• Proceedings of the Korean Society of Applied Pharmacology
• /
• 1992.05a
• /
• pp.56-56
• /
• 1992

Risperidone은 D$_2$-수용체와 HT$_2$-수용체 차단효과를 동시에 지녀, 차세대 항정신분열증 치료제로의 가능성을 보이고 있는 약물이다. 그러나 risperidone의 주대사가 CYPIID1에 의할 가능성이 시사되고 있다. 본 연구에서는 향후 항정신병 치료제의 임상 제 1상 연구의 적정 모형 검토를 위해 risperidone율 모델 약물로 체내 약물의 동태, 내약성 및 약물 유전학적 특성등을 검토하였다. CYPIID1의 대사능을 검정한 12명의 정상 성인(11명: extensive metabolizer, 1명: poor metabolizer)을 대상으로 risperidone 투여 시험(placebo, 1, 2 mg)을 무작위 단일맹검 교차시험으로 시행하였다. 투약후 72시간까지 경시적으로 혈액, 뇨 채취 및 ECG lead II, 혈압/맥박의 변동 등을 측정하고, visual analog scale에 의해 중추신경계 주관적 증상들을 관찰 하였다. 혈장 risperidone 및 그 활성형대사물 9-OH risperidone 및 prolactin 농도는 radioimmunoassay법으로 측정하였다.

• Proceedings of the Korean Society of Applied Pharmacology
• /
• 1994.11a
• /
• pp.27-30
• /
• 1994

잠재적으로 항감염 약제로 사용될 가능성이 있는 약제들의 초기 연구과정에서 주된 관심사는 이들이 미생물(세균, 바이러스, 기타 기생충)에 대한 작용들이 있는가 하는 점이다. 이러한 작용들이 실험적으로 충분히 연구가 된 후에야 실험동물에서 그 효과를 연구한다. 항 바이러스 제제의 경우에는 세포배양을 통한 연구가 그 약제의 독성과 효용성을 나타내는데 필수적인 것이 된다. 여러 종류의 동물을 이용한 생체실험에서 약제의 일반적인 흡수와 배설, 분포 등에 관한 정보와 약제 자체와 동물 내에서의 대사적 변화에 대한 정보가 제공된다. 여러 가지 미생물로 감염을 시킨 적합한 동물과 여러 가지 용량으로 치료하는 실험을 통하여 약제의 항 감염 능력이 알려지게 된다. 동물에서의 생체실험과 실험관내에서 실험을 하고 나서야 사람에서의 연구가 이루어지게 된다. 소위 전임상시험에서 대표적 병원성 미생물에 대한 생물학적효과, 약리학적 효과와 독성 그리고 동물실험모델에서의 가능한 효과가 결정된 후에 임상시험에 들어가기 마련이다. 항균제의 임상시험에는 각각의 감염질환에 대한 진단 및 치료기준을 반영하는 것이 기본이다. 새로운 항균제의 임상시험에서는 안전성과 효과가 반드시 밝혀져야 한다. 1상에서는 인체에서의 약리효과, 안전성이 주목적이며, 2상과 3상은 겹쳐지는 점도 있으나 하나 또는 그 이상의 적응증에 대한 항균제의 효과와 단기간의 부작용은 2상에서 관찰하여야하며, 다수의 환자에서 제안된 적응질환의 무작위임상시험과 다수에서의 안전성도 3상에서 관찰하여야 한다. 4상에서는 이상에서의 자료로 시판된 후에도 계속해서 감시하는 것으로 지속적으로 안전성을 관찰하는 것이다. 이러한 기본사항외에도 소아, 임산부, 고령자등에서의 임상시험도 넓은 의미에서 포함되어야 할 것이며 또한 질적인 면에서 조절하는 Quality Assurance도 중요하다.양상은 세 용량군 간 차이가 없었으나, 시험기에서 발열의 발현율이 낮았으며, 발열일 수와 항생제 사용일 수가 짧았다. 결론: 골수억제 조절 효과는 용량에 따른 혈액소견에 미치는 영향, 부작용, 감염의 빈도, 감염발생에 따른 항생제 사용기간 등을 고려하여 그 임상 유효성 평가시, 제 3상 시험에 사용할 권장량 (recommended dose) 은 250 ug/$m^2$/d $\times$ 10d 으로 관찰되었다.5주에 부검한 랫드의 간에서 c-myc 종양단백의 발현은 모든 처리군들이 대조군에 비하여 높게 발현되는. 것이 관찰되었으나 시험개시후 26주에 부검한 랫드의 간에서 c-myc 종양단백의 발현은 대조군에 비하여 차이가 거의 없었다. 따라서 랫드에서 화학적으로 유도한 간암발생 과정에서 NK 세포활성이 현저하게 억제되는 것으로 생각되며, c-myc 종양단백의 발현은 시험개시후 15주에 그 발현이 확실한 것으로 사료되어 진다.에 영향을 주는 성분이 있음을 제시하였다.1과 항우울약들의 항혈소판작용은 PKC-기질인 41-43 kD와 20 kD의 인산화를 억제함에 기인되는 것으로 사료된다.다. 것으로 사료된다.다.바와 같이 MCl에서 작은 Dv 값을 갖는데, 이것은 CdCl$_{4}$$^{2-}$ 착이온을 형성하거나 ZnCl$_{4}$$^{2-}$ , ZnCl$_{3}$$^{-}$같은 이온과 MgCl$^{+}$, MgCl$_{2}$같은 이온종을 형성하기 때문인것 같다. 한편 어떠한 용리액에서던지 NH$_{4}$$^{+}$의 경우 Dv값이 제일 작았다. 바. 본 연구의 목적중의 하나인 인체유

