亮丙瑞林注射剂联合佳蓉片治疗子宫内膜异位症伴不孕的临床研究

Clinical trial of leuprolide injection combined with Jiarong tablets in the treatment of endometriosis associated with infertility

目的观察亮丙瑞林注射剂联合佳蓉片治疗子宫内膜异位症伴不孕的临床疗效及安全性。方法将68例子宫内膜异位症伴不孕患者随机分为对照组34例与试验组34例。2组患者均进行腹腔镜手术治疗。对照组于术后月经复潮后第1~2天予以亮丙瑞林3.75 mg,皮下注射,每4周1次,连续应用6次;试验组在对照组治疗的基础上,于术后予以口服佳蓉片每次0.92 mg,tid,连续用药15 d。比较2组患者的临床疗效、卵泡刺激素(FHS)、黄体生成素(LH)、雌二醇(E2)、睾酮、性激素结合蛋白(SHBG)、妊娠率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94.12%(32/34例)和76.47%(26/34例);妊娠率分别为52.94%(18/34例)和26.47%(9/34例),差异均有统计学意义(均P<0.05)。治疗后,试验组和对照组的FHS分别为(6.33±0.75),(8.31±0.99)U·L^(-1);LH分别为(5.39±0.59),(6.21±0.86)U·L^(-1);E2分别为(38.02±5.17),(68.39±7.47)pmol·L^(-1);睾酮分别为(0.81±0.90),(1.14±0.17)nmol·L^(-1);SHBG分别为(80.07±9.17),(56.54±7.07)nmol·L^(-1),差异均有统计学意义(均P<0.05)。试验组的药物不良反应主要有出汗和经量减少,对照组的药物不良反应主要有出汗、阴道出血和下腹部痛。试验组和对照组的药物不良反应发生率分别为8.82%和11.76%,差异无统计学意义(P>0.05)。结论亮丙瑞林注射剂联合佳蓉片治疗子宫内膜异位症伴不孕的临床疗效显著,且不增加药物不良反应的发生率。

Objective To observe the clinical efficacy and safety of leuprolide injection combined with Jiarong tablets in the treatment of endometriosis associated with infertility. Methods Sixty-eight patients of endometriosis with infertility were randomly divided into control group（n = 34 cases） and treatment group（n = 34 cases）. Two groups were treated with laparoscopic surgery. Control groups was given leuprolide3. 75 mg,subcutaneous injection,at 1-2 days after menstruation,once four weeks for 6 times. Treatment group was given Jiarong tablets0. 92 mg tid oral for 15 days,on the basis of the control group. The clinical efficacy, follicule stimulating hormone（FHS）, luteinizing hormone（LH）,estradiol,testosterone,sex hormone binding globulin（SHBG）,pregnancy rate and adverse drug reactions were compared between two groups. Results After treatment,the total effective rates intreatment and control groups were 94. 12%（32/34 cases） and 76. 47%（26/34 cases）,the pregnancy rates in treatment and control groups were 52. 94%（18/34 cases） and 26. 47%（9/34 cases）,with significant difference（P〈0. 05）. After treatment,the main indexes in treatment and control groups were compared： the FHS were（6. 33 ± 0. 75）,（8. 31 ± 0. 99） U · L^-1; LH were（5. 39 ± 0. 59）,（6. 21 ± 0. 86） U · L^-1; estradiol were（38. 02 ± 5. 17）,（68. 39 ± 7. 47） pmol·L^-1; testosterone were（0. 81 ± 0. 90）,（1. 14 ± 0. 17） nmol·L^-1; SHBG were（80. 07 ± 9. 17）,（56. 54 ± 7. 07） nmol·L^-1,with significant difference（P〈0. 05）. The adverse drug reactions in treatment group were based on sweating and reduced volume,which in control group was sweating,vaginal bleeding and lower abdominal pain. The incidences of adverse drug reactions in treatment and control groups were 8. 82% and11. 76%,without significant difference（P〉0. 05）. Conclusion Leuprolide injection combined with Jiarong tablets has a definitive clinical efficacy in the treatment of endometriosis associated with infertility,without increasing the incidence of adverse drug reactions.