• Title/Summary/Keyword: adverse effect

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The Safety Guidelines for use of Ma-huang in Obesity Treatment (비만처방에서의 안전한 마황사용 지침)

  • Song, Mi-Young;Kim, Ho-Jun;Lee, Myeong-Jong
    • Journal of Korean Medicine for Obesity Research
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    • v.6 no.2
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    • pp.17-27
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    • 2006
  • Objectives : Ma-huang (Ephedra sinica) is frequently prescribed for obesity management in oriental medicine. The main component is ephedrine alkaloids which can have serious adverse side effects such as heart attack, stroke, sudden death. There are no scientific guidelines for Ma-huang usage in the safe treatment of obesity in oriental medicine. We reviewed published studies on its safety to make evidence based guidelines. Methods : We searched electronic databases up to May 2006. We limited evidence to controlled trials for efficacy or safety, case reports for safety, and studies for Ma-huang contents analysis. Results and Conclusions : In clinical trials for weight loss, Ma-huang and ephedrine promote modest short-term weight loss but have no serious adverse effects, have only a few adverse effects associated with increased risk of psychiatric, autonomic, gastrointestinal symptoms and heart palpitations. In case reports, there have been serious adverse effects including stroke, heart attack, and death using typical doses of ephedrine or no associated illness. There are factors related to serious adverse effects, such as overuse, lack of standardization, individual sensitivity, and interactions with other drugs. Studies relating to these factors should be analyzed for safe use of Ma-huang and ephedrine. After analyzing related studies, we suggest guidelines for Ma-huang usage. We propose that the dosage should be within 4.5-7.5g per day for up to 6 months for generally healthy individual. It's use is contraindicated in individuals with heart disease, thyroid disease, diabetes mellitus, hypertension, psychiatric disorders, glaucoma, urination disorders, enlarged prostate, persons using MAOIs, methyldopa and sympathomimetic agents.

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Consumption Status and Experience of Adverse Effects of High-caffeine Energy Drink among High School Students (청소년의 고카페인 에너지음료 섭취 실태 및 부작용 경험)

  • Oh, Yun-Jung
    • Journal of Convergence for Information Technology
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    • v.9 no.6
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    • pp.35-43
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    • 2019
  • This study was conducted in order to identify consumption and experience of adverse effects of high-caffeine energy drink among high school students. This study was a descriptive survey including 245 students in D city. Data were analyzed using descriptive statistics and ${\chi}^2$ test. In the results, 79.5% of the students had previous experience of energy drink consumption. 50.6% of students were experienced adverse effects, mainly palpitation. Among the general characteristics, there was a significant difference according to the experience of high-caffeine energy drink consumption depending on monthly allowance(p=.019) and drinking(p=.033), and a significant difference from adverse effects depending on gender(p=.001) and health condition(p=.006). Also, there was a significant difference according to the experience of adverse effects depending on drinking reason(p=.040) and drinking time(p=.005). After, policy measures are needed to limit the sale of high-caffeine energy drinks and continuous health education is needed to foster the ability of students to control themselves.

A Proposal on Analyzing and Preventing Adverse Effects of Ubiquitous Services (유비쿼터스 서비스의 역기능 분석 및 방지를 위한 제언)

  • Kang, Min-Cheol;Kwak, Soo-Hwan;Kim, Chang-Soo
    • The Journal of Information Systems
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    • v.19 no.4
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    • pp.87-109
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    • 2010
  • The ubiquitous computing & technology is to make passive IT machinery as the smart-object to solve the problems of information management. These ubiquitous devices can be a concierge of humans lives. In addition, the ubiquitous computing & technology added with Pro-Active processing technology is the intellectual automatic process capacity that probably enhance quality of human's life. Although the social influencing power of ubiquitous computing technology is so critical, research on the social impact of ubiquitous has been studied insufficiently. And, we also need the countermeasures to protect the societies from the side effect of the ubiquitous computing technology. The purpose of this research is to minimize the loss which comes from the new ubiquitous society, by presenting the technological and systematic alternatives and by researching the various side effects. This research suggests the proper alternatives by reviewing and by researching the adverse effects of the ubiquitous computing technology.

