• Title/Summary/Keyword: safety outcomes

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Immune Checkpoint Inhibitor with or without Radiotherapy in Melanoma Patients with Brain Metastases: A Systematic Review and Meta-Analysis

  • Pyeong Hwa Kim;Chong Hyun Suh;Ho Sung Kim;Kyung Won Kim;Dong Yeong Kim;Eudocia Q. Lee;Ayal A. Aizer;Jeffrey P. Guenette;Raymond Y. Huang
    • Korean Journal of Radiology
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    • v.22 no.4
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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.

Indigo Naturalis in Inflammatory Bowel Disease: mechanisms of action and insights from clinical trials

  • Hyeonjin Kim;Soohyun Jeong;Sung Wook Kim;Hyung-Jin Kim;Dae Yong Kim;Tae Han Yook;Gabsik Yang
    • Journal of Pharmacopuncture
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    • v.27 no.2
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    • pp.59-69
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    • 2024
  • This study investigates the therapeutic potential of Indigo Naturalis (IN) in treating a Inflammatory Bowel Disease (IBD). The objective is to comprehensively examine the effects and pharmacological mechanisms of IN on IBD, assessing its potential as an novel treatment for IBD. Analysis of 11 selected papers is conducted to understand the effects of IN, focusing on compounds like indirubin, isatin, indigo, and tryptanthrin. This study evaluates their impact on Disease Activity Index (DAI) score, colon length, mucosal damage, and macrophage infiltration in Dextran Sulfate Sodium (DSS)-induced colitis mice. Additionally, It investigate into the anti-inflammatory mechanisms, including Aryl hydrocarbon Receptor (AhR) pathway activation, Nuclear Factor kappa B (NF-κB)/nod-like receptor family pyrin domain containing 3 (NLRP3)/Interleukin 1 beta (IL-1β) inhibition, and modulation of Toll-like receptor 4 (TLR4)/myeloid differentiation primary response 88 (MYD88)/NF-κB and Mitogen Activated Protein Kinase (MAPK) pathways. Immunomodulatory effects on T helper 17 (Th17)/regulatory T cell (Treg cell) balance and Glycogen synthase kinase-3 beta (GSK3-β) expression are also explored. Furthermore, the study addresses the role of IN in restoring intestinal microbiota diversity, reducing pathogenic bacteria, and increasing beneficial bacteria. The findings reveal that IN, particularly indirubin and indigo, demonstrates significant improvements in DAI score, colon length, mucosal damage, and macrophage infiltration in DSS-induced colitis mice. The anti-inflammatory effects are attributed to the activation of the AhR pathway, inhibition of inflammatory pathways, and modulation of immune responses. These results exhibit the potential of IN in IBD treatment. Notably, the restoration of intestinal microbiota diversity and balance further supports its efficacy. IN emerges as a promising and effective treatment for IBD, demonstrating anti-inflammatory effects and positive outcomes in preclinical studies. However, potential side effects necessitate further investigation for safe therapeutic development. The study underscores the need for future research to explore a broader range of active ingredients in IN to enhance therapeutic efficacy and safety.

Quantitative Analysis of Microbiological Profiles of Retailed White Rice (시판 백미의 미생물학적 프로파일 정량분석)

