洁童阴洗液治疗女童外阴阴道炎双盲随机对照试验

Jie Tong Yin Lotion in the treatment of vulvovaginitis in girls:A randomized,double-blind controlled trial

目的:评价洁童阴洗液治疗青春期前女童外阴阴道炎(湿热下注证)的临床疗效。方法:采用随机、双盲、安慰剂对照临床试验研究。于2022年3月—2023年2月首都医科大学附属北京儿童医院采集3~9岁外阴阴道炎(湿热下注证)女童为研究对象,试验组(81例)予洁童阴洗液,对照组(38例)予安慰剂洗液。坐浴治疗,每日2次,每次10 min,疗程14 d,试验结束进行临床疗效评价。结果:试验组总有效率90.1%(73/81),痊显率85.2%(69/81),痊愈率75.3%(61/81),均显著高于对照组的总有效率52.6%(20/38),痊显率34.2%(13/38),痊愈率23.7%(9/38)(P<0.01)。临床试验结束时,试验组中有13例加用抗生素(16.0%),显著低于对照组的17例(44.7%)(P<0.01)。疾病复发率试验组为7.41%(6/81),对照组13.16%(5/38)。结论:洁童阴洗液治疗女童外阴阴道炎(湿热下注证)安全有效,可减少抗生素使用。且证实加强科普宣传、实施外阴卫生措施的必要性。

Objective:To evaluate the clinical efficacy of Jie Tong Yin Lotion in the treatment of prepubertal girls with vulvovaginitis(damp-heat pouring downward syndrome).Methods:A randomized,double-blind,placebo-controlled clinical trial was conducted.Girls aged 3 to 9 years with vulvovaginitis(damp-heat pouring downward syndrome)were studied in Beijing Children’s Hospital,Capital Medical University from March 2022 to February 2023.The test group(81 cases)was given Jie Tong Yin Lotion and the control group(38 cases)was given a placebo wash.Sitz bath treatment,twice a day,10 min each time,the course of 14 days,clinical efficacy evaluation was carried out at the end of the trial.Results:The total effective rate of the test group was 90.1%(73/81),the recovery rate was 85.2%(69/81),and the cure rate was 75.3%(61/81),while the total effective rate of the control group was 52.6%(20/38),the recovery rate was 34.2%(13/38),and the cure rate was 23.7%(9/38),with statistically significant differences between the two groups(P<0.01).At the end of the clinical trial,antibiotics were added in 13 cases(16.0%)in the test group and 17 cases(44.7%)in the control group,with a statistically significant difference in the rates of antibiotic use between the two groups(P<0.01).The disease recurrence rate was 7.41%(6/81)in the test group and 13.16%(5/38)in the control group.Conclusion:Jie Tong Yin Lotion is safe and effective in the treatment of vulvovaginitis in girls(damp-heat pouring downward syndrome),and may reduce the use of antibiotics.It is necessary to strengthen the publicity of science and the implementation of vulvar hygiene measures.