Song Ya-Ling, Wen Ya-Lu, Zhang Li, Wu Hong-Hui, Huang Ju-Kai, Guan Ting, Yang Xiao-Hui
Dongfang Hospital, Beijing University of Chinese Medicine Beijing 100078, China.
Dongzhimen Hospital, Beijing University of Chinese Medicine Beijing 100700, China.
Zhongguo Zhong Yao Za Zhi. 2021 Apr;46(7):1839-1845. doi: 10.19540/j.cnki.cjcmm.20200708.501.
According to the notice on revision of the instructions for traditional Chinese medicine injections(TCMIs) issued by the National Medical Products Administration(NMPA) from January 2006 to May 2020, the revised contents in the instructions for 29 varieties involved in the notice were sorted out, and the existing problems in the instructions for TCMIs were analyzed, so as to provide the basis for dynamic revision of the instructions. It was found that the revised items of instructions for 29 varieties all involved adverse reactions, contraindications and precautions, and warnings were added for 82.76% of 29 TCMIs preparations, indicating that all the revised contents were related to safety issues. In addition, 33.33% of the drugs risks mentioned in the precautions were not indicated in the adverse reactions; 82.76% instructions did not indicate drug interactions; 17.24% instructions lacked medication notes for special populations; 48.28% instructions did not indicate traditional Chinese medicine(TCM) syndromes of the main disease; 44.83% instructions did not indicate the type and stage of indication; and 86.21% instructions did not indicate the course of treatment. It could be concluded that the instructions for TCMIs have known risks of drugs that are not fully reflected in adverse reactions and the effective information is not comprehensive. The risk control measures proposed in the precautions need to have aftereffect evaluation and there is a lack of drug interactions and medications for special populations. As an important part of the full life-cycle management of drugs, the revision of instructions for TCMIs should be continuously improved to provide the basis for safe and reasonable application of TCMIs. Based on the above problems, it is proposed that the marketing license holder as the main body of the revision of instructions should actively carry out post-marketing basic and clinical research in accordance with the characteristics of TCM, combine the updated research with the guidance of TCM theory and improve the revision level of instructions for TCMIs to provide the basis for post-marketing evaluation.
依据国家药品监督管理局（NMPA）2006年1月至2020年5月发布的关于修订中药注射剂说明书的通知，梳理通知中涉及的29个品种说明书的修订内容，并分析中药注射剂说明书存在的问题，为说明书动态修订提供依据。研究发现，29个品种说明书修订项目均涉及不良反应、禁忌和注意事项，29个中药注射剂制剂中有82.76%增加了警示语，表明修订内容均与安全性问题相关。此外，注意事项中提及的33.33%的药品风险在不良反应中未注明；82.76%的说明书未注明药物相互作用；17.24%的说明书缺少特殊人群用药注意事项；48.28%的说明书未注明主要疾病的中医证候；44.83%的说明书未注明适应证类型及分期；86.21%的说明书未注明疗程。可以得出结论，中药注射剂说明书存在已知药品风险在不良反应中未充分体现、有效信息不全面的问题。注意事项中提出的风险控制措施需要有后续效果评价，且缺乏药物相互作用及特殊人群用药内容。作为药品全生命周期管理的重要组成部分，中药注射剂说明书修订应不断完善，为中药注射剂安全合理应用提供依据。基于上述问题，建议以说明书修订主体的上市许可持有人应根据中药特点积极开展上市后基础及临床研究，结合更新的研究与中医理论指导，提高中药注射剂说明书修订水平，为上市后评价提供依据。
