Effectiveness and Safety Evaluation of Qixiong Zhongzi Decoction (芪芎种子汤) in Idiopathic Asthenozoospermia Treatment:A Randomized Controlled Trial  

作　　者：WANG Fu GAO Qing-he GENG Qiang HAN Qiang ZHAO Jia-you YU Guo-jin ZHANG Ji-wei YAN Bin GUO Jun SONG Chun-sheng 

机构地区：[1]Department of Andrology,Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing(100091),China [2]Department of Andrology,The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin(300193),China [3]Department of Andrology,Beijing Traditional Chinese Medicine Hospital Affiliated to Capital Medical University,Beijing(100010),China [4]Graduate School,China Academy of Chinese Medical Sciences,Beijing(100700),China

出　　处：《Chinese Journal of Integrative Medicine》2020年第2期146-151,共6页中国结合医学杂志（英文版）

基　　金：Supported by the Fundamental Research Funds for the Central Public Welfare Research Institutes(No.ZZ070855)

摘　　要：Objective:To evaluate the clinical effectiveness and safety of the Chinese medicine(CM)Qixiong Zhongzi Decoction(芪芎种子汤,QZD)in the treatment of patients with idiopathic asthenozoospermia.Methods:A total number of 66 patients with idiopathic asthenozoospermia were included and randomly divided into treatment and control groups by SAS-generated code from January 2015 to August 2016,33 patients in each group.Patients in the treatment group were administered with 150 m L of QZD twice a day,whereas those in the control group were given 1 g of levocarnitine oral liquid twice a day.The two groups received the indicated medication for 12 weeks and were then followed up for 4 weeks.The primary outcome was sperm motility,and the secondary therapeutic indices were sperm volume,density,pregnancy probability,and CM syndrome score.The comparison between groups was carried out at 4,8 and 12 weeks,respectively.The safety was determined before and after treatment.Results:(1)Drop-off:5 cases(7.58%)were lost after treatment(2 from the treatment group and 3 from the control group).(2)Primary outcomes:after 8-and 12-week treatment,the progressive sperms in the two groups were significantly higher than the baseline(all P<0.05);however,the treatment group showed greater improvement compared with the control group at 12-week treatment(22.7%±9.0%vs.14.1%±8.8%,P<0.05).The increasement of non-progressive grade sperms at both groups was observed at 8-and 12-week treatment with statistical difference(all P<0.05),however,the treatment group showed remarkable improvement compared with the control group at 12-week treatment(38.7%±14.1%vs.26.2%±15.4%,P<0.05).(3)Secondary outcomes:no significant statistical differences were found in semen volume and density(4,8,and 12-week treatment)and pregnancy probability of patients’wives(12-week treatment)between two groups(all P>0.05),however,the CM syndrome score of the treatment group significantly declined compared with baseline level at each time points(all P<0.05).(4)Safety:no obvious siObjective: To evaluate the clinical effectiveness and safety of the Chinese medicine(CM) Qixiong Zhongzi Decoction(芪芎种子汤, QZD) in the treatment of patients with idiopathic asthenozoospermia. Methods: A total number of 66 patients with idiopathic asthenozoospermia were included and randomly divided into treatment and control groups by SAS-generated code from January 2015 to August 2016, 33 patients in each group. Patients in the treatment group were administered with 150 m L of QZD twice a day, whereas those in the control group were given 1 g of levocarnitine oral liquid twice a day. The two groups received the indicated medication for 12 weeks and were then followed up for 4 weeks. The primary outcome was sperm motility, and the secondary therapeutic indices were sperm volume, density, pregnancy probability, and CM syndrome score. The comparison between groups was carried out at 4, 8 and 12 weeks, respectively. The safety was determined before and after treatment. Results:(1) Drop-off: 5 cases(7.58%) were lost after treatment(2 from the treatment group and 3 from the control group).(2) Primary outcomes: after 8-and 12-week treatment, the progressive sperms in the two groups were significantly higher than the baseline(all P<0.05); however, the treatment group showed greater improvement compared with the control group at 12-week treatment(22.7%±9.0% vs. 14.1%±8.8%, P<0.05). The increasement of non-progressive grade sperms at both groups was observed at 8-and 12-week treatment with statistical difference(all P<0.05), however, the treatment group showed remarkable improvement compared with the control group at 12-week treatment(38.7%±14.1% vs. 26.2%±15.4%, P<0.05).(3) Secondary outcomes: no significant statistical differences were found in semen volume and density(4, 8, and 12-week treatment) and pregnancy probability of patients’ wives(12-week treatment) between two groups(all P>0.05), however, the CM syndrome score of the treatment group significantly declined compared with baseline level at each t

关 键 词：idiopathic asthenozoospermia Qixiong Zhongzi Decoction Chinese medicine random controlled trial 

分 类 号：R277.5[医药卫生—中医学]