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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 the treatment of 10 ~ 16 weeks gestation and missed abortion. Methods One hundred and seventy-nine patients with pregnancy terminated at 10-16 weeks (269 cases) and missed abortion (150 cases) were randomly divided into 95 cases of unilateral pregnancy termination group (A group), 174 cases of termination pregnancy complex group (B group), missed abortion 53 cases of unilateral group (C group), 97 cases of missed abortion compound group (D group). Groups A and C were treated with mifepristone 50 mg bid twice daily for 0.9% NaCl humidified misoprostol 0.6 mg 12 h after the third dose. Groups B and D received compound mifepristone 35 mg qd orally, and placed 0.9% NaCl humidified misoprostol 0.6 mg vaginally 12 hours after the second dose. The success rates of medical abortion and adverse drug reactions in 4 groups were compared. Results After treatment, the success rates of drug flow in groups A, B, C and D were 92.63% (88/95 cases), 82.76% (144/174 cases), 77.36% (41/53 cases) and 76.29% (74 / 97 cases). There was significant difference between A and B groups (P <0.05). There was no significant difference between C and D groups (P> 0.05). The adverse reactions of the four groups were mainly nausea, vomiting, dizziness, rash, pruritus, fever and diarrhea. The adverse drug reactions in groups A, B, C and D were 51.58%, 53.45% and 54.72% , 55.67%, the difference was not statistically significant (P> 0.5). Conclusion The efficacy of combination mifepristone tablets and misoprostol tablets in the termination of 10 ~ 16 weeks’ gestation is less than that of mifepristone tablets and misoprostol tablets. However, the combination of mifepristone tablets and misoprostol tablets with mifepristone tablets in combination with misoprostol The clinical effect of alcohol tablets is equivalent, and does not increase the incidence of adverse drug reactions.