| BackgroundSepsis is an injurious systemic inflammatory response syndrome caused by various infection factors. In severe cases it can lead to dysfunction of organs. The typical symptoms of sepsis patients with gastrointestinal dysfunction includes acute or emerging severe abdominal distension, decreased or absence of bowel sounds in critical states. And once severe bloating causes toxic intestinal paralysis, poor prognosis with high mortality rate is expected. Therefore, to block the development of sepsis through effective treatment of gastrointestinal dysfunction is the key. At present, "purgating fu-organs to eliminate heat" method is commonly used for the treatment of gastrointestinal dysfunction in sepsis. However, the outcome of this method is not optimistic due to the malabsorption of patients.In recent years, we treated gastrointestinal dysfunction in sepsis with Xiaozhang Patch applying to Shenque point and it showed satisfying results. The Xiaozhang Patch consists of four Chinese herbs with spicy flavour:Evodia rutaecarpa, Aquilaria sinensis, borneol and frankincense. It includes both ascending and decending, warm and cool herbs, and together they can ascend lucidity and descend turbidity, reconcile cold and heat, and promote the running of stomach and intestinal Qi. The use of external treatment ensured the absorption of the drug to regulate Qi without impairing it. In 2007, for the first time we observed the effect of Xiaozhang Patch on 60 patients undergoing mechanical ventilation and acute gastrointestinal dysfunction. The results showed that Xiaozhang Patch could significantly reduce the duration of mechanical ventilation and improve the success rate of ventilator weaning. In this study, we observed the change of syndromes integral, abdominal circumference, abdominal cavity pressure and bowel sounds in gastrointestinal dysfunction patients with sepsis, and monitored relevant indicators of infection, inflammation, blood clotting mechanism and pathogenesis, to further evaluate the the effectiveness of this therapy and formula.ObjectivesTo evaluate the therapeutic efficacy of Xiaozhang Patch applying to Shenque point as a treatment to gastrointestinal dysfunction in sepsis.MethodsAll cases were inpatients admitted from March 2014 to June 2015 in ICU department of either Guang An Men Hospital or its branch in Daxing district, Chinese Academy of Traditional Chinese Medicine. Patients were randomly divided into treatment group and control group, both given anti-infection and basic organ support treatment. In addition, control group was treated with oral prokinetic agents and the treatment group was applied Xiaozhang Patch to Shenque point. The main outcome measures included the overall effecary, the changes of traditional Chinese medicine syndrome scores, abdominal circumference, abdominal cavity pressure and bowel sounds 72h and 7 days after the treatment. Secondary outcomes measures included infection and inflammation indicators (leukocytes and neutrophils ratio), clotting mechanism related indicators (platelets and fibrinogen), pathological mechanisms related indicators (serum DAO, plasma MTL and VIP, sIgA). The results were analyzed with statistical software SPSS 20.0 with significance level set at α= 0.05.Results1 General information and baseline analysisA total of 120 cases of patients were included,60 cases in each the treatment group and the control group. There were 62 male(51.7%) and 58 female(48.3%). The mean of age was 74.0 ±11.4 years. The baseline of the APACHE Ⅱ scrore in the two group showed no significance(P> 0.05). The difference of APACHE Ⅱ score 7 days after treatment between two groups was significant (P<0.05).The most common underlying disease was severe pneumonia, a total of 50cases(41.7%), followed by chronic obstructive pulmonary disease(15.0%) and chronic kidney disease(11.7%), and etc. The most common sources of infection are lower respiratory tract, which is 91 cases(75.8%), followed by blood in 14 cases(11.7%), skin and soft tissue (gangrene) in 6 cases(5.0%), and etc. The most common symptoms included abdominal distention or pain (100%), loss of appetite and nausea (96.7%), constipation (80.0%), and etc. The most comme TCM syndrome in 120 cases are 32 cases (26.7%) of "Deficiency of Qi and Yin with intermingled phlegm and blood stagnation",17 cases (14.2%) of "Qi deficiency",16 cases (13.3%) of "phlegm-heat retention in lung".2 Gastrointestinal function2.1 Efficacy analysis72 hours after treatment, in the control group,4 cases were markedly effective,24 cases effective, and 32 cases ineffective, with a total effective rate of 46.7%; in the treatment group,12 cases were markedly effective,24 cases effective and 24 cases ineffective, with a total effective rate of 60.0%. Chi-square test showed no significant difference on the total effective rate between the two groups (P>0.05).7 days after treatment,4 cases in the control group were markedly effective,28 cases effective and 28 cases ineffective, with a total effective rate of 53.3%; 10 cases in the treatment group were markedly effective,35 cases effective and 15 cases ineffective, with a total effective rate of 75.0%. Chi-square test showed significant difference on the total effective rate between the two groups (P＜0.05).2.2 Comparison of abdominal circumferenceChanges of abdominal circumference in the treatment group were significant difference (F= 122.936, P= 0.000), while in the control group no statistically significance was observed.Difference between the two groups was statistically significant (F= 4.105, P= 0.045).2.3Comparison of abdominal pressureChanges of Abdominal pressure before and after treatment were statistically significant in both groups respectively (control group F= 4.686, P= 0.011, the treatment group F= 199.431, P= 0.000). Difference between the two groups was statistically significant (F= 23.667, P= 0.000).2.4 Comparison of bowel soundsChange of bowel sounds before and after treatment were statistically significant in both groups (control group F= 12.029, P= 0.000, treatment group F= 187.408, P= 0.000). Differences between the two groups were statistically significant (F= 29.527, P= 0.000).2.5 Comparison of serum diamine oxidase (DAO)Changes of serum DAO were statistically significant in both groups (control group F= 6.811, P= 0.002, treatment group F= 40.089, P= 0.000). The difference between groups was statistically significant (F= 19.001, P= 0.000).2.6 Comparison of plasma motilin (MTL)Changes of MTL in the treatment group was statistically significant (F= 9.986, P = 0.000), while the control group showed no significant difference. The difference between groups was statistically significant (F= 2.562, P= 0.112).2.7 Comparison of vasoactive peptide (VIP)Changes of VIP in the treatment group was statistically significant (F= 3.290, P= 0.041), while the control group showed no significant difference. The difference between groups was not statistically significant (F= 0.146, P= 0.703).2.8 Comparison of secretory IgA (sIgA)The differences of the SIgA level before and after treatment were not statistically significant in both groups (control group:F= 1.229, P= 0.296, treatment group:F= 1.534, P= 0.222). The difference between groups was not statistically significant (F= 0.921, P= 0.339).3 Inflammation and coagulation3.1 Comparison of leukocyte and neutrophil ratioChanges of leukocyte before and after treatment in both groups were statistically significant (control group F= 3.687, P= 0.028, treatment group F= 4.782, P= 0.017). Difference between the two groups was not statistically significant (F= 0.299, P= 0.655). Change of the neutrophil ratio(NEUT%) before and after treatment in both groups were statistically significant (control group F= 8.140, P= 0.000, the treatment group F= 6.756, P= 0.003). Difference between the two groups was not statistically significant (F= 0.581, P= 0.447).3.2 Comparison of platelet and fibrinogenThe differences of platelet before and after treatment in both groups were statistically significant (control group:F= 3.000, P= 0.070, treatment group:F= 1.637, P= 0.207). Comparison between the two groups showed no significant difference (F= 0.408, P= 0.524). The differences of fibrinogen before and after treatment in both groups were not statistically significant (control group:F= 3.304, P = 0.055, treatment group:F= 2.089, P= 0.134). The difference between groups was statistically significant (F= 5.700, P= 0.019).4 TCM syndrome scroe and curative effect judgement4.1 the