论文部分内容阅读
目的 :观察人体对于醋酸甲孕酮 ( DMPA)与十一酸睾酮 ( TU )注射液合用的耐受程度 ,对安全性做出评估以及观察精子发生对 DMPA与 TU不同剂量合用的反应 ,推荐临床应用剂量配伍和注射间隔。方法 :2 5例年龄 2 5～ 45岁的正常男性志愿者 ,筛选合格后纳入该项临床试验。受试者随机分成 5组 ,每组 5例 ,包括 4个剂量配伍试验组( A组 :3 0 0 mg DMPA+1 0 0 0 mg TU,B组 :1 50 mg DMPA+50 0 mg TU,C组 :1 50 mgDMPA+1 0 0 0 mg TU,D组 :3 0 0 mg DMPA+50 0 mg TU)和 1个 1 0 0 0 mg TU单用对照组。整个试验周期为 56周 ,由 8周的对照期、2 4周的抑制期及 2 4周的恢复期组成。各组受试者每 2个月接受指定的剂量配伍注射 ,并定期进行随访。结果 :2 5名受试者均可耐受上述剂量注射、无严重不良反应。仅对照组 1例未达到无精子症 ,其余均达到无精子症。在抑制期 ,各组平均血清睾酮 ( T)浓度在正常范围内显著增加 ,各组平均血清黄体生成素( L H)和卵泡刺激素 ( FSH)水平显著降低 ,在恢复期内三者均逐渐恢复到基线水平 ;各试验组血红蛋白浓度在正常范围内增加 ;血清高密度脂蛋白在正常范围内降低。结论 :DM-PA与 TU不同剂量配伍以 2个月间隔注射均能有效地抑制中国人的精子发生 ,达无精子症水平。注射剂量可耐受 ,且
OBJECTIVE: To observe the degree of human tolerance to combination of DMPA and TU injection, evaluate the safety and observe the reaction of spermatogenesis with different doses of DMPA and TU. Application dose compatibility and injection interval. Methods: Twenty-five normal male volunteers aged 25 to 45 years were screened for inclusion in the clinical trial. Subjects were randomly divided into 5 groups of 5 patients each, including 4 dose compatibility groups (group A: 300 mg DMPA + 100 mg TU, group B: 150 mg DMPA + 50 mg TU, Group C: 1 50 mg DMPA + 100 mg TU, Group D 300 mg DMPA + 50 0 mg TU) and 1 control group with 100 mg TU alone. The entire trial period was 56 weeks, consisting of an 8-week control period, a 24-week inhibitory period, and a 24-week recovery period. Subjects in each group received the prescribed dose of injection every 2 months and were followed up on a regular basis. Results: Twenty-five subjects were able to tolerate the above dose injection without serious adverse reactions. Only one case of control group did not reach azoospermia, the rest reached azoospermia. During the inhibition phase, the average serum testosterone (T) concentration in each group increased significantly in the normal range, mean serum LH and FSH levels decreased significantly in all groups, and all recovered gradually during the recovery phase To baseline; hemoglobin concentration in each experimental group increased within the normal range; serum high-density lipoprotein decreased in the normal range. Conclusion: The combination of different dosages of DM-PA and TU at 2-month intervals can effectively inhibit spermatogenesis in Chinese people without reaching the level of spermatozoa. Injectable doses are tolerable, and