  • Kim, Min-Ju;Kim, Byung-Hoon;Park, Sung-Soo;Park, Sung-Hee;Kim, Dong-Ho;Kim, Keun-Sung
    • Journal of Food Hygiene and Safety
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    • v.26 no.3
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    • pp.198-202
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    • 2011
  • Rice has been the most important staple food in everyday meals of Korean people for thousands of years. Nowadays, it is getting increasingly used as flour ingredients in a variety of processed foods, so that it is consumed in more diversified ways. As a consequence, production volume of rice flour to manufacture rice cakes, noodles, breads, or confectioneries is recently getting increased in Korea. But there are not sufficient research outcomes to guarantee Korean consumers microbiological qualities of rice flour as well as rice. As a preliminary experiment, therefore, the microbiological profiles (aerobic mesophilic bacteria (AMB), spore-forming aerobic bacteria (SAB), lactic acid bacteria (LAB), yeasts and molds (YM), and Escherichia coli and coliforms) have been monitored for nine retailed white rice samples in this study. AMB counts ranged $10^2-10^6$ CFU/g for all the nine white rice samples. All the nine rice samples have SAB counts within a narrow range $(1.0{\times}10^2-2.5{\times}10^3$ CFU/g). LAB was detected in two white rice samples ($4.0{\times}10^2$ and $3.7{\times}10^3$ CFU/g), YM was detected in one white rice sample ($2.0{\times}10^2$ CFU/g) only. E. coli was not detected from all the nine samples. Coliforms were detected in one white rice sample ($4.1{\times}10$ CFU/g) only. All the rice samples were conclusively considered to have various microorganisms, though most of them are harmless and some, such as coliforms, may be harmful.

Evaluation of the Safety and Feasibility of D2 Lymphadenectomy in Elderly Patients with Gastric Cancer (평균 수명 이상의 고령 위암 환자에서의 D2 림프절 절제술의 안정성)

  • Kang, Woo Sung;Cheong, Oh;Jeong, Mi Ran;Kim, Ho Goon;Ryu, Sung Yeop;Park, Yeong Kyu;Kim, Dong Yi;Kim, Young Jin
    • Journal of Gastric Cancer
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    • v.8 no.2
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    • pp.85-90
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    • 2008
  • Purpose: The aim of this study was to evaluate the safety and feasibility of D2 lymphadenectomy in elderly patients with gastric cancerby comparing the surgical outcomes and postoperative courses between an elderly group and a control group undergoing the same procedure. Materials and Methods: Clinical information was reviewed for 1251 patients with gastric cancer who underwent gastrectomy between May 2004 and May 2007. Patients were classified into the following two groups: an elderly group (older than the average life span in Korea) and a control group (younger than the elderly group). Clinicopathologic features and postoperative courses after D2 lymphadenectomy were reviewed and compared between the two groups. Results: There were a total of 120 (9%) elderly group patients among all those reviewed, and 86 (72.2%) of them underwent D2 lymphadenectomy. There was 27.5% postoperative morbidity in the elderly group, which was significantly different from thecontrol group (12.8%, p=0.003). However, on multivariate analysis, ASA score and combined resection were independent predictive factors of postoperative complications, while age was not predictive. Conclusion: Older age is not a predictive factor of postoperative complications in itself, and D2 lymphadenectomy can be safely performed in elderly patients with gastric cancer, provided they have good ASA scores and do not undergo accompanying combined resection.

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Comparison of Clinical Results of Excimer Laser Correction of Myopia and Compound Myopic Astigmatism Using VISX 20/20B $VisionKey^{TM}$ (VISX 20/20B $VisionKey^{TM}$ 엑시머레이저의 version 4.01 software를 이용한 근시교정술 및 근시성난시교정술의 임상성적 비교)

