• Title/Summary/Keyword: Adverse reactions

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Therapeutic Evaluation of a Topical Unani Formulation, Tila-i Muhāsā in Buthūr Labaniyya (Acne Vulgaris): A Randomized, Controlled Clinical Study

  • Azahar, Mohd;Uddin, Qamar;Kazmi, Munawwar Husain;Khatoon, Faiza;Husain, Nazim
    • CELLMED
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    • v.10 no.2
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    • pp.15.1-15.9
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    • 2020
  • Introduction: Buthūr Labaniyya (Acne vulgaris) is a multifactorial disorder of the pilosebaceous units characterized by non-inflammatory and inflammatory clinical lesions. Several Unani medications have been used for centuries to treat acne. Objectives: Evaluation of safety and efficacy of Tila-i Muhāsā in patients with acne vulgaris Materials and Methods: This clinical study was conducted in patients with acne vulgaris. Patients applied Tila-i Muhāsā or 5% Benzoyl Peroxide (BPO) once daily for 6 weeks. Assessment of efficacy was carried out by Global Acne Grading System (GAGS) and Patient Global Assessment (PGA) scores. In addition, overall severity of acne was evaluated on a 5-point Cook's acne grading scale using photographic standards. Assessment of safety was performed through adverse drug reactions, local dermal tolerability, vital signs, and routine laboratory investigations. Results: A total of 60 patients (30 in each group) completed 6 weeks of treatment. The mean percentage reduction in GAGS score at 6 weeks from baseline in Unani group (66.97%) and BPO group (59.09%) was statistically significant (P<0.0001). After 6 weeks of therapy, the mean percentage reduction in PGA score compared to baseline in Unani group (57.44%) and BPO group (50.23%) was statistically significant (P<0.0001). No serious adverse events were reported in both groups; however, mild adverse events occurred more frequently in BPO group (30%) compared to Unani group (10%). Conclusion: Tila-i Muhāsā was found to be effective and safe in the treatment of acne vulgaris. However, further clinical studies with larger sample size and longer duration of therapy need to be conducted.

A Clinical Case Report of Contrast-induced drug eruption patient Treated with Traditional Oriental Medicine (조영제로 유발된 약진(藥疹)환자 치험 1례)

  • Jerng, Ui-Min;Jeong, Jong-Soo;Yoon, Seong-Woo;Park, Jae-Woo
    • Journal of Korean Traditional Oncology
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    • v.12 no.1
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    • pp.75-82
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    • 2007
  • Drug eruption is a cutaneous reaction caused by various drugs. It is a very common drug induced adverse reaction. Contrast media induced drug eruption is rare. But approximately 10% of people injected with contrast media experience adverse reaction, and drug eruption accounts for more than 40% of all adverse reactions. We report a case of mild drug eruption and its treatment process based on korean traditional medicine. The patient is a 50 years old female diagnosed with functional dyspepsia. The patient had gastric discomfort and alternation between diarrhea and constipation. All symptoms showed nearly complete remission with continued korean traditional medical treatment. The patient had been injected with contrast media for Computed tomography(CT) evaluation of her breast cancer history. Rashes appeared on back and abdomen, and urticaria and pruritus appeared on the patient's finger 1 day after injection. We prescribed Goreisan(TSUMURA CO &, TJ-17) and acupuncture on Quchi(LI11), Zusanli(ST36), Yangxi(LI5), Yanggu(SI5). Consequently, the drug eruption showed remarkable improvement. So the author reports korean traditional medicine is effective complementary treatment for drug eruption.

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Initiation of Pharmaceutical Care Service in Medical Intensive Care Unit with Drug Interaction Monitoring Program (내과계 중환자실 약료 서비스 도입과 약물상호작용 모니터링)

