CAJ | 학술논문

目的：评价中医药治疗肝硬化腹水随机对照临床试验的质量。方法：检索国内外数据库中有关中医药治疗肝硬化腹水随机对照临床试验的文献，参照 Cochrane 手册有关临床试验评价标准对其进行分析和质量评价。结果：通过筛选最终纳入560篇相关临床试验文献进行研究，发现样本量在60例以上的临床研究仅占13．57％；所有临床试验均选择阳性药作为对照；只有52篇文献报道的试验选用了低偏倚风险的随机方法，且普遍缺乏对随机分配的隐藏；实施盲法的临床试验文献只有6篇；326篇文献描述了使用的统计方法；518篇文献进行了组间均衡性的比较；大多数临床试验过程中缺乏对不良反应的监测以及对病例随访／脱失的记录。结论：目前国内外已报道的中医药治疗肝硬化腹水的随机对照临床试验数量较多，但大部分质量偏低，亟需依据临床试验评价标准来开展相关试验，以提高临床试验质量，增强证据力度。
목적：평개중의약치료간경화복수수궤대조림상시험적질량。방법：검색국내외수거고중유관중의약치료간경화복수수궤대조림상시험적문헌，삼조 Cochrane 수책유관림상시험평개표준대기진행분석화질량평개。결과：통과사선최종납입560편상관림상시험문헌진행연구，발현양본량재60례이상적림상연구부점13．57％；소유림상시험균선택양성약작위대조；지유52편문헌보도적시험선용료저편의풍험적수궤방법，차보편결핍대수궤분배적은장；실시맹법적림상시험문헌지유6편；326편문헌묘술료사용적통계방법；518편문헌진행료조간균형성적비교；대다수림상시험과정중결핍대불량반응적감측이급대병례수방／탈실적기록。결론：목전국내외이보도적중의약치료간경화복수적수궤대조림상시험수량교다，단대부분질량편저，극수의거림상시험평개표준래개전상관시험，이제고림상시험질량，증강증거력도。
Objective:To assess the quality of randomized controlled trials of ascites due to cirrhosis treated with chinese medicine or in-tegrated Chinese medicine and western medicine.Methods: the articles about randomized controlled trials of ascites due to cirrhosis treated with chinese medicine or integrated chinese medicine and western medicine in domestic and international databases were srarched, and the quality of these trials according to the assessment standard for clinical trials in Cochrane Handbook was assessed.Results:Five hundred and sixty articles of related trails were screened to study finally.It was found that only 13.57% of trails had more than 60 samples.All trails had positive drugs as control.The methods with low risk to generate random sequence had been used only in 52 trails, and most of them didn’t do well in allocation concealment.Blinding had been used only in 6 trails.326 articles showed their statistical methods.518 trails had the com-parison of equilibrium between the two groups.Most trails lacked the monitor of adverse reactions and the records of following up or dropping out of patients.Conclusion: There are a number of randomized controlled trials of ascites due to cirrhosis treated with chinese medicine or in-tegrated Chinese medicine and western medicine reported at home and abroad, but most of them are of low quality.We need the trails based on assessment standard of clinical trials to improve their quality and enhance the evidence strength.