世界中医药

目的：观察耳穴压丸联合早熟方治疗女童性早熟临床疗效。方法：选取2014年6月至2016年3月上海中医药大学附属曙光医院儿科性早熟专科门诊收治的患儿62例，随机分为观察组和对照，每组31例，观察组给予耳穴压丸联合早熟方，对照组给予早熟方。治疗期为3个月。入组时、治疗1个月、2个月、3个月以及6个月随访，观察患儿身高、体质量、症状、乳核大小、Tanner分期以及中医证候量化评分指标。入组时、治疗3个月分别检查子宫、卵巢容积，血清促黄体生成素（Luteinizing Hormone,LH）、促卵泡生成素（Follicle Stimulating Hormone,FSH）、雌二醇（Estradiol,E2）、垂体泌乳素（Prolactin,PRL），安全性指标（Alanine Transaminase，ALT；Blood Urea Nitrogen，BUN；Creatinine，Cr），并评价临床疗效。入组时、治疗6个月检查骨龄（Bone Age，BA）。结果：1）观察组与对照组临床疗效总有效率分别为100%、71%；2组间临床疗效比较，差异有统计学意义（P<0.05）。2）观察组和对照组的改善中医证候总有效率分别为100%、100%，组间比较，差异有统计学意义（P<0.001）。3）观察组与对照组治疗前后身高增长速率比较，差异有统计学意义（P<0.001）；治疗后组间比较差异亦有统计学意义（P<0.001）。4）观察组与对照组治疗前后体质量比较，差异有统计学意义（P<0.05）；治疗后组间比较，差异有统计学意义（P<0.001）。5）观察组与对照组子宫、卵巢治疗前后比较，差异无统计学意义（P>0.05）；治疗后组间比较，差异无统计学意义（P>0.05）。6）观察组及对照组性激素治疗前后组内比较，差异无统计学意义（P>0.05）；治疗后组间比较，差异无统计学意义（P>0.05）。7）观察组与对照组骨龄变化，治疗前后组内比较，差异有统计学意义（P<0.05）；治疗后组间比较，差异有统计学意义（P<0.001）。8）观察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）；治疗后组间比较，差异有统计学意义（P<0.001）。9）治疗后ALT、BUN、Cr均在正常范围内。结论：耳穴压丸联合早熟方能有效治疗女童痰热互结型性早熟，能改善中医证候，提高身高生长速度，控制体质量，延缓骨骼生长，但对性激素水平、子宫卵巢容积无明显影响。临床疗效优于早熟方。

English Summary:

To observe the clinical effects of auricular-plaster therapy with seeds combined with precocity fang for precocious puberty girls. Methods:A randomized controlled clinical trial was used in this study, which was aimed to observe the clinical effects of auricular-plaster therapy with seeds combined with precocity fang for precocious puberty girls with the control of precocity fang. A total of 62 cases who were received in specialist outpatient of pediatrics department in our hospital from June 2014 to March 2016 were selected. 31children were given auricular-plaster therapy with seeds combined with precocity fang in the treatment group, and another 31children were given precocity fang in the control group. The treatment period was 3 months. The indexes of height, weight, symptoms, diameter of nodules in the breast, Tanner stage and TCM syndrome were observed before treatment, treatment for 1 month, 2 months, 3 months and 6 months. Uterine volume, ovarian volume, the level of Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH), Estradiol (E2), Prolactin (PRL) and Alanine Transaminase (ALT), Blood Urea Nitrogen (BUN), Creatinine (Cr) were detected before treatment and treatment for 3 months, and the clinical effects were evaluated. The bone age was detected before treatment and treatment for 3 months. Results:1) The total effective rate was 100% in treatment group and 71% in control group with statistically significant difference (P<0.05). 2) The total effective rate for improving the TCM syndrome was 100% in treatment group and 100% in control group with statistically significant difference (P<0.001). 3) Within both of the groups, there was statistically significant difference in the height growth rate before and after treatment (P<0.001), and also statistically significant difference between the 2 groups (P<0.001). 4) Within both of the groups, there was statistically significant difference in the weight before and after treatment (P<0.05), and also statistically significant difference between the 2 groups (P<0.001). 5) Within both of the groups, there was no statistically significant difference in the uterine and ovarian volume before and after treatment (P>0.05), and also no statistically significant difference between the 2 groups (P>0.05). 6) Within both of the groups, there was no statistically significant difference in the level of LH, FSH, E2, PRL before and after treatment (P>0.05), and also no statistically significant difference between the 2 groups (P>0.05). 7) Within both of the groups, there was statistically significant difference in the bone age before and after treatment (P<0.05), and also statistically significant difference between the 2 groups (P<0.001). 8) Within both of the groups, there was statistically significant difference in the TCM syndrome grades before and after treatment (P<0.001), and also statistically significant difference between the 2 groups (P<0.001). 9) Within both of the groups, the levels of ALT, BUN, Cr before and after treatment were within normal range. Conclusion:The auricular-plaster therapy with seeds combined with precocity fang can effectively treat precocious puberty girls of phlegm-heat syndrome, and it can improve TCM syndrome grades, increase the height growth rate, control body weight, slow down the bone growth, but it has no significant influence on the level of LH, FSH, E2, PRL and uterine and ovarian volume. The clinical curative effect of auricular-plaster therapy with seeds combined with precocity fang is better than that of precocity fang.

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