Therapeutic efficacy evaluation of the reference drug ursodeoxycholic acid and its analogues in the biliary sludge dissolution: a meta-analysis
Aim. To compare the therapeutic efficacy of the reference drug ursodoxycholic acid (UDCA) for Russian Federation (Ursofalk) and generic UDCA preparations of other manufacturers in the solution of biliary sludge (BS). Materials and methods. The search for studies was carried out in the electronic...
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| Format: | Article |
| Language: | Russian |
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ZAO "Consilium Medicum"
2023-02-01
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| Series: | Consilium Medicum |
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| Online Access: | https://consilium.orscience.ru/2075-1753/article/viewFile/111183/85627 |
| _version_ | 1828009812493860864 |
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| author | Yury A. Kucheryavyy Sergei V. Cheremushkin |
| author_facet | Yury A. Kucheryavyy Sergei V. Cheremushkin |
| author_sort | Yury A. Kucheryavyy |
| collection | DOAJ |
| description | Aim. To compare the therapeutic efficacy of the reference drug ursodoxycholic acid (UDCA) for Russian Federation (Ursofalk) and generic UDCA preparations of other manufacturers in the solution of biliary sludge (BS).
Materials and methods. The search for studies was carried out in the electronic databases MEDLINE/PubMed, EMBASE, Cochrane, Russian Science Citation Index (RSCI) until February 2022. Inclusion criteria for the meta-analysis were controlled trials, trials using the reference drug for RF Ursofalk in one of the groups, diagnosis and subsequent assessment of the dynamics of resolution of BS according to transabdominal ultrasound, the absence of simultaneous use of other therapy that could affect therapeutic outcomes, a documented endpoint, which reflects the percentage of the total resolution of the BS in each of the compared groups.
Results. The final analysis included 6 studies involving 671 patients with BS (324 with Ursophalc, 347 with other UDCA). When using any UDCA preparations, the generalized frequency of BS dissolution within 3 months was 52.010% (95% confidence interval CI 36.55467.272; I2=94.07%), and after 6 months 78.204% (95% CI 67.84087.024; I2=86.90%). When using the RF reference drug Ursofalk, the generalized frequency of dissolution of BS during 3 months of therapy was 64.826% (95% CI 49.24278.941; I2=87.53%), while when using other UDCA drugs it was 39.187% (95% CI 17.52063.390; I2=95.24%). Ursofalk was more effective than other UDCA preparations (odds ratio OR 3.183; 95% CI 1.495-6.777; I2=74.52%). A similar trend persisted when evaluating the effectiveness of a 6-month course of therapy (OR 4.614; 95% CI 2.8817.388; I2=26.41%). Thus, the generalized frequency of dissolution of BS in the Ursofalk groups was 88.381% (95% CI 80.89094.198; I2=64.98%), and for other UDCA drugs 65.978% (95% CI 60.12571.491; I2=43.22%).
