• Title/Summary/Keyword: Adverse effect

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Status of reports of adverse events related to botanical herbal medicines with toxic precautions officially managed by Korean government: A descriptive analysis from WHO VigiAccess (WHO VigiAccess에 수록된 식물성 독성주의한약재 관련 이상사례 보고 현황)

  • Mikyung Kim
    • The Journal of Korean Medicine
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    • v.45 no.1
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    • pp.165-181
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    • 2024
  • Objectives: This study was aimed to review the global status of adverse event (AE) reports and the characteristics of the reported AEs of plants managed as herbal medicines (HMs) with toxic precautions in Korea. Methods: This is a cross-sectional quantitative study that analyzed information available through VigiAccess, a website that provides summarized statistical information from the WHO's global AE database to the public. VigiAccess was searched in 8 Jan, 2024. Information on the total number of reports, number of reports by year and continent, and the age and gender of patients were obtained, and the types of frequently reported AEs were also reviewed. Results: Data on the status of report submissions were obtained for a total of 9 HMs including Aconitum ciliare, Aconitum carmichaeli, Arisaema japonicum, Pinellia ternata, Euphorbiae Lathyridis, Croton tiglium, Strychni Ignatii, Strychnons nux-vomica, and Linum usitatissimum. The number of reports per HM was from 1 to 137. The most commonly reported type of AEs were gastrointestinal disorders in most of the HMs, followed by neurological disorders. Serious adverse events were reported only in Strychni Ignatii, Strychnons nux-vomica, and Linum usitatissimum, including one case of death. Conclusions: This study shows the status of reported AEs of botanicals considered as HMs with toxic precautions in Korea based on real world data. However, when interpreting the findings of this study, readers should consider the significant limitations of this study mainly because of the characteristics of the data source.

The Effect of Needle-embedding Therapy on the Improvement Against Facial Wrinkles: A Case Series (매선치료의 안면주름 개선효과 10례)

  • Lee, Seung-Min;Lee, Chang-Woo;Jeon, Ju-Hyun;Kim, Young-Il
    • Journal of Acupuncture Research
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    • v.28 no.4
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    • pp.143-147
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    • 2011
  • Objectives : The purpose of this study was to examine the effect of needle-embedding therapy against facial wrinkle. Methods : Ten patients with facial wrinkles were treated with needle-embedding therapy. Pictures and satisfaction questionnaire were compared before and after the treatment. And all patients were examined for adverse side effect after needle-embedding therapy. Results : After treatment, facial wrinkles were visibly improved after needle-embedding therapy. There were no adverse side effect except bruise. Conclusions : This study suggests that needle-embedding therapy can improve facial wrinkles.

Can oliceridine (TRV130), an ideal novel µ receptor G protein pathway selective (µ-GPS) modulator, provide analgesia without opioid-related adverse reactions?

  • Ok, Hwoe Gyeong;Kim, Su Young;Lee, Su Jung;Kim, Tae Kyun;Huh, Billy K;Kim, Kyung Hoon
    • The Korean Journal of Pain
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    • v.31 no.2
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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.

Effects of Ephedra on Weight Loss and Heart Rate Variability: A Double-Blind Randomized Controlled Pilot Study (마황복용이 정상성인의 체중 감소와 심박변이도에 미치는 영향에 관한 예비 연구: 무작위배정 이중맹검시험)

  • Yang, Chang-Sop;Hsing, Li-Chang;Yeo, Jin-Ju;Seo, Eui-Seok;Jang, In-Soo
    • The Journal of Internal Korean Medicine
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    • v.27 no.4
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    • pp.836-844
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    • 2006
  • Background: Mahuang (Ephedra sinica STAPF) is well known as an herbal medicine and has been widely used to reduce body weight and increase athletic ability. However, as a result of reporting many cases of adverse effects on the cardiovascular system, use of dietary supplements containing ephedra was prohibited by the FDA. Objectives : The object of this study was to find the effectiveness of ephedra on weight loss without severe adverse effect. Methods : 16 healthy volunteers consisting of an ephedra group (N=8) and a placebo group (N=8) were investigated. Study form was a randomized, controlled, double-blind clinical trial. The ephedra group took 12g of ephedra while the placebo group took 12g of glutinous rice powder. Both groups were measured with BCA (body composition analysis) on weight loss and with HRV (heart rate variability) on its adverse effect before and after medication. Results : The following results were obtained after taking 12g of ephedra for 14 days. In the ephedra group, body weight reduced significantly. In the placebo group, there were no significant differences of body weight between before and after placebo treatment. There was a slight increase of heart beat rate and deactivation of cardiac activity. Parasympathetic nerves were deactivated, but balances of autonomic nervous system were well maintained. Conclusions : The results suggest that ephedra in healthy adults tends to reduce body weight and deactivation of autonomic nervous system and cardiac activity.

