PowerPoint プレゼンテーション

Size: px

Start display at page:

Download "PowerPoint プレゼンテーション"

くにもとおおばま
6 years ago
Views:

The Society for Minimally Invasive spine

org 2 nd International MISt Congress in Sapporo,

Venue President Ken Ishii, MD Secretary-General

Nakanishi, MD Exchanging clinical experiences in

1 The Society for Minimally Invasive spine Stabilization 2 nd International MISt Congress in Sapporo, Japan Theme : MISt Globalism -The HONNE KAI- Date Venue President Ken Ishii, MD Secretary-General Yoshihisa Kotani, MD Secretary-General Kazuo Nakanishi, MD Exchanging clinical experiences in Asia-Pacific Cosponsored by Japan MISt Study Group and GE Healthcare MIS SPINE WEEK with JASMISS and PASMISS

3 General Information for Participants Venue International Convention Center Pamir, Sapporo Prince Hotel (same building as JASMISS and PASMISS) South 2 West 11, Chuo-ku Sapporo-shi, Hokkaido Japan Main venue: Room Hokuto at 5 th floor Exhibition and banquet: Chapel at 5 th floor (next to Hokuto) Floor map Hokuto Chapel Registration Fee JPY 10,

Welcome Message Dear Participant, It is my great pleasure and honor to personally welcome all of you to the 2 nd International MISt Congress to be held in Sapporo, July 29 th, 2017.

4 Welcome Message Dear Participant, It is my great pleasure and honor to personally welcome all of you to the 2 nd International MISt Congress to be held in Sapporo, July 29 th, In 2009, Society for MISt has been established in Boston. The society has rapidly grown up and has 7 regional MISt societies with over 750 members now. The 1 st International MISt Congress 2016 held in Singapore was extremely on a grand scale. Many MISt spinal surgeons in foreign countries participated and had a successful and fruitful discussion. The member of International MISt Society is now dramatically increasing. In this 2 nd Congress, we invite two great guest speakers, Profs Yu Liang and John YS Choi, who are prominent specialists of MISt all over the world. During 2017 MIS SpineWeek, it is a good opportunity that MISt surgeons in the world meet together to exchange information and maintain good friendships each other. I hope MISt procedures would spread all over the world through this congress. I would like to thank whose leadership and diligent efforts have created such a successful meeting, including Yoshihisa Kotani MD, Kazuo Nakanishi MD, MISt Committee, and participating company. With regards, Ken Ishii, MD, PhD President, Society for MISt Congress President for 2 nd international MISt congress Professor and Chairman, Department of Orthopaedic Surgery, School of Medicine, International University of Health and Welfare (IUHW) - 4 -

5 Welcome Message Dear Participants I am very pleased to welcome you for the 2nd international MISt meeting in Sapporo. In this week, JASMISS and PASMISS will be also scheduled as MIS SpineWeek and many Asia- Pacific participants will be gathering together. In the 2nd international MISt meeting, we invite top spine surgeons from China and Australia for special lectures and are expecting meaningful presentations and discussions as a leading Japanese society for spinal MIS. We, society office, are willing to contribute to International MISt meeting, growing toward one of global international academic societies over Asia-Pacific in the near future. After this meeting, we would like to let all participants enjoy the banquet and conversations with spectacular Hokkaido Tastes. Finally, I greatly appreciate all your participation in this meeting. Sincerely Yoshihisa Kotani, M.D. Secretary General The 2nd international MISt Meeting Vice President, Chief of Spine and Spinal Cord Center Steel Memorial Muroran Hospital Muroran, Hokkaido Japan Visiting associate professor Hokkaido University

6 What is MISt? MISt stands for Minimally Invasive Spine Stabilization. MISt is a comprehensive methodology which includes not only minimally invasive spine surgery such as MIS-PLIF/TLIF but also percutaneous vertebroplasty, related instrumentation and conservative treatment. Japan MISt study group Minimally invasive spine stabilization (MISt) is new concept of spinal surgical procedure, which represents stabilizing the spine with various minimally invasive techniques. MISt is typically applied to the patients with spinal instability and spinal deformity. MISt includes various techniques such as MIS-PLIF/ TLIF, MIS-long fixation using percutaneous pedicle screw, lateral interbody fusion (XLIF/ OLIF/ DLIF), cortical bone trajectory (CBT), percutaneous vertebroplasty (BKP/VBS), interspinous spacer (X-stop, etc.), video-assisted thoracoscopic surgery (VATS), cervical/ lumber total disc replacement (TDR), posterior second sacral alar iliac screw insertion (S2AI), sacroiliac arthrodesis, and so on. The Society for MISt was established in April 2009 at a meeting in Boston, MA, USA, by Koji Sato (Nagoya), Takanori Saito (Osaka), Masahiro Hoshino (Tokyo), Tsuyoshi Arizono (Fukuoka) and Ken Ishii (Tokyo). The Society for MISt is engaged in the following activities for propagation of safe MISt based on an All-Japan policy that transcends academic cliques and organizations: - 6 -

