| Chapter 1 A retrospective analysis of the effect of ulinastatin on the clinical outcome of patients undergoing laparoscopic colectomy.Objectives:The purpose of this study was to investigate the effect of preoperative intravenous infusion of ulinastatin 500 000 units on the postoperative clinical outcomes of patients undergoing elective laparoscopic colon cancer resection.Methods:1.General Information:This study included 454 patients undergoing elective laparoscopic radical resection of colon cancer from January 2015 to September 2017 in our hospital.there were 278 males and 176 females,aged 25-87 years,with an average age of 57.08 Years old,ASA grading ?-? level,heart function grading 1-3 level.According to whether Ulinastatin was prescribed,all patients were divided into two groups:ulinastatin group(259 cases)and control group(195 cases).Using propensity score matching to balance the Preoperative basic information,surgical approaches,intraoperative management and other baseline levels between two groups.As a result,each 155 cases of two groups were successfully matched.After matching,there was no significant difference in preoperative indexes between the two groups.2.Clinical indicators:Collecting date of clinical indicators from preoperative baseline and postoperative three days and analyzing:(1)Inflammatory indexes:white blood cell counts(WBC),C-reactive protein(CRP),procalcitonin(PCT);(2)liver function indicators:alanine aminotransferase,aspartate aminotransferase,total bilirubin;(3)renal function indicators:serum creatinine,blood urea nitrogen;(4)postoperative hospital length of stay.3.Statistical Analysis:IBM SPSS 22.0 statistical software was used for statistical analysis.Because the research design was two-way repeated measures,there are quite a few missing values and significant correlation between the measured values before and after the surgery.Therefore,the mixed linear fixed effects model was used to compare the effect of preoperative intravenous infusion of 500,000 IU ulinastatin on the different clinical indicators postoperatively.Results:1.General Information:There were a total of 454 patients included pre-match,with 278 males and 176 females,aged 25-87 years,with an average age of 57.08 years.The ASA grade ?-? and the heart function grade 1-3.Age,anesthesia methods,intraoperative fluid volume were significantly different between two groups.To reduce the selection bias,we used propensity score matching method to balance between various confounding factors within the two groups.After matching,155 patients of each groups were successfully matched.The general information and the clinical indicators of the baseline level showed no significant difference(P>0.05).2.Inflammatory index:The fixed effect model of mixed linear model was applied to exam the effect of ulinastatin.The results showed that lower WBC counts and CRP levels in the ulinastatin groups than that of the control group(P=0.036 and 0.025,respectively).PCT showed no significant difference between the two groups.Further analysis of the fixed-effect coefficients of WBC counts and CRP found in ulinastatin can reduce the WBC counts with 1.04×109/L and CRP level 23.93mg/L respectively,which was 11.1%and 29.9%lower than that of the control group respectively.Moreover,the ulinastatin factor had no interaction with time factor(P>0.05).3.Liver and renal function indicators:Transaminase,total bilirubin,serum creatine and blood urea nitrogen level were all within the normal range and not significantly different between the two groups(P>0.05)4.Postoperative length of stay:the average postoperative length of stay in the ulinastatin group was 7.55 ± 2.98 days and was 7.33±2.87 days in the control group.There was no significant difference between the two groups(P>0.05).Conclusions:we used propensity score matching and did a retrospective analysis.The results showed that ulinastatin can reduce the overall postoperative inflammation response in patients undergoing elective laparoscopic colectomy.Ulinastatin can reduce the postoperative white blood cell counts and C-reactive protein level with no effect on the liver function,kidney function and postoperative hospital length of stay.Chapter two A prospective observation of the postoperative anti-inflammatory effect of the ulinastatin.Objectives:To further validate the conclusions drawn from the previous retrospective study by prospective observation.At the same time,to observe the postoperative early recovery quality of gastrointestinal function and the incidence of complications in patients underwent laparoscopic colon resection to illustrate the role of ulinastatin of enhancing early recovery after surgery.Methods:1.General information:this study included 80 patients from October 2017 to January 2018 in our hospital undergoing elective laparoscopic radical resection,with ASA grading ?