1.Efficacy and safety of filgotinib as induction and maintenance therapy for Japanese patients with moderately to severely active ulcerative colitis: a post-hoc analysis of the phase 2b/3 SELECTION trial
Toshifumi HIBI ; Satoshi MOTOYA ; Tadakazu HISAMATSU ; Fumihito HIRAI ; Kenji WATANABE ; Katsuyoshi MATSUOKA ; Masayuki SARUTA ; Taku KOBAYASHI ; Brian G FEAGAN ; Chantal TASSET ; Robin BESUYEN ; Chohee YUN ; Gerald CRANS ; Jie ZHANG ; Akira KONDO ; Mamoru WATANABE
Intestinal Research 2023;21(1):110-125
Background/Aims:
The safety and efficacy of filgotinib, a once-daily oral Janus kinase 1 preferential inhibitor, were evaluated in Japanese patients with ulcerative colitis (UC) in the phase 2b/3 SELECTION trial.
Methods:
SELECTION (NCT02914522) was a randomized, placebo-controlled trial comprising 2 induction studies and a maintenance study. Adults with moderately to severely active UC were randomized in induction study A (biologic-naïve) or B (biologic-experienced) to receive filgotinib 200 mg, 100 mg, or placebo once daily for 11 weeks. Patients in clinical remission or Mayo Clinic score response at week 10 entered the 47-week maintenance study. Efficacy and safety outcomes were assessed in Japanese patients enrolled in Japan.
Results:
Overall, 37 and 72 Japanese patients were enrolled in Japan in induction studies A and B, respectively, and 54 entered the maintenance study. Numerically higher proportions of filgotinib 200 mg-treated than placebo-treated patients achieved clinical remission in induction study A (4/15 [26.7%] vs. 0/6 [0%]) and the maintenance study (5/20 [25.0%] vs. 0/9 [0%]), but not induction study B (1/29 [3.4%] vs. 1/14 [7.1%]). Both doses were well tolerated, and no new safety signals were noted. Herpes zoster was reported in 1 filgotinib 200 mg-treated patient in each of induction study A (2.3%, 1/44) and the maintenance study (5.0%, 1/20).
Conclusions
These data, alongside those of the overall SELECTION population, suggest the potential of filgotinib 200 mg as a viable treatment option for Japanese patients with UC. Owing to small patient numbers, data should be interpreted cautiously.
2.Verification of the Effectiveness of the Health Support Pharmacy “Toyonaka Model,” an Industry-Government-Academia Collaboration Project Aiming to Promote Community Health through the Information from Community Pharmacies via Digital Signages
Tamaki SAWADA ; Kazuyuki NIKI ; Nichika ONISHI ; Kozo TADA ; Akiyo NISHIDA ; Koji DOHI ; Takashi KOZAI ; Yaeko OKUDA ; Yukiji MORIKAWA ; Takehiko MAE ; Mitsuyo KUROKI ; Yumi TAKAOKA ; Taro MATSUOKA ; Yasuhiro ASHIDA ; Kenji IKEDA ; Mikiko UEDA
Japanese Journal of Social Pharmacy 2022;41(2):175-186
Advances in information and communication technology (ICT)-especially, the spread of social networking services (SNSs)-have facilitated the dissemination of information and an explosion of health information lacking scientific evidence. Therefore, we believe that community pharmacies are the most suitable bases for distributing health information. In 2019, we launched the health support pharmacy “Toyonaka Model” in collaboration with the pharmaceutical association, municipal government, and university. Touch-panel digital signage (DS) was used for real-time distribution of ever-changing information and a rapid grasp of pharmacy users’ responses to various types of information. Between September 2019 and August 2021, one DS was installed in a pharmacy in each of Toyonaka City’s seven areas along with 14 questions on the usefulness of the delivered information. Respondents answered the 14 questions by a tablet or questionnaire; touch logs for DS were collected. When a pharmacy user consulted with a pharmacist about information delivered via DS, the contents were recorded and described by the pharmacist on a 4-point scale (e.g., “inquiry only,” “went through to execution”). From the 850 completed questionnaires and 61,565 touches, 88.7% of the respondents indicated that the information was useful, and 90.0% expressed interest in receiving more health information in the future. Thus, health information provided by DS may be useful to pharmacy users, as demonstrated by 113 cases in which the pharmacist was consulted regarding such information. In 62 of these cases, there were indications that the DS information might have influenced users’ behavior and intended actions.
