Clinical Study Of Xiangbin Prescription For Recovery Of Gastrointestinal Function After Gynecological Surgery

The content of this study mainly includes two parts:The first part is the literature research.This research adopts literature investigation and bibliometric analysis methods to understand the latest research progress in the treatment of post-operative gastrointestinal disorders at home and abroad.The literature on gastrointestinal motility after gynecological surgery treated with Yiqi Tongfu therapy is evaluated systematically and meta-analyzed to provide evidence for evidence-based medical research.The second part is clinical research.The traditional Chinese medicine Xiangbin prescription(XBP)is applied to the patients after gynecological surgery.The clinical study aim to evaluate the safety and efficacy of the use of XBP to promote gastrointestinal function recovery after gynecological surgery and discuss its mechanism of action.A.Literature research:Meta analysis of Yiqi Tongfu therapy promoting the recovery of gastrointestinal function after gynecologic surgery.Objective:After gynecological abdominal surgery,the deficiency of vital qi,qi stagnation and blood stasis are common syndromes,through the literatures,suggesting that for early postoperative obstruction of“asthenia requiring tonification,sthenia requiring purgation”,oral prescription of traditional Chinese medicine preferred Yiqi Tongfu method.The clinical studys on the effect of gastrointestinal disorder with Yiqi Tongfu treatment after gynecological operation were collated.Meta analysis was used to evaluate its efficacy and safety.Its results will provide a theoretical basis and clinical reference for TCM therapy on gastrointestinal dysfunction after gynecologic surgery recovery.Methods:PubMed,Embase,Cochrane Library,China National Knowledge Infrastructure(CNKI)database,Wanfang Data and the VIP Information database(1980-2018.1)were searched through computer to collected data about randomized clinical trials of Yiqi Tongfu therapy on gastrointestinal dysfunction after gynecological surgery.The treatment group received oral Yiqi Tongfu traditional Chinese medicine(containing Astragalus membranaceus,ginseng or red ginseng,Atractylodes macrocephala,Codonopsis pilosula,etc).And the control group received conventional postoperative treatment or placebo and conventional treatment or western medicine and conventional treatment.The literature data extraction and analysis were conducted through Excel spreadsheet and RevMan 5.3 software,and systematic evaluation and meta-analysis were conducted.Results:15 articles,1957 patients were included in the study,including 1027 cases in traditional Chinese medicine treatment group and 930 cases in control group.According to the results of meta analysis,patients were divided into subgroups(laparoscopic surgery,transabdominal surgery,and other)base on surgical procedures or primary outcomes.For anal exhaust as primary outcome,a random effect model was used,traditional Chinese medicine treatment group compared with the control group(Z=5.51,P<0.00001,MD=-9.62,95%CI=-13.05~-6.20,I~2=97%);for defecation as primary outcome,a random effect model was used,traditional Chinese medicine treatment group compared with the control group(Z=4.78,P<0.00001,MD=-13.56,95%CI=-19.13~-8.00,I~2=96%);for bowel sound recovery as primary outcome,a random effect model was used,traditional Chinese medicine treatment group compared with the control group(Z=10.55,P<0.00001,MD=-7.50,95%CI=-8.89~-6.11,I~2=67%);for the time of abdominal distension remission as primary outcome,a random effect model was used,traditional Chinese medicine treatment group compared with the control group(Z=1.46,P=0.14,MD=-12.44,95%CI=-29.10~4.22,I~2=99%);for effective rate as primary outcome,a fixed effect model was used,traditional Chinese medicine treatment group compared with the control group(Z=8.45,P<0.00001,OR=4.57,95%CI=3.21~6.50,I~2=15%).Conclusion:Yiqi 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.B.Clinical research:Clinical study of Xiangbin prescription for recovery of gastrointestinal function after gynecological surgeryObjective:A prospective,randomized,controlled trial was designed to observe the effect of traditional Chinese medicine XBF on the recovery of gastrointestinal function in patients after gynecological abdominal operation,and to explore the mechanism of XBF on promoting gastric motility.Methods:Time of taking medicine and method:Traditional Chinese medicine XBF group took 2 times daily on the basis of routine postoperative treatment,one dose per day,150 ml each time,from the first day after the operation,until defecation after surgery.The chewing gum group took one tablet once every4 hours on the basis of routine postoperative treatment after the surgery,and each time lasted for about 15 minutes until defecation.The blank control group were given conventional western basic treatment from the first postoperative day to 7 days postoperatively(or before discharge).The recovery of gastrointestinal motility after routine western medicine treatment,XBF or chewing gum intervention was observed daily(including time to first flatus,time to first defecation)were analyzed.Statistical analysis was performed on the symptoms associated with gastrointestinal motility disorders(changes in abdominal pain,nausea,vomiting,and fever).The perioperative gastrointestinal hormone-related and inflammatory factor level changes in the three groups were detected by ELISA.Statistical analysis methods R×C contingency table test or Fisher’s exact probability method,one-way ANOVA,rank sum test,or repeated measures analysis of variance were applied.Results:Baseline level:A total of 168 patients were included,including 55 in XBF group,57 in chewing gum group and 56 in control group.There were no significant difference between three groups with age,type of diseases,basic disease,history of abdominal surgery,preoperative leukocyte,red blood cell,hemoglobin,and