1.Identification and International Comparison of Drugs Contraindicated for Pregnant Women in the Package Inserts
Takamasa SAKAI ; Yuri SATO ; Shiro HATAKEYAMA ; Daisuke KIKUCHI ; Masami TSUCHIYA ; Yuki KONDO ; Izumi SATO ; Yuko OKADA ; Taku OBARA
Japanese Journal of Drug Informatics 2024;25(4):211-219
Objective: The package inserts are official clinical decision-making documents that provide pharmacological treatment information. However, it has been noted that package inserts on perinatal drug usage differ greatly from expert opinions. This study identified Japanese package insert drugs that are contraindicated for pregnant women and compared them to foreign risk categories.Methods: The survey included 19,022 drugs on the drug pricing list as of April 2022, with package inserts available on the Pharmaceuticals and Medical Devices Agency website. We retrieved the package inserts with the word “pregnant” in the “Contraindications” section and reviewed the descriptions to exclude those that satisfied the exclusion criteria. We also checked the foreign risk categories of contraindicated ingredients for pregnant women. This study used the Australian Therapeutic Goods Administration’s categorization for prescribing medicines in pregnancy (the TGA classification).Results: Of the 19,022 medicines studied, 4,111 (21.6%) were contraindicated for pregnant women. Conversely, 19 (5.1%) ingredients categorized under the relatively safe TGA classifications A, B1, and B2 were also contraindicated for pregnant Japanese women.Conclusion: This study revealed that Japanese package inserts contraindicate over 20% of drugs for pregnant women. On the other hand, some forbidden ingredients did not match the foreign risk categories. Therefore, healthcare professionals should be aware of the limitations of Japanese package inserts concerning pregnant women and make careful decisions based on both package inserts and additional drug information.
2.Advancements and Challenges in Robot-Assisted Bone Processing in Neurosurgical Procedures
Yoshihiro KITAHAMA ; Hiroo SHIZUKA ; Yuto NAKANO ; Yukoh OHARA ; Jun MUTO ; Shuntaro TSUCHIDA ; Daisuke MOTOYAMA ; Hideaki MIYAKE ; Katsuhiko SAKAI
Neurospine 2024;21(1):97-103
Objective:
Practical applications of nerve decompression using neurosurgical robots remain unexplored. Our ongoing research and development initiatives, utilizing industrial robots, aim to establish a secure and efficient neurosurgical robotic system. The principal objective of this study was to automate bone grinding, which is a pivotal component of neurosurgical procedures.
Methods:
To achieve this goal, we integrated an endoscope system into a manipulator and conducted precision bone machining using a neurosurgical drill, recording the grinding resistance values across 3 axes. Our study encompassed 2 core tasks: linear grinding, such as laminectomy, and cylindrical grinding, such as foraminotomy, with each task yielding unique measurement data.
Results:
In linear grinding, we observed a proportional increase in grinding resistance values in the machining direction with acceleration. This observation suggests that 3-axis resistance measurements are a valuable tool for gauging and predicting deep cortical penetration. However, problems occurred in cylindrical grinding, and a significant error of 10% was detected. The analysis revealed that multiple factors, including the tool tip efficiency, machining speed, teaching methods, and deflection in the robot arm and jig joints, contributed to this error.
Conclusion
We successfully measured the resistance exerted on the tool tip during bone machining with a robotic arm across 3 axes. The resistance ranged from 3 to 8 Nm, with the measurement conducted at a processing speed approximately twice that of manual surgery performed by a surgeon. During the simulation of foraminotomy under endoscopic grinding conditions, we encountered a -10% error margin.
3.Advancements and Challenges in Robot-Assisted Bone Processing in Neurosurgical Procedures
Yoshihiro KITAHAMA ; Hiroo SHIZUKA ; Yuto NAKANO ; Yukoh OHARA ; Jun MUTO ; Shuntaro TSUCHIDA ; Daisuke MOTOYAMA ; Hideaki MIYAKE ; Katsuhiko SAKAI
Neurospine 2024;21(1):97-103
Objective:
Practical applications of nerve decompression using neurosurgical robots remain unexplored. Our ongoing research and development initiatives, utilizing industrial robots, aim to establish a secure and efficient neurosurgical robotic system. The principal objective of this study was to automate bone grinding, which is a pivotal component of neurosurgical procedures.
Methods:
To achieve this goal, we integrated an endoscope system into a manipulator and conducted precision bone machining using a neurosurgical drill, recording the grinding resistance values across 3 axes. Our study encompassed 2 core tasks: linear grinding, such as laminectomy, and cylindrical grinding, such as foraminotomy, with each task yielding unique measurement data.
