• The Journal of Korean Medicine
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• v.30 no.3
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• pp.79-85
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• 2009

Aim : To evaluate the pharmaceutical safety of the herbal formula Myelophil, composed of Astragali Radix and Salviae Radix, via systemic subacute toxicological study using SD rats. Methods : Forty male and 40 female SD rats were fed with Myelophil (5000, 2500 or 1250 mg/10 mL/kg) or distilled water for four weeks. Adverse effects were examined intensively by comparing the differences between normal and drug-administered groups using clinical signs, necropsies, histopathologic findings, hematology, urinalysis, and blood biochemical analysis. Results : No altered clinical symptoms including body weight, diarrhea, anorexia, death, and abnormal necropsy of major organs were observed in male or female rats. No drug-induced abnormalities in histopathological finding, hematological values, urinalysis, and blood biochemical values were found at any doses of Myelophil. Conclusion : Myelophil should be very safe when used in a clinical application with a wide therapeutic index.

• Biomolecules & Therapeutics
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• v.17 no.1
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• pp.1-11
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• 2009

Since the Committee for Proprietary Medicinal Products (CPMP) of the European Union issued in 1997 a "points to consider" document for the assessment of the potential for QT interval prolongation by non-cardiovascular agents to predict drug-induced torsades de pointes (TdP), the QT liability has become the critical safety issue in the development of pharmaceuticals. As TdP is usually linked to delayed cardiac repolarization, international guideline (ICH S7B) has advocated the standard repolarization assays such as in vitro IKr (hERG current) and in vivo QT interval, or in vitro APD (as a follow up) as the best biomarkers for predicting the TdP risk. However, the recent increasing evidence suggests that the currently used above biomarkers and/or assays are not fully predictive for TdP, but also does not address potential new druginduced TdP due to the selective disruption of hERG protein trafficking to the cell membrane or VT and/or VF with QT shortening. There is, therefore, an urgent need for other surrogate markers or assays that can predict the proarrhythmic potential of drug candidate. In this review, we provide an ideal pre-clinical strategy to predict the potentials of QT liability and lethal arrhythmia of the drug candidates with recent issues in this field in mind, not at the expense of discarding therapeutically innovative drugs.

• The Journal of Korean Medicine
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• v.38 no.3
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• pp.170-184
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• 2017

Objectives: The objective of this study was to summarize randomized clinical trials (RCTs) that have assessed efficacy and safety of mahuang and ephedrine on treatment of obesity and to propose better process of study. Methods: NLM Medline (pubmed), the Cochrane library, Scopus, Science Direct, RISS, KISS were systemically searched for clinical trials investigating the efficacy, safety of mahuang and ephedrine on treatment of obesity from 2000 to 2017. Results: 16 RCTs met all the inclusion criteria. In most reports, mahuang and ephedrine significantly reduced body weight, body fat mass. There were no serious adverse events associated with mahuang and ephedrine in all studies. Conclusions: In appropriate dose of mahuang and ephedrine for healthy adult was safe, and weight loss effect of mahuang and ephedrine was better than control group. Improved clinical practice guidelines should be developed for safe use of mahuang and ephedrine.

• Safety and Health at Work
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• v.3 no.3
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• pp.224-234
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• 2012

Objectives: This study was conducted in order to obtain information concerning the health hazards that may result from a 13 week inhalation exposure of n-pentane in Sprague-Dawley rats. Methods: This study was conducted in accordance with the Organization for Economic Co-operation and Development (OECD) guidelines for the testing of chemicals No. 413 'Subchronic inhalation toxicity: 90-day study (as revised in 2009)'. The rats were divided into 4 groups (10 male and 10 female rats in each group), and were exposed to 0, 340, 1,530, and 6,885 ppm n-pentane in each exposure chamber for 6 hour/day, 5 days/week, for 13 weeks. All of the rats were sacrificed at the end of the treatment period. During the test period, clinical signs, mortality, body weights, food consumption, ophthalmoscopy, locomotion activity, urinalysis, hematology, serum biochemistry, gross findings, organ weights, and histopathology were assessed. Results: During the period of testing, there were no treatment related effects on the clinical findings, body weight, food consumption, ophthalmoscopy, urinalysis, hematology, serum biochemistry, gross findings, relative organ weight, and histopathological findings. Conclusion: The no-observable-adverse-effect level (NOAEL) of n-pentane is evaluated as being more than 6,885 ppm (20.3 mg/L) in both male and female rats. n-pentane was not a classified specific target organ toxicity in the globally harmonized classification system (GHS).

• Journal of Food Hygiene and Safety
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• v.10 no.1
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• pp.13-17
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• 1995

In order to study the effects of Aloe vera treatment on blood glucose level and clinical chemistry in diabetic patients, eight diabetic patients were administered orally with 800 mg of Aloe vera three time a day for three months. The high levels of blood and urine glucose in diabetic patients were significantly reduced by administration of Aloe vera. The increased plasma triglyceride concentration was also significantly reduced by Aloe vera treatment. A little amount of urine bilirubin, hematuria, nitrite, urobilinogen, protein and ketone bodies were detected before treatment, but not detected after Aloe vera treatment. But other blood parameters of clinical chemistry values were not affected by Aloe vera treatment. These data suggest that Aloe vera can be effective in the treatment of the diabetic patients.

