• 제목/요약/키워드: Clinical safety

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Panax ginseng: An Overview of the Clinical Evidence

  • Ernst, Edzard
    • Journal of Ginseng Research
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    • 제34권4호
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    • pp.259-263
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    • 2010
  • This overview is focused on Panax ginseng, one of the most commonly used herbal remedies. The currently available data regarding its clinical efficacy is somewhat confusing, despite the fact that many clinical trials and systematic reviews have been published. The risks of Panax ginseng seem to be only minor. Numerous mechanisms of action have been described. Future studies of this fascinating herbal remedy seem warranted but they should overcome the methodological limitations of the previous research.

Rats를 이용한 Iso-butylalcohol의 아만성 흡입독성 연구 (Study on Inhalation Toxicity of Iso-butylalcohol Using SD Rats)

  • 김현영;윤효인;이성배;장범수;정재황;임철홍;정용현;한정희;전윤석;장동혁;하창수;김종춘;이용묵
    • 한국산업보건학회지
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    • 제9권2호
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    • pp.66-78
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    • 1999
  • The purpose of this study was to investigate the toxic effects of iso-butylalcohol on Sprague-Dawley (SD) rats which were treated 0, 333, 1,000 and 3,000 ppm for 6 hours a day, 5 days a week for 13 weeks by inhalation. Iso-butylalcohol did not induce any abnormal change in the viewpoint of clinical signs, feed consumption, ophthalmic test, urinalysis, hematology and blood biochemistry during and at the termination of the inhalation toxicity test. We did not find any abnormal findings in the gross and microscopic observations due to the inhalation of iso-butylalcohol. There was no alteration in relative organ weight owing to the inhalation of the iso-butylalcohol. In conclusion, concentration was 3,000 ppm in rats under the inhalation of 6 hours a day, 5 days a week for 13 week. Iso-butylalcohol did not show any change in the clinical signs, feed consumption, ophthalmic test, urinalysis, hematology and blood biochemistry, together with no alteration in the gross and pathological findings.

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건칠(乾漆) 추출물(Nexia)의 독성 실험과 급성 림프 구성 백혈병환자의 임상증례군 보고 (The Study on the Safety and Case Series of the Acute Lymphocytic Leukemia using Rhus Verniciflua Stokes Extract (Nexia))

  • 박재우;김경석;정현식;최원철;윤성우
    • 대한암한의학회지
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    • 제11권1호
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    • pp.1-21
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    • 2006
  • This study was undertaken to evaluate safety and antitumor activity of Nexia, a processed extract of Rhus verniciflua STOKES by heating according to Korean patent 0504160 through toxicology, cancer research and clinical application. Nexia did not exhibit any toxicological symptoms through 13 week continuous treatment, dosage accumulation study and anaphylaxis response. The lifespan of four patients with acute lymphocytic leukemia under complete remission were 110, 83, 97, and 86 months after treatment of Nexia, respectively. These data suggest that Nexia, a processed extract by removing allergen from Rhus verniciflua STOKES, may have safety and antitumor activity and also still need continuous study on its mechanism and clinical trial.

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오령산 열수추출물의 단회투여 급성독성 연구 (Acute Toxicity Study on Oryeong-san in Mice)

  • 박화용;황윤환;하정호;정기연;마진열
    • 대한한의학방제학회지
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    • 제21권1호
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    • pp.111-118
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    • 2013
  • Objectives : Traditional medicine Oryeong-san (ORS) has been prescribed for a long time to treat light fever, thirst, dysuria, and accompanying edema. However, the acute toxicity and safety were not reported. In this study, we evaluated the potent acute toxicity and safety of ORS. Methods : ICR mice were used to evaluate acute toxicity and safety by oral administration of 0, 500, 1,000, 2,000mg/kg of ORS. Mortality, body weight, and clinical symptoms were observed, and organ weight and blood biochemical parameters were analyzed after necropsy. Results : We found no mortality and no toxic or abnormal clinical symptoms by administration of ORS. Comparing with control group, no significant alterations in organ weight and blood biochemical parameters were observed. Conclusions : ORS recognized as safe and non-toxic medicinal material, and median lethal dose considered to be over 2,000 mg/kg in both male and female ICR mice.

