RAN Shan, FANG Zhonghong, HUANG Haiyin, et al. Problems in the Report of Traditional Chinese Medicine Drug-Induced Liver Injury and Recommondations[J]. Journal of Traditional Chinese Medicine2021, 62(7): 581-584.
RAN Shan, FANG Zhonghong, HUANG Haiyin, et al. Problems in the Report of Traditional Chinese Medicine Drug-Induced Liver Injury and Recommondations[J]. Journal of Traditional Chinese Medicine2021, 62(7): 581-584.DOI: 10.13288/j.11-2166/r.2021.07.007.
Objective To evaluate the papers reporting traditional Chinese medicine(TCM) drug-induced liver injury(DILI) in China
and to provide references for developing reporting standards of TCM DILI. Methods Terms including "Chinese herbal medicine(中药)"
"drugs(药物)"
and "liver damage(肝损伤)" were searched in CNKI for papers reporting TCM DILI. The basic characteristics regarding to the disease history
use of health-care products
drinking history
medications of both TCM and western medicine
source of Chinese medicinals and its identification were collected
and the problems in reporting TCM DILI were summarized. Results Totally
327 reports on TCM DILI were included. The number of papers reporting history of multiple diseases was 186(56.9%)
while that of history of multiple drugs
use of health-care products
drinking history
TCM medication history
use of western medicine drugs was 180(55.0%)
57(17.4%)
110(33.6%)
192(58.7%)
and 171(52.3%)
respectively. Information on manufacturers
batch numbers
dosage
duration
source of Chinese medicinals
and identification were reported in 21(6.4%)
15(4.6%)
95(29.1%)
253(77.4%)
9(2.8%) and 8(2.4%) papers respectively. One hundred and forty(42.8%) papers reported the correlation between TCM and DILI. Sixty nine papers were by clinical researchers
while 257 were retrospective studies based on medical records
and one was based on adverse drug reaction report(78.9%). Conclusion Current TCM DILI papers have not comprehensively reported both DILI-related patients′ information and TCM information
and mostly lacked the information on drug-related adverse reactions or adverse events
indicating a low reliability of the reporting. In future studies
full information on Chinese herbal medicine should be reported
confounding factors of western medicine should be excluded
and the standard procedures for reporting TCM DILI must be implemented.