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目的 :观察正常中国男性每 2个月注射一次长效醋酸甲孕酮 /十一酸睾酮 (DMPA/TU)抑制精子发生的效果。 方法 :30例年龄在 2 5～ 4 0岁已婚的健康中国男性在体检及化验筛查合格后参加本试验 ,并被随机分成 3组 :1个TU单用组 (1 0 0 0mgTU)和 2个DMPA/TU合用组 (1 0 0 0mgTU +1 5 0mgDMPA ,1 0 0 0mgTU +30 0mgDMPA) ,每组各 1 0例 ,以 8周间隔进行注射。试验共计 5 6周 :对照期 8周、抑制期 2 4周和恢复期 2 4周。 结果 :在抑制期 ,除了TU单用组有 2例精子密度出现反跳 ,其余所有受试者均达到无精子状态。所有志愿者都能耐受试验 ,没有发生严重不良反应。 结论 :在本试验条件下 ,TU单用能抑制精子发生但抑制效果不恒定 ,而DMPA/TU合用能恒定地抑制精子发生 ,1 0 0 0mgTU +1 5 0mgDMPA是最佳剂量组合 ,可用于进一步的临床扩大试验或避孕有效性试验。
OBJECTIVE: To observe the effect of long-acting DMPA / TU injection on the spermatogenesis in normal Chinese men every two months. Methods: Thirty healthy Chinese men aged 25 ~ 40 years old were enrolled in this study after physical examination and laboratory screening. They were randomly divided into 3 groups: 1 TU single group (100 mg TU) and Two DMPA / TU combined groups (100 mg TU + 150 mg DMPA, 100 mg TU + 300 mg DMPA) were injected intraperitoneally at intervals of 10 weeks. A total of 56 weeks of trial: control period of 8 weeks, 24 weeks of inhibition and recovery of 24 weeks. Results: During the inhibition phase, except for 2 cases in the TU alone group, the sperm density rebounded, and all the other subjects reached the state of azoospermia. All volunteers were able to tolerate the trial without serious adverse reactions. Conclusion: Under the test conditions, TU alone can inhibit spermatogenesis but the effect of inhibition is not constant, and DMPA / TU combination can constrain spermatogenesis constantly. The best dose combination of 100 mg TU +150 mg DMPA can be used for further Clinical Expansion Test or Contraceptive Effectiveness Test.