• Title/Summary/Keyword: clinical response

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Treatment Result and Prognostic Factors in Pateints with Esophageal Cancer (식도암의 근치적 치료성적 및 예후인자)

  • Chung, Weon-Kuu;Kim, Soo-Kon;Kim, Min-Chul;Jang, Myoung;Moon, Sun-Rock
    • Radiation Oncology Journal
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    • v.13 no.3
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    • pp.233-241
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    • 1995
  • Purpose : To analyse clinical outcome and prognostic factors according to treatment modality, this paper report our experience of retrospective study of patients with esophageal cancer Materials and Methods : One hundred and ten patients with primary esophageal cancer who were treated in Presbyterian Medical Center from May 1985 to December 1992. We analysed these patients retrospectively with median follow up time of 28 months, one hundred and four patients($95{\%}$) were followed up from 15 to 69 months. In methods, twenty-eight patients were treated with median radiation dose irradiated 54.3Gy only. Fifty-six patients were treated with combined chemoradiotherapy. Sixteen cases of these patients were treated with concurrent chemoradiation and the other patients(forty cases) were treated sequential chemoradiotherapy. In concurrent chemoradiotherapy group, patients received 5-FU continuous IV infusion for 4 days. Cisplatin IV bolus. and concurrent esophageal irradiation to 30 Gy. After that patients received 5-FU continuous IV, Cisplatin bolus injection and Mitomycin-C bolus IV, Bleomycin continuous IV, and irradiation to 20 Gy. In sequential chemoradiotherapy group, the chemotherapy consisted of 5-FU 1,000mg/$m^2$ administered as a continuous 24 hour intravenous infusion during five days and Cisplatin 80-100mg/$m^2$ bolus injected, or Bleomycin, Vinblastine, Cisplatin, Methotrexate were used of 1 or 2 cycles. After preoperative concurrentm chemoradiation twenty-six patients underwent radical esophagectomy. Results : Ninety-three patients could be examined for response assessment, By treatment modality, response rates were $85.1{\%}$ for radiation alone group and $86.3{\%}$ for combined chemoradiation group. But in operation group, after one cycle of concurrent chemoradiation treatment, response rate was $61.9{\%}$. The pathologic complete response were $15.4{\%}$ in operation group. Overall median survival was II months and actuarial 5-year survival rate was $8{\%}$. The median survival interval was 6 months for radiation alone group, 11 months for combined chemoradiation group and 19 months for operation group. And also median survival was 19 months for complete responder group that 8 months for noncomplete responder group. In univariative analysis, statistically significant prognostic factors were tumor size, clinical stage, tumor response, and operation. In multivariative analysis, significantly better survival was associated with clinical stage, tumor response, radiation dose, and operation. Conclusion : Compared with radiotherapy alone, combined multimodality may improve the median survival in patients with localized carcinoma of the esophagus and toxicity is acceptable.

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Efficacy of Oral Administration of Lentinula eododes Mycelia Extract for Breast Cancer Patients Undergoing Postoperative Hormone Therapy

  • Suzuki, Nobutaka;Takimoto, Yuko;Suzuki, Riho;Arai, Takanari;Uebaba, Kazuo;Nakai, Masuo;Strong, Jeffry Michael;Tokuda, Harukuni
    • Asian Pacific Journal of Cancer Prevention
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    • v.14 no.6
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    • pp.3469-3472
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    • 2013
  • Extract of Lentinula edodes mycelia (LEM) is currently utilized as an oral biological response modifier (BRM) medicine for cancer patients. However, its effectiveness for breast cancer patients with postoperative adjuvant hormone therapy has not yet been scientifically verified. In this study, we investigated the influence of LEM on the quality of life (QOL) and immune response in breast cancer patients undergoing postoperative adjuvant hormone therapy. Twenty patients were studied in total. They received only hormone therapy in the first 4 weeks followed by hormone therapy and LEM during the next 8 weeks. Laboratory tests, QOL score and peripheral blood cytokine production levels were evaluated during the study period. No changes in QOL or cytokines were noted after the first 4 weeks. In contrast, during the following combined therapy period, improvements were noted in QOL and cytokine levels. Although a future large-scale investigation is necessary to confirm these results, these data suggest that the concomitant use of LEM with postoperative adjuvant hormone therapy improves the QOL and immune function of patients.

