益母草注射液预防剖宫产产后出血的多中心临床研究

目的 探讨剖宫产术中应用益母草注射液预防产后出血的有效性和安全性.方法 采用多中心、随机、单盲、阳性药物对照的前瞻性研究方法,于2007年4至8月,选择全国15所三级医院440例因产科医学指征行剖宫产分娩的产妇为研究对象.其中益母草组147例,于胎儿娩出后子宫肌壁注射益母草注射液40 mg,术后2 h开始,益母草注射液臀部肌内注射,20 mg/12 h,共3次;益母草+缩官素组144例,于胎儿娩出后子宫肌壁注射益母草注射液40 mg及缩宫素10 U,术后2 h开始,益母草注射液臀部肌内注射,20 mg/12 h,共3次;缩宫素组149例,胎儿娩出后子宫肌壁注射缩宫素10 U,同时静脉滴注缩宫素10 U(加入5%葡萄糖液500 ml中),术后2 h开始,缩宫素臀部肌内注射,10 U/12 h,共3次.观察:(1)产时出血量、产后2、6、12、24、48 h的阴道出血量;(2)产后24 h总出血量和产后出血发生率;(3)产前及产后血红蛋白、红细胞计数的差值;(4)不良反应.结果(1)出血量:平均产时出血量益母草组为(368±258)ml,缩宫素组为(269±14t)ml,益母草+缩宫素组为(255±114)ml,3组的产时出血量分别比较,差异均有统计学意义(P<0.01);产后2、6、12、24、48 h各组阴道出血量比较,差异均无统计学意义(P>0.05).(2)产后24 h总出血量:产后24 h总出血量益母草组平均为(480±276)ml、益母草+缩宫素组为(361±179)ml、缩宫素组为(381±179)ml,3组术后24 h总出血量分别比较,差异也有统计学意义(P<0.01).(3)产后出血发生率:产后出血发生率益母草组为32.0%(47/147)、益母草+缩宫素组为11.1%(16/144)、缩宫素组为18.8%(28/149),益母草+缩宫素组产后出血发生率最低,而益母草组产后出血发生率最高,两组比较,差异有统计学意义(P<0.01).(4)产前及产后血红蛋白、红细胞计数:各组产后与产前比较,红细胞计数和血红蛋白水平均有不同程度的下降,其中益母草组红细胞计数差值为(0.3±0.5)×1012/L,血红蛋白差值为(9±13)g/L;益母草+缩宫素组红细胞计数差值为(0.2±0.4)×1012/L,血红蛋白差值为(6±10)g/L;缩宫素组红细胞计数差值为(0.2±0.4)×10124/L,血红蛋白差值为(7±30)g/L,缩宫素组、益母草+缩宫素组分别与益母草组比较,差异均有统计学意义(P<0.05);益母草+缩宫素组血红蛋白下降程度最低.(5)不良反应:3组中共有2例发生轻度过敏反应.结论剖宫产术中应用益母草注射液联合缩宫素,可明显预防产后出血的发生,且药物安全性好.

Multi-center study of motherwort injection to prevent postpartum hemorrhage after caesarian section

Objective To evaluate the efficacy and safety of motherwort (herbs leonuri/leonurus heterophyllus sweet) injection for preventing postpartum hemorrhage after caesarian section. Methods The prospective study was designed as a randomized and single blind multi-center research matched with positive agent as controls from Apt 2007 to Aug 2007. 440 women underwent caesarian section (CS) indicated by obstetric factors were enrolled from 15 teaching hospitals in China and assigned into three groups: group of motherwort: 147 cases were administered by motherwort 40 rag uterine injection during CS and 20 mg intramuscular injection per 12 hours 3 times after CS; group of motherwort + oxytocin : 144 cases were administered by motherwort 40 mg and oxytocin 10 U uterine injection during CS and motherwort 20 mg intramuscular injection per 12 hours 3 times after CS and group of oxytocin: 149 cases were administered by oxytocin 10 U uterine injection and oxytocin 10 U + 5% glucose 500 nd intravenously injection during operation and oxytocin 10 U intramuscular injection per 12 hours 3 times after CS. The following clinical parameter were collected and analyzed: (1) The amount of blood loss during operation, at 2, 6, 12, 24, 48 hours after operation. (2) The total amount of blood loss in 24 hours after CS and the incidence of postpartum hemorrhage. (3) The change of level of hemoglobin (Hb) and counting of red blood cell ( RBC ) from prepartum to postpartum. (4) Adverse reaction. Results (1) The mean amount of blood loss during operation were (368±258) ml in group of motherwort, (255±114) mi in group of motherwort + oxytocinand (269±141 ) ml in group of oxytocin, which exhibited significant difference among three groups ( P<0.01 ). Meanwhile, no statistical different amount of blood loss among three groups were observed at 2,6,12, 24, 48 hours after CS. (2)The amount of blood loss of postpartum at 24 hours were (480±276)ml ingroup of motherwort, (361±179) ml in group of motherwort + oxytocin, (381±179) nd in group of oxytocin, which showed significant difference among 3 groups(P <0.01 ). (3) The incidence of postpartum hemorrhage were 32.0% (47/147) in group of motherwort, 11.1% (16/144) in group of motherwort + oxytocin, and 18.8% in (28/149) in group of oxytocin. When comparing the lowest rate of postpartum blood loss in group of motherwort + oxytocin and the highest rate in group of motherwort, it displayed statistical difference (P<0.01). (4) The decreased level of RBC and Hb were shown that RBC(0.3±0.5)×10<'12<‘/L and Hb(9±13)g/L in group of motherwort, RBC (0.2±0.4)×10<'12/L and Hb ( 6±10) g/Lin group of motherwort + oxytocin and RBC (0.2±0.4)×10<'12/L and Hb(7±30) g/L in group of oxytocinrespectively. However, the comparison of different value of RBC and lib in group of oxytocin and motherwort +oxytocin showed significant difference (P<0.05 ). (5) Two cases with allery reaction was observed.Conclusion It is safe and efficacious that combined use of motherwort injection and oxytocin was to preventpostpartum hemorrhage during or after caesarian section.