| Objective: Through observing clinical results of Jiawei Peony Decoction(JPD),which applies the principle of treating diarrhea with purgation(TDP),on the fire damp heat syndrome of acute radiation proctitis,this study aimed to evaluate JPD’s clinical efficacy of acute radiation proctitis and its safety,etc with a view to providing more reference for clinical treatment.Subjects and methods: In this study,75 patients with acute radiation proctitis were divided into traditional Chinese medicine(TCM)group((2 cases of 36 cases fell off during the treatment)and western medicine group((1 cases of 36 cases fell off during the treatment)by randomized,controlled,single-center and single-blind method.Patients in the TCM group were administered Jiawei Peony Decoction retention enema whereas those in the Western medicine group,lidocaine + dexamethasone + montmorillonite powder + 0.9% sodium chloride injection mixture retention enema.Both groups were treated with retention enema once a day,and 7 consecutive days of treatment constituted a course of treatment.Efficacy evaluation on patients of each group was made at the end of two courses of treatment.The following items were observed before and after the treatments: changes in fecal occult blood test,CRP,TCM syndrome score,intestinal reaction,quality of life and drug safety.Research result: At the end of the study,a total of 3 cases were removed,the traditional Chinese medicine group(n = 2),western medicine group(n = 1),and the remaining 72 cases were effective.The baseline data of the two groups were comparable.1.Integrated Efficacy: TCM’s total efficacy stood at 88.9%,which was better than that of Western medicine’s 72.2%(P<0.05);2.Intestinal Reaction: Western medicine treatment group’s efficacy was 80.5% while that of TCM group was 94.4%.The former was not as good as the latter.(P<0.05);3.Fecal occult blood test: test results of both groups were significantly improved(P<0.05).Comparison between the two groups showed that improvement in TCM group was better than that of western medicine group(P <0.05);4.TCM syndrome score: clinical symptoms of patients in both groups were significantly relieved(P <0.05);Comparison between the two groups showed that increase in syndrome score in TCM group was more significant than that of western medicine group(P <0.05);5.CRP: after treatment,the mean value of CRP in TCM and Western medicine groups were 11.094±4.4328 mg/L and 34.600±7.801mg/L,respectively.TCM group achieved much better result than western medicine group in reducing the inflammatory response(P<0.05);6.KPS score: The effective rate in TCM group was 83.3% whereas that of the western medicine group was 61.1%.The difference was statistically significant(P<0.05).During the course of treatment,no significant adverse reactions were observed in either group.conclusion: As far as fire damp heat syndrome of acute radiation proctitis is concerned,Jiawei Peony Decoction retention enema treatment is better than Western Medicine(lidocaine hydrochloride,dexamethasone sodium phosphate,Montmorillonite powder)retention enema treatment.The former not only significantly boosts the cure rate of acute radiation proctitis,but also significantly relieves the clinical symptoms and improves laboratory examination results of patients suffering from acute radiation proctitis,with the added benefit of little side effect and good safety. |