A Study on the Clinical Characteristics in Oral Lichen Planus (구강편평태선 환자의 임상적 특징에 관한 연구)

  • Yoon-Mi Lee;Myoung-Chan Kim;Jong-Youl Kim
    • Journal of Oral Medicine and Pain
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    • v.21 no.1
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    • pp.141-152
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    • 1996
  • Oral Lichen Planus(OLP) is a idiopathic chronic inflammatory disease with more difficult to clear and higher recurrent rate than cutaneous lesions. But, there has been no estabilished theories about the proper treatment for OLP. The purpose of this study is to examine the clinical feature, relationship with systemic disease and dental treatment of OLP patients of Korea and to gain helpful information about clinical characteristics and treatment of OLP. The subjects chosen for the study were 54 patients who had visited Department of Oral Diagnosis & Oral Medicine at Yonsei University Dental Hospital Dental Hospital and diagnosed as OLP. Previous clinical records has been reviewed and questionnaires, oral examination, laboratory examination were done and recorded. The following results were obtained : 1. Of the 54 patients, 21 were men and 33 were women with an average age of 47.8 years. 2. The most common intraoral site was bilateral buccal mucosa, followed by unilateral buccal mucosa, gingiva, vesibule, lip mucosa, glossal mucosa, palatal mucosa and mouth floor. 3. The mixed, erosive and reticular form of OLP was most frequent(83.3%) clinical form. 4. OLP patients with liver disease were 5, and drug medication patients were 7. But, we could not find its evidence of association with OLP. 5. Associated events on onset of symptom were stress, denture wearing, dental treatemtn, and common cold. 6. Associated symptoms were dry mouth, tingling, sore throat, and altered taste perception. 30.8% of patients had no specific associated symptoms. 7. Aggravating factors of symptom were peppery food, hot food, fatigue, toothpaste, salty food, sour food, tension, and conversation. Reducing factors were cold food, sleeping. 69.2% of patients had no specific reducing factors. 8. There were no significant differences between normal papulation and OLP patients in CBC, SGOT< SGPT, Serum iron, Total iron binding capacity. 66.7% of subjects were positive response to fungus study for Candida Albicans. The incidence of stress and dental treatment on onset of symptom appeared high in OLP patients. Especially, high incidence of positive response to fungus study for Candida albicans, prescription of anti-fungal agents and dental treatment considerations may be helpful to treatment of OLP.

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Efficacy and Safety of Aerosolized Colistin in the Treatment of Ventilator-Associated Pneumonia: A Systematic Review and Meta-analysis (기계환기관련 폐렴치료 시 Aerosolized Colistin의 효과 및 안전성에 대한 체계적 문헌 고찰 및 메타분석)

  • Paik, Minwoo;Jeung, Kyeonghye;Kim, Eun Young
    • Korean Journal of Clinical Pharmacy
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    • v.27 no.4
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    • pp.207-213
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    • 2017
  • Background: It is recommended to use aerosolized (AS) colistin in patients undergoing mechanical ventilation therapy as an adjunctive in the latest guidelines, in spite of high nephrotoxicity and limited studies. In this study, systematic reviews and meta-analyzes were conducted to evaluate the safety and efficacy of AS colistin in patients with ventilator-associated pneumonia Methods: Two authors independently searched related literature published from Pubmed and EMBASE until July 2016 and included a study comparing adjunctive AS colistin with intravenous (IV) colistin monotherapy. The primary outcome was the clinical response rate, the secondary outcome was the overall mortality, and nephrotoxicity. The publication bias was evaluated using the Egger's test. Results: Of the total 279 articles, nine were finally included in the final analysis. There was a significant difference between the adjunctive AS colistin group and the IV colistin monotherapy group for the treatment-response rate (odds ratio (OR), 1.56; 95% CI, 1.14-2.14; p = 0.005; $I^2=36%$), although there was no significant difference in overall mortality (OR, 0.77; 95% CI, 0.57-1.04; p = 0.09; $I^2=20%$). However, there was no significant difference between the two groups in nephrotoxicity (OR, 1.13; 95% CI, 0.74-1.74; p = 0.57; $I^2=4%$). Conclusion: The addition of aerosolized colistin to IV colistin monotherapy showed better results in terms of efficacy than IV colistin monotherapy and did not show any significant difference in terms of total mortality and nephrotoxicity. Additional large-scale studies of this need to be verified.

Efficacy of Transarterial Chemoembolization Combined with Radiofrequency Ablation in Treatment of Hepatocellular Carcinoma

  • Xu, Chuan;Lv, Peng-Hua;Huang, Xin-En;Wang, Shu-Xiang;Sun, Ling;Wang, Fu-An
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.14
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    • pp.6159-6162
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    • 2015
  • Purpose: To evaluate efficacy of transarterial chemoembolization (TACE) combined with radiofrequency ablation (RFA) in treatment of patients with hepatocellular carcinoma. Materials and Methods: During January 2009 to March 2012, 80 patients with hepatocellular carcinoma underwent TACE, with or without RFA. Alfafetoprotein (AFP) was checked before and after procedure. CT scans were obtained one month after TACE or RFA for all patients to evaluate tumor changes. Complete response+partial response+stable disease (CR+PR+SD)/n were used to assess the disease control rate (DCR). Survival at 3, 6 and 12 months was compared in both groups. Results: AFP levels in TACE + RFA group dropped rapidly, becoming obviously lower than that of the TACE group. In the TACE + RFA group DCR was 93.8%, while only 76.8% in the TACE group. The treatment effect between the two groups was statistically significant (P<0.05) by Ridit analysis. 1 year survival rate in the TACE + RFA group was 92.5%, significantly higher than that of the TACE group at 77.5% (P<0.05). Conclusions: TACE and RFA as combined therapy method for patients with middle and terminal stage HCC gives full play to synergy between the two and improves the therapeutic effect.

