单位：[1]The First Affiliated Hospital, Sun Yat-Sen University, and院本部中山大学附属第一医院[2]Guangzhou Red Cross Hospital Affiliated to Medical College of Jinan University, Guangzhou, Guangdong Province,[3]The Second Affiliated Hospital of Chinese Medical University, Shenyang, Liaoning Province,[4]The First Affiliated Hospital of Anhui University, Hefei, Anhui Province,[5]Zhongshan Hospital Affiliated to Xiamen University, Xiamen, Fujian Province,[6]The Second Xiangya Hospital of Central South University, Changsha, Hunan Province,[7]China-Japan Union Hospital of Jilin University, Changchun, Jilin Province,吉林大学中日联谊医院[8]The Third Hospital of Peking University,[9]Beijing FriendshipHospital, CapitalMedical University, and[10]The First Hospital of PekingUniversity, Beijing,[11]Changhai Hospital of Shanghai, Second Military Medical University, Shanghai,[12]Qilu Hospital of Shandong University, Jinan, Shandong Province,[13]The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi Province,[14]Tongji Hospital, Tongji Medical College,[15]Union Hospital, TongjiMedical College, Huazhong University of Science and Technology, Wuhan, Hubei Province and华中科技大学同济医学院附属协和医院[16]The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China
Background and Aim The treatment of patients with functional dyspepsia (FD) remains unsatisfactory. We assessed the efficacy of Zhizhu Kuanzhong (ZZKZ) capsule, a traditional Chinese medicine formula, in patients with postprandial distress syndrome (PDS) of FD. Methods The study was designed as a multicenter, randomized, double-blinded, controlled clinical trial. Three-hundred ninety-two patients with PDS defined by Rome III criteria from 16 centers in China were randomly assigned to receive either ZZKZ or placebo. The proportion of the responders at 4 weeks after randomization was considered primary endpoint. Secondary endpoint was the symptom score reduction of each dyspeptic symptom relative to the baseline at 4 weeks after randomization in all subjects. Results In terms of the primary endpoint, the proportion of the responders concerning the composite PDS symptom score was 38.8% and 54.7% in placebo group and ZZKZ group, respectively (P = 0.003), in per protocol analysis at 4 weeks after randomization. Concerning the individual evaluated upper gastrointestinal symptoms, only postprandial fullness and early satiety showed significant difference in symptom score reduction at 4 weeks after randomization between placebo and ZZKZ groups. Conclusions Zhizhu Kuanzhong is superior to placebo in the treatment of PDS with FD. The exact mechanisms by which ZZKZ improves symptoms remain to be established ().
基金：
Longch Group Shanxi Shuang Ren Pharmaceuticals Co. Ltd, Shangxi Province, China
第一作者单位：[1]The First Affiliated Hospital, Sun Yat-Sen University, and
通讯作者：
通讯机构：[1]The First Affiliated Hospital, Sun Yat-Sen University, and[*1]The First Affiliated Hospital, Sun Yat-Sen University, No. 58, ZhongShan 2 Road, Guangzhou, Guangdong Province, China.
推荐引用方式(GB/T 7714)：
Xiao Yinglian,Li Yuwen,Shu Jianchang,et al.The efficacy of oral Zhizhu Kuanzhong, a traditional Chinese medicine, in patients with postprandial distress syndrome[J].JOURNAL of GASTROENTEROLOGY and HEPATOLOGY.2019,34(3):526-531.doi:10.1111/jgh.14467.
APA：
Xiao, Yinglian,Li, Yuwen,Shu, Jianchang,Li, Yan,Xu, Jianming...&Chen, Minhu.(2019).The efficacy of oral Zhizhu Kuanzhong, a traditional Chinese medicine, in patients with postprandial distress syndrome.JOURNAL of GASTROENTEROLOGY and HEPATOLOGY,34,(3)
MLA：
Xiao, Yinglian,et al."The efficacy of oral Zhizhu Kuanzhong, a traditional Chinese medicine, in patients with postprandial distress syndrome".JOURNAL of GASTROENTEROLOGY and HEPATOLOGY 34..3(2019):526-531
