输卵管注药绝育术效果影响因素Cox模型分析

本研究采用多中心随机化临床试验设计,共接纳1705例合格受术对象,其条件为术时年龄25～35岁已有两个或两个以上孩子的健康妇女。试验遵照随机原则将复方苯酚糊剂(PAP)和显影苯酚胶浆(PM)分配给合格受术对象。PAP组接纳871例,PM组接纳834例。施术采用细塑料经宫颈插入输卵管间质部定量注药0.08ml,术后拍摄盆腔X光片测量药物在输卵管内的充盈长度。在5年随访观察期间内发生明确诊断妊娠者为失败,其中PAP组失败41例,PM组失败99例。随访率分别为97.5％和98.1％。该随访资料属生存资料,因此本文应用Cox模型对影响生存期(有效期)的主要因素进行了分析。结果表明,绝育药物种类和术后盆腔X光片显影长度与本术节育效果显著有关。以PM组为参照组,PAP组的RR值为0.3407;以输卵管注药显影长度间质部≤0.5cm为参照组,X光显影输卵管峡部1.5～1.9cm组的RR值为0.3163。说明应用PAP和X光片显影显示峡部达1.5cm以上者的失败风险小。分析结果提示,除选择高效粘堵药物外,熟练掌握施术技巧则是保证本术成功的关键。

Cox's Regression Model Analysis on Factors Influencing Contraceptive Effectiveness of the Tubal Sterilization by Chemical Instillation

Analysis on factors influencing contraceptive effectiveness of the tubal sterilization by chemical instillation. Methods:A multi-center randomized clinical trial. 1705 eligible women were divided randomly into two groups, 871 women using phenol-atabrine paste(PAP) and 834 women using phenol mucilage(PM). The five-year follow-up rates for the two groups were 97. 5%and 98. 1 % ,respeetively. The data obtained from the study belong survival data in essence. Cox's regression model, proportional hazard model,were used for the analysis of the factors influencing contraceptive effectiveness of the procedure. The main outcome measure indicator is risk ratio (RR). The failure rate were used for single factor analysis. Results: The results of Cox's regression analysis showed that the two independent variables, the type of chemicals and the film length of the occlusion by chimical reagent on the pelvic X-ray after the procedure, among introduced six variables were highly significant (P = 0. 0001). The RR value of PAP users was 0. 3407 compared with reference group,PM users. 95%CI were 0. 2363-0. 4913. Regard the film length of the occlusion less than 0. 5cm for users as reference group, the RR of the film length 1. 5-1. 9cm for users was 0. 3163. 95% CI were 0. 2808-0. 3563. The results of single factor analysis using failure rate were same above. Conclusion: The contraciptive effectiveness of PAP was significantly higher than that of PM. In addition, the key determinant to ensure a success of the Fallopian tubal Sterilization by Chemical reagents must be with high-level skills of the procedure.