喜炎平注射液符合说明书适应症用药安全性的系统评价

Systematic review of medication safety of Xiyanping injection in conformity with indications of package inserts

系统评价喜炎平注射液符合说明书适应症用药的安全性。计算机检索国内、外8个数据库中有关喜炎平注射液符合说明书适应症(支气管炎、扁桃体炎、细菌性痢疾)用药的临床研究,根据纳排标准筛选文献,按照国际公认的评价标准进行质量评估,提取数据,并做分析。纳入118个研究,最终分析94个研究,包括70个随机对照试验,8个非随机对照试验,16个病例报告,共4 716名患者使用喜炎平注射液,发生0例不良事件(AE),148例不良反应(ADR)。其中15例严重不良反应,包括1例植物状态,4例过敏性休克及其他心血管一般损害等;133例一般ADR中以腹泻最多,皮疹次之。大部分研究按说明书剂量使用。现有证据表明,临床应用中不合理配伍及使用可能导致部分ADR。大部分研究无法获知具体用药过程及患者情况,不能明确推测ADR与年龄、溶媒等关系。建议临床工作者按相关规定及标准判读因果关系,并上报不良反应报告,为评价此药安全性提供更多有力证据。

To systematically review the medication safety of Xiyanping injection in conformity with indications of package inserts. Eight databases at home and abroad were searched for studies on the safety of Xiyanping injection. Literature screening, quality assess- ment, data extraction and analysis were performed according to internationally recognized inclusion and exclusion criteria. There were 118 clinical studies included, and 94 studies were finally studied, including 70 randomized controlled trials and eight non-randomized controlled trials, involving 16 case reports, and 4 716 patients treated with Xiyanping injection, with 148 adverse drug reactions （ADR） and no adverse event（AE）. Among them, 15 cases reported serious adverse drug reactions, including 1 vegetative state, 4 al- lergic shock and other general cardiovascular damages. Diarrhea was the most commonly reported ADR among the 133 general adverse reactions, accounting for 30. 12% , which was followed by rash. Most of the studies adopted the dosage set forth in package inserts. Some current evidences showed that irrational combined administration and use of Xiyanping may cause some ADRs. Because the most of studies didn＇t report the medication process and patient conditions, we can＇t infer the relations between the ADR and the age or sol- vent. Clinicians shall judge the causality according to relevant provisions and standards, and report ADRs, so as to provide more evi- dences for evaluating the safety of the drug.