Efficacy and safety of bicyclol for treating patients with idiosyncratic acute drug‐induced liver injury: A multicenter, randomized, phase II trial
Background and Aims Evidence for using bicyclol in drug‐induced liver injury (DILI) is limited. This study aimed to explore the efficacy and safety of bicyclol in acute DILI. Methods This was a multicenter, randomized, double‐blinded, double‐dummy, active‐controlled, superiority and phase II trial....
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| Veröffentlicht in: | Liver international 2022-08, Vol.42 (8), p.1803-1813 |
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| creator | Tang, Jieting Gu, Jin Chu, Naihui Chen, Yu Wang, Yongliang Xue, Dongying Xie, Qing Li, Lei Mei, Zaoxian Wang, Xiaojin Li, Jun Chen, Jun Li, Yi Yang, Changqing Wang, Yingxin Shang, Jia Xie, Wen Hu, Peng Li, Dongliang Zhao, Limin Lan, Pei Wang, Chen Chen, Chengwei Mao, Yimin |
| description | Background and Aims
Evidence for using bicyclol in drug‐induced liver injury (DILI) is limited. This study aimed to explore the efficacy and safety of bicyclol in acute DILI.
Methods
This was a multicenter, randomized, double‐blinded, double‐dummy, active‐controlled, superiority and phase II trial. Patients with idiosyncratic acute DILI were randomized 1: 1:1 to low‐dose bicyclol (25 mg times a day [TID]), high‐dose bicyclol (50 mg TID) and polyene phosphatidylcholine (control) groups. The primary endpoint was the decrease from baseline in serum alanine aminotransferase (ALT) levels at post‐treatment for 4 weeks.
Results
Overall, 241 patients were included in the full analysis set, with 81, 82 and 78 patients in the low‐dose bicyclol, high‐dose bicyclol, and control groups respectively. ALT levels decreased across groups (−249.2 ± 151.1, −273.6 ± 203.1, and −180.8 ± 218.2 U/L in the low‐dose bicyclol, high‐dose bicyclol and control groups, respectively; both p |
| doi_str_mv | 10.1111/liv.15290 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2664791275</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2692532847</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3530-1e755baf54ca5932b6e44387f8612690f75f18d5813c8ac2aa98681596c5a5f43</originalsourceid><addsrcrecordid>eNp1kcFu1DAQhi0EoqVw4AXQSFyo1G1jO47t3qqqlJVW4gJcI68zbr1y4sVOqMKJR-iFF-RJati2B6TOZUbWp29G_gl5S6tjWuok-B_HVDBdPSP7tJZqwRmnzx9nxvfIq5w3VUW1FvQl2eNCNFIKuU9-XzjnrbEzmKGDbByOM0QHa29nG2IAFxOMCc3ohyvYlobDmOHGj9fgOx_zPNhUXi0YO40IXZqu_vy69UM3WeygXIYJ_LCZ0nwKZ9BPobBFgekIUlkZe_8TuyPYXpuMsFyWXd6E1-SFMyHjm_t-QL5-vPhy_mmx-ny5PD9bLSwXvFpQlEKsjRO1NUJztm6wrrmSTjWUNbpyUjiqOqEot8pYZoxWjaJCN1YY4Wp-QD7svNsUv0-Yx7b32WIIZsA45ZY1TS01ZVIU9P1_6CZOaSjXFUozwZmqZaEOd5RNMeeErt0m35s0t7Rq_2bVlh9p_2VV2Hf3xmndY_dIPoRTgJMdcOMDzk-b2tXy2055B_t4n9w</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2692532847</pqid></control><display><type>article</type><title>Efficacy and safety of bicyclol for treating patients with idiosyncratic acute drug‐induced liver injury: A multicenter, randomized, phase II trial</title><source>Access via Wiley Online Library</source><creator>Tang, Jieting ; Gu, Jin ; Chu, Naihui ; Chen, Yu ; Wang, Yongliang ; Xue, Dongying ; Xie, Qing ; Li, Lei ; Mei, Zaoxian ; Wang, Xiaojin ; Li, Jun ; Chen, Jun ; Li, Yi ; Yang, Changqing ; Wang, Yingxin ; Shang, Jia ; Xie, Wen ; Hu, Peng ; Li, Dongliang ; Zhao, Limin ; Lan, Pei ; Wang, Chen ; Chen, Chengwei ; Mao, Yimin</creator><creatorcontrib>Tang, Jieting ; Gu, Jin ; Chu, Naihui ; Chen, Yu ; Wang, Yongliang ; Xue, Dongying ; Xie, Qing ; Li, Lei ; Mei, Zaoxian ; Wang, Xiaojin ; Li, Jun ; Chen, Jun ; Li, Yi ; Yang, Changqing ; Wang, Yingxin ; Shang, Jia ; Xie, Wen ; Hu, Peng ; Li, Dongliang ; Zhao, Limin ; Lan, Pei ; Wang, Chen ; Chen, Chengwei ; Mao, Yimin</creatorcontrib><description>Background and Aims
Evidence for using bicyclol in drug‐induced liver injury (DILI) is limited. This study aimed to explore the efficacy and safety of bicyclol in acute DILI.
