Department of Andrology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.
Department of Andrology, The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, China.
Chin J Integr Med. 2020 Feb;26(2):146-151. doi: 10.1007/s11655-020-3211-7. Epub 2020 Jan 29.
To evaluate the clinical effectiveness and safety of the Chinese medicine (CM) Qixiong Zhongzi Decoction (, QZD) in the treatment of patients with idiopathic asthenozoospermia.
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 mL 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.
(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 side reactions were found during the treatment in both groups.
QZD could improve the progressive and non-progressive grade sperm in the treatment of idiopathic asthenozoospermia. It is safe with no obvious side effects.
评价中药芪芎种子汤（QZD）治疗特发性弱精子症的临床疗效和安全性。
采用 SAS 产生的随机数字表法，将 2015 年 1 月至 2016 年 8 月期间收治的 66 例特发性弱精子症患者分为治疗组和对照组，每组 33 例。治疗组患者每天服用 QZD150ml，分两次服用；对照组患者每天服用左卡尼汀口服液 1g，分两次服用。两组患者均接受 12 周的治疗，然后随访 4 周。主要结局指标为精子活动力，次要治疗指标为精子体积、密度、妊娠概率和中医证候评分。分别在治疗 4、8 和 12 周时比较两组患者的情况。治疗前后均对安全性进行了评估。
（1）脱落：治疗后有 5 例（7.58%）患者失访（治疗组 2 例，对照组 3 例）。（2）主要结局：治疗 8 周和 12 周后，两组的前向运动精子均明显高于基线水平（均 P<0.05）；但治疗组在治疗 12 周时的改善程度优于对照组（22.7%±9.0%比 14.1%±8.8%，P<0.05）。两组患者的非前向运动精子在治疗 8 周和 12 周时均有增加，差异均有统计学意义（均 P<0.05），但治疗组在治疗 12 周时的改善程度优于对照组（38.7%±14.1%比 26.2%±15.4%，P<0.05）。（3）次要结局：两组患者的精液量和密度（治疗 4、8 和 12 周）以及患者妻子的妊娠概率（治疗 12 周）在治疗期间均无显著统计学差异（均 P>0.05），但治疗组的中医证候评分在各时间点均较基线水平显著下降（均 P<0.05）。（4）安全性：两组患者在治疗期间均未出现明显的不良反应。
芪芎种子汤可改善特发性弱精子症患者的前向运动和非前向运动精子，安全性好，无明显不良反应。
