The Clinical Study Of Efficacy Of Areca On Recovery Of Gastrointestinal Function After Gynecological Surgery

The thesis consists of two parts.The first part is the literature research including research progress and clinical application of traditional Chinese medicine Areca,meta analysis of Liqi Tongfu therapy promoting recovery of gastrointestinal function after gynecological surgery.The second part is the clinical research of efficacy of Areca on recovery of gastrointestinal function after gynecological surgery.1.Literature research.1.1 Research progress and cl inical applicat ion of ArecaThe review of research progress on pharmacology and toxicology of Areca,and the clinical application of Areca in traditional Chinese medicine lay the foundation for the clinical application of Areca on recovery of gastrointestinal function in perioperative period and new drug development.The literature related to Areca and prescription containing Areca were searched by using literature retrieval system.The pharmacological and toxicological research,clinical application in traditional Chinese medicine and experience of composition were analyzed and summarized according to the literure.The results reveal pharmacological and toxicological effects of Areca on multiple systems(including nervous system,digestive system,cardiovascular system,urinary and reproductive system)and status of clinical application in Chinese medicine.Areca and formula containing Areca have great potential in the new drug development.1.2 Meta analysis of Liqi Tongfu therapy promoting the recovery of gastrointestinal function after gynecologic surgery.Objective:After gynecological abdominal surgery patients for surgery and golden blade anxiety depression,the deficiency of vital qi,qi stagnation and blood stasis syndrome is a common disease,through the literature,suggesting that for early postoperative obstruction of“Urgent is to treat their standard”,oral prescription of traditional Chinese medicine preferred Liqi Tongfu method,it was found that the classical or experience Areca is also in the herbs Tongfu Qi play an important role in.The clinical study on the effect of gastrointestinal function in Qi Tongfu treatment after gynecological operation were analyzed and the Meta evaluation system,evaluate its efficacy and safety,and provide a theoretical basis and clinical reference for TCM therapy of gastrointestinal function after abdominal surgery recovery.Methods:We searched PubMed,CBM,CNKI database,collected data about randomized clinical trials of Liqi Tongfu therapy on gastrointestinal dysfunction after gynecological surgery.We independently chose the literature,extracted data,and run Meta analysis according to the RevMan5.3 software research methods.Resulis:16 articles,1886 patients were included in the study,including 992 cases in traditional Chinese medicine treatment group and 894 cases in western medicine routine control group.According to the results of Meta analysis,patients were divided into subgroups base on surgical procedures or primary outcomes.For anal exhaust as primary outcome,traditional Chinese medicine treatment group compared with the control group[MD:-13.74,95%CI(-17.02,-10.29),Z=7.80,P?0.00001];for defecation as primary outcome,traditional Chinese medicine treatment group compared with the control group[MD:-22.98,95%CI(-28.63,-17.34),Z=7.98,P<0.00001];for bowel sound recovery as primary outcome,traditional Chinese medicine treatment group compared with the control group[MD:-6.82,95%CI(-8.43,-5.21),Z=8.30,P<0.00001];for the improvement of abdominal distension and pain as primary outcome,traditional Chinese medicine treatment group compared with the control group[MD-18.40,95%CI(-22.11,-14.69),Z=9.73,P?0.00001].Conclusion:Liqi Tongfu therapy has clinical effects on promoting the recovery of gastrointestinal function after gynecologic surgery which is one of the clinical selectable therapeutic principles for promoting the recovery of gastrointestinal function in early period of postoperation.However,due to the low quality of the literature,there is still a certain publication bias,further develop high-quality clinical research is needed to provide evidence for evidence-based medicine.2.Cl ini cal research:The clinical study of efficacy of Areca on recovery of gastrointestinal function after gynecological surgeryObjective:A prospective,randomized,controlled trial was designed to observe the effect of traditional Chinese medicine Areca on the recovery of gastrointestinal function in patients after gynecological abdominal operation,and to explore the mechanism of the effect of promoting gastric motility.Methods:100 patients underwent gynecologic abdominal surgery were randomly divided into Areca treatment group and placebo control group.Each group includes 50 patients.The recovery of gastrointestinal function after Areca treatment were observed every day since 6 hours until 7 days after the operation(or before discharge),including postoperative exhaust time,postoperative defecation time and the score of gastrointestinal function after surgery(such as gastric distention,nausea and vomiting,bowel sounds).The two groups were taking granules,time and method for 6 hours after taking first times,the first day after the operation take 2 times a day,150ml each time with warm water.Areca granules were dosed 0.5g(equivalent to 10g crude drug)every time on areca treatment group,placebo control group was the same dose and method of areca treatment group.ELISA method was used to detect the changes of brain gut peptide hormone levels in two groups of patients during perioperative period.Statistical analysis of variance analysis was used t test,rank sum test,covariance analysis and repeated measures.Results:1.Recovery time of gastrointestinal function after operation ? There was no significant difference(P?0.05)between two groups with age,basic disease,history of abdominal surgery and the baseline before treatment(including intraoperative anesthesia time,operative time,postoperative abdominal drainage tube indwelling time,postoperative catheter indwelling time,postoperative antibiotic use time etc.)The general data of the two groups in this research were comparable.2.treatment results(1)Recovery time of gastrointestinal function after operation ? Overall comparison showed that the exhaust time after surgery in areca group(22.19± 7.32h,n=48)is decreasing compared with placebo group(26.30± 11.87h,n=47),but the difference was not statistically significant;the postoperative defecation time in areca group was significantly shortened compared with placebo group(P<0.05).? The covariance analysis of postoperative exhaust time for the first time:due to the time of anesthesia operation type,patient age and surgical process were important factors influencing the postoperative gastrointestinal function recovery time,the postoperative exhaust time for the first time as a result of the variable in patients group,operation is full house as fixed factors,age and operation the anesthesia time as a covariate,using analysis of covariance statistics of two groups of postoperative first exhaust time,results show that the main effect of group F=6.322,P=0.014.The results showed that the first exhaust time of the areca group was significantly shorter than that of the placebo group,and the difference was statistically significant(P<0.05).