• 대한임상약리학회:학술대회논문집
• /
• 1998.12a
• /
• pp.70-70
• /
• 1998

• Journal of Preventive Medicine and Public Health
• /
• v.33 no.1
• /
• pp.51-55
• /
• 2000

Objectives . In large-scale field trials, randomization by cluster is frequently used because of the administrative convenience, a desire to reduce the effect of treatment contamination, and the need to avoid ethical issues that might of otherwise arise. Cluster randomization trials are experiments in which intact social unit, e.g., families, schools, cities, rather than independent individuals are randomly allocated to intervention groups. The positive correlation among responses of subjects from the same cluster is in matter in cluster randomization. This thesis is to compare the results of three randomization methods by standard error of estimator of treatment effect. Methods : We simulated cholesterol data varing the size of the cluster and the level of the correlation in clusters and analyzed the effect of cholesterol-lowering agent. Results : In intra-cluster randomization the standard error of the estimator of treatment effect is smallest relative to that in inter-cluster randomization and that in individual randomization. Conclusions : Infra-cluster randomization is the most efficient in its standard error of estimator of treatment effect but other factor should be considered when selecting a specific randomization method.

• The Journal of Korean Obstetrics and Gynecology
• /
• v.32 no.4
• /
• pp.55-66
• /
• 2019

Objectives: This review is to figure out evidence that suggests the effectiveness of Korean Medicine treatments against Human Papilloma virus (HPV) infection and Cervical Dysplasia. Methods: Studies on HPV infection and cervical dysplasia were searched through 5 databases: Oriental Medicine Advanced Searching Integrated System (OASIS), Korean Studies Information Service System (KISS), the Journal of Korean Obstetrics & Gynecology, China Academic Journal (CAJ), Pubmed. After that, the articles were extracted with reference point of Korean Traditional Medicine. Results: 21 studies were included lastly according to selection criteria. In 21 studies, HPV turning - negative rate of Korean Medicine treatment group was higher than the control treatment group. Conclusions: 21 studies indicates that Korean Medicine treatment is effective in HPV infection and Cervical Dysplasia.

• Journal of the Korea Academia-Industrial cooperation Society
• /
• v.22 no.2
• /
• pp.434-439
• /
• 2021

We assessed the effects of intravenous (IV) ascorbic acid administration on fatigue in women undergoing laparoscopic myomectomy. We analyzed the secondary endpoint results of a randomized, double-blind, placebo-controlled trial. Fifty patients undergoing laparoscopic myomectomy received IV ascorbic acid (2g) or placebo (randomly 1:1 ratio) intravenously during surgery. On day 2 post-surgery, we measured the level of fatigue using the Brief Fatigue Inventory-Korean version. Forty-five women (experimental arm 23, control arm 22) were eligible for analysis after 5 women (experimental arm 2, control arm 3) were excluded due to withdrawal of consent, cancellation of surgery or non-measurement of the endpoints. The baseline and operative characteristics were similar between arms and the global fatigue score of the experimental arm (4.56 ± 2.63) was not significantly different from that of the control arm (5.21 ± 2.02, P = 0.351). However, the fatigue score of the experimental arm tended to be lower than that of the control arm in most domains. IV ascorbic acid administration did not significantly reduce the level of fatigue in women undergoing laparoscopic myomectomy as compared to placebo. More research is needed to better understand the effects of ascorbic acid on fatigue in surgical patients.

