• 제목/요약/키워드: efficacy and safety

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Immuno-enhancement effects of Korean Red Ginseng in healthy adults: a randomized, double-blind, placebo-controlled trial

  • Hyun, Sun Hee;Ahn, Ha-Young;Kim, Hyeong-Jun;Kim, Sung Won;So, Seung-Ho;In, Gyo;Park, Chae-Kyu;Han, Chang-Kyun
    • Journal of Ginseng Research
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    • 제45권1호
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    • pp.191-198
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    • 2021
  • Background: Most clinical studies of immune responses activated by Korean Red Ginseng (KRG) have been conducted exclusively in patients. However, there is still a lack of clinical research on immune-boosting benefits of KRG for healthy persons. This study aims to confirm how KRG boosts the immune system of healthy subjects. Methods: A total of 100 healthy adult subjects were randomly divided into two groups that took either a 2 g KRG tablet or a placebo per day for 8 weeks. The primary efficacy evaluation variables included changes in T cells, B cells, and white blood cells (WBCs) before and after eight weeks of KRG ingestion. Cytokines (TNF-α, INF-γ, IL-2 and IL-4), WBC differential count, and incidence of colds were measured in the secondary efficacy evaluation variables. Safety evaluation variables were used to identify changes in laboratory test results that incorporated adverse reactions, vital signs, hematological tests, blood chemistry tests, and urinalysis. Results: Compared to the placebo group, the KRG intake group showed a significant increase in the number of T cells (CD3) and its subtypes (CD4 and CD8), B cells, and the WBC count before and after eight weeks of the intake. There were no clinically significant adverse reactions or other notable results in the safety evaluation factors observed. Conclusion: This study has proven through its eight-week intake test and subsequent analysis that KRG boosts the immune system through an increase in T cells, B cells, and WBCs, and that it is safe according to the study's safety evaluation.

Meta-analysis for Efficacy and Safety of Propofol during Dental Sedation

  • Choi, Seong-Seok;Seo, Kwang-Suk;Kim, Hyun-Jeong
    • 대한치과마취과학회지
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    • 제12권2호
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    • pp.75-91
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    • 2012
  • Background: Dental sedation reduces fear and phobia during dental treatment and helps patients get quality treatment by inducing adequate consciousness control. Propofol has recently grabbed the spotlight, but no meta-analysis for efficacy and safety of propofol in dentistry has yet been performed. Thus, the purpose of this study was to perform meta-analysis to verify the efficacy and safety of propofol for use in dental sedation. Methods: Articles published between 1980 and 2010 were searched in the web sites, journals and medical database including The Cochrane Library, MEDLINE and EMBASE. And a total of 22 studies were selected among the randomized controlled trials (RCTs) that compared the use of propofol with other sedatives (control group). The data was collected from these studies and meta-analysis for efficacy and safety was performed using Comprehensive Meta-Analysis 5.0 (CMA 5.0). Results: The patient recovered significantly faster and discharged significantly earlier in the propofol group (SMD = -1.442, P < 0.001). The satisfaction of patient and that of operator was higher in the propofol group (P < 0.05). The incidence of arrhythmia and apnea/ hypoventilation was significantly lower in the propofol group (OR = 0.071, P < 0.05), and there was no significant difference in the other side effects. On the level of sedation, although the sedation score was significantly lower in the propofol group (SMD = -0.430, P < 0.05). Conclusions: The present analysis showed that the use of propofol resulted in high satisfaction levels on the part of the patients and operators, a shorter recovery time, and faster hospital discharge. The incidence of complications, however, was lower in the propofol groups or not much different between the propofol and control groups. Thus, the adequate use of propofol in dentistry is believed to be helpful for the effective and safe sedation of the patients.

Safety of red ginseng and herb extract complex (RHC) in menopausal women: A randomized, double-blind, placebo-controlled trial

  • Hyun, Sun Hee;Han, Chang-Kyun;So, Seung-Ho;Park, Soo Kyung;Park, Chae-Kyu;In, Gyo;Lee, Ji Young
    • Journal of Ginseng Research
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    • 제46권4호
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    • pp.601-608
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    • 2022
  • Background: Various treatments are used to relieve menopausal symptoms for women. However, herbal substances are frequently used as complementary and alternative therapies as other treatments can increase ovarian and breast cancer risk. While the herbal substances' therapeutic effect is essential, the safety of their use is considered more important. This study aims to confirm the safety of red ginseng and herb extract complex (RHC), which are used to relieve menopausal symptoms. Methods: This randomized, double-blind, placebo-controlled clinical study recruited and divided 120 women experiencing menopausal symptoms into the RHC and placebo groups (60 women per group). Subjects were administered with 2 g RHC or placebo daily for 12 wk. Adverse reactions, female hormonal changes, and uterine thickness were observed and recorded on wk 0, 6, and 12. Hematologic and blood chemistry tests were also conducted. Results: The reactions of the subjects who received RHC or placebo at least once were analyzed. A total of six adverse reactions occurred in the RHC group, while nine occurred in the placebo group; common reactions observed in both groups were genital, subcutaneous tissue, and vascular disorders. However, there was no statistically significant difference between the administration groups (p = 0.5695), and no severe adverse reactions occurred in both groups.

