{"id":1971,"date":"2020-09-04T09:23:17","date_gmt":"2020-09-04T00:23:17","guid":{"rendered":"http:\/\/www.hcfm.jp\/journal\/?p=1971"},"modified":"2020-09-04T09:23:17","modified_gmt":"2020-09-04T00:23:17","slug":"%e6%97%a5%e6%9c%ac%e4%ba%ba%ef%bc%92%e5%9e%8b%e7%b3%96%e5%b0%bf%e7%97%85%e6%82%a3%e8%80%85%e3%81%ab%e5%af%be%e3%81%99%e3%82%8b%e7%b5%8c%e5%8f%a3%e3%82%bb%e3%83%9e%e3%82%b0%e3%83%ab%e3%83%81%e3%83%89","status":"publish","type":"post","link":"https:\/\/www.hcfm.jp\/journal\/?p=1971","title":{"rendered":"\u65e5\u672c\u4eba\uff12\u578b\u7cd6\u5c3f\u75c5\u60a3\u8005\u306b\u5bfe\u3059\u308b\u7d4c\u53e3\u30bb\u30de\u30b0\u30eb\u30c1\u30c9\u5358\u5264\u7642\u6cd5\u306e\u7528\u91cf\u53cd\u5fdc\u6027\u3001\u52b9\u679c\u3001\u5b89\u5168\u6027(PIONNER9)"},"content":{"rendered":"<p>\uff0d\u6587\u732e\u540d\uff0d<br \/>\nYamada Y, Katagiri H, Hamamoto Y, et al. Dose-response, efficacy, and safety of oral semaglutide monotherapy in Japanese patients with type 2 diabetes (PIONEER 9): a 52-week, phase 2\/3a, randomised, controlled trial. Lancet Diabetes Endocrinol. 2020;8(5):377-391. doi:10.1016\/S2213-8587(20)30075-9<\/p>\n<p>\uff0d\u8981\u7d04\uff0d<br \/>\n\u80cc\u666f\u3000\u65e5\u672c\u4eba\uff12\u578b\u7cd6\u5c3f\u75c5\u7279\u6709\u306e\u8868\u73fe\u578b\u3092\u8003\u3048\u308b\u3068\u7d4c\u53e3\u30bb\u30de\u30b0\u30eb\u30c1\u30c9\u306a\u3069\u306e\u65b0\u898f\u4e21\u65b9\u306f\u3001\u3053\u306e\u96c6\u56e3\u3067\u306e\u8a55\u4fa1\u3092\u5fc5\u8981\u3068\u3059\u308b\u3002PIONEER9\u306f\u7d4c\u53e3\u30bb\u30de\u30b0\u30eb\u30c1\u30c9\u306e\u7528\u91cf\u53cd\u5fdc\u3092\u8a55\u4fa1\u3057\u3001\u65e5\u672c\u4eba\u96c6\u56e3\u306b\u304a\u3051\u308b\u7d4c\u53e3\u30bb\u30de\u30b0\u30eb\u30c1\u30c9\u306e\u6709\u52b9\u6027\u3068\u5b89\u5168\u6027\u3092\u30d7\u30e9\u30bb\u30dc\u304a\u3088\u3073\u76ae\u4e0bGLP\uff11\u53d7\u5bb9\u4f53\u30a2\u30b4\u30cb\u30b9\u30c8\u3068\u6bd4\u8f03\u3059\u308b\u3053\u3068\u76ee\u7684\u3068\u3057\u305f\u3002<br \/>\n\u65b9\u6cd5<br \/>\n\u3000PIONEER9\u306f\u65e5\u672c\u306e\uff11\uff16\u65bd\u8a2d\uff08\u8a3a\u7642\u6240\u3068\u5927\u5b66\u75c5\u9662\uff09\u3067\u884c\u308f\u308c\u305f52\u9031\u306e\u30d5\u30a7\u30fc\u30ba2\/3a\u306e\u30e9\u30f3\u30c0\u30e0\u5316\u8a66\u9a13\u3002<br \/>\n\u53c2\u52a0\u8005\u306f\u98df\u4e8b\u3084\u904b\u52d5\u306b\u3088\u308b\u52a0\u7642\u3067\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u4e0d\u826f\u306e\uff12\u578b\u7cd6\u5c3f\u75c5(HbA1c7.0~10.0%)\u3001\u307e\u305f\u306f\u7d4c\u53e3\u8840\u7cd6\u964d\u4e0b\u85ac\u5358\u5264(HbA1c6.5~9.5%)\u3067\u52a0\u7642\u4e2d\u306e20\u6b73\u4ee5\u4e0a\u306e\u65e5\u672c\u4eba\u60a3\u8005\u3002\u9664\u5916\u9805