• Title/Summary/Keyword: randomized clinical

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Systematic Review of Hominis Placenta Pharmacopuncture in English and Korean Literature

  • Ryoo, Dek-Woo;Kim, Hong-Guk;Kim, Sung-Jin;Baek, Seung-Won;Jeong, Seong-Mok;Yoon, Jin-Young;Lee, Chang-Hee;Goo, Bon-Hyuk;Kim, Min-Jeong;Park, Yeon-Cheol;Baek, Yong-Hyeon;Nam, Sang-Soo;Seo, Byung-Kwan
    • Journal of Acupuncture Research
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    • v.34 no.4
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    • pp.153-158
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    • 2017
  • Background: Hominis placenta (HP) is used in Korean medicine to tonify qi and blood, and enrich yin and tonify yang. HP has been reported to have therapeutic effects. Methods: A survey of international and Korean electronic databases was conducted using the search terms "hominis placenta pharmacopuncture" and "hominis placenta extract". The search was limited to material published up to May 31, 2017. Results: A total of 83 studies were included in this systematic review: 50 were clinical studies, 25 were basic studies, and 8 were other types of study. Among clinical studies, the most frequently treated disease groups were musculoskeletal diseases and nervous system diseases. In vitro studies were conducted mainly on anti-inflammatory, analgesic, and anti-cell necrosis models. Most of the in vivo studies were performed in rheumatoid arthritis or diabetic complications models. Conclusion: HP pharmacopuncture has effects in the treatment of various diseases. Further large-scale randomized controlled trials are needed to improve the level of evidence for HP pharmacopuncture. It would be helpful if future in vitro and in vivo studies could identify the mechanism of action of HP pharmacopuncture.

GnRH antagonist multiple dose protocol with oral contraceptive pill pretreatment in poor responders undergoing IVF/ICSI

  • Kim, Chung-Hoon;You, Rae-Mi;Kang, Hyuk-Jae;Ahn, Jun-Woo;Jeon, Il-kyung;Lee, Ji-Won;Kim, Sung-Hoon;Chae, Hee-Dong;Kang, Byung-Moon
    • Clinical and Experimental Reproductive Medicine
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    • v.38 no.4
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    • pp.228-233
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    • 2011
  • Objective: To investigate the effectiveness of GnRH antagonist multiple-dose protocol (MDP) with oral contraceptive pill (OCP) pretreatment in poor responders undergoing IVF/ICSI, compared with GnRH antagonist MDP without OCP pretreatment and GnRH agonist low-dose long protocol (LP). Methods: A total of 120 poor responders were randomized into three groups according to controlled ovarian stimulation (COS) options; GnRH antagonist MDP after OCP pretreatment (group 1), GnRH antagonist MDP without OCP pretreatment (group 2) or GnRH agonist luteal low-dose LP without OCP pretreatment (group 3). Patients allocated in group 1 were pretreated with OCP for 21days in the cycle preceding COS, and ovarian stimulation using recombinant human FSH (rhFSH) was started 5 days after discontinuation of OCP. Results: There were no differences in patients' characteristics among three groups. Total dose and days of rhFSH used for COS were significantly higher in group 3 than in group 1 or 2. The numbers of mature oocytes, fertilized oocytes and grade I, II embryos were significantly lower in group 2 than in group 1 or 3. There were no significant differences in the clinical pregnancy rate and implantation rate among three groups. Conclusion: GnRH antagonist MDP with OCP pretreatment is at least as effective as GnRH agonist low-dose LP in poor responders and can benefit the poor responders by reducing the amount and duration of FSH required for follicular maturation.

Clinical Comparison of Low-dose and High-dose Steroid in Pediatric Cardiac Surgery with Cardiopulmonary Bypass

