Wauer R R, Schmalisch G, Menzel K, Schröder M, Müller K, Tiller R, Methfessel G, Sitka U, Koepke E, Plath C, Schlegel C, Böttcher M, Köppe I, Fricke U, Severin K, Jacobi R, Schmidt W, Hinkel G K, Nitz I, Kunze D, Reichmann G, Lachmann B, Lampe K, Grauel E L
Int J Biol Res Pregnancy. 1982;3(2):84-91.
A prospective double-blind clinical trial was carried out to determine whether ambroxol (bromhexine metabolite VIII) treatment (1000 mg/day for a period of 5 days) reduces the risk of hyaline membrane disease (HMD) in potentially premature infants. Amniocentesis was performed before the first and 24 h after the last application of ambroxol or placebo to assess the development of the total phospholipid phosphorus content, the L/S ratio, the P/S ratio, and the properties of the surface tension of the amniotic fluid after ambroxol or placebo. There were 246 infants born to 224 mothers. Of the 116 infants with less than or equal to 36 completed weeks' gestation, 56 were in the ambroxol and 60 in the placebo group. No differences between groups occurred in risk factors for HMD (diabetes, asphyxia, male sex, cesarean section). Statistically significant differences in favor of the infants in the ambroxol group were found in the HMD incidence: 23.2% in the ambroxol group compared with 41.7% in the placebo group (p less than 0.05). There was no reduction of the HMD incidence in the less than or equal to 32-week gestational age category in the ambroxol group compared with the placebo group inspite of the fact that all the examined parameters for determining lung maturity reflected a stimulatory effect of ambroxol compared with the results of the placebo group, particularly before the 33rd week of gestation. Prolonged rupture of the membranes played no protective role against HMD.
进行了一项前瞻性双盲临床试验，以确定氨溴索（溴己新代谢物VIII）治疗（1000毫克/天，持续5天）是否能降低潜在早产婴儿患透明膜病（HMD）的风险。在首次应用氨溴索或安慰剂之前以及最后一次应用后24小时进行羊膜腔穿刺术，以评估氨溴索或安慰剂治疗后羊水总磷脂磷含量、L/S比值、P/S比值以及表面张力特性的变化。共有224名母亲所生的246名婴儿参与研究。在116名妊娠周数小于或等于36周的婴儿中，56名在氨溴索组，60名在安慰剂组。两组在HMD的危险因素（糖尿病、窒息、男性、剖宫产）方面无差异。在HMD发病率方面发现了有利于氨溴索组婴儿的统计学显著差异：氨溴索组为23.2%，而安慰剂组为41.7%（p<0.05）。尽管与安慰剂组相比，所有用于确定肺成熟度的检查参数都显示氨溴索有刺激作用，尤其是在妊娠33周之前，但氨溴索组中妊娠周数小于或等于32周的婴儿的HMD发病率与安慰剂组相比并未降低。胎膜早破对HMD没有保护作用。
