摘要
目的：探讨复方地芬诺酯片致儿童不良反应/事件（ADR/ADE）发生特点及其相关因素,为临床合理用药提供参考。方法：检索有关复方地芬诺酯片致儿童ADR/ADE的文献,对其中符合条件的文献分别就患儿性别、年龄、服药剂量、用药原因、ADR/ADE发生时间及临床表现、转归情况等信息进行整理和分析。结果：共检索到符合条件的文献106篇,涉及病例1 988例,主要为儿童中毒病例（99.70%）;≤6岁的患儿占83.30%;治疗急慢性腹泻剂量使用不当和误服为致ADR/ADE的主要原因;患儿多在0.5~24 h内出现症状;ADR/ADE主要累及中枢神经系统和呼吸系统;有39例患儿死亡,3例患儿留有严重后遗症,其余患儿经治疗后均好转或痊愈;该药的使用可能有明显的城乡差别。结论：复方地芬诺酯片致ADR/ADE与多方面因素相关,应采取修改其说明书、改进其制剂工艺、加强安全用药宣传等措施,更好地保障儿童用药安全。
OBJECTIVE：To investigate the occurrence and related factors of pediatric ADR/ADE induced by Compound diphenoxylate tablets,and to provide reference for rational drug use in the clinic. METHODS：The literatures about pediatric ADR/ADE induced by Compound diphenoxylate tablets were retrieved. The included literatures were summarized and analyzed statistically in respects of gender,age,dosage,medication reasons,occurrence time of ADR/ADE,clinical manifestation,outcomes,etc.RESULTS：106 literatures were retrieved,involving 1 988 cases. There mainly were pediatric poisoning cases（99.70%）;the children ≤6 years old accounted for 83.30%;the main reasons for ADR/ADE were unsuitable dosage for acute chronic diarrhea and misuse;ADR/ADE mostly appeared within 0.5 h to 24 h. The central nervous system and respiratory system were mainly involved in ADR/ADE. There were 39 death cases,and 3 cases had severe sequela. The others were improved or cured after treatment. The application of drugs had significant regional variations. CONCLUSIONS：ADR/ADE induced by Compound diphenoxylate tablets is associated with various factors. It is suggested to amend the description,improve pharmaceutical technology and strengthen the publicity of safe medication so as to ensure the security of pediatric medication.
出处
《中国药房》
CAS
CSCD
2014年第28期2644-2646,共3页
China Pharmacy
