孕康颗粒联合地屈孕酮治疗早期先兆流产的临床观察

Clinical Observation of Yunkang Granule Combined with Dydrogesterone in the Treatment of Early Threatened Abortion

目的:探讨孕康颗粒联合地屈孕酮治疗早期先兆流产的临床疗效及安全性。方法:将128例早期先兆流产患者按随机数字表法分为单药组和联合组,各64例。单药组患者口服地屈孕酮片,首次剂量为40 mg,然后以10 mg、q12 h至阴道出血止;联合组患者在单药组基础上加服孕康颗粒,每次8 g,tid,用药至症状消失止。比较两组患者人绒膜促性腺激素(HCG)、临床症状缓解和消失时间、妊娠期/分娩期并发症、妊娠结局和新生儿不良结局以及药品不良反应发生情况。结果:两组患者治疗后HCG较治疗前明显升高,且联合组高于单药组,差异均有统计学意义(P<0.05);联合组患者临床症状缓解时间和消失时间均明显短于单药组,差异有统计学意义(P<0.05)。两组患者妊娠期/分娩期并发症发生率、各妊娠结局和新生儿不良结局比较,差异均无统计学意义(P>0.05)。联合组患者药品不良反应发生率为10.9%,明显低于单药组的40.6%,差异有统计学意义(P<0.05)。结论:单用地屈孕酮与孕康颗粒联合地屈孕酮治疗早期先兆流产均能获得较好疗效,但联合用药更能缩短患者临床症状缓解时间和消失时间、减少药品不良反应发生率。

OBJECTIVE：To explore the clinical efficacy and safety of Yunkang granule combined with dydrogesterone in the treatment of early threatened abortion. METHODS：128 patients with early threatened abortion were randomly divided into single drug group and combined medication group,64 cases in each group. Single drug group received Dydrogesterone tablet with first dose of 40 mg,then 10 mg,q 12 h until vaginal bleeding;combined medication group additionally received 8 g Yunkang granule,tid,until symptoms disappeared. Human chorionic gonadotropin（HCG）,clinical symptoms remission time and disappearance time,pregnancy/childbirth complications,pregnancy outcome and neonatal adverse outcome,and the incidence of adverse reactions in 2 groups were compared. RESULTS：After treatment,HCG in 2 groups significantly increased,and combined medication group was higher than single drug group,the differences were statistically significant（P〈0.05）;clinical symptoms remission time and disappearance time in combined medication group were shorter than single drug group,the difference was statistically significant（P〈0.05）. There were no significant differences in incidence of pregnancy/childbirth complications,pregnancy outcome and neonatal adverse outcomes in 2 groups（P〈0.05）. The incidence of adverse reactions in combined medication group was 10.9%,which was significantly lower than single drug group（40.6%）,the difference was statistically significant（P〈0.05）. CONCLUSIONS：Both dydrogesterone alone and Yunkang granule combined with dydrogesterone show good efficacy in the treatment of early threatened abortion,but the remission time and disappearance time of clinical symptoms and adverse reactions in combined medication group are less than that in single drug group.