• Title/Summary/Keyword: Adverse events

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A Systematic Review and Meta-Analysis of Foot Bath Therapy for Insomnia Disorder (불면 장애에 대한 족욕 치료법의 체계적 문헌고찰과 메타분석 연구)

  • Dong-Hyun Kim;Jun-Hee Cho;Jung-Hwa Lim;Bo-Kyung Kim
    • Journal of Oriental Neuropsychiatry
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    • v.34 no.3
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    • pp.163-179
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    • 2023
  • Objectives: The purpose of this study was to provide evidence for the clinical effects of foot bath therapy for insomnia disorder through a systematic review and meta-analysis. Methods: Studies were selected from seven domestic and international literature databases. Data on diagnostic tools, pattern identification, sample size, intervention methods, outcome measurements, results, and adverse events were extracted. The quality of the selected literature was assessed using Cochrane's risk of bias (RoB) assessment tool. Results: A total of 11 studies were included in this study. The primary diagnostic tool for insomnia dis- order was the criteria for the diagnosis and therapeutic effect of diseases and syndromes in traditional Chinese medicine (CDTDSTCM), along with the Chinese classification of mental disorders-3 (CCMD-3). Treatment effects were mainly evaluated by the effective rate and the Pittsburgh Sleep Quality Index (PSQI). The meta-analysis results showed statistically higher effectiveness rates for treating insomnia disorder in the experimental groups receiving herbal medicine foot bath therapy with sleeping or herbal medication compared to the control group. The PSQI was lower in the treatment group receiving herbal medicine foot bath therapy with sleeping medication. The herbal materials used in herbal medicine foot bath therapy mainly included Radix Angelicae Sinensis, Polygonum Multiflorum, Ziziphi Spinosae Semen, Rhizoma Coptidis, Radix Salviae Miltiorrhizae, and Cortex Albizziae. The quality of the included studies was generally poor. Conclusions: This study found that foot bath therapy had clinical efficacy for treating insomnia disorder. The research findings could provide foundational evidence for establishing the clinical basis of foot bath therapy in the treatment of insomnia.

Clinical outcomes and characteristics of acute myocardial infarction patients with developing fever after percutaneous coronary intervention

  • Jae-Geun Lee;Yeekyoung Ko;Joon Hyouk Choi;Jeong Rae Yoo;Misun Kim;Ki Yung Boo;Jong Wook Beom;Song-Yi Kim;Seung-Jae Joo
    • Journal of Medicine and Life Science
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    • v.19 no.2
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    • pp.46-56
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    • 2022
  • The incidence of fever complicating percutaneous coronary intervention (PCI) is rare. However, little is known regarding the cause of fever after PCI. Therefore, this study aimed to determine the clinical characteristics of patients with acute myocardial infarction (AMI), with or without fever, after PCI. We enrolled a total of 926 AMI patients who underwent PCI. Body temperature (BT) was measured every 4 hours or 8 hours for 5 days after PCI. Patients were divided into two groups according to BT as follows: BT<37.7℃ (no-fever group) and BT ≥37.7℃ (fever group). The 2 years clinical outcomes were compared subsequently. Fever after PCI was associated with higher incidence of major adverse cardiac events (MACE) (hazard ratio [HR], 1.56; 95% confidence interval [CI], 1.07-2.28; P=0.021), all-cause death (HR, 2.32; 95% CI, 1.18-4.45; P=0.014), cardiac death (CD) (HR, 2.57; 95% CI, 1.02-6.76; P=0.049), and any revascularization (HR, 1.69; 95% CI, 1.02-2.81; P=0.044) than without fever. In women, prior chronic kidney disease, lower left ventricular (LV) ejection fraction, higher LV wall motion score index, white blood cell count, peak creatine kinase-myocardial band level, and longer PCI duration were associated with fever after PCI. Procedures such as an intra-aortic balloon pump, extracorporeal membrane oxygenation, continuous renal replacement therapy, central and arterial line insertion, and cardiopulmonary resuscitation were related to fever after PCI. Fever after PCI in patients with AMI was associated with a higher incidence of MACE, all-cause death, CD, and any revascularization at the 2 years mark than in those without fever.

