Hymecromone Administration in Real Clinical Practice: Results of the Prospective Multicentre Observational Study in the Republic of Kazakhstan

Introduction. This multicentre prospective non-interventional observational study was conducted to obtain additional data about Odeston efficacy and safety in routine clinical practice. The objectives of the study included collection of clinical characteristics of patients, evaluation of Odeston effects in treatment of biliary pain and changes in the gallbladder emptying, evaluation of compliance to therapy, and treatment effect satisfaction.Materials and methods. The study was conducted from July 2020 to April 2021 at the premises of 60 study sites in 4 cities of the Republic of Kazakhstan. Patients having indications for Odeston administration according to the patient leaflet were enrolled. The study included 2 patient visits and an intermediate telephone contact. A visual analogue scale and RAPID questionnaire were used to characterise biliary pain; severity of associated symptoms, bowel habit and a quality of life according the SF-12 were also assessed. A rate of a ≥50 % reduction in symptom severity was used as a primary efficacy criterion; a rate of a ≥10 improvement in the SF-12 quality of life score was used as a secondary efficacy criterion. Compliance to treatment was evaluated using a number of days on Odeston. Treatment satisfaction was assessed using 5 grades.Results. 877 patients, 68.2 % of females and 31.8 % of males, were included in the study; the mean age was 46.0 ± 14.9 years. Primary functional biliary disorder was diagnosed in 65.3 % of patients, chronic non-calculous cholecystitis — 51.4 %, uncomplicated gallbladder disease — in 8.9 %, biliary sludge — 38.4 %, sphincter of Oddi functional disorder — 5.3 % of patients. A dose of Odeston was prescribed at the discretion of the physician. Group A patients received 600 mg (n = 89), group B received 1200 mg of Odeston a day (n = 788). In group B, an incidence of pronounced pain interference with daily living activities was higher. In both groups, the mean VAS scores were reduced to 1 point on treatment, a primary efficacy criterion was achieved in 77.3 % of patients in group A and in 79.8 % of patients in group B, р < 0.05. In both groups, a reduction in the incidence of constipation and diarrhea (р < 0,001) and an increase in the mean scores of physical and mental functioning were noted (р < 0.001, though a secondary efficacy criterion was not achieved (a ≥10 change in the SF-12 score). A prevalence of ultrasonographic sings of biliary sludge was reduced, and an increased gallbladder emptying was observed (p < 0.001). 77.4 % of patients in a total group of patients reported about drug administration for 21 days. A number of patients who were completely satisfied with treatment was higher in group B (p = 0.027).Conclusions. It was found that biliary pain interfered with daily living activities and commonly accompanied by other symptoms of gastrointestinal dysmotility. Odeston effectively reduces the severity of biliary pain, corrects dyspeptic disorders and normalizes stool pattern in patients with functional and organic diseases of the biliary system. Treatment satisfaction was higher with a dose of 1200 mg a day, particularly in more pronounced interference of pain with daily living activities.

Therapeutic physical factors in restorative treatment of patients with nonalcoholic steatohepatitis combined with biliary sludge

Purpose of the study. To study the effectiveness of restorative treatment of patients with nonalcoholic steatohepatitis in combination with biliary sludge at the inpatient stage when low-mineralized mineral water and preformed peloid therapy are included in the basic scheme. Material and methods. A total of 119 patients with nonalcoholic steatohepatitis in combination with biliary sludge were observed and distributed into 3 randomized groups: in the main group, 39 patients received basic drug therapy in accordance with the Federal Clinical Recommendations, «Sernovodskaya» mineral water for ingestion and in the form of gallbladder cleanse, and preformed application peloid therapy; in the comparison group, 40people received only pharmacotherapy and balneotherapy, in the control group — pharmacotherapy. The control of the effectiveness of the treatment was carried out according to the dynamics of clinical, biochemical and functional studies. Results. The inclusion of medium-mineralized mineral water «Sernovodskaya» in the form of drinking treatment and cleanse and preformed peloid therapy in the complex of therapeutic measures for patients provides a significant decrease in the intensity of clinical manifestations by 54.4% versus 40% with the use of pharmaco- and balneotherapy and 28,8% — with only drug therapy; cytolysis and cholestasis syndromes — by 46,2; 39,8 and 28.9%, respectively. Restoration of the contractile function of the gallbladder is observed in 78,8% of cases versus 65.6% when using only pharmacotherapy. The duration of hospitalization in the main group was reduced by 3 days, and in the comparison group — by 1,5 days, compared with the indicators in the control group. Conclusion. The developed new medical technology for the treatment of patients with nonalcoholic steatohepatitis in combination with biliary sludge with the combined use of mineral waters and preformed peloid preparations against the background of basic pharmacotherapy at the inpatient stage provides a significant increase in the efficiency of therapeutic measures.