Results:
In linear grinding, we observed a proportional increase in grinding resistance values in the machining direction with acceleration. This observation suggests that 3-axis resistance measurements are a valuable tool for gauging and predicting deep cortical penetration. However, problems occurred in cylindrical grinding, and a significant error of 10% was detected. The analysis revealed that multiple factors, including the tool tip efficiency, machining speed, teaching methods, and deflection in the robot arm and jig joints, contributed to this error.
Conclusion
We successfully measured the resistance exerted on the tool tip during bone machining with a robotic arm across 3 axes. The resistance ranged from 3 to 8 Nm, with the measurement conducted at a processing speed approximately twice that of manual surgery performed by a surgeon. During the simulation of foraminotomy under endoscopic grinding conditions, we encountered a -10% error margin.
4.Current trends in intraoperative neurophysiological monitoring among Asia–Pacific countries: an Asia–Pacific Spine Society survey
Hideki SHIGEMATSU ; Akimasa YASUDA ; Ronald TANGENTE ; Chris Yin Wei CHAN ; Ajoy Prasad SHETTY ; Jason Pui Yin CHEUNG ; Yong HAI ; Daisuke SAKAI ; Kyu-Jung CHO ; Chih-Wei CHEN ; Gabriel LIU ; I Gusti Lanang Ngurah Agung Artha WIGUNA ; Brian HSU ; Mun Keong KWAN
Asian Spine Journal 2024;18(6):813-821
Methods:
Spine surgeons of the Asia–Pacific Spine Society were asked to respond to a web-based survey on IONM. The questionnaire covered various aspects of IONM, including its common modality, Tc-MEP details, necessities for consistent use, and recommended modalities in major spine surgeries and representative surgical procedures.
Results:
Responses were received from 193 of 626 spine surgeons. Among these respondents, 177 used IONM routinely. Among these 177 respondents, 17 mainly used SEP, whereas the majority favored Tc-MEPs. Although a >50% decrease is the commonly used alarm point in Tc-MEP, half of the Tc-MEP users had no protocols planned for such scenarios. Moreover, half of the Tc-MEP users experienced complications, with bite injuries being the most common. Most respondents strongly recommended IONM in deformity surgery for pediatric and adult populations and tumor resection surgery for intramedullary spinal cord tumors. Conversely, IONM was the least recommended in lumbar spinal canal stenosis surgery.
Conclusions
Spine surgeons in Asia–Pacific countries favored IONM use, indicating widespread routine utilization. Tc-MEP was the predominant modality for IONM, followed by SEPs.
5.Advancements and Challenges in Robot-Assisted Bone Processing in Neurosurgical Procedures
Yoshihiro KITAHAMA ; Hiroo SHIZUKA ; Yuto NAKANO ; Yukoh OHARA ; Jun MUTO ; Shuntaro TSUCHIDA ; Daisuke MOTOYAMA ; Hideaki MIYAKE ; Katsuhiko SAKAI
Neurospine 2024;21(1):97-103
Objective:
Practical applications of nerve decompression using neurosurgical robots remain unexplored. Our ongoing research and development initiatives, utilizing industrial robots, aim to establish a secure and efficient neurosurgical robotic system. The principal objective of this study was to automate bone grinding, which is a pivotal component of neurosurgical procedures.
Methods:
To achieve this goal, we integrated an endoscope system into a manipulator and conducted precision bone machining using a neurosurgical drill, recording the grinding resistance values across 3 axes. Our study encompassed 2 core tasks: linear grinding, such as laminectomy, and cylindrical grinding, such as foraminotomy, with each task yielding unique measurement data.
Results:
In linear grinding, we observed a proportional increase in grinding resistance values in the machining direction with acceleration. This observation suggests that 3-axis resistance measurements are a valuable tool for gauging and predicting deep cortical penetration. However, problems occurred in cylindrical grinding, and a significant error of 10% was detected. The analysis revealed that multiple factors, including the tool tip efficiency, machining speed, teaching methods, and deflection in the robot arm and jig joints, contributed to this error.
Conclusion
We successfully measured the resistance exerted on the tool tip during bone machining with a robotic arm across 3 axes. The resistance ranged from 3 to 8 Nm, with the measurement conducted at a processing speed approximately twice that of manual surgery performed by a surgeon. During the simulation of foraminotomy under endoscopic grinding conditions, we encountered a -10% error margin.
