中西药结合三步序贯法用于异位妊娠药物保守性治疗的临床观察

Chinese Herbs Combined Three-stage Sequential Therapy for Conservative Treatment of Ectopic Pregnancy

目的观察应用甲氨蝶呤加米非司酮加中药宫外孕方三步序贯法治疗异位妊娠的临床疗效及安全性。方法 250例均为2010年1月—2014年12月南昌大学附属赣州医院和瑞金市妇幼保健院采用药物保守性治疗的异位妊娠患者,根据所采用的治疗方法分为观察组和对照组。对照组97例单用西药甲氨蝶呤加米非司酮,观察组153例第1天给予甲氨蝶呤50 mg/m2肌肉注射1次,第2-6天给予米非司酮150 mg/日口服5天,第7天起给予中药宫外孕方加味,每天1剂,水煎服。观察两组患者的临床症状,检测血绒毛膜促性腺激素（β-hCG）、孕酮、盆腔包块,比较两组治疗效果;观察两组患者的口腔溃疡、胃肠道反应等并发症情况,监测血细胞、肝、肾功能,比较两组不良反应发生率。治愈后行子宫输卵管造影检查评估输卵管功能,比较两组输卵管通畅率。结果 （1）观察组血β-h CG转阴时间和盆腔包块消失时间分别为（16.70±5.88）天、（4.34±1.15）周,明显短于对照组[（22.31±3.35）天和（5.80±0.80）周],两组比较,差异均有统计学意义（t分别为-7.476、-9.982,P〈0.01）。观察组治愈150例,治愈率为98.0%（150/153）,对照组治愈71例,治愈率为73.2%（71/97）,两组比较,差异有统计学意义（χ^2=35.730,P〈0.01）。（2）观察组输卵管通畅136例,通畅率为90.7%（136/150）,对照组输卵管通畅56例,通畅率为78.9%（56/71）,两组比较,差异有统计学意义（χ^2=5.879,P〈0.05）。（3）不良反应发生率：胃肠道反应观察组22.0%（33/150）,对照组22.1%（15/71）;肝功能轻度受损观察组9.3%（14/150）,对照组8.5%（6/71）;口腔溃疡观察组8.0%（12/150）,对照组7.0%（5/71）;白细胞减少观察组2.0%（3/150）,对照组2.8%（2/71）,两组比较差异均无统计学意义（χ^2=0.022、0.046、0.062、0.145,P〉0.05）。结论中西药结合三步序贯法对有生育要求的异位妊娠患者可能是一种更安全而有效的治疗方法。

Objective To observe the clinical efficacy and safety of three-stage sequential therapy[（methotrexate ＋ mifepristone ＋ Gongwaiyun Recipe（GR）]for conservative treatment of ectopic pregnancy.Methods Recruited were 250 ectopic pregnancy patients,who received conservative treatment at Affiliated Ganzhou Hospital of Nanchang University and Ruijin Maternal Child Health Care Hospital from January 2010 to December 2014.They were assigned to the observation group（153 cases） and the control group（97 cases） according to different treatment methods used.Patients in the control group were treated with Western medicine only（methotrexate ＋mifepristone）.Those in the observation group were intramuscularly injected with methotrexate 50 mg/m^2at day 1.Then they took mifepristone 150 mg per day from day 2 to day 6,once per day for 5 successive days.Afterwards they took modified GR decoction from day 7,one dose per day.Clinical symptoms of all patients were observed.Blood levels of p-hCG and progesterone were detected.Pelvic mass was examined in order to compare the curative effects between the two groups.Complications such as oral ulcer and gastrointestinal reactions were observed.Blood cells,hepatic and renal functions were monitored.The incidence of adverse reactions was compared between the two groups.Fallopian tube function was assessed by hysterosalpingography after healing.The fallopian tube patency rate was compared between the two groups.Results（1） The blood p-hCG negative conversion time was（1 6.70 ±5.88） days and the mass disappearance time was（4.34 ± 1.15） weeks in the observation group,obviously shorter than those of the control group[（22.31 ±3.35） days,（5.80 ±0.80） weeks,t=-7.476,-9.982;P0.01]in the control group.The cure rate was 98.0%（150/1 53） in the observation group,and it was 73.2%（71 /97） in the control group,with statistical difference（χ^2=35.730,P〈0.01）.（2） The fallopian tube patency rate was 90.7%（136/150） in the observation group and 78.9%（56/97） in the control group,with statistical difference between the two groups（χ^2=5.879,P〈0.05）.（3） The incidence of adverse reactions：The incidence of gastrointestinal reactions was 22.0%（33/1 50） in the observation group and 22.1%（15/71） in the control group.The incidence of mild gastrointestinal reactions was 9.3%（14/150） in the observation group and 8.5%（6/71）in the control group.The incidence of oral ulcer was 8.0%（12/150） in the observation group and 7.0%（5/71） in the control group.The incidence of leukopenia was 2.0%（3/150） in the observation group and 2.8%（2/71） in the control group.There was no statistical difference in these indices aforesaid between the two groups（χ^2=0.022,0.046,0.062,0.145;P 〉0.05）.Conclusion Chinese herbs combined three-stage sequential therapy might be a safer and more effective treatment for ectopic pregnancy patients who had requirement for pregnancy.