Research On The Adaptive Symptoms And Dose-Effect Relationship When Houpusanwu Dispensing Granule Promoting The Gastrointestinal Motility Recovery Of Patients After Laparoscopic Cholecystectomy

1. Part of theoretical researchIn the study of adaptive symptoms, connotation of TCM syndromes is summarized:TCM syndromes has the characteristics of diagnostical and comprehensive index,ant it changes dynamically. Adaptive symptoms includes effect index and attribute index,and it was designed in order to guide the drug usage.The evaluation of daptive symptoms is also studied. Among the various concepts of Chinese Herbs dose,the true concept should be the actual available amount that used in the body when we study the dose-effect relationship. The dose is chosen according to the resistance of the drugs,the disease state and physique of patients..The Chinese Herbs dosage has many questions in clinical application such as the imprecision and confusion of dose and actual available amount. At the same time,in the paper, I also studies the clinical efficacy characteristics of Chinese Herbs which are multiplicity, bidirectional regulation and slow effect onset. It is the dose that influences the clinical efficacy critically. There are four situations of the influence:(1)the clinical efficacy dosen't enhance simultaneously with the dose increase of herbs.They have no correlation; (2)the clinical efficacy enhances with the dose increase of herbs in some range.They have positive correlation; (3)the clinical efficacy decreases and even side effect takes place with the increase dose of herbs when the dose exceeds some range.They have negative correlation; (4)the clinical efficacy shows wholly or nothing when the dose changes. Next, some samples are given.Other influencing factors are those the drug quality, the modes of processing, the types of preparation, decoction methods, administration route, the time and frequency of medicine taking,Compatibility etc.The Chinese Herbs can widen the therapeutic range, reinforce or weaken original efficacy, relieve or aggravate the drug toxicity by the compatibility. Examples were also given about the influence of the compatibility on the clinical efficacy. Syndrome of TCM can influence the dose-effect relationship of Chinese Herbs as the same. For example, the different dose is needed if the syndrome is different,although the disease is same,or the efficacy is different at the same dose if the syndrome is different.There are still other influencing factors such as the constitution.The different constitution,the different therapeutic method at the same etiology.The different constitution,the different reactivity and tolerability at the herbs. At the same time, the different constitution,the different prognosis. Then, origin on the dose-effect relationship of Chinese Herbs is traced back by studying ancient medical classics. Then, the general situation of Chinese Herbs and dose-effect relationship study are summarized through the classification of basic research,clinical research and methodological study.In the following, three hypotheses are put forward according to the above study:Abdominal distension,abdominal pain and constipation are the adaptive symptoms of Houpusanwu Dispensing Granule; Houpusanwu Dispensing Granule has the dose-effect relationship with its clinical effect; the TCM syndrome and physical attributes may influend the dose-effect relationship.Before the dose-effect relationship study of the Chinese Herbs is carried out,something is studied preliminarily such as the choice of target adpted Population,the target indication,the drugs,the effect indicators,the efficacy evaluation.2. Part of clinical researchObjective:Main Objective:To explore the adaptive symptoms of Houpusanwu Dispensing Granule Promoting the Gastrointestinal Motility Recovery after Biliary Selective OperationSecondary objective:To estimate the dose-effect relationship of Houpusanwu Dispensing Granule Promoting the Gastrointestinal Motility Recovery after Biliary Selective Operation.Research method:Research design type:randomized block, non-blind, parallel control, superiority testStudy drug:low dose group equivalent to 1/2 dosage of Classical Prescriptions as follows: Magnolia officinalis 2g, Rhubarblg, citrus aurantium0.5g; high dose group equivalent to the same dosage of Classical Prescriptions as follows:Magnolia officinalis 4g, Rhubarb 2g, citrus aurantium 1g; blank controlTest procedure:Subjects entering the group are divided into 3 groups randomly, and syndrome differentiation is established before the operation. Subjects of the treatment group take Houpusanwu Dispensing Granule orally 6 hours after the operation. Then I begin to explore the adaptive symptoms of Houpusanwu Dispensing Granule and observe the time of intestinal sound recovery,first exhaust and defecation,and estimate the relationship between the clinical efficacy and dosage.Indexes for therapeutic effects:the time of intestinal sound recovery,first exhaust and defecation.Statistical method:The data which reflect character is shown by frequency,percent or structure ratio.The data which reflect numerical value is shown by mean value,standard error or median.Comparison of three group:The data which reflect character is verified withχ2 test,R×C Fisher test,Wilcoxon test or CMHχ2 test.The data which reflect numerical value is verified with t test which accord with normal school,other wise we choose Wilcoxon test.All the suppose test we choose two-side test which offer all the Stat number and the P corresponded. There is statistical value if P≤0.05 or P≤0.01.Result:The difference of age,height,weight,temperature,pulse,respiratory,systolic blood pressure and diastolic blood pressure has no statistical value (P>0.05).The difference of diagnostic index data(like drugs that used before, the condition of the complication, classification of constitution and syndrome), and the difference of operation time(anaesthesia time),the interval time between the first bed-off, intake time and operation time have no statistical value (P>0.05). Diagnosis has the remarkably statistical value (P<0.05),which would not influence the evaluation of clinical efficacy. All the patients in these three groups have no combined medication and adverse events.When analyzing the adaptive symptoms,Ⅰconclude that bitter taste and halitosis, dry mouth and dry throat are the adaptive symptoms, abdominal distension, preference for sighing and eructation are the inadaptative symptoms, which is held within the patients that are operated by biliary resection because of the acute and chronic cholecystitis, bile duct stone, gallbladder polyps.When analyzing the difference of clinical effect with different constitution,the result is that the time of intestinal sound recovery,first exhaust and defecation have no statistical value (P>0.05)When analyzing the dose-effect relationship of Houpusanwu Dispensing Granule, the clinical dose-effect line is oblique, b (slope)=-0.84, showing statistically significant trends in the establishment of dose-effect relationship.Conclusion:(1)The adaptative symptoms of Houpusanwu Dispensing Granule Promoting the Gastrointestinal Motility Recovery after Biliary Selective Operation is middle-jiao damp-heat which has the symptoms of bitter taste and halitosis, dry mouth and dry throa. (2) Houpusanwu Dispensing Granule has the dose-effect relationship.(3) The TCM syndrome and physical attributes may not influend the dose-effect relationship.