| Objective: To observe the clinical efficacy and safety of Fuzheng Qingchangyin combined with probiotics in the treatment of chronic radiation proctitis after radiotherapy for cervical cancer.Methods: According to the principle of randomized control,64 patients who met the inclusion criteria were divided into treatment group(32 cases)and control group(32 cases).Due to the reasons that some patients did not take medicine,re-examine or change the treatment methods according to the regulations during the observation period,4 cases were excluded in the treatment group and 5 cases in the control group.Finally,28 cases in the treatment group and control group were found to be effective.The number of effective cases in group A was 27.The treatment group was treated with Fuzheng Qingchang Yin combined with probiotics,while the control group was treated with probiotics alone for 28 days.By comparing the clinical efficacy evaluation,syndrome integral evaluation,stool routine examination changes,colonoscopy changes,quality of life changes,and safety evaluation of the two groups before and after treatment,the results were analyzed statistically.Results:(1)Clinical efficacy evaluation: After treatment,the clinical efficacy of the two groups was evaluated.In the treatment group,9 cases were markedly effective,16 cases were effective,3 cases were ineffective,and 0 cases were aggravated.The total effective rate was 88.29%(25/28).In the control group,6 cases were markedly effective,8 cases were effective,12 cases were ineffective and 1 case was aggravated.The total effective rate was 51.85%(14/27).Rank sum test was used to compare the curative effect of the two groups after treatment(P < 0.05),the difference was statistically significant.(2)Syndrome integral evaluation: After treatment,the syndrome integral of the treatment group and the control group decreased compared with before treatment.The syndrome integral of the treatment group was 33.57±4.47,and that of the control group was 42.07±5.09.The treatment group was significantly lower than that of the control group,P=0.000(P < 0.01).The difference was statistically significant.(3)Improvement of stool routine examination: Two groups of patients after treatment,review of stool routine examination.The routine examination changes of stool in the treatment group were markedly effective in 14 cases,effective in 6 cases,ineffective in 5 cases and aggravated in 3 cases.In the control group,3 cases were markedly effective,3 cases were effective,14 cases were ineffective and 7 cases were aggravated.The curative effect of the two groups after treatment was compared by rank sum test(P < 0.05),and the difference was statistically significant.(4)Comparison of changes of enteroscopy: After treatment,the changes of enteroscopy in the treatment group were cured in 3 cases,markedly effective in 12 cases,effective in 13 cases and ineffective in 0 cases.In the control group,1 case was cured,8 cases were markedly effective,11 cases were effective and 7 cases were ineffective.Rank sum test was used to compare the curative effect of the two groups after treatment(P < 0.05).The difference was statistically significant,indicating that the therapeutic effect of the treatment group was better than that of the control group in the change of enteroscopy.(5)Quality of life change comparison: two groups of patients after treatment,according to patients KPS score to assess the quality of life changes.In the treatment group,the quality of life improved in 16 cases,stabilized in 10 cases and decreased in 2 cases.In the control group,the quality of life improved in 7 cases,stabilized in 17 cases and decreased in 3 cases.The quality of life of the two groups was compared by rank sum test(P < 0.05),with statistical difference.(6)Safety evaluation: There were no significant adverse reactions in the two groups during the treatment.Before and after treatment,the vital signs,blood routine,urine routine,liver function,renal function,Myocardial Zymogram and electrocardiogram of the two groups were examined.Statistical analysis showed,after treatment,some indicators changed correspondingly compared with before treatment,but there was no statistical significance(P > 0.05),which did not affect the clinical observation.Conclusion: By comparing the clinical efficacy evaluation,syndrome integral evaluation,stool routine examination changes,colonoscopy changes,quality of life changes,and safety evaluation of two groups of patients after treatment,it is known that Fuzheng Qingchangyin combined with probiotic preparation is superior to traditional Chinese medicine in the treatment of chronic radiation proctitis(cold-heat miscellaneous syndrome)after radiotherapy for cervical cancer.The use of probiotics alone shows that Fuzheng Qingchang Yin has a certain effect on chronic radiation proctitis(cold-heat miscellaneous syndrome)after radiotherapy for cervical cancer,which is worthy of clinical application. |
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