Efficacy and Safety of Laser Surgery and Transurethral Resection of the Prostate for Treating Benign Prostate Hyperplasia: a Network Meta-analysis

  • Wang, Li;Yu, Qiu-Yan;Liu, Yan;Zhu, Zhen-Li;Huang, Yuan-Wei;Li, Ke
    • Asian Pacific Journal of Cancer Prevention
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    • 제17권9호
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    • pp.4281-4288
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    • 2016
  • Background: Traditional meta-analyses or systematic reviews of randomized controlled trials (RCTs) have been used to compare laser surgeries and transurethral resection of the prostate (TURP) for benign prostate hyperplasia (BHP), but they cannot provide a hierarchy regarding efficacy and safety of treatment. Objective: We therefore performed a network meta-analysis (NMA) to compare and create hierarchies for efficacy and safety of TUPR and laser surgeries for BPH. Materials and Methods: We searched for reports of RCTs published up to April 25, 2015. After methodological quality assessment and data extraction, we performed an NMA to compare TURP and laser surgeries for BPH. Results: We ranked the treatments of TURP and laser surgeries for BPH. For IPSS at 6 months, holmium laser resection of the prostate (HoLRP) ranked the first-best and at 12 months, holmium laser enucleation of the prostate (HoLEP). For Qmax at 6 and 12 months, HoLEP ranked the first-best; for operative time it was TURP; for cathedral removal time, diode laser enucleation of the prostate (DiLEP) ranked the first-best. Conclusions: Although TURP is considered the gold standard for treating BPH, it is not better in terms of efficacy and safety compared with the laser surgery. Our NMA created hierarchies for the 9 types of surgery in terms of efficacy and safety, which should help clinicians choose the best approach for the individual patient.

고콜레스테롤 식이 랫드에서 천마혼합액의 혈액개선 효과 (Effect of Mixture of Gastrodiae rhizoma on Blood Amelioration in High Cholesterol-diet Rats)

  • 이영선;한옥경;전태원;이은실;김광중;배재칠;김효정
    • 동의생리병리학회지
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    • 제16권2호
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    • pp.226-232
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    • 2002
  • This study was carried out to investigate the effect of mixture of Gastrodiae rhizoma (GM) on blood amelioration in high cholesterol-diet rats. Sprague-Dawley male rats were randomly assigned to one normal diet and three high cholesterol-diet groups which contained 1 % (w/w) cholesterol diet. The groups of high cholesterol-diet were classified to control (high cholesterol-diet only), GM-1 (high cholesterol-diet and GM) and ST-1 (high cholesterol-diet and Statin drug). The body and organs weight were not significantly changed among the tested groups. Contents of serum total cholesterol and LDL-cholesterol were significantly increased in cholesterol-diet groups compared with normal diet group but significantly decreased in the group of GM-1. Morphology of red blood cell in GM-1 group was similar to normal diet group but the control group had many crystals of cholesterol. Hepatic xanthine oxidase activity in the rats of high cholesterol-diet was decreased up to the levels of normal diet group according to oral administration of GM. The results of the present study demonstrate that the orally injection of GM can ameliorate the status of total cholesterol and LDL-cholesterol, and repress xanthine oxidase in liver in high cholesterol-diet rats. These finding suggest that GM is expected to be an effective tea for the blood amelioration in high cholesterol-diet rats.

랫드에서 헛개나무와 천마 혼합 추출물의 에탄올 섭취에 의한 숙취 제거 효과 (Eliminatory Effect of Mixed Extract of Hovenia Dulcis Thunb and Gastrodia Elata on Ethanol-Induced Hangover in Rats)

  • 전태원;이은실;이영선;한옥경;배재칠;김광중;김효정
    • 동의생리병리학회지
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    • 제16권5호
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    • pp.905-910
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    • 2002
  • To investigate an eliminatory effect of mixed extract of Hovenia dulcis Thunb, Gastrodia elata and Alnus japonica etc., on the ethanol-induced hangover, 12 hr-fasted male Sprague-Dawley rats weighing 220±20 g were given mixed extract (10 mL/kg, p.o.) and administered ethanol at a dose of 3 g/kg bw (25% in distilled water) orally 30 min postdosing. Blood was collected from caudal artery at 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hr and then the animals were sacrificed at 24 hr after the ethanol treatment. From 0 to 12 hr, the administration of mixed extract significantly decreased the area under the serum alcohol concentrations-vs.-time curves by 21 % compared with control group. In these experiments, liver function indices, such as alanine aminotransferase, aspartate aminotransferase and sorbitol dehydrogenase activities, showed unaltered results in all treated groups compared with the normal group. These results suggest that oral intake of the mixed extract may be effective on elimination of ethanol-induced hangover.

