| BackgroundIntestine is very important in the pathogenesis of sepsis. Patients with sepsis are prone to intestinal dysfunction where intestinal dysfunction in turn can aggravate sepsis and induced multiple organ dysfunction syndrome. Carrying out investigation on the risk factors of intestinal dysfunction to sepsis patients and identifying vulnerable patients at high risk of intestinal dysfunction have great significance to intestinal dysfunction in sepsis for early diagnosis and intervention.Syndrome differentiation is the method and essence of Chinese medicine. There are lack of Chinese medicine syndromes on study of sepsis at present. Therefore, carrying out research on the elements of Sepsis Chinese medicine syndromes, summarizing its characteristics have great importance to the formation of the Chinese medicine treatment for sepsis.Although Chinese medicine has achieved a certain effect in the treatment of intestinal dysfunction in sepsis, but its TCM intervention programs needs to be further improved. Forming the TCM Tiaochang bundles therapy to intervene intestinal dysfunction in sepsis based on the study of methods of bowel adjustments together with reference of the modern treatment of sepsis Tiaochang bundles therapy has achieved good result in the early clinical practice. This study-is going to confirm its efficacy through randomized controlled clinical trial, and preliminary observe on its efficacy mechanism.Object ives1. Carrying out investigation on the risk factors of intestinal dysfunction to sepsis patients, to provide reference of prevention and treatment for intestinal dysfunction in sepsis.2. Carrying out observation on the constitute elements of TCM syndromes on sepsis patients, to provide TCM syndromes research basis for Chinese medicine intervention treatment in sepsis.3. Evaluation on the clinical efficacy of TCM Tiaochang bundles therapy treatment plan of intestinal dysfunction in sepsis and observe its plan on sepsis patients with systemic inflammatory response and related inflammatory factors.4. Evaluation of whether early treatment could help to improve prognosis and systemic inflammatory response of sepsis patients.Methods1. Summarized the risk factors of sepsis patients with intestinal dysfunction through literature. Subsequently using clinical cross-sectional survey research methods and brought into 73 patients with sepsis. Among 73 cases,47 cases of which occurred intestinal dysfunction (intestinal dysfunction group), and 26 cases without intestinal dysfunction (non-intestinal dysfunction group). Carried out clinical investigations and collect the appropriate physical and chemical indicators, specifically including intestinal dysfunction score, APACHE II score, history of gastrointestinal disease or abdominal surgery, systemic edema, shock, blood lactate concentration, blood gas analysis, serum albumin, serum pre-albumin, serum alanine aminotransferase and aspartate aminotransferase. Compared the parameters of the two groups and conferred the risk factors of sepsis patients for intestinal dysfunction.2. Summarized the common elements of TCM syndromes of sepsis patients through literature. Subsequently using clinical cross-sectional survey research methods and brought into 73 patients with sepsis. Among 73 cases, 17 cases were general sepsis patients,24 cases were severe sepsis cases and 32 cases were septic MODS patients. To incorporate the basic TCM syndrome when investigating factors, including the basic deficiency:qi deficiency, blood deficiency, yin deficiency, yang deficiency, the basic excess class:phlegm, fiery, blood stasis, fluid-retention. While investigating the following: intestinal dysfunction score, APACHEâ…¡score. Carried out statistical analysis of sepsis, sepsis at different stages, constitute elements of TCM syndromes of sepsis with intestinal dysfunction, moreover, carried out correlation study on the basic elements of the TCM Syndrome and APACHEâ…¡score.3. Using prospective randomized controlled clinical research methods, brought into a total of 47 sepsis patients. Appling simple randomized method to divide into random groups,24 cases in trial group and 23 cases in control group. Experimental group and Western treatment control group treated in accordance with international guidelines of sepsis. While the experimental group was treated in Western medicine based on the use of TCM Tiaochang bundles therapy and compared the clinical efficacy of the two groups. The hospital survival rate-28 days survival as the primary endpoint; used APACHE II score, intestinal dysfunction score as a secondary efficacy evaluation.Simultaneously observed the improvement rate of the essential elements of the TCM syndrome, intestinal function, serum albumin and the relevant indicators of systemic inflammatory response of the two groups. Intestinal function was observed by plasma diamine oxidase while systemic inflammatory response was observed by inflammatory score, blood lactate concentration, C-reactive protein, TNF-a and IL-10.4. At the end of study, re-grouped all the randomized controlled clinical study into early treatment target group and non-early treatment target group, and compared their clinical efficacy. The hospital survival rate-28 days survival as the primary endpoint; used APACHE II score as a secondary efficacy evaluation. Simultaneously compared the plasma diamine oxidase, serum albumin concentration and the related indicators of systemic inflammatory response, including the systemic inflammatory response score, blood lactate concentration, C-reactive protein, serum TNF-a and serum IL-10 of the two groups.Results1. On the analysis of risk factors, the incidence rate of shock, respiratory failure, the incidence rate of blood lactate concentration and APACHEâ…¡score of the intestinal dysfunction group was higher than the group without intestinal dysfunction. Logistic regression analysis showed that blood lactate concentration, APACHE II score of intestinal dysfunction may be the risk factors, the OR of increased blood lactic acid the was 7.056 [95% CI (1.729-28.789)], APACHE II score of the OR values was 1.407 [95% CI (1.169-1.693)]. Correlation analysis showed that intestinal dysfunction score and blood lactate concentration, APACHE II score was positively correlated. With the rate of increase in intestinal dysfunction, blood lactate concentration, APACHE II score would corresponding increase.2. Carried out investigation