• Clinical Endoscopy
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• 제57권2호
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• pp.203-208
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• 2024

Background/Aims: Upper gastrointestinal bleeding (UGIB) is the most common GI condition requiring hospitalization. The present study aimed to evaluate the safety and feasibility of using the PillSense system (EnteraSense Ltd.), a novel diagnostic tool designed for the rapid in vivo detection of UGIB, in human volunteers. Methods: In the present study, 10 volunteers swallowed a PillSense capsule, followed by 2 servings of an autologous blood preparation. Participants were monitored for capsule passage, overall tolerability of the procedure, and adverse events. Results: The procedure was completed per the protocol established in the present study in 9/10 cases. In 9 of the subjects, after capsule ingestion, the device indicated the absence of blood with sensor output values of 1. After the ingestion of the first blood mixture, the sensor outputs of all devices increased to a range from 2.8 to 4, indicating that each sensor capsule detected blood. The sensor output remained within that range after the ingestion of the second mixture; however, in one case, the baseline capsule signal was positive, because of a preexisting condition. The passage of the capsule was verified in all patients, and no adverse events were reported. Conclusions: The first trial of the PillSense system in human subjects demonstrated the feasibility, safety, and tolerability of utilizing this product as a novel, noninvasive, and easy-to-use triage tool for the diagnosis of patients suspected of having UGIB.

• Clinical Endoscopy
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• 제57권3호
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• pp.309-316
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• 2024

The treatment of obesity and its comorbidities ranges from clinical management involving lifestyle changes and medications to bariatric and metabolic surgery. Various endoscopic bariatric and metabolic therapies recently emerged to address an important therapeutic gap by offering a less invasive alternative to surgery that is more effective than conservative therapies. This article comprehensively reviews the technical aspects, mechanism of action, outcomes, and future perspectives of one of the most promising endoscopic bariatric and metabolic therapies, named duodenojejunal bypass liner. The duodenojejunal bypass liner mimics the mechanism of Roux-en-Y gastric bypass by preventing food contact with the duodenum and proximal jejunum, thereby initiating a series of hormonal changes that lead to delayed gastric emptying and malabsorptive effects. These physiological changes result in significant weight loss and improved metabolic control, leading to better glycemic levels, preventing dyslipidemia and non-alcoholic fatty liver disease, and mitigating cardiovascular risk. However, concern exists regarding the safety profile of this device due to the reported high rates of severe adverse events, particularly liver abscesses. Ongoing technical changes aiming to reduce adverse events are being evaluated in clinical trials and may provide more reliable data to support its routine use in clinical practice.

• Clinical Endoscopy
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• 제55권5호
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• pp.615-625
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• 2022

Background/Aims: Mucosal incision-assisted biopsy (MIAB) for tissue acquisition (TA) from subepithelial lesions (SELs) is emerging as an alternative to endoscopic ultrasound (EUS)-guided TA. Only a limited number of studies compared the diagnostic utility of MIAB and EUS for upper gastrointestinal (GI) SELs; therefore, we conducted this systematic review and meta-analysis. Methods: A comprehensive literature search from January 2020 to January 2022 was performed to compare the diagnostic accuracy and safety of MIAB and EUS-guided TA for upper GI SELs. Results: Seven studies were included in this meta-analysis. The pooled technical success rate (risk ratio [RR], 0.96; 95% confidence interval [CI], 0.89-1.04) and procedural time (mean difference=-4.53 seconds; 95% CI, -22.38 to 13.31] were comparable between both the groups. The overall chance of obtaining a positive diagnostic yield was lower with EUS than with MIAB for all lesions (RR, 0.83; 95% CI, 0.71-0.98) but comparable when using a fine-needle biopsy needle (RR, 0.93; 95% CI, 0.83-1.04). The positive diagnostic yield of MIAB was higher for lesions <20 mm (RR, 0.75; 95% CI, 0.63-0.89). Six studies reported no adverse events. Conclusions: MIAB can be considered an effective alternative to EUS-guided TA for upper GI SELs without an increased risk of adverse events.

• Clinical Endoscopy
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• 제55권3호
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• pp.408-416
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• 2022

Background/Aims: Endoscopic band ligation (EBL) is used to treat colonic diverticular bleeding (CDB). An endoscopic variceal ligation device for esophageal varices is used as a conventional EBL device (C-EBL). A new EBL device (N-EBL) was developed by Sumitomo Bakelite Co. in August 2018. We aimed to evaluate the clinical outcomes of N-EBL compared with those of C-EBL. Methods: Seventy-nine patients who underwent EBL for CDB at St. Luke's International Hospital, Japan, between 2017 and 2020 were included in this retrospective study. Patients were divided into the C-EBL and N-EBL groups. Their clinical outcomes, including achieving initial hemostasis, early rebleeding, procedure time, and EBL-associated adverse events, were evaluated. Results: Of the 79 patients, 36 (45.6%) were in the C-EBL group and 43 (54.4%) were in the N-EBL group. The rate of achieving initial hemostasis was 100% in the C-EBL group and 93.0% in the N-EBL group. No significant difference was noted in the early rebleeding rate between the groups (p=0.24). The N-EBL group achieved a shorter median EBL procedure time than the C-EBL group (14.2 minutes vs. 18.2 minutes, p=0.02). No adverse events were observed in either group. Conclusions: The N-EBL device is safe and useful and may reduce EBL procedure time.

