• 제목/요약/키워드: Randomized Response

검색결과 358건 처리시간 0.027초

Abiraterone for Treatment of Metastatic Castration-resistant Prostate Cancer: a Systematic Review and Meta-analysis

  • Zhou, Zhi-Rui;Liu, Shi-Xin;Zhang, Tian-Song;Xia, Jun;Li, Bo
    • Asian Pacific Journal of Cancer Prevention
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    • 제15권3호
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    • pp.1313-1320
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    • 2014
  • Introduction: Although most prostate cancers initially respond to castration with luteinizing hormonereleasing analogues or bilateral orchiectomy, progression eventually occurs. Based on the exciting results of several randomized controlled trials (RCTs), it seems that patients with metastatic castration-resistant prostate cancer (mCRPC) might benefit more from treatment withabiraterone. Therefore we conducted a systematic review to evaluate the efficacy and toxicity of abiraterone in the treatment of mCRPC. Methods: Literature was searched from Embase, PubMed, Web of Science, and Cochrane Library up to July, 2013. Quality of the study was evaluated according to the Cochrane's risk of bias of randomized controlled trial (RCT) tool, then the Grading of Recommendations Assessment, Development and Evaluation (GRADE) System was used to rate the level of evidence. Stata 12.0 was used for statistical analysis. Summary data from RCTs comparing abiraterone plus prednisone versus placebo plus prednisone for mCRPC were meta-analyzed. Pooled hazard ratios (HRs) for overall survival (OS), radiographic progression-free survival (RPFS) and time to PSA progression (TTPP); Pooled risk ratios (RR) for PSA response rate, objective response rate and adverse event were calculated. Results: Ten trials were included in the systematic review; Data of 2,283 patients (1,343 abiraterone; 940 placebo) from two phase 3 trials: COU-AA-301 and COU-AA-302 were meta-analyzed. Compared with placebo, abiraterone significantly prolonged OS (HR, 0.74; 95% confidence interval [CI], 0.66 to 0.84), RPFS (HR, 0.59; 95% CI, 0.48 to 0.74) and time to PSA progression (HR, 0.55; 95% CI, 0.43 to 0.70); it also significantly increased PSA response rate (RR, 3.63; 95% CI, 1.72 to 7.65) and objective response rate (RR, 3.05; 95% CI, 1.51 to 6.15). This meta-analysis suggested that the adverse events caused by abiraterone are acceptable and can be controlled. Conclutios: Abiraterone significantly prolonged OS, RPFS and time to progression patients with mCRPC, regardless of prior chemotherapy or whether chemotherapy-na$\ddot{i}$ve, and no unexpected toxicity was evident. Abiraterone can serve as a new standard therapy for mCRPC.

Short-course versus long-course neoadjuvant chemoradiotherapy in patients with rectal cancer: preliminary results of a randomized controlled trial

