Analysis of Adverse Drug Reactions/Events of TCM Injections in 18 Third Grade Class A Hospitals from Xi ’an during 2003- 2018
- VernacularTitle:2013－2018年西安市18家“三甲”医院中药注射剂不良反应/事件分析
- Author:
Xiaoai SHOU
1
;
Yu HAO
2
;
Bin HU
1
;
Xiaorong XUE
1
;
Yuyao ZHAI
1
;
Jing WANG
1
;
Yongliang HUANG
3
;
Hui MIN
1
Author Information
1. Dept. of Pharmacy，Xi’an Forth Hospital，Xi’an 714000，China
2. Luochuan County Food Quality and Safety Inspection and Testing Center，Shaanxi Province，Shaanxi Yan’an 727400，China
3. College of Clinical Medicine，Chengdu University of TCM，Chengdu 611137，China
- Publication Type:Journal Article
- Keywords:
Xi’an;
TCM injections;
Adverse drug reaction;
Adverse drug event;
Rational drug use
- From:
China Pharmacy
2019;30(19):2696-2701
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE： To analyze the characteristics of adverse drug reactions/events （ADR/ADE） caused by TCM injections in 18 third grade class A hospitals from Xi’an， and to provide reference for rational drug use in clinic. METHODS： Totally 304 ADR/ADE cases of TCM injection reported by 18 third grade class A hospitals of Xi’an were analyzed statistically during 2013-2018 in respect of gender and ages， time distribution of ADR/ADE， distribution of ADR/ADE-inducing drugs， organs/systems involved in ADR/ADE and clinical manifestations， grading of ADR/ADE， outcome and relationship evaluation， drug combination. RESULTS： Totally 6 683 cases of ADR/ADE cases were reported in same period， 304 cases were caused by TCM injection （4.55％）. Among 304 cases of ADR/ADE， the number of women （162 cases， 53.29％） was slightly higher than that of men （142 cases， 46.71％）. The age of patients was mainly over 40 years old （223 cases， 73.35％）. Among them， 118 cases （38.82％） were over 60 years old. ADR/ADE occurred within 1 min to 10 days after administration， especially within 30 min after administration （123 cases， 40.46％）. ADR/ADE involved 36 varieties， mainly including agent for promoting blood circulation and dredging， agent for reinforcing and tonifying and agent for clearing away heat and detoxification， and Danhong injection accounted for the highest proportion （43 cases， 14.14％）. A total of 352 ADR/ADE case times occurred in 304 patients， mainly lesion of skin and appendents （164 case times， 46.59％）， followed by cardiovascular system lesions （54 case times， 15.34％） and systemic lesions （51 case times， 14.49％）. The main clinical manifestations were mainly pruritus （117 case times）， followed by rash （68 case times） and palpitation （34 case times）. Among 304 ADR/ADE reports， 26 cases （8.55％） were severe， 8 cases （2.63％） were new ADR/ADE， 302 cases （99.34％） were cured or improved， 2 cases （0.66％） were unknown， but none of them died. 266 cases （87.50％） were evaluated as likely to be related. 46 patients （15.13％） had combined use of drugs， including 9 cases of combined use of TCM injection and 37 cases of combined use of chemical medicine injection. CONCLUSIONS： TCM injections had a high incidence of ADR/ADE due to the complexity of their components， individual differences and clinical use. Most of them were rapid-onset ADR/ADE within 30 min and mild ADR/ADE commonly seen in lesion of skin and its appendents. The incidence could be reduced by rational clinical use and drug monitoring. For cardiovascular diseases and other basic diseases， attention should be paid to distinguishing their primary diseases from ADR/ADE caused by TCM injections， and more attention should be paid to their individualized drug use.
