注射用醋酸亮丙瑞林微球用于子宫内膜异位症术后患者的临床效果
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摘要
目的探讨注射用醋酸亮丙瑞林微球用于子宫内膜异位症患者腹腔镜手术后的临床效果。方法选取2014年2月至2015年5月安徽省宣城市人民医院妇产科收治的子宫内膜异位症患者122例。按患者是否接受注射用醋酸亮丙瑞林微球治疗分为观察组(61例)和对照组(61例)。对照组行单纯腹腔镜手术,观察组在术后月经第1天腹部皮下注射醋酸亮丙瑞林微球3.75 mg,每4周用药1次,共治疗3次。2组患者术后随访24个月,观察疼痛缓解率、复发率、妊娠情况及药物不良反应情况。结果治疗后观察组疼痛缓解率明显高于对照组[86.9%(53/61)比65.6%(40/61)],术后1年内复发率和2年总复发率均明显低于对照组[1.6%(1/61)比13.1%(8/61),8.2%(5/61)比27.9%(17/61)],差异均有统计学意义(均P<0.05)。观察组总妊娠率和体外受精-胚胎移植妊娠率均明显高于对照组[65.8%(25/38)比38.2%(13/34),72.2%(13/18)比31.2%(5/16)],差异均有统计学意义(均P<0.05)。结论腹腔镜手术后应用注射用醋酸亮丙瑞林微球治疗子宫内膜异位症效果较好,可有效降低复发率,并能提高妊娠率。
Objective To investigate the clinical effect of leuprorelin acetate microspheres for injection on patients after endometriosis surgery. Methods Totally 122 endometriosis patients were enrolled from February2014 to May 2015 in the People's Hospital of Xuancheng City; half of them had abdominal subcutaneous injection of leuprorelin acetate microspheres on the 1 st day of menstruation(3. 75 mg/4 weeks, 3 times in total) after laparoscopic operation( observation group); other patients had no special postoperative intervention( control group).Remission of pain, recurrence, pregnancy condition and adverse drug reactions were observed during 24 months after operation. Results Pain remission rate in observation group was significantly higher than that in control group[86. 9%(53/61) vs 65. 6%(40/61) ](P <0. 05); 1-, 2-year recurrence rates in observation group were significantly lower than those in control group[ 1. 6%(1/61) vs 13. 1 %(8/61), 8. 2%(5/61) vs 27.9%(17/61)](P<0. 05). Total pregnancy rate and in vitro fertilization-embryo transfer pregnancy rate in observation group were significantly higher than those in control group [65. 8%(25/38) vs 38. 2%(13/34), 72. 2%(13/18) vs31. 2%(5/16) ](P<0. 05). Conclusion Leuprorelin acetate microspheres treating endometriosis patients after laparoscopic operation can effectively reduce recurrence rate and improve pregnancy success rate.
Objective To investigate the clinical effect of leuprorelin acetate microspheres for injection on patients after endometriosis surgery. Methods Totally 122 endometriosis patients were enrolled from February2014 to May 2015 in the People's Hospital of Xuancheng City; half of them had abdominal subcutaneous injection of leuprorelin acetate microspheres on the 1 st day of menstruation(3. 75 mg/4 weeks, 3 times in total) after laparoscopic operation( observation group); other patients had no special postoperative intervention( control group).Remission of pain, recurrence, pregnancy condition and adverse drug reactions were observed during 24 months after operation. Results Pain remission rate in observation group was significantly higher than that in control group[86. 9%(53/61) vs 65. 6%(40/61) ](P <0. 05); 1-, 2-year recurrence rates in observation group were significantly lower than those in control group[ 1. 6%(1/61) vs 13. 1 %(8/61), 8. 2%(5/61) vs 27.9%(17/61)](P<0. 05). Total pregnancy rate and in vitro fertilization-embryo transfer pregnancy rate in observation group were significantly higher than those in control group [65. 8%(25/38) vs 38. 2%(13/34), 72. 2%(13/18) vs31. 2%(5/16) ](P<0. 05). Conclusion Leuprorelin acetate microspheres treating endometriosis patients after laparoscopic operation can effectively reduce recurrence rate and improve pregnancy success rate.