  • Aghili, Mahdi;Khalili, Nastaran;Khalili, Neda;Babaei, Mohammad;Farhan, Farshid;Haddad, Peiman;Salarvand, Samaneh;Keshvari, Amir;Fazeli, Mohammad Sadegh;Mohammadi, Negin;Ghalehtaki, Reza
    • Radiation Oncology Journal
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    • 제38권2호
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    • pp.119-128
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    • 2020
  • Purpose: Colorectal cancer is becoming an increasing concern in the middle-aged population of Iran. This study aimed to compare the preliminary results of short-course and long-course neoadjuvant chemoradiotherapy treatment for rectal cancer patients. Materials and Methods: In this clinical trial we recruited patients with rectal adenocarcinoma located from 5 cm to 15 cm above the anal verge. Patients in group I (short-course) received three-dimensional conformational radiotherapy with a dose of 25 Gy/5 fractions in 1 week plus concurrent XELOX regimen (capecitabine 625 mg/㎡ from day 1-5 twice daily and oxaliplatin 50 mg/㎡ on day 1 once daily). Patients in group II (long-course) received a total dose of 50-50.4 Gy/25-28 fractions for 5 to 5.5 weeks plus capecitabine 825 mg/㎡ twice daily. Both groups underwent consolidation chemotherapy followed by delayed surgery at least 8 weeks after radiotherapy completion. The pathological response was assessed with tumor regression grade. Results: In this preliminary report on complications and pathological response, 66 patients were randomized into two study groups. Mean duration of radiotherapy in the group II (long-course) was 5 ± 1 days (range, 5 to 8 days) and 38 ± 6 days (range, 30 to 58 days). The median follow-up was 18 months. Pathological complete response was achieved in 32.3% and 23.1% of patients in the shortcourse and long-course groups, respectively (p = 0.558). Overall, acute grade 3 or higher treatment-related toxicities occurred in 24.2% and 22.2% of patients in group I and II, respectively (p = 0.551). No acute grade 4 or 5 adverse events were observed in either group except one grade 4 hematologic toxicity that was seen in group II. Within one month of surgery, no significant difference was seen regarding grade ≥3 postoperative complications (p = 0.333). Conclusion: For patients with rectal cancer located at least 5 cm above the anal verge, short-course radiotherapy with concurrent and consolidation chemotherapy and delayed surgery is not different in terms of acute toxicity, postoperative morbidity, complete resection, and pathological response compared to long-course chemoradiotherapy.

Rapid onset of efficacy predicts response to therapy with certolizumab plus methotrexate in patients with active rheumatoid arthritis

  • Kang, Young Mo;Park, Young-Eun;Park, Won;Choe, Jung-Yoon;Cho, Chul-Soo;Shim, Seung-Cheol;Bae, Sang Cheol;Suh, Chang-Hee;Cha, Hoon-Suk;Koh, Eun Mi;Song, Yeong-Wook;Yoo, Bin;Lee, Shin-Seok;Park, Min-Chan;Lee, Sang-Heon;Arendt, Catherine;Koetse, Willem;Lee, Soo-Kon
    • The Korean journal of internal medicine
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    • 제33권6호
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    • pp.1224-1233
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    • 2018
  • Background/Aims: The objective of this study was to determine the efficacy and safety of add-on therapy with certolizumab pegol (CZP) in active rheumatoid arthritis (RA) patients of a single ethnicity. Methods: In this 24-week, phase 3, randomized, double-blind, placebo-controlled trial, eligible patients (n = 127) were randomized 2:1 to subcutaneous CZP + methotrexate (MTX; 400 mg at week 0, 2, and 4 followed by 200 mg every 2 weeks) or placebo + MTX. Results: At week 24, the American College of Rheumatology criteria for 20% (ACR20) response rate was significantly greater with CZP + MTX than with placebo (66.7% vs. 27.5%, p < 0.001). Differences in ACR20 response rates for CZP vs. placebo were significant from week 1 (p < 0.05) and remained significant through week 24. The CZP group reported significant improvement in physical function and disability compared to the placebo group (p < 0.001) at week 24, as assessed by Korean Health Assessment Questionnaire-Disability Index (KHAQ-DI). Post hoc analysis indicated that the proportion of patients who had ACR70 responses, Disease Activity Score 28 (DAS28) low disease activity, and DAS28 remission at week 24 was greater in CZP + MTX-treated patients who achieved a decrease in DAS28 ${\geq}1.2$ (43.8%) at week 4 than in nonresponders. Among 18 (22.2%) and 14 patients (35.0%) in CZP and placebo groups who had latent tuberculosis (TB), none developed active TB. Most adverse events were mild or moderate. Conclusions: CZP treatment combined with MTX in active RA patients with moderate to severe disease activity and an inadequate response to MTX resulted in rapid onset of efficacy, which is associated with better clinical outcome at week 24 and has an acceptable safety profile, especially in an intermediate TB-burden population.

