摘要
目的观察短期口服小剂量十一酸睾酮胶丸治疗46,XY男童阴茎短小的疗效及安全性。方法以前瞻性自身对照研究方法,对2008年8月至2010年8月各类青春期前46,XY阴茎短小男童的连续样本给予十一酸睾酮胶丸(2～3mg.kg-1.d-1,最大剂量120mg.d-1)口服治疗。3个月为1个疗程,最多2个疗程。以Feldman方法观测阴茎牵长(PL),睾丸模型子比较法测量睾丸体积,G-P图谱法评测骨龄,检测治疗期间性激素等生化指标,观察治疗期间的不良反应。结果 50例患儿进入研究,平均年龄3.3岁。经第1疗程治疗后PL从(1.4±0.8)cm增长至(2.9±0.7)cm(P=0.00),PL标准差分值(SDS)的变化(△PL-SDS)为(2.9±1.3)(P=0.00);34/50例PL达标(≥-2.5s)予以停药,1/50例阴茎增长良好达手术标准停药。余15例进入第2疗程治疗,11例完成疗程。第2疗程PL增长量为(0.6±0.4)cm,△PL-SDS为(1.1±0.8)。第2疗程8/11例PL达标,3/11例达手术标准。第1疗程PL增长比第2疗程明显(P<0.05)。起始PL短于-4SDS者第1疗程为24例,第2疗程为15例。所有患儿及家长对治疗效果表示满意。治疗前后身高及血清IGF-1、血常规、血电解质、糖脂代谢指标和甲状腺功能等均在正常范围,未见肝肾功能等异常。治疗前后患儿骨龄/实足年龄的平均值均<1。结论短期口服小剂量十一酸睾酮治疗青春期前46,XY男童阴茎短小能有效促进阴茎生长,第1疗程疗效优于第2疗程。初始阴茎越长,越可能1个疗程结束治疗,治疗不良反应相对较小。药物依从性和家长满意度高。
Objective To assess the short-term efficacy and safety of oral testosterone undecanoate （TU） treatment for 46, XY DSDs boys with small penis. Methods It was a prospective and self-comparison design including consecutive cases treated with oral TU at a dose of 2 - 3 mg · kg^-1 · d^ - 1 for 3 months as a duration. All cases were treated with no more than 2 durations. Penile lengths （PLs） were measured at the end of each duration with Feldman method. Testicular volume was measured with PARADA Testicular-model comparison method. Bone age （BA） was calculated by one investigator according to G-P method. Growth-related parameters and other side effects were observed. Results PLs of 50 cases increased from （ 1.4 ± 0.8 ） cm to （ 2. 9 ± 0.7 ） cm （ P = 0.00）, A PL standard deviation score （SDS） was （2.9 ± 1.3 ） （ P = 0.00） at the end of the 1 st duration. 68% （34/50） boys achieved the target （PL≥ -2.5s, another 1 case combined with hypospadias reached the surgery condition. The rest of 15 cases entered the second duration and 11 patients completed treatment. APLs were （0.6 ±0.4） cm, APL-SDS was （1.1 ±0.8）. 72.7% （8/11） and achieved the goal, 27.3% （3/11） cases received operation. Among the cases who completed 2 durations of treatment, the increment of PLs in the first duration was significantly greater than that in the second duration （ P 〈 0.05）. 48% patients whose PL were longer than -4 SDS needed the second duration while 100% patients whose PL were shorter than -4SDS needed. All patients and/or their parents were satisfied with the outcome. The biomarkers were in normal range and the average BA/CA was 〈 1. Conclusions This study shows that TU treatment in small penis improves the penis length. Thefirst duration treatment improves more increment of PL. The longer the PL is at baseline, the greater possibility the patient reaches the goal at the first duration. The effect of TU on growth and bone maturation is acceptable and this medication obtains a good adherence and satisfaction. The dosage of TU in this study is proper.
出处
《中国循证儿科杂志》
CSCD
2012年第3期167-171,共5页
Chinese Journal of Evidence Based Pediatrics
