• Title/Summary/Keyword: Long-term clinical efficacy

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Safety and antifatigue effect of Korean Red Ginseng: a randomized, double-blind, and placebo-controlled clinical trial

  • Zhang, Li;Chen, Xiaoyun;Cheng, Yanqi;Chen, Qilong;Tan, Hongsheng;Son, Dongwook;Chang, Dongpill;Bian, Zhaoxiang;Fang, Hong;Xu, Hongxi
    • Journal of Ginseng Research
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    • v.43 no.4
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    • pp.676-683
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    • 2019
  • Background: Korean Red Ginseng (KRG) is widely used for strengthening the immune system and fighting fatigue, especially in people with deficiency syndrome. However, there is concern that the long-term application or a high dose of KRG can cause "fireness" (上火 in Chinese) because of its "dryness" (燥性 in Chinese). The aim of this study was to assess the safety and efficacy of a 4-week treatment with KRG in participants with deficiency syndrome. Methods: This was a 4-week, randomized, double-blind, placebo-controlled clinical trial. A total of 180 Chinese participants were randomly allocated to three groups: placebo control group, participants were given a placebo, 3.6 g/d; KRG 1.8 g and 3.6 g groups. The primary outcomes were the changes in fireness and safety evaluation (adverse events, laboratory tests, and electrocardiogram). The secondary outcomes were the efficacy of KRG on fatigue, which include the following: traditional Chinese medicine (TCM) symptom scale and fatigue self-assessment scale. Results: Of the 180 patients, 174 completed the full study. After 4 weeks of KRG treatment, the Fire-heat symptoms score including Excess fire-heat score and Deficient fire-heat score showed no significant change as compared with placebo treatment, and no clinically significant changes in any safety parameter were observed. Based on the TCM syndrome score and fatigue self-assessment score, TCM symptoms and fatigue were greatly improved after treatment with KRG, which showed a dose- and time-dependent effect. The total effective rate was also significantly increased in the KRG groups. Conclusion: Our study revealed that KRG has a potent antifatigue effect without significant adverse effects in people with deficiency syndrome. Although a larger sample size and longer treatment may be required for a more definite conclusion, this clinical trial is the first to disprove the common conception of "fireness" related to KRG.

Substrate reduction therapy as a new treatment option for patients with Gaucher disease type 1: A review of literatures

  • Sohn, Young Bae;Yoo, Han-Wook
    • Journal of Genetic Medicine
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    • v.13 no.2
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    • pp.59-64
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    • 2016
  • Gaucher disease type 1 (GD1) is an inherited lysosomal storage disorder caused by deficiency of acid ${\beta}$-glucosidase. The diminished enzyme activity leads to the accumulation of substrates and results in multi-systemic manifestations including hepatosplenomegaly, anemia, thrombocytopenia, and bone diseases. Enzyme replacement therapy (ERT) by infusion of recombinant protein has been the standard treatment for over 20 years. Despite the successful long-term treatment with ERT, several unmet needs remain in the treatment of GD1 such as severe pulmonary and skeletal manifestations. Substrate reduction therapy (SRT) reduces the accumulation of substrates by inhibiting their biosynthesis. Eliglustat, a new oral SRT, was approved in United States and Europe as a first-line therapy for treating adult patients with GD1 who have compatible CYP2D6 metabolism phenotypes. Although eliglustat is not yet available in Korea, introduction and summary of this new treatment modality are provided in this paper by review of literatures. Despite the fact that there are only limited studies to draw resolute conclusions, the current data demonstrated that eliglustat is not inferior to ERT in terms of its clinical efficacy. The approval of eligustat enables eligible adult GD1 patients to have the option of oral therapy although it still needs further studies on long-term outcomes. The individual patient should be assessed carefully for the choice of treatment modality when eliglustat becomes available in Korea. Furthermore, the clinical guidelines for Korean patients with GD1 regarding the use of eliglustat needs to be developed in near future.

