Postmarketing Safety Surveillance and Reevaluation of Danhong Injection: Clinical Study of 30888 Cases
Traditional Chinese medicine injections (TCMIs) have played an irreplaceable role for treating some clinical emergency, severe illness, and infectious diseases in China. In recent years, the incidence rates of adverse drug reactions (ADRs) of TCMIs have increased year by year. Danhong injection (DHI...
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| Veröffentlicht in: | Evidence-based complementary and alternative medicine 2015-01, Vol.2015 (2015), p.1-9 |
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| creator | Xu, Tao Zhu, Ming-Jun Chen, Xiao-Fei Wang, Yong Zhao, Bu-Chang Zhao, Tao Li, Chun-Xiao Li, Wei-Xia Tang, Jin-Fa Li, Xue-Lin Zhang, Hui |
| description | Traditional Chinese medicine injections (TCMIs) have played an irreplaceable role for treating some clinical emergency, severe illness, and infectious diseases in China. In recent years, the incidence rates of adverse drug reactions (ADRs) of TCMIs have increased year by year. Danhong injection (DHI) is one representative TCMI comprised of Danshen and Honghua for treating cardiovascular and cerebrovascular diseases in clinic. In present study, the postmarketing safety surveillance and reevaluation of DHI were reported. Total 30888 patients in 37 hospitals from 6 provinces participated in the study. The results showed that the ADR incidence rate of DHI was 3.50‰. Seventeen kinds of new adverse reactions of DHI were found. The main type of ADRs of DHI was type A (including sweating, dizziness, headache, flushing, vasodilation, eye hemorrhage, faintness, chest pain, palpitations, breathlessness, anxious, nausea, flatulence, vomiting, hypotension, hypertension, local numbness, dyspnea, joint disease, and tinnitus) accounting for 57.75%. The severities of most ADRs of DHI were mild and moderate reactions accounting for 25.93% and 66.67%, respectively. The main disposition of ADRs of DHI was drug withdrawal and without any treatments. The results can provide basis for amendment and improvement of the instructions of DHI, as well as demonstration and reference for the postmarketing safety surveillance and reevaluation of other TCMIs. And the rationality, scientificity, and safety of clinical applications of TCMIs could be improved. |
| doi_str_mv | 10.1155/2015/610846 |
| format | Article |
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In recent years, the incidence rates of adverse drug reactions (ADRs) of TCMIs have increased year by year. Danhong injection (DHI) is one representative TCMI comprised of Danshen and Honghua for treating cardiovascular and cerebrovascular diseases in clinic. In present study, the postmarketing safety surveillance and reevaluation of DHI were reported. Total 30888 patients in 37 hospitals from 6 provinces participated in the study. The results showed that the ADR incidence rate of DHI was 3.50‰. Seventeen kinds of new adverse reactions of DHI were found. The main type of ADRs of DHI was type A (including sweating, dizziness, headache, flushing, vasodilation, eye hemorrhage, faintness, chest pain, palpitations, breathlessness, anxious, nausea, flatulence, vomiting, hypotension, hypertension, local numbness, dyspnea, joint disease, and tinnitus) accounting for 57.75%. The severities of most ADRs of DHI were mild and moderate reactions accounting for 25.93% and 66.67%, respectively. The main disposition of ADRs of DHI was drug withdrawal and without any treatments. The results can provide basis for amendment and improvement of the instructions of DHI, as well as demonstration and reference for the postmarketing safety surveillance and reevaluation of other TCMIs. And the rationality, scientificity, and safety of clinical applications of TCMIs could be improved.</description><identifier>ISSN: 1741-427X</identifier><identifier>EISSN: 1741-4288</identifier><identifier>DOI: 10.1155/2015/610846</identifier><identifier>PMID: 26508981</identifier><language>eng</language><publisher>Cairo, Egypt: Hindawi Publishing Corporation</publisher><subject>Cardiovascular disease ; Chinese medicine ; Clinical trials ; Drug dosages ; Drug overdose ; Drug stores ; Hospitals ; Market entry ; Names ; Pharmaceuticals ; Quality control</subject><ispartof>Evidence-based complementary and alternative medicine, 2015-01, Vol.2015 (2015), p.1-9</ispartof><rights>Copyright © 2015 Xue-Lin Li et al.</rights><rights>COPYRIGHT 2015 John Wiley & Sons, Inc.