6.Current trends in intraoperative neurophysiological monitoring among Asia–Pacific countries: an Asia–Pacific Spine Society survey
Hideki SHIGEMATSU ; Akimasa YASUDA ; Ronald TANGENTE ; Chris Yin Wei CHAN ; Ajoy Prasad SHETTY ; Jason Pui Yin CHEUNG ; Yong HAI ; Daisuke SAKAI ; Kyu-Jung CHO ; Chih-Wei CHEN ; Gabriel LIU ; I Gusti Lanang Ngurah Agung Artha WIGUNA ; Brian HSU ; Mun Keong KWAN
Asian Spine Journal 2024;18(6):813-821
Methods:
Spine surgeons of the Asia–Pacific Spine Society were asked to respond to a web-based survey on IONM. The questionnaire covered various aspects of IONM, including its common modality, Tc-MEP details, necessities for consistent use, and recommended modalities in major spine surgeries and representative surgical procedures.
Results:
Responses were received from 193 of 626 spine surgeons. Among these respondents, 177 used IONM routinely. Among these 177 respondents, 17 mainly used SEP, whereas the majority favored Tc-MEPs. Although a >50% decrease is the commonly used alarm point in Tc-MEP, half of the Tc-MEP users had no protocols planned for such scenarios. Moreover, half of the Tc-MEP users experienced complications, with bite injuries being the most common. Most respondents strongly recommended IONM in deformity surgery for pediatric and adult populations and tumor resection surgery for intramedullary spinal cord tumors. Conversely, IONM was the least recommended in lumbar spinal canal stenosis surgery.
Conclusions
Spine surgeons in Asia–Pacific countries favored IONM use, indicating widespread routine utilization. Tc-MEP was the predominant modality for IONM, followed by SEPs.
7.Advancements and Challenges in Robot-Assisted Bone Processing in Neurosurgical Procedures
Yoshihiro KITAHAMA ; Hiroo SHIZUKA ; Yuto NAKANO ; Yukoh OHARA ; Jun MUTO ; Shuntaro TSUCHIDA ; Daisuke MOTOYAMA ; Hideaki MIYAKE ; Katsuhiko SAKAI
Neurospine 2024;21(1):97-103
Objective:
Practical applications of nerve decompression using neurosurgical robots remain unexplored. Our ongoing research and development initiatives, utilizing industrial robots, aim to establish a secure and efficient neurosurgical robotic system. The principal objective of this study was to automate bone grinding, which is a pivotal component of neurosurgical procedures.
Methods:
To achieve this goal, we integrated an endoscope system into a manipulator and conducted precision bone machining using a neurosurgical drill, recording the grinding resistance values across 3 axes. Our study encompassed 2 core tasks: linear grinding, such as laminectomy, and cylindrical grinding, such as foraminotomy, with each task yielding unique measurement data.
Results:
In linear grinding, we observed a proportional increase in grinding resistance values in the machining direction with acceleration. This observation suggests that 3-axis resistance measurements are a valuable tool for gauging and predicting deep cortical penetration. However, problems occurred in cylindrical grinding, and a significant error of 10% was detected. The analysis revealed that multiple factors, including the tool tip efficiency, machining speed, teaching methods, and deflection in the robot arm and jig joints, contributed to this error.
Conclusion
We successfully measured the resistance exerted on the tool tip during bone machining with a robotic arm across 3 axes. The resistance ranged from 3 to 8 Nm, with the measurement conducted at a processing speed approximately twice that of manual surgery performed by a surgeon. During the simulation of foraminotomy under endoscopic grinding conditions, we encountered a -10% error margin.
8.Current trends in intraoperative neurophysiological monitoring among Asia–Pacific countries: an Asia–Pacific Spine Society survey
Hideki SHIGEMATSU ; Akimasa YASUDA ; Ronald TANGENTE ; Chris Yin Wei CHAN ; Ajoy Prasad SHETTY ; Jason Pui Yin CHEUNG ; Yong HAI ; Daisuke SAKAI ; Kyu-Jung CHO ; Chih-Wei CHEN ; Gabriel LIU ; I Gusti Lanang Ngurah Agung Artha WIGUNA ; Brian HSU ; Mun Keong KWAN
Asian Spine Journal 2024;18(6):813-821
Methods:
Spine surgeons of the Asia–Pacific Spine Society were asked to respond to a web-based survey on IONM. The questionnaire covered various aspects of IONM, including its common modality, Tc-MEP details, necessities for consistent use, and recommended modalities in major spine surgeries and representative surgical procedures.