(2)The recovery of gastrointestinal function score of the overall curative effect comparison of each time point within the group:postoperative patients of Chinese medicine group of areca after 1 days,3 days,5 days are 6 hours of score,postoperative score was significantly increased,the difference was statistically significant(P<0.05);placebo control group of patients after 1 days,3 days,5 days the score,were also compared to 6 hours after operation were significantly increased,the difference was statistically significant(P<0.05);the comparison between the groups at each time point:there was no significant difference in 6 hours after operation in the two groups score difference(P>0.05),after 1 days,2 days after surgery,postoperative day 3 score in traditional Chinese medicine group was significantly lower than that of areca a placebo control group significantly increased,the difference was statistically significant(P<0.05).The multiple comparison between groups:two groups of patients with different observation time(after 6h,1 days,after 2 days,after 3 days a total of 4 points)the overall effect of the recovery of gastrointestinal function score by repeated measures analysis of variance,G-G model,significant difference between groups(F=967.325,P<0.001).There was statistical significance(P<0.05).The overall curative effect score of postoperative gastrointestinal function recovery was significantly different between the groups.(3)determination of brain gut peptide hormonesThe two groups were detected at different time points(before surgery,1 days,3 days after surgery,postoperative 5 days a total of 4 observation point)of blood motilin(motilin,MTL)level.Comparison of each time point within the group:3 days compared with the preoperative MTL level was significantly decreased after 1 days of Chinese areca group,after the operation,the differences were statistically significant(P<0.05),had no statistical significance after 5 days compared with the preoperative MTL level difference(P>0.05);the placebo control group after 1 days and 3 days after operation also compared with the preoperative MTL level was significantly decreased,the differences were statistically significant(P<0.05),had no statistical significance after 5 days compared with the preoperative MTL level(P>0.05).Comparison between groups at each time point:in patients with MTL levels between the two groups before surgery,there was no statistically significant difference(P>0.05);patients with MTL levels between the two groups before surgery,there was no statistically significant difference(P>0.05),after 1 and 3 days after the operation of Chinese areca group than in the placebo group with high levels of MTL,the difference was statistically significant(P<0.05);compared two groups of patients MTL level 5 days after operation,there was no statistically significant difference(P>0.05).The comparison between groups:analysis of variance of 4 at MTL level using repeated measurement data,the covariance matrix and ball type test,the differences were statistically significant(P<0.05),the choice of the G-G model,the results show the differences between groups was statistically significant(F=6.006,P<0.001).The blood MTL levels of two groups were compared with the observed time point group,the difference was statistically significant(P<0.05).Detection of two groups of patients at different time points(preoperative,postoperative 1 days,3 days,4 days after 5 days of observation)blood corticotropin hormone CRH(releasing)levelsComparison of each time point within the group:Chinese areca group 1 days after operation compared with the preoperative level of CRH were significantly increased,the difference was statistically significant(P<0.05),had no statistical significance after 3 days and 5 days after surgery compared with preoperative difference(P>0.05);the placebo group increased significantly after 1 days compared with the preoperative level of MTL.The difference was statistically significant(P?0.05);no statistical significance after 3 days and 5 days after surgery compared with preoperative difference(P>0.05).Comparison between groups at different time points:before surgery,postoperative 1 days,3 days and 5 days after areca Chinese medicine group and the placebo control group the level of MTL,there were no significant differences(P?0.05);multiple comparison between groups:4 at CRH level,the variance of repeated measurement data points analysis of full football test(P=0.139),the results showed no significant difference between groups(F=0.270,P=0.061).There was no significant difference in the blood CRH levels between the two groups(P>0.05).(4)Safety and compliance analysis:In the clinical research process,a total of 5 cases of patients quit,2 cases of traditional Chinese medicine areca group,3 cases of placebo control group,the difference between the two groups was not statistically significant.1 cases of patients in the placebo group after surgery due to fever from the outside.The rest are not willing to participate in the trial of postoperative compliance offered to withdraw from the trail.In the course of treatment of patients in the two groups were no adverse reactions before and after treatment,blood routine,liver and kidney function and ECG were not abnormal.Conclusion:Areca can effectively shorten defecation and exhaustion time after gynecological surgery(P?0.05),and the scores of gastrointestinal function after surgery in Areca group was significantly higher than placebo group after postoperative 3 days(P<0.05).This research shows that traditional Chinese medicine Areca can promote the recovery of gastrointestinal function which is related to the increase of plasma MTL level.