• 대한두개안면성형외과학회지
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• 제23권4호
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• pp.152-162
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• 2022

Background: The efficacy and safety of equine cartilage as a competent xenograft material for rhinoplasty were evaluated and compared to the outcomes of rhinoplasty using silicone implants. Methods: We performed a multicenter, double-blind, non-inferiority, and randomized confirmatory study. Fifty-six patients were randomized 1:1 to the study group (using MegaCartilage-E) and control group (using silicone implants). The Rhinoplasty Outcome Evaluation (ROE) score, photo documentation, Global Aesthetic Improvement Scale (GAIS), and adverse event data were obtained until 12 months after surgery. The primary efficacy, which is the change in ROE score 6 months after surgery, was assessed in the modified intention-to-treat set. The secondary efficacy was evaluated in the per-protocol set by assessing the change in ROE score 6 and 12 months after surgery and nasofrontal angle, the height of the nasion, and GAIS 1, 6, and 12 months after surgery. Results: The change in ROE score of the study group was non-inferior to that of the control group; it increased by 24.26±17.24 in the study group and 18.27±17.60 in the control group (p= 0.213). In both groups, all secondary outcome measures increased, but there was no statistical difference. In the safety set, treatment-emergent adverse events occurred in 10 patients (35.71%) in the study group and six patients (21.43%) in the control group (p= 0.237). There were 13 adverse device events in the study group and six adverse device events in the control group (p= 0.515). Conclusion: Processed equine cartilage can be used effectively and safely as xenograft material for rhinoplasty.

• Korean Journal of Radiology
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• 제22권4호
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• pp.584-595
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• 2021

Objective: Immune checkpoint inhibitor (ICI) therapy has shown activity against melanoma brain metastases. Recently, promising results have also been reported for ICI combination therapy and ICI combined with radiotherapy. We aimed to evaluate radiologic response and adverse event rates of these therapeutic options by a systematic review and meta-analysis. Materials and Methods: A systematic literature search of Ovid-MEDLINE and EMBASE was performed up to October 12, 2019 and included studies evaluating the intracranial objective response rates (ORRs) and/or disease control rates (DCRs) of ICI with or without radiotherapy for treating melanoma brain metastases. We also evaluated safety-associated outcomes. Results: Eleven studies with 14 cohorts (3 with ICI combination therapy; 5 with ICI combined with radiotherapy; 6 with ICI monotherapy) were included. ICI combination therapy {pooled ORR, 53% (95% confidence interval [CI], 44-61%); DCR, 57% (95% CI, 49-66%)} and ICI combined with radiotherapy (pooled ORR, 42% [95% CI, 31-54%]; DCR, 85% [95% CI, 63-95%]) showed higher local efficacy compared to ICI monotherapy (pooled ORR, 15% [95% CI, 11-20%]; DCR, 26% [95% CI, 21-32%]). The grade 3 or 4 adverse event rate was significantly higher with ICI combination therapy (60%; 95% CI, 52-67%) compared to ICI monotherapy (11%; 95% CI, 8-17%) and ICI combined with radiotherapy (4%; 95% CI, 1-19%). Grade 3 or 4 central nervous system (CNS)-related adverse event rates were not different (9% in ICI combination therapy; 8% in ICI combined with radiotherapy; 5% in ICI monotherapy). Conclusion: ICI combination therapy or ICI combined with radiotherapy showed better local efficacy than ICI monotherapy for treating melanoma brain metastasis. The grade 3 or 4 adverse event rate was highest with ICI combination therapy, and the CNS-related grade 3 or 4 event rate was similar. Prospective trials will be necessary to compare the efficacy of ICI combination therapy and ICI combined with radiotherapy.

