• 제목/요약/키워드: Randomized controlled trials

검색결과 1,167건 처리시간 0.026초

혈소판 풍부 혈장 주사 요법: 근거 중심의 분석 (Platelet Rich Plasma Injection: Evidence Based Analysis)

  • 오주한;정석원
    • 대한정형외과 초음파학회지
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    • 제4권2호
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    • pp.111-122
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    • 2011
  • 혈소판 풍부 혈장은 자가 혈액으로부터 농축된 혈소판을 이용하여 성장 인자들을 제공함으로써 손상된 조직의 재생과 치유를 도모한다는 이론적 근거를 배경으로, 근골격계 손상의 치료를 위해 최근 많이 사용되고 있다. 성장 인자를 통한 조직 치유 효과는 여러 기초 과학적 연구를 통해 규명되어 왔고, 혈소판 풍부 혈장을 이용한 동물 연구 및 임상 연구들도 좋은 결과를 보고하고 있다. 그러나, 대부분의 연구들이 혈소판 풍부 혈장의 적용 방법 및 결과 측정 방법 등에서 문헌 별로 차이가 커서 서로 비교가 어렵고, 연구 대상 환자 수가 너무 적거나 대조 군이 없는 등 연구로서의 한계가 있다. 특히 잘 디자인 된 전향적 무작위 대조 연구들은 거의 없는 상황이다. 따라서, 현재까지의 결과를 확증하고 혈소판 풍부 혈장의 임상적 사용에 대한 과학적 근거를 제시하기 위해서는 좀 더 높은 수준의 잘 디자인 된 전향적 무작위 연구가 필요하다 할 수 있다. 결론적으로, 혈소판 풍부 혈장의 임상적 적용은 아직 과학적 근거가 부족한 상황이고, 따라서 혈소판 풍부 혈장을 사용하여 근골격계 질환을 치료할 때는 신중을 기해야 할 것이다.

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비만 환자에서 한방 비만 변증에 따른 방풍통성산과 방기황기탕의 치료효과 및 부작용 비교 : 무작위 배정, 이중 맹검, 위약-대조군 임상시험 (Efficacy and Adverse Events of Bangpungtongseong-san(Bofutsusho-san) and Bangkihwangki-tang(Boiogiot-tang) by Oriental Obesity Pattern Identification on Obese Subjects : Randomized, Double Blind, Placebo-controlled Trial)

  • 박정현;이명종;김호준;홍선우;이동기;유재욱;최선미;문진석;임지연;이정복
    • 한방재활의학과학회지
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    • 제21권2호
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    • pp.265-278
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    • 2011
  • Objectives : This trial were conducted to evaluate the efficacy and adverse events of Bofutsusho-san(BTS) and Boiogiot-tang(BOT) by oriental obesity pattern identification on obese subjects, as compared to placebo. Methods : 166 subjects(body mass index ${\geq}25kg/m^2$) were recruited and randomized to receive BT(n=55), FH(n=55) or placebo(n=56) for 8 weeks. Anthropometric factors, serum lipid, glucose, blood pressure(BP), pulse rate, resting metabolic rate and oriental obesity pattern identification questionnaire were measured at baseline and 8 weeks. Adverse events and safety outcome variables were also checked during trials. Results : The frequency of top-scored oriental obesity pattern was ordered by indigestion(食積) > stagnation of the liver qi(肝鬱) > yang deficiency(陽虛) > spleen deficiency(脾虛) > phlegm(痰飮) > blood stasis(瘀血) in subjects. BTS group significantly decreased body weight, body mass index(BMI), waist circumference(WC), body fat mass, total cholesterol and HDL-cholesterol in stagnation of the liver qi(肝鬱) and WC in indigestion(食積). BOT group showed significant decrease of body weight, BMI, WC, and body fat mass in indigestion(食積) not in deficiency(虛症). Adverse events were reported most frequently in yang deficiency(陽虛) by BT group and stagnation of the liver qi(肝鬱) by BOT group. Conclusions : Bofu-tsusho-san was effective in treating obesity with stagnation of the liver qi(肝鬱). Obesity pattern identification could be a useful diagnostic tool predicting treatment effects and adverse events.

