早熟方治疗痰热型女童性早熟140例临床研究

A Hundred and Forty Cases of Clinical Study on“Zaoshu Granule”for Sexually Precocious Girls of Phlegm-heat Pattern

目的:验证早熟方治疗女童痰热互结型性早熟的临床疗效。方法:本课题采用多中心、单盲、随机对照方法,研究早熟方对女童性早熟痰热互结型的临床疗效,并与抗早2号方进行阳性对照。临床收集140例痰热互结型性早熟女童病例,随机分为治疗组70例和对照组70例,2组分别予早熟方、抗早2号方治疗,疗程均为12周;每4周随访观察临床症状、体征、身高、体质量、生长速率,乳核直径,并进行中医证候评分。入组初筛及治疗12周后分别检查子宫容积、卵巢容积、骨龄的变化情况及血清促卵泡生成素(FSH)、促黄体生成素(LH)、雌二醇(E2)水平,评价临床疗效,监测ALT、BUN、Cr进行安全性评价。结果:1)治疗组与对照组总有效率分别为96%、100%;2组间临床疗效比较无统计学意义(P>0.05)。2)治疗组与对照组乳核直径治疗前后自身比较有统计学意义(P<0.05);2组间比较无统计学意义(P>0.05)。3)治疗组及对照组子宫、卵巢容积治疗前后自身比较无统计学意义(P>0.05);治疗后组间比较亦无统计学意义(P>0.05)。4)2组血清LH、E2治疗前后自身比较有统计学意义(P<0.05);治疗后组间比较无统计学意义(P>0.05)。5)治疗组与对照组治疗前后中医证候评分比较,差异有统计学意义(P<0.001);治疗后2组间比较,差异无统计学意义(P>0.05)。6)治疗前后ALT、BUN、Cr测定数值均在正常范围。结论:早熟方能有效治疗儿童痰热互结型性早熟,能明显改善中医症候积分,缩小乳核直径,降低LH、E2水平,但对FSH无明显影响,对子宫、卵巢容积无明显影响。临床疗效与抗早2号方相当。

Objective： To observe the curative effect of＂Zaoshu Granule＂in treating sexually precocious girls of phlegm-heat pattern. Methods： The clinical effect of＂Zaoshu Granule＂was investigated in a multi-center,randomized,single-blind clinical trial with the control of No. 2 prescription. Among the 140 cases,seventy patients in the treatment group were given ＂Zaoshu Granule＂and 70 patients in the control group were treated by No. 2 prescription. The course lasted for 12 weeks. Every four weeks,the clinical symptoms,sign,height,weight,growth rate,diameter of nodule in breast and evaluation for TCM syndrome grade were detected in two groups respectively. Intrauterine volume,ovarian volume,bone age,levels of FSH,LH and E2 were detected at primary screening of enrollment and after 12 weeks treatment to evaluate the clinical effects. Safety evaluation was monitored by levels of ALT,BUN and Cr. Results： 1） The total effective rate was 96% in treatment group and 100% in control group without significant difference（ P〉0. 05）. 2） Within both of the groups,there was significant difference in diameter of nodule in breast before and after treatment（ P〈0. 05）,but no significant difference was found between the two groups（ P〉0. 05）. 3） Within both of the groups,there was no significant difference in intrauterine volume and ovarian volume before and after treatment（ P〈0. 05）,and also no significant difference between the two groups（ P〈0. 05）. 4） Within both of the groups,there was significant difference in serum levels of LH and E2 before and after treatment（ P〈0. 05）,but after treatment,no significant difference was found in all the indexes between the two groups（ P〈0. 05）. 5） Within both of the groups,there was significant difference in evaluation for TCM syndrome grade before and after treatment（ P〈 0. 001）,but no significant difference was found between the two groups（ P〉0. 05）. 6） Within both of the groups,levels of ALT,BUN and Cr before and after treatment were within normal range. Conclusion： ＂Zaoshu Granule＂has positive effect on sexually precocious girls of phlegm-heat pattern and it can obviously improve TCM syndrome grade,reduce the nodule in breast diameter,and decrease the levels of LH and E2. While it has no significant effect on FSH,intrauterine volume and ovarian volume. ＂Zaoshu Granule＂has equivalent clinical effect of No. 2 prescription in treating sexually precocious girls of phlegm-heat pattern.