• 한방재활의학과학회지
• /
• 제28권3호
• /
• pp.119-124
• /
• 2018

Three cases of simple exanthematous eruption were suspected during Sumsu (Bufonis Venenum) pharmacopuncture (SP) topical anesthesia for acupotomy. Patients had skin rash with pruritus on both ankle, posterior neck, and left shoulder after 11, 12, and 7 times of SP treatment, respectively. There were no cases of systemic manifestations or changes in vital signs. As a result of using the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) causality assessment, all the cases were evaluated as 'unlikely'. However, the results of using the Korean algorithm for assessing the causality of drug adverse reactions version 2.0 were evaluated as 'possible'. This report is the first case report on adverse events suspected of occurring after SP treatment. Although the causal relationship between suspected intervention and the adverse event is not clear, there was a difficulty in completely excluding the possibility. Additional safety studies will be required to make SP more widely available.

• 대한의용생체공학회:의공학회지
• /
• 제40권5호
• /
• pp.171-178
• /
• 2019

This study was conducted to observe the differences in perspective of medical device adverse events and report exchange for domestic stakeholders. The post-market surveillance of medical device not only improves the usability and functionality of the device but also identifies new or growing risks caused by the device. APEC (Asia-Pacific Economic Cooperation) have established and operated post-market surveillance systems for medical devices based on IMDRF (International Medical Device Regulators Forum) and GHTF (Global Harmonization Task Force) guidelines. However, there are significant gaps in many aspects. It is essential to apply harmonized guidelines internationally but also to interpret and apply the guidelines consistently to report and exchange medical device adverse event in domestic. This study retrospectively analyzed the results of surveys conducted by providing examples of the adverse events and guidelines for post-market surveillance. The results of the study showed that there was a considerable difference in the judgment on the phase of using medical device for patient. In the case of medical device adverse event, different opinions shown according to knowledge and experience. Education and training are needed to have a harmonized perspective on the reporting and exchanging international guidelines of the adverse event for domestic stakeholders.

• Korean Journal of Radiology
• /
• 제23권8호
• /
• pp.828-834
• /
• 2022

Objective: This study aimed to assess the outcomes of outpatient day-care management of unruptured intracranial aneurysm (UIA), and to present the risks associated with different management strategies by comparing the outcomes and adverse events between outpatient day-care management and management with longer admission periods. Materials and Methods: This retrospective cohort study used prospectively registered data and was approved by a local institutional review board. We enrolled 956 UIAs from 811 consecutive patients (mean age ± standard deviation, 57 ± 10.7 years; male:female = 247:564) from 2017 to 2020. We compared the outcomes after embolization among the different admission-length groups (1, 2, and ≥ 3 days). The outcomes included pre- and post-modified Rankin Scale (mRS) scores and rates of adverse events, cure, recurrence, and reprocedure. Events were defined as any cerebrovascular problems, including minor and major stroke, death, or hemorrhage. Results: The mean admission period was 2 days, and 175 patients (191 aneurysms), 551 patients (664 aneurysms), and 85 patients (101 aneurysms) were discharged on the day of the procedure, day 2, and day 3 or later, respectively. During the mean 17-month follow-up period (range 6-53 months; 2757 patient years), no change in post-mRS was observed compared to pre-mRS in 99.6% of patients. Cure was achieved in 95.6% patients; minimal recurrence that did not require re-procedure occurred in 3.5% patients, and re-procedure was required in 2.3% (22 of 956) patients due to progressive enlargement of the recurrent sac during follow up (mean 17 months, range, 6-53 months). There were eight adverse events (0.8%), including five cerebrovascular (two major stroke, two minor strokes and one transient ischemic stroke), and three non-cerebrovascular events. Statistical comparison between groups with different admission lengths (1, 2, and ≥ 3 days) revealed no difference in the outcomes. Conclusion: This study revealed no difference in outcomes and adverse events according to the admission period, and suggested that UIA could be managed by outpatient day-care embolization.

