雷洛昔芬与氯米芬治疗多囊卵巢综合征合并不孕症的临床效果比较

Comparison of Raloxifene and Clomiphene in the Treatment of Polycystic Ovary Syndrome Complicated with Infertility

目的:比较雷洛昔芬与氯米芬治疗多囊卵巢综合征(PCOS)合并不孕症的临床效果。方法:采用回顾性研究法,选择2012年6月-2015年2月在我院治疗的137例PCOS合并不孕症患者的临床资料,按照治疗方案不同分为雷洛昔芬组(70例)和氯米芬组(67例)。雷洛昔芬组患者于月经周期第5天口服盐酸雷洛昔芬片120 mg,qd,连服5 d;氯米芬组患者于月经周期第5天口服枸橼酸氯米芬胶囊100 mg,qd,连服5 d。两组患者均于月经周期第12天行B超检测卵泡直径及子宫内膜发育情况,当子宫内膜厚度≥7 mm、不少于1个卵泡直径≥18 mm时,于腹部皮下注射醋酸曲普瑞林注射液0.1 mg诱发排卵,48 h后B超确认排卵;黄体功能不足者酌情口服地屈孕酮10 mg,q12 h,服用至排卵后15 d。比较两组患者醋酸曲普瑞林注射当日的子宫内膜厚度、直径≥18 mm的卵泡数、卵泡成熟时间,治疗前与醋酸曲普瑞林注射当日的血清性激素水平,排卵情况,随访期间的结局指标,以及不良反应发生情况。结果:雷洛昔芬组患者的子宫内膜厚度明显大于氯米芬组,直径≥18 mm的卵泡数明显多于氯米芬组,卵泡成熟时间明显短于氯米芬组,差异均有统计学意义(P<0.05)。治疗前,两组患者血清孕激素(P)、雌二醇(E2)、卵泡雌激素(FSH)和黄体生存素(LH)水平比较,差异均无统计学意义(P>0.05);醋酸曲普瑞林注射当日,两组患者血清P、E2、FSH与治疗前比较,差异均无统计学意义(P>0.05),但血清LH水平均明显降低,且雷洛昔芬组的LH水平明显低于氯米芬组,差异均有统计学意义(P<0.05)。雷洛昔芬组患者的排卵率明显高于氯米芬组,差异有统计学意义(P<0.05);两组患者的妊娠率、流产率、继续妊娠率比较,差异均无统计学意义(P>0.05)。两组患者总不良反应发生率比较(5.71%vs.8.96%),差异无统计学意义(P>0.05)。结论:雷洛昔芬较氯米芬有更好的促排卵效应,可有效改善PCOS合并不孕症患者的性激素水平,不良反应较少,且与氯米芬的远期临床效应类似。

OBJECTIVE：To compare the clinical efficacy of raloxifene and clomiphene in the treatment of polycystic ovary syndrome（PCOS）complicated with infertility. METHODS：In retrospective study,clinical information of 137 PCOS patients with infertility in our hospital during Jun. 2012-Feb. 2015 were selected and divided into raloxifene group（70 cases） and clomiphene group（67 cases）according to therapy plan. Raloxifene group received Raloxifene tablet 120 mg at the fifth day of menstrual cycle,qd,for consecutive 5 d. Clomiphene group received Clomiphene citrate capsule 100 mg at the fifth day of menstrual cycle,qd,for consecutive 5 d. Both groups received B-ultrasound to detect the follicular diameter and endometrial development at the twelfth day of menstrual cycle. When endometrial thickness was ≥7 mm and the diameter of one follicle was ≥18 mm at least,all patients received abdominal subcutaneous injection of Triptorelin acetate injection 0.1 mg to induce ovulation;after 48 h,ovulation was confirmed by B ultrasound. The patients with insufficient luteal function should take dydrogesterone 10 mg as appropriate,q12 h,till 15 d after ovulation. The endometrial thickness,the number of follicles with diameter≥18 mm and follicular maturation time were compared between 2 groups on the day of injection. The sex hormone levels before treatment and on the day of injection,as well as ovulation,outcome indexes and the occurrence of ADR in 2 groups were compared. RESULTS：The endometrial thickness of raloxifene group was greater than that of clomiphene group;the number of follicles with diameter ≥18 mm was more than clomiphene group;the follicular maturation time was shorter than clomiphene group,with statistical significance（P〈0.05）. Before treatment,there was no statistical significance in serum levels of P,E2,FSH and LH between 2 groups（P〈0.05）. Compared to before treatment,there was no statistical significance in serum levels of P,E2,FSH or LH in 2 groups on the day of injection（P〈0.05）. Serum levels of LH in 2 groups were decreased significantly,and serum level of LH in raloxifene group was significantly lower than in clomiphene group,with statistical significance（P〈0.05）. The ovulation rate of raloxifene group was significantly higher than clomiphene group,with statistical significance（P〈0.05）;while the pregnancy rate,abortion rate,continuous pregnancy rate of 2 groups had no statistical significance（P〈0.05）. There was no statistical significance in the total incidence of ADR（5.71% vs. 8.96%）between 2 groups（P〈0.05）. CONCLUSIONS：Raloxifene has better ovulation induction effect than clomiphene,and it can improve the sex hormone levels of PCOS patients with infertility,with few ADR,and similarity in long-term clinical effect with clomiphene.