甲氨蝶呤联合宫外孕II号方与米非司酮治疗异位妊娠的随机对照试验

Effective Analysis of Methotrexate and Mifepristone and Ectopic Pregnance II Decoction for Ectopic Pregnancy

目的对中药宫外孕II号方联合甲氨蝶呤与米非司酮保守治疗异位妊娠的疗效与米非司酮联合甲氨蝶呤进行科学对比。方法将沙井人民医院2009年1月～2011年1月间住院的异位妊娠保守治疗患者治疗过程进行研究方法学的干预：随机，盲法，对照，目的在于为循证医学的系统评价寻找较高级别的证据。结果共95例患者纳入研究，研究组（官外孕2号方组45倒）和对照组（50倒）。研究组治疗后B—HCG恢复至正常的时间，包块吸收的时间，输卵管复通率分剐为16．13±813天，30．46±7．56天和80％；对照组50例，分别为22．05±7．15天，39．99±18．26天和75％，统计学处理有显著差异；而有效率【分别为95．56％（43／45）和94％（47／50）】，药物副反应则无显著差异。结论中西药结合治疗异位妊娠对于协同西药杀胚，缩短β—HCG恢复至正常时间，包块吸收时间，改善输卵管功能方面有明显作用．

Objective To scientific analysis conservative medical treatments of ectopic pregnancies： a randomized clinical trial comparing methotrexate and mifepristone and Ectopic Pregnancy II decoction （EP=II） with methotrexate and mifepristone. Methods Patients suffering from EP at Shenzhen Shajing Affiliated Hospital of Guangzhou Medical University from Jan 2009 to Jan 2011 were randomly divided into two groups at random, Research group treated with methotrexate （MTX） and mifepristone and Ectopic Pregnancy II （EP II） decoction; and control group treated with MTX and mifepristone. Focusing on research methods： randomization, allocation concealment,and double-blind. To provide high-grade proofs tot systematic review. Results A total of 95 ectopic pregnancies were randomized, 4-5 cases for research group and 50 for control group. There were significant differences in serum β-HCG return to normal level （16.13±8.13ds; 22.05±7.15ds,P〈0.05）,the total disappearance time of EP mass （30.46±7.56ds;39.99_＋18.26ds,P〈0.05） and tubal patency rate （80%,75%,P〈0.05）. There were non significant differences in efficacy （95.56% （43/45）; 94%（4.7/50） respectively, x2=0.0809, P 〉0.05） and side effects between the two groups. Conclusions Methotrexate and mlfepristone and EP Ⅱ for ectopic pregnancy has more effective than mifepristone with methotrexate in serum β-HCG return to normal level,provide tubal patency rat6 and shorten the total disappearance time of EP mass.