Spontaneous reporting system(SRS) is an important way to monitor the adverse drug reaction(ADR) and discover the ADR signal for marketed drugs. It can detect adverse reaction signals timely and effectively, and preven...Spontaneous reporting system(SRS) is an important way to monitor the adverse drug reaction(ADR) and discover the ADR signal for marketed drugs. It can detect adverse reaction signals timely and effectively, and prevent the occurrence of drug damage. Runzao Zhiyang Capsule is mainly composed of Radix Polygoni Multiflor, Radix Polygoni Multiflori Preparata, Radix Rehmanniae Recens, Radix Sophorae Flavescentis, Folium Mori and Urtica dentata Hand.-Mazz. It has the functions of nourishing blood, nourishing yin, expelling wind to relieve itching and moistening the intestines to relieve constipation. It is mainly used for skin itching, acne, constipation and other diseases caused by blood deficiency and wind dryness. The large, national SRS database of ADRs needs effective evaluation methods. We reported on the use of Bayesian confidence propagation neural network method(BCPNN) and reporting rate ratio method(PRR) with propensity score to control confounding variables. The tendency score method was used to control the hybrid bias produced by SRS data analysis. After the calculation of PRR and BCPNN, the score of "diarrhea", "rash" and "gastric dysfunction" showed that there was an early warning before and after matching. To sum up, it indicated that diarrhea, rash and gastric dysfunction were early warning signs.展开更多
目的探究分析高州市2023—2024年疑似预防接种异常反应(adverse events following immunization,AEFI)监测结果。方法通过中国疾病预防控制信息系统检索收集2023年1月—2024年3月期间的预防接种AEFI监测报告数据,对AEFI监测结果予以描...目的探究分析高州市2023—2024年疑似预防接种异常反应(adverse events following immunization,AEFI)监测结果。方法通过中国疾病预防控制信息系统检索收集2023年1月—2024年3月期间的预防接种AEFI监测报告数据,对AEFI监测结果予以描述性分析。结果2023年1月—2024年3月高州市接种疫苗出现245例AFEI,平均每年报告发生率为15.22/10万剂次。一般反应占比80.00%(196/245)、异常反应占比10.61%(26/245),未出现接种事故以及疫苗质量事故。AFEI个案中男女性别比例为1.36∶1;以<1岁者发生AEFI最多,10~15岁者发生AEFI最少。接种至出现症状的间隔时间以<1 d发生AEFI最多。AFEI报告涉及疫苗36种,前三位是百白破疫苗(无细胞)、麻腮风疫苗、13价肺炎疫苗;报告发生率前三位是带状疱疹疫苗(CHO细胞)、ACYW135流脑疫苗(结合)、冻干甲肝减毒活疫苗;引起一般反应的疫苗前两位是带状疱疹疫苗(CHO细胞)、ACYW135流脑疫苗(结合);引起异常反应的疫苗前两位是麻腮风疫苗、23价肺炎球菌疫苗。结论2023年1月—2024年3月高州市AEFI监测结果符合监测要求,且能在一定程度上说明预防接种疫苗的安全性,但需关注AFEI报告中发生率较高的疫苗,并需加强高州市AEFI监测,提升AEFI监测的及时性与灵敏度。展开更多
基金funded by National Science and Technology Major Project of New Important Drug Creation (2015ZX09501004-001-002)The National Natural Science Foundation of China (81473798):Study on allergic reaction mechanism of Chinese medicine injections with active monitoring and network target monitoring+1 种基金Project of "One Belt, One Road" for Traditional Chinese Medicine of China Academy of Chinese Medical Sciences (GH2017-04)Construction of China-US Major Disease Clinical Research Center (GH2017-04-01)
文摘Spontaneous reporting system(SRS) is an important way to monitor the adverse drug reaction(ADR) and discover the ADR signal for marketed drugs. It can detect adverse reaction signals timely and effectively, and prevent the occurrence of drug damage. Runzao Zhiyang Capsule is mainly composed of Radix Polygoni Multiflor, Radix Polygoni Multiflori Preparata, Radix Rehmanniae Recens, Radix Sophorae Flavescentis, Folium Mori and Urtica dentata Hand.-Mazz. It has the functions of nourishing blood, nourishing yin, expelling wind to relieve itching and moistening the intestines to relieve constipation. It is mainly used for skin itching, acne, constipation and other diseases caused by blood deficiency and wind dryness. The large, national SRS database of ADRs needs effective evaluation methods. We reported on the use of Bayesian confidence propagation neural network method(BCPNN) and reporting rate ratio method(PRR) with propensity score to control confounding variables. The tendency score method was used to control the hybrid bias produced by SRS data analysis. After the calculation of PRR and BCPNN, the score of "diarrhea", "rash" and "gastric dysfunction" showed that there was an early warning before and after matching. To sum up, it indicated that diarrhea, rash and gastric dysfunction were early warning signs.
文摘目的探究分析高州市2023—2024年疑似预防接种异常反应(adverse events following immunization,AEFI)监测结果。方法通过中国疾病预防控制信息系统检索收集2023年1月—2024年3月期间的预防接种AEFI监测报告数据,对AEFI监测结果予以描述性分析。结果2023年1月—2024年3月高州市接种疫苗出现245例AFEI,平均每年报告发生率为15.22/10万剂次。一般反应占比80.00%(196/245)、异常反应占比10.61%(26/245),未出现接种事故以及疫苗质量事故。AFEI个案中男女性别比例为1.36∶1;以<1岁者发生AEFI最多,10~15岁者发生AEFI最少。接种至出现症状的间隔时间以<1 d发生AEFI最多。AFEI报告涉及疫苗36种,前三位是百白破疫苗(无细胞)、麻腮风疫苗、13价肺炎疫苗;报告发生率前三位是带状疱疹疫苗(CHO细胞)、ACYW135流脑疫苗(结合)、冻干甲肝减毒活疫苗;引起一般反应的疫苗前两位是带状疱疹疫苗(CHO细胞)、ACYW135流脑疫苗(结合);引起异常反应的疫苗前两位是麻腮风疫苗、23价肺炎球菌疫苗。结论2023年1月—2024年3月高州市AEFI监测结果符合监测要求,且能在一定程度上说明预防接种疫苗的安全性,但需关注AFEI报告中发生率较高的疫苗,并需加强高州市AEFI监测,提升AEFI监测的及时性与灵敏度。