1. Honne-kai (open discussions), 2. Clinical conferences, 3. Education of spine surgeons and other medical staff, 4. Training young lecturers to give seminars (MISt Ishin-no-kai), 5.

7 1. Honne-kai (open discussions), 2. Clinical conferences, 3. Education of spine surgeons and other medical staff, 4. Training young lecturers to give seminars (MISt Ishin-no-kai), 5. Multicenter academic research, 6. International promotion, 7. Cadaver training support, 8. Development of new medical devices Today, Society for MISt consists of 7 branch societies. The Kansai, Chugoku-Shikoku, Kanto and Kyushu MISt societies were established in 2012, followed by The Tohoku MISt society in 2013, and the Chubu MISt society and Hokkaido MISt society in Now, Society for MISt is spreading in the world and the international branches will be established in Japan MISt study group Home Page : Notification 9 th Japan MISt Congress in Sapporo Date : Sunday, March 18 th,

8 Agenda Date : Saturday, July 29 th, 2017 Time Agenda Speaker Moderator 2:00P.M. Opening Remarks Dr. Ken Ishii (President of Japan MISt) 2:05P.M. Special Lecture 1: Dr. YU LIANG Dr. Ken Ishii "Staged Minimally Invasive Surgery on Degenerative Spine Scoliosis". 2:45P.M. Special Lecture 2: Dr. Yuichi Takano Dr. Koji Sato Latest techniques and technologies in endoscope assisted spine surgery -How to realize the growth strategy- 3:20P.M. Break Time (15min) 3:35P.M. Special Lecture 3: Dr. John Choi Dr. Yoshihisa Kotani "Evolution of approaches PLIF TLIF ALIF DLIF OLIF " 4:15P.M. Mini Lecture : Dr. Takanori Saito Dr. Yasuo Itou Minimally invasive spino-pelvic fixation for unstable pelvic ring fracture (sacrum) Dr. Haruki Funao Minimally invasive spine stabilization for spinal metastases and infectious diseases

9 Time Agenda Speaker Moderator 4:45P.M. Information Imaging for our future : GE OEC Masanao Yuhara GE Healthcare 4:55P.M. 5:10P.M. Break Time (15min) General Discussion ( 7min per each) Dr. Kei Miyamoto Dr. Hachiya Dr. Tomita Comparison of surgical outcome and complication between use of conventional posterior spinal instrumentation and percutaneous pedicle screw system for infected spine Dr. Atsushi Kojima A Case of Delayed Incisional Hernia After Oblique Lateral Lumbar Interbody Fusion. Dr. Koichiro Koshimune Minimally Invasive Spinopelvic Fixation for Osteoprotic Sacral Fractures. Dr. Tetsuhiro Ishikawa Evaluation of the presence of air on abdominal computed tomography after thoracolumbar surgeries using retroperitoneal approach. -retrospective study comparing LIF and conventional anterolateral surgeries- 5:40P.M. Closing Remarks Dr. Kazuo Nakanishi 5:45P.M. Networking Dinner Presenter:Dr. Nakanishi Opening Remarks:Dr. Kotani - 9 -

Introduction of speaker Prof Yu Liang Prof Liang is a Professor, depute chief of Dept. of Orthopaedic Surgery, Chief of Spine Division in RuiJin Hospital in China.

