• 제목/요약/키워드: Randomized Clinical Trials

검색결과 940건 처리시간 0.023초

조현병 환자에서 장기지속형 항정신병 주사제 팔리페리돈 팔미테이트의 효능과 안전 : 24주 개방형 연구 (Safety and Effectiveness of Long Acting Injectable Antipsychotic Paliperidone Palmitate Treatment in Schizophrenics : A 24-Week Open-Label Study)

  • 강현구;함웅;손인기;백인호
    • 생물정신의학
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    • 제20권3호
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    • pp.111-117
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    • 2013
  • Objectives We investigated the effectiveness and safety when treated in schizophrenics with paliperidone palmitate, a long acting injectable antipsychotic. Methods This was a 24-week open-label study, performed at one center in Korea. The eligible patients with schizophrenia diagnosed by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria were enrolled. Patients received long-acting paliperidone palmitate injection (234 mg, baseline; 156 mg, week 1 ; then once 4 weeks flexible dosing). Effectiveness assessments were measured by the Positive and Negative Syndrome Scale (PANSS), The Clinical Global Impression Severity Scale (CGI-S), The Personal and Social Performance (PSP) at baseline, week 1, every 4 weeks untill 24 weeks or endpoint. Safety assessments were measured by The Extrapyramidal Symptom Rating Scale (ESRS), body weight (BW) and incidence of adverse events. Oral antipsychotics were stopped or tapered off within next 14 days. Results Of 20 patients recruited, 9 patients (45%) completed the study. Paliperidone palmitate produced a significant improvement in PANSS total score from baseline to endpoint. The response rate was 75% [mean change (${\pm}SD$) $-25.9{\pm}14.4$, all p < 0.001]. The CGI-S and PSP total scores significantly improved during 24 weeks (All p < 0.001). Eighty percent of patients reported adverse events and most common adverse events (${\geq}10%$) in paliperidone palmitate were anticholinergic adverse event, extrapyramidal symptoms, weight gain, akathisia, insomnia, headache, agitation, anxiety and GI trouble. ESRS score is not statistically significant, but tends to get better at the end of the study when compared to baseline. Conclusions Our study results demonstrated maintained effectiveness and safety of paliperidone palmitate treatment in schizophrenics. And provides both clinicians and patients with a new choice of treatment that can improve the outcome of long term therapy. Their potential effectiveness and safety should be better addressed by future randomized-controlled trials.

한방치료를 받은 여성 비만환자의 삶의 질 연구 (Acupuncture and Herbal Medicine Improved the Quality of life of Obese Women)

  • 정순관;염승룡;권영달
    • 동의생리병리학회지
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    • 제21권4호
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    • pp.1034-1038
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    • 2007
  • To examine the difference of health-related quality of life (QoL) of obese patients between before and after treatment of Korean traditional medicine. This study was assessed in 18 obese-women (age 29.72${\pm}$7.38) treated by acupuncture and herbal medicine using SF-36 quality of life questionnaire between January and July 2006, a 36 item instrument yielding 8 dimensions (Social functioning, Role limitation-Physical, Role limitation-Emotion, Mental health, Vitality, Bodily pain, and General health) and a total score. Their weight was measured by Inbody 3.0 (Biospace co. Korea). QoL and body composition was assessed twice at baseline (B) and 4 weeks after treatment. Auricular acupuncture and electrical needle stimulation to abdomen, thigh, and arm fat was used twice a week and complex herb formula was prescribed according to their constitution and symptoms for 4 weeks. Herb medication was taken 2 times a day. Respective variables were analyzed with Wilcoxon signed ranks test and the level set for statistical significance was p <0.05. The mean of the body weight (P=0.000;B64,68${\pm}$6.86, 4 WKs 60.47${\pm}$5.69), fat percentage (P=0.000;B33.14${\pm}$4.86, 4 WKs 30.16${\pm}$5.34), body mass index (P=0.000;B25.18${\pm}$2.44, 4 WKs 23.46${\pm}$2.09) and fat weight (P=0.000;B21.66${\pm}$5.06, 4 WKs 18.41${\pm}$4.57) of some obese patients decreased significantly between before and after treatment for 4 weeks. Physical functioning (P=0.48;B27.06${\pm}$3.17, 4 WKs 28.00${\pm}$1.71), Mental health (P=0.01 ;B18.83${\pm}$5.25, 4 WKs 22.00${\pm}$3.73), Vitality (P=0.028;B13.89${\pm}$3.03, 4 WKs 15.44${\pm}$2.53), Bodily pain (P=.0014;B8.84${\pm}$1.75, 4 WKs 10.15${\pm}$1.78), and the total scores (P=0.001;B104.99${\pm}$12.60, 4 WKs 114.58${\pm}$11.11) of SF-36 were increased significantly after treatments. These data show some differences in QoL and BMI between before and after treatment on obesity and suggest that the treatment with acupuncture and herbal medicine have a positive impact on several domains of QoL of some obese patients. Further randomized clinical trials (RCTs) including follow-up are needed to examine whether acupuncture and herb medicine have a positive effect on QoL of treatment group compared with control group.

