Coulam C B
Reproductive Immunology, Genetics and IVF Institute, Fairfax, VA 22031.
Am J Reprod Immunol. 1994 Dec;32(4):286-9. doi: 10.1111/j.1600-0897.1994.tb01127.x.
Recurrent spontaneous abortion (RSA) is the cause of childlessness in 2-5% of reproducing couples. Immunological mechanisms have been proposed as an etiology in some cases of RSA. Various forms of immunotherapy have been attempted in individuals thought to have an immunologic mechanism associated with RSA. Intravenous immunoglobulin (IVIG) has been used in a pilot study to successfully treat women with RSA.
To evaluate the efficacy of IVIG in the prevention of RSA as prospective randomized, placebo-controlled clinical trial was undertaken. Women experiencing two or more consecutive RSAs receive either IVIG 500 mg/kg/month or placebo (albumin).
To date 92 women have been enrolled in the study and 58 pregnancies have been achieved. The outcome of the 58 pregnancies include 20 deliveries, 9 ongoing pregnancies and 29 losses. Fourteen (49%) of the 29 pregnancy losses were blighted ova (empty gestational sacs) and 15 (51%) were intrauterine fetal deaths (IUFD's) occurring in the first trimester of pregnancy. Of 14 blighted ova, 8 were in women receiving IVIG and 6 were receiving placebo. Fifteen IUFD's occurred: 3 (20%) in women receiving IVIG and 12 (80%) placebo. Of 11 pregnancy losses occurring in women receiving IVIG, 8 (73%) were blighted ova and 3 (27%) were IUFD's. Eighteen losses occurred in women receiving placebo: 6 (33%) were blighted ova and 12 (67%) were IUFD's.
These preliminary data suggest IVIG may be effective treatment for RSA. Analysis of data from the completed randomized placebo-controlled trial will test this suggestion.
复发性自然流产(RSA)是2%至5%的育龄夫妇无法生育的原因。免疫机制被认为是部分RSA病例的病因。针对一些被认为存在与RSA相关免疫机制的个体,人们尝试了各种形式的免疫疗法。静脉注射免疫球蛋白(IVIG)已在一项初步研究中用于成功治疗患有RSA的女性。
为评估IVIG预防RSA的疗效,开展了一项前瞻性随机、安慰剂对照临床试验。经历两次或更多次连续RSA的女性接受500毫克/千克/月的IVIG或安慰剂(白蛋白)治疗。
迄今为止,已有92名女性参与该研究,共实现了58次妊娠。这58次妊娠的结果包括20次分娩、9次持续妊娠和29次流产。29次妊娠丢失中,有14次(49%)为空孕囊(枯萎卵),15次(51%)为妊娠早期发生的宫内胎儿死亡(IUFD)。在14次枯萎卵中,8次发生在接受IVIG治疗的女性中,6次发生在接受安慰剂治疗的女性中。发生了15次IUFD:3次(20%)发生在接受IVIG治疗的女性中,12次(80%)发生在接受安慰剂治疗的女性中。在接受IVIG治疗的女性发生的11次妊娠丢失中,8次(73%)为空孕囊,3次(27%)为IUFD。接受安慰剂治疗的女性发生了18次妊娠丢失:6次(33%)为空孕囊,12次(67%)为IUFD。
这些初步数据表明IVIG可能是治疗RSA的有效方法。对已完成的随机安慰剂对照试验的数据进行分析将验证这一推测。