A comprehensive review of the comparative studies of Korean(Panax ginseng) and American(Panax quinquefolium) Ginsengs on the Thermogenic Response (고려인삼(Panax ginseng)과 미국삼(Panax quinquefolium)의 승열작용에 대한 비교 고찰)

  • Nam, Ki Yeul;Yang, Byung Wook;Shin, Wang Soo;Park, Jong Dae
    • Korean Journal of Pharmacognosy
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    • v.49 no.3
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    • pp.203-218
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    • 2018
  • It has been extensively known in the high temperature regions such as southern China and south east Asia that Korean ginseng(Panax ginseng) intake raises body heat, while American ginseng(Panax quinquefolium) lowers it, based upon oriental medicine. This is likely due to the misunderstanding of the conception that Korean ginseng shows a warm property, resulting in enhanced blood circulation and stimulation of metabolism. It's further supported by the fact that current scientific studies have shown no notable side effects. Moreover, it has been demonstrated in animal experimental test that Korean ginseng shows a complementary effect in a high temperature environment, together with scientific evidence of a preventive effect of ginseng saponin against cold conditions, suggesting it to exhibit an adaptogenic effect normalizing the body under abnormal body conditions. However, there is a shortage of studies published concerning comparative clinical and animal studies of Korean and American ginsengs, and also, on natives of high temperature countries. Therefore, a further placebo-controlled clinical study has to be considered to elucidate scientifically clinical evaluation of Korean and American ginsengs on the body heat. In this article, we summarize the scientific publications reporting the clinical comparative study of Korean and American ginsengs on body heat response.

Bayesian methods in clinical trials with applications to medical devices

  • Campbell, Gregory
    • Communications for Statistical Applications and Methods
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    • v.24 no.6
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    • pp.561-581
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    • 2017
  • Bayesian statistics can play a key role in the design and analysis of clinical trials and this has been demonstrated for medical device trials. By 1995 Bayesian statistics had been well developed and the revolution in computing powers and Markov chain Monte Carlo development made calculation of posterior distributions within computational reach. The Food and Drug Administration (FDA) initiative of Bayesian statistics in medical device clinical trials, which began almost 20 years ago, is reviewed in detail along with some of the key decisions that were made along the way. Both Bayesian hierarchical modeling using data from previous studies and Bayesian adaptive designs, usually with a non-informative prior, are discussed. The leveraging of prior study data has been accomplished through Bayesian hierarchical modeling. An enormous advantage of Bayesian adaptive designs is achieved when it is accompanied by modeling of the primary endpoint to produce the predictive posterior distribution. Simulations are crucial to providing the operating characteristics of the Bayesian design, especially for a complex adaptive design. The 2010 FDA Bayesian guidance for medical device trials addressed both approaches as well as exchangeability, Type I error, and sample size. Treatment response adaptive randomization using the famous extracorporeal membrane oxygenation example is discussed. An interesting real example of a Bayesian analysis using a failed trial with an interesting subgroup as prior information is presented. The implications of the likelihood principle are considered. A recent exciting area using Bayesian hierarchical modeling has been the pediatric extrapolation using adult data in clinical trials. Historical control information from previous trials is an underused area that lends itself easily to Bayesian methods. The future including recent trends, decision theoretic trials, Bayesian benefit-risk, virtual patients, and the appalling lack of penetration of Bayesian clinical trials in the medical literature are discussed.

