Study On The Clinical Dose - Effect Relationship Of Dachengqi Decoction In Treating Intestinal Obstruction Based On Literature Research And Clinical Trial

The secret lies in the dose of TCM is not preach. It has a long history of traditional Chinese medicine, however, due to a variety of reasons, such as the changes of history and the lost of medicine books, opinions on doses of herbs vary in modern clinical and research of traditional Chinese medicine, which confuses many scholars. Classic medical prescriptions refers to those which recorded in the books before han dynasty, and "Treatise on Febrile and Miscellaneous Diseases"written by Zhang zhongjing is regarded as a typical model. With quite less herbs, classic medical prescriptions become the best carrier of the research of dose effect relationship. Based on the classical medical prescriptions Dachengqi Decoction, research is carried out:to summarize the clinical dosage range of Dachengqi Decoction in the treatment of intestinal obstruction in modern clinical practice depending on published literature, to explore the best dosage of Dachengqi Decoction in the treatment of intestinal obstruction. And taking functional intestinal obstruction as an example, a prospective randomized double-blind parallel controlled clinical trial is designed to further explore the dose-effect relationship of Dachengqi Decoction in the treatment of intestinal obstruction.Objective:To explore the effective and safe dosage range and the relationship of dose and effect of Dachengqi Decoction in the management of intestinal obstruction on the basis of periodical literature about it;To study the dose-effect relationship of Dachengqi Decoction in the management of functional intestinal obstruction (Yangming Fushi) based on a randomized controlled clinical trial.Methods:(1)Literature research:select published literature focusing on evaluating the effect of Dachengqi Decoction in the management of intestinal obstruction from CNKI database according to certain inclusion and exclusion criteria. Key information will be extracted from identified papers, which will be analyzed by SPSS19.0.(2) Clinical trials:randomized, double-blind, parallel dose-controlled, multi-center trial design is introduced. Those who meet the clinical diagnosis of functional intestinal obstruction are randomly divided into3groups,of which Dachengqitang high dose group, middle dose group, low dose group are given respectively. The follow-up period is72hours. Primary efficacy endpoint, such as the time of the first anal exsufflation and defecation, and other secondary outcome related will be recorded in the observation point24hours,48hours,72hours.Results:(1) In the first part, forty-two papers are included in the research, which demonstrate the dosage of the Dachengqi Decoction were as follows:Rhubarb5-40g, Glauber5-30g, fructus aurantii immaturus8-30g, and Mangnolia officinalis8-30g.(2) In the second part, twenty-one RCT researches are included, and the results as follows:in a certain dosage range, the curative effect and dosage are positively correlated when the total dose of Rhubarb, Glauber, fructus aurantii immaturus and Mangnolia officinalis in Dachengqi Decoction is greater than61g; curative effect is less satisfied while the number is61g; the dose of the whole prescription in papers and the curative effect shows no obvious correlation, nor the proportion of the the total dose of Rhubarb, Glauber, fructus aurantii immaturus and Mangnolia officinalis in the whole prescription; drugs matching the Dachengqi.(3) Clinical trial shows that the curative effect of72hours of Dachengqi Decoction in the management of functional intestinal obstruction of the three groups are100%;48-hour effect of every group is more than90%, and there was no remarkable difference among them; in the first24hours, the curative effect (80.95%) of middle dose group dose is obviously better than high dose group (40%) and low dose group (31.25%), with significant difference, while there was no remarkable difference between the high dose group and low dose group.Conclusion:(1)In the modern clinical practice, dose range of the four drugs in Dachengqi Decoction have exceeded the prescribed dose for Pharmacopoeia in the treatment of intestinal obstruction. At this dose range, curative effect is satisfactory and no adverse reactions was reported.(2) In a certain range of doses, the curative effect of intestinal obstruction is significantly and positively related with the dose of Dachengqi Decoction,namely the greater the dosage of Dachengqi Decoction is, the better the total curative effect is.(3) In a certain range of doses, curative effect of Dachengqi Decoction in of treatment of functional intestinal obstruction and the dosage are positively correlated relationship.