Results:
Responses were received from 193 of 626 spine surgeons. Among these respondents, 177 used IONM routinely. Among these 177 respondents, 17 mainly used SEP, whereas the majority favored Tc-MEPs. Although a >50% decrease is the commonly used alarm point in Tc-MEP, half of the Tc-MEP users had no protocols planned for such scenarios. Moreover, half of the Tc-MEP users experienced complications, with bite injuries being the most common. Most respondents strongly recommended IONM in deformity surgery for pediatric and adult populations and tumor resection surgery for intramedullary spinal cord tumors. Conversely, IONM was the least recommended in lumbar spinal canal stenosis surgery.
Conclusions
Spine surgeons in Asia–Pacific countries favored IONM use, indicating widespread routine utilization. Tc-MEP was the predominant modality for IONM, followed by SEPs.
9.Advancements and Challenges in Robot-Assisted Bone Processing in Neurosurgical Procedures
Yoshihiro KITAHAMA ; Hiroo SHIZUKA ; Yuto NAKANO ; Yukoh OHARA ; Jun MUTO ; Shuntaro TSUCHIDA ; Daisuke MOTOYAMA ; Hideaki MIYAKE ; Katsuhiko SAKAI
Neurospine 2024;21(1):97-103
Objective:
Practical applications of nerve decompression using neurosurgical robots remain unexplored. Our ongoing research and development initiatives, utilizing industrial robots, aim to establish a secure and efficient neurosurgical robotic system. The principal objective of this study was to automate bone grinding, which is a pivotal component of neurosurgical procedures.
Methods:
To achieve this goal, we integrated an endoscope system into a manipulator and conducted precision bone machining using a neurosurgical drill, recording the grinding resistance values across 3 axes. Our study encompassed 2 core tasks: linear grinding, such as laminectomy, and cylindrical grinding, such as foraminotomy, with each task yielding unique measurement data.
Results:
In linear grinding, we observed a proportional increase in grinding resistance values in the machining direction with acceleration. This observation suggests that 3-axis resistance measurements are a valuable tool for gauging and predicting deep cortical penetration. However, problems occurred in cylindrical grinding, and a significant error of 10% was detected. The analysis revealed that multiple factors, including the tool tip efficiency, machining speed, teaching methods, and deflection in the robot arm and jig joints, contributed to this error.
Conclusion
We successfully measured the resistance exerted on the tool tip during bone machining with a robotic arm across 3 axes. The resistance ranged from 3 to 8 Nm, with the measurement conducted at a processing speed approximately twice that of manual surgery performed by a surgeon. During the simulation of foraminotomy under endoscopic grinding conditions, we encountered a -10% error margin.
10.A novel fully covered metal stent for unresectable malignant distal biliary obstruction: results of a multicenter prospective study
Arata SAKAI ; Atsuhiro MASUDA ; Takaaki EGUCHI ; Keisuke FURUMATSU ; Takao IEMOTO ; Shiei YOSHIDA ; Yoshihiro OKABE ; Kodai YAMANAKA ; Ikuya MIKI ; Saori KAKUYAMA ; Yosuke YAGI ; Daisuke SHIRASAKA ; Shinya KOHASHI ; Takashi KOBAYASHI ; Hideyuki SHIOMI ; Yuzo KODAMA
Clinical Endoscopy 2024;57(3):375-383
Background/Aims:
Endoscopic self-expandable metal stent (SEMS) placement is currently the standard technique for treating unresectable malignant distal biliary obstructions (MDBO). Therefore, covered SEMS with longer stent patency and fewer migrations are required. This study aimed to assess the clinical performance of a novel, fully covered SEMS for unresectable MDBO.
Methods:
This was a multicenter single-arm prospective study. The primary outcome was a non-obstruction rate at 6 months. The secondary outcomes were overall survival (OS), recurrent biliary obstruction (RBO), time to RBO (TRBO), technical and clinical success, and adverse events.
Results:
A total of 73 patients were enrolled in this study. The non-obstruction rate at 6 months was 61%. The median OS and TRBO were 233 and 216 days, respectively. The technical and clinical success rates were 100% and 97%, respectively. Furthermore, the rate of occurrence of RBO and adverse events was 49% and 21%, respectively. The length of bile duct stenosis (<2.2 cm) was the only significant risk factor for stent migration.
Conclusions
The non-obstruction rate of a novel fully covered SEMS for MDBO is comparable to that reported earlier but shorter than expected. Short bile duct stenosis is a significant risk factor for stent migration.


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