Methods
This was a multicenter, randomized, double‐blinded, double‐dummy, active‐controlled, superiority and phase II trial. Patients with idiosyncratic acute DILI were randomized 1: 1:1 to low‐dose bicyclol (25 mg times a day [TID]), high‐dose bicyclol (50 mg TID) and polyene phosphatidylcholine (control) groups. The primary endpoint was the decrease from baseline in serum alanine aminotransferase (ALT) levels at post‐treatment for 4 weeks.
Results
Overall, 241 patients were included in the full analysis set, with 81, 82 and 78 patients in the low‐dose bicyclol, high‐dose bicyclol, and control groups respectively. ALT levels decreased across groups (−249.2 ± 151.1, −273.6 ± 203.1, and −180.8 ± 218.2 U/L in the low‐dose bicyclol, high‐dose bicyclol and control groups, respectively; both p < .001, the bicyclol‐dependent groups vs. control group). The ALT normalization rates at weeks 1, 2, 4, 6 and 8 were higher in the bicyclol‐dependent groups than in the control group (p = .002 at week 1 and all p < .001 at weeks 2, 4, 6 and 8 respectively). The median times to ALT normalization in the low‐dose bicyclol, high‐dose bicyclol and control groups were 29, 16 and 43 days respectively. Adverse events, serious adverse events and adverse drug reactions were similar across groups.
Conclusions
Bicyclol (25 and 50 mg TID) appeared efficacious and safe for treating idiosyncratic acute DILI, while bicyclol 50 mg TID showed higher efficacy.
Trial Registration Number
www.Clinicaltrials.gov (registration no. NCT02944552).</description><identifier>ISSN: 1478-3223</identifier><identifier>EISSN: 1478-3231</identifier><identifier>DOI: 10.1111/liv.15290</identifier><identifier>PMID: 35567757</identifier><language>eng</language><publisher>United States: Wiley Subscription Services, Inc</publisher><subject>Active control ; Adverse events ; Alanine ; Alanine transaminase ; bicyclol ; Drug dosages ; drug‐induced liver injury ; Injury prevention ; Lecithin ; Liver ; Patients ; Phosphatidylcholine ; randomized clinical trial ; Safety ; Side effects</subject><ispartof>Liver international, 2022-08, Vol.42 (8), p.1803-1813</ispartof><rights>2022 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.</rights><rights>This article is protected by copyright. All rights reserved.</rights><rights>2022 John Wiley & Sons A/S</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3530-1e755baf54ca5932b6e44387f8612690f75f18d5813c8ac2aa98681596c5a5f43</citedby><cites>FETCH-LOGICAL-c3530-1e755baf54ca5932b6e44387f8612690f75f18d5813c8ac2aa98681596c5a5f43</cites><orcidid>0000-0002-9744-792X ; 0000-0002-6048-9173 ; 0000-0002-2582-8803 ; 0000-0002-7314-8175 ; 0000-0001-8481-0841 ; 0000-0002-2928-3425</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fliv.15290$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fliv.15290$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1417,27924,27925,45574,45575</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/35567757$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Tang, Jieting</creatorcontrib><creatorcontrib>Gu, Jin</creatorcontrib><creatorcontrib>Chu, Naihui</creatorcontrib><creatorcontrib>Chen, Yu</creatorcontrib><creatorcontrib>Wang, Yongliang</creatorcontrib><creatorcontrib>Xue, Dongying</creatorcontrib><creatorcontrib>Xie, Qing</creatorcontrib><creatorcontrib>Li, Lei</creatorcontrib><creatorcontrib>Mei, Zaoxian</creatorcontrib><creatorcontrib>Wang, Xiaojin</creatorcontrib><creatorcontrib>Li, Jun</creatorcontrib><creatorcontrib>Chen, Jun</creatorcontrib><creatorcontrib>Li, Yi</creatorcontrib><creatorcontrib>Yang, Changqing</creatorcontrib><creatorcontrib>Wang, Yingxin</creatorcontrib><creatorcontrib>Shang, Jia</creatorcontrib><creatorcontrib>Xie, Wen</creatorcontrib><creatorcontrib>Hu, Peng</creatorcontrib><creatorcontrib>Li, Dongliang</creatorcontrib><creatorcontrib>Zhao, Limin</creatorcontrib><creatorcontrib>Lan, Pei</creatorcontrib><creatorcontrib>Wang, Chen</creatorcontrib><creatorcontrib>Chen, Chengwei</creatorcontrib><creatorcontrib>Mao, Yimin</creatorcontrib><title>Efficacy and safety of bicyclol for treating patients with idiosyncratic acute drug‐induced liver injury: A multicenter, randomized, phase II trial</title><title>Liver international</title><addtitle>Liver Int</addtitle><description>Background and Aims
Evidence for using bicyclol in drug‐induced liver injury (DILI) is limited. This study aimed to explore the efficacy and safety of bicyclol in acute DILI.
