A placebo-controlled double-blind randomized trial of the use of combined L-carnitine and L-acetyl-carnitine treatment in men with asthenozoospermia

复合左旋肉碱对男性弱精子症的治疗—— 设有安慰剂对照组的双盲随机试验结果报告

Objective: To determine the efficacy of combined L-carnitine and L-acetyl-carnitine therapy in infertile males
with oligo-astheno-teratozoospermia.
试验目的：检测复合左旋肉碱（左旋肉碱 + 乙酰左旋肉碱）疗法，对由少精、弱精和/或精子畸形引起的男性不育的治疗效果。

Design: Placebo-controlled double-blind randomized trial.
设计方案：设有安慰剂对照组的双盲随机试验

Setting: University tertiary referral center.
场所：三所大学的医学治疗中心

Patient(s): Sixty infertile patients (aged 20–40 years) with the following baseline sperm selection criteria:
concentration, 10 to 40 x 106/mL; forward motility, <15%; total motility, 10% to 40%; and atypical forms,
<80%. Fifty-six patients completed the study.
试验病人：60名不育病人（年龄20-40岁），起始精子检测的指标至少达到以下入选标准：
精子浓度为10-40 X 106/mL，精子的前向活动率，小于15%，总活动率10%-40%，非典型形式小于80%，56名病人完成了本试验。

Intervention(s): Patients were submitted to a combined treatment of L-carnitine (2 g/d) and L-acetyl-carnitine
(1 g/d) or of placebo; the study design was 2 months’ wash-out, 6 months of therapy or of placebo, and 2 months’ follow-up.
干预措施：病人服用复合左旋肉碱，即：左旋肉碱（2g/天）加乙酰左旋肉碱（1g/天）进行治疗；或服用安慰剂，研究时间计：2个月无药的洗脱期，6个月服用复合左旋肉碱/安慰剂，再加个月跟踪。

Main Outcome Measure(s): Variation in the semen parameters that were used for patient selection.
主要结果测量：测量病人的精子参数变化。

Result(s): Even though increases were seen in all sperm parameters after combined carnitine treatment, the most significant improvement in sperm motility (both forward and total) was present in patients who had lower initial absolute values of motile sperm (<4 x 106 forward or <5 x 106 total motile spermatozoa per ejaculate).
结果：实验结果表明，服用复合左旋肉碱治疗后，精子的所有参数都有所提高，尤其是精子的活动能力（包括前向活动率和总活动率）的提高，在初始值比较差的病人（即每次射出的精液中前向活动率小于4 x 106，或总活动率小于5 x 106的病人）中的作用特别明显。

Conclusion(s): Combined treatment with L-carnitine and L-acetyl-carnitine in a controlled study of efficacy
was effective in increasing sperm motility, especially in groups with lower baseline levels.
结论：根据此设有对照组的双盲试验研究结果表明，复合左旋肉碱能提高精子的活动度，尤其是对治疗前基数较低的病人更为有效。
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