  • Choi, Jae Hee;Choi, Kyung Sook;Lee, Kwang Seup;Rhie, Sandy Jeong
    • Korean Journal of Clinical Pharmacy
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    • v.25 no.3
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    • pp.138-144
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    • 2015
  • Objective: It is to evaluate the drug interaction monitoring program as a pilot project to develop a pharmaceutical care model in a medical intensive care unit and to analyze the influencing factors of drug interactions. Method: Electronic medical records were retrospectively investigated for 116 patients who had been hospitalized in a medical intensive care unit from October to December in 2014. The prevalence of adverse reaction with risk rating higher than 'D' was investigated by Lexi-$Comp^{(R)}$ Online database. The factors related with potential drug interaction and with treatment outcomes were analyzed. Results: The number of patients with a potential interaction of drug combination was 92 (79.3%). Average ages, the length of stay in the intensive care unit and the numbers of prescription drugs showed significant differences between drug interaction group and non-drug interaction group. Opioids (14.4%), antibiotics (7.2%), and diuretics (7.2%) were most responsible drug classes for drug interactions and the individual medications included furosemide (6.4%), tramadol (4.9%), and remifentanil (4.5%). There were 950 cases with a risk rating of 'C' (84.6%), 142 cases with a risk rating of 'D' (12.6%), and 31 cases with a risk rating of 'X' (avoid combination) (2.8%). The factors affecting drug interactions were the number of drugs prescribed (p < 0.0001) and the length of stay at intensive care unit (p < 0.01). The patients in intensive care unit showed a high incidence of adverse reactions related to potential drug interaction. Therefore, drug interaction monitoring program as a one of pharmaceutical care services was successfully piloted and it showed to prevent adverse reaction and to improve therapeutic outcomes. Conclusion: Active participation of a pharmacist in the drug management at the intensive care unit should be considered.

Adverse Drug Reactions with Oseltamivir Treatment in the South Korea Outbreak of 2009 Pandemic Influenza A(H1N1) (2009년 국내 신종플루 유행시기의 Oseltamivir 부작용 평가)

  • Do, Youn-A;Lee, Suk-Hyang
    • Korean Journal of Clinical Pharmacy
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    • v.21 no.4
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    • pp.353-363
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    • 2011
  • The World Health Organization (WHO) declared the outbreak of H1N1 pandemic in 2009. South Korea also had outbreaks of H1N1 virus and used oseltamivir in large volume with increased reports of adverse drug reaction(ADR). The present study was aimed to investigate the ADR frequency, the factors related to ADR, and characteristics of oseltamivir's ADR. Participants for the study were patients randomly drawn from those who were prescribed oseltamivir for treatment from CHA Bundang Medical Center during October 1 and October 30. The information examined as factors related to ADR were collected by a subsequent cross-sectional telephone survey. The factors are the following; a) age; b) gender; c) patient medical history; d) diagnosis of H1N1 virus; e) adherence; f) whether taking other medication with oseltamivir or not; and g) the number of combined medications. We also asked ADR after taking oseltamivir. Total subjects were 86 patients. The average age is $22.6{\pm}18.48$ years old. The gender was 45.3% women and 54.7% men. Half (50%) of all respondents showed one or more ADR, 67.4% were positively diagnosed for H1N1 virus, and 54.7% were completed the full course of oseltamivir (i.e. twice daily x 5days). The most frequently reported ADR symptoms were: dizziness (15.1%), nausea (11.6%), lethargy (10.4%), diarrhea (10.4%), abdominal pain (8.1%), headache and vomiting (6.9%). ADR classifications by categories are gastro intestinal (44.2%), neuropsychiatric events (22.1%), systemic symptom (20.9%), skin events (5.8%), eye events (4.7%), and other cases (2.3%). The onset of ADR 'after taking 1~3 doses' was 69.7%. No increase in neuropsychiatric events was detected in children and adolescents. No factors examined for the study do have significant influence on the presence of ADR. This study showed that ADR of oseltamivir have occurred in half of the patients. The use of oseltamivir is essential for treatment and prophylaxis of influenza A(H1N1). But mass treatment should be properly monitored for ADR.

Adverse Drug Event Surveillance System using Electronic Data and the Signals (전산 데이타를 활용한 약물이상반응검토 및 시그널)

  • Kim, Eun-Young;Kang, Won-Ku;Kwon, Kwang-Il
    • Korean Journal of Clinical Pharmacy
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    • v.21 no.4
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    • pp.383-389
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    • 2011
  • CSS for identifying ADEs are sufficiently developed for broad use and they are much more accurate than spontaneous reporting and more time- and cost-effective than manual chart review. Also computer alert systems can be used to identify opportunities to prevent or reduce patient injury associated with a broad range of ADEs. This CSS can be used to identify opportunities to prevent or reduce patient injury associated with preventable ADEs and increase patient safety, increase quality of drug therapy and decrease the extra-cost of the treatment for ADEs. In the future, increasing utilization of this concurrent CSS should have an enormous beneficial impact on the quality of medical care.