  • Choi Seok-Cheol;Kim Song-Myung;Kim Yang-Weon
    • Biomedical Science Letters
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    • v.12 no.3
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    • pp.289-301
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    • 2006
  • Cardiopulmonary bypass (CPB) for cardiac surgery triggers the production and release of numerous chemotactic substances and cytokines, ensuing systemic inflammatory response that leads to postoperative major organ dysfunction. Traditionally, corticosteroids (steroid) have been administered to patients undergoing cardiac surgery to ward off these detrimental physiologic alterations. However, the majority of the studies have been performed on adult patients with high-dose steroid. We carried out a randomized, prospective, double-blind study to compare the efficacy of low-dose steroid with that of high-dose steroid and to determine the adequate dose of pretreated-steroid for prophylactic effects in pediatric cardiac surgery. Thirty pediatric patients scheduled for elective cardiac surgery were randomly assigned to two groups; fifteen patients received low-dose methylprednisolone (10mg/kg intravenously, n=15, low-dose group) and the others received high-dose methylprednisolone (30mg/kg intravenously, n=15, high-dose group) 1 hour prior to CPB. Arterial blood samples were taken before CPB (Pre-CPB), 10 minutes after start of CPB (CPB-10), and immediately after CPB-end (CPB-OFF) for measuring total leukocyte counts (T-WBC) and diff-counts, platelet counts, interleukin-6 (IL-6), myeloperoxidase (MPO), total antioxidant (TAO), neuron-specific enolase (NSE), troponin I (TNI), aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatinine, and blood urea nitrogen (BUN) levels. Other parameters such as volumes of urine output, pulmonary index $(PI,\;PaO_2/FiO_2)$, mechanical ventilating period, intensive care unit (ICU)-staying period, postoperative complications (fever, wound problem), postoperative 24 hrs and total volumes in blood loss, and hospitalized days were also assessed. All parameters were compared between two groups. There were no significant differences in T-WBC counts, monocyte fraction, platelet counts, TA levels, NSE levels, creatinine levels, BUN levels, the volumes of total urine output, PI, the incidences of fever and wound problem, postoperative 24hrs- and total-blood loss volumes and ICU-staying period between two groups (P>0.05). At CPB-OFF, neutrophil fraction, MPO level, TNI level, and AST level were higher in the high-dose group than in the low-dose group (P<0.05). IL-6 level at CPB-10 was higher in the high dose-group than in the low-dose group (P<0.05). Furthermore, mechanical ventilating periods and hospitalized days of the high-dose group were significantly longer than those of low-dose group (P<0.05). The high-dose group had significantly low lymphocyte fi-action at CPB-OFF compared with the low-dose group (P<0.001). These findings suggest that pretreatment of high-dose steroid is not superior to that of low-dose steroid regrading its potential benefits in pediatric cardiac surgery. Therefore, the conventional strategy of steroid treatment, high-dose pretreatment, should be modified in the cardiac surgery with CPB. However, further studies must be performed on the larger number of patients in as much as small number of patients in this study.

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Aromatase Inhibition and Capecitabine Combination as 1st or 2nd Line Treatment for Metastatic Breast Cancer - a Retrospective Analysis

  • Shankar, Abhishek;Roy, Shubham;Rath, Goura Kishor;Julka, Pramod Kumar;Kamal, Vineet Kumar;Malik, Abhidha;Patil, Jaineet;Jeyaraj, Pamela Alice;Mahajan, Manmohan K
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.15
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    • pp.6359-6364
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    • 2015
  • Background: Preclinical studies have shown that the combination of an aromatase inhibitor (AI) and capecitabine in estrogen receptor (ER)- positive cell lines enhance antitumor efficacy. This retrospective analysis of a group of patients with metastatic breast cancer (MBC) evaluated the efficacy and safety of combined AI with capecitabine. Materials and Methods: Patients with hormone receptor-positive metastatic breast cancer treated between 1st January 2005 and 31st December 2010 with a combination of capecitabine and AI were evaluated and outcomes were compared with those of women treated with capecitabine in conventional dose or AI as a monotherapy. Results: Of 72 patients evaluated, 31 received the combination treatment, 22 AI and 19 capecitabine. The combination was used in 20 patients as first-line and 11 as second-line treatment. Mean age was 46.2 years with a range of 28-72 years. At the time of progression, 97% had a performance status of <2 and 55% had visceral disease. No significant difference was observed between the three groups according to clinical and pathological features. Mean follow up was 38 months with a range of 16-66 months. The median PFS of first-line treatment was significantly better for the combination (PFS 21 months vs 8.0 months for capecitabine and 15.0 months for AI). For second-line treatment, the PFS was longer in the combination compared with capecitabine and Al groups (18 months vs. 5.0 months vs. 11.0 months, respectively). Median 2 year and 5 year survival did not show any significant differences among combination and monotherapy groups. The most common adverse events for the combination group were grade 1 and 2 hand-for syndrome (69%), grade 1 fatigue (64%) and grade 1 diarrhoea (29%). Three grade 3 hand-foot syndrome events were reported. Conclusions: Combination treatment with capecitabine and AI used as a first line or second line treatment was safe with much lowered toxicity. Prospective randomized clinical trials should evaluate the use of combination therapy in advanced breast cancer to confirm these findings.