引文
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[4]吴素林.腹腔镜手术联合促性腺激素释放激素激动剂治疗子宫内膜异位症的临床研究[J].中国医药,2014,9(11):1681-1683.DOI:10.3760/cma.j.issn.1673-4777.2014.11.032.Wu SL.Clinical research on laparoscopic surgery combined with gonadotropin-releasing hormone agonist in the treatment of endometriosis[J].China Medicine,2014,9(11):1681-1683.DOI:10.3760/cma.j.issn.1673-4777.2014.11.032.
[5]中华医学会妇产科学分会子宫内膜异位症协作组.子宫内膜异位症的诊治指南[J].中华妇产科杂志,2015,50(3):161-169.DOI:10.3760/cma.j.issn.0529-567x.2015.03.001.Group of Endometriosis,Chinese Society of Obstetrics and Gynecology,Chinese Medical Association.Guidelines for diagnosis and treatment of endometriosis[J].Chinese Journal of Obstetrics and Gynecology,2015,50(3):161-169.DOI:10.3760/cma.j.issn.0529-567 x.2015.03.001.
[6]夏艳丽.腹腔镜手术治疗子宫内膜异位症合并不孕症的疗效观察[J].实用妇科内分泌电子杂志,2015,2(12):117,119.Xia YL.Effect of laparoscopic surgery on endometriosis complicated with infertility[J].Journal of Practical Gynecologic Endocrinology,2015,2(12):117,119.
[7]王景,蒋欣峰,李小梅,等.不同时机启动反向添加疗法对子宫内膜异位症术后促性腺激素释放激素类似物治疗的影响[J].中国妇幼保健,2015,30(5):783-786.DOI:10.7620/zgfybj.j.issn.1001-4411.2015.05.48.Wang J,Jiang XF,Li XM,et al.Effect of reverse adjunctive therapy on gonadotropin releasing hormone analogues therapy after endometriosis surgery[J].Maternal&Child Health Care of China,2015,30(5):783-786.DOI:10.7620/zgfyhj.j.issn.1001-4411.2015.05.48.
[8]姜海琴.腹腔镜联合促性腺激素释放激素激动剂治疗中重度子宫内膜异位症的疗效分析[J].实用妇科内分泌电子杂志,2015,2(9):52,54.Jiang HQ.Efficacy of laparoscopy combined with gonadotropinreleasing hormone agonisl in treatment of moderate to severe endometriosis[J].Journal of Practical Gynecologic Endocrinology,2015,2(9):52,54.
[9]Granese R,Perino A,Calagna G,et al.Gonadolrophin-releasing hormone analogue or dienogest plus estradiol valerate to prevent pain recurrence after laparoscopic surgery for endometriosis:a multi-center randomized trial[J].Acta Obstet Gynecol Scand,2015,94(6):637-645.DOI:10.1111/aogs.12633.
[10]张碧云,罗小芳.腹腔镜联合促性腺激素释放激素激动剂治疗子宫内膜异位症后对生育功能的影响[J].现代实用医学,2016,28(6):769-770.DOI:10.3969/j.issn.1671-0800.2016.06.038.Zhang BY,Luo XF.Effect of laparoscopy combined with gonadotropinreleasing hormone agonist treating endometriosis on fertility function[J].Modern Practical Medicine,2016,28(6):769-770.DOI:10.3969/j.issn.1671-0800.2016.06.038.
[11]熊红莲,姜艳朋,韩磊,等.腹腔镜手术在子宫内膜异位症治疗中的应用进展[J].检验医学与临床,2015,12(14):2124-2126.DOI:10.3969/j.issn.1672-9455.2015.14.066.Xiong HL,Jiang YP,Han L,et al.Research progress of laparoscopic operation in endometriosis[J].Laboratory Medicine and Clinic,2015,12(14):2124-2126.DOI:10.3969/j.issn.1672-9455.2015.14.066.
[12]李君琴,徐兰波,邹玲玲,等.子宫内膜异位症患者促性腺激素释放激素激动剂治疗的依从性及影响因素分析[J].护理与康复,2012,11(7):621-623.DOI:10.3969/j.issn.1671-9875.2012.07.006.Li JQ,Xu LB,Zou LL,et al.Compliance and influencing factors analysis on gonadotropin releasing hormone agonist in treating patients with endometriosis[J].Nursing and Rehabilitation Journal,2012,11(7):621-623.DOI:10.3969/j.issn.1671-9875.2012.07.006.
