中文摘要：

目的：研究清开灵注射液不良反应的发生率、累及系统-器官的临床表现及性质，评价清开灵临床使用的安全性，为临床合理用药提供依据。方法采取多中心、药物源性、非对照的医院集中监测。结果清开灵注射液的不良反应发生率为0.086%，虽涉及全身多个系统，但症状均较轻微，停药后可较快好转或消失。结论清开灵注射剂不良反应属于罕见，且与说明书基本相符，大规模的医院监测是安全性再评价的主要方法，可以实时反映临床用药的真实情况，确保安全用药。

英文摘要：

Objective To study the adverse reaction incidence, clinical manifestation and nature of organ involvement of Qingkailing injection, evaluate the safety of clinical usage of Qingkailing injection, offer references for rational application in clinical practice. Methods The multi-center, drug-induced and non-controlled intensive hospital monitoring was conducted. Results The rate of Qingkailing injection adverse reaction is 0.086%.Although many systems of the patients were involved, the symptoms of Qingkailing injection adverse reactions were mild, which were improved or disappeared quickly after drug withdrawal. Conclusion The adverse reactions of Qingkailing injection are rare, and consistent with its specification. Large-scale hospital monitoring is the main method of safety re-evaluation, which can reflect the real situation of clinical application, thus ensure the safety of drug use.