10 Introduction of speaker Prof Yu Liang Prof Liang is a Professor, depute chief of Dept. of Orthopaedic Surgery, Chief of Spine Division in RuiJin Hospital in China. Ruijin Hospital is the largest clinical teaching base of the Shanghai Jiao Tong University School of Medicine. He has been involving in many important academic societies. He is now the council member and Chairman of Spine Centers & Fellowships Committee of AO Spine Asia Pacific, vice chairman of Chinese Society of Minimally Invasive Spine, Chief of Chinese Society of Spinal Microsurgery, Member of Chinese Society of Spine Surgery, etc. He has been focusing on MIS, spinal degenerative conditions and spinal microsurgery

11 Prof John YS Choi FRACS FAorthA Orthopaedic Spine Surgeon Spine Ortho Clinic, Mornington Australia Prof. Choi is an orthopaedic spine surgeon specialising in adult deformity and minimally invasive spine surgery based in Melbourne, Australia. After his orthopaedic training in Melbourne, he has travelled to Hong Kong for a complex spine fellowship at Queen Mary Hospital and Duchess of Kent Children s hospital, following this he has undertaken an AO spine fellowship in MIS surgery with St. Mary s hospital in Seoul. He has subsequently travelled abroad to a number of leading spinal centres to develop his skills and experiences. He frequently hosts and trains surgeons from around the world in OLIF and Adult deformity surgery

Yuichi Takano Sex: Male Date of birth: Place of birth: Marital status: Nationality: E-mail: 20/Oct/1963 Niigata, Japan Married Japan y-takano@iwai.

12 Yuichi Takano Sex: Male Date of birth: Place of birth: Marital status: Nationality: 20/Oct/1963 Niigata, Japan Married Japan Address-Hospital: Department of Orthopaedics, Iwai Orthopaedic Medical Hospital Minami-Koiwa, Edogawa-ku, Tokyo Tel: Present position: Director, Iwai Orthopaedic Medical Hospital Professional Training and Employment: Staff of Orthopedic Surgery, Niigata University Staff of Orthopedic Surgery, Akita Red Cross Hospital Staff of Orthopedic Surgery, Nagaoka Central General Hospital Staff of Orthopedic Surgery, Niigata University Overseas Study at Indiana University Medical Center (IUPUI) Staff of Orthopedic Surgery, Ryoutsu City Hospital Director of Orthopedic Surgery, Akita Red Cross Hospital Director of Orthopedic and Spine Surgery, Iwai Orthopedic Medical Hospital Assistant director, Iwai Orthopaedic Medical Hospital Director, Iwai Orthopaedic Medical Hospital Lecturer (part-time), division of Orthopedic Surgery, Niigata University Graduate School of Medical and Dental Sciences Education: 1983~1989 Niigata University, School of Medicine 1993~1997 Niigata University, Graduate school of Medicine(PhD course) 1994 Overseas Study at Indiana University Medical Center Qualifications License for Medical Doctor Japanese Orthopedic Medical Specialist: The Japanese Orthopedic Association Spine and Spinal Cord Medical Surgeon: The Japanese Orthopedic Association Endoscopic Spinal Surgery Certified Physician: The Japanese Orthopedic Association Spine Surgeon Instructor: The Japanese Society for Spine Surgery and Related Research Membership The Japan Orthopedic Association (JOA) The Japanese Society of Spine Surgery and Related Research (JSSR) The Japanese Association Rehabilitation Medicine, Board-certificated Physiatrist The Japanese Society for the Study of Minimally Invasive Spine Surgery (JASMISS), Board member Japanese Society for Minimally Invasive Orthopedic Surgery The Niigata Spine Surgery Research Society, Board member

Yasuo Ito Sex: Male Date of birth: July 22, 1961 Place of birth: Hiroshima prefecture, Japan Nationality: Japanese Present address: Department of Orthopaedic Surgery, Kobe Red Cross Hospital 1-3-1

13 Yasuo Ito Sex: Male Date of birth: July 22, 1961 Place of birth: Hiroshima prefecture, Japan Nationality: Japanese Present address: Department of Orthopaedic Surgery, Kobe Red Cross Hospital Wakihamakaigandori, Chuo-ku, Kobe, Japan Tel: , Fax: Major field of study: Spine surgery Spinal trauma, Cervical myelopathy, degenerative disc disease, Computed navigation surgery, Minimally invasive spine surgery Education and Occupation: 1986 M.D. Okayama University, Medical School Ph.D. Okayama University graduate school of medicine Vice director, Department of Orthopaedic Surgery, Kobe Red Cross Hospital June, Director and Chief spinal surgeon, Department of Orthopaedic Surgery, Kobe Red Cross Hospital April, Clinical Associate Professor, Department of Orthopaedic Surgery, Okayama University, Medical School April, Clinical Professor, Department of Orthopaedic Surgery, Okayama University, Medical School License and certification: Japanese medical License Registration Diplomat, Japanese Board of Orthopaedic Surgery Membership of academic societies: The Japanese Orthopaedic Association The Japanese Society for Spine Surgery and Related Research The Japan Medical Society of Spinal Cord lesion American Academy of Orthopaedic Surgeons (International Affiliate Member) Councilor of Japanese Spinal Instrumentation Society (JSIS) Councilor of Japanese Society for Spine Surgery and Related Research (JSSR) Councilor of Japan Medical Society of Spinal Cord lesion (JasCoL) Councilor of Kansai Minimally Invasive Spinal Stabilization Society