  • Lee, Sang-Bumm;Bae, Sang-Bok
    • Journal of Yeungnam Medical Science
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    • v.17 no.1
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    • pp.55-65
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    • 2000
  • Purpose: To compare the efficacy, predictability, stability and safety of excimer laser photorefracive keratectomy(PRK) for myopia and photoastigmatic refractive keratectomy(PARK) for compound myopic astigmatism. Methods: Two-hundred and three eyes(l18 eyes < -7D spherical equivalent, 85 eyes ${\geq}$ -7D spherical equivalent) received excimer laser correction for compound myopic astigmatism and 152 eyes(116 eyes < -7D, 36 eyes ${\geq}$ -7D) for simple myopia. A VISX 20/20B $VisionKey^{TM}$ excimer laser was used to perform either PARK or PRK. Visual acuity with and without correction, refraction, IOP, corneal haze, and topography were evaluated at 1, 3, 6, and 12 months postoperatively. All patients were followed up for more than 12 months. Results: Postoperative refraction were generally stable after 3 months without significant early overcorrection. At 12 months, 110(94.8%) eyes that underwent PRK and 104(88.1%) eyes that underwent PARK achieved UCVA of 20/30 or better in the group who had lower than -7D correction. For eyes treated with -7D or more, these figures were 31(86.1%) eyes after PRK and 57(67.1%) eyes after PARK. The incidences of within 1D of plano refraction at 1 year follow-up were 97.4% after PRK and 93.2% after PARK in the group who had lower than -7D correction. For eyes treated with -7D or more, these figures were 80.6% after PRK and 70.6% after PARK. Conclusions Myopia with or without astigmatism was successfully treated in most of the eyes using PRK or PARK with VISX 20/20B $VisionKey^{TM}$ excimer laser. The predictability and stability of the postoperative refraction during the first 12 months seem to be quite reliable. Further improvement of excimer laser system and software should increase the clinical outcomes and safety of refractive procedures.

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Efficacy and Safety of Red Ginseng on Women's Health Related Quality of Life and Sexual Function (여성의 건강관련 삶의 질과 성기능에 대한 홍삼의 효과 및 안전성 연구)

  • Kim, Dong-II;Choi, Min-Sun;Alm, Hong-Yeop
    • Journal of Ginseng Research
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    • v.33 no.2
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    • pp.115-126
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    • 2009
  • To evaluate the efficacy and safety of red ginseng on women's health-related quality of life (QOL) and sexual function. A randomized, double-blind, placebo-controlled, crossover clinical study was performed. The main efficacy was measured using the Female Sexual Function Index (FSFl) and the 36-Item Short-Form Health Survey (SF-36). Twenty-four healthy, married women aged 30-45 years with FSFl scores below 25 were randomly divided into two groups: the red-ginseng group (N=12) and the placebo group (N=12). During the first six-week period (Study 1), each group was given red ginseng or placebo twice a day. Before the start of the second six-week period (Study 2), a crossover design was chosen with a two-week break (washout period). Interchanging the two groups after the washout period, red ginseng and placebo were given to each group. The outcomes were measured before and after each six-week period. Overall, 23 participants completed the study. In Study 1, the changes relative to the baseline in the FSFl total score were 22.50% and 22.99% for red ginseng and placebo, respectively. In Study 2, the relative changes were 8.14% for red ginseng and 6.29% for placebo. The results showed a greater improving trend in Study 1 with respect to all of the participants' sexual functions, but no significant difference was found between the groups (P=0.9567). After taking red ginseng, all the participants exhibited an improving trend in the desire domain of FSFl, but no significant difference was shown. In the measurement of SF-36, no significant difference was likewise shown. After taking red ginseng, though, all the participants exhibited an improving trend in the physical functioning (PF) domain of SF-36, with no significant difference. Moreover, there was no significant adverse event related to red ginseng. The QOL and sexual function of the study participants in the red-ginseng group were mostly improved, but no statistically significant effect of red ginseng was shown. It is supposed that this result was partly due to the affirmative impression of red ginseng in Korea. Thus, it is anticipated that a long-term clinical trial will show a significant effect of red ginseng on the QOL and sexual function.

The Risk Factors Influencing the Postoperative Mortality of the Patients with an Abdominal Aortic Aneurysm (복부대동맥류 환자에서의 수술 후 사망의 위험인자 분석)