급성 요통 증후군 환자에 대해 봉독약침요법을 병행한 한의학적 치료 효과: 증례보고 (Effects of Sweet Bee Venom Pharmacopuncture Combined with Korean Medicine Treatment for Acute Low Back Pain Syndrome Patient: A Case Report)

  • 봉성민;장우석;김경호
    • Korean Journal of Acupuncture
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    • 제37권1호
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    • pp.54-62
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    • 2020
  • 2019년 10월 16일부터 2019년 12월 16일까지 동국대학교 일산한방병원에서 요통을 호소하시며 X-ray 상 급성기 이상 소견이 없는 환자 3명을 대상으로 하였다. 한방응급실을 통해 입원한 급성 요통 증후군 환자에 대한 봉독약침요법을 포함한 한의학적 치료를 시행한 증례에 있어서 다양한 치료 효과를 확인하였다. NRS, ODI, EQ-5D, EQ-VAS의 모든 지표에서 임상적 호전의 결과를 관찰할 수 있었으며 환자의 주관적인 호전도에 있어서도 큰 변화를 얻을 수 있었고, 봉독약침에 대한 이상반응은 없었다. 봉독약침요법을 포함한 한의학적 치료를 통해 급성 요통이 완화되었으며 요추 ROM 증진 및 운동기능이 개선되고, 치료 기간을 단축시켜 환자의 삶의 질적인 측면에서 큰 호전을 보였다. 향후 급성 요통 증후군에 대한 봉독약침요법의 치료효과를 확인하기 위해 대규모 전향적 연구뿐만 아니라 대조군 연구가 필요할 것으로 사료된다.

뇌졸중 환자의 상지기능 향상을 위한 경두개 직류 자극과 강제 유도 운동 치료의 결합 중재 효과에 대한 체계적 고찰 (Impact of Transcranial Direct Current Stimulation Combined With Constraint-Induced Movement Therapy on Upper Limb Function in Chronic Stroke: A Systematic Review)