[13]Chen J,Gao H,Li Q,et al.Efficacy and safety of remifemin on peri-menopausal symptoms induced by post-operative GnRH-a therapy for endometriosis:a randomized study versus tibolone[J].Med Sci Monitor,2014(20):1950-1957.DOI:10.12659/MSM.891353.
[14]陈芳.促性腺激素释放激素激动剂治疗子宫内膜异位症的进展[J].中国优生与遗传杂志,2011,19(4):127-128,109.Chen F.Research progress of gonadotropin-releasing hormone agonist treating endometriosis[J].Chinese Journal of Birth Health&Heredity,2011,19(4):127-128,109.
[15]赵霞,方向明.醋酸亮丙瑞林预处理联合腹腔镜下子宫肌瘤剔除术治疗巨大子宫肌瘤临床观察[J].中华全科医学,2015,13(8):1293-1295,1309.Zhao X,Fang XM.Clinical observation on treatment of large uterine fibroids by leuprorelin acetate pretreatment with laparoscopic myomectomy[J].Chinese Journal of General Practice,2015,13(8):1293-1295,1309.
[16]Jee BC,Lee JY,Suh CS,et al.Impact of GnRH agonist treatment on recurrence of ovarian endometriomas after conservative laparoscopic surgery[J].Fertil Steril,2009,91(I):40-45.DOI:10.1016/j.fertnstert.2007.11.027.
[17]向亚利,毛平.腹腔镜下个体化手术联合促性腺激素释放激素激动剂治疗子宫内膜异位症75例疗效观察[J].中国内镜杂志,2015,21(1):59-61.Xiang YL,Mao P.Clinical efficacy of individualized laparoscopy combined with Gnrh-A in treament of pelvic endometriosis in 75patients[J].China Journal of Endoscopy,2015,21(1):59-61.
[18]张玲玲,应小燕.腹腔镜手术联合促性腺激素释放激素激动剂治疗子宫内膜异位症疗效的比较研究[J].中国微创外科杂志,2015,15(4):305-308.DOI:10.3969/j.issn.1009-6604.2015.04.005.Zhang LL,Ying XY.Efficacy of laparosocpic surgery combined with GnRH-a in the treatment of endometriosis[J].Chinese Journal of Minimally Invasive Surgery,2015,15(4):305-308.DOI:10.3969/j.issn.1009-6604.2015.04.005.
[19]黄玥,张蔚,王勇,等.腹腔镜手术联合促性腺激素释放激素激动剂治疗子宫内膜异位症的Meta分析[J].中华实用诊断与治疗杂志,2015,29(3):270-274.DOI:10.13507/j.issn.1674-3474.2015.03.023.Huang Y,Zhang W,Wang Y,et al.Meta analysis of gonadotrophinreleasing hormone analogue treatment combined with laparosocpic conservative surgery for endometriosis[J].Journal of Chinese Practical Diagnosis and Therapy,2015,29(3):270-274.DOI:10.13507/j.issn.1674-3474.2015.03.023.
[20]卞美璐,黄书慧,邓文红,等.醋酸亮丙瑞林微球治疗子宫内膜异位症随机盲法Ⅱ期临床试验[J].中华妇产科杂志,2015,50(3):188-193.DOI:10.3760/cma.j.issn.0529-567x.2015.03.005.Bian ML,Huang SH,Deng WH,et al.Randomized,blind,parallel-controlled and multiple-centre clinical trial on the effectiveness and safety of leuprolide acetate in the treatment of endometriosis[J].Chinese Journal of Obstetrics and Gynecology,2015,50(3):188-193.DOI:10.3760/cma.j.issn.0529-567x.2015.03.005.
[2]Alborzi S,Hosseini-Nohadani A,Poordast T,et al.Surgical outcomes of laparoscopic endometriosis surgery:a 6 year experience[J].Curr Med Res Opin,2017,33(12):2229-2234.DOI:10.1080/03007995.2017.1362377.