Robotic versus Laparoscopic Gastrectomy for Gastric Carcinoma: a Meta-Analysis of Efficacy and Safety

  • Hu, Li-Dong;Li, Xiao-Fei;Wang, Xiu-Yue;Guo, Tian-Kang
    • Asian Pacific Journal of Cancer Prevention
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    • v.17 no.9
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    • pp.4327-4333
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    • 2016
  • Purpose: To systematically review efficacyand safety of robotic gastrectomy (RG) compared with conventional laparoscopic gastrectomy (LG) for gastric carcinoma. Materials and Methods: A systematic literature search was carried out using PubMed, Cochrane Library, CBM, CNKI, WanFang, VIP and other sources like relevant references to obtain comparative studies assessing the effectiveness and safety between RG and LG published between 2013 and 2016. Then the literature was screened and the data were extracted by 2 independent reviewers. The quality of the literature was assessed, and the data analyzed using Stata/SE 14 software. Fixed effects or random effects models wereapplied according to heterogeneity. Results: A total of 12 non-randomized observational clinical studies involving 3,580 patients were included, of which 1,096 had undergone RG and 2,484 had received LG. The results of the meta-analysis showed in terms of effectiveness, RG was associated with less blood loss, less time to first flatus and greater number of harvested lymph nodes, but there were no significant differences in proximal and distal resection margins, compared with LG. In terms of efficiency, RG was associated with shorter hospital stay, but longer operative time. In terms of safety, there were no statistically significant differences in complications, mortality and conversions between RG and LG. Conclusions: RG can achieve comparable or better short-term and radical effects than LG, with respect to effectiveness, efficiency and safety in treatment of gastric carcinoma. Future studies involving RG should focus on decreasing operative time and reducing cost. Moreover, there is a need for randomized controlled trials comparing the two techniques with long-term follow-up.

Retrospective Analyses of Long-Term Use of SSRI in Children and Adolescents with Autism Spectrum Disorder (소아청소년 자폐성 스펙트럼 장애에서 SSRI 장기 사용에 대한 후향적 분석)

  • Goo, Ae-Jin;Park, Jin-Park;Lee, Jong-Il;Jhin, Hye-Kyung;Kim, Yeni
    • Korean Journal of Biological Psychiatry
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    • v.19 no.4
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    • pp.205-210
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    • 2012
  • Objectives The purpose of this study was to investigate clinical profile, efficacy, and safety of long-term treatment with selective serotonin reuptake inhibitors (SSRIs) in Korean autism spectrum disorders (ASDs) patients. Methods Effectiveness was assessed through a retrospective review of self-reported target symptom improvement at the last follow-up visit. Changes in illness severity and improvement were measured using the Clinical Global Impression-Severity (CGI-S) of illness and Clinical Global Impression-Improvement (CGI-I) Scales. Tolerability was assessed through a review of the reason for discontinuation of SSRI and documented adverse events. Results A total of 21 ASDs patients (aged 9 to 19 years) treated with SSRI during July 2010 to July 2011 in department of child and adolescent psychiatry of Seoul National Hospital were identified. The mean duration of SSRI treatment was 47.9 (standard deviation = 36.9) months (range 0.7-114.5), and the mean fluoxetine equivalent dosage of SSRIs was $27.1{\pm}10.8$ mg. Nineteen (90.5%) patients were using concomitant medication. We found that SSRIs were prescribed for symptoms of agitation, stereotyped behavior, aggression, depression, impulsivity and self-injury in ASDs. Ten patients (47.6%) reported improvement in their target symptom after SSRI treatment based on CGI-I scores (CGI-I ${\leq}$ 2). The side effects were reported in 5 patients (23.8%) ; vomiting (n = 2, 9.5%), excessive mood elevation (n = 1, 4.8%), insomnia (n = 1, 4.8%), somnolence (n = 1, 4.8%) and decreased appetite (n = 1, 4.8%). Self-injurious behavior was reported in one patient (4.8%). Conclusions The results of this study suggest that SSRIs may be used effectively in children and adolescents diagnosed with ASDs. However, safety issues need to be considered carefully when choosing SSRIs for treatment. Future controlled trials are needed to confirm these findings.

