氨甲环酸用于减少产后出血量的临床研究

目的：探讨抗纤溶药物氨甲环酸注射液用于减少产后出血量的效果和安全性,方法：选择足月妊娠、阴道分娩的单胎、头位妇产妇400例,在分娩第二产程胎肩娩出后常规静脉注射缩宫素10U,随后随机分为4组,第1组（94例）静脉滴注氨甲环酸1．0g;第2组（92例）静脉滴注氨甲环酸0．5g;第3组（92例）静脉滴注国产止血芳酸0．5g;第4组（87例）为未作任何处理的对照组,另35例产妇因分娩巨大儿会影响产后出血量的计算而剔除。用容积法和称重法分别测量4组产妇胎盘娩出即时出血量和产后2h内出血量,两部分相加和总出血量。结果：（1）胎盘娩出即时出血量4组之间比较,差异无显著性（P＞0．05）。（2）产后2h出血量和总出血量4例之间比较;第1组分别为129．7ml和243．3ml;第2组分别为133．9ml和242．9ml;第3组分别为168．5ml和308．1ml;第4组分别为178．2ml和314．8ml。第1、2组与第3、4组相比,差异有极显著性（P＜0．01）;第1组产妇产后出血量少于第2组,但差异无显著性（P＞0．05）。（3）产后出血（≥400ml）发生率,第1组6．4％;第2组13．0％,第3组20．7％;第4组25．3％。（4）4组产妇均未出现明显的副作用。结论：氨甲环酸用于产后出血的治疗是安全有效的,其中1．0g剂量对减少产后出血量的效果最好,0．5g剂量的效果次之。

Clinical study on the efficacy of tranexamic acid in reducing postpartum blood lose: a randomized, comparative, multicenter trial

OBJECTIVE: To study the efficacy and safety of Transamin (tranexamic acid) in reducing postpartum blood loss. METHODS: Four hundred primipara with term singleton pregnancy, vertex presentation, spontaneous delivery were enrolled. Ten U Oxytocin was injected intravenously immediately after the delivery of fetal shoulders in the second stage of labor. Then all the puerperants were randomly assigned to 4 groups. Group I (n = 94): Transamin 1.0 g was injected i.v.; Group lI (n = 92): Transamin 0.5 g i.v.; Group III (n = 92): aminomethylbenzoic acid 0.5 g i.v. was given; Group IV (n = 87): no treatment. Vaginal bleeding was precisely collected, and examined immediately after the expulsion of placenta and from placenta expulsion till 2 hours after delivery. The amount of blood loss was measured by both methods of weight and volume. RESULTS: There were no significant differences of blood loss immediately after the expulsion of placenta among the 4 groups (P > 0.05). For the average blood loss at 2 hour postpartum, it was 129.7 ml, 133.9 ml, 168.5 ml and 178.2 ml for group I, II, II and IV respectively, while the total blood loss for the 4 groups was 243.3 ml, 242.9 ml, 308.1 ml, and 314.8 ml respectively. The average blood loss of group I and II was significantly less than group III and IV (P < 0.01), however, there was no significant difference between group I and group II (P > 0.05). The occurrences of postpartum hemorrhage (blood lose > or = 400 ml) were 6.4%, 13.3%, 20.7% and 25.3% for group I, II, III and IV respectively. There was no major adverse effects appeared. CONCLUSIONS: Transamin is efficient and safe in reducing the postpartum blood loss. 1.0 g of Transamin has the best efficacy, and 0.5 g of Transamin followed.