albumin levels that reflect the general nutritional status(P>0.05).And the baseline before treatment after operation(including intraoperative anesthesia time,operative time,postoperative abdominal drainage tube indwelling time,postoperative catheter indwelling time,postoperative antibiotic use time etc)that reflect the general nutritional status(P>0.05).The general data of the three groups in this research were comparable.Treatment results:1.Recovery of gastrointestinal function after surgery(1)Overall comparisonPostoperative gastrointestinal motility recovery time mainly includes time to first flatus,time to first defecation.According to the test of normality,the postoperative first exhalation time of the XBF group,the chewing gum group and the blank control group was a normal distribution.Therefore,an independent sample one-way ANOVA was used to compare the groups.The statistical results showed that:The difference in the time to first flatus between Chinese herbal XBF group,gum chewing group and blank control group was statistically significant(P<0.05).Among them,XBF Chinese medicine group had statistical significance compared with blank control group(P<0.05);Through the test of normality,the first postoperative defecation time of patients in Chinese medicine XBF group,gum chewing group and blank control group was abnormal distribution,so Non-parametric rank sum test was used to compare the groups.Time to first defecation of the Chinese medicine XBF group,chewing gum group and blank control group all significantly shortened,and the difference was statistically significant(P<0.05).The XBF Chinese medicine group had statistically significant differences compared to the chewing gum group and the blank control group(P<0.05).(2)Stratified comparison of anesthesia timeComparison of time to first flatus and time to first defecation after surgery of patients with anesthetic time of 2 to 4 hours:After normality test,time to first flatus after surgery of patients with anesthetic time of 2 to4 hours in the traditional Chinese medicine XBF group,the gum chewing group,and the blank control group were normal distribution.Using the independent sample one-way ANOVA,the results showed that there was statistically significant difference in the three groups of time to first flatus.There was a statistically significant difference between traditional Chinese medicine XBF group and blank control group(P<0.05).After normality test,time to first defecation after surgery of patients with anesthetic time of 2 to 4 hours in the three groups was non-normal distribution.The non-parametric rank sum test was used.The results showed that there was statistically significant difference in the three groups of time to first defecation(P<0.05).Compared with the gum chewing group and blank control group,the time to first defecation after surgery was significantly different in the XBF group(P<0.05).Comparison of time to first flatus and time to first defecation after surgery of patients with anesthesia time greater than 4 hours:After normality test,time to first flatus and time to first defecation of patients with anesthesia time greater than 4 hours in the three groups were normal distribution.Using the independent sample one-way ANOVA,the results showed that there was no statistically significant difference in the three groups of time to first flatus(P>0.05).Comparison of time to first defecation after surgery in the three groups,the recovery time was different,and the difference was statistically significant(P<0.05).There was a statistically significant difference between traditional Chinese medicine XBF group and blank control group(P<0.05).(3)Stratified comparison of surgical timeComparison of time to first flatus and time to first defecation after surgery of patients with surgical time less than 2 hours:After normality test,time to first flatus after surgery of patients with surgical time less than2 hours in the three groups were normal distribution.Using the independent sample one-way ANOVA,the results showed that there was no statistically significant difference in the three groups of time to first flatus(P>0.05).After normality test,time to first defecation after surgery of patients with surgical time less than 2 hours in the three groups was non-normal distribution.The non-parametric rank sum test was used.The results showed that there was no statistically significant difference in the three groups of time to first defecation(P>0.05).Comparison of time to first flatus and time to first defecation after surgery of patients with surgical time of 2 to 4 hours:After normality test,time to first flatus and time to first defecation of patients with surgical time of 2 to 4 hours in the three groups were normal distribution.Using the independent sample one-way ANOVA,the results showed that there was no statistically significant difference in the three groups of time to first flatus(P>0.05).Comparison of time to first defecation after surgery in the three groups,the recovery time was different,and the difference was statistically significant(P<0.05).There was a statistically significant difference between traditional Chinese medicine XBF group and blank control group(P<0.05).