乳房自我检查对降低女性乳腺癌死亡率干预效果的评估

Evaluation on the effect of intervention regarding breast self-examination for decreasing breast cancer mortality

目的评估乳房自我检查(BSE)对降低女性乳腺癌死亡率的作用。方法采用大样本随机对照前瞻性研究。自1989年10月起,在上海市纺织系统519个单位26．6万名年龄30～64岁的妇女中,随机分为指导组或对照组各13．3万人。指导组采用上课和个别指导、影视录像教育、定期测评、监察下自查、提醒卡督促自查等方法,对入组妇女进行强化型BSE教育和指导5年,持续密切观察两组人群乳房疾病的发生、手术和生存状况7年。对乳腺癌患者随访到2001年12月,实际随访12年。死亡病例均做死因调查。设计有26种表格记录队列人群与BSE有关的各种事件,进行全方位跟踪。统计分析采用Kaplan-Meier方法、log-rank检验以及Cox模型。结果经14年的研究,指导组检出乳腺癌864例,死亡133例；对照组检出乳腺癌896例,死亡130例,两组检出率分别为70．6/ 10万和72．6/10万(P＞0．05),累积死亡率分别为150．6/10万和120．6/10万(P=0．72)；两组乳腺癌病例肿块大小(直径≤2．0 cm)分别为48．0%和44．6%(P=0．07)；0+Ⅰ期病例分别为29．7%和27．6%(P=0．39),两组差异均无统计学意义。两组人群良性肿块检出率分别为2．3%和1．2%,特别是纤维腺瘤检出率及肿块大小,两组差异有统计学意义(P＜0．01)。结论对女性人群开展BSE教育和指导未能降低人群的乳腺癌死亡率；在指导组,有较多的良性乳房肿块被检出,造成过多的乳房肿块活检。

Objective A randomized trial of breast self-examination （BSE） Program was carried out to evaluate whether the intensive BSE could reduce the number of deaths among women from breast cancer. Methods This study was a randomized controlled trial（RCT）. A total of 266 064 women （age of 30 to 64 years ） associated with 519 textile factories in Shanghai had been randomly assigned to a BSE group （132 979 women ） or a control group （133 085 women ） since 1989. Initial instruction in BSE group would include demonstration of proper palpation techniques and was followed by 2 reinforcement sessions during the subse quent 4 years including video shows, BSE instruction sessions and BSE practice under medical supervision. These activities were continued for 5 years. Attendance at all events was recorded. The cohort was followed through July 2000 for development of breast diseases, and the breast cancer cases were followed through 2001 for vital status. Data analysis methods used would include Kaplan-Meier plots, log-rank test and Cox modeling. Results Among women under instruction, 864 breast cancers detected and 133 breast cancer deaths occurred while 896 breast cancers were detected and 130 deaths recorded in the control group. The tumor size （ P = 0.07 ）, TNM stage （ P = 0.39 ） and cumulative breast cancer mortality rate（P = 0.72） were not significantly different between the 2 groups. However, more and smaller {ibroadenomas were detected in the instruction group than in the control group （P〈 0.01）. Conclusion Intensive instruction in BSE did not seem to have reduced the mortality rate of breast cancer, but more and smaller benign breast lumps could be detected.