Conclusion. This meta-analysis demonstrated that the reference drug UDCA for RF (Ursofalk) is more effective than generic UDCA drugs from other manufacturers in diluting BS. |
| first_indexed | 2024-04-10T08:45:24Z |
| format | Article |
| id | doaj.art-054c1e8cbe84407696ace99e275a7c77 |
| institution | Directory Open Access Journal |
| issn | 2075-1753 2542-2170 |
| language | Russian |
| last_indexed | 2024-04-10T08:45:24Z |
| publishDate | 2023-02-01 |
| publisher | ZAO "Consilium Medicum" |
| record_format | Article |
| series | Consilium Medicum |
| spelling | doaj.art-054c1e8cbe84407696ace99e275a7c772023-02-22T08:42:52ZrusZAO "Consilium Medicum"Consilium Medicum2075-17532542-21702023-02-01241286086410.26442/20751753.2022.12.2014294647Therapeutic efficacy evaluation of the reference drug ursodeoxycholic acid and its analogues in the biliary sludge dissolution: a meta-analysisYury A. Kucheryavyy0https://orcid.org/0000-0001-7760-2091Sergei V. Cheremushkin1https://orcid.org/0000-0002-0982-2006Ilyinskaya HospitalYevdokimov Moscow State University of Medicine and DentistryAim. To compare the therapeutic efficacy of the reference drug ursodoxycholic acid (UDCA) for Russian Federation (Ursofalk) and generic UDCA preparations of other manufacturers in the solution of biliary sludge (BS). Materials and methods. The search for studies was carried out in the electronic databases MEDLINE/PubMed, EMBASE, Cochrane, Russian Science Citation Index (RSCI) until February 2022. Inclusion criteria for the meta-analysis were controlled trials, trials using the reference drug for RF Ursofalk in one of the groups, diagnosis and subsequent assessment of the dynamics of resolution of BS according to transabdominal ultrasound, the absence of simultaneous use of other therapy that could affect therapeutic outcomes, a documented endpoint, which reflects the percentage of the total resolution of the BS in each of the compared groups. Results. The final analysis included 6 studies involving 671 patients with BS (324 with Ursophalc, 347 with other UDCA). When using any UDCA preparations, the generalized frequency of BS dissolution within 3 months was 52.010% (95% confidence interval CI 36.55467.272; I2=94.07%), and after 6 months 78.204% (95% CI 67.84087.024; I2=86.90%). When using the RF reference drug Ursofalk, the generalized frequency of dissolution of BS during 3 months of therapy was 64.826% (95% CI 49.24278.941; I2=87.53%), while when using other UDCA drugs it was 39.187% (95% CI 17.52063.390; I2=95.24%). Ursofalk was more effective than other UDCA preparations (odds ratio OR 3.183; 95% CI 1.495-6.777; I2=74.52%). A similar trend persisted when evaluating the effectiveness of a 6-month course of therapy (OR 4.614; 95% CI 2.8817.388; I2=26.41%). Thus, the generalized frequency of dissolution of BS in the Ursofalk groups was 88.381% (95% CI 80.89094.198; I2=64.98%), and for other UDCA drugs 65.978% (95% CI 60.12571.491; I2=43.22%). Conclusion. This meta-analysis demonstrated that the reference drug UDCA for RF (Ursofalk) is more effective than generic UDCA drugs from other manufacturers in diluting BS.https://consilium.orscience.ru/2075-1753/article/viewFile/111183/85627biliary sludgecholelithiasischolelithiasisursodeoxycholic acidursofalk |
| spellingShingle | Yury A. Kucheryavyy Sergei V. Cheremushkin Therapeutic efficacy evaluation of the reference drug ursodeoxycholic acid and its analogues in the biliary sludge dissolution: a meta-analysis Consilium Medicum biliary sludge cholelithiasis cholelithiasis ursodeoxycholic acid ursofalk |
| title | Therapeutic efficacy evaluation of the reference drug ursodeoxycholic acid and its analogues in the biliary sludge dissolution: a meta-analysis |
| title_full | Therapeutic efficacy evaluation of the reference drug ursodeoxycholic acid and its analogues in the biliary sludge dissolution: a meta-analysis |
| title_fullStr | Therapeutic efficacy evaluation of the reference drug ursodeoxycholic acid and its analogues in the biliary sludge dissolution: a meta-analysis |
| title_full_unstemmed | Therapeutic efficacy evaluation of the reference drug ursodeoxycholic acid and its analogues in the biliary sludge dissolution: a meta-analysis |
| title_short | Therapeutic efficacy evaluation of the reference drug ursodeoxycholic acid and its analogues in the biliary sludge dissolution: a meta-analysis |
| title_sort | therapeutic efficacy evaluation of the reference drug ursodeoxycholic acid and its analogues in the biliary sludge dissolution a meta analysis |
| topic | biliary sludge cholelithiasis cholelithiasis ursodeoxycholic acid ursofalk |
| url | https://consilium.orscience.ru/2075-1753/article/viewFile/111183/85627 |
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