  • 김선호
    • 재활치료과학
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    • 제8권4호
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    • pp.7-18
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    • 2019
  • 목적 : 경두개 직류 자극과 강제 유도 운동 치료의 결합된 중재를 적용한 뇌졸중 환자의 회복과 관련된 연구 동향을 알아보고, 중재 계획 시, 도움이 될 수 있는 정보 및 근거를 제시하는 데 목적이 있다. 연구방법 : 전자 데이터베이스 PubMed, NDSL 등을 이용하여 2009년 1월부터 2018년 12월까지 10년간 온라인 데이터에 등록된 논문을 검색하였다. 주요 검색어로 'Transcranial direct current stimulation' or 'tDCS', 'Constraint-induced movement therapy' or 'CIMT', 'Upper extremity function', 'Upper limb', 'Stroke'을 혼용하여 사용하여 본 연구의 선정기준과 배제기준에 부합하는 6편의 논문을 최종 선정하여 분석하였다. 결과 : 경두개 직류 자극의 적용 전류의 세기, 적용시간 등과 강제 유도 운동 치료의 프로토콜은 다양한 방법으로 이루어져 있었지만, 경두개 직류 자극 직 후 CIMT를 시행하는 중재 절차는 동일하게 시행되었다. 중재 효과를 알아보기 위해 상지기능, 일상생활동작, 대뇌피질 활성도 평가 등이 사용되었다. 경두개직류 자극과 강제 유도 운동 치료의 결합된 중재는 뇌졸중 환자의 상지기능과 일상생활동작 개선에 효과적인 것으로 나타났으며, 대뇌피질의 활성화에도 유의미한 효과가 있는 것으로 나타났다. 결론 : 본 연구를 통해 경두개 직류 자극과 강제 유도 운동 치료의 결합된 중재 적용에 필요한 정보 제공 및 근거를 마련하였다. 추후 연구를 통해, 경두개 직류 자극의 자극시간과 전류의 세기, 전극의 부착 위치 등에 대한 일반화가 필요할 것이며 가장 적절한 강제 유도 운동 치료 프로토콜을 사용하여 큰 모집단을 대상으로 장기간 추적 관찰을 포함한 무작위 대조군 실험연구가 필요하다.

갱년기 여성의 안면홍조 증상에 대한 국내 한의학 연구 동향 분석 (A Review on Domestic Study Trends on Hot Flush in Menopausal Women with Traditional Korean Medicine)

  • 홍누리;장영숙;양수현;최윤영;오다윤;이수진;남궁진;김진환
    • 대한한방부인과학회지
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    • 제33권1호
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    • pp.86-103
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    • 2020
  • Objectives: The purpose of this study is to analyse the domestic trends of Traditional Korean Medicine on Hot flush in menopausal women. Methods: We searched six databases and selected relevant papers according to the criteria. Results: 12 papers included case report, literature review, randomized controlled clinical trials (RCTs), Non-RCTs, and retrospective chart analysis study design. 1. The daily diary, Kupperman's Index, Menopause Rating Scale, Menopause-specific Quality of Life Questionnaire, Digital Infrared Thermographic Imaging were used as a measure of the symptoms of hot flush. 2. There were significant correlations between Thermographic images, Pulse energy, Lifestyle Habits, Low frequency power/High frequency power (LF/HF) ratio and certain items of Menopausal Symptoms Measurement. 3. The case report using Er-Xian decoction and Hwangryunhaedoktang-Gamibang showed significant effect. 4. Domestic RCT studies using herbal or acupuncture treatments showed a significant value of 3.4 on average in the quality assessment conducted in the study. However, the number of domestic studies included was five, which is not enough compared to foreign countries. Conclusions: This study examined domestic research trends on hot flushes of menopausal women and found that various evaluation tools and diagnostic methods were applied. It is necessary to conduct various RCT studies in Korea, where the number of studies is insufficient compared to overseas.

Efficacy of Different Number of XELOX or SOX Chemotherapy Cycles After D2 Resection for Stage III Gastric Cancer

