1.Improvements in Intractable Lumbar and LowerExtremity Symptoms after Systemic Administration of Tocilizumab, an Anti-interleukin-6 Receptor Antibody
Takeshi SAINOH ; Takeshi SAINOH ; Sumihisa ORITA ; Sumihisa ORITA ; Masayuki MIYAGI ; Masayuki MIYAGI ; Miyako SUZUKI-NARITA ; Miyako SUZUKI-NARITA ; Yoshihiro SAKUMA ; Yoshihiro SAKUMA ; Yasuhiro OIKAWA ; Yasuhiro OIKAWA ; Go KUBOTA ; Go KUBOTA ; Jun SATO ; Jun SATO ; Yasuhiro SHIGA ; Yasuhiro SHIGA ; Kazuki FUJIMOTO ; Kazuki FUJIMOTO ; Yawara EGUCHI ; Yawara EGUCHI ; Masao KODA ; Masao KODA ; Yasuchika AOKI ; Yasuchika AOKI ; Tsutomu AKAZAWA ; Tsutomu AKAZAWA ; Takeo FURUYA ; Takeo FURUYA ; Junichi NAKAMURA ; Junichi NAKAMURA ; Hiroshi TAKAHASHI ; Hiroshi TAKAHASHI ; Satoshi MAKI ; Satoshi MAKI ; Masahiro INOUE ; Masahiro INOUE ; Hideyuki KINOSHITA ; Hideyuki KINOSHITA ; Masaki NORIMOTO ; Masaki NORIMOTO ; Takashi SATO ; Takashi SATO ; Masashi SATO ; Masashi SATO ; Masahiro SUZUKI ; Masahiro SUZUKI ; Keigo ENOMOTO ; Keigo ENOMOTO ; Hiromitsu TAKAOKA ; Hiromitsu TAKAOKA ; Norichika MIZUKI ; Norichika MIZUKI ; Takashi HOZUMI ; Takashi HOZUMI ; Ryuto TSUCHIYA ; Ryuto TSUCHIYA ; Geundong KIM ; Geundong KIM ; Takuma OTAGIRI ; Takuma OTAGIRI ; Tomohito MUKAIHATA ; Tomohito MUKAIHATA ; Takahisa HISHIYA ; Takahisa HISHIYA ; Seiji OHTORI ; Seiji OHTORI ; Kazuhide INAGE ; Kazuhide INAGE
Asian Spine Journal 2022;16(1):99-106
		                        		
		                        			 Methods:
		                        			This prospective, single-arm study included 11 patients (eight men; mean age, 62.7 years) with ≥3-months’ chronic pain history due to lumbar disease. Subcutaneous TCZ injections were administered twice, at a 2-week interval. We evaluated low back pain, leg pain, and leg numbness using numeric rating scales and the Oswestry Disability Index (ODI; baseline and 6 months postinjection); serum IL-6 and tumor necrosis factor-α levels (baseline and 1 month postinjection); and clinical adverse events. 
		                        		
		                        			Results:
		                        			Intractable symptoms reduced after TCZ administration. Low back pain improved for 6 months. Improvements in leg pain and numbness peaked at 4 and 1 month, respectively. Improvements in ODI were significant at 1 month and peaked at 4 months. Serum IL-6 was increased at 1 month. IL-6 responders (i.e., patients with IL-6 increases >10 pg/mL) showed particularly significant improvements in leg pain at 2 weeks, 1 month, and 2 months compared with nonresponders. We observed no apparent adverse events. 
		                        		
		                        			Conclusions
		                        			Systemic TCZ administration improved symptoms effectively for 6 months, with peak improvements at 1–4 months and no adverse events. Changing serum IL-6 levels correlated with leg pain improvements; further studies are warranted to elucidate the mechanistic connections between lumbar disorders and inflammatory cytokines. 
		                        		
