Objective:By observing the clinical efficacy of modified Guizhi Poria Pills combined with compound glutamine enteric-soluble capsules in the treatment of chronic radiation proctitis(damp-heat stasis type),and evaluating its safety and feasibility.Methods:Sixty-four patients(33 in the treatment group and 31 in the control group)who met the Inclusion and exclusion criteria of this study were collected from December2021 to December 2022 at the outpatient and inpatient departments of the Guanghua Hospital,Department of Oncology,Yunnan Provincial Hospital of Traditional Chinese Medicine.The control group was given compound glutamine enteric-soluble capsules orally,and the treatment group was given modified Guizhi Poria Pills orally on the basis of the control group.Three times a day for 14 days.Observe,record and compare the changes of TCM symptom score,intestinal reaction grade,fecal occult blood test,serum laboratory indexes,KPS scores and safety indexes before and after treatment.Through statistical analysis,the clinical efficacy of modified Guizhi Poria Pills combined with oral Western medicine in the treatment of chronic radiation proctitis(damp-heat stasis type)was comprehensively evaluated.Results: There was no obvious difference in baseline data between the two groups(P>0.05),which were comparable.The results showed as follows:(1)The total effective rate(84.8%)of modified Guizhi Poria pills combined with compound glutamine enteric-coated capsules in the treatment of chronic radio-proctitis was significantly higher than that of Western medicine compound glutamine enteric-coated capsules alone(67.7%),the difference was statistically significant(P<0.05).Meanwhile,the TCM symptom scores of both the treatment and control groups decreased in contrast the baseline period(P<0.05);the TCM symptom scores of the treatment group enhanced observably worse than those of the control group,particularly in relieving abdominal pain,diarrhea,mucopurulent stools,urgency and burning pain in the anus(P<0.05);the differences in the single symptom scores of abdominal distension and fatigue between the two groups were not statistically obvious(P>0.05).(2)the grade of intestinal reaction in both groups dwindled after treatment,and the betterment degree of intestinal reaction in the treatment group was better than that in the control group(P<0.05).(3)The serum laboratory indexes of the treatment group and the control group were improved compared with the baseline period After treatment(P<0.05).what’s more,The decline levels of CRP,TNF-α and IL-6 in the treatment group were higher than those in the control group(P<0.05).(4)The fecal occult blood test in the two groups was also alleviated compared with that before treatment,and the number of effective patients in the treatment group was more than that in the control group(P<0.05).(5)KPS scores in both the treatment and control groups improved compared with the previous group,and the improvement in the treatment group was superior to in the control group(P<0.05).Conclusion:(1)The modified Guizhi Poria Pills combined with oral administration of Western medicine can effectively relieve the degree of intestinal reaction and increase patients’ quality of life compared with oral administration of Western medicine alone.(2)The modified Guizhi Poria Pills combined with Western medicine can improve the symptoms of traditional Chinese medicine of patients,and has significant efficacy in relieving abdominal pain,diarrhea,mucous abscess and blood stool,tenesmus,and anal burning pain of patients.It proves that the modified Guizhi Poria Pills can effectively inhibit intestinal toxicity and side effects caused by radiation,enhance the immunity of the body,and promote the repair of intestinal mucosa,which is clinically safe and effective. |