  • Yu, Yuanyuan;Zhang, Zicheng;Meng, Qianhao;Wang, Ke;Li, Qingwei;Ma, Yue;Yao, Yuanfei;Sun, Jie;Wang, Guangyu
    • Journal of Gastric Cancer
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    • 제22권2호
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    • pp.107-119
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    • 2022
  • Purpose: We aimed to explore whether the prognosis of patients treated with capecitabine and oxaliplatin (XELOX) or S-1 and oxaliplatin (SOX) regimens who received fewer cycles of chemotherapy after D2 radical resection for gastric cancer (GC) would be non-inferior to that of patients who received the standard number of cycles of chemotherapy. Materials and Methods: Data on patients who received XELOX or SOX chemotherapy after undergoing D2 radical resection at Harbin Medical University Cancer Hospital between January 2011 and May 2016 were collected. Results: In patients who received 4, 6, and 8 cycles of chemotherapy, the 5-year overall survival (OS) rates were 59.4%, 64.8%, and 62.7%, respectively. Compared to patients who received 4 cycles of chemotherapy, those who received 6 cycles (hazard ratio [HR], 0.882; 95% confidence interval [CI], 0.599-1.299; P=0.52) or 8 cycles (HR, 0.882; 95% CI, 0.533-1.458; P=0.62) of chemotherapy did not exhibit significantly prolonged OS. The 3-year disease-free survival (DFS) rate of patients who received 4, 6, and 8 cycles of chemotherapy was 62.1%, 67.2%, and 60.8%, respectively. Compared to patients who received 4 cycles of chemotherapy, those who received 6 cycles (HR, 0.835; 95% CI, 0.572-1.221; P=0.35) or 8 cycles (HR, 0.972; 95% CI, 0.606-1.558; P=0.91) of chemotherapy did not show significantly prolonged DFS. However, the 3-year DFS and 5-year OS rates of patients who received 6 cycles of chemotherapy appeared to be superior to those of patients who received 4 and 8 cycles of chemotherapy. Conclusions: For patients with stage III GC, 4 to 6 cycles of XELOX or SOX chemotherapy may be a favorable option. This study provides a rationale for further randomized clinical trials.

일반 인구 집단에서 전암성 병변 유무에 따른 헬리코박터 제균 치료의 위암 예방 효과 연구: 메타분석 (Effect of Helicobacter pylori Eradication on the Prevention of Gastric Cancer in the General Population with or without Precancerous Lesions: A Meta-analysis)

  • 강수진;신철민;강승주
    • Journal of Digestive Cancer Reports
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    • 제8권2호
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    • pp.81-90
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    • 2020
  • 배경 및 목적: Helicobacter pylori (H. pylori) 제균 치료는 위암 발병률을 줄이는 것으로 알려져 있다. 그러나 만성 위축성 위염, 장상피화생 및 이형성증이 있는 일반 집단에서도 위암의 발생 위험을 예방할 수 있는지에 대해서는 여전히 논란의 여지가 있다. 우리는 포괄적인 메타분석을 통해 이에 대한 연구를 수행해 보고자 한다. 방법: 2019년 12월까지 H. pylori 제균 치료가 위암에 미치는 영향을 평가한 논문들을 PubMed, KoreaMed, EMBASE 및 Cochrane Library에서 검색하였다. 전암성 병변(만성 위축성 위염/장상피화생/이형성증), 지역(아시아/비아시아) 및 추적관찰기간에 따라 하위 집단 분석을 수행하였다. 모든 데이터는 Review Manager 5.3으로 분석하였다. 결과: 본 연구에서는 총 6편의 전향적 무작위 연구가 최종 분석에 포함되었다. 전체 집단에서 H. pylori 제균 치료는 위암 발생 위험을 유의하게 감소시켰다(위험비[RR]=0.56; 95% 신뢰구간[CI]: 0.41-0.77, p<0.01). 또한, 하위 집단 분석을 보면, H. pylori 제균 치료는 아시아 지역과 10년 이상의 추적관찰을 시행한 집단에서 위암 발생 위험을 현저하게 감소시키는 것을 보여주었다(RR=0.54, 95% CI: 0.39-0.75, p<0.01 및 RR=0.51; 95% CI: 0.35-0.73, p<0.01). 그러나, 전암성 병변 유무에 따른 하위 집단 분석에서는 유의한 결과가 도출되지 않았다(전암성 병변이 있는 군, RR=0.86, 95% CI: 0.47-1.59, p=0.63; 전암성 병변이 없는 군, RR=0.42, 95% CI: 0.02-7.69, p=0.56). 결론: H. pylori 제균 치료는 일반 집단, 특히 아시아 지역에서 위암 발생 위험을 낮춘다. 제균 치료의 위암 예방 효과는 10년 이상 장기간 추적관찰 하였을 때 유의하다. 한편, 전암성 병변이 있는 일반 집단에서 위암 예방을 위해 H. pylori 제균 치료를 시행하는 것은 아직 근거가 명확하지 않아 권고하기 어렵다. 따라서 앞으로 이에 대한 더 많은 연구가 필요하다.

