210种中成药说明书妊娠禁忌标注情况调查分析

Investigation and Analysis of Pregnancy Contraindication in Package Inserts of 210 Kinds of Chinese Patent Medicines

目的:为妊娠期中成药的药物咨询提供参考。方法:收集我院2016年1-6月使用的中成药说明书,参考2015年版《中国药典》(一部)中妊娠禁用、忌用、慎用药材和饮片,依据《中国药典》及2010年版《临床用药须知》中"注意"项,对比分析药品说明书妊娠禁忌标注存在的问题。结果:《中国药典》中收录妊娠禁用、忌用、慎用药材和饮片共计99种。我院除儿童专用中成药外的210种中成药说明书中,含禁用药材的有32种,含慎用药材的有61种,仅21种标注与所含药材相符。在含禁用、慎用药材的93种中成药说明书中,《中国药典》收录有27种,《中国药典》未收录而《临床用药须知》收录的有13种,两者均收录的有17种,但三者禁忌标注一致的仅有6种。在含禁用药材的32种中成药说明书中,明确标注禁用的有6种,标注为忌用或慎用的有17种,缺禁忌标注的有9种。在含慎用药材的61种中成药说明书中,标注为禁用或忌用的有29种,明确标注为慎用的有15种,缺禁忌标注的有17种。在117种不含禁用、忌用、慎用药材的中成药说明书中,标注妊娠期忌用的有8种,标注妊娠期禁用的有18种。结论:大部分中成药说明书妊娠禁忌标注欠规范,与《中国药典》或《临床用药须知》一致性差。药师除应遵照《中国药典》《临床用药须知》及药品说明书提供药物咨询外,对缺妊娠禁忌标注的中成药可通过分析所含药材的妊娠禁忌分类来判断。使用中药并不代表安全用药,且某些中成药中含有西药成分,因此药师应对妊娠期使用中成药的患者进行用药教育。考虑到中药注射剂新的、严重的不良反应较多,其不良反应存在不可预测性,因此对于妊娠期患者药师应建议避免使用中药注射剂。

OBJECTIVE： To provide reference for drug consultation of Chinese patent medicine （CPM） in pregnancy. METH- ODS： Package inserts of CPM in our hospital during Jan.-Jun. 2016 were collected. Referring to the prohibited, contraindicated and caution materials and decoction pieces in Chinese Pharmacopoeia （part 1, 2015 edition）, based on ＂note＂ item in Chinese Pharma- copoeia and Clinical Application Guidelines （2010 edition）, problems existing in pregnancy contraindication labeling of package in- serts were compared and analyzed. RESULTS： There were 99 kinds of prohibited, contraindicated and caution materials and decoc-tion pieces in Chinese Pharmacopoeia. There were 210 package inserts of CPM except for the special medicine for children, in which 32 contained prohibited materials, 61 contained caution materials, only 21 were in line with the contained materials. Among the package inserts of 93 CPM containing prohibited or caution materials, 27 were included in Chinese Pharmacopoeia, 13 in Clini- cal Application Guidelines only, 17 in both, but only 6 had the same contraindication labeling. Among the package inserts of 32 CPM containing prohibited materials, 6 were explicitly labeled prohibited, 17 labeled contraindicated or caution, and 9 labeled none. Among the package inserts of 61 CPM containing caution materials, 29 were labeled prohibited or contraindicated, 15 la- beled caution, and 17 labeled none. Among the package inserts of 117 CPM containing no prohibited, contraindicated or caution materials, 8 were labeled contraindicated in pregnancy, and 18 labeled prohibited in pregnancy. CONCLUSIONS： The pregnancy contraindications of most CPM are not normative, showing poor consistency with Chinese Pharmacopoeia or Clinical Application Guidelines. Except for providing drug consultation by complying with Chinese Pharmacopoeia, Clinical Application Guidelines and package insert, pharmacists can judge the CPM without labeled pregnancy contraindication by analyzing its classification of con- tained materials. Using TCM does not indicate safety drug use, in addition, some CPM contain westem medicine ingredients. There- fore, pharmacists should conduct medication education for patients who used CPM in pregnancy. Considering the new and severe adverse reactions of TCM injections are more, its adverse reactions exist unpredictability, so that pregnant patients should be sug- gested to avoid using TCM injections by pharmacists.