• Title/Summary/Keyword: Act of Clinical Research

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A Systematic Review on Potential Drug Interactions of Korean Ginseng Based upon Cytochrome P450 and P-Glycoprotein (고려인삼의 Cytochrome P450 및 P-Glycoprotein 매개 약물 상호작용에 미치는 영향)

  • Nam, Ki Yeul;Yang, Byung Wook;Shin, Wang Soo;Park, Jong Dae
    • Korean Journal of Pharmacognosy
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    • v.49 no.2
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    • pp.85-102
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    • 2018
  • A drug interaction is a situation in which a substance affects the activity of a drug, synergistically or antagonistically, when both are administered together. It has been shown that orally taken ginsenosides are deglycosylated by intestinal bacteria to give ginsenosides metabolites, which has been considered to be genuine pharmacological constituents and to exhibit drug interactions. Animal experimental results demonstrated that ginsenoside metabolites play an important role in the inhibitory or inductive action of both CYPs (cytochrome p450) and P-gp (p-glycoprotein), thereby can be applied as metabolic modulator to drug interactions. Very few are known on the possibility of drug interaction if taken the recommended dose of ginseng, but it has been found to act as CYPs inductor and P-gp inhibitor in any clinical trial, suggesting the risk that side effects will occur. It has been recently reported that interactions might also exist between ginseng and drugs such as warfarin, phenelzine, imatinib and raltegravir. Moreover, medicinal plants are increasingly being taken in a manner more often associated with prescription medicines. Therefore, considering the extensive applications of ginseng for safety, the aim of this review is to present a comprehensive overview of ginseng and drug interactions based upon pharmacodynamic and pharmacokinetic evidences.

Identification of novel potential drugs and miRNAs biomarkers in lung cancer based on gene co-expression network analysis

  • Sara Hajipour;Sayed Mostafa Hosseini;Shiva Irani;Mahmood Tavallaie
    • Genomics & Informatics
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    • v.21 no.3
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    • pp.38.1-38.8
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    • 2023
  • Non-small cell lung cancer (NSCLC) is an important cause of cancer-associated deaths worldwide. Therefore, the exact molecular mechanisms of NSCLC are unidentified. The present investigation aims to identify the miRNAs with predictive value in NSCLC. The two datasets were downloaded from the Gene Expression Omnibus (GEO) database. Differentially expressed miRNAs (DEmiRNA) and mRNAs (DEmRNA) were selected from the normalized data. Next, miRNA-mRNA interactions were determined. Then, co-expression network analysis was completed using the WGCNA package in R software. The co-expression network between DEmiRNAs and DEmRNAs was calculated to prioritize the miRNAs. Next, the enrichment analysis was performed for DEmiRNA and DEmRNA. Finally, the drug-gene interaction network was constructed by importing the gene list to dgidb database. A total of 3,033 differentially expressed genes and 58 DEmiRNA were recognized from two datasets. The co-expression network analysis was utilized to build a gene co- expression network. Next, four modules were selected based on the Zsummary score. In the next step, a bipartite miRNA-gene network was constructed and hub miRNAs (let-7a-2-3p, let-7d-5p, let-7b-5p, let-7a-5p, and let-7b-3p) were selected. Finally, a drug-gene network was constructed while SUNITINIB, MEDROXYPROGESTERONE ACETATE, DOFETILIDE, HALOPERIDOL, and CALCITRIOL drugs were recognized as a beneficial drug in NSCLC. The hub miRNAs and repurposed drugs may act a vital role in NSCLC progression and treatment, respectively; however, these results must validate in further clinical and experimental assessments.

