中医药及中西医结合治疗乳腺癌研究文献的质量评价

Quality Analysis of Literature of Traditional Chinese Medicine or Integrated Traditional and Western Medicines on Breast Cancer

目的对近二十年来有关乳腺癌中医药及中西医结合的治疗性文献进行系统性评价,了解研究质量的总体水平及中医药及中西医结合治疗乳腺癌的有效性。方法按照临床流行病学及循证医学的原则和方法,对1981-2001年CBMdisc与TCMLRS两库公开发表的、研究中医药及中西医结合治疗乳腺癌方面的临床文献进行质量评价。结果共对11篇中医药及中西医结合治疗乳腺癌的临床对照文献进行了质量评价。关于随机化的质量:11篇文献中,提到“随机”字样的文献(RCT)为8篇(有6篇考虑为随机的可信性不足);均没有提到随机分配方法的隐匿。关于盲法:11篇文献均未提及设盲。对不良事件或不良反应的报告与分析:82%的试验中未对不良反应进行观察;只有1篇报告未观察到不良事件及反应发生,1篇试验报告了不良反应的观察,但未说明用何种方法。结论从评价的文献质量来看,近二十年来国内期刊发表的有关乳腺癌中医药及中西医结合治疗性的文献,普遍处于低质量的水平,高质量的文献很少。中医药及中西医结合治疗乳腺癌的疗效尚待根据高质量的大样本随机对照临床试验的结果进一步证实。

Objective To assess the methodological quality of clinical studies about traditional Chinese medicine or integrated traditional and western medicine in treating breast cancer and to evaluate its efficacy and safety. Methods A systematic review of clinical controlled trials or randomized controlled trials(CCT/RCT). A comprehensive search strategy was designed to identify all trials about traditional Chinese medicine or integrated traditional and western medicine in treating breast cancer by searching the CBMdisc and TCMLRS database (1981-2001). The methodological quality of the trials was assessed on a self,made quality assessment scale. Results 11 RCTs/CCTs were identified and assessed. The methodological quality was unsatisfied. There are 8 RCTs, but the reliability of randomized design in 6 trials was dubious. No article refers to randomized secretiveness and blind procedure. 82% articles didn't report the side effects/ adverse events of the medicine. Conclusions It should be improved that the methodological quality of the study about traditional Chinese medicine or integrated traditional and western medicine in treating breast cancer. Further well designed clinical trials should be performed.