < 0.05).(3)Evaluation of the curative effect of traditional Chinese medicine: The total effective rate of the experimental group was significantly higher than that of the control group(P< 0.05).The difference was statistically significant(P < 0.05);(4)The score of Vienna proctoscopy: The rectal condition of the experimental group was more significantly improved than that of the control group after treatment,and the difference was statistically significant(P < 0.05).(5)Serum laboratory examination: At the 6th week,the levels of C-reactive protein and TNF-α in the experimental group and the control group decreased significantly,and the difference was statistically significant(P < 0.05).At the same time,the levels of C-reactive protein and TNF-α in the experimental group were better than those in the control group,and the difference was statistically significant.Before and after treatment,the safety indexes of patients were maintained in the normal range,and there were no adverse reactions in the process.Conclusion: The results show that the KPS score,TCM symptom score,TCM curative effect evaluation,serum laboratory examination index and Viennese proctoscope score before and after treatment in patients with chronic radiation proctitis treated by oral Qingjie prescription combined with western medicine retention enema are significantly better than those in the control group,and there are no obvious adverse reactions.At the same time,in the course of treatment,the effect time of Qingjie prescription oral combined with western medicine enema group was earlier than that of single western medicine enema group,and the degree of symptom improvement of patients in single western medicine enema group was significantly lower than that of single western medicine enema group.It is suggested that Qingjie prescription combined with western medicine retention enema has good clinical efficacy and safety in the treatment of chronic radiation proctitis. |
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