Adoption and Efficacy of ISO 15189 in Medical Laboratories for Diagnostic and Research (메디컬시험기관에서 ISO 15189 도입의 필요성과 시행의 효용성)

  • Yang, Man-Gil;Lee, Won Ho;Jun, Jin Hyun
    • Korean Journal of Clinical Laboratory Science
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    • v.48 no.2
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    • pp.158-167
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    • 2016
  • The requirements for medical laboratories ISO 15189 is examined in organization and a quality management system, stressing the importance of evidence, document control, and control of records and clinical material. Medical services are provided from the areas of resource management, and pre-examination, examination and post-examination processes. The main goal of ISO 15189 accreditation is to improve the quality of laboratory services provided for patients and clinical users not only through compliance with consensually developed and harmonized requirements but also by adopting the philosophy of continual improvement using the Plan-Do-Check-Act cycle. Laboratory quality should be evaluated and improved in all steps of the testing process as the state-of-the art indicates that the pre- and post-analytical phases are more vulnerable to errors than the intra-analytical phase. The Korea Laboratory Accreditation Scheme (KOLAS), a national accreditation body, provides medical laboratory accreditations for appropriate approaches to evaluating the competence of a medical laboratory in providing effective services to its customers and clinical users. Adoption of ISO 15189 in 2010s as a government policy has been delayed, and only 5 laboratories have been accredited to date in Korea. The medical laboratories should seek the adoption of ISO 15189 with a positive attitude for quality improvement and strengthening of international competitiveness.

The Fiduciary Duties of Doctor in Clinical Trials (임상시험에서 의사의 선량한 관리자의 주의의무)

  • Lee, Jiyoun
    • The Korean Society of Law and Medicine
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    • v.21 no.2
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    • pp.163-207
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    • 2020
  • Korea has been positioned as the leading country in the industry of clinical trials as the clinical trail of Korea has developed for the recent 10 years. Clinical trial has plays a significant role in the development of medicine and the increase of curability. However, it has inevitable risk as the purpose of the clinical trial is to prove the safety and effectiveness of new drugs. Therefore, the clinical trial should be controlled properly to protect the health of the subjects of clinical trial and to ensure that they exercise a right of self-determination. In this context, the fiduciary duties of doctors who conduct clinical trials is especially important. The Pharmaceutical Affairs Act and the relevant regulations define several duties of doctors who conduct clinical trials. In particular, the duty to protection of subjects and the duty to provide information constitute the main fiduciary duties to the subjects. Those are essentially similar to the fiduciary duties of doctors in usual treatment from the perspective of the values promoted by the law and the content of the law. Nonetheless, clinical trials put more emphasis on the duties to provide explanation than in usual treatment. Further research and study are required to establish the concrete standard for the duty of care. However, if the blind pursuit of higher standards for the duty of care or to pass the burden of proof to doctors may result in disrupting the development of clinical trials, limiting the accessibility of patients to new treatment and even violating the principle of sharing damage equally and properly. In addition to these duties, the laws of clinical trials define several duties of doctors. Any decision on whether the violation of the law constitutes the violation of the fiduciary duty and justifies the demand for compensation of damages should be based on whether relevant law aims to protect the safety and benefit of subjects, even if in an incidental way, the degree to which such violation breaches the values promoted by the law and the concrete of violation of benefit of law, the detailed acts of such violation. The legal interests of the subjects can be protected effectively by guaranteeing compliance with those duties and establishing judicial and administrative controls to ensure that the benefit of subjects are protected properly in individual cases.

The Physiological Efficacy of Aloe Gel (Aloe Gel의 생리 효과에 대한 고찰 - Gel의 다당류와 미량 성분을 중심으로 -)

