氯米芬联合暖宫七味丸治疗不孕多囊卵巢综合征的前瞻性对照研究

Prospective case-control study on clomifene combined with Nuangong Qiwei pill in the treatment of infertile polycystic ovary syndrome

目的:探讨氯米芬联合暖宫七味丸治疗不孕多囊卵巢综合征的有效性及安全性。方法:前瞻性选取2014年4月至12月我院收治的有生育需求的不孕多囊卵巢综合征患者160例,按数字表随机法分为联合组(n=80)和对照组(n=80)。对照组单纯口服氯米芬治疗,联合组在对照组的基础上进行暖宫七味丸治疗。比较两组疗效、治疗前后的内分泌激素水平、子宫内膜厚度、卵巢体积、月经情况、随访1年妊娠情况及不良反应和并发症发生情况。结果:联合组治疗有效率和随访1年妊娠率分别为97.50%和53.75%,均高于对照组的88.75%和20.00%(P<0.05)。与对照组比较,联合组治疗后的血清黄体生成素(LH)、卵泡刺激素(FSH)、雌二醇(E2)、睾酮(T)、胰岛素(INS)等内分泌激素水平降低,卵巢体积减小,子宫内膜厚度变薄,月经改善率升高(P<0.05)。与治疗前比较,两组治疗后的血清内分泌激素水平均降低,卵巢体积减小,子宫内膜厚度变薄(P<0.05)。两组治疗及随访期间均无卵巢过度刺激综合征、消化道反应等不良反应和并发症的发生。结论:氯米芬联合暖宫七味丸治疗不孕多囊卵巢综合征疗效显著,可有效调节激素水平,减小子宫内膜厚度和卵巢体积,促进排卵,改善月经状况,提高妊娠率,且无明显的不良反应和并发症发生,具有良好的有效性及安全性,值得临床推广应用。

Objective： To explore the efficiency and safety of clomifene combined with Nuangong Qiwei pill in treating infertile polycystic ovary syndrome. Methods： One hundred and sixty cases of women with infertile polycystic ovary syndrome treated in our hospital from April 2014 and December 2014 were selected and divided into combination group （ n = 80） and control group （ n = 80） according to digital random method. The control group received oral clomifene treatment while the combination group received Nuangong Qiwei pill treatment in addition to clomifene. Endocrine hormone level, endometrial thickness, ovarian volume and menstrual status were compared before and after the treatment. Pregnancy rate, adverse reaction and complications after one year follow-up were also compared. Results： The curative efficiency and pregnancy rate of one year follow-up in the combination group were 97.50% and 53.75% respectively, which were higher than those of 88.75% and 20. 00% in the control group （P 〈 O. 05 ）. Compared with the control group, serum luteinizing hormone （LH）, follicle-stimulating hormone （FSH）, estradiol （E2 ） , testosterone （T）, insulin （INS） and other endocrine hormone levels and ovarian volume of the combination group after treatment were decreased. The endometrial thickness was reduced and the rate of menstrual was increased （P 〈 0.05 ）. Compared with those before treatment, serum endocrine hormone levels and ovarian volume of the two groups after treatment were lower and the endometrial thickness of two groups was thinned （P 〈 0. 05 ）. No adverse reactions, such as ovarian hyperstsimulation syndrome and gastrointestinal reaction, and complications were found during the treatment and follow-up in both groups. Conclusion： Clomifene combined with Nuangong Qiwei pill can effectively treat infertile polycystic ovary syndrome with no obvious adverse reactions.