Pinaverium Bromide in Post-cholecystectomy Sphincter of Oddi Dysfunction

1.1 Background (I) 1.1.1 10%\~50% of the patients who previously underwent cholecystectomy experience recurrent abdominal pain with or without diarrhea, abdominal distention, enzymatic changes, etc., and sphincter of Oddi dysfunction (SOD) accounts for about 13% of such cases; 1.1.2 Sphincter of Oddi dysfunction (SOD): * It refers to biliary kinetic abnormality of the sphincter of Oddi (SO), often accompanied by pain, hepatic and pancreatic enzyme elevation, common bile duct (CBD) dilation or onset of pancreatitis. * Pain caused by SOD affects the quality of life (QoL). 1.1.3 The diagnosis of SOD is still being disputed, and there has been no optimal solution so far. * The diagnosis of SOD is largely based on clinical judgment * The gold standards ERCP and SOM are invasive diagnostic criteria 1.2 Background (II) 1.2.1 If biliary-type abdominal pain after cholecystectomy is considered as SOD, most of the patients are classified as SOD II and SOD III according to Rome III Criteria-modified. Biliary SOD Type I: moderate or severe biliary-type abdominal pain; transient ALT / AST/ALP elevation \> 2ULN; CBD dilation \> 8mm as evidenced by ultrasound or other non-invasive examination Type II: biliary-type abdominal pain; One or two of above items Type III:only biliary-type abdominal pain 1.3 Background (III) 1.3.1 Treatment of SOD is being disputed: currently, the main method is to relax sphincter of Oddi (SO). * Medications: antispasmodic drugs, nitrates, calcium ion antagonists, modulators of gastrointestinal (GI) motility * EST(endoscopic sphincterotomy): postoperative complications and mortality 1.3.2 EST is not well effective in the treatment of SOD type II and type III, which are mostly caused by functional abnormalities -ASGE guideline 2015 points out that EST is not recommended for patients with SOD type III. Endoscopic stents are not recommended, either. 1.3.3 Danshu Capsules: contains the active pharmaceutical ingredient (API) and has the effects of fighting infection, alleviating pain, promoting bile secretion and lifting muscle spasms; literature showed that Danshu Capsules effectively improved the symptoms of biliary disorders, such as pain, nausea and abdominal distension. 1.3.4 Pinaverium Bromide: able to improve the spasms of SO; literature showed that it treated biliary disorders effectively.·10%\~50% of the patients who previously underwent cholecystectomy experience recurrent abdominal pain with or without diarrhea, abdominal distention, enzymatic changes, etc., and sphincter of Oddi dysfunction (SOD) accounts for about 13% of such cases.