• Clinical and Experimental Pediatrics
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• 제58권4호
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• pp.129-135
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• 2015

Purpose: This study investigated the long-term clinical outcomes of patients with $p22^{phox}$-deficient chronic granulomatous disease (CGD) on Jeju Island and retrospectively evaluated the effects of interferon-gamma (IFN-${\gamma}$) prophylaxis. Methods: The medical records of 15 patients with CGD were retrospectively reviewed. The efficacy of IFN-${\gamma}$ prophylaxis was evaluated by comparing the frequency of severe infections before and after starting continuous prophylaxis with IFN-${\gamma}$. Results: At the time of the analysis, 14 patients were alive, with a median age of 14.3 years. The diagnosis of CGD was made at a median age of 2.4 years, and the median age at onset of severe infection was 0.3 years. Thirteen of the 15 patients had their first severe infection within the first year of life. The overall incidence of severe infection was 1.36 infections per patient-year; pneumonia, suppurative lymphadenitis, and skin and subcutaneous abscesses were the most common infections. Aspergillus species were the most frequently isolated microorganisms, present in 15.8% of isolates. IFN-${\gamma}$ did not significantly change the rate of severe infection. The survival rate for patients after 2 years of age was 93%; there was a prolonged survival plateau beyond the age of 2. Conclusion: Compared with cases of X-linked CGD reported in other studies, patients with CGD on Jeju Island did not show obviously different clinical manifestations, but they had a significantly higher survival rate. Further studies with a substantially longer period of observation, and with more patients under intensive surveillance are necessary to elucidate the prophylactic efficiency of IFN-${\gamma}$.

• Asian Pacific Journal of Cancer Prevention
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• 제15권20호
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• pp.8987-8992
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• 2014

Background: The efficacy of concurrent chemoradiotherapy in the treatment of locally advanced cervical cancer is well established. We aimed to investigate the long-term efficacy of definitive concurrent chemoradiotherapy for cervical cancer in the University of Malaya Medical Centre. Materials and Methods: A cohort of 60 patients with FIGO stage IB2-IVA cervical cancer who were treated with definitive concurrent chemoradiotherapy with cisplatin followed by intracavitary brachytherapy or external beam radiotherapy (EBRT) boost between November 2001 and May 2008 were analysed. Patients were initially treated with weekly intravenous cisplatin ($40mg/m^2$) concurrent with daily EBRT to pelvis of 45-50Gy followed by low dose rate brachytherapy or EBRT boost to tumour. Local control rate, progression free survival, overall survival and treatment related toxicities graded by the RTOG criteria were evaluated. Results: The mean age was 56. At the median follow-up of 72 months, the estimated 5-year progression-free survival (PFS) (median PFS 39 months) and the 5-year overall survival (OS) (median OS 51 months) were 48% and 50% respectively. The 5-year local control rate was 67.3%. Grade 3-4 late gastrointestinal and genitourinary toxicity occurred in 9.3% of patients. Conclusions: The 5-year PFS and the 5-year OS in this cohort were lower than in other institutions. More advanced stage at presentation, longer overall treatment time (OTT) of more than fifty-six days and lower total dose to point A were the potential factors contributing to a lower survival.

• International Journal of Stem Cells
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• 제16권1호
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• pp.16-26
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• 2023

Despite long-term research achievements, the development of cell therapy (CT) products remains challenging. This is because the risks experienced by the subject and therapeutic effects in the clinical trial stage are unclear due to the various uncertainties of CT when administered to humans. Nevertheless, as autologous cell products for systemic administration have recently been approved for marketing, CT product development is accelerating, particularly in the field of unmet medical needs. The human experience of CT remains insufficient compared with other classes of pharmaceuticals, while there are countless products for clinical development. Therefore, for many sponsors, understanding the rationale of human application of an investigational product based on the consensus and improving the ability to apply it appropriately for CT are necessary. Thus, defining the level of evidence for safety and efficacy fundamentally required for initiating the clinical development and preparing it using a reliable method for CT. Furthermore, the expertise should be strengthened in the design of the first-in-human trial, such as the starting dose and dose-escalation plan, based on a sufficiently acceptable rationale. Cultivating development professionals with these skills will increase the opportunity for more candidates to enter the clinical development phase.

• 지역사회간호학회지
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• 제20권3호
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• pp.307-315
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• 2009

Purpose: This study was done to assess the effects of a self-help intervention on clinical, lifestyle and psycho-social outcomes in patients with Type II diabetes. Methods: Eligible adults with Type II diabetes were randomly assigned to either the intervention group receiving the diabetes self-help or the control group receiving usual care. Of the 36 patients who completed the study, 15 were in the intervention group and 21 were in the control group. The self-help group consisted of six weekly sessions covering aspects of diabetes self-care and using continuing education, discussion, and structured social activities. Outcomes included changes in glycemic control, knowledge, self-management behaviors, diabetes-related self-efficacy, and health-related quality of life. Analysis of covariance was used to compare outcomes between the groups, adjusting for baseline measures. Results: After the six week intervention, significant improvements from the baseline were observed in the measurements of self-management behaviors, diabetes-related self-efficacy, and health-related quality of life for the intervention group. Conclusion: The findings provide preliminary evidence that a diabetes self-help group intervention can benefit diabetes patients in self-management behaviors, diabetes-related self-efficacy, and health-related quality of life. However, larger longitudinal studies are needed to determine the most efficacious self-management methods to sustain long-term glycemic control and psychological well-being.

