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目的:对比观察局部与全身应用甲氨蝶呤(MTX)预防腹腔镜手术后持续性异位妊娠(PEP)的临床效果及安全性。方法:选择输卵管妊娠行腹腔镜手术160例,随机分为局部用药组50例、全身用药组52例和对照组58例。局部用药组,术毕给予MTX 10mg注射于患侧输卵管残腔壁;全身用药组,术后24h单次肌内注射MTX 50mg/m2;对照组术后不使用任何药物。3组均于术前及术后第1天、第3天、第7天检测血β-人绒毛膜促性腺激素(β-HCG)水平。结果:160例中,术后发生PEP 4例,总发生率2.5%。其中,局部用药组发生率0%(0/50),全身用药组发生率1.9%(1/52),对照组发生率5.2%(3/58)。局部用药组、全身用药组PEP发生率均非常显著低于对照组(P<0.01);局部用药组与全身用药组比较,差异不显著(P>0.05)。术后第1天,3组血β-HCG水平均较术前显著下降(P<0.05),但3组间比较,差异不显著(P>0.05)。术后第3天、第7天,局部用药组和全身用药组β-HCG水平均非常显著低于对照组(P<0.01),局部用药组β-HCG水平显著或非常显著低于全身用药组(P<0.05,P<0.01)。局部用药组和对照组均未发生药物不良反应;全身用药组发生2例,占3.8%。局部用药组、对照组药物不良反应发生率均显著低于全身用药组(P<0.05)。结论:局部应用MTX预防腹腔镜手术后PEP的临床效果优于全身应用,且较安全。
OBJECTIVE: To compare the clinical efficacy and safety of methotrexate (MTX) with local and systemic prophylaxis of persistent ectopic pregnancy (PEP) after laparoscopic surgery. Methods: One hundred and sixty cases of tubal pregnancy undergoing laparoscopic surgery were randomly divided into two groups: local drug group (n = 50), systemic drug group (n = 52) and control group (n = 58). In the local drug group, MTX 10 mg was injected into the affected side of the residual tubal wall of the tubal tuberculosis. After systemic administration, a single intramuscular injection of MTX 50 mg / m2 was given 24h after operation. No drug was used in the control group. Blood β-human chorionic gonadotropin (β-HCG) levels in the three groups were measured preoperatively and on the 1st, 3rd and 7th day after operation. Results: Among 160 cases, 4 cases had PEP after operation, the total incidence was 2.5%. Among them, 0% (0/50) in the topical drug group, 1.9% (1/52) in the systemic drug group and 5.2% (3/58) in the control group. The incidences of PEP in the topical and systemic groups were significantly lower than those in the control group (P <0.01). There was no significant difference between the topical and systemic groups (P> 0.05). On the first postoperative day, the blood levels of β-HCG in 3 groups were significantly decreased compared with that before operation (P <0.05), but there was no significant difference between the 3 groups (P> 0.05). The level of β-HCG in the local drug group and the systemic drug group were significantly lower than those in the control group on the 3rd day and the 7th day after operation (P <0.01). The level of β-HCG in the local drug group was significantly or very significantly lower than that of the systemic drug group (P <0.05, P <0.01). There were no adverse drug reactions in the topical and control groups; systemic treatment group occurred in 2 cases, accounting for 3.8%. The incidences of adverse drug reactions in the local drug group and the control group were significantly lower than those in the systemic drug group (P <0.05). CONCLUSION: Topical application of MTX is superior to systemic in preventing PEP after laparoscopic surgery and is safer.