優(yōu)良的設(shè)計(jì)是臨床研究成功的重要因素。異常子宮出血是婦科常見疾病,也是中醫(yī)藥治療的優(yōu)勢(shì)病種之一。在參考國(guó)內(nèi)外最新診療和評(píng)價(jià)指南、技術(shù)指導(dǎo)原則、專業(yè)權(quán)威著作、最新學(xué)術(shù)進(jìn)展的基礎(chǔ)上,結(jié)合本機(jī)構(gòu)與相關(guān)科室多年的臨床試驗(yàn)設(shè)計(jì)與實(shí)踐經(jīng)驗(yàn),簡(jiǎn)要介紹了異常子宮出血的定義、范疇、流行病學(xué)特點(diǎn)、預(yù)后以及最新藥物研究概況,重點(diǎn)分析了中藥治療異常子宮出血臨床試驗(yàn)的研究路徑、設(shè)計(jì)與評(píng)價(jià)的考慮要點(diǎn),以期為治療該病的中藥臨床研究設(shè)計(jì)提供參考。

Excellent design is crucial for clinical research. Abnormal uterine bleeding (AUB) is one of the most difficult problems in the department of gynecology and one of the diseases benefit most from traditional Chinese medicine (TCM) treatment. This paper gives a brief introduction on the definition, category, epidemiology, prognosis, and general situation of the latest drug treatment, based on the latest treatment and evaluation guidelines, technical guidance, professional authority work as well as the latest academic progress literature. In addition, combined with many years' experience of clinical trial design and practice, it illustrates some key considerations on the designs of TCM drugs intended for the treatment of AUB. It hopes to offer helps for research design team in this genera.