  • 서화중
    • Journal of the Korean Society of Food Science and Nutrition
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    • v.24 no.6
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    • pp.1026-1038
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    • 1995
  • Although aloe lost a lot of its previous popularity in modern clinical uses as medicine numerous scientific researches still have claimed the beneficial properties(curing and general tonic effect) of aloe gel. Whereas considerable contradictory reports have helped to confuse the aloe gel issue and continually aroused controversy about aloe gel efficacy. However health food, cosmetic and medicinal products made from aloe gel are widely available in the world market especially in U.S.A. so the growing of Aloe plant and the processing of A. vera gel have become big industries in some countries. In some previous papers the salicylic acid, one of the common trace gel components, was thought to have an analgetic and antinflammatory effect. Large amount of Mg ion in the gel was suggested to act as anesthetic, Mg-lactate as antihistamic, and Aloctin A(a glycoprotein) as wound healer by promoting the cell growth. The carboxypeptidase and bradykinase activity in the gel were proposed to have the pain relieving and antiinflammatory effect. But any of thes etheories concerining the physiological action of the trace gel components has not been demonstrated by modern pharmacology, and failed to be supported by clinical research. It was suggested by some research workers that trace amount of anthraquinone compounds in the gel play an important role to act as false substrate inhibitors for PG and TX production(antiprostanoid effect), by which, they believed, inflammation, burn and frostbite, and infected wound could be healed. This hypothesis has not been substantiated. Butthe suggested antimicrobial action, antidiabetic, and antidotic effect of aloe gel are likely to be attributed to the trace anthraquinone compounds. In a lot of recent experimental reports it has been claimed that aloe gel polysaccharides(acetylglucomannan, acetylmannan, and glycoprotein) have the antimicrobial, antinflammatory, antitumour, and infected wound healing effect by immunoenhancement. It is hoped that these effects will be soon documented in clinical studies, then the controversy on aloe gel beneficial effect will cease. In the 30 days subchronic toxicity test the lowest observed adverse effect level of acemannan(acetylmannan) on dog was 5.0 mg/kg, IP. But the aloe gel is generally agreed to be harmless and non toxic even for the internal use such as health food. In the case of idiosynrasy one must keep the delayed type hypersensitivity reaction of aloe gel in mind. In conclusion it seem to be impossible to simply refuse a lot of evidences made by research workers who have claimed aloe gel's beneficial effects and to deny the fact that there had been long therapeutic histories of Aloe plants.

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Mechanisms of Cadmium Carcinogenicity in the Gastrointestinal Tract

  • Bishak, Yaser Khaje;Payahoo, Laleh;Osatdrahimi, Alireza;Nourazarian, Alireza
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.1
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    • pp.9-21
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    • 2015
  • Cancer, a serious public health problem in worldwide, results from an excessive and uncontrolled proliferation of the body cells without obvious physiological demands of organs. The gastrointestinal tract, including the esophagus, stomach and intestine, is a unique organ system. It has the highest cancer incidence and cancer-related mortality in the body and is influenceed by both genetic and environmental factors. Among the various chemical elements recognized in the nature, some of them including zinc, iron, cobalt, and copper have essential roles in the various biochemical and physiological processes, but only at low levels and others such as cadmium, lead, mercury, arsenic, and nickel are considered as threats for human health especially with chronic exposure at high levels. Cadmium, an environment contaminant, cannot be destroyed in nature. Through impairment of vitamin D metabolism in the kidney it causes nephrotoxicity and subsequently bone metabolism impairment and fragility. The major mechanisms involved in cadmium carcinogenesis could be related to the suppression of gene expression, inhibition of DNA damage repair, inhibition of apoptosis, and induction of oxidative stress. In addition, cadmium may act through aberrant DNA methylation. Cadmium affects multiple cellular processes, including signal transduction pathways, cell proliferation, differentiation, and apoptosis. Down-regulation of methyltransferases enzymes and reduction of DNA methylation have been stated as epigenetic effects of cadmium. Furthermore, increasing intracellular free calcium ion levels induces neuronal apoptosis in addition to other deleterious influence on the stability of the genome.

Nano Capsulization of Ceramide and the Efficacy of Atopy Skin

  • Zhoh, Choon-Koo;Han, Chang-Giu;Hong, Se-Heum;Kim, In-Young;Lee, Hee-Seob
    • Proceedings of the SCSK Conference
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    • 2003.09b
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    • pp.268-279
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    • 2003
  • The nano capsulation of the ceramide was a technique that capsulated ceramide III and tocopheryl linoleate at the mono-vesicle, so as to act the horny layer in skin. It was used 0.5-5.0 wt% of hydrogenated lecithin and 0.01~2.00 wt% of lysolecithin as the membrane-strengthen agents of the mono-vesicle, 5.0~10 wt% of propylene glycol and 5.0~10.0 wt% of ethyl alcohol made by high-pressure Microfluidizer. To enhance the moisturizing efficacy and treat an atopy skin, used ceramide III and tocopheryl linoleate as the active ingredients, and it was made the nano-capsule that synthetic emulsifiers were free. The optimal condition of capsulation of nano ceramide was as follows. The conditions were 3 times at 1,000bar and 60-7$0^{\circ}C$. The particle size showed 63.1$\pm$7.34 nm such as the transparence water as the results for measuring by the laser light scattering. A zeta potential value was -55.1$\pm$0.84 ㎷. The result of the clinical test, the moisturizing effect (in-vivo, n=8, p-value<0.05) was improved 21.15% compared to control, as well as it was improved 36.31 % before the treatment. Moreover, the effectiveness of atopy skin indicated positive reaction that patients were 10 volunteers.