\u76ee\u306f90\u65e5\u4ee5\u5185\u306b\u9031\uff11\u56deGLP-1\u53d7\u5bb9\u4f53\u30a2\u30b4\u30cb\u30b9\u30c8\u3001\u9031\uff11\u56deDPP\uff14\u963b\u5bb3\u85ac\u3001\u30c1\u30a2\u30be\u30ea\u30b8\u30f3\u306b\u3088\u308b\u52a0\u7642\u3092\u884c\u308f\u308c\u305f\u60a3\u8005\u3001\u814e\u969c\u5bb3\uff08eGFR<30\uff09\u3001\u7dca\u6025\u6cbb\u7642\u3092\u8981\u3059\u308b\u5897\u6b96\u6027\u7db2\u819c\u75c7\u3084\u9ec4\u6591\u75c7\u306e\u60a3\u8005\u3002\n1\u65e5\uff11\u56de\u306e\u7d4c\u53e3\u30bb\u30de\u30b0\u30eb\u30c1\u30c9\uff08\u30ea\u30d9\u30eb\u30b5\u30b9:3mg\/7mg\/14mg\uff09\u3068\u30d7\u30e9\u30bb\u30dc\u30011\u65e5\uff11\u56de\u76ae\u4e0b\u6ce8\u5c04\u88fd\u5264\u306e\u30ea\u30e9\u30b0\u30eb\u30c1\u30c9(\u30d3\u30af\u30c8\u30fc\u30b6)0.9mg\u30921:1:1:1:1\u306b\u30e9\u30f3\u30c0\u30e0\u306b\u5272\u4ed8\u3051\u3001\u4e8c\u91cd\u76f2\u691c\u5316\u3055\u308c\u305f\u3002(Figure1)\nPrimary endpoint\n\u3000\u30e9\u30f3\u30c0\u30e0\u306b\u5272\u308a\u4ed8\u3051\u3089\u308c\u305f\u5168\u3066\u306e\u60a3\u8005\u306e\u8a66\u9a13\u88fd\u54c1\u63a8\u5b9a\u5024\u3067\u306e\u30d9\u30fc\u30b9\u30e9\u30a4\u30f3\u304b\u308926\u9031\u307e\u3067\u306eHbA1c\u306e\u5909\u5316\u3002\n\u7d50\u679c \n2017\u5e741\u670810\u65e5\u304b\u30897\u670811\u65e5\u307e\u3067\u306e\u9593\u306b243\u4eba\u306e\u60a3\u8005\u304c\u30bb\u30de\u30b0\u30eb\u30c1\u30c93mg(n=49),7mg(n=49),14mg(n=49)\u307e\u305f\u3001\u30d7\u30e9\u30bb\u30dc\uff0849\uff09,\u30ea\u30e9\u30b0\u30eb\u30c1\u30c90.9mg(n=48)\u306b\u30e9\u30f3\u30c0\u30e0\u5272\u308a\u4ed8\u3051\u3055\u308c\u305f\u3002\u60a3\u8005\u306e\u30d9\u30fc\u30b9\u30e9\u30a4\u30f3\u306b\u5dee\u306f\u306a\u304b\u3063\u305f\u3002\n26\u9031\u307e\u3067\u306eHbA1c\u306e\u30d9\u30fc\u30b9\u30e9\u30a4\u30f3\u304b\u3089\u306e\u5909\u5316(\u5e73\u57478.2%)\u306b\u304a\u3044\u3066\u7d4c\u53e3\u30bb\u30de\u30b0\u30eb\u30c1\u30c9\u306f\u7528\u91cf\u4f9d\u5b58\u7684\u3060\u3063\u305f\u3002\uff08\u30bb\u30de\u30b0\u30eb\u30c1\u30c93mg \u3067\u306fmean change-1.1%,[SE0.1]\u30017mg \u3067\u306f-1.5%[0.1]\u300114mg\u3067\u306f-1.7%[0.1]\u3001\u30d7\u30ec\u30bb\u30dc\u3067\u306f\u2212\uff10.\uff11\uff05[0.1]\u3001\u30ea\u30e9\u30b0\u30eb\u30c1\u30c90.9mg\u3067\u306f-1.4%[0.1]\uff09\n26\u9031\u6642\u70b9\u3067\u306eHbA1c\u306e\u30d9\u30fc\u30b9\u30e9\u30a4\u30f3\u304b\u3089\u306e\u63a8\u5b9a\u5909\u5316\u306f\u30d7\u30e9\u30bb\u30dc\u3068\u6bd4\u8f03\u3057\u3066\u7d4c\u53e3\u30bb\u30de\u30b0\u30eb\u30c1\u30c93mg,7mg,14mg\u5168\u3066\u3067\u512a\u4f4d\u306b\u5909\u5316\u3057\u3066\u3044\u305f\u3002\u30bb\u30de\u30b0\u30eb\u30c1\u30c914mg\u3067\u306f\u30ea\u30e9\u30b0\u30eb\u30c1\u30c90.9mg\u306b\u6bd4\u8f03\u3057\u