일반 구조물에 대한 신속한 지진 취약성 분석 방법 (Rapid Seismic Vulnerability Assessment Method for Generic Structures)

  • 정성훈;최성모;김강수
    • 콘크리트학회논문집
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    • 제20권1호
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    • pp.51-58
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    • 2008
  • 해석적 방법에 의한 지진 취약성 분석 (fragility analysis)은 입력 거동과 응답 특성의 불확실성을 고려하기 위해 임의화된 확률 변수들 (randomized response variables)로 인하여 해석 과정에 상당한 노력과 시간이 요구된다. 본 연구에서는 구조물의 기본적인 특성인 강성, 강도 및 연성 능력에 따라 지진 취약도 곡선을 바로 도출할 수 있는 새로운 방법을 제안한다. 광범위한 구조물을 대표할 수 있는 일반화된 단자유도계의 동적 해석 결과로부터 로그 정규 취약성 곡선의 도출에 필요한 파라미터를 응답 데이터베이스에 저장한다. 이를 이용함으로써 구조물의 기본적인 특성 (강성, 강도, 연성 능력)만으로 동적해석 과정을 수행하지 않고도 한계상태 취약성 곡선을 도출할 수 있다. 본 논문의 적용 사례를 통해서 제안된 방법이 지진 취약성 곡선을 얻는데 매우 효율적임을 확인 할 수 있다.

Haematologic Parameters in Metastatic Colorectal Cancer Patients Treated with Capecitabine Combination Therapy

  • Inanc, Mevlude;Duran, Ayse Ocak;Karaca, Halit;Berk, Veli;Bozkurt, Oktay;Ozaslan, Ersin;Ozkan, Metin
    • Asian Pacific Journal of Cancer Prevention
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    • 제15권1호
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    • pp.253-256
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    • 2014
  • Background: The standard treatment in the metastatic colorectal cancer consists of 5-FU based infusional regimens. However, with oral fluoropyrimidines, equal tumor responses may be obtained. Capecitabine causes macrocytosis of the cells by inhibition of DNA synthesis. In this context, a relationship was found between mean corpuscular volume (MCV) and response to therapy in breast cancer patients treated with Capecitabine, but whether this relationship also pertains in colorectal cancer has not been established. Materials and Methods: A total of 102 metastatic colorectal cancer patients treated with a oxaliplatin (XELOX)${\pm}$Bevacizumab combination were retrospectively evaluated. Patients were randomized into three groups. Hematological parameters (MCV, MPV, PCT, PLT, NLR) were recorded retrospectively, before treatment and after 3 cycles of chemotherapy. Results: After three cycles of therapy, 20 (19.6%) patients had progressive disease (PD), 41 (40.1%) had stable disease (SD), and 41 (40.1%) demonstrated a partial response (PR). In 62 (60.7%) treatment was with capesitabin plus XELOX therapy, and in 40 (39.2%) it was XELOX-Bevacizumab combination therapy. There was no difference among three groups before the treatment in terms of MCV, MPV, PCT, PLT, and NLR. MCV showed significant increase in chemotherapy response groups (PR and SD). In addition, a significant decrease was observed for platelet count in chemotherapy response groups. While NLR decrease was seen in only a PR group, PCT decrease was observed in all three groups. PCT and PLT values were higher in patients receiving Bevacizumab. Conclusions: PLT, PCT, MPV, and NLR values were decreased due to Capecitabine-based chemotherapy, however MCV was increased. PCT and PLT values were higher in patients who received Bevacizumab than those who did not. MCV, PLT, and NLR can be considered as important factors in predicting response to colorectal carcinoma treatment.

만성 피로증후군과 특발성 만성 피로에 대한 침 치료 효과: 무작위 대조 예비 임상연구 (Acupuncture for Chronic Fatigue Syndrome and Idiopathic Chronic Fatigue: a Pilot Randomized Controlled Trial)

