Effectiveness and safety of Xuefu Zhuyu oral liquid(血府逐瘀口服液)on Qi-stagnation and blood-stasis pattern in patients with stable angina,tension-type headache and primary dysmenorrhea:rationale and design of a master protocol  

作　　者：CAO Wencong LIAO Shaojun ZHANG Yuanwen ZHOU Li LI Geng OUYANG Wenwei WEN Zehuai 

机构地区：[1]Second Clinical Medical College(Second Affiliated Hospital),Guangzhou University of Chinese Medicine,Guangzhou 510405,China [2]First Clinical Medical College(First Affiliated Hospital),Guangzhou University of Chinese Medicine,Guangzhou 510405,China [3]Key Unit of Methodology in Clinical Research,Guangdong Provincial Hospital of Chinese Medicine,Guangzhou 510120,China [4]State Key Laboratory of Dampness Syndrome of Chinese Medicine,Second Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou 510120,China [5]Science and Technology Innovation Center,Guangzhou University of Chinese Medicine,Guangzhou 510405,China

出　　处：《Journal of Traditional Chinese Medicine》2023年第4期815-823,共9页中医杂志（英文版）

基　　金：the National Key Research and Development Program of China:Research on“the Pattern Dominating Disease”of Postmarket Evaluation on Two Classic Chinese Herbal Formulas based on Basket Design(No.2018YFC1707407)。

摘　　要：We present the rationale and design of a master protocol study that clarifies the effectiveness and safety of Chinese herbal formulas on Qi-stagnation and blood-stasis pattern(QBP).Three randomized controlled trials(RCTs)and real-world observational studies.Based on three registry cohorts of stable angina,tension-type headache and primary dysmenorrhea,patients with QBP will be enrolled in RCTs to receive either Xuefu Zhuyu(血府逐瘀,XFZY)oral liquid or a placebo,while patients with non-QBP will be enrolled in the observational studies and experience follow-up.1414 patients(RCTs:574;observational studies:840)will be recruited at seven centers in China over a 3-year period.The primary outcome is the visual analog scale of pain intensity.Adverse events will also be reported.The analysis will be undertaken separately in each sub-study,and then an overall analysis combining multiple subgroups will be performed to comprehensively investigate the effect of XFZY oral liquid.This study will provide high-quality evidence of XFZY oral liquid for QBP patients and show a paradigm of post-marketing evaluation of the effectiveness and safety for Chinese medicine following the notion of the pattern dominating different disease research models.

关 键 词：ANGINA stable tension-type headache primary dysmenorrhea Chinese herbal formula Chinese medicine pattern master protocol 

分 类 号：R259[医药卫生—中西医结合] R277.7[医药卫生—中医内科学] R271.113[医药卫生—中医学]