Empirical And Clinical Study Of Treating Chronic Functional Contispation Due To Disorder Of Qi By The Composing Of TiaoChangLiQi Tablets

Objective and Significance:Chronic functional contispation (CFC) is a kind of normal disease in the gastricinternal medical, it can debase the patient's QOL obviously, and also can bring on somesevere result. During the clinical treatment, we found that Chronic functional contispationdue to disorder of qi——Qi sickness syndrome such as Qi stagnation and/or Qi deficiencyin CFC is much more than other syndromes else.On the contrary, there has no correspondchinese patent medicine to treate it. TCLQ Tablets was created by professor Yunjian, Luo,and has been used widely in our hospital. It was used to treate contispation caused bychronic colonitis, but we also used it to treat patients with Chronic functional contispationdue to disorder of qi often, and got good curative effect.To get a prescription which hasbetter curative effect and has less herbs, we will use the orthogonal test, validating itcurative effect and if it accord with the pathogenesis of TCM or not by twosides:1).Experiment study: we will take part the composing of TCLQ Tablets, using it totherapy the model mice of CFC and get the best composing, and explore it partmechanism; 2).Clinical study: Observe the curative effect of TCLQ Tablets or the methodof TCLQ, and compare the superiority or shortage with Zelmac, so we can make a goodbase for the exploiture of patent medicine for Chronic functional contispation due todisorder of qi.Methods:The study including two parts:animal study and clinical research.The animal study wasdivided into two stepes: 1). Orthogonal test was used for studying the herb and dose of theTCLQ Tablet, the first tary stool time of every mouse is our observing object, and shoosethe shortest group to continue next step.2).Use the prescription get from the fist step totreat the model mice of CFC with Qi sickness syndrome (Qi stagnation and Qi deficiency),noting down the first tary stool time of every mouse,the concentration of gastric-intestinal hormone (MOT,CGRP), and comparing with Zelmac group,normal group,naturallyresume,TCLQ Tablet original prescription (TCLQ-OP) group.The clinical study adopted at random, contrasting principle. Zelmac Tablets was thecontrasting medicine. we divided the patients into two groups:35 cases in the observinggroup who were treated by TCLQ tablets or prescription based TCLQ method (TCLQgroup); the other group included 30 cases as contrasting group who were treated by ZelmacTablets, the observing time is 4 weeks, the changes of patients' symptoms,signs,A valueand D value were what we are interesting.Results:Animal studies results:Through the fist step, we found that the second experiment group mice have theshortest time of the first tary stool, the dose is original, so we shoosed it as the best group tocontinue next step experimentation.The second step results:1.The model mice were accord with the stagnation of the Qi sickness syndrome bytheir appearance and behavior, and the time of the first tary stool was also longer than thenormal mice (P＜0.01), so the model is successful;2.After being treated by each medicine, the rank of the time of the first tary stool was:Zelmac＜the best group＜normal＜TCLQ-OP＜naturally resume.The time of Zelmac groupwas the shortest, but it had no significant differences between the best group or the normalgroup(P＞0.05); the naturally resume group is the longest one, has no significant differencesbetween TCLQ-OP (P＞0.05), but has no significant differences among the other threegroups (P＜0.05, P＜0.01).Zelmac and TCLQ-OP have the highest rate of small intestineboosting, the differences is significant (P＜0.01), the other three groups have no significantdifferences (P＞0.05).3.The results of gastric-intestinal hormone (MOT,CGRP) shew: The rank ofconcentration of MOT in plasma was: Zelmac＞naturally resume＞TCLQ-OP＞normal＞thebest.Zelmae was the highest one, and the best group was the lowest; there had significantdifferences among the normal group,the best group and the TCLQ-OP group (P＜0.05,P＜0.01), but not between the naturally resume group (P＞0.05); the best group was belowto naturally resume group (P＜0.05), but had no significant differences among the othergroups (P＞0.05).The rank of concentration of CGRP in plasma was: TCLQ-OP＞the best＞normal＞Zelmac＞naturally resume.TCLQ-OP was the highest one, there had significantdifferences among the naturally resume and Zelmac group (P＜0.05, P＜0.01), but not between the best and normal group (P＞0.05); the other groups had no significantdifferences between each one (P＞0.05).The rank of concentration of MOT in colon was: TCLQ-OP＞normal＞the best＞Zelmac＞naturally resume.TCLQ-OP was the highest one, there had significant differencesamong the best group, naturally resume and Zelmac group (P＜0.01), but not between thenormal group (P＞0.05); the other four groups had no significant differences between eachone (P＞0.05).The rank of concentration of CGRP in colon was. TCLQ-OP＞Zelmac＞naturallyresume＞the best＞normal.TCLQ-OP wa the highest one, there had significant differencesamong the other four groups (P＜0.05, P＜0.01), the naturally resume group was higher thanthe normal, the differences was significant (P＜0.05); the best