A Survey on Attitude and Awareness of Health-Care Professionals Regarding Pharmacovigilance System and Experience for Adverse Drug Reaction (ADR) from a Single University Hospital (약물감시사업과 약물유해반응에 대한 인식도 조사)

  • Kyung, Eun Jung;Rew, Ji Hyun;Oh, Mina;Kim, Eun Young
    • Korean Journal of Clinical Pharmacy
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    • v.23 no.3
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    • pp.256-268
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    • 2013
  • Objective: To study the attitudes and awareness of healthcare professionals (physicians, pharmacists, nurses and others) toward the Pharmacovigilance system and experience for adverse drug reactions (ADRs) from a Single University Hospital in Deajeon. Methods: A survey was performed using a structured questionnaire involving 360 health-care professionals at the hospital between $1^{st}$ November and $16^{th}$ November, 2012. Results: Sixty-five percent (n=235) of all respondents were experienced incidences of ADRs for their patients and 55.8% (n=201) knew the ADR Spontaneous Reporting System in the hospital. However, three-fourths (n=273, 75.8%) of respondents did not know the existence of the Korean Association of Regional Pharmacovigilance Centers (KARP) and 61.7% (n=222) were unaware of the obligation of ADR report from KFDA in cases of serious ADRs. About 83% (n=299) answered that the electronic ADR report system of the hospital was helpful while their work and most (n=336, 93.3%) agreed on the necessaries of the promotion and education about ADR. Conclusion: Seventy-five percent (n=271) of respondents wanted to continue the work for evaluation and feedback for ADRs reported in the hospital. However, the barriers to reporting ADR were; inconvenient ADR reporting system and the lack of time to report ADRs. This study showed that the easier ADR reporting system and education and promotion about ADRs for health-care providers are needed to improve the ADR reporting.

Real-World Clinical Efficacy and Tolerability of Direct-Acting Antivirals in Hepatitis C Monoinfection Compared to Hepatitis C/Human Immunodeficiency Virus Coinfection in a Community Care Setting

  • Gayam, Vijay;Hossain, Muhammad Rajib;Khalid, Mazin;Chakaraborty, Sandipan;Mukhtar, Osama;Dahal, Sumit;Mandal, Amrendra Kumar;Gill, Arshpal;Garlapati, Pavani;Ramakrishnaiah, Sreedevi;Mowyad, Khalid;Sherigar, Jagannath;Mansour, Mohammed;Mohanty, Smruti
    • Gut and Liver
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    • v.12 no.6
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    • pp.694-703
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    • 2018
  • Background/Aims: Limited data exist comparing the safety and efficacy of direct-acting antivirals (DAAs) in hepatitis C virus (HCV) monoinfected and HCV/human immunodeficiency virus (HIV) coinfected patients in the real-world clinic practice setting. Methods: All HCV monoinfected and HCV/HIV coinfected patients treated with DAAs between January 2014 and October 2017 in community clinic settings were retrospectively analyzed. Pretreatment baseline patient characteristics, treatment efficacy, factors affecting sustained virologic response at 12 weeks (SVR12) after treatment, and adverse reactions were compared between the groups. Results: A total of 327 patients were included in the study, of which 253 were HCV monoinfected, and 74 were HCV/HIV coinfected. There was a statistically significant difference observed in SVR12 when comparing HCV monoinfection and HCV/HIV coinfection (94% and 84%, respectively, p=0.005). However, there were no significant factors identified as a predictor of a reduced response. The most common adverse effect was fatigue (27%). No significant drug interaction was observed between DAA and antiretroviral therapy. None of the patients discontinued the treatment due to adverse events. Conclusions: In a real-world setting, DAA regimens have lower SVR12 in HCV/HIV coinfection than in HCV monoinfection. Further studies involving a higher number of HCV/HIV coinfected patients are needed to identify real predictors of a reduced response.