• Pediatric Infection and Vaccine
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• 제16권2호
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• pp.183-190
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• 2009

목 적: 본 연구에서는 일본뇌염 백신의 종류별 이상반응 발생실태를 조사하여 일본뇌염 백신의 안전성에 대한 평가를 통해 향후 일본뇌염 국가예방접종사업의 효율화를 위한 토대를 제공하고자 하였다. 방 법: 2006년 8월부터 2007년 2월까지 본 연구에 협력하기로 한 일개 대도시 지역의 보건소 4개소와 소아과 의원 9개소에서 실시되었다. 총 658명의 어린이를 대상으로 이상반응 평가가 완료되었다. 이들 어린이들을 대상으로 예방접종 당일부터 4일후까지 발적, 동통, 발열, 두통 등 상대적으로 흔한이상반응의 발생빈도 등을 전향적으로 추적 관찰하였다. 결과: 대상 소아의 평균 연령은 사백신이 1.4세(1-8.5), 생백신이 1.7세(1-8.3)였다. 그 중 보건소에서 사백신을 접종받았던 어린이는 425명(64.6%)이었으며 소아과 의원에서 생백신을 접종받은 경우는 233명(35.4%)이었다. 사백신의 경우 전체 접종 어린이 중 3.3%인 14명이 한 가지 이상의 국소 이상 반응이 나타났으며, 생백신 접종 어린이들의 2.6%가 한 가지이상의 국소 이상반응을 호소하였다. 이러한 차이는 통계적으로 유의한 수준은 아니었다(P =.607). 발열 등의 전신반응의 경우 사백신과 생백신 접종 어린이들의 각각 5.2%와 8.2%에서 나타났으나 역시 유의한 수준의 차이는 아니었다(P =.131). 사백신 접종 어린이들에서는 접종당일 발적이 4명(0.9%), 종창이 2명(0.7%), 동통이 7명(1.7%), 발열이 2명(0.5%) 나타났다. 반면 생백신 접종 어린이들의 경우 각각 4명(1.8%), 2명 (0.9%), 0명(0.0%), 6명(2.6%)에서 해당 증상을 호소하였다. 발열의 경우 통계적으로 유의하게 생백신 접종 어린이들에서 빈번하였다(P=.026). 발적, 종창, 동통, 발열 중 한 가지 이상 나타난 어린이들의 백분율은 사백신과 생백신 접종자들의 각각 3.3%와 5.2%였으며, 이는 유의한 수준의 차이는 아니었다(P =.243). 접종 1, 2, 3, 4일 후 주요 국소 및 전신 이상반응 발생빈도는 사백신과 생백신에서 유의한 차이를 보이지는 않았다. 이상반응의 세부 항목 중에서는 설사 증상만이 생백신접종 어린이들에서 유의하게 많이 나타났다(P =.044). 결 론 : 본 연구에서는 일본뇌염백신의 이상반응 발생률이 이전의 보고보다 낮았고, 접종 당일 사백신 접종자들에 비해 생백신 접종자들에서 발열이 빈번하게 관찰되었다. 그 외 사백신과 생백신의 이상반응 발생에 뚜렷한 차이가 없었다. 그러나 사백신의 경우 향후 더 많은 수의 인구 표본을 대상으로 안전성에 대한 전향적 연구가 필요하며, 생백신의 경우 안전성에 대한 객관적 경험이 더 축적되어야 할 것으로 생각된다. 아울러 가장 문제가 되고 있는 중증이상반응의 발생을 확인하기 위해서는 대규모 표본을 대상으로 지속적인 감시활동이 필요할 것으로 사료된다.

• 대한안과학회지
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• 제60권2호
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• pp.144-151
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• 2019

목적: 당뇨황반부종 환자에서 항혈관성장인자의 유리체내주입술의 유효성과 안전성을 알아보고자 하였다. 대상과 방법: 연구목적에 부합하는 최근의 고품질의 체계적인 검토를 선정하였고, 선정된 문헌 고찰에 7건의 최근 수행된 무작위 임상시험을 추가하여 메타분석 및 네트워크 메타분석을 시행하였다. 유효성 결과 지표로는 1) 시력의 평균 향상, 2) 15글자 이상의 최대교정시력 개선을 경험한 환자의 비율, 3) 15글자 이상의 최대교정시력 저하를 경험한 환자의 비율을 파악하였고, 안전성 결과에는 전신이상 반응 및 안구 관련 이상 반응을 분석하였다. 결과: 라니비주맙과 베바시주맙의 교정시력의 평균 차이는 0.16 (95% confidence interval [CI]: -0.02, 0.345)이었고, 라니비주맙 대 애플리버셉트의 평균시력 차이는 -0.08 (95% CI: -0.26, 0.10)이었다. 치료 전후의 시력변화를 약제 간의 비교한 최대교정시력 변화지표에서 라니비주맙(-0.20; 95% CI: -0.40, -0.01)과 베바시주맙(-0.34; 95% CI: -0.53, -0.14)이 각각 애플리버셉트에 비해 효과가 낮은 것으로 나타났다. 전신 및 안구 부작용에서 약제 간에 유의한 차이가 없었다. 결론: 당뇨황반부종에서 애플리버셉트는 라니비주맙 또는 베바시주맙에 비하여 최대교정시력의 변화에 있어서 보다 효과적인 것으로 나타났다. 그러나 15글자 이상의 시력향상이나 시력저하에 있어서는 세 가지 약제에서 유의한 차이를 보이지 않았다. 항혈관성장인자의 안전성은 약제 간에 유의한 차이를 보이지 않았다.

