• Title/Summary/Keyword: Medication safety

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Mesenchymal stem cells in the treatment of osteonecrosis of the jaw

  • Nifosi, Gianfilippo;Nifosi, Lorenzo;Nifosi, Antonio Fabrizio
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
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    • v.47 no.2
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    • pp.65-75
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    • 2021
  • Medication-related osteonecrosis of the jaw (MRONJ) has recently associated to the increase in antiresorptive and anti-angiogenic drugs prescriptions in the treatment of oncologic and osteoporotic patients. The physiopathogenesis of MRONJ remains unclear and available treatments are unsatisfactory. Newer pharmacological treatments have shown good results, but are not curative and could have major side effects. At the same time as pharmacological treatments, mesenchymal stem cells (MSCs) have emerged as a promising therapeutic modality for tissue regeneration and repair. MSCs are multipotential non-hematopoietic progenitor cells capable to differentiating into multiple lineages of the mesenchyme. Bone marrow MSCs can differentiate into osteogenic cells and display immunological properties and secrete paracrine anti-inflammatory factors in damaged tissues. The immunomodulatory, reparative, and anti-inflammatory properties of bone marrow MSCs have been tested in a variety of animal models of MRONJ and applied in specific clinical settings. The aim of this review is to discuss critically the immunogenicity and immunomodulatory properties of MSCs, both in vitro and in vivo, the possible underlying mechanisms of their effects, and their potential clinical use as modulators of immune responses in MRONJ, and to identify clinical safety and recommendations for future research.

Screening of Nitrosamine Impurities in Sartan Pharmaceuticals by GC-MS/MS

  • Chang, Shu-Han;Ho, Hui-Yu;Zang, Chi-Zong;Hsu, Ya-Hui;Lin, Mei-Chih;Tseng, Su-Hsiang;Wang, Der-Yuan
    • Mass Spectrometry Letters
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    • v.12 no.2
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    • pp.31-40
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    • 2021
  • Probable human carcinogenic compounds nitrosamines, have been detected as by-product impurities in sartan pharmaceuticals in recent years which has drawn worries for medication safety. To provide a sensitive and effective method for the quality control of sartan pharmaceuticals, this study established a feasible gas chromatography-tandem mass spectrometry (GC-MS/MS) method for simultaneous determination of 13 nitrosamines. The target analytes were separated on a DB-WAX Ultra Inert column (30 m × 0.25 mm; i.d., 0.25 ㎛) and were then subjected to electron impact ionization in multiple reaction monitoring mode. The established method was validated and further employed to analyze authentic samples. Limits of detection (LODs) and limits of quantification (LOQs) of the 13 nitrosamines were 15-250 ng/g and 50-250 ng/g, respectively, which also exhibited intra-day and inter-day accuracies of 91.4-104.8%, thereby satisfying validation criteria. Five nitrosamines, viz., N-nitrosodiethylamine, N-nitrosodimethylamine, N-nitrosodiphenylamine, N-nitrosomorpholine, and N-nitrosopiperidine were detected at concentrations above their LODs in 68 positive samples out of 594 authentic samples from seven sartans.

Review of Clinical Researches for Herbal Medicine Treatment on Functional Abdominal Pain in Children. (소아 기능성 복통의 한약치료에 대한 임상연구 동향 - 중의학 논문을 중심으로 -)

  • Park, Se Mi;Yu, Sun Ae
    • The Journal of Pediatrics of Korean Medicine
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    • v.35 no.1
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    • pp.104-121
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    • 2021
  • Objectives The purpose of this study is to evaluate the efficacy and safety of herbal medication for the treatment of functional abdominal pain in children by analyzing randomized controlled trials conducted in China. Methods Literatures from China National Knowledge Infrastructure published up to 23 November, 2020 were searched. Then they were collected and analyzed by their publication year, demographic information, treatment methods used, duration of illnesses, duration of treatments, follow-up periods, outcome measurement and adverse events. Results A total of 27 studies were selected for the analysis. In all studies, the total efficacy of the herbal medicine treatment group was reported to be higher than that of the control group. The most frequently used medical herb was Root of Glycyrrhiza uralensis Fischer (甘草). The most frequently used classes of herbal medications are Qi regulating medicine (理氣藥), Qi tonics (補氣藥), Aromatic wet medicine (芳香化濕藥), and Digestant (消食藥). The adverse events rate for the herbal medicine treatment group were significantly lower than those in the Western medicine treatment group. Conclusions This study showed that herbal medicine treatment can be effective and safe option for treating pediatric functional abdominal pain. However, additional well-designed clinical studies are needed to solidify the findings.