• The Journal of Internal Korean Medicine
• /
• v.43 no.4
• /
• pp.559-566
• /
• 2022

Introduction: The aim of this systematic review is to provide evidence confirming the efficacy and safety of herbal medicines used in the treatment of liver cancer. Methods: The review will include randomized clinical trials that compared herbal medicines used as treatments for liver cancer with other therapies, such as placebos and Western medicine. Only randomized controlled trials will be included in this review, and all types of herbal medicine will be evaluated. Eleven electronic databases will be searched from the inception date: the Cochrane Database of Systematic Reviews, MEDLINE, EMBASE, AMED, CINAHL, one Chinese database (CNKI), and five Korean databases (OASIS, DBpia, RISS, KISS, and NDSL). The selection of studies, data extraction, and management will be performed independently by four researchers. Methodological quality, including the risk of bias, will be assessed using the Cochrane risk-of-bias assessment tool. Results: The review of current evidence for the effectiveness of herbal medicine for liver cancer will be summarized and quantitatively analyzed. Conclusions: Our systematic review will provide evidence of the efficacy of herbal medicines as treatments for liver cancer. This evidence will provide useful information for practitioners and patients in the fields of oncology and complementary medicine.

• Journal of Genetic Medicine
• /
• v.8 no.1
• /
• pp.28-34
• /
• 2011

Most clinicians understand clinical trials as the evaluation process for new medicine before their use. However, clinical trials can also be applied to laboratory diagnostic tests (LDTs) to verify diagnostic accuracy and efficacy before their clinical laboratory implementation for patients. The clinical trial of LDT has two distinctive characteristics that are different from the case of pharmaceuticals and thus worth special consideration. One of them is the level of evidence. The well-designed randomized controlled trials (RCTs) are known to provide the best evidence to prove the clinical efficacy of any pharmaceutical products. However, RCTs lose practicality when applied to LDTs due to various issues including ethical complications. For this reason, comparative study format is considered more feasible approach for LDTs. In addition pharmaceuticals and LDTs are different in that the user's intervention is not required for the former but critical to the latter. Moreover, in the case of pharmaceuticals, end-products are produced by manufacturers before being used by clinicians. However, in LDTs, once reagents and instruments are provided by manufacturers, they are first utilized by clinical laboratories to produce test results in order for clinicians to use them later. In other words, when it comes to LDTs, clinical laboratories play the role of manufacturers, providing reliable test results with improved quality assurance. Considering the distinctive characteristics of LDTs, we would like to offer detailed suggestions to successfully perform clinical trials in LDTs, which include analytical performance measures, clinical test performance measures, diagnostic test accuracy measures, clinical effectiveness measures, and post-implementation surveillance.

• The Journal of Internal Korean Medicine
• /
• v.42 no.4
• /
• pp.455-474
• /
• 2021

The aim of this study was to perform a systematic review and meta-analysis of randomized controlled trials (RCTs) that applied herbal medicine to treat viral hepatitis B and C in order to determine the therapeutic efficacy of herbal medicine. EMBASE, Pubmed, NDSL, KMBASE, KISS, KISTI, Koreamed, Koreantk, and Oasis databases were searched to identify RCTs. The selected studies were assessed by the Cochrane group's risk of bias tool. A total of 15 RCTs were selected, and the hepatitis B virus (HBV) DNA reduction was significantly higher in patients treated with herbal medicine combined with Western medicine than in patients treated with herbal medicine. Herbal medicine combined with Western medicine was also superior to Western medicine alone in achieving hepatitis B e-antigen (HBeAg) and alanine aminotransferase [ALT] reduction. Only herbal medicine alone was not superior to Western medicine treatments in achieving HBV DNA, HBeAg, and ALT reduction.

• The Journal of Korean Obstetrics and Gynecology
• /
• v.32 no.2
• /
• pp.50-70
• /
• 2019

Objectives: The purpose of this study was to show effectiveness of Korean medicine external treatment on bacterial vaginosis by analyzing randomized controlled clinical trials. Methods: We searched randomized controlled clinical trials related with Korean external treatment on bacterial vaginosis through national and overseas database and analyzed them in detail. Results: 15 articles were included according to our selection criteria and 2,176 women were involved. 1. All treatment groups were treated with intervention including Korean medicine external treatment and their results were statistically more effective than control groups. 2. External washing was the most frequently used method followed by vaginal tablet, fumigation and powder. 3. The most frequently used herbal medicine was Sophorae Radix followed by Phellodendri Cortex, Cindi Fructus, Dictamni Radicix Cortex and Kochiae Fructusa. 4. There were 4 studies reporting side effects of treatment and no significant side effects were observed. Conclusions: There was significant difference in the effectiveness of the intervention including Korean external therapy. Based on the analysis, it could be an effective way for the treatment of bacterial vaginosis in clinical practice.