3066\u6709\u610f\u306b\u5909\u5316\u3057\u3066\u3044\u305f\u3002(Figure2)\n\u30d7\u30e9\u30bb\u30dc\u3068\u6bd4\u8f03\u3057\u305fHbA1c\u306e\u5909\u5316\u306e\u63a8\u5b9a\u6cbb\u7642\u5dee\n\u7d4c\u53e3\u30bb\u30de\u30b0\u30eb\u30c1\u30c93mg\u3067-1.1%\u30dd\u30a4\u30f3\u30c8(95%CI-1.4to0.8;p<0.0001)\n\u7d4c\u53e3\u30bb\u30de\u30b0\u30eb\u30c1\u30c97mg\u3067-1.5%\u30dd\u30a4\u30f3\u30c8(\u20131\u00b77 to \u20131\u00b72; p<0\u00b70001)\n\u7d4c\u53e3\u30bb\u30de\u30b0\u30eb\u30c1\u30c914mg\u3067-1.7%\u30dd\u30a4\u30f3\u30c8(\u20132\u00b70 to \u20131\u00b74; p<0\u00b70001)\n\u30ea\u30e9\u30b0\u30eb\u30c1\u30c90.9mg\u3068\u6bd4\u8f03\u3057\u305f\u63a8\u5b9a\u6cbb\u7642\u5dee\n\u7d4c\u53e3\u30bb\u30de\u30b0\u30eb\u30c1\u30c93mg\u30670.3%\u30dd\u30a4\u30f3\u30c8(95% CI \u20130\u00b70 to 0\u00b76; p=0\u00b70799)\n\u7d4c\u53e3\u30bb\u30de\u30b0\u30eb\u30c1\u30c97mg\u3067-0.1%\u30dd\u30a4\u30f3\u30c8(\u20130\u00b74 to 0\u00b72; p=0\u00b73942)\n\u7d4c\u53e3\u30bb\u30de\u30b0\u30eb\u30c1\u30c914mg\u3067-0.3%\u30dd\u30a4\u30f3\u30c8(\u20130\u00b76 to \u20130\u00b70; p=0\u00b70272)\n\u4f53\u91cd\u5909\u5316\u306f\u7d4c\u53e3\u30bb\u30de\u30b0\u30eb\u30c1\u30c914mg\u3067\u306f26\u9031\u3067\u30d9\u30fc\u30b9\u30e9\u30a4\u30f3\u304b\u3089\u6e1b\u5c11\u3057\u300152\u9031\u307e\u3067\u6301\u7d9a\u7684\u306b\u6e1b\u5c11\u3057\u305f\u300226\u9031\u3067\u30d7\u30e9\u30bb\u30dc\uff08P\uff1d0.0073\uff09\u3001\u30ea\u30e9\u30b0\u30eb\u30c1\u30c9\uff08\u30bb\u30de\u30b0\u30eb\u30c1\u30c97mg P=0.0312\/\u30bb\u30de\u30b0\u30eb\u30c1\u30c914mg P<0.0001\uff09\u3068\u6bd4\u8f03\u3057\u3066\u7d4c\u53e3\u30bb\u30de\u30b0\u30eb\u30c1\u30c914mg\u306f\u6709\u610f\u306b\u4f53\u91cd\u6e1b\u5c11\u3057\u305f(Figure3)\u3002\n\u4e3b\u8981\u306a\u8efd\u5ea6\u307e\u305f\u306f\u4e2d\u7b49\u5ea6\u306e\u6d88\u5316\u7ba1\u30a4\u30d9\u30f3\u30c8\u304c\u7d4c\u53e3\u30bb\u30de\u30b0\u30eb\u30c1\u30c9\u3067\u6700\u3082\u983b\u7e41\u306b\u5831\u544a\u3055\u308c\u305f\u6709\u5bb3\u4e8b\u8c61\u3060\u3063\u305f\u3002\u4fbf\u79d8\u304c\u6700\u3082\u4e00\u822c\u7684\u3067\u3001\u7d4c\u53e3\u30bb\u30de\u30b0\u30eb\u30c1\u30c9\u306e\u60a3\u80055~6\u4eba(10~13%)\u3001\u30d7\u30e9\u30bb\u30dc\u3067\uff13\u4eba\uff08\uff16\uff05\uff09\u3001\u30ea\u30e9\u30b0\u30eb\u30c1\u30c99\u4eba\uff0819%\uff09\u3060\u3063\u305f\u3002\n\u7d50\u8ad6\u3000\u3053\u306e\u7814\u7a76\u306f\u7d4c\u53e3\u30bb\u30de\u30b0\u30eb\u30c1\u30c9\u304c\uff12\u578b\u7cd6\u5c3f\u75c5\u306e\u65e5\u672c\u4eba\u60a3\u8005\u306b\u304a\u3051\u308b\u30d7\u30e9\u30bb\u30dc\u3068\u30ea\u30e9\u30b0\u30eb\u30c1\u30c9\u306e\u4e21\u65b9\u3068\u6bd4\u8f03\u3057\u305f\u7d4c\u53e3\u30bb\u30de\u30b0\u30eb\u30c1\u30c