Efficacy of alpha-lipoic acid in patients with burning mouth syndrome compared to that of placebo or other interventions: a systematic review with meta-analyses

  • Christy, Jessica;Noorani, Salman;Sy, Frank;Al-Eryani, Kamal;Enciso, Reyes
    • Journal of Dental Anesthesia and Pain Medicine
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    • 제22권5호
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    • pp.323-338
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    • 2022
  • Burning mouth syndrome (BMS) is a chronic oral disorder of unknown etiology which presents therapeutic challenges. Alpha-lipoic acid (ALA) has been studied as a potential treatment for BMS. The objective of this systematic review and meta-analysis was to evaluate the effectiveness of ALA compared to that of placebo or other interventions in individuals with BMS. Randomized controlled trials (RCT) using ALA to treat BMS were identified from MEDLINE, Cochrane Library, EMBASE, and Web of Science up to February 3, 2021. The assessment of the risk of bias in the included studies was based on the Cochrane guidelines. The primary outcome evaluated was the visual analog scale (VAS) pain intensity. ALA was compared with placebo, clonazepam, gabapentin, pregabalin, ALA plus gabapentin, capsaicin, Biotène®, and laser therapy. Altogether, 137 records were scanned for inclusion/exclusion, and nine RCTs (two unclear and seven at high risk of bias) were included in the qualitative and quantitative analyses, with a total of 594 patients with BMS included in this review. All studies reported an improvement in VAS pain scores ranging from -0.72 to -2.77. Meta-analysis results showed a non-significant reduction in pain intensity for ALA (P = 0.616) compared to that of placebo on a VAS of 0-10. Patients taking ALA were 1.923 times more likely to show an improvement in self-reported BMS symptoms (P = 0.031) than those in the placebo group. Clonazepam and pregabalin showed a significant VAS pain reduction of 4.08 and 4.68 (P < 0.001), respectively, compared to that with ALA. Although ALA intervention provided a non-significant improvement in the pain score and was more likely to produce a reduction in BMS symptoms, the evidence was of low quality. Further research is needed to establish clear guidelines for the use of ALA for BMS treatment.

금연에 대한 침술 병용 치료의 효과 및 안전성 : 체계적 검토를 위한 프로토콜 (The effectiveness and safety of acupuncture combination treatment on smoking cessation: A protocol for systematic review)

  • 최인서;성원석;조민기;김정현;박연철;김은정;백용현;김근우;서병관
    • 대한융합한의학회지
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    • 제3권1호
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    • pp.5-13
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    • 2022
  • Objectives: Smoking had a long negative impact on public health. The ingredients of a cigarette are major risk factors for several diseases. Owing to the problems about economic and quality of life, we need to ensure smoking cessation (SC). There are several approaches for SC including pharmacological therapy, nicotine replacement therapy, education, and behavioral intervention. However, due to some limitations, other alternative approaches are gaining popularity. Acupuncture has been reported to have few side effects and be more effective than some conventional treatments in several articles. However, there are no systematic reviews on the comparison of acupuncture combination treatment with other conventional monotherapies. Methods: Randomized controlled trials that used acupuncture as an adjunct treatment for SC will be searched and data will be summarized according to the predefined criteria. The primary outcome will be the abstinence rate, and secondary outcomes will be adverse events and biochemical indicators. We will use Review Manager to perform a meta-analysis, Cochrane Collaboration Risk of Bias tool for the risk of bias assessment, and the Grades of Recommendation, Assessment, Development and Evaluation approach to determine the quality of evidence. We will investigate the efficacy and safety of acupuncture combination treatment for SC with this study. Ethics and dissemination: This study will provide reliable clinical evidence on additional effect of acupuncture on smoking cessation. We will publish our results in a peer-review journal.