• Title/Summary/Keyword: Clinical safety

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A Systematic Review of Cupping Therapy for Insomnia Disorder (불면장애에 대한 부항요법의 체계적 문헌고찰)

  • Jeong-Han Lee;Mi-Ra Choi;Jung-Hwa Lim;Bo-Kyung Kim
    • Journal of Oriental Neuropsychiatry
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    • v.34 no.3
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    • pp.181-212
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    • 2023
  • Objectives: To examine the efficacy and safety of cupping therapy for insomnia disorder and provide clinical evidence that could contribute to further research. Methods: We searched randomized controlled trials (RCTs) that verified effects of cupping therapy for insomnia disorder from 11 domestic and foreign databases. Included studies were evaluated using Risk of Bias (RoB). Results: Nineteen RCTs were selected. Wet cupping was more frequently used than dry cupping. Moving cupping was mostly used among dry cupping methods. Dry cupping was mainly performed in Bladder Meridian on the back. Wet cupping was mainly performed on BL18, LR14, and BL15. The most common treatment period was 4 weeks. The average number of treatments per week was about 2.4 times for all types of cupping, about 3.2 times for dry cupping and about 1.9 times for wet cupping. All selected studies showed a significant sleep improvement compared to the control group. As a result of the meta-analysis, in terms of effective rate, SAS score, and SDS score, the wet cupping in combination with acupuncture was significantly more effective than acupuncture alone, although the quality of selected RCTs was low. Conclusions: Cupping therapy is effective for insomnia disorder. Based on results of this study, it is reasonable to use wet cupping two times per week on BL18, LR14, and BL15 or use moving cupping three times per week in Bladder Meridian on the back for 4 weeks to treat insomnia disorder.

Application of a Synbio-Glucan Functional Spray for Canine Atopic Dermatitis

  • Yoon-Hwan Kim;Yunho Jeong;Ju-Hyun An;Jin-Ok Ahn;Jin-Young Chung
    • Journal of Veterinary Clinics
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    • v.40 no.1
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    • pp.8-15
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    • 2023
  • Atopic dermatitis (AD) is a common skin disease in animals and several therapeutic trials with various drugs have been conducted for more effective management of AD. However, these trials have not been able to properly address all the aspects of AD management because of the lack of good efficacy or due to significant side effects of the drugs being tested. Synbio-glucan functional spray is a functional skin spray using Synbio-glucan composed of β-glucan and probiotics. We designed a functional spray composed of Synbio-glucan (patent application number:10-1805863), distilled water, glycerin, solubilizer, and 40% alcohol. We tested the efficacy and safety of the functional spray on six dogs with AD. The trial was conducted with the consent of the caregivers. The spray was applied to the skin lesions, including the trunk, axillae, inguinal region, or periocular areas, thrice a day for 30 days. To evaluate the efficacy of this functional spray, we assessed the pruritus visual analog scale (PVAS) and the canine atopic dermatitis extent and severity index (CADESI)-4. At the end of one month, the results clinical scores after functional spray treatment showed a significant decrease in the PVAS (p = 0.03) and CADESI-4 (p = 0.03) in all the subject dogs with AD. This study thus confirmed that the Synbio-glucan functional spray is efficacious and safe for the treatment of AD in dogs.

Epidemiologic Changes of Facial Bone Fracture before and after Coronavirus Disease 2019: A Level 1 Trauma Center in Korea

  • Jeong Ho Kim;Chae Eun Yang;Sug Won Kim;Jiye Kim
    • Archives of Plastic Surgery
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    • v.50 no.1
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    • pp.37-41
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    • 2023
  • Background The coronavirus disease 2019 (COVID-19) outbreak has had a major impact worldwide. Several countries have implemented restrictions on social interaction ("social distancing"). Several studies have reported that the epidemiology of trauma patients, such as those with facial bone fractures, has changed after COVID-19 pandemic. This study aimed to further explore these specific changes. Methods This was a retrospective study of patients who presented to a single institution with facial bone fractures between January 1, 2016, and December 31, 2020. Baseline patient demographics, clinical information, type of fracture, etiology, and operative management were compared before and after COVID-19. Results Of all cases, 3,409 occurred before COVID-19, and 602 occurred after COVID-19. Since the outbreak of COVID-19, the number of patients with facial fractures has not decreased significantly. A significant increase was noted in fractures that occurred outdoors (p < 0.001). However, a decrease was observed in operative management between the groups (p < 0.001). There was no significant difference in the proportion of assault, fall-down, industrial accident, or roll-down. In contrast, the proportion of traffic accidents and slip-down categories increased significantly (p < 0.05). Moreover, a significant decrease was found in the proportion of the sports category (p = 0.001) Conclusions It was confirmed through this study that COVID-19 pandemic also affected epidemiology of facial fractures. Focusing on these changes, it is necessary to develop safety measures to reduce facial fractures.