change of TCM syndrome scroeThe changes of TCM syndrome score were significantly different in both groups (control group F= 14.2, P= 0.000, treatment group F= 119.08, P= 0.000). Differences between the two groups were statistically significant (F= 14.305, P= 0.000).4.2Curative effect judgement72h after treatment 0 cases in the control group was markedly effective,13 cases effective and 47 cases ineffective, total effective rate 21.7%; while 3 cases in treatment group was markedly effective,30 cases effective and 27 cases ineffective, total effective rate 55.0%. Chi-square test showed significant difference on the total effective rate between the two groups (P＜0.05).7 days after treatment,3 cases in the control group were markedly effective,23 cases effective,34 cases ineffective, and total effective rate 43.3%; while 14 cases in the treatment group were markedly effective,32 cases effective,14 cases ineffective, and total effective rate 76.7%. Chi-square test showed significant difference on the total effective rate between the two groups (P＜0.05).4.3Multiple linear correlation analysis of TCM syndrome score and the pathological mechanisms related indicatorsThe TCM syndrome scores 7d after treatment and MTL showed a significant negative correlation, with a constant of 12.328, P value of XMTL 0.002 and the correlation coefficient -0.084. The regression equation was Y= 12.328-0.084XMTL,4.4 Comparison of effecacy among main concomitant syndromesThe most common concomitant syndromes in this study being "deficiency of Qi and Yin with intermingled phlegm and blood stagnation", "deficiency of Qi and Yin", and "phlegm-heat retention in lung" took 12 cases,10 cases,12 cases in the treatment groups, respectively. After 72h treatment, in patients with "Deficiency of Qi and Yin with intermingled phlegm and blood stagnation" syndrome,6 cases were effective,6 cases ineffective and the efficiency was 50.0%; in patients with "deficiency of Qi and Yin" syndrome,4 cases were effective,6 cases ineffective and the efficiency was 40.0%; in patients with "phlegm-heat retention in lung" syndrome,7 cases were effective,5 cases ineffective and the efficiency was 58.3%; in patients with other syndromes 16 cases were effective,10 cases ineffective and the efficiency was 61.5%. Chi-square test showed no significant difference in efficiency among those patients (P = 0.675>0.05). After 7d of treatment, in patients with "Deficiency of Qi and Yin with intermingled phlegm and blood stagnation" syndrome,8 cases were effective,4 cases ineffective and the efficiency was 66.7%; in patients with "deficiency of Qi and Yin" syndrome,7 cases were effective,3 cases ineffective and the efficiency was 70.0%; in patients with "phlegm-heat retention in lung" syndrome,9 cases were effective,3 cases ineffective and the efficiency was 75.0%; in patients with other syndromes 22 cases were effective,4 cases ineffective and the efficiency was 84.6%. Chi-square test showed no significant difference in efficiency among those patients (P= 0.603>0.05).5 Follow-up AnalysisChi-square test showed that the total mortality between two groups had no significant difference (P>0.05). However, the mortality of the treatment group was lower than the control group. The difference of the average hospitalization days in ICU between the two groups were not statistically significant (P>0.05).ConclusionThe syndromes of simultaneous cold-heat and clearing qi-turbid substance is the key pathogenesis of gastrointestinal dysfunction in sepsis. The Xiaozhang Patch applying to Shenque point could ascend lucidity and descend turbidity, reconcile cold and heat, and promote the running of stomach and intestinal Qi. Xiaozhang Patch may significantly improve symptoms caused by "Qi stagnation in stomach and intestine", such as abdominal distension or pain, loss of appetite, nausea, constipation, chest distress, shortness of breath in sepsis patients with gastrointestinal disorders. It can effectively improve gastrointestinal hypoxia, increase gastrointestinal motility, thus reduce abdominal circumference, lower abdominal pressure and increase the bowel sounds. It is more effective, flexible and easy-to-use than oral prokinetic agents. |
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