Radiographic Features of Traumatically Caused Retroflexion of Urinary Bladder in Two Dogs

  • Lee, Hae-Beom;Kang, Hye-Won;Kim, Min-Su;Kim, Nam-Soo;Lee, Ki-Chang
    • 한국임상수의학회지
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    • 제25권6호
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    • pp.553-556
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    • 2008
  • The urinary bladder retroflexion, flipped over backwards into the pelvic canal, by trauma has been rarely reported in dogs. This paper describes clinical and radiological features of urinary bladder retroflexion in two dogs with a history of traffic accident. The main clinical signs were hind limb lameness, severe pain and dysuria. Radiography and ultrasonography were performed to evaluate the patient's damages. No remarkable findings were observed except pelvic fracture on survey radiograph. On cystourethrography, caudal displacement and retroflexion of the bladders were identified. Cystopexy was performed and the bladders were repositioned. After surgery one dog with severe azotemia and bilateral hydroureteronephrosis was deteriorated noticeably and euthanized by request of the owner, while the other dog was recovered no recurrence of the problem by 12 months post-surgery. It should be considered that contrast study and serial assessment in urinary tract be important to demonstrate the evidence of bladder retroflexion and evaluate the prognosis in dogs with severe trauma.

In vivo Imaging Biodistribution Profile of a New Macrocyclic Gadolinium Chelate as a Highly Stable Multifunctional MRI Contrast Agent

  • Sung, Bo Kyung;Jo, Yeong Woo;Chang, Yongmin
    • Investigative Magnetic Resonance Imaging
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    • 제23권1호
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    • pp.34-37
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    • 2019
  • Gadolinium contrast agents (CAs) are integral components of clinical magnetic resonance imaging (MRI). However, safety concerns have arisen regarding the use of gadolinium CAs, due to their association with nephrogenic systemic fibrosis (NSF). Furthermore, recently the long-term retention of $Gd^{3+}-based$ CAs in brains patients with normal renal function raised another possible safety issue. The safety concerns of $Gd^{3+}-based$ CAs have been based on the ligand structure of $Gd^{3+}-based$ CAs, and findings that $Gd^{3+}-based$ CAs with linear ligand structures showed much higher incidences of NSF and brain retention of CAs than $Gd^{3+}-based$ CAs with macrocyclic ligand structure. In the current study, we report the in vivo biodistribution profile of a new highly stable multifunctional $Gd^{3+}-based$ CA, with macrocyclic ligand structure (HNP-2006). MR imaging using HNP-2006 demonstrated a significant contrast enhancement in many different organs. Furthermore, the contrast enhanced tumor imaging using HNP-2006 confirmed that this new macrocyclic CA can be used for detecting tumor in the central nervous system. Therefore, this new multifunctional HNP-2006 with macrocyclic ligand structure shows great promise for whole-body clinical application.

여성의 주요우울증에 대한 노에스액(육울탕)의 안전성, 유효성 평가 : 무작위배정, 양측눈가림, 위약대조, 평행설계 임상시험 프로토콜 (A Research to Evaluate the Safety and Efficacy of Yukwool-tang (Liuyu-tang) for Major Depression in Women: A Study Protocol for a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Trial)

  • 서영경;이은희;김환;이지윤;박채린;최선영;장은수;권오진;김형준;정인철
    • 동의신경정신과학회지
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    • 제29권1호
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    • pp.35-46
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    • 2018
  • Objectives: The aim of this trial is to evaluate the efficacy and safety of Yukwool-tang (Liuyu-tang) for the treatment of major depression in women by comparing the Yukwool-tang (Liuyu-tang)-treated group with the placebo-treated group and assessing the association of various biological factors related to depression through various outcome measures. Methods: This study is a single-center, randomized, double-blind, placebo-controlled, parallel-design clinical trial. The subjects to be selected are women between the ages of 19 and 65, and the registered subjects are to be randomly assigned to treatment with Yukwool-tang or the placebo control. The Yukwool-tang group will take 1 bottle of Yukwool-tang (30 mg) for 8 weeks, 3 times a day, before meals. The control group will take the placebo in the same way. The primary outcome to be examined will be the change between the total score after 8 weeks and the total score before the start of the study of the K-HDRS score. Secondary outcomes are assessed by the change in total score after 12 weeks of K-HDRS, K-HDRS remission rate, K-HDRS improvement rate, BDI-K, PITD, KSCL-95, ISI, STAI-K, EQ-5D, VAS, Emotional Stimulation Test, BDNF test, inflammatory cytokine and tumor necrosis factor test, intestinal microbiome test, dietary report and Beck's hopelessness scale. Results: This protocol has been approved by the IRB of Dunsan Korean Medicine Hospital of Daejeon University and is registered in the CRIS, and it is made public in advance to ensure transparency of the research process and conduct ethical clinical trials. Conclusions: Based on this protocol, when the trial is completed, its data can be used to access the validity and safety of Yukwool-tang for major depression in women, and it is also expected to be helpful in the study of the correlation between future treatment of Korean medicine for depression and related biological factors, and quality of life.

