| Objective: To investigate the clinical efficacy of self-made Bupi Rougan Decoction in the treatment of chronic anal sinusitis with deficiency of both qi and yin by comparing with oral metronidazole tablets by a randomized controlled method.Study the effectiveness and advantages of the drug,analyze its mechanism of action and safety,and make adequate preparations for its further clinical service.Methods: The selected research objects for this project were treated in the outpatient and inpatient department of the Anorectal Department of the Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine from June 2019 to October 2020,and were diagnosed as chronic anal sinusitis based on clinical symptoms,signs and anoscopy results A total of 58 patients(the type of deficiency of both qi and yin)who meet the criteria for inclusion in this trial,were divided into treatment group and control group according to the principle of randomized control.The control group and the treatment group were treated with metronidazole tablets and self-made Nourishing Spleen Rougan Decoction.After 1 week and 2 weeks,respectively,the changes in the scores of anal swelling,pain,and itching of the test patients before and after treatment,and the changes in the scores of anal sinus congestion and edema under anoscopy were included in the patient’s mental state assessment score changes.Statistical software SPSS22.0 performs statistical analysis on the collected data.During the treatment period,it is necessary to closely observe whether there are adverse reactions in the two groups of test patients in order to evaluate the safety of the drug.After the course of treatment,effective cases were followed up for a period of one month to observe the recurrence of the two groups.Results: 1.Comparison of baseline dimensions: First,compare the data of the two groups before treatment in terms of gender,age,and disease course distribution.The difference was not statistically significant(P>0.05);secondly,the severity of clinical symptoms and signs were compared.Before treatment,the two groups of subjects were compared with anal swelling,pain,itching scores,anal sinus congestion and edema scores,mental state scores,and total symptoms and signs scores.The differences between the two groups were not statistically significant(P> 0.05),that is,balanced comparability.2.Symptom score comparison: During the treatment period,through the comparison within the group,it can be known that the symptoms of anal swelling,pain,and itching of the two groups of subjects have achieved a certain improvement.After 1 week of treatment,the comparison between the groups showed that there was no significant difference in symptom improvement between the treatment group and the control group(P>0.05);after 2 weeks of treatment,the scores of anal swelling,pain,and itching were compared between the two groups.The gap is significant and statistically significant(P<0.05).3.Comparison of physical signs scores: During the treatment,the two groups of subjects were compared with the scores of lower anal sinus congestion and edema under anoscopy.After 1 week of treatment,the comparison between the groups showed that there was no significant difference in the improvement of signs between the treatment group and the control group(P>0.05);after 2 weeks of treatment,the scores of anal sinus congestion and edema were compared between the two groups.Significant(P<0.05),especially the reduction of edema(P<0.01).4.Psychological status score comparison: After 1 week of treatment,from the comparison results within the group,the score of the control group did not show a significant decrease compared with the pretreatment score(P>0.05),while the score of the treatment group has been significantly reduced(P<0.05));After 2 weeks of treatment,the comparison between the two groups of the anxiety and depression scale scores showed a significant difference(P<0.01).5.Comparison of total scores: After 1 week of treatment,the comparison of the total scores of symptoms and signs between the two groups has opened a significant gap(P<0.01);after the treatment is terminated,the comparison again shows that the difference between the two components has been further widened,and the difference is huge.Have greater statistical significance(P<0.01).6.Overall curative effect comparison: After the treatment period is terminated,according to the Nimodipine score method,the number of people who reach the curative effect index of each level after taking the medicine is calculated.The total effective rate is 75.00% in the control group and 89.66% in the treatment group.And after analysis,the overall efficacy gap between the two groups is very different(P<0.05).7.Comparison of recurrence: After the treatment period is terminated,close observation of the two groups of effective patients is extended by 1 month,and it is concluded that 2 out of 26 cases in the treatment group have relapsed,and 8 out of 21 cases in the control group have relapsed.For example,there is a significant difference(P<0.05).8.Safety comparison: 1 patient in the control group asked to withdraw from the trial due to allergies,and 3 patients had mild adverse reactions,which did not affect the follow-up treatment,and none of the treatment groups had adverse reactions.Conclusion: The self-made Bupi Rougan Decoction group is better than the metronidazole tablet group in terms of anal swelling,pain,itching,anal sinus congestion,edema,and psychological improvement,and there is no adverse reaction in the treatment group,indicating that the self-made group has no adverse reactions.Bupi Rougan Decoction is not only good in curative effect,but also safe,and it is worthy of clinical promotion and use. |