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A Survey on Nurses' Utilization of Computerization in Nursing Practice (간호사의 간호업무 전산화 활용에 대한 조사연구)

  • Rhee, In-Soon
    • Journal of Korean Academy of Nursing Administration
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    • v.5 no.2
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    • pp.209-224
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    • 1999
  • I have practiced this reserch for the purpose of proposition of basic data for amendment and addition of computer system after I surveyed the degree of abilities and satisfaction on the computerization in nursing\ practice. Subjects were collected from September 1 to September 30, 1998. Study subjects are 151 clinical nurses who are working at university hospital in Chonbuk area. Study instrument consists of 116 questionnaire which was developed by Kim H. K(1998). The data were analized number, mean ,t-test, ANOVA by using SPSS. The study results are as follows: 1. Most of the nurses who answered the questions were educated computerizing(96%). The abilities of computer program utilities were the most in inputting data(74%). The program nurses wanted computerizing education was wordprocess, dealing internet and statistics. 2. As for applying parts of computer system in nursing, the most nurses were Dr's order check (96%), treatment activity(91.4%), medication(89.4%), lab. test(87 .4%), transfering department(85.4%), transfering room(79.5%), diet(71.8%), discharge (70.2%), Barcord Sticker(70.2%) , reservation(62.2%) in order that were all conected order system mutually to other part. It showed that computer system was not applied for treating the original nursing work such as nursing record (13%), duty scheduling(6.0%) , nursing process(4.6%) , Q.I(1.3%), nursing research(1.3%), education(1.3%), 3. As for the benefit when computer system is applied for, the most respondence was promptness of work and convenience(90.6%) , exactness of work (82.8%), offering information exactily and efficiently(36.3%), offering good quality of nursing (6.0%) in order. 4. The degree of contentment on computerizing in nursing practice showed average 3.24%. The best marking item is that they are eager to participate in the computer education. Next, the automatic output of label and giving the number automatically is to prevent loss and mentioned items of patient registration from being changed(3.95) and to prevent mistakes possibly happening because of doctor's difficult order(3.85). 5. The problems which may happen to in nurses' utilization of computerization for the nursing practice showed average 3.18. The most problem is that the practice may stop because of the problem of computer itself(3.67), and the next, the indication of act can be imperfect(3.66) , manual training may overlap because of incomplete computerization (3.60), practical education for the computerizing is lack(3.41), and the computer literate nurses are lack(3.40) . 6. Study subject's contentment by age was significant difference(F=3.10,P=0.0119). Study subject's contentment by job posision was significant difference(F=6.001P=0.0034) I will propose the following according to the above results. The domain of original nursing practice is urgernt. Manual and indication of act should be made before long in computer obstacle. Nursing department should support the nurses so that they could receive the education needed for the nurses themselves.

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Clinical Applications and Efficacy of Korean Ginseng (고려인삼의 주요 효능과 그 임상적 응용)

