生脉注射液临床应用及不良反应的系统评价

目的 调查生脉注射液临床应用情况，不良反应及相关因素。 方法 以“生脉注射液”为检索词，检索中国期刊全文数据库（CNKI）（1983年1月—2009年3月），收集国内期刊发表的生脉注射液临床研究，并分析纳入研究中生脉注射液的用药剂量、适应病证、给药途径、方法、溶媒、疗程及不良反应。 结果 最终纳入文献647篇，共28 305例（不包括对照组病例）患者。共发生不良反应215例，不良反应类型包括过敏反应（过敏性休克、全身过敏反应和皮疹）共56例和全身各系统、组织器官的不良反应159例，包括急性严重的急性肝损害和窦性停搏严重的心脏损害各1例。均经治疗好转，未见死亡病例的报道。 结论 生脉注射液自1983年上市以来已在临床广泛应用，其不良反应以过敏反应为主，除与患者个体体质有关外，与临床不合理用药如合并用药、剂量过大、年龄等因素有关。临床医师应重视不良反应的预防、观察，及时治疗，规范合理用药。

Systematic Review on the Application and Adverse Reactions of Shengmai Injection

Objective To investigate the clinical application and adverse reactions of Shengmai Injection and their related factors. Methods China National Knowledge Infrastructure （CNKI） database was searched with the key word of ＂ Shengmai Injection＂ from January 1983 to March 2009 to collect the literature regarding clinical study on Shengmai Injection, and the dose, indication, medicating path and method, solvent of the drug used, as well as the duration of treatment course and adverse reaction occurred were analysed. Results Finally, 647 documents involving 28 305 patients were included. Adverse reactions occurred in 215 patients, including anaphylactic response （anaphylactic shock, systemic anaphylaxis and skin rash） in 56 patients, and the adverse reactions on various systems, organs and tissues in 159 patients among whom there were a case of acute severe liver damage and a case of heart damage with severe sinus arrest. All patients were improved after treatment with no report of dead case. Conclusion Shengmai Injection has been widely applied in clinical practice since it came into the market in 1983, and its chief adverse reaction is the anaphylactic reaction. Excepting the relation with in- dividual constitution, the occurrence of the adverse reaction is also related to its improper clinical application, such as incorrect combination with other drugs, over-high dosage used and age factor, etc. The prevention, monitoring and in time treatment of the adverse reactions and standardized rational medication of the drug should be stressed in the application of Shengmai Injection by clinical physicians.