In Silico Prediction of Organ Level Toxicity: Linking Chemistry to Adverse Effects

  • Cronin, Mark T.D.;Enoch, Steven J.;Mellor, Claire L.;Przybylak, Katarzyna R.;Richarz, Andrea-Nicole;Madden, Judith C.
    • Toxicological Research
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    • v.33 no.3
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    • pp.173-182
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    • 2017
  • In silico methods to predict toxicity include the use of (Quantitative) Structure-Activity Relationships ((Q)SARs) as well as grouping (category formation) allowing for read-across. A challenging area for in silico modelling is the prediction of chronic toxicity and the No Observed (Adverse) Effect Level (NO(A)EL) in particular. A proposed solution to the prediction of chronic toxicity is to consider organ level effects, as opposed to modelling the NO(A)EL itself. This review has focussed on the use of structural alerts to identify potential liver toxicants. In silico profilers, or groups of structural alerts, have been developed based on mechanisms of action and informed by current knowledge of Adverse Outcome Pathways. These profilers are robust and can be coded computationally to allow for prediction. However, they do not cover all mechanisms or modes of liver toxicity and recommendations for the improvement of these approaches are given.

Clinical Assessment on the Safety of Chunghyul-dan (Qingwie-dan) (청혈단(淸血丹)의 임상적인 부작용에 대한 연구)

  • 조기호;정우상;박성욱;문상관;김영석;배형섭
    • The Journal of Korean Medicine
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    • v.24 no.3
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    • pp.45-50
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    • 2003
  • Background and Purpose : Chunghyul-dan has been widely used in the Department of Cardiovascular & Neurologic Diseases, Kyung Hee Oriental Medical Center to prevent stroke by lowering serum cholesterol level. Previous experimental and clinical studies revealed that Chunghyul-dan had therapeutic effects on hyperlipidemia by inhibiting HMG-CoA reductase and pancreatic lipase. It was also reported that Chunghyul-dan showed an anti-oxidation effect by scavenging free radicals and inhibiting nitric oxide synthesis. Therefore, we examined the safety of Chunghyul-dan on all subjects who had been treated with it. Methods : We performed a retrospective study by reviewing the medical records of those who had been administrated Chunghyul-dan at Kyung Hee Oriental Medical Center from February 8,2001 to December 31,2002. The subjects' general characteristics (gender, age, medical history, and present illness), recorded adverse effects, and the results of laboratory findings were obtained and analyzed to assess the clinical safety of Chunghyul-dan. Results : Six hundred fifty six subjects were treated with Chunghyul-dan. Clinical adverse effects appeared in 13 subjects, the major symptom being indigestion (8 subjects). The apparent frequency of adverse effects was much lower than that in previous reports on the safety of certain medications. On investigation of laboratory findings, we could not find any hepatic or renal toxicity. Conclusion : We suggest that our results contribute towards confirming the safety of Chunghyul-dan by offering clinical evidence.

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Adverse Effects of Chloral Hydrate in Neonates: Frequency and Related Factors (신생아에서 Chloral Hydrate의 부작용의 빈도와 관련 인자)

