【目的】探讨化瘀杀胚汤 （由丹参、赤芍、桃仁、蜈蚣、紫草、天花粉、三七等中药组成） 联合甲氨蝶呤治疗异位妊娠 疗效及对患者TGF-β/Smad2/3蛋白水平和microRNA- 30d-5p表达量的影响。 【方法】将104例异位妊娠患者随机分为观察组 和对照组，每组各52例。对照组给予甲氨蝶呤联合米非司酮治疗，观察组在对照组的基础上加用化瘀杀胚汤治疗，连续用 药3 d并随访观察1个月。比较2组患者保守治疗成功率、血β人绒毛膜促性腺激素 （β-HCG） 水平恢复正常时间以及异位妊 娠包块吸收时间、治疗后输卵管完全通畅率与不通畅率，观察2组保守治疗成功患者治疗前后血清TGF-β/Smad2/3蛋白水平 和microRNA-30d-5p相对表达量的变化情况。 【结果】（1） 观察组的保守治疗成功率为94.23% （49/52） ，明显高于对照组的 71.15% （37/52） ，差异有统计学意义 （P＜0.05） 。 （2） 与对照组比较，观察组的血β-HCG恢复正常时间及包块吸收时间均明显 缩短，差异均有统计学意义 （P＜0.01） 。 （3） 观察组治疗后的输卵管完全通畅率为55.77% （29/52） ，明显高于对照组的21.15% （11/52） ；不通畅率为19.23% （10/52） ，明显低于对照组的59.62% （31/52） ，差异均有统计学意义 （P＜0.05或P＜0.01） 。 （4） 与 治疗前比较， 2组保守治疗成功患者治疗结束1个月后的TGF-β/Smad2/3蛋白水平和microRNA-30d-5p相对表达量均明显降 低 （P＜0.05或P＜0.01） ；与对照组比较，观察组治疗结束1个月后的TGF-β/Smad2/3蛋白水平和microRNA-30d-5p相对表达 量均明显降低，差异均有统计学意义 （P＜0.01） 。 （5） 2组患者的不良反应均以胃肠道不适为主，观察组的不良反应发生率为 25.00% （13/52） ，明显低于对照组的46.15% （24/52） ，组间比较，差异有统计学意义 （P＜0.05） 。 【结论】化瘀杀胚汤联合甲氨 蝶呤治疗异位妊娠，可有效提高药物保守治疗的成功率，有助于包块的吸收以及输卵管通畅，能有效降低患者的TGF-β/ Smad2/3蛋白水平及microRNA-30d-5p的相对表达量，且药物安全性较高。

Objective To investigate the effect of Huayu Shapei Decoction（mainly composed of Salviae Miltiorrhizae Radix et Rhizoma， Paeoniae Radix Rubra， Persicae Semen， Scolopendra， Arnebiae Radix， Trichosanthis Radix，and Notoginseng Radix et Rhizoma） combined with Methotrexate in the treatment of ectopic pregnancy，and to observe its effect on TGF-β/Smad2/3 protein level and microRNA-30d-5p expression in the patients. Methods A total of 104 patients with ectopic pregnancy were randomly divided into an observation group and a control group，52 cases in each group. The control group was treated with Methotrexate combined with Mifepristone，and the observation group was treated with Huayu Shapei Decoction on the basis of treatment for the control group. The patients were treated for three continuous days and then were followed up for one month. The success rate of conservative treatment， the time for blood β -human chorionic gonadotropin（β -HCG） levelreturning to normal （β-HCG recovery time），the time for the absorption of ectopic pregnancy mass，the complete patency rate and non-patency rate of fallopian tube after treatment between the two groups were compared. The changes of serum TGF- β/Smad2/3 protein level and microRNA-30d-5p relative expression before and after treatment in the patients with successful conservative treatment in the two groups were observed. Results （1） The success rate of conservative treatment in the observation group was 94.23% （49/52） ，which was significantly higher than 71.15%（37/52） in the control group， and the difference was statistically significant（P＜0.05） . （2） Compared with the control group，the blood β-HCG recovery time and mass absorption time in the observation group were significantly shortened，and the differences were statistically significant （P＜0.01） . （3） The complete patency rate of fallopian tube after treatment in the observation group was 55.77% （29/52） ，which was significantly higher than that in the control group （21.15%，11/52） ；the non-patency rate in the observation group was 19.23% （10/52） and that in the control group was 59.62% （31/52） ，and the difference was statistically significant （P＜0.05 or P＜0.01） . （4） Compared with those before treatment，the levels of TGF-β/Smad2/3 protein and the relative expression level of microRNA-30d-5p in the patients with successful conservative treatment in the two groups one month after the end of treatment were significantly decreased（P＜0.05 or P＜0.01） ；the inter-group comparison showed that compared with the control group，the TGF-β/Smad2/3 protein level and the relative expression level of microRNA-30d-5p in the observation group were significantly decreased one month after the end of treatment， and the differences were statistically significant （P＜0.01） . （5） The adverse reactions of the two groups were mainly manifested as gastrointestinal discomforts. The incidence of adverse reactions in the observation group was 25.00%（13/52），which was significantly lower than that in the control group（46.15%，24/52） . The difference between the two groups was statistically significant （P＜0.05） . Conclusion For the treatment of ectopic pregnancy， Huayu Shapei Decoction combined with Methotrexate is effective on improving the success rate of conservative medicinal treatment，promoting the absorption of mass and tubal patency，decreasing the level of TGF-β/Smad2/3 protein and the relative expression of microRNA-30d-5p. The safety of drug therapy is high.

R271.9

国家自然科学基金青年科学基金项目 （编号：82104905）；南京中医药大学技术开发项目 （编号：2017005）