오적산 병용투여가 혈당강하 치료를 받고 있는 제2형 당뇨병 환자의 혈당에 미치는 영향 (A Retrospective Study on the Effect of the Co-Administration of Ojeok-san and Hypoglycemic Agents on Blood Glucose Levels in Type 2 Diabetes Mellitus)

  • 이민승;정수민;오승현;이한영;임형근;안영민;안세영;이병철
    • 대한한방내과학회지
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    • 제42권1호
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    • pp.40-52
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    • 2021
  • Objective: This study was conducted to investigate the hypoglycemic effect and safety of Ojeok-san in patients with type 2 Diabetes Mellitus. Methods: We investigated type 2 diabetes mellitus patients at Kyung-Hee University Korean Medical Hospital who were administered Ojeok-san for at least one day between January 2012 and September 2020, basal characteristics and laboratory tests were reviewed retrospectively. The hypoglycemic effect of Ojeok-san was assessed by comparing fasting blood sugar (FBS) and two hours post-prandial plasma glucose (PP2) levels from before and after taking Ojeok-san. Subgroup analyses were conducted according to baseline hypoglycemic treatments and glycated hemoglobin levels (< or ≥6.5%). The safety of Ojeok-san was assessed by comparing levels of aspartate aminotransferase, alanine aminotransferase, γ-glutamyl transferase, blood urea nitrogen, and creatinine. Results: After Ojeok-san administration, FBS and PP2 were significantly reduced to an average of 14.33 mg/dL and 27.67 mg/dL respectively. In the subgroup analysis, PP2 in patients receiving metformin mono therapy was significantly reduced to 28.67 mg/dL, and those receiving a dual therapy of metformin and DPP-4 inhibitor, it was significantly reduced to 32.33 mg/dL. In patients with glycated hemoglobin of lower than 6.5%, FBS was significantly reduced to 12.20 mg/dL, and both FBS and PP2 were significantly reduced, to 15.50 mg/dL and 40.00 mg/dL, respectively, in those with glycated hemoglobin levels of more than 6.5%. The safety profile showed no significant difference after Ojeok-san administration. Conclusions: Ojeok-san has significant hypoglycemic effects in patients with type 2 diabetes mellitus who are also taking hypoglycemic agents.

일 지역 종합병원 간호사의 환자안전문화 인식이 안전간호활동에 미치는 영향 (Effects of Perceived Patient Safety Culture on Safety Nursing Activities in the General Hospital Nurse's)

  • 김화영;김혜숙
    • 간호행정학회지
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    • 제17권4호
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    • pp.413-422
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    • 2011
  • Purpose: This descriptive correlation study was done to identify how perception of patient safety culture of general hospital nurses affects safety during nursing activities. Data from this study should provide information on management of patient safety as well as improvement in patient safety. Method: Participants in this study were 357 clinical nurses working in a general hospital in M city which had two medical evaluations. A survey was conducted to gather the data. Results: The score for perception of patient safety culture of the general hospital nurses was 3.42, out of a possible 5 points, and the score for safety care activities was 3.90. There was a statistically significant positive relationship between the nurses' perception of patient safety culture and their safety care activities, Perception of patient safety culture, Supervisor/manager, communication and procedures, and frequency of accident reporting were factors that impacted significantly on safety nursing activity. Conclusion: The results of the study indicate that patient safety cultural perception significantly affects the safety of nursing activities and thus systematic educational strategies to increase perception should be provided to increase the level of patient safety culture. Also, other specific methods that increase the level of patient safety culture should be considered.

한약의 안전성에 대한 인터넷 보도의 특성을 통해 본 한약 부작용 관리 체계 확립의 필요성 (Necessity of Adverse Event Reporting System through the Trend of Internet News about Safety of Herbal Medicine)

  • 전천후;박정수;박선주;권기태;신용철;고성규
    • 대한예방한의학회지
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    • 제15권2호
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    • pp.131-143
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    • 2011
  • Objective : The aims of this study are to investigate the trend of internet journalism about the toxicity and safety of the herbal medicine, and to suggest the regulatory solution of the issue. Method : In this study, we had searched the internet news article published from 2001 to 2011 in the five major portal sites-NAVER, DAUM, Nate, Google Korean, and Yahoo Korean. The search terms were 'herbal medicine', 'adverse event', 'toxicity'. If the articles described the same event in the same form and tone, the articles were considered overlapping. The overlapped articles were excluded. The articles were categorized by the form and tone. The form categories were straight news, interpretative story, editorial, interview, and the tone categories are the positive, the negative, and the neutral. The regulations were searched about the negative issue. Result : Total 56 articles were reviewed. There were 19 positive articles, 29 negative articles, 8 neutral articles. Most negative issues have the proper regulations, but insufficient measures for the adverse event reporting system. Conclusion : The herbal medicine specified adverse event reporting system is essential.