[3]Bedaiwy MA,Allaire C,Alfaraj S.Long-term medical management of endometriosis with dienogest and with a gonadotropin-releasing hormone agonist and add-back hormone therapy[J].Fertil Steril,2017,107(3):537-548.DOI:10.1016/j.fertnstert.2016.12.024.
[4]吴素林.腹腔镜手术联合促性腺激素释放激素激动剂治疗子宫内膜异位症的临床研究[J].中国医药,2014,9(11):1681-1683.DOI:10.3760/cma.j.issn.1673-4777.2014.11.032.Wu SL.Clinical research on laparoscopic surgery combined with gonadotropin-releasing hormone agonist in the treatment of endometriosis[J].China Medicine,2014,9(11):1681-1683.DOI:10.3760/cma.j.issn.1673-4777.2014.11.032.
[5]中华医学会妇产科学分会子宫内膜异位症协作组.子宫内膜异位症的诊治指南[J].中华妇产科杂志,2015,50(3):161-169.DOI:10.3760/cma.j.issn.0529-567x.2015.03.001.Group of Endometriosis,Chinese Society of Obstetrics and Gynecology,Chinese Medical Association.Guidelines for diagnosis and treatment of endometriosis[J].Chinese Journal of Obstetrics and Gynecology,2015,50(3):161-169.DOI:10.3760/cma.j.issn.0529-567 x.2015.03.001.
[6]夏艳丽.腹腔镜手术治疗子宫内膜异位症合并不孕症的疗效观察[J].实用妇科内分泌电子杂志,2015,2(12):117,119.Xia YL.Effect of laparoscopic surgery on endometriosis complicated with infertility[J].Journal of Practical Gynecologic Endocrinology,2015,2(12):117,119.
[7]王景,蒋欣峰,李小梅,等.不同时机启动反向添加疗法对子宫内膜异位症术后促性腺激素释放激素类似物治疗的影响[J].中国妇幼保健,2015,30(5):783-786.DOI:10.7620/zgfybj.j.issn.1001-4411.2015.05.48.Wang J,Jiang XF,Li XM,et al.Effect of reverse adjunctive therapy on gonadotropin releasing hormone analogues therapy after endometriosis surgery[J].Maternal&Child Health Care of China,2015,30(5):783-786.DOI:10.7620/zgfyhj.j.issn.1001-4411.2015.05.48.
[8]姜海琴.腹腔镜联合促性腺激素释放激素激动剂治疗中重度子宫内膜异位症的疗效分析[J].实用妇科内分泌电子杂志,2015,2(9):52,54.Jiang HQ.Efficacy of laparoscopy combined with gonadotropinreleasing hormone agonisl in treatment of moderate to severe endometriosis[J].Journal of Practical Gynecologic Endocrinology,2015,2(9):52,54.
[9]Granese R,Perino A,Calagna G,et al.Gonadolrophin-releasing hormone analogue or dienogest plus estradiol valerate to prevent pain recurrence after laparoscopic surgery for endometriosis:a multi-center randomized trial[J].Acta Obstet Gynecol Scand,2015,94(6):637-645.DOI:10.1111/aogs.12633.
[10]张碧云,罗小芳.腹腔镜联合促性腺激素释放激素激动剂治疗子宫内膜异位症后对生育功能的影响[J].现代实用医学,2016,28(6):769-770.DOI:10.3969/j.issn.1671-0800.2016.06.038.Zhang BY,Luo XF.Effect of laparoscopy combined with gonadotropinreleasing hormone agonist treating endometriosis on fertility function[J].Modern Practical Medicine,2016,28(6):769-770.DOI:10.3969/j.issn.1671-0800.2016.06.038.
[11]熊红莲,姜艳朋,韩磊,等.腹腔镜手术在子宫内膜异位症治疗中的应用进展[J].检验医学与临床,2015,12(14):2124-2126.DOI:10.3969/j.issn.1672-9455.2015.14.066.Xiong HL,Jiang YP,Han L,et al.Research progress of laparoscopic operation in endometriosis[J].Laboratory Medicine and Clinic,2015,12(14):2124-2126.DOI:10.3969/j.issn.1672-9455.2015.14.066.
