张雪 李天人 郭毅
[摘要] 目的 探索使用氨甲环酸治疗狄波-普维拉(DMPA)所致的子宫不规则出血(IUB)的疗效与安全性。 方法 选择2015年12月~2016年12月中国医科大学附属第一医院收治的80例DMPA所致IUB患者,采用块状随机法将其分为氨甲环酸5 d治疗的治疗组和安慰剂5 d治疗的安慰剂组,每组各40例。随访观察4周,通过患者汇报的IUB信息表观察患者的7 d止血例数、28 d无出血时间及不良反应发生情况。 结果 安慰剂组失访1例,治疗组中33例(82.5%)受试者用药后7 d内止血;安慰剂组中10例(25.6%)受试者用药7 d内止血,差异有统计学意义(P < 0.05)。治疗组受试者28 d无出血时长为(20.73±4.07)d,安慰剂组为(11.90±5.78)d,差异有统计学意义(P < 0.05)。治疗组1例患者有轻微恶心。 结论 氨甲环酸治疗DMPA所致的IUB疗效显著,安全性好。
[关键词] 狄波-普维拉;氨甲环酸;疗效;安全性
[中图分类号] R711 [文献标识码] A [文章编号] 1673-7210(2017)05(c)-0121-03
[Abstract] Objective To explore the efficacy and safety of Tranexamic Acid in treating irregular uterine bleeding secondary to Depot-medroxyprogesterone acetat. Methods From December 2015 to December 2016, in First Affiliated Hospital of Chinese Medical Sciences University, 80 patients with irregular uterine bleeding secondary to Depot-medroxyprogesterone acetat treatment were recruited. According to random number table, they were divided into treatment group and placebo group with 40 cases in each group, and they were treated with Tranexamic Acid and placebo respectively. All patients were followed up for 4 weeks, the outcomes were evaluated by the number of blood termination within 7 days and 28-day bleeding-free days and side effects reports were observed by information table. Results One case of the placebo group lost during follow-up, 33 cases (82.5%) in the treatment group and 10 cases (25.6%) in the placebo group stopped bleeding within 7 days after treatment initiation, the difference was statistically significant (P < 0.01). The 28-day bleeding-free proportion in treatment group was (20.73±4.07) d, that in the placebo group was (11.90±5.78) d, the difference was statistically significant (P < 0.01). One case of mild nausea was reported. Conclusion Tranexamic Acid is an effective and safe choice in dealing with irregular uterine bleeding secondary to Depot-medroxyprogesterone acetat treatment.
[Key words] Depot-medroxyprogesterone acetat; Tranexamic Acid; Efficacy; Safety
狄波-普維拉(Depot-medroxyprogesterone acetate,DMPA)是一种长效避孕针,疗效确切,使用方便。但该药容易激发子宫不规则出血(irregular uterine bleeding,IUB),严重影响依从性。有研究发现,DMPA的年依从度为20%~30%,而IUB是患者停药的主要原因[1-3]。事实上,醋酸甲孕酮所致的IUB对患者健康并无重要影响,也与患者疾病发展无相关性[2],因此,控制IUB很可能会提高该药的依从度。IUB的病理机制尚不明确,研究多从子宫内膜形态学、血管显微结构、组织学、生物化学等多种角度进行研究[4-7],发现其与组织因子、维生素E、孕酮受体、前列腺素E2、前列腺素F的浓度相性。目前临床上主要采用1.25 mg联合雌激素给药或2 mg E2连续用药7 d,也可通过持续口服避孕药1~3个月加以缓解[8]。针对DMPA所致的IUB,目前常采用甲芬那酸[9]、伐地考昔[10]进行治疗,但部分患者无法耐受雌激素,因此目前仍在探索更好的治疗方案。氨甲环酸是一种合成性赖氨酸衍生物,能够有效阻止纤维蛋白降解[11-16]。……