황기 추출액이 Acetaminophen으로 유발된 마우스의 간 손상에 미치는 영향 (Effect of Astragali radix Extract on Acetaminophen-induced Hepatotoxicity in Mice)

  • 이영선;한옥경;전태원;이은실;김광중;박찬우;김효정
    • 동의생리병리학회지
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    • 제16권4호
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    • pp.707-713
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    • 2002
  • Astragali radix (AR) is one of the oldest and mast frequently used crude drug for traditional medicine in many Asian countries. This study designed to investigate the hepatoprotective effects of the aqueous extracted AR (ARE) against acetaminophen (APAP)-induced hepatic damage in ICR mice. APAP at the dose of 450 mg/kg i.p produced liver damage in ICR mice. Serum enzyme activities of alanine aminotransferase, aspartate aminotransferase and sorbitol dehydrogenese was dramatically decreased up to control level by pretreatment of ARE. However, hepatic glutathione level did not show a significant change between the tested groups. We also investigated TNF α mRNA gene expression on APAP-induced liver damage by RT-PCR. APAP dramatically induced TNF α mRNA gene expression in ICR mice. Pretreatment of mice with ARE led to a marked decrease of TNF α mRNA gene expression. These data indicate that 1) ARE has clearly revealed a hepatoprotective effect against APAP-induced hepatic damage in ICR mice, and 2) the protective effect of ARE may be, in part, associated with the regulation of TNF α mRNA gene expression.

Efficacy of Korean Red Ginseng in the Treatment of Alopecia Areata

  • Oh, Ga-Na;Son, Sang-Wook
    • Journal of Ginseng Research
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    • 제36권4호
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    • pp.391-395
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    • 2012
  • Alopecia areata (AA) is an autoimmune disease that can affect any hair-bearing area. AA is known to be caused by immunological disorder but still, the pathogenesis is not fully understood. Many therapeutic modalities have been used to treat alopecia areata, with variable efficacy and safety profiles. Unfortunately, none of these agents is definitely curative or preventive alone. We studied hair growth efficacy and safety of Korean red ginseng (KRG) in AA comparing corticosteroid intra-lesional injection (ILI) alone patient group with ILI with KRG taking patient group using Folliscope 2.5 for 12 wk. Herein, we would like to report the efficacy of KRG in the treatment of AA and recommend KRG as a useful complimentary food for gaining efficacy of treatment for AA.

광학이성질체 의약품의 안전성과 유효성 측면에서 의약품 허가신청 자료에 대한 비교연구 (Investigation of New Drug Submission Documents for the Safety and Efficacy Evaluation of Stereoisomeric Drugs)

  • 김광준;최인;이범규;문홍섭;한효경;최은주;이원재
    • 통합자연과학논문집
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    • 제4권4호
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    • pp.315-322
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    • 2011
  • This study was performed to investigate the current regulatory guidances of safety and efficacy evaluation for the approval of stereoisomeric drugs in Korea and US. According to the regulatory guidelines in major countries (EU, Canada, US), the important categories for the development of stereoisomeric drugs are classified as 1) development of a single enantiomer as a new active substances 2) development of a racemate as a new active substance 3) development of a new single enantiomer from an approved racemate. For this study, domestic regulatory documents for current guidelines of stereoisomeric drugs were investigated. Also four typical stereoisomeric drugs for three categories were chosen to investigate the new drug submission documents of KFDA and FDA for the safety and efficacy evaluation of stereoisomeric drugs. It is expected that these comparative results between KFDA and FDA will be useful for the safety and efficacy for the regulatory approval of stereoisomeric drugs in Korea.

간호사의 문제해결능력, 자기효능감이 투약안전역량에 미치는 영향 (Influence of Problem-solving Ability and Self-efficacy on Medication Safety Competence among Clinical Nurses)

  • 정다은;이영휘;류경민;우한솔;김잔디
    • 융합정보논문지
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    • 제12권5호
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    • pp.21-31
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    • 2022
  • 본 연구는 임상간호사의 투약안전역량에 영향을 미치는 요인을 규명하고자 시도되었다. 자료의 수집은 상급종합병원 두 곳에 재직하고 있는 154명의 간호사를 대상으로 진행하였다. 자료의 분석은 SPSS 26.0 프로그램으로 t-검정, ANOVA, 상관관계, 단계적 다중회귀분석을 하였다. 연구결과 투약안전역량은 문제해결능력과 자기효능감과 유의한 상관관계가 있었다. 자기효능감, 문제해결능력, 근무형태, 현부서 근무경력 순으로 투약안전역량에 영향을 미치는 것으로 나타났고 이들 변수는 전체변량의 64.7%의 설명력을 가졌다. 따라서 임상간호사의 투약안전역량을 증진시키기 위해서는 무엇보다도 자기효능감과 문제해결능력을 증진시키기 위한 프로그램이 개발 될 필요가 있겠다.