Efficacy and Safety of COVID-19 Vaccines in Adolescents: Systematic Review of Randomized Controlled Studies and Observational Studies

  • Soo-Han Choi;Su-Yeon Yu;Jimin Kim;Miyoung Choi;Youn Young Choi;Jae Hong Choi;Ki Wook Yun;Young June Choe
    • Pediatric Infection and Vaccine
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    • 제31권1호
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    • pp.12-24
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    • 2024
  • 본세계적으로 소아 코로나바이러스 감염 2019 (COVID-19) 환자 수가 질병 초기와 비교하여 증가하고 있으며, 이는 고도로 전염성이 있는 중증 급성 호흡기 증후군 코로나바이러스 변이와 성인 COVID-19 백신 접종 증가와 관련이 있다. 본 연구는 청소년 대상 COVID-19 백신 접종의 무작위 임상시험 (randomized controlled trial, RCT) 후향적 관찰연구를 대상으로 신속 체계적 문헌고찰과 메타 분석을 수행했다. 체계적 문헌고찰 결과, 17개의 연구가 최종적으로 포함되었다. 메타 분석 결과, 청소년 대상 예방접종은 후향적 관찰 연구에서 COVID-19 감염을 예방하는 데 유의미하게 효과적이었으나 (risk ratio [RR], 0.29; 95% confidence interval [CI], 0.22-0.37; I2=100%), RCT보다 COVID-19 감염을 예방하는 효과가 낮았다 (RR, 0.05; 95% CI, 0.01-0.27). 5개의 후향적 관찰 연구에서, 국민 10만 명당 심근염 및/또는 심낭염 비율은 2.33명 (95% CI, 0.97-5.61 명)이었다. 성별 및 백신 접종 횟수에 따른 하위 그룹 분석 결과, 남성 (국민 10만 명당 5.35 명) 및 두 번째 접종 (국민 10만 명당 9.71명)은 여성 (국민 10만 명당 1.09명) 및 첫 번째 접종 (국민 10만 명당 1.61명)보다 심근염 및/또는 심낭염 발생률이 유의하게 높았다. 본 연구에서는 청소년을 대상으로 mRNA COVID-19 백신을 접종하는 것은 RCT 및 관찰연구 모두에서 COVID-19에 대해 효과적이었다. 또한 청소년 대상 BNT162b2 백신의 안전성 결과를 탐색하였으며, 성별 및 백신 접종 횟수에 따른 안전성의 차이를 확인했다. 향후 mRNA COVID-19 예방접종 후 부작용 발생은 계속 모니터링할 필요가 있다.

Efficacy of ketamine in the treatment of migraines and other unspecified primary headache disorders compared to placebo and other interventions: a systematic review