3.Postoperative Radiographic Early-Onset Adjacent Segment Degeneration after Single-Level L4–L5 Posterior Lumbar Interbody Fusion in Patients without Preoperative Severe Sagittal Spinal Imbalance
Yuji MATSUOKA ; Kenji ENDO ; Hidekazu SUZUKI ; Yasunobu SAWAJI ; Hirosuke NISHIMURA ; Taichiro TAKAMATSU ; Osamu KOJIMA ; Kazuma MURATA ; Takeshi SEKI ; Shinji HORIE ; Takamitsu KONISHI ; Kengo YAMAMOTO
Asian Spine Journal 2018;12(4):743-748
STUDY DESIGN: Retrospective study. PURPOSE: To investigate the relationship between preoperative total spinal sagittal alignment and the early onset of adjacent segment degeneration (ASD) after single-level posterior lumbar interbody fusion (PLIF) in patients with normal sagittal spinal alignment. OVERVIEW OF LITERATURE: Postoperative early-onset ASD is one of the complications after L4–L5 PLIF, a common surgical procedure for lumbar degenerative disease in patents without severe sagittal imbalance. A better understanding of the preoperative characteristics of total spinal sagittal alignment associated with early-onset ASD could help prevent the condition. METHODS: The study included 70 consecutive patients diagnosed with lumbar degenerative disease who underwent single-level L4–L5 PLIF between 2011 and 2015. They were divided into two groups based on the radiographic progression of L3–L4 degeneration after 1-year follow-up: the ASD and the non-ASD (NASD) group. The following radiographic parameters were preoperatively and postoperatively measured: sagittal vertebral axis (SVA), thoracic kyphosis (TK), lumbar lordosis, pelvic tilt, and pelvic incidence (PI). RESULTS: Eight of the 70 patients (11%) experienced ASD after PLIF (three males and five females; age, 64.4±7.7 years). The NASD group comprised 20 males and 42 females (age, 67.7±9.3 years). Six patients of the ASD group showed decreased L3–L4 disc height, one had L3–L4 local kyphosis, and one showed both changes. Preoperative SVA, PI, and TK were significantly smaller in the ASD group than in the NASD group (p <0.05). CONCLUSIONS: A preoperative small SVA and TK with small PI were the characteristic alignments for the risk of early-onset ASD in patients without preoperative severe sagittal spinal imbalance undergoing L4–L5 single-level PLIF.
Animals
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Female
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Follow-Up Studies
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Humans
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Incidence
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Kyphosis
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Lordosis
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Male
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Retrospective Studies
4.Research of PSC (Phenomenon of the Propagated Sensation along Channels), Locations and Clinical Effects of the Meridian Point in Japan and China
Kansho YAMADA ; Tomofumi OZAKI ; Kenji MATSUOKA ; Shunji SAKAGUCHI ; Cai Yuan WANG ; Kazuhiro MORIKAWA ; Miho MATSUSHITA ; Atsushi YOSHIDA
Journal of the Japan Society of Acupuncture and Moxibustion 2009;59(4):353-374
The Research Committee for the Meridian Point held its third workshop at the 57th Annual Meeting of the Japan Society Acupuncture and Moxibustion in Kyoto. Evaluations and reports were presented on two topics.
The first topic:Study of PSC in Japan and China.
1) Literature search on PSC in China (Wang):A literature search on major studies on PSC in China since 1979 was conducted. The report introduces the definition, characteristics and the mechanism of PSC development together with meridian phenomena.
2) PSC in reference to the ryodoraku (Morikawa):Development of the reactive ryodo point in patients under hemodialysis or those who have had a total gastrectomy and the cases in which reactive ryodo points or needle sensation developed when specific regions were stimulated were reported. The relationship between reactive ryodo points and PSC was examined.
3) The mechanism by which PSC develops (Yamada):Neurotransmitter substances are released from sensory nerve endings during acupuncture stimulation. Absorbed by lymphatic vessels, these substances stimulate the smooth muscle of these vessels, thus causing the PSC. Based on factors such as transmission velocity and inhibitory factors, the mechanism by which PSC develops was investigated.
The second topic:Specific locations of meridian points and clinical effects of the meridian point.
1) Anatomical regions for GB 30 huantiao (Ozaki and Matsuoka):In establishing the international standard for the meridian points under the guidance of WHO, both Chinese and Japanese proposals were listed for GB 30. The clinical effects-presumably emanating from the subcutaneous structure when acupuncture stimuli are applied to these points in a direction perpendicular to the body surface-were comparatively evaluated.
2) Transition in the regions and main effects of GB 30 (Sakaguchi):As stated above, both Japanese and Chinese definitions were cited in establishing the international standard for GB 30 under the guidance of WHO. By quoting the classic literature from China and Japan, changes in the regions and main effects of GB 30 were comparatively evaluated.
