1.Evaluation of the Regulatory Required Post-Authorization Safety Study for Propacetamol:Nested Case-Control and Case-Time-Control Studies
Sungho BEA ; Dongwon YOON ; Han Eol JEONG ; Juhong JUNG ; Seung-Mok PARK ; Juhee JEON ; Young-Min YE ; Jae-Hyun LEE ; Ju-Young SHIN
Yonsei Medical Journal 2024;65(2):120-128
Purpose:
Following the withdrawal of propacetamol in Europe owing to safety issues, the regulatory authority of South Korea requested a post-marketing surveillance study to investigate its safety profile.
Materials and Methods:
We conducted nested case-control and case-time-control (CTC) analyses of cases and controls identified for outcomes of interest, including anaphylaxis, thrombosis, and Stevens–Johnson syndrome (SJS), using the claims database of South Korea, 2010–2019. Risk-set sampling was used to match each case with up to 10 controls for age, sex, cohort entry date, and follow-up duration. Exposure to anaphylaxis, thrombosis, and SJS was assessed within 7, 90, and 30 days of the index date, respectively. We calculated odds ratios (OR) with 95% confidence intervals (CIs) using conditional logistic regression to assess the risk of outcomes associated with propacetamol.
Results:
We identified cases of anaphylaxis (n=61), thrombosis (n=95), and SJS (n=1) and matched them to controls (173, 268, and 4, respectively). In the nested case-control analysis, the ORs for anaphylaxis and SJS were inestimable given the small number of propacetamol users during the risk period; meanwhile, the OR for thrombosis was 1.60 (95% CI 0.71–3.62). In the CTC design, the effect estimate was only estimated for thrombosis (OR 0.56, 95% CI 0.09–3.47).
Conclusion
In both nested case-control and CTC analyses, propacetamol was not associated with an increased risk of anaphylaxis, thrombosis, or SJS. The findings from this study, which used routinely collected clinical data, provide reassuring real-world evidence regarding the safety of propacetamol in a nationwide population to support regulatory decision-making.
2.Complication of the Cervical Thrust Technique in a Patient with Athetoid Cerebral Palsy: A Case Report
Myungsang KIM ; Han Eol CHO ; Min Chul PAEK ; Jung Hyun PARK
Clinical Pain 2022;21(1):38-40
Manual therapy has been widely practiced in almost all countries worldwide. With its potential complications, there are contraindications for thrust technique. A 56-year-old woman diagnosed with athetoid cerebral palsy visited a local clinic due to a tingling sensation in right hand that lasted for a year and aggravated to both upper extremities. The patient underwent three sessions of cervical manual therapy including thrust technique. No evaluation was performed. The patient immediately felt weakness in all extremities after performing cervical thrust technique. Magnetic resonance imaging showed atlantoaxial instability and cervical myelopathy. Approximately one-third of adults with cerebral palsy reported chronic musculoskeletal pain and they often experience neck pain. Particularly in athetoid cerebral palsy, malalignment or instability of the cervical spine is prevalent and often results in myelopathy. Therefore, musculoskeletal evaluation is necessary to identify cervical instability in case of cervical thrust technique, and it should be performed by relevant medical professionals.
3.Lateral Septum Somatostatin Neurons are Activated by Diverse Stressors
Myungmo AN ; Hyun-Kyung KIM ; Hoyong PARK ; Kyunghoe KIM ; Gyuryang HEO ; Han-Eol PARK ; ChiHye CHUNG ; Sung-Yon KIM
Experimental Neurobiology 2022;31(6):376-389
The lateral septum (LS) is a forebrain structure that has been implicated in a wide range of behavioral and physiological responses to stress. However, the specific populations of neurons in the LS that mediate stress responses remain incompletely understood. Here, we show that neurons in the dorsal lateral septum (LSd) that express the somatostatin gene (hereafter, LSd Sst neurons) are activated by diverse stressors. Retrograde tracing from LSd Sst neurons revealed that these neurons are directly innervated by neurons in the locus coeruleus (LC), the primary source of norepinephrine well-known to mediate diverse stress-related functions in the brain. Consistently, we found that norepinephrine increased excitatory synaptic transmission onto LSd Sst neurons, suggesting the functional connectivity between LSd Sst neurons and LC noradrenergic neurons. However, optogenetic stimulation of LSd Sst neurons did not affect stress-related behaviors or autonomic functions, likely owing to the functional heterogeneity within this population. Together, our findings show that LSd Sst neurons are activated by diverse stressors and suggest that norepinephrine released from the LC may modulate the activity of LSd Sst neurons under stressful circumstances.