  • Chah, Neysan;Jones, Mike;Milord, Steve;Al-Eryani, Kamal;Enciso, Reyes
    • Journal of Dental Anesthesia and Pain Medicine
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    • 제21권5호
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    • pp.413-429
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    • 2021
  • Background: Migraine headaches are the second leading cause of disability worldwide and are responsible for significant morbidity, reduction in the quality of life, and loss of productivity on a global scale. The purpose of this systematic review and meta-analysis was to evaluate the efficacy of ketamine on migraines and other primary headache disorders compared to placebo and other active interventions, such as midazolam, metoclopramide/diphenhydramine, and prochlorperazine/diphenhydramine. Methods: An electronic search of databases published up to February 2021, including Medline via PubMed, EMBASE, Web of Science, and Cochrane Library, a hand search of the bibliographies of the included studies, as well as literature and systematic reviews found through the search was conducted to identify randomized controlled trials (RCTs) investigating ketamine in the treatment of migraine/headache disorders compared to the placebo. The authors assessed the risk of bias according to the Cochrane Handbook guidelines. Results: The initial search strategy yielded 398 unduplicated references, which were independently assessed by three review authors. After evaluation, this number was reduced to five RCTs (two unclear risk of bias and three high risk of bias). The total number of patients in all the studies was 193. Due to the high risk of bias, small sample size, heterogeneity of the outcomes reported, and heterogeneity of the comparison groups, the quality of the evidence was very low. One RCT reported that intranasal ketamine was superior to intranasal midazolam in improving the aura attack severity, but not duration, while another reported that intranasal ketamine was not superior to metoclopramide and diphenhydramine in reducing the headache severity. In one trial, subcutaneous ketamine was superior to saline in migraine severity reduction; however, intravenous (I.V.) ketamine was inferior to I.V. prochlorperazine and diphenhydramine in another study. Conclusion: Further double-blind controlled studies are needed to assess the efficacy of ketamine in treating acute and chronic refractory migraines and other primary headaches using intranasal and subcutaneous routes. These studies should include a long-term follow-up and different ketamine dosages in diagnosed patients following international standards for diagnosing headache/migraine.

캥거루 케어가 미숙아와 어머니에게 미치는 효과 : 체계적 문헌고찰 및 메타분석 (Effects for kangaroo care: systematic review & meta analysis)

  • 임정희;김가은;신영희
    • 한국산학기술학회논문지
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    • 제17권3호
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    • pp.599-610
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    • 2016
  • 본 연구는 미숙아와 어머니를 대상으로 캥거루 케어 효과를 비교하기 위해 수행된 체계적 문헌고찰 및 메타분석 연구이다. 2015년 2월까지 출간된 무작위 임상실험연구를 검토하였으며, 국내문헌은 연구설계수준에 따른 제한 없이 비무작위 임상실험연구를 포함하였다. 문헌은 Ovid-Medline, CINAHL, PubMed와 국내 DB인 KoreaMed, 국립중앙도서관, 국회도서관, 국가과학기술전자도서관, KISS, RISS, 한국의학논문을 통해 ((kangaroo OR KC OR skin-to-skin) AND (care OR contact)) AND (infant OR preterm OR Low Birth Weight OR LBW), ((캥거루 OR 캉가루 OR 캉가루식) AND (케어 OR 간호 OR 관리 OR 돌보기 OR 피부접촉)) 등을 주요어로 조합하여 검색하였으며, 선택배제과정을 거쳐 최종 25편(n=3051)의 문헌이 분석에 포함되었다. 문헌에 대한 질평가는 SIGN에서 제시한 평가도구를 사용하였으며, 질평가 결과는 16편에서 ++, 9편에서 +로 평가되어 전반적으로 비뚤림 위험은 없는 것으로 판단하였다. 미숙아를 대상으로 한 캥거루 케어의 효과에 대한 메타분석 결과, 미숙아 사망률, 중증 감염/패혈증 발생률, 저체온 발생률, 병원입원기간, 모유수유율, 수면상태, 어머니의 불안, 어머니 역할수행 자신감, 어머니 역할수행 만족도에서 통계적으로 유의한 효과가 있었으며, 고체온 발생률, 미숙아의 성장발달(신장, 체중), 모아애착, 우울, 스트레스는 유의미한 차이가 없었다. 국내에서 캥거루 케어에 대한 무작위 임상실험연구 수가 적어 효과크기에 대한 확증적 결과를 얻는 데에는 다소 제한이 있었으므로 향후 이와 관련된 무작위 임상실험연구의 효과검증에 대한 노력이 지속적으로 이루어져야 할 것으로 사료된다.