5.An Anatomical and Clinical Examination of Meridian and Meridian Point
Kansho YAMADA ; Tomofumi OZAKI ; Kenji MATSUOKA ; Shunji SAKAGUCHI ; Cai Yuan WANG ; Kazuhiro MORIKAWA ; Shyungo MORI ; Atsushi YOSHIDA ; Seiichiro KITAMURA ; Sakae YONEYAMA ; Kazuhisa TANIGUCHI
Journal of the Japan Society of Acupuncture and Moxibustion 2006;56(1):27-56
Six members of the Research Committee for the Meridian Point (former Committee for the Meridian Point) reported on three themes regarding meridian and acupuncture point at Workshop II of the 54th Science Rally of The Japan Society of Acupuncture and Moxibustion held in Fukuoka.
1st theme : Anatomical examination of the meridian and meridian point.
1) Anatomic structure showing path and meridian running. (Kenji Matsuoka) : Similarity of meridian pathway and course of nerve and blood vessels in cadaver.
2) Gross anatomical study of meridian and acupuncture point in upper limbs (Kansho Yamada) : Doctoral study of Katsuyosi Toyoda, former Nagoya City University School of Medicine researcher and Yamada's study (Relation between running of meridian & acupuncture point and subdermal nerve & blood vessels) were reported.
2nd theme : Study of acupuncture safety depth in Japan and China.
1) Research and progress situation of acupuncture safety depth in China. (WANG Cai Yuan) : Data of Yan Zhenguo, professor of anatomy at Shanghai University of Traditional Chinese Medicine, an authority on the study of acupuncture safety depth and progress situation of recent study of acupuncture safety depth in China.
2) Retrospective study of acupuncture safety depth (Tomofumi Ozaki) : Study of acupuncture safety depth published by Ozaki to date and comparative study alongside Prof. Yan Zhenguo data.
3rd theme : Examination of clinical effect of a few meridian points.
1) Acupuncture clinical effect using a few meridian points (Syunji Sakaguchi) : Paper research and analysis of acupuncture clinical effects using 1-4 meridian points of Japana Centra Revuo Medicina.
2) Inflence on skin energizing current by various acupuncture stimulation of LI4 (Gokoku) (Kazuhiro Morikawa) : Influence on the amount of skin energizing current by acupuncture stimulation, direct current electricity stimulation and stimulation of electroacupuncture to LI4.
6.A Consideration of Safely Applying Acupuncture of the Meridian Point (Gaohuang, Koko, BL43) based on Dissection of a Cadaver, and Clinical Findings and CT Radiographic Findings in Vivo.
Tomofumi OZAKI ; Shungo MORI ; Toyotsugu SAKAMOTO ; Kouji TAKENAKA ; Tooru YUTANI ; Sakae YONEYAMA ; Kenji MATSUOKA ; Tetsuo TATSUMI ; Atsushi YOSHIDA ; Seiichiro KITAMURA
Journal of the Japan Society of Acupuncture and Moxibustion 2002;52(4):413-420
Acupuncture to Gaohuang carries a risk of causing pneumothorax because it reaches the lungs at deep portion. This study was designed to consider a safe depth for acupuncture to Gaohuang.
1) We inserted a needle to Gaohuang on both sides of a cadaver to examine the location of the needle tip and measure the distance from the body surface of the left Gaohuang to the pleura. The tip was located at the fifth intercostal region on both sides, and the distance was 44 mm with a rib thickness of 10 mm. 2) Using 104 students, we inserted a needle to the left Gaohuang until the tip reached the rib, and measured the distance between the bodysurface and rib. The minimal distance was 14 mm. 3) We inserted a needle to Gaohuang on both sides of two males and took CT-radiographs to examine the location of the needle tip and measure the distance from the body surface of Gaohuang to the pleura. In a man of standard body size, the needle reached the rib on the left and the intercostal region on the right. The thickness of the left rib was 10.9 mm, and the distance from body surface to pleura was 33.6 mm on the left and 28.4 mm on the right. In a man of thin body size, the needle reached the rib on both sides, with the rib thickness was 9.8 mm on the left and 8.8 mm on the right. The distance from body surface to pleura was 29.4 mm on the left and 31.8 mm on the right. The above results showed that needle insertion within 19 mm (the minimal value of the measured distance between the body surface and rib + the half thickness of the rib) is safe.
7.An Anatomical Study of the Projection Region of the Dome of the Pleura to the surface of the Anterior Neck. (Part II). Geographical Relationship with the Sternocleidomastoid Muscle, Clavicle, and Acupuncture Points of the Lower Anterior Neck.
