摘要
目的评价国内瘢痕疙瘩及肥厚性瘢痕临床治疗试验的质量,为改变和提高临床治疗试验水平提供依据。方法对1993/2002发表在国内116种医学杂志上的瘢痕疙瘩及肥厚性瘢痕临床治疗试验文献共261篇进行调查和分析。结果随机对照试验(Randomizedcontrolledtrial,RCT)25篇(9.58%),多中心协作3篇(1.15%);RCT中,仅1篇介绍了随机化方法,所有文献均未说明是否盲法;217篇(83.15%)的文献既无纳入标准也无排除标准;疗效标准及疗效评定时间混乱。结论瘢痕疙瘩及肥厚性瘢痕临床治疗试验设计总体有待提高。
AIM:To assess the quality of clinical trials relevant to keloilds and hypertrophic scars in the past 10 years to Chinese medical literatures so as to provide scientific bases for the improvement of clinical treatment level. METHODS:Totally 261 clinical trials for keloids and hypertrophic scars published in 116 domestic medical journals during then years of 1993-2002 were investigated and analyzed.RESULTS:Among the 261 trials,randomized controlled trials(RCTs) were 25 trials(9.58%),multiple center clinical trials were 3 trials(1.15%). Among the RCTs,only 1 issue described the method for randomized allocation and no issues described the blindness.Two hundred and twenty seven clinical trails(83.15%) had neither explicit inclusion criteria for subject selection nor exclusion criteria.The evaluation criteria and the time for therapeutic effect were inconstant.CONCLUSION:The quality of clinical trials relevant to keloids and hypertrophic scars should be improved as a whole.
出处
《中国临床康复》
CSCD
2004年第23期4692-4693,共2页
Chinese Journal of Clinical Rehabilitation
