Xu D Z, Li M F, Wu X M, Li L S, Ma Q L, Fang Q L, Zhang H Y, Li G Y
Dept. of Epidemiology, Hospital No. 1, Fourth Medical College, Xian, People's Republic of China.
Contraception. 1990 Jun;41(6):663-70. doi: 10.1016/s0010-7824(09)91011-3.
A randomized triple-blind and placebo-controlled clinical trial on the effect of lidocaine and Anodyne-lubricant jelly (ALJ) containing dicaine on cervical dilatation is reported. Three-hundred-seventy-two consecutive cases were randomly allocated to 4 groups. The four groups were given: ALJ and placebo (placebo 1); and lidocaine and placebo (placebo 2). ALJ and placebo 1 treatment was by topical application, and lidocaine and placebo 2 by injection. In parous women, a significant difference was found for satisfactory dilatation (SD) rate (p less than 0.01) among four groups. It was unexpected that there were no significant differences between drug and placebo groups, neither between ALJ treatment group and placebo 1 group (p greater than 0.5), nor between lidocaine and placebo 2 (p greater than 0.75). However, the combined SD rate was 60.9% for the topical groups compared with 39.0% for the injection groups (p less than 0.005). The findings suggested that the effect of ALJ on cervical dilatation was not mainly due to dicaine, but associated with the lubricant and the topical treatment.
本文报道了一项关于利多卡因和含地卡因的止痛润滑凝胶(ALJ)对宫颈扩张效果的随机三盲安慰剂对照临床试验。372例连续病例被随机分为4组。四组分别给予:ALJ和安慰剂(安慰剂1);利多卡因和安慰剂(安慰剂2)。ALJ和安慰剂1采用局部应用治疗,利多卡因和安慰剂2采用注射治疗。在经产妇中,四组之间在满意扩张(SD)率方面存在显著差异(p<0.01)。出乎意料的是,药物组与安慰剂组之间没有显著差异,ALJ治疗组与安慰剂1组之间(p>0.5)以及利多卡因与安慰剂2组之间(p>0.75)均无显著差异。然而,局部应用组的联合SD率为60.9%,而注射组为39.0%(p<0.005)。研究结果表明,ALJ对宫颈扩张的作用并非主要归因于地卡因,而是与润滑剂和局部治疗有关。