		                        		
		                        		
		                        	
2.Usefulness of Simultaneous Magnetic Resonance Neurography and Apparent T2 Mapping for the Diagnosis of Cervical Radiculopathy
Keigo ENOMOTO ; Yawara EGUCHI ; Takashi SATO ; Masaki NORIMOTO ; Masahiro INOUE ; Atsuya WATANABE ; Takayuki SAKAI ; Masami YONEYAMA ; Yasuchika AOKI ; Sumihisa ORITA ; Miyako NARITA ; Kazuhide INAGE ; Yasuhiro SHIGA ; Tomotaka UMIMURA ; Masashi SATO ; Masahiro SUZUKI ; Hiromitsu TAKAOKA ; Norichika MIZUKI ; Geundong KIM ; Takashi HOZUMI ; Naoya HIROSAWA ; Takeo FURUYA ; Satoshi MAKI ; Junichi NAKAMURA ; Shigeo HAGIWARA ; Masao KODA ; Tsutomu AKAZAWA ; Hiroshi TAKAHASHI ; Kazuhisa TAKAHASHI ; Seiji OHTORI
Asian Spine Journal 2022;16(1):47-55
		                        		
		                        			 Methods:
		                        			A total of 14 patients with unilateral radicular symptoms and five healthy subjects were subjected to simultaneous apparent T2 mapping and neurography with nerve-sheath signal increased with inked rest-tissue rapid acquisition of relaxation enhancement signaling (SHINKEI-Quant) using a 3-Tesla magnetic resonance imaging. The Visual Analog Scale (VAS) score for neck pain and upper arm pain was used to evaluate clinical symptoms. T2 relaxation times of the cervical dorsal root ganglia of the brachial plexus were measured bilaterally from C4 to C8 in patients with radicular symptoms and from C5 to C8 in healthy controls. The T2 ratio was calculated as the affected side to unaffected side. 
		                        		
		                        			Results:
		                        			When comparing nerve roots bilaterally at each spinal level, no significant differences in T2 relaxation times were found between patients and healthy subjects. However, T2 relaxation times of nerve roots in the patients with unilateral radicular symptoms were significantly prolonged on the involved side compared with the uninvolved side (p<0.05). The VAS score for upper arm pain was not significantly correlated with the T2 relaxation times, but was positively correlated with the T2 ratio. 
		                        		
		                        			Conclusions
		                        			In patients with cervical radiculopathy, the SHINKEI-Quant technique can be used to quantitatively evaluate the compressed cervical nerve roots. The VAS score for upper arm pain was positively correlated with the T2 ratio. This suggests that the SHINKEI-Quant is a potential tool for the diagnosis of cervical nerve entrapment. 
		                        		
		                        		
		                        		
		                        	
3.Time-Course Changes in Bone Metabolism Markers and Density in Patients with Osteoporosis Treated with Romosozumab: A Multicenter Retrospective Study
Kazuhide INAGE ; Sumihisa ORITA ; Yawara EGUCHI ; Yasuhiro SHIGA ; Masao KODA ; Yasuchika AOKI ; Toshiaki KOTANI ; Tsutomu AKAZAWA ; Takeo FURUYA ; Junichi NAKAMURA ; Hiroshi TAKAHASHI ; Miyako SUZUKI-NARITA ; Satoshi MAKI ; Shigeo HAGIWARA ; Masahiro INOUE ; Masaki NORIMOTO ; Hideyuki KINOSHITA ; Takashi SATO ; Masashi SATO ; Keigo ENOMOTO ; Hiromitsu TAKAOKA ; Norichika MIZUKI ; Takashi HOZUMI ; Ryuto TSUCHIYA ; Geundong KIM ; Takuma OTAGIRI ; Tomohito MUKAIHATA ; Takahisa HISHIYA ; Seiji OHTORI
Yonsei Medical Journal 2021;62(9):829-835
		                        		
		                        			Purpose:
		                        			In this multicenter retrospective observational study, we examined the early effects of romosozumab in patients with severe osteoporosis in terms of time-course changes in bone metabolism marker, improvement in bone density, and adverse effects. 
		                        		
		                        			Materials and Methods:
		                        			Patients with severe osteoporosis were included. We investigated the progress of TRACP 5b and P1NP before and 1–2 months after the administration of romosozumab. We also investigated the bone density of lumbar spine, femoral neck, and the entire femur, measured by the DXA method, before and 5–7 months after the administration of romosozumab. 
		                        		