9\u5358\u5264\u7642\u6cd5\u306e\u6709\u52b9\u6027\u3068\u5b89\u5168\u6027\u3092\u793a\u3057\u3066\u3044\u308b\u3002\u7528\u91cf\u53cd\u5fdc\u95a2\u4fc2\u304c\u78ba\u7acb\u3055\u308c\u3001\u7d4c\u53e3\u30bb\u30de\u30b0\u30eb\u30c1\u30c914mg\u306b\u3088\u308a26\u9031\u76ee\u306b\u304a\u3044\u3066HbA1c\u3068\u4f53\u91cd\u4e21\u65b9\u304c\u30d7\u30e9\u30bb\u30dc\u304a\u3088\u3073\u65e5\u672c\u3067\u627f\u8a8d\u3055\u308c\u305f\u30ea\u30e9\u30b0\u30eb\u30c1\u30c9\u306e\u7dad\u6301\u91cf(0.9mg)\u3088\u308a\u3082\u6709\u610f\u306b\u6e1b\u5c11\u3059\u308b\u3053\u3068\u304c\u308f\u304b\u3063\u305f\u3002\u7d4c\u53e3\u30bb\u30de\u30b0\u30eb\u30c1\u30c97mg\u306f\u30ea\u30e9\u30b0\u30eb\u30c1\u30c90.9mg\u3068\u540c\u7b49\u306bHb1c\u3092\u4e0b\u3052\u308b\u3053\u3068\u304c\u308f\u304b\u3063\u305f\u3002\n\n<a href=\"https:\/\/www.hcfm.jp\/journal\/wp-content\/uploads\/2020\/08\/JC\u767d\u6c34\uff11.png\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.hcfm.jp\/journal\/wp-content\/uploads\/2020\/08\/JC\u767d\u6c34\uff11-1024x610.png\" alt=\"JC\u767d\u6c34\uff11\" width=\"660\" height=\"393\" class=\"alignnone size-large wp-image-1972\" srcset=\"https:\/\/www.hcfm.jp\/journal\/wp-content\/uploads\/2020\/08\/JC\u767d\u6c34\uff11-1024x610.png 1024w, https:\/\/www.hcfm.jp\/journal\/wp-content\/uploads\/2020\/08\/JC\u767d\u6c34\uff11-300x179.png 300w, https:\/\/www.hcfm.jp\/journal\/wp-content\/uploads\/2020\/08\/JC\u767d\u6c34\uff11.png 1098w\" sizes=\"auto, (max-width: 660px) 100vw, 660px\" \/><\/a><\/p>\n<p><a href=\"https:\/\/www.hcfm.jp\/journal\/wp-content\/uploads\/2020\/08\/JC\u767d\u6c34\uff12.png\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.hcfm.jp\/journal\/wp-content\/uploads\/2020\/08\/JC\u767d\u6c34\uff12.png\" alt=\"JC\u767d\u6c34\uff12\" width=\"534\" height=\"709\" class=\"alignnone size-full wp-image-1973\" srcset=\"https:\/\/www.hcfm.jp\/journal\/wp-content\/uploads\/2020\/08\/JC\u767d\u6c34\uff12.png 534w, https:\/\/www.hcfm.jp\/journal\/wp-content\/uploads\/2020\/08\/JC\u767d\u6c34\uff12-226x300.png 226w\" sizes=\"auto, (max-width: 534px) 100vw, 534px\" \/><\/a><\/p>\n<p><a href=\"https:\/\/www.hcfm.jp\/journal\/wp-content\/uploads\/2020\/08\/JC\u767d\u6c34\uff13.png\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.hcfm.jp\/journal\/wp-content\/uploads\/2020\/08\/JC\u767d\u6c34\uff13.png\" alt=\"JC\u767d\u6c34\uff13\" width=\"536\" height=\"381\" class=\"alignnone size-full wp-image-1974\" srcset=\"https:\/\/www.hcfm.jp\/journal\/wp-content\/uploads\/2020\/08\/JC\u767d\u6c34\uff13.png 536w, https:\/\/www.hcfm.jp\/journal\/wp-content\/uploads\/2020\/08\/JC\u767d\u6c34\uff13-300x213.png 