가와사키병에서의 TNF-alpha 유전자의 다형성 및 관상동맥 합병증과의 연관성 (Polymorphisms of tumor necrosis factor-alpha promotor gene in Kawasaki disease and relation to the risk of coronary artery lesion)

  • 김세화;윤장원;이영혁;천은정
    • Clinical and Experimental Pediatrics
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    • 제52권4호
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    • pp.476-480
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    • 2009
  • 목 적 : 저자들은 가와사키병 환아에서 TNF-alpha 유전자의 다형성을 조사함으로써 가와사키병과 유전자 다형성의 관련 여부를 알아보고, 또한 관상동맥 병변의 발생과 연관이 있는지를 살펴보려 하였다. 방 법 : 2003년 1월부터 2007년 1월까지 가와사키병 환아 51명과 대조군 48명을 대상으로 TNF-alpha 촉진자의 단일 유전자 다형성을 살펴보았으며, 가와사키병 환아 중 관상동맥 병변이 있는 24명(관상동맥병변군)과 관상동맥 이상이 없었던 27명(정상관상동맥군)에서의 유전자 다형성을 또한 비교하였다. 말초 혈액에서 DNA를 추출하여 TNF-alpha 유전자 -308 부위의 촉진자에 위치한 2개의 단일 염기 서열 G/A에 대한 대립 유전자의 다형성을 Polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP) 방법으로 분석하였다. 결 과 : 가와사키병 환아군에서의 -308번 TNF-alpha 유전자의 다형성은 51명 중 9명으로 17.6%였고, 정상 대조군에서는 48명 중 3명으로 6.8%로 가와사키병 환아군에서 높았으나 통계학적으로 유의성은 없었다. 가와사키병 환아 중 관상동맥병병군 24명 중 3명인 12.5%에서 유전자 다형성이 있었고 정상관상동맥군은 27명 중 6명인 22.2%로 정상관상동맥군에서 더 높은 빈도 이었으나 통계학적으로 유의하지 않았다. 결 론 : 본 연구에서는 가와사키병 환아의 TNF-alpha의 다형성과 가와사키병의 발병과의 관련성이 통계학적으로 유의한 수준은 아니지만 가와사키병 환아에서 G/A 빈도수가 17.6%으로 대조군에서 6.8% 보다 다소 높게 나타난 결과를 얻었고 앞으로 많은 수의 환아를 대상으로 한다면 유의한 차이가 있을 것으로 생각되므로 향후 대규모의 지속적인 연구가 필요할 것이다.

Comparison Different Methods of Intraoperative and Intraperitoneal Chemotherapy for Patients with Gastric Cancer: A Meta-analysis

  • Huang, Jin-Yu;Xu, Ying-Ying;Sun, Zhe;Zhu, Zhi;Song, Yong-Xi;Guo, Peng-Tao;You, Yi;Xu, Hui-Mian
    • Asian Pacific Journal of Cancer Prevention
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    • 제13권9호
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    • pp.4379-4385
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    • 2012
  • Purpose: To investigate the efficacy and safety of intraperitoneal chemotherapy (IPC) for patients with gastric cancer and to compare effects between different regimens of IPC. Method: Randomized controlled trials comparing the effects of surgery plus intraperitoneal chemotherapy with surgery alone or comparing the efficacy between different regimens of intraperitoneal chemotherapy were searched for in Medline, Embase, Pubmed, the Cochrane Library and the Chinese BioMedical Disc and so on by two independent reviewers. After quality assessment and data extraction, data were pooled for meta-analysis using RevMan5.16 software. Tests of interaction were used to test for differences of effects among subgroups grouped according to different IPC regimens. Results: Fifteen RCTs with a total of 1713 patients with gastric cancer were included for quality assessment and data extraction. Ten studies were judged to be of fair quality and entered into meta-analysis. Hyperthermic intraoperative intraperitoneal chemotherapy (HR=0.60, P<0.01), hyperthermic intraoperative intraperitoneal chemotherapy plus postoperative intraperitoneal chemotherapy (HR=0.47, P<0.01) and normothermic intraoperative intraperitoneal chemotherapy (HR=0.70, P=0.01) were associated with a significant improvement in overall survival. Tests of interaction showed that hyperthermia and additional postoperative intraperitoneal chemotherapy did not impact on its effect. Further analysis revealed that intraperitoneal chemotherapy remarkably decrease the rate of postoperative hepatic metastasis by 73% (OR=0.27, 95% CI=0.12 to 0.67, P<0.01). However, intraperitoneal chemotherapy increased risks of marrow depression (OR=5.74, P<0.01), fever (OR=3.67, P=0.02) and intra-abdominal abscess (OR=3.57, P<0.01). Conclusion: The present meta-analysis demonstrates that hyperthermic intraoperative intraperitoneal chemotherapy and normothermic intraoperative intraperitoneal chemotherapy should be recommended to treat patients with gastric cancer because of improvement in overall survival. However, it is noteworthy that intraperitoneal chemotherapy can increase the risks of marrow depression, intra-abdominal abscesses, and fever.

