单次肌内注射与分次口服60万国际单位维生素D治疗营养性佝偻病的安全性和有效性的随机对照试验
A Randomized controlled trial on safety and efficacy of single intramuscular versus staggered oral dose of 600 000IU Vitamin D in treatment of nutritional rickets.
作者信息
Mondal Krishanu, Seth Anju, Marwaha Raman K, Dhanwal Dinesh, Aneja Satinder, Singh Ritu, Sonkar Pitambar
机构信息
Department of Paediatrics, Lady Hardinge Medical College, Kalawati Saran Children's Hospital, New Delhi, DL 110001, India.
Department of Paediatrics, Lady Hardinge Medical College, Kalawati Saran Children's Hospital, New Delhi, DL 110001, India
出版信息
J Trop Pediatr. 2014 Jun;60(3):203-10. doi: 10.1093/tropej/fmt105. Epub 2014 Jan 8.
OBJECTIVE
Comparison of efficacy and safety of two different regimens of vitamin D-600 000 IU as a single intramuscular dose, and 60 000IU orally once a week for 10 weeks-in treatment of nutritional rickets.
METHODS
Children with nutritional rickets (age: 0.5-5 years, n = 61) were randomized to receive either 60 000IU vitamin D orally once a week for 10 weeks or 600 000IU single intramuscular injection. Serum calcium, phosphate, alkaline phosphatase, urinary calcium/creatinine ratio, serum 25 hydroxy vitamin D and radiological score were compared at 12-week follow-up.
RESULTS
No difference was found in efficacy of the two regimens on comparing biochemical and radiological parameters. Serum 25 hydroxy vitamin D >100 ng/ml was found in two children in the oral group and one child in the intramuscular group. No child developed hypercalcemia or hypercalciuria after starting treatment.
CONCLUSION
Staggered oral and one-time intramuscular administrations of 600 000IU vitamin D are equally effective and safe in treatment of nutritional rickets.
目的
比较两种不同方案的维生素D（单次肌内注射600000IU和每周口服一次60000IU，共10周）治疗营养性佝偻病的疗效和安全性。
方法
将营养性佝偻病患儿（年龄：0.5 - 5岁，n = 61）随机分为两组，一组每周口服一次60000IU维生素D，共10周；另一组单次肌内注射600000IU。在12周随访时比较血清钙、磷、碱性磷酸酶、尿钙/肌酐比值、血清25羟维生素D及放射学评分。
结果
比较生化和放射学参数时，两种方案的疗效无差异。口服组有2名儿童、肌内注射组有1名儿童血清25羟维生素D>100 ng/ml。开始治疗后无儿童发生高钙血症或高钙尿症。
结论
分次口服和单次肌内注射600000IU维生素D治疗营养性佝偻病同样有效且安全。
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