Ye Wen-qian, Liang Yan, Cui Yi-min, Ding Jie
Department of Pediatrics, Peking University First Hospital, Beijing 100034, China.
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Zhonghua Er Ke Za Zhi. 2013 Dec;51(12):888-91.
Development and use of better medicine for children is a worldwide problem recently, especially in China. The current situation of drugs for children's renal diseases is far from well-understood now. This survey focused on drugs for pediatric renal diseases including immunosuppressants, corticosteroids, diuretics, anticoagulants, hypotensives and antilipemic agents.Information regarding the dosage, form, precaution, usage and administration in inserts was collected in this study.
Drugs for pediatric renal diseases were selected according to the guidelines established by the Chinese Society of Pediatric Nephrology. The detailed information about the dosage, form of drugs was searched on the website of China-State Food and Drug (SFDA). The information of the precaution, usage and administration was obtained from the China Pharmaceutical Reference, the first edition.
In this study, there were 5 categories of medicine including immunosuppressants, corticosteroids, diuretics, anticoagulants, hypotensives and antilipemic agents, and 89 kinds of medicine for renal diseases. Among these medicines, 65.2% were found not suitable for children in terms of drug dosage and form, 19.1% did not indicate the precaution, 51.7% did not indicate clearly the safety and effectiveness for children, and 56.2% lacked the detailed information about the usage and administration for children. There were only 4 kinds of these medicines which were studied via clinical trials in children population.
There is a lack of drugs for children with renal diseases. Most of the time, the medicines used by doctors are not specially manufactured for children. The safety and efficacy of drugs that are currently used to treat pediatric renal diseases are not clear and definite.In addition, few clinical trials have been conducted for evaluation of drugs for pediatric renal diseases.In clinic, the situation of off-label drug treatment is very serious.
研发和使用更适合儿童的药物是当前一个全球性问题，在中国尤为如此。目前对于儿童肾脏疾病用药的现状还远未完全了解。本次调查聚焦于儿童肾脏疾病用药，包括免疫抑制剂、皮质类固醇、利尿剂、抗凝剂、降压药和抗血脂药。本研究收集了药品说明书中关于剂量、剂型、注意事项、用法和用量的信息。
根据中华医学会儿科学分会肾脏病学组制定的指南选择儿童肾脏疾病用药。药物剂量、剂型的详细信息在中国国家食品药品监督管理总局（SFDA）网站上查询。注意事项、用法和用量的信息来自《中国药物参考》第一版。
本研究中有免疫抑制剂、皮质类固醇、利尿剂、抗凝剂、降压药和抗血脂药5类，肾脏疾病用药89种。在这些药物中，65.2%在药物剂量和剂型方面不适合儿童，19.1%未标明注意事项，51.7%未明确标明对儿童的安全性和有效性，56.2%缺乏儿童用法用量的详细信息。这些药物中只有4种在儿童人群中进行了临床试验研究。
儿童肾脏疾病用药匮乏。大多数情况下，医生使用的药物并非专门为儿童生产。目前用于治疗儿童肾脏疾病的药物的安全性和有效性尚不明确。此外，针对儿童肾脏疾病用药评估的临床试验很少。临床上，超说明书用药情况非常严重。