Efficacy and Toxicity of Anti-VEGF Agents in Patients with Castration-Resistant Prostate Cancer: a Meta-analysis of Prospective Clinical Studies

  • Qi, Wei-Xiang;Fu, Shen;Zhang, Qing;Guo, Xiao-Mao
    • Asian Pacific Journal of Cancer Prevention
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    • 제15권19호
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    • pp.8177-8182
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    • 2014
  • Background: Blocking angiogenesis by targeting vascular endothelial growth factor (VEGF) signaling pathway to inhibit tumor growth has proven to be successful in treating a variety of different metastatic tumor types, including kidney, colon, ovarian, and lung cancers, but its role in castration-resistant prostate cancer (CRPC) is still unknown. We here aimed to determine the efficacy and toxicities of anti-VEGF agents in patients with CRPC. Materials and Methods: The databases of PubMed, Web of Science and abstracts presented at the American Society of Clinical Oncology up to March 31, 2014 were searched for relevant articles. Pooled estimates of the objective response rate (ORR) and prostate-specific antigen (PSA) response rate (decline ${\geq}50%$) were calculated using the Comprehensive Meta-Analysis (version 2.2.064) software. Median weighted progression-free survival (PFS) and overall survival (OS) time for anti-VEGF monotherapy and anti-VEGF-based doublets were compared by two-sided Student's t test. Results: A total of 3,841 patients from 19 prospective studies (4 randomized controlled trials and 15 prospective nonrandomized cohort studies) were included for analysis. The pooled ORR was 12.4% with a higher response rate of 26.4% (95%CI, 13.6-44.9%) for anti-VEGF-based combinations vs. 6.7% (95%CI, 3.5-12.7%) for anti-VEGF alone (p=0.004). Similarly, the pooled PSA response rate was 32.4% with a higher PSA response rate of 52.8% (95%CI: 40.2-65.1%) for anti-VEGF-based combinations vs. 7.3% (95%CI, 3.6-14.2%) for anti-VEGF alone (p<0.001). Median PFS and OS were 6.9 and 22.1 months with weighted median PFS of 5.6 vs. 6.9 months (p<0.001) and weighted median OS of 13.1 vs. 22.1 months (p<0.001) for anti-VEGF monotherapy vs. anti-VEGF-based doublets. Conclusions: With available evidence, this pooled analysis indicates that anti-VEGF monotherapy has a modest effect in patients with CRPC, and clinical benefits gained from anti-VEGF-based doublets appear greater than anti-VEGF monotherapy.