  • Lee, Ju-Young;Youn, Young-Ah;Kim, Soon-Ju;Lee, Hyun-Seung;Kim, So- Young;Sung, In-Kyung;Chun, Chung-Sik
    • Neonatal Medicine
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    • v.18 no.1
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    • pp.130-136
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    • 2011
  • Purpose: Chloral hydrate is a common drug frequently used for procedural sedation. But data on chloral hydrate use in the newborns are limited. This study examined the frequency of adverse effects of chloral hydrate and factors related to the adverse effects. We also examined if there were additional adverse effects when an additional sedative was used. Methods: The medical records of 104 patients admitted to neonatal intensive care unit of Seoul St. Mary's Hospital from March 2010 to February 2011 who used chloral hydrate for procedural sedation were retrospectively reviewed. Results: Adverse effects after administration of chloral hydrate were noted in 41.3% of the 104 patients. The adverse events included oxygen desaturation (18.8%), increase in apneic episodes (17.5%), increase in bradycardia (10%), and feeding intolerance (3.8%). Using oxygen at the time of chloral hydrate administration was independently associated with adverse effects (odds ratio [OR], 10.911: 95% confidence interval [CI], 2.082-57.178) and with the necessity for an additional sedative after administration of chloral hydrate (OR, 4.151: 95% CI, 1.455-11.840). Using one additional sedative agent after chloral hydrate showed no difference in adverse effects except feeding intolerance. Conclusion: Patients dependent on oxygen at the time of chloral hydrate administration may were found to be at higher risk for adverse effect of chloral hydrate and for an additional sedative. When an additional sedative is needed, it could be used with monitoring feeding intolerance after chloral hydrate administration.

A prospective study to assess the efficacy and safety of oral propranolol as first-line treatment for infantile superficial hemangioma

  • Yun, Yeong Ju;Gyon, Yun Hee;Yang, Sohyoung;Lee, Youn Kyung;Park, Joohyun;Park, Meerim
    • Clinical and Experimental Pediatrics
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    • v.58 no.12
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    • pp.484-490
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    • 2015
  • Purpose: To determine the efficacy and safety of oral propranolol as a first-line treatment for superficially located infantile hemangioma (IH) and propose an assessment tool to measure treatment response. Methods: Patients with superficial IH under 1 year of age were prospectively recruited between May 2012 and December 2013 at the Department of Pediatrics of Chungbuk National University Hospital. Propranolol was administered to 12 infants (median age, 3.8 months) while monitoring cardiovascular and adverse metabolic effects. If a patient showed no adverse events, the dosage was gradually increased up to 3 mg/kg/day and maintained for 1 year. We used our own scoring system to assess treatment response using parameters like change in color, and longest diameter, and thickness of the IH. Results: Eleven out of 12 patients completed the protocol with consistent improvement of hemangiomas during therapy. Patients on propranolol showed a more than 50% involution in the first 3 months, with additional steady involution until 1 year. Patients with the highest scores at 1 month maintained their score and showed better responses until treatment termination. The patient with the lowest score at 1 month did not show any further regression and stopped propranolol treatment 4 months after initiation. In two children with recurrences after successful therapeutic regression, propranolol was effective after being reintroduced. Propranolol treatment was not interrupted in any patient due to adverse events. Conclusion: Oral propranolol at 3 mg/kg/day showed a consistent, rapid, and therapeutic effect on superficial IHs without significant adverse events.

Retrospective Pharmacotherapeutic Evaluation of Dutasteride not Approved by US FDA for Androgenetic Alopecia in Korea (미국 식품의약국 미승인 두타스테라이드의 국내 남성형 탈모증 약물요법 적용에대한 후향적 평가)

  • Cheon, Young Ju;Kim, Jung Tae;Lim, Sung Cil
    • Korean Journal of Clinical Pharmacy
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    • v.25 no.3
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    • pp.171-177
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    • 2015
  • Background: Androgenetic alopecia (AGA), one of alopecias, requires continuous treatment in order to prevent or stop it, and patient's compliance is very important. Currently, only two drugs (finasteride, minoxidil) have been approved for AGA by Food and Drug Administration of United States (US FDA). However, another ${\alpha}-2$ reductase inhibitor, dutasteride, is approved by Korea Ministry of Food and Drug Safety (MFDS) through a phase III trial. For treatment, pharmacotherapy of AGA usually combines topical minoxidil 7% with one of oral <${\alpha}-2$ reductase inhibitor. Objectives: We evaluated the comparative efficacy and adverse effect between topical minoxidil 7%/finasteride 1 mg and topical minoxidil 7%/dutasteride 0.5 mg pharmacotherapy for outpatients with AGA. Also we evaluated the relationship between therapeutic effect and regular hospital visit. Method: This study was performed retrospectively based on electronic medical record (EMR) data of total 98 patients (topical minoxidil 7% with dutasteride 0.5 mg ($Avodart^{(R)}$) or finasteride 1 mg ($Alopecia^{(R)}$, $Propecia^{(R)}$) with diagnosis of AGA from department of dermatology at a secondary hospital from January $1^{st}$, to May $31^{st}$, 2014. Results: The efficacy and adverse event of topical minoxidil 7%/dutasteride 0.5 mg (DUTA group) were 100% and 45.7%, and of topical minoxidil 7%/finasteride 1 mg (FINA group) were 92.1% and 33.3%, respectively. The mean onset time of responses and adverse events in the FINA group were 3.86 months and 4.43 months. Those in the DUTA group were 3.97 months and 5.06 months. Conclusion: Both FINA and DUTA group were highly effective, but the DUTA group showed higher efficacy and adverse effects than those in the FINA group. Dutasteride may be another alternative in AGA treatment.

