Clinical Studies Of Simotang Oral Solution To The Impact Of Gynecological Laparotomy Postoperative Gastrointestinal Motor Function

Objectives:Explore clinical effect and safety of Simotang oral solution on gynecological laparotomy postoperative gastrointestinal motor function.Methods:This trial adopt randomized, double-blind, placebo-controlled, prospective study, and a study of145cases of gynecological laparotomy postoperative was completed, in which Simotang oral solution treatment group was79cases, the placebo control group was66cases. Both groups were forbidden to drinking and eating after operation for6hours and with conventional treatment. At the first postoperative day, treatment group was treated with Simotang oral solution, the control group was treated with simulated Simotang oral solution, by the treatment volume20ml, three times a day, once every3days. Visit postoperative patients with body check and record vital sign, time of first bowel sound, time of first passage of flatus, time of first defecation, nausea, vomiting and abdominal distension, quality life scores, indicators of safety, adverse reactions, complications and so on. The clinical data of the two groups were compared after statistical analysis.Results:1. Clinical effect of Simotang oral solution on gynecological laparotomy postoperative gastrointestinal motor function was compared in Simotang oral solution treatment group and the placebo control group, using paired-t tset. Time of the first bowel sound’s recovery in the treatment group was26.29±9.85hrs, time of the first bowel sound’s recovery in the control group was35.02±16.20hrs (P<0.001); time of first passage of flatus in the treatment group was43.47±13.73hrs, time of first passage of flatus in the control group was50.79±15.53hrs (P<0.05); time of first defecation in the treatment group was49.99±13.02hrs, time of first defecation in the control group was57.89±14.75hrs(P＜.05), all were statistically significant. Compared the impact of increasing gastrointestinal motor function, using chi-square test, the total effective rate in the treatment group was67.09%, markedly effective rate in the treatment group was12.66%; the total effective rate in the control group was42.42%, markedly effective rate in the control group was3.03%, using the statistical analysis,.P<0.05, on the promotion of gastrointestinal movement, treatment group being superior to control group.2. Gynecological laparotomy postoperative quality life scores were compared in Simotang oral solution treatment group and the placebo control group, using paired-t tset. Quality life scores of the first day after operation in the treatment group was40.33±12.51, in the control group was38.18±11.54, and P>0.05, with no statistical significant and they were comparable. Quality life scores of the forth day after operation in the treatment group was18.39±8.78, Quality life scores of the forth day after operation in the control group was26.94±12.89,P<0.001; compared the quality life scores of the first day and the forth day after operation in the treatment group, P<0.001; compared the quality life scores of the first day and the forth day after operation in the control group, P<0.001; they are all statistical significant, proving that Simotang oral solution can effectively improve gynecological laparotomy postoperative quality life. These hint that Simotang oral solution can improve appetite, bloating, sleep after gynecological laparotomy with obvious effective, but with no obvious improvement in nausea and vomiting after gynecological laparotomy.3. Gynecological laparotomy postoperative medication safety was compared in Simotang oral solution treatment group and the placebo control group, using chi-square test. Adverse reaction rate was3.797%in the treatment group, and2.941%in the control group, all were mild-moderate adverse reactions, such as abdominal pain, nausea, diarrhea(P>0.05), with no statistical significant. The safety indicators, liver and kidney function, ECG, blood, urine, stool routine examination, with no abnormal changes, and no complication occurred.Conclusions:1. Simotang oral solution can effectively promote gynecological laparotomy postoperative recovery of gastrointestinal motor function, reduce the degree of postoperative abdominal distension, in favor of early feeding, to reduce the fluid volume.2. Simotang oral solution can effectively improve gynecological laparotomy postoperative quality life of patients, alleviate the suffering.3. Use of Simotang oral solution after gynecological laparotomy was safe, no significant clinical side effects.