Post-marketing Safety Investigation In Eight Key Monitored Traditional Chinese Medicine Injections

Objective:In order to understand the reasons, rules, and major influence factors of adverse drug reactions (ADR) caused by traditional Chinese medicine (TCM) injections,8kinds of TCM injection (Xiyanping, Shuanghuanglian, Qingkailing, Shenmai, Shengmai, Xiangdan, Danshen and Mailuoning Injection) of the key monitoring varieties issued by State Food and Drug Administration in2011are selected. Based on the statistics and analysis on the data from literature reports and ADR reports in Tianjin region of the8key monitored TCM injections, the causes and major influence factors of the TCM injections inducing ADR are summarized. The views on pharmaceutical care and measures to minimize or avoid the occurrence of ADR are presented, that contribute to help clinicians understanding the characteristics, rules and risk factors of ADR caused by TCM injections. Thus the early diagnosis and treatment can be done to reduce the incidence and mortality of ADR, and can provide the basis for the rational use of TCM injections.Methods:I. Literature analysis on safety of the8key monitored TCM injections:(1) Literature reports over ADR of the8TCM injections are searched from major domestic medical literature databases from1992to2012.(2) The literatures are read and selected to bring in the ADR case reports, information notifications and drug safety research reports with full data and clear correlation into the study.(3) Data record form is designed and literature data is recorded. Classification statistics is performed according to the ADR involving systems-organs and its clinical manifestations.(4) ADR data are analyzed and summarized from the patients’ individual factors, drug factors, the occurrence and performance of ADR, disposal of ADR and the results, so as to conclude the major influence factors of ADR induced by TCM injections.Ⅱ. Analysis on ADR reports of the8key monitored TCM injections in Tianjin region:(1) ADR reports in Tianjin region from2010to2012are collected, and ADR report of the suspected8TCM injections involving Xiyanping injection are included in the research.(2) With correlation evaluation on the ADR reports, ADR reports with certain correlation with the8TCM injections are included into the research.(3) Data record form is designed and ADR report data in Tianjin region recorded. Classification statistics is performed according to the ADR involving systems-organs and its clinical manifestations.(4) The ADR data are analyzed and summarized from the patients’individual factors, drug factors, the occurrence and performance of ADR, disposal of ADR and the results, so as to conclude the major influence factors of ADR induced by TCM injections.(5) The influence of disposal methods on duration time of ADR is discussed.Results:(1) Major influence factors of ADR induced by Xiyanping Injection include age, patient’s physical condition, rationality of medication, drug combination.(2) Major influence factors of ADR induced by Shuanghuanglian Injection include age, patient’s physical condition, drug combination, drug dosage, solvent selection and solvent dosage.(3) Major influence factors of ADR induced by Qingkailing Injection include age, gender, patient’s physical condition, drug combination, and drug dosage.(4) Major influence factors of ADR induced by Shenmai Injection include age, patient’s physical condition, rationality of medication, drug combination, drug dosage, solvent selection and solvent dosage.(5) Major influence factors of ADR induced by Shengmai Injection include age, patient’s physical condition, rationality of medication, drug combination.(6) Major influence factors of ADR induced by Xiangdan Injection include age, gender, patient’s physical condition, drug combination, and drug dosage.(7) Major influence factors of ADR induced by Danshen Injection include age, gender, patient’s physical condition, rationality of medication, drug combination, and drug dosage.(8) Major influence factors of ADR induced by Mailuoning Injection include age, patient’s physical condition, drug combination, and drug dosage.(9) ADR caused by TCM injections appear generally faster. Most of the ADRs occur within1hour after medication, and some occur within24hours after medication. The ADR involved systems-organs have wide range of distribution, which mostly in skin and appendages disorders, respiratory system disorders, and body as a whole-general disorders, with very different severities of the clinical manifestations.(10) The result of Chi-square test confirmed that there is a significant difference of ADR duration time between medication group and control group at the level of1hour.Conclusion:(1) Major influence factors of ADR induced by eight TCM injections are screened.(2) Rational use of TCM injections can avoid or reduce it causing ADR.(3) Symptomatic drug treatment can effectively reduce the duration time of ADR caused by TCM injections.(4) Improvement of ADR reports specification is beneficial to improve the post-marketing drug safety monitoring, thus can better ensure patients’ medication safety.