摘要
研究设计采用多中心随机化临床试验,1705例合格受术对象被随机分配使用两种粘堵剂,867例使用8％阿的平苯酚糊剂(PAP),838例使用显影苯酚胶浆(PM)。两组受术对象人口学特征、妇科检查结果和术时情况均衡可比。五年随访率分别为97.5％和98.1％。多终点递减率生命表法分析表明,两组间各顺序月的粗累积失败率经log-rank检验均有显著差异。第60个顺序月的粗累积失败率,PAP组为4.61％,PM组为11.87％。PAP的节育效果显著优于PM。97.7％受术对象做了宫颈刮片检查,均未查见可疑癌细胞或癌细胞。同时,也未发现与粘堵剂可能有关的潜在疾患。这可能由于注入每侧输卵管内的粘堵剂的剂量(0.08ml)甚微之故。五年随访结果进一步表明,该术是一种简便、安全、有效的女性绝育术。作者建议在进一步改进粘堵剂配制、规范手术操作和加强施术技术标准化管理的基础上适时地推广这项新技术。
A multi-center randomized clinical trial was adopted in the present study. 1705 eligible women with identical demographic and gynecological characteristics were divided into two groups: 867 using phenol-atabrine paste (PAP) and 836 using phenol mucilage (PM). The five-year follow-up rates for the two groups were 97. 5% and 98. 1% .respectively. The multiple decrement life table analysis showed that there was a significant difference in the gross cumulative failure rates between the two groups. The 60th gross cumulative failure rates for PAP group and PM group were 4. 61% and 11. 87% , respectively, which indicated the efficacy of PAP was significantly higher than that of PM. 97. 7% adopters had cervical smear examination, and no suspected cancer cells or cancer cells were found. Meanwhile, there was no known diseases related to the chemical reagent due to the very small dose (0. 08ml) used. This follow-up study indicates that the tubal sterilization by chemical instillation is a simple, safe and efficient female method. It is suggested that this method can be introduced to a wider use on the basis of modification in the composition of chemical agents, standardized operational preceduce, and improved regulation to administration in the use of this technology.
出处
《中国计划生育学杂志》
1996年第3期142-145,共4页
Chinese Journal of Family Planning
关键词
绝育术
输卵管注药绝育
安全性
Female tubal sterilization by chemical instillation PAP PM Randomized multi-center clinical trial Life table method
