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目的通过经期使用卫生棉条及卫生巾的随机性比较,探讨中国妇女使用卫生棉条的安全性。方法2003-08-2004-07在首都医科大学附属北京友谊医院与上海市计划生育科研所征集300例具有规则月经周期的已婚健康育龄妇女,随机分为卫生棉条组和卫生巾对照组,并在使用产品后的第1、3、6个月经周期后行妇科检查和评分,同时取样行实验室阴道分泌物悬滴试验、氢氧化钾(KOH)试验、细菌性阴道病试验(BV-Blue)、阴道酸碱度(pH)检查。结果在3次随访中,棉条组外阴和阴道症状发生率为0.8%(1/130)~1.4%(2/144),较卫生巾组发生率0.7%(1/136)~4.1%(6/145)略低,程度亦轻,无一例因此而终止试验。棉条组阴道炎症总感染发生率4.0%(6/150),对照组为4.6%(7/150),两组比较差异无统计学意义(P>0.05)。试验结束时棉条组慢性宫颈炎的比例为12.3%,较试验开始时的21.3%有所下降,与对照组相似(结束时12.5%,开始时25.3%)。其中轻度宫颈糜烂入选时有27例,研究结束时为12例,且无一例中度或重度宫颈糜烂发生,此结果亦与对照组相似(入选时37例,结束时16例)。结论卫生棉条未增加阴道感染和宫颈炎症的发生率,并且未加重宫颈炎症的程度,无不良反应,在中国妇女中使用卫生棉条是安全的。
Objective To explore the safety of Chinese women using tampons through the random comparison of tampons and sanitary napkins during menstruation. Methods A total of 300 married women of childbearing age with regular menstrual cycle were enrolled in Beijing Friendship Hospital Affiliated to Capital Medical University and Shanghai Family Planning Research Institute from August 2003 to April 2004. They were randomly divided into four groups: Gynecological examinations and grading were performed after the first, third and sixth menstrual cycles after using the product. At the same time, the vaginal discharge drop test, potassium hydroxide (KOH) test, BV- Blue), vaginal pH (pH) examination. Results The incidence of vulvar and vaginal symptoms was 0.8% (1/130) ~ 1.4% (2/144) in the three follow-up visits and 0.7% (1/136) -4.1% in the sanitary napkin group 6/145) slightly lower, to a lesser extent, without any cause to terminate the trial. The total incidence of vaginal inflammation was 4.0% (6/150) in the sliver group and 4.6% (7/150) in the control group, with no significant difference between the two groups (P> 0.05). At the end of the trial, the rate of chronic cervicitis was 12.3% in the sliver group, down from 21.3% at the start of the trial, similar to the control group (12.5% at the end and 25.3% at the beginning). There were 27 cases of mild cervical erosion at the end of the study, 12 cases at the end of the study, and no case of moderate or severe cervical erosion. The results were also similar to the control group (37 cases at the end of the study, 16 cases at the end). Conclusion The tampons did not increase the incidence of vaginal infections and cervical inflammation, and did not increase the degree of cervical inflammation, no adverse reactions, the use of tampons in Chinese women is safe.