HARUKI FUNAO PROFESSIONAL ADDRESS AND TELEPHONE Assistant Professor, 1. Department of Orthopaedic Surgery, School of Medicine, International University of Health and Welfare (IUHW) 2.

14 HARUKI FUNAO PROFESSIONAL ADDRESS AND TELEPHONE Assistant Professor, 1. Department of Orthopaedic Surgery, School of Medicine, International University of Health and Welfare (IUHW) 2. Spine and Spinal Cord Center, International University of Health and Welfare Mita Hospital Address: 1-4-3, Mita, Minato-ku, Tokyo, , Japan Tel: Fax: EDUCATION Medical school: 1995(April)-2001(March) School of Medicine, Keio University Residency: 2001(April)-2005(March) Department of Anesthesiology, School of Medicine, Keio University Department of Orhopaedic Surgery, School of Medicine, Keio University Fellowship: 2005(April)-2006(March) Department of Orhopaedic Surgery, School of Medicine, Keio University PhD: 2008(April)-2012(March) Musculoskeletal Infection, Bioluminescence Imaging Department of Orhopaedic Surgery, School of Medicine, Keio University PROFESSIONAL EXPERIENCE Attending surgeon: 2009(Oct.)-2012(June) Nerima General Hospital ( ), Chief of Spine Division -Affiliated hospitals of Department of Orhopaedic Surgery, Keio University Spine Research fellowship: 2012(July)-2014(June) Department of Orthopaedic Surgery, School of Medicine, Johns Hopkins University Attending surgeon: 2014(July)-2017(Mar.) Kawasaki Municipal Hospital, Chief of Spine Division -Affiliated hospitals of Department of Orhopaedic Surgery, Keio University Attending surgeon: 2017(Apr.)-present Department of Orthopaedic Surgery, School of Medicine, International University of Health and Welfare (IUHW), Spine and Spinal Cord Center, International University of Health and Welfare Mita Hospital MEDICAL LICENSURE & BOARD CERTIFICATION Full medical license (# in Japan) The Ministry of Welfare certified anesthesiologist (#10206) Board-certified orthopaedic doctor of the Japanese Orthopaedic Association (#119700) Spine specialist certified by the Japanese Orthopaedic Association (#4676) Board-certified spine surgeon, certified by the Board of the Japanese Society for Spine Surgery and Related Research (#11528) USMLE/ECFMG certificate (# ) MEMBERSHIP 1. Scoliosis Research Society, member (candidate fellow) 2. North American Spine Society, member 3. The Japanese Orthopaedic Association, member 4. The Japanese Society for Spine Surgery and Related Research, member 5. The Japanese Scoliosis Society, member 6. Japanese Society for the Study of Minimally Invasive Spine Surgery, member 7. The Eastern Japan Association of Orthopaedics and Traumatology, member 8. Japan Society for Study of Surgical Technique for Spine and Spinal Nerves, member 9. The Kanto Society of Orthopedics and Traumatology, member 10. The Japan Medical Society of Spinal Cord Lesion, member 11. Japanese Society for Minimally Invasive Orthopedic Surgery, member 12. Society for Minimally Invasive Spine Stabilization (Clinical Research Group), member 13. International Spine Study Group (Clinical Research Group) 14. Keio Spine Research Group (Clinical Research Group)