		                        			Results:
		                        			A total of 70 patients (7 males and 63 females, age 75.0±3.6 years) participated in this study. Significant improvements in TRACP 5b and P1NP levels were observed before and 1–2 months after romosozumab administration. The average bone density of lumbar spine, femoral neck, and the entire femur were measured before and 5–7 months after romosozumab administration;and a significant increase only observed in the lumbar spine. 
		                        		
		                        			Conclusion
		                        			Consistent with the findings of previous clinical studies, romosozumab has both bone formation-enhancing and bone resorption effects (dual effect). In addition, romosozumab also demonstrated improvement in bone density from the early phase after the administration, though the result was only seen in the lumbar spine.
		                        		
		                        		
		                        		
		                        	
4.Time-Course Changes in Bone Metabolism Markers and Density in Patients with Osteoporosis Treated with Romosozumab: A Multicenter Retrospective Study
Kazuhide INAGE ; Sumihisa ORITA ; Yawara EGUCHI ; Yasuhiro SHIGA ; Masao KODA ; Yasuchika AOKI ; Toshiaki KOTANI ; Tsutomu AKAZAWA ; Takeo FURUYA ; Junichi NAKAMURA ; Hiroshi TAKAHASHI ; Miyako SUZUKI-NARITA ; Satoshi MAKI ; Shigeo HAGIWARA ; Masahiro INOUE ; Masaki NORIMOTO ; Hideyuki KINOSHITA ; Takashi SATO ; Masashi SATO ; Keigo ENOMOTO ; Hiromitsu TAKAOKA ; Norichika MIZUKI ; Takashi HOZUMI ; Ryuto TSUCHIYA ; Geundong KIM ; Takuma OTAGIRI ; Tomohito MUKAIHATA ; Takahisa HISHIYA ; Seiji OHTORI
Yonsei Medical Journal 2021;62(9):829-835
		                        		
		                        			Purpose:
		                        			In this multicenter retrospective observational study, we examined the early effects of romosozumab in patients with severe osteoporosis in terms of time-course changes in bone metabolism marker, improvement in bone density, and adverse effects. 
		                        		
		                        			Materials and Methods:
		                        			Patients with severe osteoporosis were included. We investigated the progress of TRACP 5b and P1NP before and 1–2 months after the administration of romosozumab. We also investigated the bone density of lumbar spine, femoral neck, and the entire femur, measured by the DXA method, before and 5–7 months after the administration of romosozumab. 
		                        		
		                        			Results:
		                        			A total of 70 patients (7 males and 63 females, age 75.0±3.6 years) participated in this study. Significant improvements in TRACP 5b and P1NP levels were observed before and 1–2 months after romosozumab administration. The average bone density of lumbar spine, femoral neck, and the entire femur were measured before and 5–7 months after romosozumab administration;and a significant increase only observed in the lumbar spine. 
		                        		
		                        			Conclusion
		                        			Consistent with the findings of previous clinical studies, romosozumab has both bone formation-enhancing and bone resorption effects (dual effect). In addition, romosozumab also demonstrated improvement in bone density from the early phase after the administration, though the result was only seen in the lumbar spine.
		                        		
		                        		
		                        		
		                        	
5.Successful Use of the Hybrid Assistive Limb for Care Support to Reduce Lumbar Load in a Simulated Patient Transfer
Kousei MIURA ; Hideki KADONE ; Tetsuya ABE ; Masao KODA ; Toru FUNAYAMA ; Hiroshi NOGUCHI ; Hiroshi KUMAGAI ; Katsuya NAGASHIMA ; Kentaro MATAKI ; Yosuke SHIBAO ; Kosuke SATO ; Hiroaki KAWAMOTO ; Yoshiyuki SANKAI ; Masashi YAMAZAKI
Asian Spine Journal 2021;15(1):40-45
		                        		
		                        			 Methods:
		                        			Nineteen volunteers (16 men, three women) lifted a 60-kg doll from a seated position to a standing position. The first transfer was performed without the HAL for Care Support, and the second was performed with the HAL for Care Support assistive robot. We evaluated transfer performance, the visual analog scale (VAS) score for lumbar fatigue, and electromyogram analyses of the trunk and hip. 
		                        		