The Bioequivalence of Two Carbamazepine Controlled Release Formulations (카르바마제핀 서방형 제제간의 생물학적 동등성 비교)

  • Kim, Min J.;Lee, Hyun J.;Rheu, Yoon M.;Shin, Wan G.;Park, Sung H.
    • Korean Journal of Clinical Pharmacy
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    • v.6 no.2
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    • pp.19-23
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    • 1996
  • Carbamazepine is an anticonvulsant drug that has been shown to be as effective as phenytoin or phenobarbital in treatment of grand mal and complex partial seizures and is also approved as the drug of choice for treatment of the pain associated with trigerminal neuralgia. And the therapeutic or toxic effects of carbamazepine are better related to plasma concentration than to dosage, which can be attributed to interindividual variability in the pharmacokinetics. A slow rate of carbamazepine dissolution in the gastrointestinal tract is believed to be the cause of its relatively slow and erratic rate of absorption. For these reasons pharmacokinetic evaluation of newly formulated carbamazepine is neccessary. In this study, the bioequivalence in carbamazepine between the $TegretoI^{TM}$ CR tablet (Geigy Co.) and $Carmazepine^{TM}$ CR tablet (Myung In Co.) was evaluated. 12 normal volunteers (age $21\~27$ years old) was divided into two groups, and a randomized cross-over study was employed. The pharmacokinetic parameters ($C_{max},\;T_{max}$ and AUC) obtained of oral administration of each formulatim of carbamazepine 400 mg were evaluated and ANOVA was utilized for the statistical analysis of parameters. $C_{max}\;is\;8.26{\pm}3.1{\mu}g/ml\;(C.V.\;37.3\%)\;in\;TegretoI^{TM}\;and\;9.39\{pm}2.9{\mu}g/ml\;(C.V.\;30.5\%)$ in $Carmazepine^{TM},\;T_{max}\;is\;28.0{\pm}5.9\;hrs(C.V.\;21.1\%)$ in $Tegretol^{TM}\;and\;24.0{\pm}7.2\;hrs(C.V.\;30.2\%)$ in $Carmazepine^{TM}$ and AUC is $786.4{\pm}360.5{\mu}g{\cdot}hr/ml\;(C.V.\;45.8\%)$ in $TegretoI^{TM}\;and\;792.8{\pm}228.6{\mu}g{\cdot}hr/ml\;(C.V.\;28.8\%)$ in $Carmazepine^{TM}$, respectively. As the result of the data, two formulations are bioequvalent, and the lower C.V. of $Carmazepine^{TM}$ in every individual can be merit.

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Effectiveness and Safety of Pemetrexed Versus Docetaxel as a Treatment for Advanced Non-small Cell Lung Cancer: a Systematic Review and Meta-analysis

  • Di, Bao-Shan;Wei, Kong-Ping;Tian, Jin-Hui;Xiao, Xiao-Juan;Li, Yan;Zhang, Xu-Hui;Yu, Qin;Yang, Ke-Hu;Ge, Long;Huang, Wen-Hui;Zhang, Fang-Wa
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.8
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    • pp.3419-3424
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    • 2014
  • Background: Our aim was to conduct a meta-analysis to compare the efficacy and safety of pemetrexed and docetaxel for non-small cell lung cancer (NSCLC). Materials and Methods: We systematically searched the Cochrane Library, PubMed, Embase, China Biology Medicine Database for randomized controlled trials (RCTs) comparing the efficacy and toxicities of pemetrexed versus docetaxel as a treatment for advanced NSCLC. We limited the languages to English and Chinese. Two reviewers independently screened articles to identify eligible trials according to the inclusion and exclusion criteria and assessed the methodological quality of included trials, and then extracted data. The meta-analysis was performed using STATA12.0. Results: Six RCTs involving 1,414 patients were identified. We found that there was no statistically significant differences in overall response rate, survival time, progression-free survival, disease control rate, and 1-2yr survival rate (p>0.050) but it is worthy of mention that patients in the pemetrexed arms had significantly higher 3-yr survival rate (P=0.002). With regard to the grade 3 or 4 hematological toxicity, compared with docetaxel, pemetrexed led to lower rate of grade 3-4 febrile neutropenia, neutropenia, and leukocyts toxicity (p<0.001). There was no significant difference in anemia between the two arms (p=0.08). In addition, pemetrexed led to higher rate of grade 3-4 thrombocytopenia toxicity (p=0.03). As for the non-hematological toxicities, compared with docetaxel, pemetrexed group had lower rate of grade 3-4 diarrhea and alopecia. Conclusions: Pemetrexed was almost as effective as docetaxel in patients with advanced NSCLC. At the same time, pemetrexed might increase the 3-yr survival rate. As for safety, pemetrexed led to lower rate of grade 3-4 febrile neutropenia, neutropenia, leukocytes, diarrhea and alopecia toxicity. However, it was associated with a higher rate of grade 3-4 thrombocytopenia.