Yukie UESHIMA ; Seiichiro KITAMURA ; Tetsuo TATSUMI ; Mitsuo GODA ; Tomohumi OZAKI ; Shungo MORI ; Kenji MATSUOKA ; Masanori KANEDA ; Ikiko TAKESHITA ; Yasukiyo NISHIZAKI ; Kenzou KUMAMOTO
Journal of the Japan Society of Acupuncture and Moxibustion 1994;44(4):317-328
Twenty-six domes of the pleura of thirteen cadavers were investigated. The summits of all domes protruded above the clavicle. Mediolateral positions of the summits were located between the lateral edge of the origin of the sternal head of the sternocleidomastoid muscle (CL3) and the lateral edge of the origin of its clavicular head (CL5), and their craniocaudal positions were located between the Point “Suitotsu” (S10) and the medial edge of the origin of the clavicular head (CL4). The lateral edges of the domes did not reach the level of the clavicle. Their mediolateral positions were located between CL4 and the Point “Ketsubon” (S12), and their craniocaudal positions were located between CL5 and the sternal extremity of the clavicle (CL2). The medial edges of the domes were both mediolaterally and craniocaudally located between CL2 and the suprasternal point. Projection regions of the domes of the pleura to the surface of the anterior neck were included, in all cases, within the quadrate region connecting the following four points: the Point “Suitotsu” (S10), a point of intersection between the median line and a line drawn vertically from the Point “Suitotsu” (S10) toward the median line, the suprasternal point, and a point on the clavicle corresponding to the medial one-third of the half shoulder width.
8.Topographic anatomical observations of the points of the posterior neck.
Kenji MATSUOKA ; Seiichiro KITAMURA ; Masanori KANEDA ; Akira SAKAI ; Tatsuzo NAKAMURA
Journal of the Japan Society of Acupuncture and Moxibustion 1989;39(2):195-202
The relation of needles inserted to the points of the posterior neck with the anatomical structures was investigated with dissection of four cadavers. The points investigated here are the five points of “Amon”, “Tenchuu”, “Fuuchi”, “Kankotsu”, and “Eifu”. The needles inserted to the respective points of the former three were found to penetrate the posterior atlantooccipital membrane and then the dura mater, and finally to reach the medulla oblongata. The depth from the inserted spots on the surface of the skin to the dura mater are 50, 51, and 49mm in the Amon, Tenchuu, and Fuuchi, respectively, in a cadaver with 39.1cm of circumference of the neck. Furthermore, it was found that the vertebral, the occipital, and the external carotid and the maxillar arteries were penetrated by or located near the needles which were inserted to the Fuuchi, Kankotsu, and Eifu, respectively.
9.Anatomical consideration of the acupuncture to the dorsal sacral foramina.
Masanori KANEDA ; Seiiciro KITAMURA ; Kenji MATSUOKA ; Tatsuzo NAKAMURA
Journal of the Japan Society of Acupuncture and Moxibustion 1989;39(2):203-211
The positional relation between the dorsal sacral foramina and a needle inserted in the point “T, ze-Liao” according to the method of Takenouchi-Hamazoe, and the projection positions of the respective foramina to the body surface were anatomically and bilaterally examined using fifteen cadavers. The results were as follows. (1) The needles inserted in the point “T, ze-Liao” missed the second dorsal sacral foramen caudally or latero-caudally in many cases. (2) In the mediolateral direction, the first to fourth dorsal sacral foramina were located in the middle zone between the dorsal median line and the posterior superior iliac spine. (3) In the rostro-caudal direction, the first dorsal sacral foramen were, approximately located at the same level as that of the posterior superior iliac spine. The second to fourth foramina corresponded to three points which divided the rostro-caudal distance between the posterior superior iliac spine and the sacral cornua equally into four.
10.Anatomical study of the projection region of the dome of the pleura to the surface of the anterior neck.
Yukie UESHIMA ; Seiichiro KITAMURA ; Tetsuo TATSUMI ; Mitsuo GODA ; Yoshitaka NAGASE ; Tomohumi OZAKI ; Shungo MORI ; Kenji MATSUOKA ; Masanori KANEDA ; Ikiko TAKESHITA ; Yasukiyo NISHIZAKI ; Akira SAKAI
Journal of the Japan Society of Acupuncture and Moxibustion 1989;39(2):212-220
The projection region of the dome of the pleura to the surface of the anterior neck was investigated in 31 domes of 17 cadavers. The point “Tentotsu”, and a line connecting that point and the most lateral edge of the acromion were adopted for a basis of measurement of the projection region. The mean length of the Tentotsu-Acromion line was 185mm on either side of the body. Its upward angle to the horizontal plane was 22° and 23° in average on the right and left sides, respectively, while its backward angle to the frontal plane was 23° on the right and 25° on the left. The right pleural domes (17 cases) were included within a range 0-58mm lateral to the Tentotsu and lower than 44mm above, and on the left side (14 cases), these values were 5-58mm and 49mm, respectively. On the other hand, when adopting the Tentotsu-Acromion line as the basis, the pleural domes were located within the medial one-third of the line. Their summits lay on the point of its medial one-fourth in medio-lateral direction, and were situated at levels lower than about 35 (on the right) or 32mm (on the left) above the line.


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