The Role of Aviation Medical Examiners in the Diagnosis, Treatment and Aeromedical Assessment of Patients with Allergic Rhinitis (알레르기 비염 진단 및 치료, 항공업무 적합성 평가에 있어 항공전문의사의 역할)

  • Kim, Young Hyo
    • Korean journal of aerospace and environmental medicine
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    • v.30 no.2
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    • pp.66-69
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    • 2020
  • Since allergic rhinitis is a disease with a very high prevalence, it is common to find patients with allergic rhinitis among aviation workers. However, they are so afraid that the report of rhinitis will have a negative effect on the evaluation of one's work suitability. Therefore, aviation medical examiners (AMEs) must be able to accurately understand the nature of allergic rhinitis, and confidently explain that appropriate treatment of rhinitis has a positive effect on their performance. In the treatment of allergic rhinitis, there are some medications that may cause drowsiness, which may impair the accuracy and safety of the aviation service. Therefore, AMEs should accurately know safe drugs that do not cause drowsiness and prescribe them to patients. In addition, it is necessary to know exactly whether air workers may receive the latest treatments for allergic rhinitis, such as surgical treatment and immunotherapy, and be able to recommend these treatments appropriately. Therefore, in this paper, we first briefly describe the pathophysiology, genetics, causative antigen, symptoms, diagnosis, and treatment of allergic rhinitis. We also aimed to discuss safe medication and other treatment modalities for allergic rhinitis.

A Retrospective Study of the Effectiveness and Safety of Banhasasim-tang, Gumiganghwal-tang, or Pyeongwee-san in Patients with Type 2 Diabetes Mellitus (표준 치료를 받고 있는 제2형 당뇨병 환자에 대한 구미강활탕, 평위산, 반하사심탕 복용이 혈당에 미치는 영향 및 안전성 연구)

  • Oh, Seung-hyun;Lee, Min-seong;Jung, Woo-nyoung;Noh, Ji-won;Ahn, Young-min;Ahn, Se-young;Lee, Byung-cheol
    • The Journal of Internal Korean Medicine
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    • v.43 no.3
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    • pp.363-374
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    • 2022
  • Objective: This study was conducted to evaluate the hypoglycemic effect and safety of herbal extracts in patients with type 2 diabetes mellitus. Methods: We investigated 19 hospitalized patients with type 2 diabetes mellitus who were administered Banhasasim-tang (BST), Gumiganghwal-tang (GGT), or Pyeongwee-san (PWS) at Kyung Hee University Korean Medical Hospital for at least three days between January 2012 and December 2021. Their clinical characteristics and laboratory tests were reviewed retrospectively. The glucose-lowering effect of the herbal extracts was assessed by comparing blood glucose levels, including fasting blood sugar (FBS), two-hour postprandial glucose (PP2) levels, and glycated hemoglobin levels. To evaluate the safety of the herbal extract, liver function test and kidney function test results were compared, including aspartate aminotransferase (AST), alanine aminotransferase (ALT), blood urea nitrogen (BUN), and creatinine (Cr). Results: After taking herbal extracts, PP2 and HbA1c levels significantly decreased from 205.82 mg/dL to 171.41 mg/dL and 7.58% to 6.62%, respectively. The safety profile reported no significant difference after taking herbal extracts. Conclusions: BST, GGT, and PWS may have hypoglycemic effects in patients with type 2 diabetes mellitus taking hypoglycemic medication.

Moxibustion for Benign Prostatic Hyperplasia: A Systematic Review and Meta-analysis (전립선 비대증에 대한 뜸치료의 효과 : 체계적 문헌고찰과 메타분석)

  • Bae, Go-eun;Lee, Seung-hwan;Hong, Jin-woo;Lee, In;Kim, So-yeon;Choi, Jun-young;Han, Chang-woo;Yun, Young-ju;Park, Seong-ha;Kwon, Jung-nam
    • The Journal of Internal Korean Medicine
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    • v.39 no.3
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    • pp.372-388
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    • 2018
  • Objective: This study evaluates the effectiveness and safety of moxibustion for benign prostatic hyperplasia (BPH). Methods: Using the keywords "benign prostatic hyperplasia", "benign prostatic hypertrophy", "benign prostatic enlargement", "prostatic hyperplasia", and "moxibustion", we searched papers in numerous databases, including National Discovery for Science Leaders (NDSL), Korean Traditional Knowledge Portal (KTKP), Oriental Medicine Advanced Searching Integrated System (OASIS), Research Information Sharing Service (RISS), PubMed, Embase, and CENTRAL. The search range included randomized controlled trials (RCTs). Papers not matched with inclusion criteria were excluded. The methodological quality of each RCT was assessed using the Cochrane risk-of-bias tool. Where appropriate, meta-analyses were performed. Results: Initially, 77 studies were found. Of these, 11 duplicate studies were removed and 27 were excluded following title and abstract screening. After the remaining 39 papers were scanned, 13 RCTs were selected and analyzed. Among these 13 RCTs, five compared moxibustion therapy and oral medication, seven compared moxibustion plus acupuncture therapy and oral medication, and one compared moxibustion plus acupuncture therapy and sham-moxibustion. The meta-analysis showed positive results for the use of moxibustion therapy in terms of International Prostate Symptom Score (IPSS), Quality Of Life (QOL), Maximum Flow Rate (Qmax), Prostate Volume (PV), and the efficacy rate. The meta-analysis showed positive results for the use of moxibustion plus acupuncture therapy in terms of IPSS, QOL, and the efficacy rate. Conclusions: This meta-analysis of clinical trials suggests that moxibustion is effective intreating BPH patients. The results of this study could be applied to clinical treatment of BPH. However, additional large-scale clinical researches should be conducted.