An Analytic Study on the Occurrence of Adverse Drug Reactions of Traditional Chinese Medicine Injections (중약주사제 부작용 발생에 관한 분석 연구)

  • Hwang, Ji Hye;Song, Ho Sueb
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.35 no.6
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    • pp.219-227
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    • 2021
  • The purpose of this study is to analyze the side effects (ADR) of Traditional Chinese Medicine (TCM) injections by age, injection type, symptoms, and causes, and to find preventive solutions for ADR. For the ADR of TCM injection data collected during the search period from January 1, 2010 to December 31, 2020, the correlation between each section was analyzed by subdividing it into age, injection type, symptoms and causes. CNKI, PubMed, and EMBASE were used to collect the clinical data. 'Chinese herbal injection', 'Traditional Chinese Medicine injection', 'Chinese herbal injection side effect', 'Chinese herbal injection adverse drug reaction' were used for the keyword from the database. All data were collected mainly for TCM injection and the causes of ADR due to TCM injection. However, data not related to the relevant study or TCM injection were excluded from this study. Among a total of 941 studies collected during the search period from January 1, 2010 to December 31, 2020, a total of 10 studies were selected for final analysis. In 1462 clinical data sets, ADR by gender was higher in males than females. By age, 41 to 60 years were the most common. The incidence of ADR by injection type was highest in the blood regulating injection type. Data analysis showed Xueshuantong injection had the highest ADR. Among the symptoms of ADR, skin diseases were the most common. The most common cause of ADR was the unreasonable use of drugs. In China, for ADR management, the use of TCM injections is recommended according to the basic principles for the clinical use of TCM injections established by the Chinese government. In this study, we analyzed the current status and causes of ADR in TCM injections, and found a preventive solution. It is expected that it can be used as basic data to increase the usability of pharmacopuncture and herbal medicines in Korea in the future.

A study on perceptions of university students about the COVID-19 vaccine (코로나19 백신에 대한 대학생의 인식 조사)

  • Lee, Yeon-Hee;Yang, Ok-Yul
    • Journal of the Health Care and Life Science
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    • v.9 no.1
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    • pp.185-193
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    • 2021
  • This study conducted a survey using Google Survey targeting 415 college students over the age of 20 to investigate college students' perceptions of the COVID-19 vaccine. As a result, the average result of 'I think the COVID-19 vaccination is necessary' for herd immunity was 3.90, and 65.8% of the 'necessity of vaccination' recognized the 'necessity of vaccination', but 35.4% negatively evaluated 'the safety of the vaccine'. showed. As for the intention to vaccinate against COVID-19, 34.7% said 'I will vaccinate as soon as the order arrives'. This showed that the current COVID-19 vaccination is not positive. As the reasons for not wanting to be vaccinated, 65.3% answered 'adverse reaction to the vaccine' and 25.8% 'distrust of the vaccine itself'. In addition, they perceived the vaccine supply between developed and underdeveloped countries as unequal, and the average was 3.94, indicating that they were afraid of adverse reactions to the COVID-19 vaccine. Therefore, in order to more effectively acquire information about the COVID-19 vaccine, research, platform development, and education on publicity methods through the media frequently used by college students are required.

Efficacy and safety of low dose oral ketamine for controlling pain and distress during intravenous cannulation in children: a double-blind, randomized, placebo-controlled trial

  • Bagheri, Mahdi;Soltani, Alireza Ebrahim;Qorbani, Mostafa;Sureda, Antoni;Faghihi, Toktam
    • The Korean Journal of Pain
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    • v.35 no.3
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    • pp.311-318
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    • 2022
  • Background: Ketamine is widely used in infants and young children for procedural sedation and anesthesia. The aim of this study was to evaluate the efficacy and safety of low dose oral ketamine to control pain and distress in children during intravenous (IV) cannulation. Methods: This is a prospective, randomized, double-blind study, including children aged between 3 and 6 years requiring a non-emergent IV-line placement. Children were randomly assigned to two groups, treated either with oral ketamine or a placebo. All patients were monitored for vital signs. Pain was assessed using the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) and Wong-Baker Faces Pain Rating Scale (WBFS) scales and sedation using a 5-point sedation score. The facility of IV-line placement was measured by a 3-point scale. Adverse effects were recorded after 1 and 24 hours. Results: A total of 79 and 81 children were entered in the ketamine and placebo groups, respectively. The heart and respiratory rates increased significantly in the placebo group. The median CHEOPS 4 (95% confidence interval [CI]: 3, 4, P < 0.001) and WBFS 6 (95% CI: 4, 6, P < 0.001) scores decreased statistically in the ketamine group. IV-line placement was 50% easier in the ketamine group (95% CI: 37%, 63%, P < 0.001). No serious adverse effects were observed in all cases. Conclusions: Low dose oral ketamine effectively decreased the pain and distress during IV cannulation in children without any significant adverse reactions.