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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。
The study design used a multicenter randomized clinical trial in which 1705 eligible subjects were randomly assigned to use two types of sticking and blocking agents, 867 with 8% pro-phenol paste (PAP), 838 with developing phenol glue ). Demographic characteristics of the two groups of subjects by surgery, gynecological examination results and the time of the situation comparable. Five-year follow-up rates were 97.5% and 98.1% respectively. Multi-endpoint decline rate of life table analysis showed that the order of the two groups of large cumulative failure rate by log-rank test were significantly different. The cumulative failure rate for the 60th month was 4.61% in the PAP group and 11.87% in the PM group. The birth control effect of PAP is significantly better than that of PM. 97.7% of the subjects underwent cervical smear examination, did not detect suspicious cancer cells or cancer cells. In the meantime, no potential problems related to the sticking agent were found. This may be due to a small dose (0.08 ml) injected into the adhesive in each fallopian tube. Five-year follow-up results further show that the technique is a simple, safe and effective female sterilization. The authors suggest that this new technology should be timely promoted on the basis of further improving the preparation of sticking agent, regulating the operation of the operation and strengthening the standardized management of the operation technique.