Screening Tool for Anxiety Disorders: Development and Validation of the Korean Anxiety Screening Assessment

  • Kim, Yeseul;Park, Yeonsoo;Cho, Gyeongcheol;Park, Kiho;Kim, Shin-Hyang;Baik, Seung Yeon;Kim, Cho Long;Jung, Sooyun;Lee, Won-Hye;Choi, Younyoung;Lee, Seung-Hwan;Choi, Kee-Hong
    • Psychiatry investigation
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    • v.15 no.11
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    • pp.1053-1063
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    • 2018
  • Objective This study evaluated the psychometric properties of the Korean Anxiety Screening Assessment (K-ANX) developed for screening anxiety disorders. Methods Data from 613 participants were analyzed. The K-ANX was evaluated for reliability using Cronbach's alpha, item-total correlation, and test information curve, and for validity using focus group interviews, factor analysis, correlational analysis, and item characteristics based on item response theory (IRT). The diagnostic sensitivity and specificity of the K-ANX were compared with those of the Beck Anxiety Inventory (BAI) and Generalized Anxiety Disorder 7-item scale (GAD-7). Results The K-ANX showed excellent internal consistency (${\alpha}=0.97$) and item-total coefficients (0.92-0.97), and a one-factor structure was suggested. All items were highly correlated with the total scores of the BAI, GAD-7, and Penn State Worry Questionnaire. IRT analysis indicated the K-ANX was most informative as a screening tool for anxiety disorders at the range between 0.8 and 1.6 (i.e., top 21.2 to 5.5 percentiles). Higher sensitivity (0.795) and specificity (0.937) for identifying anxiety disorders were observed in the K-ANX compared to the BAI and GAD-7. Conclusion The K-ANX is a reliable and valid measure to screen anxiety disorders in a Korean sample, with greater sensitivity and specificity than current measures of anxiety symptoms.

Consecutive versus concomitant follicle-stimulating hormone and highly purified human menopausal gonadotropin: A milder response but better quality

  • Maghraby, Hassan Ali;Agameya, Abdel Fattah Mohamed;Swelam, Manal Shafik;El Dabah, Nermeen Ahmed;Ahmed, Ola Youssef
    • Clinical and Experimental Reproductive Medicine
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    • v.49 no.2
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    • pp.135-141
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    • 2022
  • Objective: This study investigated the impact of two stimulation protocols using highly purified human menopausal gonadotropin (HP-hMG) on the endocrine profile, follicular fluid soluble Fas levels, and outcomes of intracytoplasmic sperm injection (ICSI) cycles. Methods: This prospective clinical trial included 100 normal-responder women undergoing ovarian stimulation for ICSI; 55 patients received concomitant follicle-stimulating hormone (FSH) plus HP-hMG from the start of stimulation, while 45 patients received FSH followed by HP-hMG during mid/late follicular stimulation. The primary outcome was the number of top-quality embryos. The secondary outcomes were the number and percentage of metaphase II (MII) oocytes and the clinical pregnancy rate. Results: The number of MII oocytes was significantly higher in the concomitant protocol (median, 13.0; interquartile range [IQR], 8.5-18.0 vs. 9.0 [8.0-13.0] in the consecutive protocol; p=0.009); however, the percentage of MII oocytes and the fertilization rate were significantly higher in the consecutive protocol (median, 90.91; IQR, 80.0-100.0 vs. 83.33 [75.0-93.8]; p=0.034 and median, 86.67; IQR, 76.9-100.0 vs. 77.78 [66.7-89.9]; p=0.028, respectively). No significant between-group differences were found in top-quality embryos (p=0.693) or the clinical pregnancy rate (65.9% vs. 61.8% in the consecutive vs. concomitant protocol, respectively). The median follicular fluid soluble Fas antigen level was significantly higher in the concomitant protocol (9,731.0 pg/mL; IQR, 6,004.5-10,807.6 vs. 6,350.2 pg/mL; IQR, 4,382.4-9,418.4; p=0.021). Conclusion: Personalized controlled ovarian stimulation using HP-hMG during the late follicular phase led to a significantly lower response, but did not affect the quality of ICSI.

Nursing Students' Clinical Judgment Skills in Simulation: Using Tanner's Clinical Judgment Model (시뮬레이션에서의 간호대학생의 임상적 판단 기술 분석: Tanner의 Clinical Judgment Model을 적용하여)

  • Kim, Eun Jung
    • The Journal of Korean Academic Society of Nursing Education
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    • v.20 no.2
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    • pp.212-222
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    • 2014
  • Purpose: The purpose of this study was to evaluate the nursing students' clinical judgment skills in simulation using Tanner's Clinical Judgment Model. Method: Forty-five teams of a total 93 nursing students participated in a post-operative patient care scenario using human patient simulator. Data were collected from students' responses in scenario and guided reflective journaling according to the framework of Tanner's model which comprised noticing, interpreting, responding, and reflecting on response. Data were analyzed using descriptive statistics. Results: The students' responses of the situation were in accordance with the goals of scenario, i.e. relieving patient' pain and preventing pulmonary complications. However, most of students needed clinical cues and focused on a given clue to solve the issues. They were lack of ability to collect additional information as well as connect the relevant clues in simulated clinical situation. Conclusion: The nursing students have difficulty in what they notice, how they interpret finding, and respond appropriately to the situation. The simulation training using Tanner's model could provide faculty and nursing students with an effective teaching and learning strategy to develop the clinical judgment skills.