A Systematic Review of Acupuncture for Chronic Fatigue Syndrome

  • Kim, Hong Guk;Ryoo, Dek Woo;Jeong, Seong Mok;Kim, Sung Jin;Baek, Seung Won;Lee, Chang Hee;Yoon, Jin Young;Goo, Bon Hyuk;Kim, Min Jeong;Park, Yeon Cheol;Seo, Byung Kwan;Baek, Yong Hyeon;Nam, Sang Soo;Kim, Yong Suk
    • Journal of Acupuncture Research
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    • v.34 no.2
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    • pp.93-112
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    • 2017
  • Objectives : To evaluate and summarize the efficacy and safety of acupuncture treatment (AT) in chronic fatigue syndrome (CFS). Methods : Fifteen databases (Pubmed, Cochrane, EMBASE, AMED, CINAHL, CNKI, Wanfang, and eight Korean databases) were searched up to September 2016. Only trials in which acupuncture was the sole treatment were included. Fatigue was used as the primary outcome measure, while the quality of life, pain, mood disorders, and adverse events were used as secondary outcome measures. We adopted three classifications: AT vs Sham AT, AT vs Wait-list, AT vs Western medication. The Cochrane risk of bias tool was used to assess the methodological quality. Results : A total of 11 randomized controlled trials involving 869 participants were identified. In comparison with Sham AT, AT significantly alleviated fatigue and pain, but no conclusions about the quality of life and mood disorders could be drawn. In the Wait-list group and Western medication groups, patients with CFS might feel less fatigued following acupuncture treatment, but the evidence was insufficient due to lack of study. Nine of 11 RCTs (81.8%) reported adverse events and there were two cases of mild subcutaneous hemorrhage, but no serious adverse cases. Conclusion : This review found evidence that patients with CFS may generally benefit from alleviation of symptoms by acupuncture treatment, and there is no evidence of worsening symptoms or causing of serious adverse events. A positive effect on fatigue and pain was observed, but no conclusion for improving quality of life and mood disorders.

Moxibustion for Knee Osteoarthritis : A Protocol for a Pilot Randomized Controlled Trial (슬관절염에 대한 뜸 치료의 유효성 및 안전성 연구 : 무작위 대조 예비 임상연구 프로토콜)

  • Lee, Seung-Hoon;Kim, Kun-Hyung;Kim, Tae-Hun;Kim, Jung-Eun;Kim, Joo-Hee;Kang, Kyung-Won;Jung, So-Young;Kim, Ae-Ran;Park, Hyo-Ju;Shin, Mi-Suk;Hong, Kwon-Eui;Choi, Sun-Mi
    • Korean Journal of Acupuncture
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    • v.28 no.4
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    • pp.1-15
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    • 2011
  • Objectives : The purpose of this study is to evaluate the feasibility of massive clinical research and to make a basic analysis on the effectiveness and safety of moxibustion treatment on knee osteoarthritis compared to usual care. Methods and Results : This study is a protocol for a pilot randomized controlled trial. Forty participants are assigned to the moxibustion group (n=20) and usual care group (n=20). Participants assigned to the moxibustion group receive moxibustion treatment on the affected knee(s) at six standard acupuncture points (ST36, ST35, ST34, SP9, Ex-LE04 and SP10) three times per week for four weeks (total of 12 sessions). Participants in the usual care group don't receive moxibustion treatment during the study period and follow-up are made on the 5th, 9th and 13th weeks after random allocation. Both groups are allowed to use any kind of treatment, including surgery, conventional medication, physical treatment, acupuncture, herbal medicine, over-the-counter drugs and other active treatments. Education material that explains knee osteoarthritis and current management options and self-exercise is provided for each group. The pain scale of the Korean Western Ontario and McMaster Universities Questionnaire (K-WOMAC) is the primary outcome measurement used in this study. Other subscales of the K-WOMAC, the Short-Form 36 Health Survey (SF-36), Beck Depression Inventory (BDI), Physical Function test, Patient Global Assessment, and Pain Numeric Rating Scale (NRS) are used as outcome variables to evaluate the effectiveness of acupuncture. Safety is assessed at every visit. Conclusions : The result of this trial will provide a basis for the effectiveness and safety of acupuncture treatment for knee osteoarthritis.