• Clinical and Experimental Pediatrics
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• v.58 no.2
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• pp.47-51
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• 2015

Debriefing is a conversational session that revolves around the sharing and examining of information after a specific event has taken place. Debriefing may follow a simulated or actual experience and provides a forum for the learners to reflect on the experience and learn from their mistakes. Originating from the military and aviation industry, it is used on a daily basis to reflect and improve the performance in other high-risk industries. Expert debriefers may facilitate the reflection by asking open-ended questions to probe into the framework of the learners and apply lessons learned to future situations. Debriefing has been proven to improve clinical outcomes such as the return of spontaneous circulation after cardiac arrest and the teaching of teamwork and communication in pediatrics. Incorporating debriefing into clinical practice would facilitate the cultural change necessary to talk more openly about team performance and learn from near misses, errors, and successes that will improve not only clinical outcome but also patient safety.

• Journal of Food Hygiene and Safety
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• v.10 no.4
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• pp.249-254
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• 1995

In order to study the effects of Aloe vera Linne treatment on the clinical chemistry in patients with liver disease, seven patients were administered orally with 800~1, 600 mg of Aloe vera Linne four times day for six months. The high levels of serum AST, ALT, ALP, ${\gamma}$-GTP and total bilirubin in patients were significantly reduced by adminstration of Aloe vera L. The reduced serum albumin/globulin value was increased by Aloe vera L. treatment. But other blood parameters of clinical chemistry values were not affected by Aloe vera L. treatment. These data suggest that Aloe vera L. can be effective in treatment of the patients with liver disease.

• Korean Journal of Clinical Pharmacy
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• v.34 no.1
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• pp.1-20
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• 2024

This review examines the pivotal clinical trials that evaluated the efficacy and safety of semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, in the management of obesity. The reported findings underscore significant and sustained weight loss achieved with semaglutide in diverse patient groups, although gastrointestinal disorders occurred frequently, leading to therapy discontinuation. Overall, the studies demonstrated the potential of semaglutide as a therapeutic option not only for type 2 diabetes but also for obesity. The treatment landscape in obesity is evolving, as reflected in changing regulatory approvals and clinical guidelines, suggesting a paradigm shift toward personalized approaches in this chronic disease states to achieve optimal treatment outcomes for patients.

• Journal of Acupuncture Research
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• v.15 no.2
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• pp.183-198
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• 1998

This study was done in order to present clinical trial method for safety of herb-acupuncture. The results were summerized as follow: In case of western medicine, clinical trial divides into four phase 1. Phase I: Investigate safety and drug movement for health people. 2. The first phase II: Investigate safety, effectiveness for the limited patient. The late phase II: Investigate propriety of an applicable disease, the way to use and dose. 3. Phase III: Through the comparative, public trial, investigate a final, applicable disease and side effect. 4. Phase IV: After NDA, investigate safety and effectiveness for the wide patients. In case of herb-acupuncture, we have to investigate the following for safety and effectiveness 1. Drug dose: Decide with 1/2 or 1/3 of oral dosage or a basis of animal's of maximum dosage or a ratio of man and animal. 2. Toxicity: Examine blood, urine, liver function, EKG, after herb-acupuncture during acertain period of time. 3. Regional response: Estimate response of swelling, redness, pruritus. etc 4. Treatment effectiveness: After exactly diagnosis, estimate effectiveness with a objective guide post.

• The Korea Journal of Herbology
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• v.32 no.4
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• pp.33-38
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• 2017

Objectives : Termitomyces albuminosus (Berk.) Heim is one of the famous wild edible mushrooms in the southern part of China. It is known that Termitomyces albuminosus, like Aconitum koreanum used in Korean traditional medicine, contains a kind of cerebroside, termitomycesphin, causing a pharmacologic effect on the neuron system. The pharmacologic effect of Termitomyces albuminosus can be used to possibly replace Aconitum koreanum. However, It needs to be certified as safe before it can be used. Here, a single-oral toxicity test and safety classification was conducted to obtain acute information of the toxicity of dried-Termitomyces albuminosus powder and to secure its safety in clinical applications. Methods : In order to calculate approximate lethal dose(ALD), test substance was orally administered to male and female SD-rat at dose levels of 5,000 and 0 (vehicle control) mg/kg (body weight). Based on the result of this toxicity, also the estimation of safety classification was calculated using the HED-based (human equivalent dose) MOS (margin of safety). Results : There were no mortalities, test substances treatment-related clinical signs, no changes in the body or organ weights, and no gross or histopathological findings at 14 days after treatment with test substance. Thus, the approximate lethal dose of dried-Termitomyces albuminosus powder was considered over 5,000 mg/kg in both female and male mice. Conclusions : Based on the limit dose, 5000 mg/kg, it was estimated that dried-Termitomyces albuminosus powder is classified as "Specified class B" indicating that clinical dose is not limited to patients as safe as food.