复方米非司酮片联合米索前列醇片治疗终止10～16周妊娠及稽留流产的临床研究
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摘要
目的观察复方米非司酮片联合米索前列醇片治疗终止10~16周妊娠及稽留流产的临床疗效和安全性。方法将419例自愿终止10~16周妊娠(269例)以及稽留流产(150例)患者随机分为终止妊娠单方组(A组)95例、终止妊娠复方组(B组)174例、稽留流产单方组(C组)53例、稽留流产复方组(D组)97例。A、C组予以米非司酮50 mg,bid,口服,在第3次服药后的12 h阴道放置0.9%NaCl湿化的米索前列醇0.6 mg。B、D组予以复方米非司酮35 mg,qd,口服,在第2次服药后的12 h阴道放置0.9%NaCl湿化的米索前列醇0.6 mg。比较4组患者的药流成功率和药物不良反应的发生情况。结果治疗后,A、B、C、D组的药流成功率分别为92.63%(88/95例),82.76%(144/174例),77.36%(41/53例)和76.29%(74/97例),A、B组比较差异有统计学意义(P<0.05),C、D组比较差异无统计学意义(P>0.05)。4组患者的药物不良反应均以恶心呕吐、头晕乏力、皮疹、手掌瘙痒、发热和腹泻为主,且A、B、C、D组药物不良反应发生率分别为51.58%,53.45%,54.72%,55.67%,差异无统计学意义(P>0.5)。结论复方米非司酮片联合米索前列醇片终止10~16周妊娠的疗效不及米非司酮片联合米索前列醇片,但在治疗稽留流产方面与米非司酮片联合米索前列醇片的临床效果相当,且不增加药物不良反应的发生率。
Objective To observe the clinical efficacy and safety of compound mifepristone tablets combined with misoprostol tablets in termination pregnancy from 10 to 16 weeks and treatment of missed abortion.Methods A total of 419 patients with pregnancy from 10 to 16 weeks(n =269 cases) and missed abortion(n =150 cases) were randomly divided into group A(termination pregnancy with mifepristone,n = 95cases),group B(termination pregnancy with compound mifepristone,n = 174 cases),group C(missed abortion with mifepristone,n = 53cases) and group D(missed abortion with compound mifepristone,n =97 cases).Group A and group C were given mifepristone 50 mg bid oral,12 h after the third administration,misoprostol 0.6 mg in 0.9%NaCl humidified was placed in the vagina.Group B and group D were given compound mifepristone 35 mg qd oral,12 h after the second administration,misoprostol 0.6 mg in 0.9%NaCl humidified was placed in the vagina.The success rate of drug abortion and adverse drug reactions were compared between four groups.Results After treatment,the success rates of drug abortion and adverse drug in groups A,B,C,D were 92.63%(88/95 cases),82.76%(144/174 cases),77.36%(41/53 cases),76.29%(74/97 cases),the difference was significant between group A and group B(P <0.05),but which was not significant between group C and group D(P >0.05).The adverse drug reactions were based on nausea and vomiting,dizziness,fatigue,rash,palms itching,fever and diarrhea in four groups.The incidences of adverse drug reactions in groups A,B,C,D were 51.58%,53.45%,54.72%,55.67%,without significant difference(P > 0.05).Conclusion Clinical efficacy of compound mifepristone tablets combined with misoprostol tablets in the treatment of termination pregnancy from 10 to 16 weeks is less than mifepristone combined with misoprostol tablets,but they have the same clinical efficacy in the treatment of missed abortion,without increasing the incidence of adverse drug reactions.