Granisetron in the Treatment of Radiotherapy-Induced Nausea and Vomiting (방사선치료 중 오심 및 구토에 대한 그라니세트론의 효과)

  • Hong, Seong-Eon;Kang, Jin-O
    • Radiation Oncology Journal
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    • v.17 no.2
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    • pp.141-145
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    • 1999
  • Purpose : Granisetron is a potent, the most selective 5-HT3 receptor antagonist and is reported to b effective in treatment of radiation-induced emesis. The antiemetic efficacy and safety of oral granisteron was evaluated in patients with receiving highly emetogenic treatment by conventional fractionated irradiation. Materials and Methods : Patients with various cancers who were being treated with irradiation were accrued into the present study. The intensity of nausea was evaluated on first 24 hours and on day-7 by patients according to the degree of interference with normal daily life as followings; a) none; b) present but no interference with normal daily life (mild): c) interference with normal daily life (moderate): and d) bedridden because of nausea (severe). Non or mild state was considered to indicate successful treatment. The efficacy of antiemetic treatment was graded as follows; a) complete response; no vomiting, no worse than mild nausea and receive no rescue antiemetic therapy over the 24h period, b) major response; either one episode of vomiting or moderate/severe nausea or had received rescue medication over 24h period, or any combination of these, c) minor response; two to four episodes of vomiting over the 24h period, regardless of nausea and rescue medication, d) failure; more than four medication. The score of the most symptom was recorded and the total score over 24 hours was summarized. The complete or major response was considered to indicate successful treatment. Results : A total of 10 patients were enrolled into this study, and all were assessable for efficacy analysis. Total nausea control was achieved in 90$\%$ (9/10:none=60$\%$ plus mild=30$\%$) of total patients after 7 days. The control of vomiting by granisteron was noted in seven patients (70$\%$) of complete response and three (30$\%$) of major response with a hundred-percent successful treatment over 7 days. The minor response or treatment failure were not observed. No significant adverse events or toxicities from granisetron were recorded in patient receiving granisetron. Conclusion : We concluded that granisetron is a highly effective antiemetic agent in controlling radiotherapy-induced nausea or vomiting with a minimal toxicity profile.

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Association of Liver Dysfunction with Self-Medication History in Korean Healthy Male Adults (건강한 한국 성인남성의 자가약물복용력에 따른 간기능 장애 발생여부 조사)

  • Bae, Jong-Myon;Park, Byung-Joo;Lee, Moo-Song;Kim, Dong-Hyun;Shin, Myung-Hee;Ahn, Yoon-Ok
    • Journal of Preventive Medicine and Public Health
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    • v.29 no.4 s.55
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    • pp.801-814
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    • 1996
  • Background: Korean people could abuse healthy foods as well as medications, which might cause serious side effects. The aim of this study was elucidating liver dysfunction due to the self-medications of hepatotonics, healthy foods and herb medications by nested case-control study. Methods: Study subjects were drawn from male members of Seoul Cohort Study who were recruited by self-administered structured questionnaire survey through mailing to the healthy men between the age of 40 and 59 years through the program of biennial health check-up offered by Korea Medical Insurance Corporation(KMIC). The liver dysfunction was defined as the level of serum AST and ALT above 40 IU/L and increased in more than one hunderd per-cent during the 2 year follow-up period. To estimate the odds ratio between self-medication and liver dysfunction after controlling for potential confounders, logistic regression was performed. Results: During the follow-up period, 30 members were identified to fit into case criteria and 2,625 members were selected as control. In logistic regression analyses, history of healthy foods intake, age under 45 years, obesity, and habit of regular exercise were significantly associated with liver dysfunction. The following factors exhibited no statistical significance: intake of hepatotonics, of herb medicine; history of disease in family, of operation, and of radiologic examination; smoking habits and drinking amounts. Conclusion: The significant association between the intake of healthy foods and the liver dysfunction illustrates that chronically optional overuse of healthy foods might bring to hazards to health. As the increasing trend of the size of purchasing healthy foods in Korea, pharmacoepidemiologic studies evaluating the safety and efficacy of the widely used healthy foods should be performed in the near future.

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