Digestive Tolerance and Safety of an Anti-Regurgitation Formula Containing Locust Bean Gum, Prebiotics and Postbiotics: A Real-World Study

  • Marc Bellaiche;Patrick Tounian;Raish Oozeer;Emilie Rocher;Yvan Vandenplas
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.26 no.5
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    • pp.249-265
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    • 2023
  • Purpose: Infant regurgitation is associated with other functional gastrointestinal disorders and signs and symptoms that have a major impact on the quality of life of infants and their families. This study evaluated the safety, tolerance, and real-world effectiveness of an anti-regurgitation formula containing locust bean gum (LBG), prebiotics, and postbiotics to alleviate digestive symptoms beyond regurgitation. Methods: This 3-month study involved infants with regurgitation requiring the prescription of an anti-regurgitation formula according to usual clinical practice. Outcomes included evaluation of the evolution of stool consistency and frequency; occurrence of colic, constipation, and diarrhea; and assessment of regurgitation severity. Infant crying, parental assessment of infant well-being, and parental satisfaction with the stool consistency were also evaluated. Results: In total, 190 infants (average age: 1.9±1.1 months) were included. After three months, stool frequency and consistency remained within the normal physiological range, with 82.7% of infants passing one or two stools per day and 90.4% passing loose or formed stools. There was no significant increase in the number of infants with diarrhea, whereas a decrease was observed in the number of infants with constipation after 1 month (p=0.001) and with colic after both 1 and 3 months (p<0.001). Regurgitation severity and crying decreased and parental satisfaction with stool consistency, formula acceptability, infant well-being, and sleep quality increased. Monitoring of adverse events did not reveal any safety concerns. Conclusion: Formulas containing LBG, prebiotics, and postbiotics were well tolerated and provided an effective strategy for managing infant regurgitation and gastrointestinal discomfort.

The Analysis of Registration Status of Interventional Clinical Trials for Children and Adolescents with Chronic Cough - Focused on WHO ICTRP - (소아 청소년 만성기침 환자를 대상으로 한 중재 임상시험 등록 현황 분석 - WHO ICTRP를 중심으로 -)

  • Jeong Yoon Kyoung;Choi Seo Yeon;Bang Miran;Lee Jun-Hwan;Lee Boram;Chang Gyu Tae
    • The Journal of Pediatrics of Korean Medicine
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    • v.37 no.3
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    • pp.75-93
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    • 2023
  • Objectives We aimed to analyze the registration status of interventional clinical trials in children and adolescents with chronic cough. Methods All interventional clinical trials registered up to 3 July, 2023 on the international clinical trial registry platform (ICTRP) of the World Health Organization (WHO) were analyzed. Information was extracted including study design, interventions, inclusion and exclusion criteria, and outcome indicators. Results A total of 18 interventional clinical trials were analyzed. For study design, multicentre trials, randomized allocation, parallel group design and phase 4 trials were the most frequently reported. Blinding was used in 44.4% and informed consents were obtained from 61.1%. For intervention, drugs were used in 61.1%, using placebo control group in 27.8%. Quality of life questionnaires were most frequently reported in 50% as the primary outcome, and adverse events were the most as the secondary outcome. In most cases, the assessment timepoints were after two weeks. Conclusions Based on the characteristics of clinical trial design analyzed in this study, it is necessary to design traditional Korean medicine clinical trials with improved quality and accuracy of information.

Potentially Inappropriate Medications and Regimen Complexity on Readmission of Elderly Patients with Polypharmacy: A Retrospective Study

  • Sunmin Lee
    • Korean Journal of Clinical Pharmacy
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    • v.33 no.1
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    • pp.1-7
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    • 2023
  • Background: Along with the increase in the elderly population, concerns about polypharmacy, which can cause medication-related problems, are increasing. This study aimed to find out the association between drug-related factors and readmission in elderly patients within 30 days after discharge. Methods: Data of patients aged ≥65 years who were discharged from the respiratory medicine ward of a tertiary hospital between January and March 2016 were retrospectively obtained. The medication regimen complexity at discharge was calculated using the medication regimen complexity index (MRCI) score, comorbidity status was assessed using the Charlson comorbidity index (CCI), potentially inappropriate medications (PIMs) were evaluated based on the Beer 2019 criteria, and adverse drug events (ADEs) were examined using the ADE reporting system. Multivariable logistic regression analysis was used to evaluate the effect of medication-related problems on hospital readmission after controlling for other variables. Results: Of the 206 patients included, 84 (40.8%) used PIMs, 31 (15%) had ADEs, and 32 (15.5%) were readmitted. The mean age, total medications, MRCI, CCI, and PIMs in the readmission group were significantly higher than those in the non-readmission group. Age significantly decreased the risk of readmission (odds ratio [OR], 0.89; 95% confidence interval [CI], 0.84-0.96) after adjusting for sex, length of hospital stay, and ADEs. The use of PIMs (OR, 2.38; 95% CI, 1.10-5.16) and increased CCI (OR, 1.50; 95% CI, 1.16-1.93) and MRCI (OR, 1.04; 95% CI, 1.01-1.07) were associated with an increased occurrence of readmission. Conclusion: PIMs were associated with a significantly greater risk for readmission than MRCI.