Objective To observe the clinical efficacy and safety of compound mifepristone tablets combined with misoprostol tablets in termination pregnancy from 10 to 16 weeks and treatment of missed abortion.Methods A total of 419 patients with pregnancy from 10 to 16 weeks(n =269 cases) and missed abortion(n =150 cases) were randomly divided into group A(termination pregnancy with mifepristone,n = 95cases),group B(termination pregnancy with compound mifepristone,n = 174 cases),group C(missed abortion with mifepristone,n = 53cases) and group D(missed abortion with compound mifepristone,n =97 cases).Group A and group C were given mifepristone 50 mg bid oral,12 h after the third administration,misoprostol 0.6 mg in 0.9%NaCl humidified was placed in the vagina.Group B and group D were given compound mifepristone 35 mg qd oral,12 h after the second administration,misoprostol 0.6 mg in 0.9%NaCl humidified was placed in the vagina.The success rate of drug abortion and adverse drug reactions were compared between four groups.Results After treatment,the success rates of drug abortion and adverse drug in groups A,B,C,D were 92.63%(88/95 cases),82.76%(144/174 cases),77.36%(41/53 cases),76.29%(74/97 cases),the difference was significant between group A and group B(P <0.05),but which was not significant between group C and group D(P >0.05).The adverse drug reactions were based on nausea and vomiting,dizziness,fatigue,rash,palms itching,fever and diarrhea in four groups.The incidences of adverse drug reactions in groups A,B,C,D were 51.58%,53.45%,54.72%,55.67%,without significant difference(P > 0.05).Conclusion Clinical efficacy of compound mifepristone tablets combined with misoprostol tablets in the treatment of termination pregnancy from 10 to 16 weeks is less than mifepristone combined with misoprostol tablets,but they have the same clinical efficacy in the treatment of missed abortion,without increasing the incidence of adverse drug reactions.
引文
[1]李瑞满,葛楠,秦佳佳.复方米非司酮终止早期妊娠的临床疗效探讨[J].生殖与避孕,2007,27(3):234-236.
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[3]子学珍.复方米非司酮配伍米索前列醇终止早孕疗效观察[J].当代医学,2011,17(4):113-114.
[4]李晓平,张永水,曹宇梅,等.复方米非司酮配伍米索前列醇终止稽留流产269例疗效观察[J].中国妇幼保健,2009,24(31):4465-4466.
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[6]程利南,车焱.现代计划生育学[M].上海:复旦大学出版社,2014:260-265.
[7]NEULEN J,WILLIAMS R F,BRECKWOLDT M,et al.Noncompetitive anti-oestrogenic actions of progesterone antagonists in primate endometrium:enhancement of oestrogen and progesterone receptors with blockade of post-receptor proliferative mechanisms[J].Hum Reprod,1996,11(7):1533-1537.
[8]刘芳,于俊荣,李杰,等.复方米非司酮对人早孕绒毛、蜕膜组织结构和分泌功能的影响[J].生殖与避孕,2001,21(5):293-299.
[9]CHENG L,KELLY R W,THONG K J,et al.The effect of mifepristone(Ru486)on the immuno-his-tochemical distribution of prostaglandin E and its metabolite in decidual and chorionic tissue in early pregnancy[J].J Clin Endocrinol Metab,1993,77(3):873.
[2]吴文娟,陈茜.复方米非司酮和米非司酮终止早期妊娠的临床疗效比较[J].中国实用医药,2009,4(3):164-165.
[3]子学珍.复方米非司酮配伍米索前列醇终止早孕疗效观察[J].当代医学,2011,17(4):113-114.
[4]李晓平,张永水,曹宇梅,等.复方米非司酮配伍米索前列醇终止稽留流产269例疗效观察[J].中国妇幼保健,2009,24(31):4465-4466.
[5]丰有吉,沈铿.妇产科学[M].2版.北京:人民卫生出版社,2012:46-47.
[6]程利南,车焱.现代计划生育学[M].上海:复旦大学出版社,2014:260-265.
[7]NEULEN J,WILLIAMS R F,BRECKWOLDT M,et al.Noncompetitive anti-oestrogenic actions of progesterone antagonists in primate endometrium:enhancement of oestrogen and progesterone receptors with blockade of post-receptor proliferative mechanisms[J].Hum Reprod,1996,11(7):1533-1537.
[8]刘芳,于俊荣,李杰,等.复方米非司酮对人早孕绒毛、蜕膜组织结构和分泌功能的影响[J].生殖与避孕,2001,21(5):293-299.
[9]CHENG L,KELLY R W,THONG K J,et al.The effect of mifepristone(Ru486)on the immuno-his-tochemical distribution of prostaglandin E and its metabolite in decidual and chorionic tissue in early pregnancy[J].J Clin Endocrinol Metab,1993,77(3):873.