one had no significantdifferences among the three groups but the TCLQ-OP one.4.Ananysing the correlation among the time of the first tary stool,the push rate insmall intestine,the MOT and CGRP in plasm/colon tissue, we found that the time of thefirst tary stool had positive correlation with MOT in plasm/colon tissue, and had negativecorrelation with CGRP in plasm/colon tissue, it accorded with the action characteristic ofthe two kinds of gastric-intestinal hormone.the time of the first tary stool had positivecorrelation with the push rate in small intestine, but the correlation was so small (r=0.043)that we thought it has no so much correlation between each other, it could explain why thebest group didn't have the highest push rate in small intestine but could accelerate mice todefecate very effectively, so we concluded that maybe the colon is it's main acting part.Clinical observation results:1.The overall curative effect results indicated: In the group treated by TCLQ method,the cure rate was 17.14%, the significantly rate was 42.86%, the effective rate was 28.57%, the ineffective rate was 11.43%, the whole effecte rate was 88.57%; in the grouptreated by Zelmac tablets, the cure rate was 16.67%, the significantly rate was 60.00%,the effective rate was 16.67%, the ineffective rate was 6.67%, the whole effecte rate was93.33%; the curative effect between two groups had no significant differences (p＞0.05).2. The changes of HAD results indicated: The patients with Chronic functionalcontispation due to disorder of qi have some changes in mood, especially depression.To thedegree of anxiety, the two groups all had some improvement, but there was no significantdifferences(p＞0.05), thus as between the two groups.To the degree of the depression, therewas significant differences in TCLQ group (p＞0.05), but not between the Zelmac group,there had no significant differences with before treating in the Zelmac group (p＞0.05), and2 patients turned to severity. After being treated, the anxiety value all declined but had no significant differences(p＞0.05), thus as between the two groups; the depression value declined in the grouptreated by TCLQ method and had significant differences with before treating or the Zelmacgroup (p＜0.05).3. There had similarities or differences in the side of the clinical symptomimprovement.TCLQ group improved all of the symptom related contispation, and improvedthe symptom such as defacate hardly,fatigue,adominal distention,intestinal flatus fromanus obviously (p＜0.01), and there was no significant differences in the improvement ofanorexia and belching (p＞0.05).Zelmac tablets improved the symptom such as defacatehardly,fatigue,adorninal distention,anorexia specially (p＜0.01), and there was nosignificant differences in the improvement of anorexia and belching (p＞0.05).the value ofintestinal flatus from anus reduced, but there had no significant differences (p=0.206＞0.05), and it had no effect to belching.Comparing with the Zelmac group, the TCLQgroup had superiority in the improvement of symptoms such as fatigue,adominal distentionand intestinal flatus from anus (p＜0.01), but had no significant differences in defacatehardly,anorexia and belching (p＞0.05).Conclusions:1. The animal study showed that the best prisciption apart from TCLQ-OP could notonly accelerate normal mice but also the model mice of CFC with Qi stagnation syndrometo defecate, the effect was closed to Zeimae tablets, it primarily proved that the TCLQtheory was suitable to the TCM mechanism of Chronic functional contispation due todisorder of qi.2. Accoding to the reaults of gastric-intestinal hormone, the concentration of MOT incolon of the best group only below, the normal group, it shew that the best group canaccelerate colon move better; the concentration of CGRP in colon of the best group wasonly higher the normal group, it shew that the best group can have little power ofrestraining colon move.The TCLQ-OP had the highiest concentration of MOT and CGRP incolon than other groups, it tell us though it can accelerate colon move better, it also has thepower of restraining colon move, so it hadn't the best effect of accelerating todefecate.From these results, we can get the idea that the hormone in colon had morecorrelation with accelerating defecate than it in plasma.The study only observed part of the hormone, there also has many other factors canhave effect on the movement and secretion of digest system, so, the results only reflected asmall part of the mechanism of CFC.we also concluded that maybe the colon is it's mainacting part. 3. The clinical research results shew that the priscription get by TCLQ method andZelmac tablets all have good treatment to patients of Qi stagnation type of CFC, they hadcertain curative effect, but the TCLQ had some superiority in some sides such as improvingsome mainly symptom of CFC, the patients'mood and so on.So, we think that the method of TCLQ is a effective method to CFC with Qi sicknesssyndrome which has the right theory of TCM, it also has superiority than westem medicinein the improvement of HAD, and has less side-effect, so it is worthing of being study moredeeply, and we should carry out the corresponding exploitation of chinese patent medicine,offering more choices to doctor treating CFC.