• Environmental Analysis Health and Toxicology
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• 제30권
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• pp.11.1-11.19
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• 2015

Objectives The objective of this study was to conduct a systematic review to provide summarized evidence on the association between maternal exposure to particulate air pollution and birth weight (BW) and preterm birth (PTB) after taking into consideration the potential confounding effect of maternal smoking. Methods We systematically searched all published cohort and case-control studies examining BW and PTB association with particulate matter (PM, less than or equal to $2.5{\mu}m$ and $10.0{\mu}m$ in diameter, $PM_{2.5}$ and $PM_{10}$, respectively) from PubMed and Web of Science, from January 1980 to April 2015. We extracted coefficients for continuous BW and odds ratio (OR) for PTB from each individual study, and meta-analysis was used to combine the coefficient and OR of individual studies. The methodological quality of individual study was assessed using a standard protocol proposed by Downs and Black. Forty-four studies met the inclusion criteria. Results In random effects meta-analyses, BW as a continuous outcome was negatively associated with $10{\mu}g/m^3$ increase in $PM_{10}$ (-10.31 g; 95% confidence interval [CI], -13.57 to -3.13 g; I-squared=0%, p=0.947) and $PM_{2.5}$ (-22.17 g; 95% CI, -37.93 to -6.41 g; Isquared=92.3%, p<0.001) exposure during entire pregnancy, adjusted for maternal smoking. A significantly increased risk of PTB per $10{\mu}g/m^3$ increase in $PM_{10}$ (OR, 1.23; 95% CI, 1.04 to 1.41; I-squared=0%, p=0.977) and $PM_{2.5}$ (OR, 1.14; 95% CI, 1.06 to 1.22; I-squared=92.5%, p<0.001) exposure during entire pregnancy was observed. Effect size of change in BW per $10{\mu}g/m^3$ increase in PM tended to report stronger associations after adjustment for maternal smoking. Conclusions While this systematic review supports an adverse impact of maternal exposure to particulate air pollution on birth outcomes, variation in effects by exposure period and sources of heterogeneity between studies should be further explored.

• Asian Pacific Journal of Cancer Prevention
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• 제14권5호
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• pp.3337-3343
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• 2013

This systematic review was conducted to assess the efficacy and safety of bisphosphonates for prevention and treatment of osteopenia or osteoporosis in men with non-metastatic prostate cancer receiving androgendeprivation therapy. We searched for randomised controlled trials (RCTs) of bisphosphonates compared with placebo from Pubmed, Embase, the Cochrane Library, and ISI - Science Citation Index. Meta-analyses of prespecified outcomes (bone mineral density, fractures, and adverse events) were performed using Review Manager. Ten RCTs with a total patient population of 1,017 were identified. There was generally more improvement in bone mineral density of the lumbar spine for patients who received bisphosphonate treatment than placebo or other medical treatment at 12 months (WMD 6.02,95%CI 5.39 to 6.65). Similar effects were also observed for total hip, trochanter or femoral neck bone mineral density. However, there was no significant reduction in fractures. Fever and gastrointestinal symptoms were the most common adverse events (10.4% vs. 1.2%; 0.10% vs. 0.03%). Currently, our meta-analysis suggested that oral and intravenous bisphosphonates caused a rapid increase in spine and hip or femoral BMD in non-metastatic prostate cancer patients receiving androgen-deprivation therapy. Fever and gastrointestinal symptoms were common with the use of bisphosphonates. These short-term trials (maximum of 12 months) did not show fracture reduction. In future, more efficient performance of higher quality, more rigorous, large sample, long-term randomised controlled trials (>12 months) are needed where outcomes are detailed.