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The prevention of mortality after botulinum toxin injection in oral maxillofacial region (구강 악안면 영역에서 보툴리눔 독소 주사 후 사망 부작용의 예방)

  • Lee, Won-Kang;Choi, Young-Chan;Choi, Moon-Jong;Kim, Seong-Taek
    • Journal of Dental Rehabilitation and Applied Science
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    • v.30 no.4
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    • pp.299-306
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    • 2014
  • Botulinum toxin (BoNT) has been used for a wide spectrum of therapeutic and cosmetic indications, and the range of indications is continually increased. Though BoNT is a powerful poison, the fact that not only the effect but also the adverse effect of it fader about 6 months after injection makes clinicians to neglect its dangerous property in clinical application. But Many reports about the adverse effects including death of BoNT injection have been reported, the FDA edited in additional warnings about hospitalizations and deaths. In this study, we intended to look through the metabolic process in human body, possible adverse effect, matters to be attended in application, and cases reports about deaths of BoNT by reviewing the previous studies.

Influence of the Concomitant Use of Clopidogrel and Proton Pump Inhibitors on Adverse Cardiovascular Events in Korean Patients with Acute Coronary Syndrome (Clopidogrel에 Proton Pump Inhibitors 병용 시 급성 관동맥 증후군 환자의 심장관련 부작용에 미치는 영향)

  • Kim, Su Hyun;Lee, Yu Jeung
    • Korean Journal of Clinical Pharmacy
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    • v.24 no.2
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    • pp.106-114
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    • 2014
  • Purpose: Recent investigations suggest that the antiplatelet effect of clopidogrel may be decreased when this medication is taken together with certain proton pump inhibitors (PPIs). However, there has been no study conducted in Korea regarding the clinical effect of clopidogrel-PPI interaction. This study targeted patients who received stents to investigate the effect of the concomitant use of clopidogrel and PPIs on the occurrence of adverse cardiovascular events in Korean patients. Methods: The patients who received a stent insertion at the Yeouido St. Mary's Hospital between January 2010 and April 2011 were included. The patients were divided into two groups, clopidogrel and clopidogrel + PPI, and followed for 12 months after the date of stent insertion using prescription history and medical records. The recurrence rates of the cardiovascular events among the two patient groups were statistically analyzed. Results: There was no difference between the two groups in the basic characteristics of the 157 patients in the clopidogrel group and the 62 patients in the clopidogrel+PPI group. Simple logistic regression showed a significantly higher rate of re-hospitalization in the clopidogrel+PPI group (OR=1.893, 95% CI 1.040-3.445, p=0.037). However, the results of the multivariate logistic regression of the variables found to have statistical significance by crosstabulation showed no significant difference in the rate of adverse cardiovascular events or re-hospitalization between the two groups. Conclusions: There was no significant difference between the clopidogrel and clopidogrel+PPI group among new patients with cardiovascular stents with respect to the occurrence of revascularization procedures, stent thrombosis, or chest pain, or with respect to the re-hospitalization rate for all cardiovascular events.

A Study on the Removal of Low-Concentration Ozone by means of Activated Carbon (활성탄을 이용한 저농도 오존(OZONE)제거에 관한 연구)

  • 양원호;최경호;정문식
    • Journal of Environmental Health Sciences
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    • v.23 no.2
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    • pp.57-63
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    • 1997
  • This study was carried out to find the adverse health effects of ozone by papers, the potential indoor sources of ozone by papers, and then the removal mechanism of ozone by experiments. The exposure of individuals to excessive levels of ozone both in the industrial and ambient environment is a continuing public health concern. Ozone indoors may play a role in generating secondary pollutants that may have adverse health effects. The removal efficiency of ozone was studied by (1) the effect of concentration on breakthrough time, (2) the effect of flow rate on breakthrough time, (3) the effect of adsorbent's weight on breakthrough time, (4) the effect of temperature on breakthrough time, (5) the application of Langmuir's isotherm equation in using activated carbon. The followings are the conclusions that were derived from this study. 1. In the effect of concentration on breakthrough time, the adsorption capacity of activated carbon was inversely proportional to ozone concentratuion (0.1, 0.2, 0.3 ppm). 2. In the effect of flow rate on breakthrough time, the service life of activated carbon was inversely proportional to flow rate (2, 8, 14l/min). 3. The difference in removal efficiency of ozone between weights(100 mg and 150 mg) was seen. And when weight of activated carbon was 100 mg and 150 mg, pressure loss was 4-5mmHg and 6-7mmHg, respectively. It is required to study relations among flow rate and adsorbent's weight and ventilation quantity, too. 4. Generally, Langmuir's equation, one of the oldest and most used frequently isotherm equation, applies to chemisorption. In case of ozone, when the weight of activated carbon was 70 mg and temperature 40, slope(1/a) was $6.25\times 10^{-1}$ and intercept(1/ab) was $1.9\times 10^{-4}$ (average r=0.94).