[12]李君琴,徐兰波,邹玲玲,等.子宫内膜异位症患者促性腺激素释放激素激动剂治疗的依从性及影响因素分析[J].护理与康复,2012,11(7):621-623.DOI:10.3969/j.issn.1671-9875.2012.07.006.Li JQ,Xu LB,Zou LL,et al.Compliance and influencing factors analysis on gonadotropin releasing hormone agonist in treating patients with endometriosis[J].Nursing and Rehabilitation Journal,2012,11(7):621-623.DOI:10.3969/j.issn.1671-9875.2012.07.006.
[13]Chen J,Gao H,Li Q,et al.Efficacy and safety of remifemin on peri-menopausal symptoms induced by post-operative GnRH-a therapy for endometriosis:a randomized study versus tibolone[J].Med Sci Monitor,2014(20):1950-1957.DOI:10.12659/MSM.891353.
[14]陈芳.促性腺激素释放激素激动剂治疗子宫内膜异位症的进展[J].中国优生与遗传杂志,2011,19(4):127-128,109.Chen F.Research progress of gonadotropin-releasing hormone agonist treating endometriosis[J].Chinese Journal of Birth Health&Heredity,2011,19(4):127-128,109.
[15]赵霞,方向明.醋酸亮丙瑞林预处理联合腹腔镜下子宫肌瘤剔除术治疗巨大子宫肌瘤临床观察[J].中华全科医学,2015,13(8):1293-1295,1309.Zhao X,Fang XM.Clinical observation on treatment of large uterine fibroids by leuprorelin acetate pretreatment with laparoscopic myomectomy[J].Chinese Journal of General Practice,2015,13(8):1293-1295,1309.
[16]Jee BC,Lee JY,Suh CS,et al.Impact of GnRH agonist treatment on recurrence of ovarian endometriomas after conservative laparoscopic surgery[J].Fertil Steril,2009,91(I):40-45.DOI:10.1016/j.fertnstert.2007.11.027.
[17]向亚利,毛平.腹腔镜下个体化手术联合促性腺激素释放激素激动剂治疗子宫内膜异位症75例疗效观察[J].中国内镜杂志,2015,21(1):59-61.Xiang YL,Mao P.Clinical efficacy of individualized laparoscopy combined with Gnrh-A in treament of pelvic endometriosis in 75patients[J].China Journal of Endoscopy,2015,21(1):59-61.
[18]张玲玲,应小燕.腹腔镜手术联合促性腺激素释放激素激动剂治疗子宫内膜异位症疗效的比较研究[J].中国微创外科杂志,2015,15(4):305-308.DOI:10.3969/j.issn.1009-6604.2015.04.005.Zhang LL,Ying XY.Efficacy of laparosocpic surgery combined with GnRH-a in the treatment of endometriosis[J].Chinese Journal of Minimally Invasive Surgery,2015,15(4):305-308.DOI:10.3969/j.issn.1009-6604.2015.04.005.
[19]黄玥,张蔚,王勇,等.腹腔镜手术联合促性腺激素释放激素激动剂治疗子宫内膜异位症的Meta分析[J].中华实用诊断与治疗杂志,2015,29(3):270-274.DOI:10.13507/j.issn.1674-3474.2015.03.023.Huang Y,Zhang W,Wang Y,et al.Meta analysis of gonadotrophinreleasing hormone analogue treatment combined with laparosocpic conservative surgery for endometriosis[J].Journal of Chinese Practical Diagnosis and Therapy,2015,29(3):270-274.DOI:10.13507/j.issn.1674-3474.2015.03.023.
[20]卞美璐,黄书慧,邓文红,等.醋酸亮丙瑞林微球治疗子宫内膜异位症随机盲法Ⅱ期临床试验[J].中华妇产科杂志,2015,50(3):188-193.DOI:10.3760/cma.j.issn.0529-567x.2015.03.005.Bian ML,Huang SH,Deng WH,et al.Randomized,blind,parallel-controlled and multiple-centre clinical trial on the effectiveness and safety of leuprolide acetate in the treatment of endometriosis[J].Chinese Journal of Obstetrics and Gynecology,2015,50(3):188-193.DOI:10.3760/cma.j.issn.0529-567x.2015.03.005.