</rights><rights>Copyright © 2015 Xue-Lin Li et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</rights><rights>Copyright © 2015 Xue-Lin Li et al. 2015</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c495t-39dd9b9f57c896aeca9fb0f9a44f4c7590446494e00936ef5134e07190bcd5903</citedby><cites>FETCH-LOGICAL-c495t-39dd9b9f57c896aeca9fb0f9a44f4c7590446494e00936ef5134e07190bcd5903</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4609862/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4609862/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,881,27901,27902,53766,53768</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26508981$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><contributor>Hawk, Cheryl</contributor><creatorcontrib>Xu, Tao</creatorcontrib><creatorcontrib>Zhu, Ming-Jun</creatorcontrib><creatorcontrib>Chen, Xiao-Fei</creatorcontrib><creatorcontrib>Wang, Yong</creatorcontrib><creatorcontrib>Zhao, Bu-Chang</creatorcontrib><creatorcontrib>Zhao, Tao</creatorcontrib><creatorcontrib>Li, Chun-Xiao</creatorcontrib><creatorcontrib>Li, Wei-Xia</creatorcontrib><creatorcontrib>Tang, Jin-Fa</creatorcontrib><creatorcontrib>Li, Xue-Lin</creatorcontrib><creatorcontrib>Zhang, Hui</creatorcontrib><title>Postmarketing Safety Surveillance and Reevaluation of Danhong Injection: Clinical Study of 30888 Cases</title><title>Evidence-based complementary and alternative medicine</title><addtitle>Evid Based Complement Alternat Med</addtitle><description>Traditional Chinese medicine injections (TCMIs) have played an irreplaceable role for treating some clinical emergency, severe illness, and infectious diseases in China. In recent years, the incidence rates of adverse drug reactions (ADRs) of TCMIs have increased year by year. Danhong injection (DHI) is one representative TCMI comprised of Danshen and Honghua for treating cardiovascular and cerebrovascular diseases in clinic. In present study, the postmarketing safety surveillance and reevaluation of DHI were reported. Total 30888 patients in 37 hospitals from 6 provinces participated in the study. The results showed that the ADR incidence rate of DHI was 3.50‰. Seventeen kinds of new adverse reactions of DHI were found. The main type of ADRs of DHI was type A (including sweating, dizziness, headache, flushing, vasodilation, eye hemorrhage, faintness, chest pain, palpitations, breathlessness, anxious, nausea, flatulence, vomiting, hypotension, hypertension, local numbness, dyspnea, joint disease, and tinnitus) accounting for 57.75%. The severities of most ADRs of DHI were mild and moderate reactions accounting for 25.93% and 66.67%, respectively. 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And the rationality, scientificity, and safety of clinical applications of TCMIs could be improved.</description><subject>Cardiovascular disease</subject><subject>Chinese medicine</subject><subject>Clinical trials</subject><subject>Drug dosages</subject><subject>Drug overdose</subject><subject>Drug stores</subject><subject>Hospitals</subject><subject>Market entry</subject><subject>Names</subject><subject>Pharmaceuticals</subject><subject>Quality control</subject><issn>1741-427X</issn><issn>1741-4288</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>RHX</sourceid><sourceid>8G5</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqN0c-LEzEUB_AgiruunrzLgBdR6ub3Dw_CUn8tLChWwVtIMy9t6jRZJzOV_vdm6FpXT54S8j58k5eH0GOCXxIixDnFRJxLgjWXd9ApUZzMONX67nGvvp2gB6VsMKZGKXUfnVApsDaanKLwKZdh6_rvMMS0ahYuwLBvFmO_g9h1LnloXGqbzwA7141uiDk1OTRvXFrn6i_TBvx0-KqZdzFF77pmMYztfkIMa62buStQHqJ7wXUFHt2sZ-jru7df5h9mVx_fX84vrmaeGzHMmGlbszRBKK-NdOCdCUscjOM8cK-EwZxLbjhgbJiEIAire0UMXvq2VtkZen3IvR6XW2g9pKF3nb3uY-1xb7OL9u9Kimu7yjvLJTZa0hrw7Cagzz9GKIPdxuJh-grIY7FEUU2F5kJU-vQfusljn2p7k6JaMIXlH7VyHdiYQq73-inUXnChJReKmqpeHJTvcyk9hOOTCbbTlO00ZXuYctVPbnd5tL_HWsHzA1jH1Lqf8f_SoBII7haWjCnFfgGTCbdT</recordid><startdate>20150101</startdate><enddate>20150101</enddate><creator>Xu, Tao</creator><creator>Zhu, Ming-Jun</creator><creator>Chen, Xiao-Fei</creator><creator>Wang, Yong</creator><creator>Zhao, Bu-Chang</creator><creator>Zhao, Tao</creator><creator>Li, Chun-Xiao</creator><creator>Li, Wei-Xia</creator><creator>Tang, Jin-Fa</creator><creator>Li, Xue-Lin</creator><creator>Zhang, Hui</creator><general>Hindawi Publishing Corporation</general><general>John Wiley & Sons, Inc</general><general>Hindawi Limited</general><scope>ADJCN</scope><scope>AHFXO</scope><scope>RHU</scope><scope>RHW</scope><scope>RHX</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7T5</scope><scope>7TO</scope><scope>7X7</scope><scope>7XB</scope><scope>88G</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>H94</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M2M</scope><scope>M2O</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PSYQQ</scope><scope>Q9U</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20150101</creationdate><title>Postmarketing