Methods
This was a multicenter, randomized, double‐blinded, double‐dummy, active‐controlled, superiority and phase II trial. Patients with idiosyncratic acute DILI were randomized 1: 1:1 to low‐dose bicyclol (25 mg times a day [TID]), high‐dose bicyclol (50 mg TID) and polyene phosphatidylcholine (control) groups. The primary endpoint was the decrease from baseline in serum alanine aminotransferase (ALT) levels at post‐treatment for 4 weeks.
Results
Overall, 241 patients were included in the full analysis set, with 81, 82 and 78 patients in the low‐dose bicyclol, high‐dose bicyclol, and control groups respectively. ALT levels decreased across groups (−249.2 ± 151.1, −273.6 ± 203.1, and −180.8 ± 218.2 U/L in the low‐dose bicyclol, high‐dose bicyclol and control groups, respectively; both p < .001, the bicyclol‐dependent groups vs. control group). The ALT normalization rates at weeks 1, 2, 4, 6 and 8 were higher in the bicyclol‐dependent groups than in the control group (p = .002 at week 1 and all p < .001 at weeks 2, 4, 6 and 8 respectively). The median times to ALT normalization in the low‐dose bicyclol, high‐dose bicyclol and control groups were 29, 16 and 43 days respectively. Adverse events, serious adverse events and adverse drug reactions were similar across groups.
Conclusions
Bicyclol (25 and 50 mg TID) appeared efficacious and safe for treating idiosyncratic acute DILI, while bicyclol 50 mg TID showed higher efficacy.
Trial Registration Number
www.Clinicaltrials.gov (registration no. NCT02944552).</description><subject>Active control</subject><subject>Adverse events</subject><subject>Alanine</subject><subject>Alanine transaminase</subject><subject>bicyclol</subject><subject>Drug dosages</subject><subject>drug‐induced liver injury</subject><subject>Injury prevention</subject><subject>Lecithin</subject><subject>Liver</subject><subject>Patients</subject><subject>Phosphatidylcholine</subject><subject>randomized clinical trial</subject><subject>Safety</subject><subject>Side effects</subject><issn>1478-3223</issn><issn>1478-3231</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><recordid>eNp1kcFu1DAQhi0EoqVw4AXQSFyo1G1jO47t3qqqlJVW4gJcI68zbr1y4sVOqMKJR-iFF-RJati2B6TOZUbWp29G_gl5S6tjWuok-B_HVDBdPSP7tJZqwRmnzx9nxvfIq5w3VUW1FvQl2eNCNFIKuU9-XzjnrbEzmKGDbByOM0QHa29nG2IAFxOMCc3ohyvYlobDmOHGj9fgOx_zPNhUXi0YO40IXZqu_vy69UM3WeygXIYJ_LCZ0nwKZ9BPobBFgekIUlkZe_8TuyPYXpuMsFyWXd6E1-SFMyHjm_t-QL5-vPhy_mmx-ny5PD9bLSwXvFpQlEKsjRO1NUJztm6wrrmSTjWUNbpyUjiqOqEot8pYZoxWjaJCN1YY4Wp-QD7svNsUv0-Yx7b32WIIZsA45ZY1TS01ZVIU9P1_6CZOaSjXFUozwZmqZaEOd5RNMeeErt0m35s0t7Rq_2bVlh9p_2VV2Hf3xmndY_dIPoRTgJMdcOMDzk-b2tXy2055B_t4n9w</recordid><startdate>202208</startdate><enddate>202208</enddate><creator>Tang, Jieting</creator><creator>Gu, Jin</creator><creator>Chu, Naihui</creator><creator>Chen, Yu</creator><creator>Wang, Yongliang</creator><creator>Xue, Dongying</creator><creator>Xie, Qing</creator><creator>Li, Lei</creator><creator>Mei, Zaoxian</creator><creator>Wang, Xiaojin</creator><creator>Li, Jun</creator><creator>Chen, Jun</creator><creator>Li, Yi</creator><creator>Yang, Changqing</creator><creator>Wang, Yingxin</creator><creator>Shang, Jia</creator><creator>Xie, Wen</creator><creator>Hu, Peng</creator><creator>Li, Dongliang</creator><creator>Zhao, Limin</creator><creator>Lan, Pei</creator><creator>Wang, Chen</creator><creator>Chen, Chengwei</creator><creator>Mao, Yimin</creator><general>Wiley Subscription