Assessment of acute inhalation toxicity of citric acid and sodium hypochlorite in rats

  • Jinhee Kim;Chul-Min Park;Su Hyun Choi;Mi Jin Yang;Ju-Yeon Lee;Byung-Suk Jeon;Hyun-Ok Ku;Min-Seok Kim
    • Journal of Veterinary Science
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    • v.24 no.2
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    • pp.22.1-22.12
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    • 2023
  • Background: Citric acid (CA) and sodium hypochlorite (NaOCl) have been used to disinfect animals to protect them against avian influenza and foot-and-mouth disease. Objectives: We performed a good laboratory practice (GLP)-compliant animal toxicity study to assess the acute toxic effects of CA and NaOCl aerosol exposure in Sprague-Dawley rats. Methods: Groups of five rats per sex were exposed for 4 h to four concentrations of the two chemicals, i.e., 0.00, 0.22, 0.67, and 2.00 mg/L, using a nose-only exposure. After a single exposure to the chemicals, clinical signs, body weight, and mortality was observed during the observation period. On day 15, an autopsy, and then gross findings, and histopathological analysis were performed. Results: After exposure to CA and NaOCl, body weight loss was observed but recovered. Two males died in the CA 2.00 mg/L group and, two males and one female died in the 2.00 mg/L NaOCl group. In the gross findings and histopathological analysis, discoloration of the lungs was observed in the CA exposed group and inflammatory lesions with discoloration of the lungs were observed in the NaOCl exposed group. These results suggest that the lethal concentration 50 (LC50) of CA is 1.73390 mg/L for males and > 1.70 mg/L for females. For NaOCl, the LC50 was 2.22222 mg/L for males and 2.39456 mg/L for females. Conclusions: The Globally Harmonized System is category 4 for both CA and NaOCl. In this study, the LC50 results were obtained through a GLP-based acute inhalation toxicity assessment. These results provide useful data to reset safety standards for CA and NaOCl use.

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.

Case Series of Low Back Pain and Pelvic Pain Caused by Traffic Accident during Pregnancy (임신 중 교통사고로 인한 요통 및 골반통으로 입원한 환자 증례 보고)

  • O, Kwang-Woo;Ryu, Ik-Han;Kim, Ji-Ryang;Kim, Hae-Jung;Kang, Jung-Ah;Lee, Su-Jeong;Choi, Chang-Min
    • The Journal of Korean Obstetrics and Gynecology
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    • v.22 no.4
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    • pp.194-204
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    • 2009
  • Purpose: When pregnant women get symptom like pain, because of fear of using analgesic drugs and X-ray test during pregnancy, pain is nevertheless often left. This study was to report the clinical application and safety of oriental treatment to low back pain and pelvic pain caused by traffic accident during pregnancy. Methods: We experienced seven patients who suffered from low back pain and pelvic pain caused by traffic accident during pregnancy. During their admission, we treated with acupuncture, cupping therapy and herbal medicine. We checked the symptoms during admission at progress note, and follow up by phone call. Results: The degree of low back pain and pelvic pain were decreased or resolved. After treatment, no serious adverse effects were found on the patients, and there were no adverse effects at all on the infants. Conclusion: The results indicate that oriental treatment can be effective for the management of low back pain and pelvic pain caused by traffic accident during pregnancy. And these treatments are safe to both patients and infants.

Large-scale purification and single-dose oral-toxicity study of human thioredoxin and epidermal growth factor introduced into two different genetically modified soybean varieties

  • Jung-Ho, Park
    • Korean Journal of Agricultural Science
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    • v.48 no.4
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    • pp.1003-1013
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    • 2021
  • Thioredoxin (TRX) protein is an antioxidant responsible for reducing other proteins by exchanging cysteine thiol-disulfide and is also known for its anti-allergic and anti-aging properties. On the other hand, epidermal growth factor (EGF) is an important material used in the cosmetics industry and an essential protein necessary for dermal wound healing facilitated by the proliferation and migration of keratinocytes. EGF also assists in the formation of granulation tissues and stimulates the motility of fibroblasts. Hence, genetically modified soybeans were developed to overexpress these industrially important proteins for mass production. A single-dose oral-toxicity-based study was conducted to evaluate the potential toxic effects of TRX and EGF proteins, as safety assessments are necessary for the commercial use of seed-specific protein-expressing transgenic soybeans. To achieve this rationale, TRX and EGF proteins were mass purified from recombinant E. coli. The single-dose oral-toxicity tests of the TRX and EGF proteins were carried out in six-week old male and female Institute of Cancer Research (ICR) mice. The initial evaluation of the single-dose TRF and EGF treatments was based on monitoring the toxicity signatures and mortality rates among the mice, and the resultant mortality rates did not show any specific clinical symptoms related to the proteins. Furthermore, no significant differences were observed in the weights between the treatment and control groups of male and female ICR mice. After 14 days of treatment, no differences were observed in the autopsy reports between the various treatment and control groups. These results suggest that the minimum lethal dose of TRX and EGF proteins is higher than the allowed 2,000 mg·kg-1 limit.