-?,NYHA heart function grading 1-2.80 patients were Randomly divided into ulinastatin group(40 cases)and control group(40 cases).2.Anesthesia management:Patients were prepared with routine preoperatively.All patients required general anesthesia with Total intravenous anesthesia technique.After initial induction and stabilization,patients in the ulinastatin group were given a dose of 10 000/kg body weight ulinastatin intravenously before surgery,while 100ml normal saline were given in the control group.Anesthesia maintenance were using target-controlled infusing of propofol,Cisatracurium and sufentanyl were given to meet of surgical needs.Vital signs were monitored during the surgery.Blood pressure was maintained above 90/60mmHg and remain within 20%of basal blood pressure.Intraoperative warm-up techniques were used to keep the nasopharyngeal temperature no lower than 36?.Patients received Patients Controlled Intravenous Analgesia postoperative with the formulation sufentanyl 2?g/kg+flurbiprofen 2mg/kg+tropisetron mesylate 8.96mg+normal saline diluted to 200ml.Background dose was 3mg/h,additional dose was 3ml,locking time was 15 minutes,maintaining VAS<3.3.Clinical observation:Collect and observe various clinical indicators of the two groups of patients in the preoperative(TO),the first day after surgery(T1),the second day after surgery(T2)and the third day after surgery(T3):(1)inflammation indicators:white blood cell count(WBC),C-reactive protein(CRP);(2)ulinastatin drug-related side effects;(3)the occurrence of complications during hospitalization,how they were treated and final outcomes;(4)Early recovery of gastrointestinal function,the first time of flatus and defecation time was recorded and analyzed.4.Statistical Analysis:IBM SPSS 22.0 statistical software(Chicago,IL,USA)was used for statistical analysis.Continuous variables are expressed as mean ±standard deviation(x±s),and categorical variables are expressed as counts or percentages.Independent samples t-test was used to compare the observation indexes and the chi-square test was used to compare the qualitative data.P<0.05 indicates the difference was statistically significant.Results:1.General information:80 patients from October 2017 to January 2018 were included in this study,with 52 males and 28 females,with an average age 53.41±12.2 78 years old and mean weight 61.77±10.36kg.Age,sex,height,weight,ASA grades,NYHA grades,surgical approaches,total surgery duration and intraoperative fluid volume were compared,which revealed no significantly difference between the two groups(P>0.05).2.Inflammation indicators:WBC counts and CRP in two groups at TO time showed no significant difference(P>0.05).The postoperative WBC counts and CRP levels were significantly higher than TO and peaked at the T2,which gradually decreased from T3.WBC counts and CRP level in the ulinastatin group were significantly lower than those in the control group at T1 and T2 time(P<0.05),and there was no significant difference between the two groups at T3 time(P>0.05).3.Postoperative length of hospital stay and Early postoperative gastrointestinal function recovery:The average postoperative hospital stay in the ulinastatin group and control group were 6.35±1.981 days and 6.33±2.379 days respectively,which showed no significant difference between the two groups(P=0.959).In the ulinastatin group,the first postoperative flatus time was 1.81±0.79 days,0.51 days earlier than the control group(P=0.017).The first postoperative defecation time in the ulinastatin group was 2.39±1.08 days,0.55 days earlier than that in the control group(P=0.044).The statistical analysis showed that the postoperative gastrointestinal function of patients in ulinastatin group recovered earlier than control group.4.Perioperative complications:All patients during anesthesia had stable vital signs,blood pressure fluctuations were within 20%of the baseline blood pressure.No intraoperative prolonged severe hypotension and hypoxemia occurred.Operation went smoothly with no intraoperative complications occurring,including tumor rupture,vascular injury and unintentional injuries.Ulinastatin related side effects such as anaphylaxis,cytopenias,eosinophilia,phlebitis were not observed during hospitalization in patients receiving ulinastatin.23 cases of postoperative complications were observed,with 17 cases in control group and 6 cases in ulinastatin group.In control group,there were 7 cases of surgical sites infection,4 cases of postoperative bleeding,2 cases of anastomotic leakage,2 cases of urinary retention and 1 case of pulmonary infection.While in ulinastatin group,there were 5 cases of surgical sits infection and 1 case of postoperative bleeding(P=0.034).There was a statistically significant difference in postoperative grade ?complications between the two groups.All patients were finally cured and discharged without any deaths or readmission 30 days after surgery.Conclusion:Ulinastatin can reduce postoperative inflammation response in patients undergoing laparoscopic radical resection of colon cancer,enhance the recovery of early postoperative gastrointestinal function,reduce postoperative complications and improve the quality of postoperative recovery. |
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