  • Lee, Seong-Kwang;Jun, Hee-Jae;Park, Kyung-Taek;Yoon, Young-Chul;Han, IL-Yong;Lee, Yang-Haeng;Cho, Kwang-Hyun
    • Journal of Chest Surgery
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    • v.43 no.6
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    • pp.655-662
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    • 2010
  • Background: Despite the rapid expansion of percutaneous endovascular repair, open surgical repair is still recognized as an option to achieve a cure. We retrospectively analyzed over a 6 year period the surgical outcomes, the complications and the mortality-related factors for patients with abdominal aortic aneurysms. Material and Method: We analyzed 36 patients who underwent surgery for abdominal aortic aneurysms between May 2001 and June 2005, and between April 2007 and November 2009. The indications for surgery were rupture, a maximal aortic diameter > 50 mm, and medically intractable hypertension or pain. Result: The mean patient age was $69.67{\pm}6.97$ years (range: 57 to 84 years). Thirty two patients (88.9%) were males and 4 patients (11.1%) were females. Extension to the iliac artery existed in 28 patients (77.8%). Thirteen patients (36.1%) had ruptured aortic aneurysms. The mean maximal diameter of the aorta was $73.7{\pm}13.3$ mm (60 to 100 mm). Surgery was performed by a midline laparotomy and 10 patients (27.8%) underwent emergency surgery. The mortality rate was 8.3%; the mortality rate for the patients with ruptured aneurysms was 23.1 % and the mortality rate for patients with unruptured aneurysms was 0%. The postoperative complications included wound infection (3 cases), sepsis (2 cases), renal failure (2 cases) and pneumonia (1 case). Unstable vital signs, pre-operative transfusion, ruptured aneurysm, emergency surgery, comorbidity (DM and syncope) and complications (sepsis and renal failure) were the statistically significant mortality-related factors (p < 0.05). Conclusion: Emergency surgery for ruptured aortic aneurysms continues to have high mortality, but the unruptured cases are repaired with relative safety. Even though endovascular aortic repair is the trend for abdominal aortic aneurysms, an elective operation of the unruptured aneurysms could decrease the procedure's morbidity and the inconvenient for repeat evaluation with good surgical results.

Surgical Option for Sufficient Safety Margine in Locally Advanced Type II Cardia Cancer - Left Colon Interposition (국소 진행된 Type II 분문부 선암의 절제연 확보를 위한 수술 방법: 좌측 대장 간치술)

  • Yoon, Ho Young;Kim, Hyoung-Il;Lee, Sang Hoon;Kim, Choong Bai
    • Journal of Gastric Cancer
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    • v.8 no.2
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    • pp.97-103
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    • 2008
  • Purpose: Radical surgery is the standard therapy for patients with resectable cardia cancer. In the case of type II disease with esophageal invasion, a transhiatal extended radical total gastrectomy is needed or a gastroesophagectomy through an abdomino-thoracotomy, depending on the extent of the esophageal invasion. We analyzed the indications and outcome of left colon interposition as an esophageal substitution. Materials and Methods: Between 1 January 1994 and 31 December 2006, 10 patients underwent left colon interposition after gastroesophagectomy through an abdomino-thoracotomy or the tanshiatal approach for type II cardia cancer at the Department of surgery, Yonsei University College of Medicine. The outcomes of these patients were reviewed and compared, with those who underwent a Roux-en-Y, by gender and age matched analysis, retrospectively. Results: There were nine males and one female with a mean age of 52.5 (range, 16~72). The operation time was $449.00{\pm}87.39minutes$. The mean distance between the proximal resection margin and the cancer was $6.56{\pm}3.65cm$; the maximum size of the tumor was $9.90{\pm}3.97cm$. These measures differed significantly from patients who underwent Roux-en-Y. The patients had a double primary cancer in the cardia and esophagus. There were no events of colon necrosis. However, a pneumothorax occurred in one patient (10%) and a proximal anastomotic stricture occurred in one patient. There were no reports of heartburn, regurgitation, thoracic or epigastric fullness, and one patient even gained weight, 16 kg. Conclusion: Colon interposition after esophagogastrectomy was safe and effective and should be considered as an additional surgical option for locally advanced type II cardia cancer patients with esophageal invasion.