4.Ultrasonography-Guided Multifidus Cervicis Plane Block as a New Approach for the Treatment of Chronic Axial Neck Pain
Jun Taek HONG ; Han Eol CHO ; Jung Hyun PARK
Clinical Pain 2021;20(1):30-34
Multifidus cervicis plane block has been effectively used to provide analgesia during and after cervical spine surgery, but not for any other purpose. Here, we report three cases of chronic axial neck pain unresponsive to medical treatment. We performed multifidus cervicis plane block bilaterally, which lowered numerical rating scale (NRS) score within 2 weeks. Thus, multifidus cervicis plane block is one of the novel options that may be used for chronic axial neck pain.
5.Ultrasound Guided Thoracic Paravertebral Space Block for Chronic Intractable Upper Back Pain
Myungsang KIM ; Min Chul PAEK ; Han Eol CHO ; Jung Hyun PARK
Clinical Pain 2021;20(2):141-144
There are some cases of myofascial pain syndrome (MPS) with chronic upper back pain that does not respond to dry needling or trigger point injection, well-known treatments for MPS. A 67-year-old female developed a stabbing upper back pain with trigger point at left T7∼8 levels 10 years ago. She complained of the pain with Numeral Rating Scale (NRS) 8 points. Myofascial release technique and trigger point injection had no effect. Under ultrasound guidance 20 ml of 1% lidocaine was injected into thoracic paravertebral space. Immediately, the pain was reduced to NRS 4 points. One week later, the second block was performed in the same way as the first, and the pain was reduced to NRS 2 points. The stabbing pain disappeared, and oral opioids were discontinued. Ultrasound guided thoracic paravertebral space block is an effective and safe treatment for refractory MPS with chronic upper back pain.
6.Effect of Ultrasound-Guided Perineural Injection with Dextrose for Direct Traumatic Injury of Median Nerve
Yu Sang JUNG ; Hyerin PARK ; Jung Hyun PARK ; Hee Jae PARK ; Han Eol CHO
Clinical Pain 2021;20(2):127-130
Ultrasound (US)-guided hydrodissection (HD) is a widely applied therapeutic method to release the entrapped peripheral nerve. However, this therapy has only been studied for the nerve entrapments such as carpal tunnel syndrome, and there are no reports of its effect on direct nerve injuries with incomplete axonal damage. Here, we report a case of direct traumatic injury of a median nerve with incomplete axonal injury in a 28-year-old man. He presented hypoesthesia and weakness along with the median nerve territory of the left hand after a laceration wound of the wrist. The patient underwent a surgical procedure, but did not experience prominent improvement for the next six months. Symptoms improved after we performed the US-guided HD with dextrose. We propose this procedure as one of the new treatment methods for direct axonal injury of nerves including the median nerve.
7.Ultrasonography-Guided Multifidus Cervicis Plane Block as a New Approach for the Treatment of Chronic Axial Neck Pain
Jun Taek HONG ; Han Eol CHO ; Jung Hyun PARK
Clinical Pain 2021;20(1):30-34
Multifidus cervicis plane block has been effectively used to provide analgesia during and after cervical spine surgery, but not for any other purpose. Here, we report three cases of chronic axial neck pain unresponsive to medical treatment. We performed multifidus cervicis plane block bilaterally, which lowered numerical rating scale (NRS) score within 2 weeks. Thus, multifidus cervicis plane block is one of the novel options that may be used for chronic axial neck pain.