• Korean Journal of Biological Psychiatry
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• 제20권3호
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• pp.111-117
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• 2013

Objectives We investigated the effectiveness and safety when treated in schizophrenics with paliperidone palmitate, a long acting injectable antipsychotic. Methods This was a 24-week open-label study, performed at one center in Korea. The eligible patients with schizophrenia diagnosed by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria were enrolled. Patients received long-acting paliperidone palmitate injection (234 mg, baseline; 156 mg, week 1 ; then once 4 weeks flexible dosing). Effectiveness assessments were measured by the Positive and Negative Syndrome Scale (PANSS), The Clinical Global Impression Severity Scale (CGI-S), The Personal and Social Performance (PSP) at baseline, week 1, every 4 weeks untill 24 weeks or endpoint. Safety assessments were measured by The Extrapyramidal Symptom Rating Scale (ESRS), body weight (BW) and incidence of adverse events. Oral antipsychotics were stopped or tapered off within next 14 days. Results Of 20 patients recruited, 9 patients (45%) completed the study. Paliperidone palmitate produced a significant improvement in PANSS total score from baseline to endpoint. The response rate was 75% [mean change (${\pm}SD$) $-25.9{\pm}14.4$, all p < 0.001]. The CGI-S and PSP total scores significantly improved during 24 weeks (All p < 0.001). Eighty percent of patients reported adverse events and most common adverse events (${\geq}10%$) in paliperidone palmitate were anticholinergic adverse event, extrapyramidal symptoms, weight gain, akathisia, insomnia, headache, agitation, anxiety and GI trouble. ESRS score is not statistically significant, but tends to get better at the end of the study when compared to baseline. Conclusions Our study results demonstrated maintained effectiveness and safety of paliperidone palmitate treatment in schizophrenics. And provides both clinicians and patients with a new choice of treatment that can improve the outcome of long term therapy. Their potential effectiveness and safety should be better addressed by future randomized-controlled trials.

• Journal of Acupuncture Research
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• 제34권2호
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• pp.93-112
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• 2017

Objectives : To evaluate and summarize the efficacy and safety of acupuncture treatment (AT) in chronic fatigue syndrome (CFS). Methods : Fifteen databases (Pubmed, Cochrane, EMBASE, AMED, CINAHL, CNKI, Wanfang, and eight Korean databases) were searched up to September 2016. Only trials in which acupuncture was the sole treatment were included. Fatigue was used as the primary outcome measure, while the quality of life, pain, mood disorders, and adverse events were used as secondary outcome measures. We adopted three classifications: AT vs Sham AT, AT vs Wait-list, AT vs Western medication. The Cochrane risk of bias tool was used to assess the methodological quality. Results : A total of 11 randomized controlled trials involving 869 participants were identified. In comparison with Sham AT, AT significantly alleviated fatigue and pain, but no conclusions about the quality of life and mood disorders could be drawn. In the Wait-list group and Western medication groups, patients with CFS might feel less fatigued following acupuncture treatment, but the evidence was insufficient due to lack of study. Nine of 11 RCTs (81.8%) reported adverse events and there were two cases of mild subcutaneous hemorrhage, but no serious adverse cases. Conclusion : This review found evidence that patients with CFS may generally benefit from alleviation of symptoms by acupuncture treatment, and there is no evidence of worsening symptoms or causing of serious adverse events. A positive effect on fatigue and pain was observed, but no conclusion for improving quality of life and mood disorders.