Relationships between Fatigue, Sleep Disturbance, Stress, Self-efficacy and Depression in Hemodialysis Patients (혈액투석환자의 피로와 수면장애, 스트레스, 자기효능감 및 우울 관계)

  • Seo, Nam Sook;Kang, Seung Ja;Kim, Jae Hee;Kim, Sea Ja
    • Journal of Korean Clinical Nursing Research
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    • v.19 no.2
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    • pp.285-297
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    • 2013
  • Purpose: This study was conducted to investigate the differences in sleep disturbance, stress, self-efficacy and depression by fatigue level and to identify the factors influencing fatigue in hemodialysis patients. Methods: This study used a cross-sectional design and the subjects were 195 patients undergoing hemodialysis in a local unit. Data were collected using a structured questionnaire and medical records from June to August 2012. The data were analyzed using descriptive statistics, independent t-test, one way ANOVA, $Scheff{\grave{e}}$ test, and Pearson's correlation coefficients. Also a multiple regression analysis was used to assess the independent association between fatigue status and indices of sleep disturbance, stress, self-efficacy and depression. Results: A total of 99 (50.8%) subjects experienced a high level of fatigue and 96 (49.2%) experienced a low level of fatigue. There were significant differences in the levels of sleep disturbance, stress, self-efficacy and depression between the two groups. Fatigue was significantly correlated to sleep disturbance, stress, self-efficacy and depression. The most important factor related to fatigue was stress, followed by sleep disturbance. These factors explained about 37% of fatigue of the respondents. Conclusion: The results of this study showed that sleep disturbance and stress were significant predictors of fatigue in hemodialysis patients. Possible interventions for minimizing fatigue in patients undergoing long-term hemodialysis should be aimed to manage the known contributing factors.

A Research on 7 Cases of the Treatment Process for Patients with Idiopathic Parkinson's Disease or Parkinsonism (특발성 파킨슨병.파킨슨증후군 환자 7례의 치료경과사례 고찰)

  • Park, Byeong-Jun
    • Journal of Oriental Neuropsychiatry
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    • v.20 no.3
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    • pp.283-295
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    • 2009
  • Objectives : Parkinson's disease is a chronic neuron-degenerative disease. The medication of dopamine, one of the most common treatment for the disease, has effects of improving the symptom, but when taken for a long term, the medicine brings about side-effects such as the phenomenon of medicinal efficacy disappearance and dyskinesia. In addition, it doesn't have any effects in slowing down or stopping the development of Parkinson's disease. Methods : Accordingly, this study aims to investigate the clinical cases to stop or improve the development of Parkinson's disease by carrying out an independent treatment with Oriental medicine and a combined treatment with Western and Oriental medicines respectively for over 6 months. Results and Conclusions : The results of the study is expected to be an important precedent for the treatment of neuron-degenerative diseases of cranial nerve including Parkinson's disease in the future.

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Endoscopic treatment of vesicoureteral reflux in pediatric patients

  • Kim, Jong Wook;Oh, Mi Mi
    • Clinical and Experimental Pediatrics
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    • v.56 no.4
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    • pp.145-150
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    • 2013
  • Endoscopic treatment is a minimally invasive treatment for managing patients with vesicoureteral reflux (VUR). Although several bulking agents have been used for endoscopic treatment, dextranomer/hyaluronic acid is the only bulking agent currently approved by the U.S. Food and Drug Administration for treating VUR. Endoscopic treatment of VUR has gained great popularity owing to several obvious benefits, including short operative time, short hospital stay, minimal invasiveness, high efficacy, low complication rate, and reduced cost. Initially, the success rates of endoscopic treatment have been lower than that of open antireflux surgery. However, because injection techniques have been developed, a recent study showed higher success rates of endoscopic treatment than open surgery in the treatment of patients with intermediate- and high-grade VUR. Despite the controversy surrounding its effectiveness, endoscopic treatment is considered a valuable treatment option and viable alternative to long-term antibiotic prophylaxis.

