Clinical Study Of Qingyi Lidan Mixture Enema To Prevent Pancreatitis And Hyperamylaseemia After ERCP

Objective:Prevention of complications after ERCP has become the focus of current research,especially for h prevention of PEP and PEH,reduce the incidence,alleviate postoperative abdominal pain.Many studies have confirmed that indomethacin can effectively prevent the occurrence of PEH and PEP,control the inflammatory reaction,decrease blood amylase activity,but for the patients with digestive diseases,particularly for patients with peptic ulcer or hemorrhage this drug also increases the risk of postoperative perforation,and the traditional Chinese medicine has unique advantages,not only can promote flow of qi to relieve pain,but also promote blood circulation to remove stasis,dredge gallbladder and eliminate stones,purge fuorgans to eliminate heat,the risk of gastrointestinal bleeding of western medicine was avoided.The method of non-inferiority test was used,and indomethacin recommended by guideline of ERCP in western medicine was used as control drug,This study was to evaluate the efficacy and safety of Qingyi Lidan mixture in preventing PEP and PEH,and to provide clinical evidence for its application in the future.Methods:The research subjects:in this study came from the hospitalized patients who received ERCP operation in endoscopy center of Dongfang Hospital,Beijing University of Traditional Chinese Medicine.60 cases were randomly divided into two groups group:the Chinese medicine group(n=31)and the western medicine group(n=29).Both groups were given 10 mg of anisodamine,50 mg of pethidine hydrochloride and 10 mg of diazepam by intramuscular injection,10ml of silicone oil by oral administration.The traditional Chinese medicine group was treated with Qingyi Lidan mixture 100ml retention enema for 30 min 2 hours before ERCP,western medicine group treated with 0.1g indomethacin suppository 2 hours before operation.Record the changes of serum amylase,CRP and procalcitonin before operation,4 hours after operation and 24 hours after operation,and record symptoms of abdominal pain,abdominal distension and vomiting.Evaluated the postoperative pain degree by VAS.Record the incidence of PEP and PEH,record the operation of ERCP,including the duration and times of biliary cannulation,the frequency of pancreatic duct cannulation,the duration of operation,the use of equipment,etc.The data were statistically analyzed by SPSS20.0 software.Results:1.There was no significant difference in the incidence of PEP and PEH between the traditional Chinese medicine group and the western medicine group(P>0.05).2.In terms of pain score,there was no significant difference in pain score between the two groups before operation,4 hours after operation and 24 hours after operation and the difference of pain scores before and after ERCP(P>0.05),but when compare the mean,the pain score of the Chinese medicine group at 24 hours after operation was 0.45±0.92,lower than that of the western medicine group(0.93±2.05).The mean value of abdominal pain score in the traditional Chinese medicine group decreased within 24 hours after operation,and the difference of abdominal pain score 24 hours after ERCP and before ERCP was less than 0,however,the mean of abdominal pain score in the western medicine group has been on an upward trend,which suggested that the traditional Chinese medicine group has a significant effect on relieving postoperative abdominal pain,especially at 24 hours after operation.3.The serum amylase level in the Chinese medicine group was significantly lower than that in the western medicine group at 24 hours after operation(P<0.05),and the serum amylase mean value in the traditional Chinese medicine group was significantly lower than that in the western medicine group at 4 hours or 24 hours after operation.When compare the differences of the serum amylase before and after ERCP,the difference in the traditional Chinese medicine group is smaller than that in the western medicine group.It is suggested that the Chinese medicine group can reduce the level of serum amylase after ERCP and accelerate the fall of serum amylase,especially at 24 hours after ERCP,the effect of reducing serum amylase level is better than that of western medicine group.4.There was no significant difference between the Chinese medicine group and the western medicine group for related inflammatory infacors.But,when compare the mean value of each time point and the difference before and after operation,the level of CRP or PCT at 24 hours after operation of the traditional Chinese medicine group was significantly decreased.Conclusion:1.The efficacy of traditional Chinese medicine in the prevention of PEP and PEH is similar to that of the control drug indomethacin.2.Qingyi Lidan mixture can reduce the incidence of PEP and PEH,relieve abdominal pain at 24 hours after operation lower the level of serum amylase in a certain range than western medicine,alleviate the inflammatory reaction,and reduce postoperative costs.It is suggested that Chinese herbal medicine has some advantages in alleviating the early abdominal pain after ERCP.3.There was no obvious adverse reaction in clinical application of Qingyi lidan mixture,which avoided the side effects of western medicine and was safe to use.