Services, Inc</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QO</scope><scope>7T5</scope><scope>7U9</scope><scope>8FD</scope><scope>FR3</scope><scope>H94</scope><scope>P64</scope><scope>RC3</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-9744-792X</orcidid><orcidid>https://orcid.org/0000-0002-6048-9173</orcidid><orcidid>https://orcid.org/0000-0002-2582-8803</orcidid><orcidid>https://orcid.org/0000-0002-7314-8175</orcidid><orcidid>https://orcid.org/0000-0001-8481-0841</orcidid><orcidid>https://orcid.org/0000-0002-2928-3425</orcidid></search><sort><creationdate>202208</creationdate><title>Efficacy and safety of bicyclol for treating patients with idiosyncratic acute drug‐induced liver injury: A multicenter, randomized, phase II trial</title><author>Tang, Jieting ; Gu, Jin ; Chu, Naihui ; Chen, Yu ; Wang, Yongliang ; Xue, Dongying ; Xie, Qing ; Li, Lei ; Mei, Zaoxian ; Wang, Xiaojin ; Li, Jun ; Chen, Jun ; Li, Yi ; Yang, Changqing ; Wang, Yingxin ; Shang, Jia ; Xie, Wen ; Hu, Peng ; Li, Dongliang ; Zhao, Limin ; Lan, Pei ; Wang, Chen ; Chen, Chengwei ; Mao, Yimin</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3530-1e755baf54ca5932b6e44387f8612690f75f18d5813c8ac2aa98681596c5a5f43</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Active control</topic><topic>Adverse events</topic><topic>Alanine</topic><topic>Alanine transaminase</topic><topic>bicyclol</topic><topic>Drug dosages</topic><topic>drug‐induced liver injury</topic><topic>Injury prevention</topic><topic>Lecithin</topic><topic>Liver</topic><topic>Patients</topic><topic>Phosphatidylcholine</topic><topic>randomized clinical trial</topic><topic>Safety</topic><topic>Side effects</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Tang, Jieting</creatorcontrib><creatorcontrib>Gu, Jin</creatorcontrib><creatorcontrib>Chu, Naihui</creatorcontrib><creatorcontrib>Chen, Yu</creatorcontrib><creatorcontrib>Wang, Yongliang</creatorcontrib><creatorcontrib>Xue, Dongying</creatorcontrib><creatorcontrib>Xie, Qing</creatorcontrib><creatorcontrib>Li, Lei</creatorcontrib><creatorcontrib>Mei, Zaoxian</creatorcontrib><creatorcontrib>Wang, Xiaojin</creatorcontrib><creatorcontrib>Li, Jun</creatorcontrib><creatorcontrib>Chen, Jun</creatorcontrib><creatorcontrib>Li, Yi</creatorcontrib><creatorcontrib>Yang, Changqing</creatorcontrib><creatorcontrib>Wang, Yingxin</creatorcontrib><creatorcontrib>Shang, Jia</creatorcontrib><creatorcontrib>Xie, Wen</creatorcontrib><creatorcontrib>Hu, Peng</creatorcontrib><creatorcontrib>Li, Dongliang</creatorcontrib><creatorcontrib>Zhao, Limin</creatorcontrib><creatorcontrib>Lan, Pei</creatorcontrib><creatorcontrib>Wang, Chen</creatorcontrib><creatorcontrib>Chen, Chengwei</creatorcontrib><creatorcontrib>Mao, Yimin</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>Biotechnology Research Abstracts</collection><collection>Immunology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Technology Research Database</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Liver international</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Tang, Jieting</au><au>Gu, Jin</au><au>Chu, Naihui</au><au>Chen, Yu</au><au>Wang, Yongliang</au><au>Xue, Dongying</au><au>Xie, Qing</au><au>Li, Lei</au><au>Mei, Zaoxian</au><au>Wang, Xiaojin</au><au>Li, Jun</au><au>Chen, Jun</au><au>Li, Yi</au><au>Yang, Changqing</au><au>Wang, Yingxin</au><au>Shang, Jia</au><au>Xie, Wen</au><au>Hu, Peng</au><au>Li, Dongliang</au><au>Zhao, Limin</au><au>Lan, Pei</au><au>Wang, Chen</au><au>Chen, Chengwei</au><au>Mao, Yimin</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and