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Laparoscopy Assisted Total Gastrectomy with Lymph Node Dissection-77 Consecutive Cases (복강경 보조 위 전절제술-연속된 77예의 경험)

  • Lee, Joong-Ho;Song, Jye-Won;Oh, Sung-Jin;Kim, Sung-Soo;Choi, Won-Hyuk;Cheong, Jae-Ho;Hyung, Woo-Jin;Choi, Seung-Ho;Noh, Sung-Hoon
    • Journal of Gastric Cancer
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    • v.7 no.4
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    • pp.206-212
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    • 2007
  • Purpose: The number of laparoscopy assisted distal gastrectomies (LADG) is gradually increasing for the treatment of early gastric cancer (EGC) patients as a surgical modality for improving quality of life. However, there are few reports on laparoscopy-assisted total gastrectomy (LATG), mainly because this procedure is performed relatively infrequently, and the procedure is more complicated than LADG. This study was performed to evaluate the technical feasibility, safety, and surgical results of LATG with lymphadenectomy through a review of our experience. Materials and Methods: From July 2003 to June 2007, 77 LATG with Roux-en-Y esophagojejunostomy were performed for patients with a preoperative diagnosis of EGC. The clinicopathological features and surgical outcomes were analyzed. Results: There were 49 males and 28 females in the study with a mean age of 61 years (range $30{\sim}85$ years). The mean operation time was 210 minutes (range $100{\sim}400$ minutes) and the operation time was gradually decreased as the case numbers increased. There were 13 operative morbidities (16.9%) and no operative mortalities. The restoration of bowel motility was noted at 3.2 postoperative days; a soft diet was started at 4.4 postoperative days and the duration of hospital stay was 10 days. There were 20 mucosal lesions, 32 submucosal lesions, 15 proper muscle lesions, 7 subserosal lesions and 3 serosal lesions. A total of 20 patients were treated by D2 lymph node dissection, 55 patients were treated by D1+$\beta$ lymph node dissection, and two patients were treated by D1+$\alpha$ lymph node dissection. The mean number of retrieved lymph nodes was 42 (range $11{\sim}86$). Lymph node metastases were noted in 12 patients. Conclusion: This study indicated LATG could be applied safely and effectively for patients with EGC. However, a prospective study comparing laparoscopy-assisted versus open gastrectomy for short-term and long-term surgical outcome is needed.

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The Correlations between Renminbi Fluctuations and Financial Results of Venture Companies in the Floating Exchange Rate (변동환율제도하의 위안화 환율변동과 벤처기업의 재무성과 간 상관관계 연구)

  • Sun, Zhong-Yuan;Chang, Seog-Ju;Na, Seung-Hwa
    • Asia-Pacific Journal of Business Venturing and Entrepreneurship
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    • v.5 no.1
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    • pp.45-67
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    • 2010
  • On July 21st in 2005, People's Bank of China (PBOC) turned the currency peg against the U.S. dollar into managed currency system based on a basket of unnamed currencies under China's exchanged rate regime. This change means that China's enterprises are not free from currency fluctuations. The purpose of this study is to analyze the relations between Renminbi fluctuations in the floating exchange rate and financial results of venture companies. The process and outcomes of this study are as follows, First, in order to measure the financial results of venture companies, I choose venture companies in Shandong Province listed on the Shanghai Stock Exchange (SSE) at random and several quarter financial sheets according to safety ratios, profitability ratios, growth ratios, activity ratios. Second, I arrange the daily Renminbi exchange rate data announced from July 21st, 2005 to December 31st, 2008 by PBOC into the quarterly data. Third, in order to confirm the relations between Renminbi fluctuations and financial results of venture companies, I carry out Pearson's correlation analysis. As a result, the revaluation of the Chinese Renminbi has weakly negative effects on debt ratio, total assets turnover ratio and equity turnover ratio in statistics. But the revaluation of the Chinese Renminbi is not related to other financial index in statistics. The result of this study is that the revaluation of the Chinese Renminbi has little influence on the export and import of Chinese venture companies and certifies the fact that Chinese venture companies have much foreign currency assets. In addition to avoid the currency exposure risk, this study shows the effective method about currency exposure risk which adjusts proportion of Renminbi to foreign currency.

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