A Survey on Procedural Sedation and Analgesia for Pediatric Facial Laceration Repair in Korea

  • Dongkyu Lee;Hyeonjung Yeo;Yunjae Lee;Hyochun Park;Hannara Park
    • Archives of Plastic Surgery
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    • v.50 no.1
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    • pp.30-36
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    • 2023
  • Background Most children with facial lacerations require sedation for primary sutures. However, sedation guidelines for invasive treatment are lacking. This study evaluated the current status of the sedation methods used for pediatric facial laceration repair in Korea. Methods We surveyed one resident in each included plastic surgery training hospital using face-to-face interviews or e-mail correspondence. The health care center types (secondary or tertiary hospitals), sedation drug types, usage, and dosage, procedure sequence, monitoring methods, drug effects, adverse events, and operator and guardian satisfaction were investigated. Results We included 45/67 hospitals (67%) that used a single drug, ketamine in 31 hospitals and chloral hydrate in 14 hospitals. All health care center used similar sedatives. The most used drug administered was 5 mg/kg intramuscular ketamine (10 hospitals; 32%). The most common chloral hydrate administration approach was oral 50 mg/kg (seven hospitals; 50%). Twenty-two hospitals (71%) using ketamine followed this sequence: administration of sedatives, local anesthesia, primary repair, and imaging work-up. The most common sequence used for chloral hydrate (eight hospitals; 57%) was local anesthesia, administration of sedatives, imaging work-up, and primary repair. All hospitals that used ketamine and seven (50%) of those using chloral hydrate monitored oxygen saturation. Median operator satisfaction differed significantly between ketamine and chloral hydrate (4.0 [interquartile range, 4.0-4.0] vs. 3.0 [interquartile range, 3.0-4.0]; p <0.001). Conclusion The hospitals used various procedural sedation methods for children with facial lacerations. Guidelines that consider the patient's condition and drug characteristics are needed for safe and effective sedation.

Retrospective analysis of keratinized tissue augmentation using a xenogeneic collagen matrix for resolving peri-implant mucositis and peri-implantitis

  • Jung Soo Park;Yeek Herr;Jong-Hyuk Chung;Seung-Il Shin;Hyun-Chang Lim
    • Journal of Periodontal and Implant Science
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    • v.53 no.2
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    • pp.145-156
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    • 2023
  • Purpose: The significance of keratinized tissue for peri-implant health has been emphasized. However, there is an absence of clinical evidence for the use of a xenogeneic collagen matrix (XCM) to manage peri-implant mucositis and peri-implantitis. Therefore, the purpose of this study was to investigate outcomes after keratinized tissue augmentation using an XCM for the management of peri-implant diseases. Methods: Twelve implants (5 with peri-implant mucositis and 7 with peri-implantitis) in 10 patients were included in this study. Non-surgical treatments were first performed, but inflammation persisted in all implant sites. The implant sites all showed a lack of keratinized mucosa (KM) and vestibular depth (VD). Apically positioned flaps with XCM application were performed. Bone augmentation was simultaneously performed on peri-implantitis sites with an intrabony defect (>3 mm). The following clinical parameters were measured: the probing pocket depth (PPD), modified sulcular bleeding index (mSBI), suppuration (SUP), keratinized mucosal height (KMH), and VD. Results: There were no adverse healing events during the follow-up visits (18±4.6 months). The final KMHs and VDs were 4.34±0.86 mm and 8.0±4.05 mm, respectively, for the sites with peri-implant mucositis and 3.29±0.86 mm and 6.5±1.91 mm, respectively, for the sites with peri-implantitis. Additionally, the PPD and mSBI significantly decreased, and none of the implants presented with SUP. Conclusions: Keratinized tissue augmentation using an XCM for sites with peri-implant mucositis and peri-implantitis was effective for increasing the KMH and VD and decreasing peri-implant inflammation.

Exploratory Analysis of Patients With Gastric/Gastroesophageal Junction Adenocarcinoma With or Without Liver Metastasis From the Phase 3 RAINBOW Study

