WEKO3
アイテム
{"_buckets": {"deposit": "8054d1b1-5f6b-4be3-965f-b0ab5b8b7d32"}, "_deposit": {"created_by": 2, "id": "5336", "owners": [2], "pid": {"revision_id": 0, "type": "depid", "value": "5336"}, "status": "published"}, "_oai": {"id": "oai:nagasaki-u.repo.nii.ac.jp:00005336", "sets": ["36"]}, "author_link": ["22497", "22496", "22495", "22499", "22498"], "item_2_biblio_info_6": {"attribute_name": "書誌情報", "attribute_value_mlt": [{"bibliographicIssueDates": {"bibliographicIssueDate": "2014-04", "bibliographicIssueDateType": "Issued"}, "bibliographicIssueNumber": "4", "bibliographicPageEnd": "381", "bibliographicPageStart": "372", "bibliographicVolumeNumber": "23", "bibliographic_titles": [{"bibliographic_title": "Pharmacoepidemiology and Drug Safety"}]}]}, "item_2_description_4": {"attribute_name": "抄録", "attribute_value_mlt": [{"subitem_description": "Purpose: To obtain safety and effectiveness data on a combined anti-HIV drug, Epzicom (abacavir 600mg/lamivudine 300mg), a post-marketing surveillance on Epzicom that was required by the Japanese regulatory authority was conducted between January 2005 and December 2010. Methods: A joint survey (HIV-related drug [HRD] survey) has been conducted involving manufacturers of drugs for treatment of HIV infection in Japan. Safety and effectiveness data from total 624 cases (1107.3person-years) registered to the HRD surveys and received Epzicom were obtained. Adverse drug reactions (ADRs) were defined as adverse events (AE) of which association with Epzicom could not be \u0027ruled out\u0027. Results: It was found that the incidence of ADR was 32.4% (202/624 cases) on the case basis. In addition, the frequently reported ADR included hyperlipidaemia (59 cases), hypertriglyceridaemia (21 cases), blood bilirubin increased (19 cases), gamma-glutamyltransferase increase (14 cases), blood triglyceride increase (14 cases) and rash (14 cases). Serious AEs were seen in 19 patients (30 events), including one death (no evident association with Epzicom). There were four cases (0.6%) of survey-defined \u0027hypersensitivity\u0027, and the incidence was 0.9% (4/445) among abacavir naive patients; none of which was reported as serious. No case of myocardial infarction was reported. One pregnant case who delivered a normal baby by caesarean section was reported to have experienced aggravation of anaemia and nausea. Conclusions: The post-marketing surveillance indicated that the incidence of both ischaemic heart disease and hypersensitivity associated with Epzicom was considerably low, suggesting that this drug can be safely used in the Japanese population.", "subitem_description_type": "Abstract"}]}, "item_2_description_63": {"attribute_name": "引用", "attribute_value_mlt": [{"subitem_description": "Pharmacoepidemiology and Drug Safety, 23(4), pp.372-381; 2014", "subitem_description_type": "Other"}]}, "item_2_publisher_33": {"attribute_name": "出版者", "attribute_value_mlt": [{"subitem_publisher": "John Wiley and Sons Ltd"}]}, "item_2_relation_12": {"attribute_name": "DOI", "attribute_value_mlt": [{"subitem_relation_type": "isIdenticalTo", "subitem_relation_type_id": {"subitem_relation_type_id_text": "10.1002/pds.3588", "subitem_relation_type_select": "DOI"}}]}, "item_2_rights_13": {"attribute_name": "権利", "attribute_value_mlt": [{"subitem_rights": "c 2014 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley \u0026 Sons, Ltd."}, {"subitem_rights": "This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited."}]}, "item_2_source_id_7": {"attribute_name": "ISSN", "attribute_value_mlt": [{"subitem_source_identifier": "10538569", "subitem_source_identifier_type": "ISSN"}]}, "item_2_version_type_16": {"attribute_name": "著者版フラグ", "attribute_value_mlt": [{"subitem_version_resource": "http://purl.org/coar/version/c_970fb48d4fbd8a85", "subitem_version_type": "VoR"}]}, "item_creator": {"attribute_name": "著者", "attribute_type": "creator", "attribute_value_mlt": [{"creatorNames": [{"creatorName": "Kurita, Tomoko"}], "nameIdentifiers": [{"nameIdentifier": "22495", "nameIdentifierScheme": "WEKO"}]}, {"creatorNames": [{"creatorName": "Kitaichi, Tomomi"}], "nameIdentifiers": [{"nameIdentifier": "22496", "nameIdentifierScheme": "WEKO"}]}, {"creatorNames": [{"creatorName": "Nagao, Takako"}], "nameIdentifiers": [{"nameIdentifier": "22497", "nameIdentifierScheme": "WEKO"}]}, {"creatorNames": [{"creatorName": "Miura, Toshiyuki"}], "nameIdentifiers": [{"nameIdentifier": "22498", "nameIdentifierScheme": "WEKO"}]}, {"creatorNames": [{"creatorName": "Kitazono, Yoshifumi"}], "nameIdentifiers": [{"nameIdentifier": "22499", "nameIdentifierScheme": "WEKO"}]}]}, "item_files": {"attribute_name": "ファイル情報", "attribute_type": "file", "attribute_value_mlt": [{"accessrole": "open_date", "date": [{"dateType": "Available", "dateValue": "2020-12-21"}], "displaytype": "detail", "download_preview_message": "", "file_order": 0, "filename": "PDS23_372.pdf", "filesize": [{"value": "185.5 kB"}], "format": "application/pdf", "future_date_message": "", "is_thumbnail": false, "licensetype": "license_free", "mimetype": "application/pdf", "size": 185500.0, "url": {"label": "PDS23_372.pdf", "url": "https://nagasaki-u.repo.nii.ac.jp/record/5336/files/PDS23_372.pdf"}, "version_id": "7da99593-782d-4fcb-8a95-f9f6c93fd9d5"}]}, "item_keyword": {"attribute_name": "キーワード", "attribute_value_mlt": [{"subitem_subject": "Abacavir", "subitem_subject_scheme": "Other"}, {"subitem_subject": "Human immunodeficiency virus", "subitem_subject_scheme": "Other"}, {"subitem_subject": "Hypersensitivity", "subitem_subject_scheme": "Other"}, {"subitem_subject": "Japan", "subitem_subject_scheme": "Other"}, {"subitem_subject": "Lamivudine", "subitem_subject_scheme": "Other"}, {"subitem_subject": "Myocardial infarction", "subitem_subject_scheme": "Other"}, {"subitem_subject": "Pharmacoepidemiology", "subitem_subject_scheme": "Other"}]}, "item_language": {"attribute_name": "言語", "attribute_value_mlt": [{"subitem_language": "eng"}]}, "item_resource_type": {"attribute_name": "資源タイプ", "attribute_value_mlt": [{"resourcetype": "journal article", "resourceuri": "http://purl.org/coar/resource_type/c_6501"}]}, "item_title": "Safety analysis of EpzicomR (lamivudine/abacavir sulfate) in post-marketing surveillance in Japan", "item_titles": {"attribute_name": "タイトル", "attribute_value_mlt": [{"subitem_title": "Safety analysis of EpzicomR (lamivudine/abacavir sulfate) in post-marketing surveillance in Japan"}]}, "item_type_id": "2", "owner": "2", "path": ["36"], "permalink_uri": "http://hdl.handle.net/10069/34401", "pubdate": {"attribute_name": "公開日", "attribute_value": "2014-05-21"}, "publish_date": "2014-05-21", "publish_status": "0", "recid": "5336", "relation": {}, "relation_version_is_last": true, "title": ["Safety analysis of EpzicomR (lamivudine/abacavir sulfate) in post-marketing surveillance in Japan"], "weko_shared_id": -1}
Safety analysis of EpzicomR (lamivudine/abacavir sulfate) in post-marketing surveillance in Japan
http://hdl.handle.net/10069/34401
http://hdl.handle.net/10069/34401ee86079e-3d09-481e-9748-c83ea68ecca7
