中药注射剂不良反应报告分析与危险因素评估

Analysis of adverse drug reaction reports and evaluation of risk factors in traditional Chinese medicine injections

目的分析宣城市人民医院中药注射剂不良反应资料,评估危险因素,为临床安全用药提供科学依据。方法回顾性分析2014年1月至2016年1月宣城市人民医院发生中药注射剂不良反应患者107例(阳性组)与同期应用相关药物未发生不良反应患者119例(阴性组)。对比分析两组性别、年龄、基础疾病、药物过敏史等患者自身因素与合并用药、配伍禁忌、溶媒不当及输注过快等药物相关因素,探讨中药注射剂不良反应发生的危险因素,同时对不良反应发生时间、涉及药品品种、主要累及器官系统及严重程度等方面进行统计分析。结果中药注射剂不良反应发生的危险因素依次为基础疾病、配伍禁忌、溶媒不当、高龄、药物过敏史与女性性别(OR值分别为4.649、4.232、3.028、2.879、2.799、2.256,P<0.05);不良反应发生的时间主要是集中于用药过程中(41.12%)及用药结束后30 min内(34.58%),涉及药品品种以心脑血管系统用药为主(91.67%),累及多器官系统,以皮肤及其附件受累所占比例最高(36.04%),临床表现复杂多样,多为一般不良反应(81.08%)。结论对于合并基础疾病并有药物过敏史的老年女性患者应用中药注射剂时应权衡利弊,注意药品不良反应的防治,选用正确的溶媒与合理的配伍药品,尤其应在用药早期重点关注、及时发现药品不良反应,立即采取有效措施,降低中药注射剂的用药风险。

Objective To analyze the adverse drug reaction（ ADR） data of traditional Chinese medicine injections（ TCMIs） in the People＇s Hospital of Xuancheng and to evaluate the risk factors in order to provide scientific evidences for clinical drug safety. Methods One hundred and seven cases with ADR of TCMIs（ positive group） and 119 cases without ADR when receiving relevant TCMIs（ negative group） in The People＇s Hospital of Xuancheng form January 2014 to January 2016 were studied retrospectively. The patient relative factors such as gender,age,underlying diseases condition,drug allergic history,and the drug relative factors including combined medication,incompatibility,incorrect drug solvent and extraordinarily fast intravenous infusion were compared; the risk factors of the occurrence of ADR were evaluated,and the occurrence time,the relative drug varieties,the main organs involved and the severity of ADR were analyzed at the same time. Results The risk factors of the occurrence of ADR were underlying diseases condition,incompatibility,incorrect drug solvent,advanced age,drug allergic history and female gender in turn（ OR = 4. 649,4. 232,3. 028,2. 879,2. 799,2. 256,P〈0. 05）. The occurrence time of ADR concentrated in the progress of intravenous infusion（ 41. 12%） and 30 minutes after intravenous infusion（ 34. 58%）. The main relative drug varieties were the cardiovascular and cerebrovascular system drugs（ 91. 67%）. The skin and its attachments were most common（ 36. 04%） in all those involving multiple organs and systems. The clinical manifestations were complex and varied,and mostly general adverse reactions（ 81. 08%）. Conclusion Clinicians should pay more attention to the prevention of ADR when infusing TCMIs to the elderly women patients with underlying diseases and drug allergic history,select the correct drugs solvent and reasonable compatibility,enhance the monitoring and detect the ADR without delay especially during the early stage of the medication,and take effective measures to reduce the risk of TCMIs.