• 한국임상약학회지
• /
• 제27권4호
• /
• pp.214-220
• /
• 2017

Background: Dapagliflozin is an oral selective inhibitor of sodium-glucose cotransporter 2(SGLT2), the kidney transporter chiefly responsible for glucose reabsorption from the glomerular filtrate. Because this mechanism does not require the action of insulin, dapagliflozin rarely causes hypoglycemia. Dapagliflozin may affect blood glucose control as well as blood pressure and the body weight which are one of the cardiovascular disease risk factors. However, dehydration and ketoacidosis are reported as the side effects of the dapagliflozin treatment and the safety issues have been occurred. The aim of this study is to analyze the effectiveness and adverse events of dapagliflozin in Korean patients. Methods: From December 2014 to August 2015, we retrospectively reviewed the electronic medical records of type 2 diabetes patients who were prescribed dapagliflozin at Severance Hospital. Results: A total of 202 Korean patients were enrolled in this study. The effectiveness in the reduction of blood glucose was statistically significant(p<0.001). Dapagliflozin decreased 0.74% of HbA1c after 24 weeks. Significantly more participants achieved the target HbA1c level(HbA1c<7%) after 24 weeks(n=42, 35.3%) than before taking dapagliflozin(n=21, 17.6%). Blood pressure decreased 5.7 mmHg systolic blood pressure(SBP), 1.9 mmHg diastolic blood pressure(DBP) after 24 weeks. More than one quarter of participants(n=35, 29.4%) experienced weight loss. Most common adverse event was genitourinary symptoms. Conclusion: In this study, the effectiveness of dapagliflozin in improving glycemic control, blood pressure control, and weight loss was statistically significant. However, elderly and female patients, who have higher incidence of adverse events, should use dapagliflozin cautiously.

• Journal of Korean Neurosurgical Society
• /
• 제52권3호
• /
• pp.228-233
• /
• 2012

Objective : Chronic neck or back pain can be managed with various procedures. Although these procedures are usually well-tolerated, a variety of side effects have been reported. In this study we reviewed cases of unexpected temporary adverse events after blocks and suggest possible causes. Methods : We reviewed the records of patients treated with spinal pain blocks between December 2009 and January 2011. The types of blocks performed were medial branch blocks, interlaminar epidural blocks and transforaminal epidural blocks. During the first eight months of the study period (Group A), 2% mepivacaine HCL and triamcinolone was used, and during the last six months of the study period (Group B), mepivacaine was diluted to 1% with normal saline. Results : There were 704 procedures in 613 patients. Ten patients had 12 transient neurologic events. Nine patients were in Group A and one was in Group B. Transient complications occurred in four patients after cervical block and in eight patients after lumbar block. Side effects of lumbar spine blocks were associated with the concentration of mepivacaine (p<0.05). The likely causes were a high concentration of mepivacaine in five patients, inadvertent vascular injection in three patients, intrathecal leak of local anesthetics in one, and underlying conversion disorder in one. Conclusion : Spinal pain blocks are a good option for relieving pain, but clinicians should always keep in mind the potential for development of inevitable complications. Careful history-taking, appropriate selection of the anesthetics, and using real-time fluoroscopy could help reduce the occurrence of adverse events.

• Clinical and Experimental Pediatrics
• /
• 제58권12호
• /
• pp.484-490
• /
• 2015

Purpose: To determine the efficacy and safety of oral propranolol as a first-line treatment for superficially located infantile hemangioma (IH) and propose an assessment tool to measure treatment response. Methods: Patients with superficial IH under 1 year of age were prospectively recruited between May 2012 and December 2013 at the Department of Pediatrics of Chungbuk National University Hospital. Propranolol was administered to 12 infants (median age, 3.8 months) while monitoring cardiovascular and adverse metabolic effects. If a patient showed no adverse events, the dosage was gradually increased up to 3 mg/kg/day and maintained for 1 year. We used our own scoring system to assess treatment response using parameters like change in color, and longest diameter, and thickness of the IH. Results: Eleven out of 12 patients completed the protocol with consistent improvement of hemangiomas during therapy. Patients on propranolol showed a more than 50% involution in the first 3 months, with additional steady involution until 1 year. Patients with the highest scores at 1 month maintained their score and showed better responses until treatment termination. The patient with the lowest score at 1 month did not show any further regression and stopped propranolol treatment 4 months after initiation. In two children with recurrences after successful therapeutic regression, propranolol was effective after being reintroduced. Propranolol treatment was not interrupted in any patient due to adverse events. Conclusion: Oral propranolol at 3 mg/kg/day showed a consistent, rapid, and therapeutic effect on superficial IHs without significant adverse events.