• 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.

• Pediatric Gastroenterology, Hepatology & Nutrition
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• 제17권2호
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• pp.104-111
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• 2014

Purpose: To evaluate safety, gastrointestinal tolerance, and growth of a new experimental starter formula (NESF) fortified with lutein, prebiotics, probiotics, nucleotides and beta-carotene, fed to infants within the first months of life. Methods: This was a non-randomized, open, uncontrolled study conducted from December 2010 to May 2011. Twenty-three healthy infants aged 10 days to 2 months old were enrolled. Outcomes included gastrointestinal tolerance, physical growth and safety. Prior to the initiation of the trial, the Scientific Research Institute of Nutrition of the Russian Academy of Medical Sciences confirmed that the NESF met all safety and nutritional parameters. Results: NESF was well tolerated. The majority of infants fed this formula passed semi-liquid, yellow or yellow-brown. The mean stool frequency/day was $2.5{\pm}0.4$ on study-day 14 and $1.8{\pm}0.5$ on study-day 28. The mean daily weight gain was $30.9{\pm}3.8$ grams and the mean length gain during the 28 days of follow up was $3.1{\pm}0.8cm$, corresponding to the average physical growth normally seen in the first months of life in Russian infants. Six children left the study: one refused to drink the formula, one left the study as parents changed residence; and one child's parents have recalled their informed consent due to adverse event unrelated to the product. Three infants presented adverse events possibly related to the product (rash; colic and abdominal pain; constipation). Seventeen infants completed the trial. Conclusion: This study demonstrated that lutein-fortified formula is safe, well-tolerated and supported physical growth of evaluated infants.

• Maxillofacial Plastic and Reconstructive Surgery
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• 제23권5호
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• pp.428-434
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• 2001

Few topics in operative and perioperative patient management generate more controversy than that of appropriate fluid and electrolyte therapy. especially, controversy has swirled around colloid vs crystalloid therapy and the composition of administered fluids, agreement among clinicians as to what fluid therapy is appropriate, and in what amount, is rare. This controversy likely will be enhanced by Arieff' s provocative article. He described 11 adults and 2 pediatric patients. All developed fatal postoperative pulmonary edema, seemingly caused solely by excessive postoperative fluid administration. From January 1999 to December 1999, we investigated 24 patients, which were operated by orthognathic surgery, about the intraoperative fluid therapy and the associated effect in orthognathic surgery, which is regarded as one of the major surgery of oral and maxillofacial surgery. First, They were devided into two groups, that is one-jaw surgery and two-jaw surgery, and each groups were devided by intraoperative fluid volume of 8ml/kg/hr. Subjective assesment was collected through use of a series of 3 questionnaries. In each questionnaire, a 5-point Liekert scale was used far assessment of following parameters of recovery from anesthesia: headache, dizziness, drowsiness, nausea/vomiting, thirst. The patient completed questionnaire 1 at 4 hour after surgery, questionnaire 2 was completed at 24 hours after surgery, and questionnaire 3 was completed at 48 hours after surgery. This study demonstrated that appropriated perioperative rehydration decreases postoperative adverse outcomes and improved the patient's perception of the postoperative period.

• 대한암한의학회지
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• 제24권2호
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• pp.13-21
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• 2019

Objective : The purpose of this study is to report and observe effects of Traditional Korean Medicine (TKM) on stage IV metastatic breast cancer patient. Method : A right breast cancer patient diagnosed with metastatic lesions on liver, lung, spleen, multiple bones and skin on right breast April 2013. The patient received Herceptin + Docetaxel + Zometa from May 2013 and started to receive TKM since July 2013 to decrease side effects of chemotherapy. From December 2013 to November 2014, she had received Herceptin 18 times more. The clinical outcomes were measured by computed tomography, laboratory findings including tumor markers (CEA, CA15-3), liver function test (AST, ALT), and numeric rating scales (NRS). Results : After 6 years of TKM treatment combined with standard chemotherapy, tumor size was partially decreased in lung, liver, right pleura and spleen. Levels of tumor markers also showed decrease. There were no severe adverse events induced by TKM based on National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE) version 4.0. Conclusion : This case suggests that TKM combined with standard chemotherapy could be a promising method for treating metastatic stage IV breast cancer.