名前 / ファイル | ライセンス | アクション |
---|---|---|
PDS23_372.pdf (185.5 kB)
|
|
Item type | 学術雑誌論文 / Journal Article(1) | |||||
---|---|---|---|---|---|---|
公開日 | 2014-05-21 | |||||
タイトル | ||||||
タイトル | Safety analysis of EpzicomR (lamivudine/abacavir sulfate) in post-marketing surveillance in Japan | |||||
言語 | ||||||
言語 | eng | |||||
キーワード | ||||||
主題Scheme | Other | |||||
主題 | Abacavir | |||||
キーワード | ||||||
主題Scheme | Other | |||||
主題 | Human immunodeficiency virus | |||||
キーワード | ||||||
主題Scheme | Other | |||||
主題 | Hypersensitivity | |||||
キーワード | ||||||
主題Scheme | Other | |||||
主題 | Japan | |||||
キーワード | ||||||
主題Scheme | Other | |||||
主題 | Lamivudine | |||||
キーワード | ||||||
主題Scheme | Other | |||||
主題 | Myocardial infarction | |||||
キーワード | ||||||
主題Scheme | Other | |||||
主題 | Pharmacoepidemiology | |||||
資源タイプ | ||||||
資源タイプ識別子 | http://purl.org/coar/resource_type/c_6501 | |||||
資源タイプ | journal article | |||||
著者 |
Kurita, Tomoko
× Kurita, Tomoko× Kitaichi, Tomomi× Nagao, Takako× Miura, Toshiyuki× Kitazono, Yoshifumi |
|||||
抄録 | ||||||
内容記述タイプ | Abstract | |||||
内容記述 | Purpose: To obtain safety and effectiveness data on a combined anti-HIV drug, Epzicom (abacavir 600mg/lamivudine 300mg), a post-marketing surveillance on Epzicom that was required by the Japanese regulatory authority was conducted between January 2005 and December 2010. Methods: A joint survey (HIV-related drug [HRD] survey) has been conducted involving manufacturers of drugs for treatment of HIV infection in Japan. Safety and effectiveness data from total 624 cases (1107.3person-years) registered to the HRD surveys and received Epzicom were obtained. Adverse drug reactions (ADRs) were defined as adverse events (AE) of which association with Epzicom could not be 'ruled out'. Results: It was found that the incidence of ADR was 32.4% (202/624 cases) on the case basis. In addition, the frequently reported ADR included hyperlipidaemia (59 cases), hypertriglyceridaemia (21 cases), blood bilirubin increased (19 cases), gamma-glutamyltransferase increase (14 cases), blood triglyceride increase (14 cases) and rash (14 cases). Serious AEs were seen in 19 patients (30 events), including one death (no evident association with Epzicom). There were four cases (0.6%) of survey-defined 'hypersensitivity', and the incidence was 0.9% (4/445) among abacavir naive patients; none of which was reported as serious. No case of myocardial infarction was reported. One pregnant case who delivered a normal baby by caesarean section was reported to have experienced aggravation of anaemia and nausea. Conclusions: The post-marketing surveillance indicated that the incidence of both ischaemic heart disease and hypersensitivity associated with Epzicom was considerably low, suggesting that this drug can be safely used in the Japanese population. | |||||
書誌情報 |
Pharmacoepidemiology and Drug Safety 巻 23, 号 4, p. 372-381, 発行日 2014-04 |
|||||
出版者 | ||||||
出版者 | John Wiley and Sons Ltd | |||||
ISSN | ||||||
収録物識別子タイプ | ISSN | |||||
収録物識別子 | 10538569 | |||||
DOI | ||||||
関連タイプ | isIdenticalTo | |||||
識別子タイプ | DOI | |||||
関連識別子 | 10.1002/pds.3588 | |||||
権利 | ||||||
権利情報 | c 2014 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd. | |||||
権利 | ||||||
権利情報 | This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. | |||||
著者版フラグ | ||||||
出版タイプ | VoR | |||||
出版タイプResource | http://purl.org/coar/version/c_970fb48d4fbd8a85 | |||||
引用 | ||||||
内容記述タイプ | Other | |||||
内容記述 | Pharmacoepidemiology and Drug Safety, 23(4), pp.372-381; 2014 |