  • 김정은;강경원;김애란;김주희;김태훈;박효주;신미숙;이민희;이상훈;이승훈;정소영;정희정;홍권의;최선미
    • Journal of Acupuncture Research
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    • 제29권5호
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    • pp.109-118
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    • 2012
  • Objectives : The aim of this study was to evaluate the effectiveness and safety of acupuncture for chronic fatigue syndrome and idiopathic chronic fatigue. Methods : A randomized, controlled pilot trial was conducted. Twenty-four participants were randomized into one of the two groups: an acupuncture group(n=12) and wait-list group(n=12). The treatment group received 12 sessions of acupuncture over 4 weeks. Eight points($GV_{20}$; bilateral GB20, $BL_{11}$, $BL_{13}$, $BL_{15}$, $BL_{18}$, $BL_{20}$, and $BL_{23}$) were selected for needling. The control group did not receive acupuncture treatment during study period and follow-up were done in the $5^{th}$ and $9^{th}$ weeks after randomization in both groups. The primary outcome was fatigue severity scale(FSS) and the secondary outcomes included a short form of stress response inventory(SRI-short form), beck depression inventory(BDI), and insomnia severity index(ISI). Safety was assessed at every visit. Results : There were statistically significant differences in the between group values of FSS at $5^{th}$ weeks after randomization(p=0.0002), SRI-short form, BDI, and ISI at $5^{th}$, $9^{th}$ weeks after randomization(p<0.01). There were no adverse events. Conclusions : The results suggest that acupuncture is associated with benefits on the short-term outcomes in chronic fatigue syndrome and idiopathic chronic fatigue.

Clonazepam Treatment of Pathologic Aerophagia in Children with Mental Retardation

  • Lee, Ga-Hyun;Jang, Hyo-Jeong;Hwang, Jin-Bok
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • 제17권4호
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    • pp.209-213
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    • 2014
  • Purpose: Pathologic aerophagia (PA) may lead to bowel perforation or volvulus in mentally retarded patients. The authors investigated the effects of clonazepam on the management of PA in children with severe to profound mental retardation (MR). Methods: This study was undertaken as a retrospective case analysis of 21 PA patients with MR who were followed for over 12 months and diagnosed as having PA. Patients were assigned to two management groups, that is, to a clonazepam randomized open-labeled, treatment group or a reassurance group. The following were recorded and analyzed; age, response, remission rate to clonazepam treatment, and the side effect of clonazepam. It was defined positive response (response+) as being symptom-free for a whole week within 1 month of commencing treatment and remission(+) as being symptom-free for a whole month within 6 months of treatment. Results: The average age of the 21 PA children with MR was 10 years and 13 patients were female. Symptom duration before diagnosis of PA was 7 months. Clinical features of the clonazepam-trial group (n=11) and the reassurance group (n=10) were non-significantly different. Response(+) was achieved by 2 patients (18.2%) in the clonazepamtrial group and by no patient in the reassurance group. Remission(+) was achieved by 6 patients (54.5%) in the clonazepam-trial group and by one patient (10%) in the reassurance group (p=0.040). Conclusion: When PA children with MR with severe bowel distention are considered for surgical treatment to prevent acute abdomen, a trial of clonazepam could be recommended.

두경부 상피세포암의 화학요법 (Chemotherapy for Head and Neck Squamous Cell Carcinoma)

  • 노재경
    • 대한두경부종양학회지
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    • 제6권1호
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    • pp.11-23
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    • 1990
  • Systemic chemotherapy is usually regarded as the standard treatment for palliation in patients with recurrent or metastatic cancer who have failed the definite local treatment with surgery and/or radiotherapy. Recently, with the introduction of more active chemotherapeutic agents and combinations, systemic chemotherapy is being increasingly used before or after local therapy in patients with previously untreated locally advanced head and neck cancer. The most active agents for the head and neck caner are methotrexate, 5-fluorouracil (5-FU), cisplatin and bleomycin. The overall response rates to each of these four drugs are 15-30% expecially when used as first line therapy. But most of these responses are partial with a mean duration of 3-5 months. Various combinations with methotrexate, 5-FU, cisplatin, and bleomycin have been tried with overall response rates of 50-90%, and 10-20% of complete responses. The introduction of chemotherapy prior to local therapy, induction chemotherapy, has been investigated with improved survivals in patients with complete response, especially pathologic, though improvement in overall survival has not been proved yet after the induction chemotherapy. Other therapeutic modalities, such as 'Sandwich' chemotherapy between surgery and radiotherapy, concomittent chemo-radiotherapy and post local treatment adjuvant chemotherapy have been pursued with some hopeful results but these trials should be compared with prospective randomized Phase III trials. To increase the response rates and enhance the survival, important work still remains; 1. Identification of better prognostic factors, 2. Improvement in staging, 3. Development of more active and safter chemotherapeutic agents, 4. Identification of the proper sequence for the addition of chemotherapy to multimodality treatment, and 5. Testing the value of such chemotherapy in locally advanced cancer patients.