New platinum-complex compounds with reduced nephrotoxicity discovered in long term histoculture of human renal cortex

  • Chang, S-G.;Jung, J.C.;Rho, Y.S.;Kwon, D.U.;Hoffman, R.M.
    • Proceedings of the Korean Society of Applied Pharmacology
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    • 1995.04a
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    • pp.124-124
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    • 1995
  • Cisplatinum is often effective in cancer treatment, but potent nephrotoxicity limits its clinical use. We have, therefore, developed new anticancer drugs that contain platinum. We have synthesized six new platinum compounds based on Figure 1. Drugs were initially administrated at 5${\times}$10$\^$-4/M with 48 hours exposure in monolayer cultures of primary rabbit proximal tubular cells and human renal cortical cells with the M.T.T. endpoint to measure toxicity. Drug concentrations of 10$\^$-3/M, 10$\^$-4/M, and 10$\^$-5/M with 72 hours exposure were used for human renal cortical tissues in 7 weeks histoculture with toxicity measured by the glucose-consumption endpoint. From these studies, we determined that the new platinum drugs have lower nephrotoxicity than cisplatinum. Drugs D, E, and H. have lower nephrotoxicity than the other new drugs. We are currently measuring the anticancer efficacy of drugs D, E, and H.

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Practice for preterm patent ductus arteriosus; focusing on the hemodynamic significance and the impact on the neonatal outcomes

  • Lee, Jin A
    • Clinical and Experimental Pediatrics
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    • v.62 no.7
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    • pp.245-251
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    • 2019
  • Hemodynamically significant preterm patent ductus arteriosus (PDA) affects mortality; comorbidities such as necrotizing enterocolitis, intraventricular hemorrhage, and bronchopulmonary dysplasia; and adverse long-term neurodevelopmental outcomes in preterm infants, particularly in very low birth weight infants. However, recent studies have indicated that there is no consensus on the causal relationship between PDA and neonatal outcomes, the benefit of PDA treatment, the factors guiding the need for treatment, and optimal treatment strategies. Such uncertainty has resulted in wide variations in practice for treating preterm PDA between units, regions, and nations. Nowadays, there has been a paradigm shift to more conservative treatment for preterm PDA, and suggestions regarding selective management of preterm PDA considering risk factors and hemodynamic significance are increasing. Neonatologist-performed echocardiography and advances in modalities to assess hemodynamic significance such as biologic markers and near-infrared spectroscopy also help improve the efficacy of selective treatment of preterm PDA.

Home mechanical ventilation in children with chronic respiratory failure: a narrative review

  • Soyoung Kwak
    • Journal of Yeungnam Medical Science
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    • v.40 no.2
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    • pp.123-135
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    • 2023
  • Advances in perinatal and pediatric intensive care and recent advances in mechanical ventilation during the last two decades have resulted in an exponential increase in the number of children undergoing home mechanical ventilation (HMV) treatment. Although its efficacy in chronic respiratory failure is well established, HMV in children is more complex than that in adults, and there are more considerations. This review outlines clinical considerations for HMV in children. The goal of HMV in children is not only to correct alveolar hypoventilation but also to maximize development as much as possible. The modes of ventilation and ventilator settings, including ventilation masks, tubing, circuits, humidification, and ventilator parameters, should be tailored to the patient's individual characteristics. To ensure effective HMV, education for the parent and caregiver is important. HMV continues to change the scope of treatment for chronic respiratory failure in children in that it decreases respiratory morbidity and prolongs life spans. Further studies on this topic with larger scale and systemic approach are required to ensure the better outcomes in this population.