  • Takatsugu Ogata;Yukiya Narita;Zev A. Wainberg;Eric Van Cutsem;Kensei Yamaguchi;Yongzhe Piao;Yumin Zhao;Patrick M. Peterson;Sameera R. Wijayawardana;Paolo Abada;Anindya Chatterjee;Kei Muro
    • Journal of Gastric Cancer
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    • v.23 no.2
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    • pp.289-302
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    • 2023
  • Purpose: Liver metastasis (LM) is reported in approximately 40% of patients with advanced/metastatic gastric/gastroesophageal junction adenocarcinoma (metastatic esophagogastric adenocarcinoma; mGEA) and is associated with a worse prognosis. This post-hoc analysis from the RAINBOW trial reported the efficacy, safety, and biomarker outcomes of ramucirumab and paclitaxel combination treatment (RAM+PAC) in patients with (LM+) and without (LM-) LM at baseline. Materials and Methods: Patients (n=665) were randomly assigned on a 1:1 basis to receive either RAM+PAC (LM+: 150, LM-: 180) or placebo and paclitaxel (PL+PAC) (LM+: 138, LM-: 197). The overall survival (OS) and progression-free survival (PFS) were evaluated using stratified Kaplan-Meier and Cox regression models. The correlation of dichotomized biomarkers (VEGF-C, D; VEGFR-1,2) with efficacy in the LM+ versus LM- subgroups was analyzed using the Cox regression model with reported interaction P-values. Results: The presence of LM was associated with earlier progression than those without LM, particularly in patients receiving PL+PAC (hazard ratio [HR], 1.68). RAM+PAC treatment improved OS and PFS irrespective of LM status but showed greater improvement in LM+ than that in LM- (OS HR, 0.71 [LM+] vs. 0.88 [LM-]; PFS HR, 0.47 [LM+] vs. 0.76 [LM-]). Treatment-emergent adverse events were similar between patients with and without LM. No predictive relationship was observed between biomarker levels (VEGF-C, D; VEGFR-1,2) and efficacy outcome (OS, PFS) (all interaction P-values >0.05). Conclusions: RAM provided a significant benefit, irrespective of LM status; however, its effect was numerically stronger in patients with LM. Therefore, RAM+PAC is a clinically meaningful therapeutic option for patients with mGEA and LM.

A narrative review of clinical studies on thread embedding acupuncture treatment for spasticity after stroke

  • Sooran Cho;Eunseok Kim
    • The Journal of Korean Medicine
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    • v.43 no.4
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    • pp.131-144
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    • 2022
  • Objectives: This study aimed to review clinical studies on thread embedding acupuncture (TEA) for the treatment of patients with post-stroke spasticity (PSS) Methods: Clinical studies related to TEA treatment for PSS were searched for in several electronic databases, including PubMed, Cochrane Library, MEDLINE, OASIS, and CNKI. After the selection/exclusion process, information on study design, disease, experimental/control group, intervention, outcome measurement, between-group differences, and adverse events was extracted. Results: A total of 13 randomized controlled trials were included in this review. The usual frequency of TEA treatment was once every 1-2 weeks, and the treatment most commonly included 4 sessions. In the dorsal area, EX-B2 and the acupoints in governing vessel meridian were commonly used. Acupoints in the meridian of the large intestine were most frequently used in the treatment of upper limb spasticity. Except for HT1, PC6, and PC8, all TEA points for treating PSS of the upper limb were on the Yang meridians. For the lower limb spasticity, the most frequently used acupoints were ST36, GB34, GB30, BL60, and BL57 on Yang meridians, and LR3, SP6, SP9, and SP10 on Yin meridians. TEA treatment showed better effects than conventional treatment for PSS in terms of spasticity, motor dysfunction, and activities of daily livings. Nevertheless, the absence of the follow-up observation, lack of sham TEA treatment, and low quality of the included studies necessitated caution in interpreting the results. Conclusions: The results of this review are expected to provide basic data on the modalities of TEA treatment for PSS and provide insights to facilitate well-designed studies in the future.

Comparative evaluation of intranasal midazolam-ketamine, dexmedetomidine-ketamine, midazolam-fentanyl, and dexmedetomidine-fentanyl combinations for procedural sedation and analgesia in pediatric dental patients: a randomized controlled trial

  • Abhilasha Agarwal;Afroz Alam Ansari;Rajendra Nath;Rakesh Kumar Chak;Rajeev Kumar Singh;Richa Khanna;Prem Raj Singh
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.23 no.2
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    • pp.69-81
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    • 2023
  • Background: In order to assess the effectiveness of various analgesio-sedative combinations for pain relief and sedation in pediatric dental patients, a thorough evaluation of clinical studies and patient outcomes is necessary. Methods: A total of 128 healthy, uncooperative pediatric dental patients were randomly allocated to receive one of the four combinations of drugs via the intranasal (IN) route: Group I received midazolam-ketamine (MK), Group II received dexmedetomidine-ketamine (DK), Group III received midazolam-fentanyl (MF), and Group IV received dexmedetomidine-fentanyl (DF) in a parallel-arm study design. The efficacy and safety of the combinations were evaluated using different parameters. Results: The onset of sedation was significantly faster in the DF group than in the DK, MF, and MK groups (P < 0.001). The depth of sedation was significantly higher in the DK and DF groups than in the MK and MF groups (P < 0.01). DK and DF produced significant intra- and postoperative analgesia when compared with combinations of MK and MF. No significant adverse events were observed for any of the combinations. Conclusions: The DK and DF groups showed potential as analgesio-sedatives in view of their anxiolytic and analgesic effects.