目的 探討痰熱清注射液臨床使用中不良反應(yīng)（ADR）的特點及規(guī)律，以合理用藥。方法 檢索2003年5月-2013年5月中國主要科技文獻數(shù)據(jù)庫，對ADR資料進行回顧性分析，總結(jié)ADR的一般規(guī)律和特點。結(jié)果 獲得文獻48篇56例，其中男性占66.07%、女性占33.93%，男性ADR發(fā)生率高于女性；ADR在各年齡段均有分布，平均年齡（32.6±24.9）歲；10歲以內(nèi)兒童ADR發(fā)生率（35.71%）較高；用藥30 min內(nèi)出現(xiàn)的居多（71.43%）；ADR造成多個系統(tǒng)–器官損害，類型為過敏反應(yīng)（51.79%）和皮膚反應(yīng)（30.36%）；55例患者狀態(tài)恢復(fù)正常、預(yù)后良好，死亡1例。稀釋溶液、稀釋濃度、給藥速度等均與ADR相關(guān)。結(jié)論 根據(jù)適應(yīng)癥合理使用并加強ADR監(jiān)測，確保用藥安全有效。

Objective To explore the features of adverse drug reactions (ADRs) of Tanreqing Injection occurring in clinical use. Methods With the searching term of Tanreqing, download the original case report of its ADR from China main database from May, 2003 to May, 2013 to investigate the general rules and characteristics of ADR. Results In the 56 adverse reaction cases, the male accounted for 66.07%, as well as the female accounted for 33.93%, the incidence rate of adverse reactions was higher in males than that in females. The adverse reaction cases with an average age of (32.6 ± 24.9) years old, Cases of adverse reactions in all the age distribution; Ten-year-old children reported more incidences of adverse reactions than other ages, and accounted for 35.71% of the total proportion of adverse reactions. Most patients demonstrated ADRs within 30 min after using the drug, and accounted for 71.43% of the total number of cases. The main adverse reaction caused by Tanreqing Injection involved in multiple system-organ damage involved in which 29 cases and 17 cases were mainly reflected by allergic reactions and skin reactions. After the treatment of cases with corresponding measures, 55 patients recovered to normal , and only one case of death was reported. It showed that the incidence of adverse reactions was related to dilute solvents, dilute concentration, velosity of administration. Conclusion Strengthening the monitoring of adverse reactions and rational use of Tanreqing is necessary to ensure drug use safely and effectively.

天津市中醫(yī)藥管理局中醫(yī)﹑中西醫(yī)結(jié)合科研課題（13050）