300w\" sizes=\"auto, (max-width: 536px) 100vw, 536px\" \/><\/a><\/p>\n<p><a href=\"https:\/\/www.hcfm.jp\/journal\/wp-content\/uploads\/2020\/08\/JC\u767d\u6c34\uff14.png\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.hcfm.jp\/journal\/wp-content\/uploads\/2020\/08\/JC\u767d\u6c34\uff14.png\" alt=\"JC\u767d\u6c34\uff14\" width=\"587\" height=\"656\" class=\"alignnone size-full wp-image-1975\" srcset=\"https:\/\/www.hcfm.jp\/journal\/wp-content\/uploads\/2020\/08\/JC\u767d\u6c34\uff14.png 587w, https:\/\/www.hcfm.jp\/journal\/wp-content\/uploads\/2020\/08\/JC\u767d\u6c34\uff14-268x300.png 268w\" sizes=\"auto, (max-width: 587px) 100vw, 587px\" \/><\/a><\/p>\n<p>\u3010\u958b\u50ac\u65e5\u30112020\u5e748\u670812\u65e5\uff08\u6c34\uff09<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\uff0d\u6587\u732e\u540d\uff0d Yamada Y, Katagiri H, Hamamoto Y, et al. Dose-response, efficacy, and safety of oral semaglutide monothe &hellip; <a href=\"https:\/\/www.hcfm.jp\/journal\/?p=1971\" class=\"more-link\">\u7d9a\u304d\u3092\u8aad\u3080 <span class=\"screen-reader-text\">\u65e5\u672c\u4eba\uff12\u578b\u7cd6\u5c3f\u75c5\u60a3\u8005\u306b\u5bfe\u3059\u308b\u7d4c\u53e3\u30bb\u30de\u30b0\u30eb\u30c1\u30c9\u5358\u5264\u7642\u6cd5\u306e\u7528\u91cf\u53cd\u5fdc\u6027\u3001\u52b9\u679c\u3001\u5b89\u5168\u6027(PIONNER9)<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[22,17],"tags":[],"class_list":["post-1971","post","type-post","status-publish","format-standard","hentry","category-22","category-17"],"_links":{"self":[{"href":"https:\/\/www.hcfm.jp\/journal\/index.php?rest_route=\/wp\/v2\/posts\/1971","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.hcfm.jp\/journal\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.hcfm.jp\/journal\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.hcfm.jp\/journal\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.hcfm.jp\/journal\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=1971"}],"version-history":[{"count":2,"href":"https:\/\/www.hcfm.jp\/journal\/index.php?rest_route=\/wp\/v2\/posts\/1971\/revisions"}],"predecessor-version":[{"id":1977,"href":"https:\/\/www.hcfm.jp\/journal\/index.php?rest_route=\/wp\/v2\/posts\/1971\/revisions\/1977"}],"wp:attachment":[{"href":"https:\/\/www.hcfm.jp\/journal\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=1971"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.hcfm.jp\/journal\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=1971"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.hcfm.jp\/journal\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=1971"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}