Effect of Hanwoo Diets Containing Linseed on Plasma Cholesterol Levels of Humans to Beef Consumption and Change in n-6/n-3 Fatty Acid of Loin Fat (아마씨앗 첨가 한우사료가 등심 지방의 n-6/n-3 변화 및 이를 섭취한 사람의 혈중 콜레스테롤 함량에 미치는 영향)

  • Park, Sang-Oh;Park, Byung-Sung;Yuh, In-Suh;Hwangbo, Jong;Bang, Han-Tae
    • Journal of the Korean Applied Science and Technology
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    • v.31 no.2
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    • pp.265-276
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    • 2014
  • The purpose of this study was to evaluate the effect on lowering blood LDL-C in an adult human, by taking n-6/n-3 balanced Hanwoo beef and reducing n-6/n-3 in loin of Hanwoo beef. The randomized complete block design was used to conduct an experiment with a total of 20 castrated Hanwoo cattles, which were divided into two groups. Each group had 10 cattles, and the control group consisted of absence of linseed, while n-3 treatment group (n-3 group) had linseed. The results showed that n-6/n-3 in loin and blood was decreased to under 4:1 in n-3 group, while oleic acid as an monounsaturated fatty acid was increased by 52.79% compared to the control group. In above 70% of the clinical subjects who ate the balanced Hanwoo beef, the blood triglyceride, total cholesterol, and LDL-C were decreased by 25.35, 5.22, and 17.59%. However, in the subjects who ate the imported beef, and not the common Hanwoo beef, the same parameters were increased by 9.05, 8.21, and 21.70%, respectively. When the balanced Hanwoo beef were eaten, HDL-C were increased by 6.07% but the imported beef and common Hanwoo beef had those values decreased by 14.46 and 11.46%, respectively. The blood glucose was decreased by 6.42 and 11.82% in the subjects who ate balanced Hanwoo beef and common Hanwoo beef, respectively but the subjects who ate the imported beef had an increase by 15.19%.

A Systematic Review of Constraint Induced Movement Therapy about Upper Extremity in Stroke (뇌졸중 환자의 상지 강제유도운동치료에 관한 체계적 고찰)

  • Park, Su-Hyang;Baek, Soon-Hyung;Shin, Joong-il
    • The Journal of the Korea Contents Association
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    • v.16 no.3
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    • pp.149-161
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    • 2016
  • The purpose of this study is provided to useful data to establish the Constraint Induced Movement Therapy(CIMT) in clinical plan to more specific for stroke patients. Also It is provided way for further study about CIMT. Methods used a systematic review. Systematic review is a research method that can be presented to the scientific evidence. Data were organized by PICO(Patient, Intervention, Comparison, Outcome). Research using the database Embase and Medline, It was searched for CIMT and Stroke. We selected for a total of 42 studies that meet the purpose of the present study. We was selected for a total of 42 studies that meet the purpose of the present study. Results was that the quality of the study is a systematic review, meta-analyzes, randomized controlled. CIMT studies was based on a high quality level of 50% of the total. The difference between the study period was 42.8%, more research was conducted prior to 2010. CIMT has been used more than mCIMT by to differ 40.5%. It is effective in over 75% of study, regardless of the CIMT intervention. In conclusion, CIMT has an effect on the upper limbs of stroke patients damaged, results will be used as a useful material to develop a CIMT in the clinical treatment plan. In future studies will need to validate studies on the effectiveness of the mCIMT, It will require a review of the effectiveness of validation studies.