• 대한임상독성학회지
• /
• 제13권2호
• /
• pp.103-110
• /
• 2015

Purpose: The purpose of this study is to evaluate the effectiveness and the adverse events of high dose insulin/euglycemia therapy in acute calcium channel blocker (CCB) poisoning. Methods: We developed a systematic search strategy and applied it to 4 electronic reference databases. We searched medical journals as well as the bibliographies of relevant articles. All forms of literature relevant to human use of high dose insulin for acute CCB poisoning were included. The literature search was conducted by two investigators in August, 2015 with publication language restricted to English and Korean. Case reports were divided between CCB overdose alone and multi-drug overdose including CCB. The effect and adverse event of high dose insulin and clinical outcome of each case were analyzed. Results: Among 55 searched studies, 20 studies were included. A prospective study, a retrospective study, a systematic review study, and 17 case reports were identified. Case reports consisted of 11 CCB alone and 12 multidrug overdose cases including CCB. Although most cases described significant clinical improvements, one of them showed no beneficial effect. Several adverse events including hypoglycemia and hypokalemia were reported. No significant sequalae from adverse events was reported. Conclusion: Although there were many case reports demonstrating successful use of high dose insulin for CCB poisoning, the effect cannot be estimated due to a possibility of publication bias. Therefore, high dose insulin/euglycemia therapy might be considered adjunctive therapy in cases of CCB intoxication refractory for standard therapy.

• 척추신경추나의학회지
• /
• 제12권1호
• /
• pp.13-27
• /
• 2017

Objectives: To evaluate and summarize the efficacy and safety of manual therapy in temporomandibular disorder(TMD). Methods: Ten databases (Pubmed, Cochrane, EMBASE, AMED, CINAHL, CNKI, and four Korean databases) were searched up to March 2017. Pain and range of motion(ROM) of temporomandibular joint were used as the primary outcome measure, and effective rates, dysfunction scale and adverse events were used as secondary outcome measures. The Cochrane risk of bias tool was used to evaluate the methodological quality. Results: 10 randomized controlled trials(RCTs) involving 603 participants were included. There were no significant differences between the two groups in comparison with placebo manual therapy group. In comparison with Wait-list and conventional treatment groups, manual therapy significantly alleviated pain and ROM. Five RCTs(50.0%) reported adverse events and there were no adverse cases by manual therapy. Conclusions: We found evidence that manual therapy may alleviate symptoms of patients with TMD. A positive effect was observed in comparison with conventional treatment and Wait-list, but no conclusion for the comparisons with placebo manual therapy. There is no evidence of worsening symptoms or causing adverse events.

• Korean Journal of Acupuncture
• /
• 제29권1호
• /
• pp.1-15
• /
• 2012

Objectives : This research was projected to verify the validities of needling or moxibustion- acupoints in Illustrated Manual for the Practice of Acupuncture and Moxibustion with the Help of a Bronze Figure bearing Acupuncture Points (IMPAM) and The Classic of Supplementing Life with Acupuncture and moxibustion(CSLAM) Methods; We investigated acupoints which have prohibitions, notices or adverse events when performing needling or moxibustion in IMPAM and CSLAM, then verified it in various literatures and today's medical knowledge. Results; In IMPAM, 2 acupoints were prohibited both needling and moxibustion, 22 acupoints were prohibited from needling and 29 were prohibited from moxibustion. In CSLAM, 3 acupoints were prohibited from both needling and moxibustion, 24 acupoints were prohibited from needling and 31 were prohibited from moxibustion. Most of the prohibition, the notices and adverse events of the acupoints written in IMPAM and CSLAM had medical or philological bases, and the number of them increased compared to that in A-B Classic of Acupunture and Moxibustion(ABCAM). Conslusion : The prohibotions, the notices and the adverse events when performing acupunture or moxibustion in IMPAM and CSLAM reflected the medical experience and knowledge of the time. And the knowledge was increased compared to that in ABCAM.

• 대한한방소아과학회지
• /
• 제35권3호
• /
• pp.67-88
• /
• 2021

Objectives The purpose of this study is to analyze randomized clinical trials (RCTs) on traditional Chinese medicine to summarize its efficacy and safety for the treatment of functional gastrointestinal disorders (FGIDs) in children. Methods We searched literatures published up to March 19, 2021 using two Chinese electronic databases. Data regarding patients, interventions, results, and adverse events were extracted from RCTs of herbal medicine for children with FGIDs. Results A total of 34 RCTs were included: 16 trials on functional dyspepsia, 7 trials on functional constipation, 6 trials on functional abdominal pain, 4 trials on irritable bowel syndrome, and 1 trial on functional diarrhea. 26 of 29 trials that reported total effective rate, the treatment group showed a significant improvement compared to the control group. Most of other evaluation indicators, such as symptom score, symptom disappearance time, and recurrence rate also demonstrated statistically significant improvement. Of the 16 studies which reported safety, 5 studies reported no adverse reactions in either group, and 4 studies reported no statistically significant differences in the incidence of adverse events between two groups. Also, reported adverse events were mostly mild. Conclusions Herbal medicine may help improve symptoms of FGIDs in children. However, due to limited types of studies on sub-diseases of FGIDs and small sample sizes in each study, additional large scale clinical studies on various other FGIDs are necessary.