		                        			Results:
		                        			Four participants (two men, two women) succeeded with the HAL for Care Support even though they were unable to perform the task without it. The mean lumbar fatigue VAS score for all participants without the HAL for Care Support was 62 mm, while that with it was 43 mm. With lumbar assistance from the HAL for Care Support, subjective lumbar fatigue during the transfer decreased significantly. A power analysis indicated adequate statistical power to detect a difference in the VAS score for lumbar fatigue (0.99). The activity of the left gluteus maximus alone increased significantly during transfers with the HAL for Care Support. No adverse events occurred during use of the HAL for Care Support for transfers. 
		                        		
		                        			Conclusions
		                        			The HAL for Care Support was able to reduce lumbar load in a simulated patient transfer. 
		                        		
		                        		
		                        		
		                        	
6.Current Use of Sedatives for Terminal Cancer Patients near Death Receiving Home Palliative Care, and Influence on Home Care Period
Kotaro HASHIMOTO ; Kazuki SATO ; Mitsuharu SASAKI ; Hiroaki TAKABAYASHI ; Masanori KAWAHARA ; Masao SUZUKI
Palliative Care Research 2019;14(3):187-192
		                        		
		                        			
		                        			Objective: This study investigated the association between use of sedatives in terminal cancer patients near death who were receiving home care and the home care period. Methods: We conducted a retrospective review of the medical records for 1032 cancer patients who received home palliative care from 17 specialized home care clinics between June and November 2013. We checked the use of sedatives within 48 hours before death at home, and we compared the home care period between patients with and without sedation. Results: The sedatives used were diazepam (n, %: 100, 52%), flunitrazepam (29, 15%), bromazepam (27, 14%), midazolam (26, 13%), and phenobarbital (20, 10%). The median home care period (median [quartiles]) was 26 [13, 63] days and 25 [10, 64] days (Adj p=0.79) for the patients with and without sedatives, respectively. Conclusion: Among terminal cancer patients near death receiving home care, 24% were administered sedatives, with more than half of those patients receiving diazepam. There was no association between use of sedatives and the home care period.
		                        		
		                        		
		                        		
		                        	
7.A novel unidirectional porous β-tricalcium phosphate grafting for vertebral fracture in the elderly: preliminary case series
Toru FUNAYAMA ; Toshinori TSUKANISHI ; Hiroshi KUMAGAI ; Hiroshi NOGUCHI ; Shigeo IZAWA ; Tetsuya ABE ; Kousei MIURA ; Katsuya NAGASHIMA ; Kentaro MATAKI ; Yosuke SHIBAO ; Kosuke SATO ; Masao KODA ; Masashi YAMAZAKI
Journal of Rural Medicine 2019;14(2):211-215
		                        		
		                        			
		                        			Objective: To treat vertebral fractures with posterior wall injury in the elderly, vertebral bone grafting is generally performed through a posterior transpedicular approach, combined with pedicle screw fixation. An autologous bone is ideal to treat this disorder. However, harvesting autologous bones from the elderly with osteoporosis is limited by the amount and quality of available autologous bone. Thus, we developed a bone-grafting substitute. The newly developed unidirectional porous β-tricalcium phosphate, with a porosity of 57% (UDPTCP; Affinos®, Kuraray Co., Ltd., Tokyo, Japan), is used in the bone-grafting procedure. This is the first report of UDPTCP used as an artificial bone graft in patients with an acute vertebral burst fracture.Materials and Methods: UDPTCP (mean: 4.2 g) was implanted through the pedicle, and posterior instrumentation was achieved with pedicle screws in five elderly patients. Resorption of UDPTCP and substitution with the autologous bone were evaluated on computed tomography (CT) and plain X-ray performed immediately and at 3, 6, and 12 months after the operation.Results: In case 1, the pedicle screws did not loosen, and UDPTCP was completely resorbed and replaced with the autologous bone at 3 postoperative months. In the other four cases, although the pedicle screws or the caudal part loosened because of osteoporosis, resorption of UDPTCP was observed at 3 postoperative months. At 6 postoperative months, progressive substitution with the autologous bone was confirmed, and at 12 postoperative months, formation of the good autologous bone was confirmed.Conclusion: This preliminary case series demonstrated that the newly developed UDPTCP shows good clinical potential as a bone-graft substitute for acute vertebral burst fractures in the elderly, including patients with osteoporosis.
		                        		
