粒细胞集落刺激因子治疗不明原因复发性流产:一项随机对照试验  

Granulocyte colony-stimulating factor in treatment of unexplained recurrent spontaneous abortion:a randomized controlled trial

作　　者：付锦华[1] 朱霄鹤[1] 孙红[1] 赵龙[2] 

机构地区：[1]潍坊市人民医院产科,山东潍坊261041 [2]山东大学医学院,山东济南250012

出　　处：《中国新药与临床杂志》2015年第8期602-606,共5页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：目的研究粒细胞集落刺激因子（G—CSF）在不明原因复发性流产（RSA）治疗中的作用。方法共有168例不明原因RSA患者参加本研究，均已连续流产至少4次且临床检查没有发现任何异常。所有患者被随机分配到两组中。从排卵日开始，G．CSF组（n=85）使用基本治疗（黄体酮、免疫球蛋白、丈夫淋巴细胞免疫治疗）＋隔日G—CSF皮下注射治疗（1．5μg·kg^-1），安慰剂组（n=83）使用基本治疗＋安慰剂。主要研究终点设定为分娩一个健康的没有先天性异常的婴儿。比较G—CSF组、安慰剂组及一组正常孕妇（n=45）的B人绒毛膜促性腺激素（β—hCG）水平。结果G—CSF组中73例（86％）成功分娩健康婴儿，安慰剂组为57例（69％），具有显著差异（P=0．01，OR=2．78，95％CI：1．29～5．97）。在妊娠4～7周，G—CSF组B人绒毛膜促性腺激素水平显著高于安慰剂组和正常组（P〈0．01）。结论G—CSF对于不明原因RSA可能具有治疗作用。ATM To evaluate the effectiveness of granulocyte colony-stimulating factor （G-CSF） in the treatment of unexplained recurrent spontaneous abortion （RSA） . METHODS A randomized controlled trial was conducted in our hospital with 168 unexplained RSA patients, who all had at least 4 consecutive miscarriages and had no abnormality in clinical examinations. The patients were randomly allocated into 2 groups. Based on the basic treatment （progesterone, immunoglobulin immunotherapy, lymphocyte immunotherapy for husband）, G- CSF group （n = 85） used G- CSF （ 1.5 μg·kg^-1, sc） every other day starting from the day of ovulation, while placebo group （n = 83） was treated with placebo. Delivery of a healthy baby without malformations was the primary outcome. Beta human chorionic gonadotropin （β-hCG） levels were compared among the two groups and a group of 45 agematched normal pregnant women. RESULTS There were 73 （86%） patients who delivered a healthy baby in the G-CSF group, whereas only 57 （69%） in the placebo group （P = 0.01, OR = 2.78, 95% CI： 1.29 - 5.97） . Significantly higher levels of β-hCG were observed in gestation weeks 4 to 7 in the G- CSF group versus the placebo group and normal group （P 〈 0.01 ） . CONCLUSION G-CSF can be effective in the treatment of unexplained RSA.

关 键 词：粒细胞集落刺激因子 流产 习惯性 滋养层 绒毛膜促性腺激素 β亚单位 人 妊娠结局 

分 类 号：R984[医药卫生—药品]