safety of bicyclol for treating patients with idiosyncratic acute drug‐induced liver injury: A multicenter, randomized, phase II trial</atitle><jtitle>Liver international</jtitle><addtitle>Liver Int</addtitle><date>2022-08</date><risdate>2022</risdate><volume>42</volume><issue>8</issue><spage>1803</spage><epage>1813</epage><pages>1803-1813</pages><issn>1478-3223</issn><eissn>1478-3231</eissn><abstract>Background and Aims
Evidence for using bicyclol in drug‐induced liver injury (DILI) is limited. This study aimed to explore the efficacy and safety of bicyclol in acute DILI.
Methods
This was a multicenter, randomized, double‐blinded, double‐dummy, active‐controlled, superiority and phase II trial. Patients with idiosyncratic acute DILI were randomized 1: 1:1 to low‐dose bicyclol (25 mg times a day [TID]), high‐dose bicyclol (50 mg TID) and polyene phosphatidylcholine (control) groups. The primary endpoint was the decrease from baseline in serum alanine aminotransferase (ALT) levels at post‐treatment for 4 weeks.
Results
Overall, 241 patients were included in the full analysis set, with 81, 82 and 78 patients in the low‐dose bicyclol, high‐dose bicyclol, and control groups respectively. ALT levels decreased across groups (−249.2 ± 151.1, −273.6 ± 203.1, and −180.8 ± 218.2 U/L in the low‐dose bicyclol, high‐dose bicyclol and control groups, respectively; both p < .001, the bicyclol‐dependent groups vs. control group). The ALT normalization rates at weeks 1, 2, 4, 6 and 8 were higher in the bicyclol‐dependent groups than in the control group (p = .002 at week 1 and all p < .001 at weeks 2, 4, 6 and 8 respectively). The median times to ALT normalization in the low‐dose bicyclol, high‐dose bicyclol and control groups were 29, 16 and 43 days respectively. Adverse events, serious adverse events and adverse drug reactions were similar across groups.
Conclusions
Bicyclol (25 and 50 mg TID) appeared efficacious and safe for treating idiosyncratic acute DILI, while bicyclol 50 mg TID showed higher efficacy.
Trial Registration Number
www.Clinicaltrials.gov (registration no. NCT02944552).</abstract><cop>United States</cop><pub>Wiley Subscription Services, Inc</pub><pmid>35567757</pmid><doi>10.1111/liv.15290</doi><tpages>11</tpages><orcidid>https://orcid.org/0000-0002-9744-792X</orcidid><orcidid>https://orcid.org/0000-0002-6048-9173</orcidid><orcidid>https://orcid.org/0000-0002-2582-8803</orcidid><orcidid>https://orcid.org/0000-0002-7314-8175</orcidid><orcidid>https://orcid.org/0000-0001-8481-0841</orcidid><orcidid>https://orcid.org/0000-0002-2928-3425</orcidid></addata></record> |
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| ispartof | Liver international, 2022-08, Vol.42 (8), p.1803-1813 |
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| language | eng |
| recordid | cdi_proquest_miscellaneous_2664791275 |
| source | Access via Wiley Online Library |
| subjects | Active control Adverse events Alanine Alanine transaminase bicyclol Drug dosages drug‐induced liver injury Injury prevention Lecithin Liver Patients Phosphatidylcholine randomized clinical trial Safety Side effects |
| title | Efficacy and safety of bicyclol for treating patients with idiosyncratic acute drug‐induced liver injury: A multicenter, randomized, phase II trial |
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