Natural Substance MS-10 Improves Women's Health via Regulation of Estrogen Receptor (천연소재 MS-10의 에스트로겐 수용체 조절을 통한 여성건강 증진)

  • Noh, Yoo-Hun;Lee, Ji Won;Park, Jiae;Lee, Sang Hyung;Lee, Jun Young;Kim, Sung-Su;Park, Kwang-Kyun;Kim, Tae Jin;Myung, Soon-Chul;Jeong, Yoonhwa
    • Journal of the Korean Society of Food Science and Nutrition
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    • v.45 no.6
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    • pp.903-910
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    • 2016
  • In this study, the expression level of estrogen receptor in an ovariectomized rat model was effectively enhanced by MS-10, Cirsium japonicum and Thymus vulgaris extract complex, in a reversible manner. MS-10 plays a positive role in enhancing estrogen activity at low concentrations, leading to improved women's health. In order to determine whether or not MS-10 improves menopausal symptoms clinically, a randomized, double-blinded, and placebo-controlled clinical study was carried out on 62 middle-aged women treated with 500 mg of MS-10 or placebo daily for 12 weeks. Clinical menopausal symptoms were evaluated by Kupperman's index (KI) detecting various menopausal symptoms, including hot flushes, parenthesis, insomnia, nervousness, melancholia, dizziness, fatigue, rheumatic pain, palpitations, formication, and headaches. Total KI score decreased significantly by about 18% upon ingestion of MS-10. Colpoxerosis, a main symptom of menopause, was significantly reduced by about 21% upon ingestion of MS-10 in contrast to placebo. In addition, reduction of insulin-like growth factor-1 with age was improved by over 10% upon ingestion of MS-10, whereas there were no significant difference with placebo. No side effects appeared after treatment with MS-10. Thus, MS-10 can be suggested as a plausible natural substance for improving women's health.

Clinical Study of Hepatectomy Combined with Jianpi Huayu Therapy for Hepatocellular Carcinoma

  • Zhong, Chong;Li, Hui-Dong;Liu, Dong-Yang;Xu, Fa-Bin;Wu, Jian;Lin, Xue-Mei;Guo, Rong-Ping
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.14
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    • pp.5951-5957
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    • 2014
  • Background: Traditional Chinese Medicine (TCM) possesses several advantages for treating patients with hepatocellular carcinoma (HCC). The theory of 'Jianpi Huayu Therapy' rooted from 'Jin Kui Yao Lue'is one of the most important therapies in this respect. This study was conducted to investigate the clinical effect and safety of hepatectomy combining with 'Jianpi Huayu Therapy' in the treatment of HCC. Materials and Methods: One hundred and twenty patients with HCC were randomized allocated into hepatectomy combined with 'Jianpi Huayu Therapy' group (treatment group, n=60) and hepatectomy alone group (control group, n=60). Disease- free survival (DFS) and overall survival (OS) were the primary end-points. Liver function at the end of one week after surgery, complications, average days of hospitalization as well as performance status (PS) at the end of one month post operation were also compared. Results: No significant differences existed between two groups on baseline analysis (p>0.05). No treatment related mortality occurred in either group. Post-operative complications were detected among 14 patients (23.3%) in the treatment group, and 12 (20.0%) in the control group (p=0.658). Alanine aminotransferase (ALT) at the end of one week after operation was lower in the treatment than control groups (p=0.042). No significant differences in other indexes of liver function were discovered between two groups. Average days of hospitalization reduced by 0.9 day in treatment group than in control (p=0.034). During follow-up, 104 patients (86.6%) developed recurrence. The rates of 1-, 3-, and 5-year DFS and median DFS for all patients were 77.4%, 26.3%, 9.0% and 25.6 months (range, 6.0~68.0), respectively (78.2%, 29.2%, 14.3% and 28.7 months for the 48 patients in the treatment group and 75.0%, 23.3%, 6.4%, and 22.6 months for the 56 patients in the control group (p=0.045)). 101 patients had died at the time of censor, with 1-, 3-, and 5-year overall survival rates and median survival for all patients of 97.5%, 76.4%, 40.5% and 51.2 months (range, 10.0~72.0), respectively (98.3%, 78.0%, 43.6% and 52.6 months, for treatment and 96.7%, 74.7%, 37.4%, and 49.8 months, for controls, respectively (p=0.048)). Conclusions: Hepatectomy combined with 'Jianpi Huayu therapy'was effective in the treatment of HCC, and reduced post-operative recurrence and metastasis and improved DFS and OS of HCC patients.