地屈孕酮片治疗异常子宫出血患者的临床研究

Clinical trial of dydrogesterone tablets in the treatment of patients with abnormal uterine bleeding

目的比较地屈孕酮片和炔雌醇环丙孕酮片治疗异常子宫出血患者的临床疗效及安全性。方法将140例异常子宫出血患者随机分为对照组和试验组,每组70例。对照组给予炔雌醇环丙孕酮每次2.035 mg,qd,口服,连续服用21 d停药7 d;试验组给予地屈孕酮片每次10 mg,bid,口服,连续服用12 d。2组患者均治疗3个疗程,每个疗程均为28 d。比较2组患者的临床疗效,血清环氧化酶2(COX-2)和前列腺素E2(PGE2)水平,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为95.71%(67例/70例)和72.86%(51例/70例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的血清COX-2分别为(48.30±11.33)和(55.04±12.75)U·L^-1,PGE2分别为(688.63±83.04)和(751.20±94.57)ng·L^-1,差异均有统计学意义(均P<0.05)。试验组发生的药物不良反应有食欲缺乏、乳房肿胀和精神焦虑,对照组发生的药物不良反应有食欲缺乏、乳房胀痛、精神焦虑和头痛。试验组和对照组的总药物不良反应发生率分别为5.71%和10.00%,差异无统计学意义(P>0.05)。结论地屈孕酮片治疗异常子宫出血的临床疗效显著优于炔雌醇环丙孕酮片,前者能够有效地降低COX-2和PGE2的水平,且不增加药物不良反应的发生率。

Objective To compare the clinical efficacy and safety of dydrogesterone tablets and ethinylestradiol and cyproterone acetate tablets in the treatment of patients with abnormal uterine bleeding.Methods A total of 140 patients with abnormal uterine bleeding were randomly divided into control and treatment groups with 70 cases per group.Control group was given ethinylestradiol and cyproterone acetate tablets 2.035 mg per time,qd,orally,continuously for 21 d and stopped for 7 d.Treatment group received dydrogesterone tablets 10 mg pr time,bid,orally,continuously for 12 days.Two groups were treated for 3 cycles with 28 days per cycle.The clinical efficacy,levels of serum cyclooxygenase 2(COX-2)and prostaglandin E2(PGE2),and adverse drug reactions were compared between two groups.Results After treatment,the total effective rates of treatment and control groups were 95.71%(67 cases/70 cases)and 72.86%(51 cases/70 cases)with significant difference(P<0.05).After treatment,the main indexes of treatment and control group were compared:the serum COX-2 were(48.30±11.33)and(55.04±12.75)U·L^-1,PGE2 were(688.63±83.04)and(751.20±94.57)ng·L^-1.The differences were statistically significant(all P<0.05).The adverse drug reactions of treatment group were loss of appetite,breast swelling and mental anxiety,while those in control group were loss of appetite,breast pain,mental anxiety and headache.The incidences of total adverse drug reactions in treatment and control groups were 5.71%and 10.00%without significant difference(P>0.05).Conclusion The clinical efficacy of dydrogesterone tablets in the treatment of abnormal uterine bleeding is significantly better than that of ethinylestradiol and cyproterone acetate tablets.The former can effectively reduce the levels of COX-2 and PGE2,without increasing the incidence of adverse drug reactions.