on the TCM syndromes of the 73 cases of sepsis patients, the results found out that the pattern of deficiency-excess complex was the most common, accounting for 83.6%,16.4% of pure excess, no patient was showed to be simple deficiency. In the basic elements of deficiency syndrome, qi deficiency was the most frequent (100%), followed by Yang Deficiency (42.6%), Yin deficiency syndrome (32.8%), blood deficiency (9.8%). In the basic elements of excess syndrome, the highest frequency of occurrence was phlegm (91.8%), followed by fiery (79.5%), blood stasis (52.1%), fluid-retention (16.4%). There is no significant difference in the constituent of the basic TCM syndromes in general and severe sepsis and also between severe sepsis and septic MODS patients. As compared with general sepsis patients, yang deficiency syndrome significantly increased in septic MODS patients which was statistically significant (P<0.05). Carried out investigation on the TCM syndromes of 47 cases of sepsis patients with complication of intestinal dysfunction, the results found out that the pattern of deficiency-excess complex was the most common, accounting for 83.0%,17.0% of pure excess, no patient was showed to be simple deficiency. In the basic elements of deficiency syndrome, qi deficiency the most frequent (83.0%), followed by Yang Deficiency (44.7%), Yin deficiency syndrome (25.5%), blood deficiency (12.8%); In the basic elements of excess syndrome, the most frequent was phlegm (87.2%), followed by fiery (80.9%), blood stasis (59.6 percent), fluid-retention (17.0%). APACHE II score of elements of different syndromes were compared, results showed that the APACHE II score was higher with patients which occurred yang deficiency than patients who had not occurred Yang Deficiency (P<0.05).3. From the prospective randomized controlled study,1 patient of each experimental group and control group dropped out due to their own reasons, 2 patients of the experimental group and 1 patient of the control group died within 5 days, data collection was incomplete, and to be removed, the loss rate of two groups was not statistically significant. A total of 42 cases eventually entered statistical analysis, of which 21 cases as experimental group,21 cases o control group. The results failed to confirm that cluster-based programs help to improve the 28-day mortality of sepsis patients with intestinal dysfunction. Compared with the control group, cluster-based program in improving APACHE II score of bowel also did not show greater advantages. But the application of the TCM bowel adjustments cluster-based program help to achieve early bowel treatment goals, thereby improving the intestinal dysfunction score of sepsis patients with intestinal dysfunction, lower serum DAO concentrations and improve intestinal barrier function, and may accordingly improve the intestinal absorption. In the inflammatory response, the study observed that the TCM bowel adjustments cluster-based program help reduce the concentrations of serum CRP which may play a certain role to reduce systemic inflammatory response. However, compared with the control group, treatment group in the regulation of TNF-a, IL-10 has not showed a greater advantage. In adverse events, small percentage of patients had diarrhea by treating by the TCM bowel adjustments cluster-based program, but difference between groups had no significance. In addition, the results suggest that serum DAO concentrations and the score of intestinal dysfunction had good clinical relevance, which could better reflect the situation of intestinal dysfunction, serum DAO concentrations and blood lactate concentration while the occurrence of shock also had good correlation.4. re-grouped and compared all the patients according to whether they achieve early bowel treatment, the results showed that although the 28-day mortality of the two groups had no significant difference, but the APACHEâ…¡score decreased dramatically in patients who achieved early bowel treatment, suggesting that these patients may have a better prognosis of the outcome. Compared to patients with no early treatment, it was found that patients of early treatment had low serum DAO concentrations, suggesting that serum DAO concentrations can reflect the severity of intestinal dysfunction. In addition, early treatment could improve bowel intestinal barrier function and may improve intestinal absorption in sepsis patients. In the inflammatory response, in comparison with patients of no early treatment, there were significant improvements in the SIRS score, serum CRP of patients with early treatment. On the analysis of TNF-a and IL-10 showed that TNF-a serum levels significantly decreased in patients with early treatment. Therefore, early treatment may help to improve systemic inflammatory response.Conclusions1. Blood lactate concentration, APACHEâ…¡score may be a risk factor of the occurrence of intestinal dysfunction. For septic patients who have a tendency of shock, increased blood lactate and high APACHEâ…¡score needs closely assessment of their intestinal function. Thus for early detection and intervention of intestinal dysfunction.2. Sepsis patients, especially the elderly are found to be categorized as a pattern of deficiency-excess complex. In clinical intervention, "deficiency" other than "reducing excess" is more needed to be taken into account. At the stage of MODS in sepsis, the incidence of Yang deficiency tended to increase and so attention should be paid to "support the Yang" treatment in order to prevent the violence off of yang qi.3. TCM Tiaochang bundles therapy helps to achieve treatment goals early so as to improve the intestinal dysfunction. It may also help to reduce the systemic inflammatory response in sepsis patients.4. Sepsis patients who can be treated early may have a better prognosis outcome. Early bowel treatment not only can improve the intestinal barrier function, but may also improve intestinal absorption which therefore helps to improve the systemic inflammatory response.5. Through the setting up of bowel treatment goals, Tiaochang bundles therapy for different severity is feasible in the TCM intervention treatment of intestinal dysfunction in sepsis. Such an intervention program can reflect the diagnosis and treatment, the personalization characteristics of TCM while clinical efficacy can be improved through comprehensive treatment.
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