Safety Surveillance and Reevaluation of Danhong Injection: Clinical Study of 30888 Cases</title><author>Xu, Tao ; Zhu, Ming-Jun ; Chen, Xiao-Fei ; Wang, Yong ; Zhao, Bu-Chang ; Zhao, Tao ; Li, Chun-Xiao ; Li, Wei-Xia ; Tang, Jin-Fa ; Li, Xue-Lin ; Zhang, Hui</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c495t-39dd9b9f57c896aeca9fb0f9a44f4c7590446494e00936ef5134e07190bcd5903</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Cardiovascular disease</topic><topic>Chinese medicine</topic><topic>Clinical trials</topic><topic>Drug dosages</topic><topic>Drug overdose</topic><topic>Drug stores</topic><topic>Hospitals</topic><topic>Market entry</topic><topic>Names</topic><topic>Pharmaceuticals</topic><topic>Quality control</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Xu, Tao</creatorcontrib><creatorcontrib>Zhu, Ming-Jun</creatorcontrib><creatorcontrib>Chen, Xiao-Fei</creatorcontrib><creatorcontrib>Wang, Yong</creatorcontrib><creatorcontrib>Zhao, Bu-Chang</creatorcontrib><creatorcontrib>Zhao, Tao</creatorcontrib><creatorcontrib>Li, Chun-Xiao</creatorcontrib><creatorcontrib>Li, Wei-Xia</creatorcontrib><creatorcontrib>Tang, Jin-Fa</creatorcontrib><creatorcontrib>Li, Xue-Lin</creatorcontrib><creatorcontrib>Zhang, Hui</creatorcontrib><collection>الدوريات العلمية والإحصائية - 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Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Evidence-based complementary and alternative medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Xu, Tao</au><au>Zhu, Ming-Jun</au><au>Chen, Xiao-Fei</au><au>Wang, Yong</au><au>Zhao, Bu-Chang</au><au>Zhao, Tao</au><au>Li, Chun-Xiao</au><au>Li, Wei-Xia</au><au>Tang, Jin-Fa</au><au>Li, Xue-Lin</au><au>Zhang, Hui</au><au>Hawk, Cheryl</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Postmarketing Safety Surveillance and Reevaluation of Danhong Injection: Clinical Study of 30888 Cases</atitle><jtitle>Evidence-based complementary and alternative medicine</jtitle><addtitle>Evid Based Complement Alternat Med</addtitle><date>2015-01-01</date><risdate>2015</risdate><volume>2015</volume><issue>2015</issue><spage>1</spage><epage>9</epage><pages>1-9</pages><issn>1741-427X</issn><eissn>1741-4288</eissn><abstract>Traditional Chinese medicine injections (TCMIs) have played an irreplaceable role for treating some clinical emergency, severe illness, and infectious diseases in China. In recent years, the incidence rates of adverse drug reactions (ADRs) of TCMIs have increased year by year. Danhong injection (DHI) is one representative TCMI comprised of Danshen and Honghua for treating cardiovascular and cerebrovascular diseases in clinic. In present study, the postmarketing safety surveillance and reevaluation of DHI were reported. Total 30888 patients in 37 hospitals from 6 provinces participated in the study. The results showed that the ADR incidence rate of DHI was 3.50‰. Seventeen kinds of new adverse reactions of DHI were found. The main type of ADRs of DHI was type A (including sweating, dizziness, headache, flushing, vasodilation, eye hemorrhage, faintness, chest pain, palpitations, breathlessness, anxious, nausea, flatulence, vomiting, hypotension, hypertension, local numbness, dyspnea, joint disease, and tinnitus) accounting for 57.75%. The severities of most ADRs of DHI were mild and moderate reactions accounting for 25.93% and 66.67%, respectively. The main disposition of ADRs of DHI was drug withdrawal and without any treatments. The results can provide basis for amendment and improvement of the instructions of DHI, as well as demonstration and reference for the postmarketing safety surveillance and reevaluation of other TCMIs. And the rationality, scientificity, and safety of clinical applications of TCMIs could be improved.</abstract><cop>Cairo, Egypt</cop><pub>Hindawi Publishing Corporation</pub><pmid>26508981</pmid><doi>10.1155/2015/610846</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
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| source | Wiley-Blackwell Open Access Titles; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; PubMed Central; Alma/SFX Local Collection; PubMed Central Open Access |
| subjects | Cardiovascular disease Chinese medicine Clinical trials Drug dosages Drug overdose Drug stores Hospitals Market entry Names Pharmaceuticals Quality control |
| title | Postmarketing Safety Surveillance and Reevaluation of Danhong Injection: Clinical Study of 30888 Cases |
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