15 Participants (in alphabetical order) Name Akihiro Nagamachi Akinobu Suzuki Akira Shinohara Atsushi Kojima Daiki Oyaizu Goichi Watanabe Haruki Funao Hidetomi Terai Hirofumi Kosaka Hiroko Ishihama Hisanori Ikuma Junichi Ukai Kazuo Nakanishi Kazutaka Igarashi Kazuya Kitamura Kei Miyamoto Keiji Hasegawa Keisuke Nakano Ken Ishii Ken Nagahama Kentaro Yamada Kiyoshi Kaneda Koichiro Koshimune Koji Sato Masahiro Hoshino Masaru Kobayashi Masato Nakano Masatoshi Hoshino Michio Shinohara Motoya Ikawa Norihiro Isogai Okumura Ryousuke Satoshi Baba Seiji Otsuka Seiya Watanabe Shinichi Ishihara Shinya Arataki Takamitsu Tokioka Takashi Chikawa Takashi Tomita Takayuki Ogawa Takeshi Aoyama Tetsuhiro Ishikawa Tomohiko Hirose Tomohiro Miyashita Toshinori Sakai Toyoda Hiromitsu Tsuyoshi Arizono Wataru Narita Yasuo Ito Yoshihisa Kotani Yoshinao Koike Yoshitaka Suzuki Yudo Hachiya Yusuke Kinoshita Yusuke Oshita Yuta Shiono Institution Tokushima University Graduate School Osaka City University Department of Orthopaedic Surgery, The Jikei University Daisan Hospital Funabashi Orthopaedic Hospital, Spine Center Self-Defense Forces Central Hospital Sapporo Spine Clinic International University of Health and Welfare Osaka City University Tokushima Prefectural Central Hospital Sanokousei General Hospital, Orthopaedic Surgery, Spine Center Dept.of Orthop. Kagawa Prefectural Central Hospita Nagoya Daini Red Cross Hospital Kawasaki Medical School Chofu Hospital Saiseikai Yokohamashi Tobu Hospital Gifu Municipal Hospital Toho University Takaoka Seishikai Hospital International University of Health and Welfare Wajokai Sapporo Hospital Osaka City University Hokkaido University Kure Kyousai Hospital Japanese Red Cross Society, Nagoya Daini Hospital Sonoda Medical Institute, Tokyo Spine Center Shikoku central hospital Takaoka City Hospital Osaka City Univesity Kumamoto Kinoh Hospital Hokkaido MISt Spine and Spinal cord Center, International University of Health and Welfare, Mita Hospital Toho university Tokyo Shinjuku Medical Center Nagoya City University Kawasaki Medical School Spine and Spinal cord Center, International University of Health and Welfare (IUHW), Mita Hospital Kagawa Rosai Hospital Kochi Health Sciences Center Tokushima Municipal Hospital Aomori Prefectural Central Hospital Kaisei General Hospital Teine Keijinkai Hospital Sanmu Medical Center, Chiba, Japan Okayama Medical Cente Matsudo City Hospital Tokushima University Osaka City University Kyushu Central Hospital Midorigaoka Hospital Kobe Red Cross Hospital Steel Memorial Muroran Hospital Spine and Spinal cord center, Steel Memorial Muroran Hospital, Muroran Japan Nagoya Daini Redcross Hospital Hachiya Orthopaedic Hospital Showa Univ. Northern Yokohama Hosp. Showa Univ. Northern Yokohama Hosp. Saiseikai Central Hospital Guest Name John YS Choi Yu Liang Spine Ortho Clinic, Mornington Australia RuiJin Hospital Institution

Post Script Dear MISt members and the sponsors, On behalf of the secretariat of 2nd MISt international meeting, I am writing to share my sincere gratitude for your support.

16 Post Script Dear MISt members and the sponsors, On behalf of the secretariat of 2nd MISt international meeting, I am writing to share my sincere gratitude for your support. It would not have been possible to hold meeting without the help and support of you. Thanks again and we look forward to seeing you in Sapporo. Kazuo Nakanishi, M.D. Secretary-General Associate Professor Kawasaki Medical School nakanishikazuo60@gmail.com

18 Supporting Company

19 Supporting Company

BMD 増加効果と骨折発生リスクの抑制禁忌 ( 次の患者には投与しないこと ) 1. 高カルシウム血症の患者 [ 高カルシウム血症を悪化させるおそれがある重要な基本的注意の項参照 ] 2.

原発性の悪性骨腫瘍もしくは転移性骨腫瘍のある患者 [ 症状を悪化させるおそれがある ] 4. 骨粗鬆症以外の代謝性骨疾患の患者 ( 副甲状腺機能亢進症等 ) [ 症状を悪化させるおそれがある ] 5. 妊婦又は妊娠している可能性のある婦人及び授乳婦 [ 妊婦産婦授乳婦等への投与の項参照 ] 6.