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A Case Report on the Traumatic Pneumothorax associated with Acupuncture (자침과 관련된 외상성 기흉 1례)

  • Lee, Sang-Hoon;Choi, Do-Young;Lee, Yun-Ho
    • Journal of Acupuncture Research
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    • v.18 no.4
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    • pp.205-211
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    • 2001
  • Objective : There was no report on traumatic pneumothorax associated with acupuncture in korea yet, although many people guess at its possibility. In order to make known that acupuncture can cause pneumothorax in reality and to prevent more acupuncture-related adverse effect cases in future, this report was made. Methods : Close observation was done on clinical symptoms & radiologic examination of acupuncture-related traumatic pneumothorax patient. Results : During acupuncture therapy on neck stiffness & shoulder pain, a acupuncture needle was inserted too deeply into upper part of thorax unintentionally, patient showed dyspnea, chest pain & discomfort, cough, sweating and mild rupture of right lung in chest radiologic findings, and recovered after 2 weeks of conservative treatment. Conclusion : In order to prevent traumatic pneumothorax during acupuncture therapy, needling into thorax sometimes requires tilted acupuncture needle inserting under consideration of needle width & length. At least 0.40mm width of needle is generally considered appropriate in needling into taut band of thoracic muscles, because too thin and long needle sometimes can be bent and inserted into wrong way, which can cause adverse effects like pneumothorax.

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Effects of transgenic watermelon with CGMMV resistance on the diversity of soil microbial communities using PLFA

  • Yi, Hoon-Bok;Kim, Chang-Gi
    • Animal cells and systems
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    • v.14 no.3
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    • pp.225-236
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    • 2010
  • We compared the composition of phospholipid fatty acids (PLFA) to assess the microbial community structure in the soil and rhizosphere community of non-transgenic watermelons and transgenic watermelons in Miryang farmlands in Korea during the spring and summer of 2005. The PLFA data were seasonally examined for the number of PLFA to determine whether there is any difference in the microbial community in soils from two types of watermelons, non-transgenic and transgenic. We identified 78 PLFAs from the rhizosphere samples of the two types of watermelons. We found eight different PLFAs for the type of plants and sixteen PLFAs for the interaction of plant type and season. The PLFA data were analyzed by analysis of variance separated by plant type (P<0.0085), season (P<0.0154), and the plant type${\times}$season interaction (P<0.1595). Non-parametric multidimensional scaling (NMS showed a small apparent difference but multi-response permutation procedures (MRPP) confirmed that there was no difference in microbial community structure for soils of both plant types. Conclusively, there was no significant adverse effect of transgenic watermelon on bacterial and fungal relative abundance as measured by PLFA. We could reject our hypothesis that there might be an adverse effect from transgenic watermelon with our statistical results. Therefore, we can suggest the use of this PLFA methodology to examine the adverse effects of transgenic plants on the soil microbial community.

An Analysis on the Effect of Patient-controlled Analgesia Performed by Orthopaedic Department or Postoperative Pain Control after Shoulder and Elbow Surgery

  • Yum, Jae-Kwang;Kim, Jin-Hyok;Boo, Kyung-Hwan;Ahn, Soo-Hyung
    • Clinics in Shoulder and Elbow
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    • v.18 no.4
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    • pp.237-241
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    • 2015
  • Background: We investigated the effectiveness of pain management and the adverse events of intravenous (IV) patient-controlled analgesia (PCA) after orthopedic surgery. Methods: From September 2014 and August 2015, we performed a retrospective analysis of 77 patients who underwent orthopedic surgery of the shoulder or the elbow in our hospital. The composition of the intravenous PCA administered to the patients was as follows: 250 mg of dexketoprofen trametamol, 70 mg of oxycodone, and 0.6 mg of ramosetron, which were made up to 79 ml of normal saline. We evaluated and statistically analyzed the difference in the visual analogue scale (VAS) scores for pain at immediate postoperation, at 24 hours of PCA, at 72 hours of PCA, and after discontinuation of PCA and in the incidence of adverse events. Results: We found that VAS score decreased for 3 postoperative days and that with discontinuation of IV PCA a meaningful change in VAS score was no longer seen. Of the 77 patients, 22 presented with adverse events (28.6%). We terminated IV PCA temporarily in the 21 patients who presented with adverse events; we terminated analgesia permanently in one patient (1.2%). Consequently, 76 of 77 patients carried out IV PCA till the designated period. Conclusions: Intravenous PCA after orthopedic surgery of the shoulder or the elbow may be accompanied with adverse events. Careful assessment of the patient and treatment of the adverse outcomes are key to a successful maintenance of PCA and to a successful management of postoperative pain.