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The influence of obesity on the effects of spirulina supplementation in the human metabolic response of Korean elderly

  • Park, Hee-Jung;Lee, Hyun-Sook
    • Nutrition Research and Practice
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    • 제10권4호
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    • pp.418-423
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    • 2016
  • BACKGROUND/OBJECTIVES: Spirulina, a blue-green alga, is widely produced and commercialized as a dietary supplement with bio- and immune-modulatory functions. We have previously shown that spirulina had favorable effects on lipid profiles, immune functions, and antioxidant capacity in healthy Korean elderly. Despite favorable effect of spirulina supplementation, some sub-populations have shown a poor response to supplementation. Obesity is a factor related to poor-response. Therefore, the purpose of this study was to determine the immuno-modulation, antioxidant capacity, and lipid-lowering effect of spirulina in obese and non-obese Korean elderly. SUBJECTS/METHODS: The subjects were 78 elderly aged 60-87 years. In a randomized double blind, placebo-controlled study, subjects were fed either placebo or spirulina daily, at 8 g for 12 weeks. Subjects were divided into the non-obese group and the obese group based on body mass index (BMI) criteria for Asians suggested by the International Obesity Task Force: $BMI<25kg/m^2$ (non-obese) and $BMI{\geq}25kg/m^2$ (obese). RESULTS: In the non-obese group, spirulina supplementation showed a significant lowering effect on plasma concentration of total cholesterol and LDL-cholesterol, a significant increase in interleukin (IL)-2 concentration (P < 0.01) and a significant increment (P < 0.05) in IL-2/IL-6 ratio, and a significant increase in total antioxidant status level and a significant decrease in thiobarbituric acid reactive substances level. However, these effects were not observed in the obese group. CONCLUSION: These results demonstrated that blood lipid lowering and immune and antioxidant improving response for spirulina supplement was affected by obesity in Korean elderly.

돼지에 있어 원적외선 방사물질의 첨가가 면역반응 및 분중 미생물의 변화에 미치는 영향 (Effects of far infrared radiological materials on immune response and changes of fecal microorganism in pigs)

  • 권기범;김인호;홍종욱;문태현;최상열;석호봉
    • 대한수의학회지
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    • 제41권1호
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    • pp.37-42
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    • 2001
  • This research was conducted to investigate the effects of far infrared radiological materials on growth performance, immune response and changes of microbial flora in feces for growing pigs. Twelve growing pigs($Duroc{\times}Yorkshire{\times}Landrace$, average initial body weight of $15.6{\pm}0.5kg$) were used in a 40 day growth assay. Treatments were control(saline injection with diet: S); saline injection with Bio-Plus in diet(SBP); and vaccination with Bio-Plus in diet(VBP) in a randomized complete block design with initial BW as the blocking criterion. Serum concentrations of IgG of SBP and VBP were higher than those of S at day 10(p<0.05), 20(p<0.05), 30(p<0.05) and 40(p<0.05). Pigs fed with treatment diets had increased lymphocyte level compared to S at day 20(p<0.05) and 40(p<0.05). Cortisol was lower in treatments than in S at day 30(p<0.05). At day 20, there was no significant difference in E. coli among the treatments. However, it was observed that E, coli of the treatments was decreased compared to S at day 40(p<0.01). Lactobacillus of SBP was significantly higher(p<0.05) than that of S at day 40. In conclusion, the results of the experiment suggest that far infrared radiological materials could be a very beneficial immune response for growing pigs in health aspects.

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