2 4ヵ月間までとすること < 用法用量に関連する使用上の注意 > (1 ) 本剤を投与期間の上限を超えて投与したときの安全性は確立していないので本剤の適用にあたっては投与期間の上限を守ること [ その他の注意及び臨床成績の項参照 ](2 ) 本剤の投与をやむを得ず一時中断したのちに再投与する場合であっても投与日数の合計が 2 4ヵ月を超えないことまた 2 4ヵ月の投与終了後

慎重投与 ( 次の患者には慎重に投与すること )(1) 腎障害のある患者 [ 外国の臨床薬理試験において重度の腎障害患者では血中からのテリパラチドの消失に遅延が認められている薬物動態の項参照 ](2) 重度の肝障害のある患者 [ 本剤の重度の肝障害患者における使用経験が少なく安全性は確立していない ] (3 ) 尿路結石のある患者及びその既往歴のある患者 [ 本剤の投与により

重要な基本的注意 (1 ) 本剤の薬理作用により投与後約 4から 6 時間を最大として一過性の血清カルシウム値上昇がみられるまた血清カルシウム値は投与後 16 時間でほぼ基準値まで下降することが知られているため本剤投与患者における血清カルシウム値を測定評価する場合は本剤投与後 16 時間以降の測定値を評価基準とすること本剤の投与にあたっては患者に十分な説明を行い特に嘔気嘔吐

の項参照](2) 副甲状腺ホルモンは血管平滑筋の拡張作用や心筋への陽性変時陽性変力作用を示すことが報告されている心疾患のある患者には患者の状態を観察し病態の悪化がないか注意しながら本剤を投与すること (3) 腎障害のある患者においては定期的に腎機能検査を行うこと (4) 閉経前の骨粗鬆症患者での安全性及び有効性は確立していない (Saag KG, et al.