A network pharmacology and molecular docking approach in the exploratory investigation of the biological mechanisms of lagundi (Vitex negundo L.) compounds against COVID-19

  • Robertson G. Rivera;Patrick Junard S. Regidor;Edwin C. Ruamero Jr;Eric John V. Allanigue;Melanie V. Salinas
    • Genomics & Informatics
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    • v.21 no.1
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    • pp.4.1-4.18
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    • 2023
  • Coronavirus disease 2019 (COVID-19) is an inflammatory and infectious disease caused by severe acute respiratory syndrome coronavirus 2 virus with a complex pathophysiology. While COVID-19 vaccines and boosters are available, treatment of the disease is primarily supportive and symptomatic. Several research have suggested the potential of herbal medicines as an adjunctive treatment for the disease. A popular herbal medicine approved in the Philippines for the treatment of acute respiratory disease is Vitex negundo L. In fact, the Department of Science and Technology of the Philippines has funded a clinical trial to establish its potential as an adjunctive treatment for COVID-19. Here, we utilized network pharmacology and molecular docking in determining pivotal targets of Vitex negundo compounds against COVID-19. The results showed that significant targets of Vitex negundo compounds in COVID-19 are CSB, SERPINE1, and PLG which code for cathepsin B, plasminogen activator inhibitor-1, and plasminogen, respectively. Molecular docking revealed that α-terpinyl acetate and geranyl acetate have good binding affinity in cathepsin B; 6,7,4-trimethoxyflavanone, 5,6,7,8,3',4',5'-heptamethoxyflavone, artemetin, demethylnobiletin, gardenin A, geranyl acetate in plasminogen; and 7,8,4-trimethoxyflavanone in plasminogen activator inhibitor-1. While the results are promising, these are bound to the limitations of computational methods and further experimentation are needed to completely establish the molecular mechanisms of Vitex negundo against COVID-19.

Pediatricians' perception of factors concerning the clinical application of blockchain technology to pediatric health care: a questionnaire survey

  • Yong Sauk Hau;Min Cheol Chang;Jae Chan Park;Young Joo Lee;Seong Su Kim;Jae Min Lee
    • Journal of Yeungnam Medical Science
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    • v.40 no.2
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    • pp.156-163
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    • 2023
  • Background: Interest in digital medical information has increased because it allows doctors to easily access a patient's medical records and provide appropriate medical care. Blockchain technology ensures data safety, reliability, integrity, and transparency by distributing medical data to all users over a peer-to-peer network. This study attempted to assess pediatricians' thoughts and attitudes toward introducing blockchain technology into the medical field. Methods: This study used a questionnaire survey to examine the thoughts and attitudes of 30- to 60-year-old pediatricians regarding the introduction of blockchain technology into the medical field. Responses to each item were recorded on a scale ranging from 1 (never agree) to 7 (completely agree). Results: The scores for the intentions and expectations of using blockchain technology were 4.0 to 4.6. Pediatricians from tertiary hospitals responded more positively (4.5-4.9) to the idea of using blockchain technology for hospital work relative to the general population (4.3-4.7). However, pediatricians working in primary and secondary hospitals had a slightly negative view of the application of blockchain technology to hospital work (p=0.018). Conclusion: When introducing the medical records of related pediatric and adolescent patients using blockchain technology in the future, it would be better to conduct a pilot project that prioritizes pediatricians in tertiary hospitals. The cost, policy, and market participants' perceptions are essential factors to consider when introducing technology in the medical field.

Application of cold atmospheric microwave plasma as an adjunct therapy for wound healing in dogs and cats

  • Jisu Yoo;Yeong-Hun Kang;Seung Joon Baek;Cheol-Yong Hwang
    • Journal of Veterinary Science
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    • v.24 no.4
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    • pp.56.1-56.13
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    • 2023
  • Background: Cold atmospheric plasma is a novel innovative approach for wound care, and it is currently underrepresented in veterinary medicine. Objectives: To investigate the efficacy and safety of using cold atmospheric microwave plasma (CAMP) as an adjunct therapy for wound healing in dogs and cats. Methods: Wound healing outcomes were retrospectively analyzed using clinical records of client-owned dogs and cats who were first managed through standard wound care alone (pre-CAMP period) and subsequently via CAMP therapy (CAMP period). The degree of wound healing was estimated based on wound size and a modified wound scoring system. Results: Of the 27 acute and chronic wounds included in the analysis, 81.48% showed complete healing after the administration of CAMP as an adjunct therapy to standard care. Most wounds achieved complete healing in < 5 weeks. Compared with the pre-CAMP period, the rate of wound healing significantly increased every week in the CAMP period in terms of in wound size (first week, p < 0.001; second week, p = 0.012; third week, p < 0.001) and wound score (first week, p < 0.001; second week, p < 0.001; third week, p = 0.001). No adverse events were noted except for mild discomfort and transient erythema. Conclusions: CAMP is a well-tolerated therapeutic option with immense potential to support the treatment of wounds of diverse etiology in small animal practice. Further research is warranted to establish specific criteria for CAMP treatment according to wound characteristics.