  • Nam, Ki-Yeul
    • Journal of Ginseng Research
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    • v.26 no.3
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    • pp.111-131
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    • 2002
  • Korean ginseng (Panax ginseng C.A. Meyer) received a great deal of attention from the Orient and West as a tonic agent, health food and/or alternative herbal therapeutic agent. However, controversy with respect to scientific evidence on pharmacological effects especially, evaluation of clinical efficacy and the methodological approach still remains to be solved. Author reviewed those articles published since 1980 when pharmacodynamic studies on ginseng have intensively started. Special concern was paid on metabolic disorders including diabetes mellitus, circulatory disorders, malignant tumor, sexual dysfunction, and physical and mental performance to give clear information to those who are interested in pharmacological study of ginseng and to promote its clinical use. With respect to chronic diseases such as diabetes mellitus, atherosclerosis, high blood pressure, malignant disorders, and sexual disorders, it seems that ginseng plays preventive and restorative role rather than therapeutics. Particularly, ginseng plays a significant role in ameliorating subjective symptoms and preventing quality of life from deteriorating by long term exposure of chemical therapeutic agents. Also it seems that the potency of ginseng is mild, therefore it could be more effective when used concomitantly with conventional therapy. Clinical studies on the tonic effect of ginseng on work performance demonstrated that physical and mental dysfunction induced by various stresses are improved by increasing adaptability of physical condition. However, the results obtained from clinical studies cannot be mentioned in the indication, which are variable upon the scientist who performed those studies. In this respect, standardized ginseng product and providing planning of the systematic clinical research in double-blind randomized controlled trials are needed to assess the real efficacy for proposing ginseng indication. Pharmacological mode of action of ginseng has not yet been fully elucidated. Pharmacodynamic and pharmacokinetic researches reveal that the role of ginseng not seem to be confined to a given single organ. It has been known that ginseng plays a beneficial role in such general organs as central nervous, endocrine, metabolic, immune systems, which means ginseng improves general physical and mental conditons. Such multivalent effect of ginseng can be attributed to the main active component of ginseng,ginsenosides or non-saponin compounds which are also recently suggested to be another active ingredients. As is generally the similar case with other herbal medicines, effects of ginseng cannot be attributed as a given single compound or group of components. Diversified ingredients play synergistic or antagonistic role each other and act in harmonized manner. A few cases of adverse effect in clinical uses are reported, however, it is not observed when standardized ginseng products are used and recommended dose was administered. Unfavorable interaction with other drugs has also been suggested, which the information on the products and administered dosage are not available. However, efficacy, safety, interaction or contraindication with other medicines has to be more intensively investigated in order to promote clinical application of ginseng. For example, daily recommended doses per day are not agreement as 1-2g in the West and 3-6 g in the Orient. Duration of administration also seems variable according to the purpose. Two to three months are generally recommended to feel the benefit but time- and dose-dependent effects of ginseng still need to be solved from now on. Furthermore, the effect of ginsenosides transformed by the intestinal microflora, and differential effect associated with ginsenosides content and its composition also should be clinically evaluated in the future. In conclusion, the more wide-spread use of ginseng as a herbal medicine or nutraceutical supplement warrants the more rigorous investigations to assess its effacy and safety. In addition, a careful quality control of ginseng preparations should be done to ensure an acceptable standardization of commercial products.

Therapeutic effect of Ferula assa-foetida oleo-gum resin in rats with letrozole-induced polycystic ovary syndrome

  • Amir Shieh;Seyyed Majid Bagheri;Maryam Yadegari;Davoud Javidmehr;Zeinab Farhadi
    • Clinical and Experimental Reproductive Medicine
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    • v.49 no.4
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    • pp.239-247
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    • 2022
  • Objective: Asafoetida is a gum derived from Ferula assa-foetida, which is used in traditional Iranian medicine to treat some reproductive system disorders. The effects of asafoetida on ovarian tissue, expression of certain genes associated with polycystic ovary syndrome (PCOS), and levels of liver, kidney, and blood cell factors after treatment in a rat model were investigated. Methods: Thirty rats were divided into five groups: normal, polycystic, and treatment with three doses of asafoetida (12.5, 25, and 50 mg/kg for 3 weeks after PCOS induction). PCOS was induced by letrozole at a dose of 1 mg/kg administered orally for 3 weeks. Blood samples were taken, and the ovaries were removed and prepared for histomorphometric examination. Liver and kidney parameters were measured. The mRNA expression levels of luteinizing hormone receptor, CYP11A1, adenosine monophosphate-activated protein kinase, adiponectin, and adiponectin receptors 1 and 2 were also measured by real-time polymerase chain reaction. Results: The levels of liver, kidney, and blood parameters did not significantly differ between the treatment groups and the control group. At doses of 25 and 50 mg/kg, ovarian histopathology, especially the thicknesses of the theca and granulosa layers, was significantly improved relative to the PCOS group. The expression of target genes also improved in the 25 and 50 mg/kg treatment groups. Conclusion: Asafoetida can be used to treat PCOS as a complementary approach to conventional therapies. Asafoetida appears to act by regulating and activating metabolic and ovarian cycle enzymes.