Effects Of Zhishitongjiang Granules On The Recovery Of Gastrointestinal Function And The Prevention And Treatment Of Early Postoperative Inflammatory Intestinal Obstruction After Colorectal Neoplasms Surgery:a Double-center Prospective Study

Objective To investigate the effects of Zhishitongjiang granules on the recovery of gastrointestinal function,and the prevention and treatment of early postoperative inflammatory intestinal obstruction(EPIS)after colorectal neoplasms surgery,and evaluate its efficacy and safety.Methods A total of 200 selected patients who underwent colorectal neoplasms surgery were enrolled into the double-center prospective randomized double-blind controlled clinical trial from March 2016 to October 2013.Of the 200 patients,160 were from Hunan Cancer Hospital,40 were from Hunan Hospital of Chinese Medicine.All the patients were randomly into two groups(each group have 100 patients)at the ratio of 1:1 according to the random number table.Three patients who did not meet the criteria were excluded from the study.And then there were 98 patients in the test group and 99 patients in the control group.Zhishitongjiang granules(turn out to 50ml liquid)or placebos(50ml)were administered in the test group and control group at postoperative 6 and 12 hours.The time for the recovery of regular bowel sounds,the first exhaust and first defecation time,and the time of first solid food intake of the 2 groups were recorded.Blood and urinary routine test,hepatic and renal function test,electrocardiogram examination,record of adverse drug event and adverse reactions were carried out at postoperative day 5.And at the postoperative day 1,3,5,the level of procalcitonin(PCT)and white blood cell(WBC)(patients who received preoperative neoadjuvant chemoradiation were excluded)in blood were detected.Results In the median time of the recovery of regular bowel sounds,median time for first exhaust and defecation,the test group was shorter than the control group,there were significant differences between the 2 groups(P<0.01);4 patients had EPIS in the control group and 6 patients in the control group,all the 10 patients were accepted the normal treatment as gastrointestinal decompression and total parenteral nutrition,etc.the patients of test group were given Zhishitongjiang granules oral treatment additional.The number of cases in the experimental group was less than that in the control group,but there were no statistical significance between 2 groups(P>0.05);But on postoperative hospital stay,the test group was better than control group,the difference was statistically significant(P<0.05).Except EPIS,there were no statistically difference between the 2 groups on the adverse drug events and adverse reactions(P>0.05).The levels of PCT and WBC were gradual increased at Id and significant decreased at 3d in the 2 groups,at the time points of 5d,the WBC level of all patients were returned to control level and there were no statistically significant difference between the 2 groups.But at 5d,the level of PCT in the test group was distinguished lower than in the contrast group with statistical significance(P<0.05).Conclusion Zhishitongjiang granules significantly promote the recovery of gastrointestinal function and can prevent and treat the EPIS after colorectal neoplasms surgery certainly with relatively low adverse events.