• Archives of Craniofacial Surgery
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• 제23권4호
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• pp.152-162
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• 2022

Background: The efficacy and safety of equine cartilage as a competent xenograft material for rhinoplasty were evaluated and compared to the outcomes of rhinoplasty using silicone implants. Methods: We performed a multicenter, double-blind, non-inferiority, and randomized confirmatory study. Fifty-six patients were randomized 1:1 to the study group (using MegaCartilage-E) and control group (using silicone implants). The Rhinoplasty Outcome Evaluation (ROE) score, photo documentation, Global Aesthetic Improvement Scale (GAIS), and adverse event data were obtained until 12 months after surgery. The primary efficacy, which is the change in ROE score 6 months after surgery, was assessed in the modified intention-to-treat set. The secondary efficacy was evaluated in the per-protocol set by assessing the change in ROE score 6 and 12 months after surgery and nasofrontal angle, the height of the nasion, and GAIS 1, 6, and 12 months after surgery. Results: The change in ROE score of the study group was non-inferior to that of the control group; it increased by 24.26±17.24 in the study group and 18.27±17.60 in the control group (p= 0.213). In both groups, all secondary outcome measures increased, but there was no statistical difference. In the safety set, treatment-emergent adverse events occurred in 10 patients (35.71%) in the study group and six patients (21.43%) in the control group (p= 0.237). There were 13 adverse device events in the study group and six adverse device events in the control group (p= 0.515). Conclusion: Processed equine cartilage can be used effectively and safely as xenograft material for rhinoplasty.

• The Korean Journal of Pain
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• 제31권2호
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• pp.73-79
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• 2018

All drugs have both favorable therapeutic and untoward adverse effects. Conventional opioid analgesics possess both analgesia and adverse reactions, such as nausea, vomiting, and respiratory depression. The opioid ligand binds to ${\mu}$ opioid receptor and non-selectively activates two intracellular signaling pathways: the G protein pathway induce analgesia, while the ${\beta}$-arrestin pathway is responsible for the opioid-related adverse reactions. An ideal opioid should activate the G protein pathway while deactivating the ${\beta}$-arrestin pathway. Oliceridine (TRV130) has a novel characteristic mechanism on the action of the ${\mu}$ receptor G protein pathway selective (${\mu}$-GPS) modulation. Even though adverse reactions (ADRs) are significantly attenuated, while the analgesic effect is augmented, the some residual ADRs persist. Consequently, a G protein biased ${\mu}$ opioid ligand, oliceridine, improves the therapeutic index owing to increased analgesia with decreased adverse events. This review article provides a brief history, mechanism of action, pharmacokinetics, pharmacodynamics, and ADRs of oliceridine.

• YAKHAK HOEJI
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• 제50권3호
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• pp.145-153
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• 2006

The adverse events which do not appear in the approval process tend to occur more frequently at the early stage of the use. Therefore new drugs, drugs with different active substances or routes of administration, or drugs with explicitly different efficacy added are particularly chosen for re-examination, and go through a study, which is conducted on 600 to 3,000 subjects over 4 to 6 years. Since the re-examination system was implemented in January 1995, 880 drug products have been designated as the subject of re-examination and among them 194 drugs have been completed their re-examination as of until March 2005. Post Marketing Surveillance to insure drug safety should be correlated with re-examination of new drug, re-evaluation of drug, and adverse event monitoring system. And the first labeling change should reflect all information collected for a defined period of time after the marketing authorization is granted. Furthermore centralized management through spontaneous reporting system of adverse event for whole period of time would be the most desirable type of system.

• Journal of Chest Surgery
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• 제48권1호
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• pp.25-32
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• 2015

Background: We evaluated operative outcomes after third or more cardiac operations for valvular heart disease, and analyzed whether pericardial coverage with artificial membrane is helpful for subsequent reoperation. Methods: From 2000 to 2012, 149 patients (male : female=70 : 79; mean age at operation, $57.0{\pm}11.3$ years) underwent their third to fifth operations for valvular heart disease. Early results were compared between patients who underwent their third operation (n=114) and those who underwent fourth or fifth operation (n=35). Outcomes were also compared between 71 patients who had their pericardium open during the previous operation and 27 patients who had artificial membrane coverage. Results: Intraoperative adverse events occurred in 22 patients (14.8%). Right atrium (n=6) and innominate vein (n=5) were most frequently injured. In-hospital mortality rate was 9.4%. Total cardiopulmonary bypass time ($225{\pm}77$ minutes vs. $287{\pm}134$ minutes, p=0.012) and the time required to prepare aortic cross clamp ($209{\pm}57$ minutes vs. $259{\pm}68$ minutes, p<0.001) increased as reoperations were repeated. However, intraoperative event rate (13.2% vs. 20.0%), in-hospital mortality (9.6% vs. 8.6%) and postoperative complications were not statistically different according to the number of previous operations. Pericardial closure using artificial membrane at previous operation was not beneficial in reducing intraoperative events (25.9% vs. 18.3%) and shortening operation time preparing aortic cross clamp ($248{\pm}64$ minutes vs. $225{\pm}59$ minutes) as compared to no-closure. Conclusion: Clinical outcomes of the third or more operations for valvular heart disease were acceptable in terms of intraoperative adverse events and in-hospital mortality rates. There were no differences in the incidence of intraoperative adverse events, early mortality and postoperative complications between third cardiac operation and fourth or more.