8.Precise Pulmonary Function Evaluation and Management of a Patient With Freeman-Sheldon Syndrome Associated With Recurrent Pneumonia and Chronic Respiratory Insufficiency
Jihyun PARK ; Seong-Woong KANG ; Won Ah CHOI ; Yewon LEE ; Han Eol CHO
Annals of Rehabilitation Medicine 2020;44(2):165-170
Freeman-Sheldon syndrome (FSS) is a rare distal arthrogryposis syndrome. There are few reports on the respiratory insufficiency of FSS. Additionally, there is no detailed information on pulmonary functional evaluation. A 17-year-old male patient with FSS developed respiratory failure, leading him to be admitted to hospital several times for evaluation and treatment. Of those times he was admitted, two were due to pneumonia. His pulmonary functions were indicative of a restrictive lung disease potentially caused by severe scoliosis. After a non-invasive ventilatorwas applied correctly to the patient, pulmonary hypertension was normalized. His pulmonary function has been maintained for 13 years. Since receiving proper respiratory care, which includes assisted coughing methods, the patient has not developed pneumonia. It is important to properly evaluate the pulmonary function of patients who have FSS and scoliosis to eliminate the risk of long-term respiratory complications.
9.Response: Precise Pulmonary Function Evaluation and Management of a Patient With Freeman-Sheldon Syndrome Associated With Recurrent Pneumonia and Chronic Respiratory Insufficiency (Ann Rehabil Med 2020;44:165-70)
Jihyun PARK ; Seong-Woong KANG ; Won Ah CHOI ; Yewon LEE ; Han Eol CHO
Annals of Rehabilitation Medicine 2020;44(5):411-413
10.Efficacy and Safety of Ramosetron Injection for Nausea and Vomiting in Colorectal-Cancer Patients Undergoing a Laparoscopic Colectomy: A Randomized, Double-Blind, Comparative Study
Han Eol PARK ; Min Ki KIM ; Won Kyung KANG
Annals of Coloproctology 2018;34(1):36-41
PURPOSE: A laparoscopic colectomy in colorectal-cancer patients is usually associated with a high risk of postoperative nausea and vomiting (PONV). The purpose of this study is to evaluate the efficacy of injection of long-acting 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist for the reduction of PONV in patients with colorectal cancer. METHODS: A total of 48 patients scheduled to undergo a laparoscopic colectomy for colorectal cancer were randomized in a double-blinded fashion. Patients were randomly allocated to 1 of 2 groups and assigned to receive either 0.3 mg of ramosetron intravenously (group A, n = 25) or 2 mL of normal saline (placebo) (group B, n = 22) immediately after the operation. The incidence of PONV, the nausea severity scale score, the visual analogue scale (VAS) score for pain, the total amount of patient-controlled analgesia used, the recovery of bowel function, and morbidities were assessed at 1 hour and at 24, 48, and 72 hours after surgery. RESULTS: The baseline and the operative characteristics were similar between the groups (P > 0.05). The number of cases without PONV (complete response) was higher for group A (ramosetron) than group B (normal saline): 24 hours after surgery, 92.0% (23 of 25) for group A versus 54.5% (12 of 22) for group B; 48 hours after surgery, 92% (23 of 25) for group A versus 81.8% (18 of 22) for group B (both P < 0.05). No serious adverse events occurred. CONCLUSION: Postoperative ramosetron injection is effective for the prevention of PONV after a laparoscopic colectomy in colorectal-cancer patients.
Analgesia, Patient-Controlled
;
Colectomy
;
Colorectal Neoplasms
;
Humans
;
Incidence
;
Nausea
;
Postoperative Nausea and Vomiting
;
Serotonin
;
Vomiting

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