(4)Stratified comparison of ways of operationComparison of time to first flatus and time to first defecation after surgery in patients with laparoscopic total hysterectomy(LTH):After normality test,time to first flatus,time to first defecation of patients undergoing LTH in the three groups were normal distribution.Using the independent sample one-way ANOVA,the results showed that there was no statistically significant difference in the traditional Chinese medicine XBF group,the gum chewing group,and the blank control group of time to first flatus.Comparison of time to first defecation after surgery in the traditional Chinese medicine XBF group,gum chewing group and blank control group,the recovery time was different,and the difference was statistically significant(P<0.05).There was a statistically significant difference between traditional Chinese medicine XBF group and blank control group(P<0.05).Comparison of time to first flatus and time to first defecation after surgery in patients with non-LTH:After normality test,the time to first flatus after surgery in all three groups of patients undergoing non-LTH was normal distribution.Using the independent sample one-way ANOVA,the results showed that:Compared with the gum chewing group and blank control group,the time to first flatus after surgery was significantly different in the XBF group(P<0.05).There was a statistically significant difference between the three groups(P<0.05).After the normality test,time to first defecation after surgery of the three groups of patients undergoing non-LTH was abnormal distribution.Non-parametric rank sum test was used and the results showed that:Comparison of time to first defecation after surgery in the traditional Chinese medicine XBF group,gum chewing group and blank control group,the recovery time was different,and the difference was statistically significant(P<0.05).Among them,the XBF group was different from the chewing gum group and blank control group,the difference was statistically significant(P<0.05).2.Comparison of postoperative complications for each groupBy comparing the incidence of bloating in the three groups of patients,the results showed that:The incidence of bloating in the three groups wasc~2=5.895,P=0.043.The incidence of bloating was lower in the XBF group and the chewing gum group than in the blank control group,and the difference was statistically significant(P<0.05).The incidence of nausea and vomiting in the three groups wasc~2=2.530,P=0.327.Although the incidence of nausea and vomiting in the XBF group was lower than the chewing gum group and the control group,but there was not statistically significant(P>0.05);the incidence of postoperative fever in the three groups wasc~2=2.078,P=0.368.Although the incidence of postoperative fever in the XBF group was lower than the chewing gum group and the control group,but there was not statistically significant(P>0.05).3.Comparison of cost and length of hospital stayThe cost and length of hospital stay were compared among the three groups.According to the normality test,the total hospitalization expenses and the length of hospital stay for the XBF group,the chewing gum group,and the blank control group were normally distributed.An independent sample one-way ANOVA was used to compare the differences between the groups.The statistical results showed that:compared with the total cost of hospital stay in the three groups of patients,the total hospitalization expenses of Chinese Herbal XBF group compared with gum chewing group or blank control group all decreased,but the difference was not Statistical significance(P>0.05);Compared with the length of hospital stay in the three groups of patients,the length of hospital stay in the Chinese herbal XBF group was shorter than that in the blank control group,but the difference was not statistically significant(P>0.05).4.Comparison of levels of gastrointestinal motility-related hormones,inflammatory factors and fatigue scoresThree groups of different detection time points(before surgery,the 1st day after surgery,and the 3rd day after surgery)were compared for overall GHRL levels.Data from repeated measures data analysis of variance were used.The results showed that the level of GHRL secretion of the three groups after surgery decreased.The level of GHRL in Chinese Herbal XBF group,gum chewing group and blank control group increased on the 3rd day after surgery(P<0.05);The comparison between groups the 3rd day after surgery showed that the level of GHRL in XBF group was significantly higher than that in the other two groups(P<0.05).Three groups of different detection time points(before surgery,the 1st day after surgery,and the 3rd day after surgery)were compared for overall CRH levels.Repeated measurement data analysis was used to analyze.The results showed that after the surgery the secretion of CRH increased on average.The level of CRH in Chinese Herbal XBF group,gum chewing group and blank control group decreased on the 3rd day after surgery,and the difference was statistically significant(P<0.05).However,there was no significant difference between the three groups in the same time point(P>0.05).Three groups of different time points(before surgery,the 1st day after surgery,and the 3rd day after surgery)were compared for IL-6R levels.Repeated measurement data were used for analysis of variance.The results showed that the levels of IL-6R of the three groups after surgery increased.The level of IL-6R in Chinese Herbal XBF group,gum chewing group and blank control group decreased on the 3rd day after surgery,and there was a significant difference with different time(P<0.05).However,there was no significant difference between the three groupsin the same time point(P>0.05).Three groups of different time points(before surgery,the 1st day after surgery,and the 3rd day after surgery)were compared for IL-1βlevels.Repeated measurement data analysis of variance was performed.The results showed that the levels of IL-1βof the three groups after surgery increased.The level of IL-1βin Chinese Herbal XBF group,gum chewing group and blank control group decreased on the 3rd day after surgery,and there was a significant difference with different time(P<0.05).However,there was no significant difference between the three groups in the same time point(P>0.05).Conclusion:XBF can effectively shorten the time to first flatus and time to first defecation after gynecological surgery(P<0.05),and The GHRL level of the3rd day after surgery in Chinese Herbal XBF group was better than that in the blank control group(P<0.05).This research shows that traditional Chinese medicine XBF can promote the recovery of gastrointestinal function which is related to the increase of plasma GHRL level.