26 BMD 増加効果と骨折発生リスクの抑制禁忌 ( 次の患者には投与しないこと ) 1. 高カルシウム血症の患者 [ 高カルシウム血症を悪化させるおそれがある重要な基本的注意の項参照 ] 2. 次に掲げる骨肉腫発生のリスクが高いと考えられる患者 [ その他の注意の項参照 ] (1) 骨ページェット病の患者 (2) 原因不明のアルカリフォスファターゼ高値を示す患者 (3) 小児等及び若年者で骨端線が閉じていない患者 [ 小児等への投与の項参照 ] (4) 過去に骨への影響が考えられる放射線治療を受けた患者 3. 原発性の悪性骨腫瘍もしくは転移性骨腫瘍のある患者 [ 症状を悪化させるおそれがある ] 4. 骨粗鬆症以外の代謝性骨疾患の患者 ( 副甲状腺機能亢進症等 ) [ 症状を悪化させるおそれがある ] 5. 妊婦又は妊娠している可能性のある婦人及び授乳婦 [ 妊婦産婦授乳婦等への投与の項参照 ] 6. 本剤の成分又はテリパラチド酢酸塩に対し過敏症の既往歴のある患者効能効果骨折の危険性の高い骨粗鬆症 < 効能効果に関連する使用上の注意 > 本剤の適用にあたっては低骨密度既存骨折加齢大腿骨頸部骨折の家族歴等の骨折の危険因子を有する患者を対象とすること用法用量通常成人には 1 日 1 回テリパラチド ( 遺伝子組換え ) として 2 0μg を皮下に注射するなお本剤の投与は 2 4ヵ月間までとすること < 用法用量に関連する使用上の注意 > (1 ) 本剤を投与期間の上限を超えて投与したときの安全性は確立していないので本剤の適用にあたっては投与期間の上限を守ること [ その他の注意及び臨床成績の項参照 ](2 ) 本剤の投与をやむを得ず一時中断したのちに再投与する場合であっても投与日数の合計が 2 4ヵ月を超えないことまた 2 4ヵ月の投与終了後再度 24ヵ月の投与を繰り返さないこと (3 ) 他のテリパラチド製剤から本剤に切り替えた経験はなくその安全性は確立していないなお他のテリパラチド製剤から本剤に切り替えたときにおける本剤の投与期間の上限は検討されていない [ その他の注意の項参照] * 使用上の注意 1. 慎重投与 ( 次の患者には慎重に投与すること )(1) 腎障害のある患者 [ 外国の臨床薬理試験において重度の腎障害患者では血中からのテリパラチドの消失に遅延が認められている薬物動態の項参照 ](2) 重度の肝障害のある患者 [ 本剤の重度の肝障害患者における使用経験が少なく安全性は確立していない ] (3 ) 尿路結石のある患者及びその既往歴のある患者 [ 本剤の投与により症状を悪化させるおそれがある ] 2. 重要な基本的注意 (1 ) 本剤の薬理作用により投与後約 4から 6 時間を最大として一過性の血清カルシウム値上昇がみられるまた血清カルシウム値は投与後 16 時間でほぼ基準値まで下降することが知られているため本剤投与患者における血清カルシウム値を測定評価する場合は本剤投与後 16 時間以降の測定値を評価基準とすること本剤の投与にあたっては患者に十分な説明を行い特に嘔気嘔吐便秘嗜眠及び筋力低下等の持続性の血清カルシウム値上昇が疑われる症状が認められた場合は速やかに診察を受けるように指導すること持続性高カルシウム血症の診断は血清カルシウム値と測定時点を考慮し持続性高カルシウム血症と判断された場合は本剤の投与を中止することなお血清カルシウム値上昇によりジギタリスの作用が増強することがあるためジギタリス製剤と併用する時は注意をすること [ 相互作用の項参照](2) 副甲状腺ホルモンは血管平滑筋の拡張作用や心筋への陽性変時陽性変力作用を示すことが報告されている心疾患のある患者には患者の状態を観察し病態の悪化がないか注意しながら本剤を投与すること (3) 腎障害のある患者においては定期的に腎機能検査を行うこと (4) 閉経前の骨粗鬆症患者での安全性及び有効性は確立していない (Saag KG, et al. : Arthritis Rheum. 60, , 2009) (5 ) 起立性低血圧めまいがあらわれることがあるので高所での作業自動車の運転等危険を伴う作業に従事する場合には注意させること (6 ) 本剤の自己注射にあたっては患者に十分な教育訓練を実施したのち患者自ら確実に投与できることを確認した上で医師の管理指導のもとで実施することまた器具の安全な廃棄方法について指導を徹底すること添付されている取扱説明書を必ず読むよう指導すること 3. 相互作用併用注意 ( 併用に注意すること ) 活性型ビタミン D 製剤 ( カルシトリオールマキサカルシトールファレカルシトリオールエルデカルシトール等 ) アルファカルシドールジギタリス製剤 ( ジゴキシン等 )4. 副作用国内のプラセボを対照とした臨床試験において本剤 10~4 0μg / 日を投与注 ) した安全性評価対象 252 例中 50 例 (19.8%) に副作用 ( 臨床検査値異常を含む ) が認められた主な副作用は血中尿酸上昇 9 例 (3.6%) 頭痛 7 例 (2.8%) 悪心 7 例 (2.8%) ALP 上昇 5 例 (2.0%) 筋痙縮 3 例 (1.2%) 高尿酸血症 3 例 (1.2%) 食欲不振 3 例 (1.2%) 血中尿素上昇 3 例 (1.2%) であったなおプラセボを投与した 105 例中 11 例 (10.5 %) に副作用 ( 臨床検査値異常を含む ) が認められた注 ) 本剤の用法用量はテリパラチド ( 遺伝子組換え ) として 1 日 1 回 20μg 皮下投与である (1) 重大な副作用ショックアナフィラキシー : ショックアナフィラキシー ( 呼吸困難血圧低下発疹等 ) があらわれることがあるので観察を十分に行い異常が認められた場合には投与を中止し適切な処置を行うこと禁忌を含む使用上の注意の改訂には十分ご留意くださいその他の使用上の注意については製品添付文書をご参照ください *2 014 年 7 月改訂 ( 第 10 版 ) FRT-A081(R3)

37 Note

38 Note

40 Venue International Convention Center Pamir, Sapporo Prince Hotel (same building as JASMISS and PASMISS) South 2 West 11, Chuo-ku Sapporo-shi, Hokkaido Japan :00 P.M. - 5:45 P.M. 2 nd International MISt Congress (Main venue: Room Hokuto at 5 th floor) 5:45 P.M. - 7:45 P.M. Networking Dinner - Presenter:Dr. Nakanishi - Opening Remarks:Dr. Kotani (Chapel at 5 th floor next to Hokuto) Floor map Hokuto Chapel

r' /'!\

$r' /'!\$ r' /'!\ Dear Fellow Rotarians and Guests. Please accept from June and I the warmest greetings for a successful and enjoyable Conference. District Governor Hisayoshi Nakamura and his District Conference