야제 (夜啼)의 한의학 치료에 대한 최신 중의학 임상 연구 동향 -2000년대 이후 발표된 임상 연구 논문을 중심으로- (Review of Clinical Research Literatures on Effect of Traditional Chinese Medicine for Pediatric Night Crying)

  • 김상민;이진용;이선행;도태윤
    • 대한한방소아과학회지
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    • 제32권3호
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    • pp.100-118
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    • 2018
  • Objectives The purpose of this study is to analyze some of the TCM (traditional Chinese medicine) clinical research literatures about pediatric night crying in order to learn clinical application of Korean medicine treatment for pediatric night crying. Methods We searched clinical trial literatures about TCM treatment of pediatric night crying from the CNKI (China National Knowledge Infrastructure) (January 2000 to June 2018). We analyzed the literature in regards to the treatment methods and the results. Results Among the 459 searched studies, 13 randomized controlled trials and 41 case studies were selected and analyzed. In most of the studies, the effectiveness of TCM in treating patients was significantly high, so we confirmed the effectiveness of TCM on pediatric night crying. The most commonly used pattern differentiations (辨證) were Spirit damage due to fright and fear (驚恐傷神), Spleen deficiency and cold (脾虛寒) and Heart fire heat (心火熱). Methods of treatment include herbal medicines (internal medicine and external application), massage therapy (Tuina methods), acupuncture and other treatments (bloodletting). The most commonly used herb medicines were Cicadidae Periostracum (蟬?), Poria Cocos (茯?), Glycyrrhizae Radix (甘草), Uncariae Ramulus et Uncus (釣鉤藤), Junci Medulla (燈心草), Fossilia Ossis Mastodi (龍骨), Atractylodis Rhizoma Alba (白朮), Cinnabaris (朱砂), and Coptidis Rhizoma (黃連). The most commonly used massage methods were Clearing Liver Channel (淸肝經), Clearing Heart Channel (淸心經), Kneading $Xi{\check{a}}oti{\bar{a}}nx{\bar{i}}n$ (?小天心), Supplementing Spleen Channel (補脾經), Clearing $Ti{\bar{a}}nh{\acute{e}}shu{\check{i}}$ (淸天河水), and Rubbing Abdomen (摩腹). Conclusions Based on the results of clinical studies from China, the use of Korean medicine for the treatment of pediatric night crying has been shown to be effective in relieving symptoms. Based on the results of this study, it is possible to widen the scope of Korean medicine by additionally reviewing clinical and experimental studies on pediatric night crying.

한의약 금연 임상연구의 체계적 고찰 - 연구 설계를 중심으로 (A Systematic Review on clinical studies of Korean medicine for smoking cessation - Focusing on study design)

  • 박유리;장수빈;성현경;권승욱;성주원;양재형;박봉규;고성규;박선주
    • 대한예방한의학회지
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    • 제19권3호
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    • pp.115-129
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    • 2015
  • Objective : This study aims to review clinical studies evaluating effectiveness of Korean medicine for smoking cessation. It also aims to critically analyze study design of the studies and suggest strategies for future clinical studies on smoking cessation. Method : Only domestic databases such as RISS, KISS, DBPIA, NDSL, and OASIS were searched from August to November 2011 for clinical studies on smoking cessation. There was no limitation on study design, period, and language. The studies were qualitatively analyzed focusing on study design including participants, intervention, and outcome measurements. Results : Out of 537 studies searched, 27 studies were included in the analysis. 56% of the studies were observational studies, 33% were quasi-experimental studies, and 11% were randomized controlled studies. 44% and 32% of the studies were conducted at educational institutions and hospitals, respectively. The average number of the participants were 182, which ranged from 15 to 1,056. Most of the participants were male. Intervention used were mostly auricular acupuncture, and the most frequently used acupoints were Lung, Shinmun, Endocrine, Pharynx & Larynx, and Inner nose. The average length of treatment period was four weeks, and the treatment was provided twice per week. The outcomes were measured at the end of the treatment and only 26% of the studies conducted follow-up measurements. 26% of the studies utilized questionnaires of which validity was evaluated and only 15% used objective measurements such as exhaled Carbon monoxide and Cotinine test. Conclusion : Though many clinical studies on effectiveness of Korean medicine for smoking cessation were conducted, there are still debates on quality of evidence. Recently, guidelines have been developed for clinical trials evaluating effectiveness of smoking cessation program. Thus, in the future, clinical studies should be developed based on these guidelines and designed to improve validity and reliability.