PDF(Pubmed)
Abstract：
BACKGROUND: Deer antlers have been used as strong tonifying medicine in Asian countries, especially for the growth and development of children in pediatrics of Korean medicine. The safety of deer antler in adults cannot be applied directly to children because of their physiological characteristics. To accumulate reliable data on the safety of deer antler in pediatric populations, well-designed clinical studies are required.
METHODS: This research is a 12-week, randomized, double-blind, placebo-controlled clinical trial evaluating the safety of deer antler extract (DAE) in children. The DAE group received an intervention containing 1586 mg of DAE, whereas the control group received a placebo for 12 weeks. The safety was assessed by monitoring adverse drug reactions (ADRs) and laboratory test results.
RESULTS: One hundred participants were included in the safety analysis. Three and 2 participants in the DAE and control groups, respectively, reported ADRs. There was no significant difference in incidence between the 2 groups. ADRs are categorized into gastrointestinal and skin-related symptoms. No serious ADR was observed throughout the study. The laboratory test results were within or outside the normal range at clinically insignificant levels.
CONCLUSIONS: The research discovered that the DAE is safe in terms of ADRs and laboratory parameters under the conditions studied. Further studies are required to accumulate safety data about DAE dosage adjustment and potential interactions with other medicines.
METHODS: This research is a 12-week, randomized, double-blind, placebo-controlled clinical trial evaluating the safety of deer antler extract (DAE) in children. The DAE group received an intervention containing 1586 mg of DAE, whereas the control group received a placebo for 12 weeks. The safety was assessed by monitoring adverse drug reactions (ADRs) and laboratory test results.
RESULTS: One hundred participants were included in the safety analysis. Three and 2 participants in the DAE and control groups, respectively, reported ADRs. There was no significant difference in incidence between the 2 groups. ADRs are categorized into gastrointestinal and skin-related symptoms. No serious ADR was observed throughout the study. The laboratory test results were within or outside the normal range at clinically insignificant levels.
CONCLUSIONS: The research discovered that the DAE is safe in terms of ADRs and laboratory parameters under the conditions studied. Further studies are required to accumulate safety data about DAE dosage adjustment and potential interactions with other medicines.
摘要：
背景：鹿角在亚洲国家已被用作强效补药，特别是对儿童生长发育的韩国儿科医学。由于儿童的生理特性，鹿茸在成人中的安全性不能直接应用于儿童。为积累鹿茸在儿科人群中安全性的可靠数据,需要精心设计的临床研究。
方法：这项研究为期12周，随机化，双盲,安慰剂对照临床试验评估鹿茸提取物（DAE）在儿童中的安全性。DAE组接受了包含1586mgDAE的干预，而对照组接受安慰剂12周.通过监测药物不良反应（ADR）和实验室检测结果评估安全性。
结果：100名参与者被纳入安全性分析。DAE和对照组的3名和2名参与者，分别,报告的ADR。2组发病率差异无统计学意义。ADR分为胃肠道和皮肤相关症状。在整个研究中没有观察到严重的ADR。实验室测试结果在临床上微不足道的水平上在正常范围之内或之外。
结论：研究发现，在所研究的条件下，DAE在ADR和实验室参数方面是安全的。需要进一步的研究来积累有关DAE剂量调整和与其他药物的潜在相互作用的安全性数据。
方法：这项研究为期12周，随机化，双盲,安慰剂对照临床试验评估鹿茸提取物（DAE）在儿童中的安全性。DAE组接受了包含1586mgDAE的干预，而对照组接受安慰剂12周.通过监测药物不良反应（ADR）和实验室检测结果评估安全性。
结果：100名参与者被纳入安全性分析。DAE和对照组的3名和2名参与者，分别,报告的ADR。2组发病率差异无统计学意义。ADR分为胃肠道和皮肤相关症状。在整个研究中没有观察到严重的ADR。实验室测试结果在临床上微不足道的水平上在正常范围之内或之外。
结论：研究发现，在所研究的条件下，DAE在ADR和实验室参数方面是安全的。需要进一步的研究来积累有关DAE剂量调整和与其他药物的潜在相互作用的安全性数据。