Rational pharmacotherapy in modern gastroenterology

Introduction. Modern gastroenterology is characterized by the combined (comorbid) nature of the diseases. In treatment, this promotes polypharmacy and increases complications (drug lesions, allergic reactions, exacerbation of diseases of other organs and systems), and, importantly, increases the cost of pharmacotherapy.Aim. To compare two pharmacotherapy options for patients with gallstone disease at the stage of biliary sludge and patients with biliary sludge combined with irritable bowel syndrome.Materials and methods. In the work, based on the experience of treating 170 patients, two options for pharmacotherapy are considered, which may well turn out to be rational in all respects. Option 1 - monotherapy aimed at one of the components that form a complex pathogenetic symptom complex. The basis for offering this treatment option is the biological concept of the “regulatory cascade”. Option 2 – “stepwise” (stepwise) therapy with the choice of the “base” drug for the first step. Evaluation of the effectiveness and rational correction for the second step of treatment and subsequent ones – if necessary. Results. The biliary sludge was eliminated or reduced in patients who received the UDCA monotherapy against the background of recovery of gastrointestinal motility. The overall treatment effect (for each nosology) in patients with biliary sludge and irritable bowel syndrome using the complex therapy (UDCA and mebeverin) was 84 and 87.8% respectively.Conclusions. Both options are rational today: 1st requires further study; 2nd – active use. Both options exclude polypharmacy and other adverse effects.

Calcium bilirubinate sludge causes early onset of congenital biliary dilatation: a report of two cases

Background Symptomatic congenital biliary dilatation (CBD) during early infancy is always characterized by cystic dilation of the common bile duct with a narrow segment connecting the pancreatic duct. Case presentation In two consecutive infants with a prenatal diagnosis of CBD, we found that biliary sludge had formed in the cyst upon the appearance of symptoms including acholic stool and hypertransaminasemia. Infrared absorption spectrometry revealed that the sludge consisted of calcium bilirubinate. Conclusion We suggest that overproduction of bilirubin by neonatal hemolysis causes sedimentation of bilirubin calcium, resulting in obstruction of the narrow segment and development of symptoms.

Biliary sludge: pathogenesis, etiology and drug therapy

Aim. To evaluate the effectiveness of the use of ursodeoxycholic acid (UDCA) for the treatment of biliary sludge (BS) and to compare the therapeutic effectiveness of the German substance UDCA and generic drugs from other manufacturers. Materials and methods. The study involved 65 patients diagnosed with BS (K80.8). To assess the severity of BS, ultrasound of the gallbladder was performed before treatment, after 1, 3, 6 months during therapy, as well as an assessment of its contractility. All patients were randomized into 2 groups. Patients of the main group received UDCA Ursofalk (Germany) at a dose of 10 mg/kg for at least 6 months. Patients in the comparison group received UDCA (another manufacturer) at a dose of 10 mg/kg for at least 6 months. Results. After 3 months of follow-up, the number of patients with dissolved sludge in the main group was 87.1%, while in the comparison group 50%. In 71% of patients, the normalization of the lean volume of the gallbladder was noted, and in the comparison group only in 47.1%. After 6 months of follow-up, complete resolution of BS in the main group was observed in 93.5% of cases, and in the comparison group in 73.6% of cases. Conclusion. As a result of the study, the high effectiveness of Ursofalk during oral litolysis in patients with stage I GI (BS) in the first 3 months of therapy, as well as the normalization of the contractile function of the gallbladder, were noted.

Biliary slage as a stage of gallstone disease: the successes and difficulties of treatment

Introduction. The high prevalence rates of biliary sludge and its frequent development into the stone stage of cholelithiasis constitute grounds for studying this issue, as the effective action on biliary sludge can prevent overall disease progression.Purpose of the study. To determine the options for diagnosis of biliary sludge in the polyclinic settings. Objectives: 1) Estimate the frequency of diagnosis of biliary sludge. 2) Assess the features and dependence of treatment on the type of biliary sludge. 3) Assess the outcome of treatment depending on the follow-up managing of patients. 4) Propose an algorithm for managing patients after biliary sludge has been diagnosed.Materials and methods. In the work used data of the clinics of the President of the Russian Federation. The total number of people surveyed for 1 year was 1.117. These patients underwent an ultrasound examination (dispensation) and 218 were fitted with biliary sludge (BS), which was 19.4%. Of the 70 patients with BS, 4 groups were formed: 1st group (20 patients) with BS type, 2nd (20 patients) – with BS type, 3rd (20 patients) – with BS type, 4th (10 patients) – with BS-type (BSS) type.All patients received Exchhol therapy at the rate of 15 mg/kg of weight; patients with a pronounced spastic component in the sphincter system – myotropic spasmolytic Sparex (20 mg x 2 times a day); patients of the 4th group (with a near-located sediment indicating the presence of inflammation) – Adisord (derived nitrofuran) 200 mg x 4 times a day (5 days).Results. The type of precipitation was cupped in 4 weeks of treatment; Type – for 8–12 weeks of treatment, type V – for 13–14 weeks.Conclusions. The presented data allow us to hope that early diagnosis of biliary sludge and the factors of its development will help start timely treatment and prevention of the disease.