		                        		
		                        		
		                        	
8.Comparison of the Diagnostic Yield of the Standard 22-Gauge Needle and the New 20-Gauge Forward-Bevel Core Biopsy Needle for Endoscopic Ultrasound-Guided Tissue Acquisition from Pancreatic Lesions
Shinya FUJIE ; Hirotoshi ISHIWATARI ; Keiko SASAKI ; Junya SATO ; Hiroyuki MATSUBAYASHI ; Masao YOSHIDA ; Sayo ITO ; Noboru KAWATA ; Kenichiro IMAI ; Naomi KAKUSHIMA ; Kohei TAKIZAWA ; Kinichi HOTTA ; Hiroyuki ONO
Gut and Liver 2019;13(3):349-355
		                        		
		                        			
		                        			BACKGROUND/AIMS: To compare the diagnostic yield of 20-gauge forward-bevel core biopsy needle (CBN) and 22-gauge needle for endoscopic ultrasound (EUS)-guided fine needle aspiration (FNA) of solid pancreatic masses. METHODS: The use of 20-gauge CBN was prospectively evaluated for 50 patients who underwent EUS-FNA from June 2016 to December 2016. Data were compared with those obtained by a retrospective study of 50 consecutive patients who underwent EUS-FNA using standard 22-gauge needles between December 2016 and April 2017. At least two punctures were performed for each patient; the sample from the first pass was used for cytology with or without histology and that from the second pass was used for histology. Sample quantity was evaluated using the sample obtained from the second pass. RESULTS: There was no significant difference in the diagnostic accuracy rate between the first and second passes (20-gauge CBN: 96% [48/50]; standard 22-gauge needle: 88% [44/50]). Samples >10× power fields in length were obtained from 90% (43/48) and 60% (30/50) of patients using the 20-gauge CBN and standard 22-gauge needle, respectively (p=0.01). Technical failure occurred for two patients with the 20-gauge CBN. CONCLUSIONS: Diagnostic accuracy of the 20-gauge CBN was comparable to that of the 22-gauge needle. However, two passes with the 20-gauge CBN yielded a correct diagnosis for 100% of patients when technically feasible. Moreover, the 20-gauge CBN yielded core tissue for 90% patients, which was a performance superior to that of the 22-gauge needle.
		                        		
		                        		
		                        		
		                        			Biopsy
		                        			;
		                        		
		                        			Biopsy, Fine-Needle
		                        			;
		                        		
		                        			Diagnosis
		                        			;
		                        		
		                        			Endoscopic Ultrasound-Guided Fine Needle Aspiration
		                        			;
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Needles
		                        			;
		                        		
		                        			Pancreas
		                        			;
		                        		
		                        			Prospective Studies
		                        			;
		                        		
		                        			Punctures
		                        			;
		                        		
		                        			Retrospective Studies
		                        			;
		                        		
		                        			Ultrasonography
		                        			
		                        		
		                        	
9.Appendix 1
Masao IWAGAMI ; Kotonari AOKI ; Manabu AKAZAWA ; Chieko ISHIGURO ; Shinobu IMAI ; Nobuhiro OOBA ; Makiko KUSAMA ; Daisuke KOIDE ; Atsushi GOTO ; Norihiro KOBAYASHI ; Izumi SATO ; Sayuri NAKANE ; Makoto MIYAZAKI ; Kiyoshi KUBOTA
Japanese Journal of Pharmacoepidemiology 2018;23(2):124-124
		                        		
		                        		
		                        		
		                        	
10.Appendix 2
Masao IWAGAMI ; Kotonari AOKI ; Manabu AKAZAWA ; Chieko ISHIGURO ; Shinobu IMAI ; Nobuhiro OOBA ; Makiko KUSAMA ; Daisuke KOIDE ; Atsushi GOTO ; Norihiro KOBAYASHI ; Izumi SATO ; Sayuri NAKANE ; Makoto MIYAZAKI ; Kiyoshi KUBOTA
Japanese Journal of Pharmacoepidemiology 2018;23(2):125-130
		                        		
		                        		
		                        		
		                        	
            

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