Effect of Intravenous Lipid Emulsion in the Patient with Acute Poisoning : A Systematic Review (급성 중독 환자에서 지질 유탁액 정맥투여의 효과: 체계적 고찰)

  • Myung, Jinwoo;Ko, Dong Ryul;Kong, Taeyoung;Joo, Young Seon;You, Je Sung;Chung, Sung Phil
    • Journal of The Korean Society of Clinical Toxicology
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    • v.13 no.1
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    • pp.1-10
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    • 2015
  • Purpose: The purpose of this study was to evaluate the usefulness of intravenous lipid emulsion as well as adverse events in acute poisoning patients. Methods: Literature was accessed through PubMed, EMBASE, Cochrane library, Web of science, and KoreaMed. All forms of literatures relevant to human use of intravenous lipid emulsion for acute poisoning were included. Cases reports or letters without description of clinical outcomes for each case were excluded. The literature search was conducted by two investigators in March, 2015, with publication language restricted to English and Korean. The effect, onset time, and adverse event of lipid emulsion and final outcome of each case were analyzed. Results: Eighty-one published articles were included, excluding articles whose title and abstract were not relevant to this study. No articles were classified as high level of evidence. Sixty-eight case reports were identified, consisting of 25 local anesthetics and 43 other drugs, such as tricyclic antidepressants and calcium channel blockers. Although most cases described significant clinical improvements, some of them showed no beneficial effect or worsening of clinical course. Several adverse events including hyperamylasemia and laboratory interference were reported. Conclusion: Although there were many case reports illustrating successful use of lipid for various drug poisonings, the effect cannot be estimated due to significant possibility of publication bias. Therefore, lipids might be considered in severe hemodynamic instability resulting from lipophilic drug poisoning, however further studies should follow to establish the use of lipid as the standard of care.

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3-week repeated dose oral toxicity study of Clausena excavata extract in ICR mice (ICR 마우스에서 핑크왐피 추출물의 3주간 반복 투여 독성 연구)

  • Park, Ju-Hyoung;Cho, Young-Rak;Kim, Young Min;Kang, Jae-Shin;Oh, Joa Sub;Ahn, Eun-Kyung
    • Journal of Applied Biological Chemistry
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    • v.62 no.2
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    • pp.123-127
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    • 2019
  • Medicinal herb in Asian countries has been traditionally used for a long time. However, the safety and adverse effect of medicinal herb have not been established yet. The aim of this study is to evaluate toxicity in the oral administration of Clausena excavata (C. excavata) in male ICR mice for 3 weeks and the noobserved adverse effect level (NOAEL). C. excavata has been used as a medicinal herb for the treatment of dermatopathy, malaria, abdominal pain, dysentery, and enteritis. C. excavata was orally administered daily for 21 days at a dose of 100, 250, 500, 1000, and 2000 mg/kg/day (MPK). There were no significant differences in mortalities, clinical signs, body weight changes, hematological, and serum biochemistry examination in all animals administrated with C. excavate. Consequently, these findings indicated that C. excavata did not affect the toxic effect in ICR mice and the NOAEL of C. excavata was considered as more than 2000 MPK.