• Journal of Acupuncture Research
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• 제33권1호
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• pp.79-93
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• 2016

Objectives : The purpose of this study is to explore research trends in gold implantation therapy performed on the animal and human body, through a review of clinical studies focused on gold thread, gold needle and gold bead. Methods : Medical databases, including Pubmed, CENTRAL, MEDLINE, EMBASE, RISS4u, KISTI, OASIS and KTKP, were searched for relevant articles published from their launch to December 31, 2015 using the key word 'gold' with '$thread^*$', '$needle^*$', '$acupuncture^*$', '$wire^*$', '$bead^*$', '$embed^*$', '$implant^*$', or '$insert^*$'. The results were classified into in vivo studies, clinical trials and clinical reports. Analysis of the results was conducted in several research areas, from the identity of studies such as nationality and published year, to the gold preparations-features and implanted locations and to the outcomes that reflect the clinically favorable or adverse effect of gold implantation therapy. Results : A total of 30 studies including 11 in vivo studies, 4 clinical trials and 15 case reports, were found in the search. We observed certain research trends according to the research time, nationality and target indication of the studies. The studies primarily revealed a chronic local inflammatory response which could be a useful mechanism for pain-relief in musculoskeletal diseases and facial rejuvenation. Researches concerning long-term reactions or adverse effects were rare. Conclusion : The results show that the efforts to discover the level of clinical efficacy of gold implantation therapy were steady and worldwide. However, further researches on the longterm effect, and more importantly, the safety of gold implantation therapy are required.

• The Korean Journal of Pain
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• 제30권4호
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• pp.296-303
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• 2017

Background: To achieve a prolonged therapeutic effect in patients with lumbar facet joint syndrome, radiofrequency medial branch neurotomy (RF-MB) is commonly performed. The purpose of this study was to evaluate the prognostic value of paravertebral muscle twitching when performing RF-MB in patients with lumbar facet joint syndrome. Methods: We collected and analyzed data from 68 patients with confirmed facet joint syndrome. Sensory stimulation was performed at 50 Hz with a 0.5 V cut-off value. Patients were divided into 3 groups according to the twitching of the paravertebral muscle during 2 Hz motor stimulation: 'Complete', when twitching was observed at all needles; 'Partial', when twitching was present at 1 or 2 needles; and 'None', when no twitching was observed. The relationship between the long-term effects of RF-MB and paravertebral muscle twitching was analyzed. Results: The mean effect duration of RF-MB was 4.6, 5.8, and 7.0 months in the None, Partial, and Complete groups, respectively (P = 0.47). Although the mean effect duration of RF-MB did not increase significantly in proportion to the paravertebral muscle twitching, the Complete group had prolonged effect duration (> 6 months) than the None group in subgroup analysis. (P = 0.03). Conclusions: Paravertebral muscle twitching while performing lumbar RF-MB may be a reliable predictor of long-term efficacy when sensory provocation under 0.5 V is achieved. However, further investigation may be necessary for clarifying its clinical significance.

• 한국치위생학회지
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• 제20권5호
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• pp.753-762
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• 2020

Objectives: This study was aimed at evaluating the effects of changes in the oral environment of the elderly in long-term care facilities after the intake of Weissella cibaria. Methods: The test group ingested the W. cibaria strain Chonnam Medical University (CMU), and the control group ingested the control food. Of all randomized trial subjects, 62 were analyzed (32 in the experimental group and 30 in the control group). In this 8-week demographic study, we evaluated self-perceived halitosis, changes in halitosis, sensory test results, tongue plaque index scores, saliva buffering capacity, and the salivary flow rate. Results: The W. cibaria CMU intake in the elderly in long-term care facilities during the experimental period did not demonstrate statistically significant changes in the salivary flow rate. However, self-perceived halitosis, organoleptic test results, tongue plaque index scores, and salivary buffering capacity demonstrated statistically significant differences between the experimental and control groups. These findings partially confirmed the beneficial effects of the W. cibaria CMU on the oral environment in the elderly. Conclusions: Research results on the role of probiotics in the oral cavity should be summarized, and utilization plans should be sought to obtain a clearer understanding of the clinical efficacy and related factors. The value of probiotic use may be high in improving the oral health of people by enabling treatment and prevention.

• Archives of Plastic Surgery
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• 제38권4호
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• pp.401-407
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• 2011

Purpose: A number of flap for nipple reconstruction have been well described in the literature. However, most of these techniques do not permit the reconstruction of a projecting nipple and all are hampered to some extent by long-term loss of nipple projection. The objective of this study is to evaluate the long-term result and clinical efficacy of nipple reconstruction using skate flap technique after breast reconstruction. Methods: A retrospective chart review was carried out on 23 patients who underwent 25 nipple reconstructions. In those patients with greater than 10 mm nipple projection, reconstruction with skate flap and full-thickness skin graft and/or tattooing was performed. Maintenance of nipple projection was then carefully assessed over one-year follow-up. The following factors were analyzed: type of breast reconstruction, type of areola reconstruction, followup period, decrease in nipple projection, complication, and whether secondary nipple reconstruction was necessary and/or performed. Results: Breast reconstructions were performed in 17 patients with free transverse rectus abdominis musculocutaneous flap, 3 patients with extended latissimus dorsi musculocutaneous flap, and 3 patients with expander and implant. The mean follow-up after nipple reconstruction was 17 months. Mean loss of projection were $17.0{\pm}13.99%$, $25.0{\pm}12.70%$, $30.0{\pm}12.57%$ and $30.8{\pm}12.49%$ at 3, 6, 9 months and over one year, respectively. The greatest decrease in projection was noted in the first 3 months following surgery. Conclusion: These results indicated that nipple reconstruction with skate flap showed about 70 percent of the projection achieved over one year postoperation. Therefore, the skate flap may be a reliable method of nipple reconstruction in those patients with greater than 10 mm nipple projection.

• Journal of Ginseng Research
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• 제43권4호
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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.

• Journal of Genetic Medicine
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• 제13권2호
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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.