[Post-marketing clinical study of traditional Chinese medicine--lessons learned from comprehensive evaluation of Fufang Zaoren capsule].
By comprehensive review and analysis of post-marketing clinical research on the efficacy and safety,we concluded that Fufang Zaoren capsule has certain therapeutic effects for insomnia, although current clinical research design needs improving. The post-marketing clinical studies also showed that it causes several adverse reactions at the recommended doses, such as chills, fever, dizziness, nausea, shortness of breath, chest tightness and palpitations, whereas high doses of Fufang Zaoren capsule can cause delayed extrapyramidal symptoms. Health Canada government website also prompted the L-tetrahydropalmatine in Fufang Zaoren capsule caused liver damage in pregnant women. The authors summarized the risk points, factors and risk control in the clinical use of Fufang Zaoren capsule and also present their perspective on the research status, existing problems and corresponding countermeasures in the post-marketing clinical re-evaluation of traditional Chinese medicine.
Guiyang Center for ADR Monitoring, Guiyang 550003, China. ronaldinho1999@163.com
Shan
S
Qing
Guiyang Center for ADR Monitoring, Guiyang 550003, China.
Lin
L
Gao
Center for Drug Reevaluation, China Food and Drug Administration, Beijing 100045, China.
Li
L
Zhang
The Department of Neurology, Xuan Wu Hospital Capital Medical University, Beijing 100053, China.
Jian-Ping
JP
Jia
The Institute of Medicinal Plant Development, Chinese Academy of Medical Science Peking Union Medical College, Beijing 100094, China.
Xin-Min
XM
Liu
Bejing University of Chinese Medicine, Bejing 100029, China.
Shao-Liang
SL
Ji
Dongfang Hospital Affiliated to Beijing University of Chinese Medicine, Beijing 100078, China.
Xiao-Hui
XH
Yang
D002214:Capsules / Q000191:economics; D002681:China; D004341:Drug Evaluation / Q000191:economics; D004365:Drugs, Chinese Herbal / Q000009:adverse effects* / Q000191:economics; D005260:Female; D006801:Humans; D008297:Male; D040541:Marketing; D011358:Product Surveillance, Postmarketing / Q000191:economics
D002214:Capsules; D004365:Drugs, Chinese Herbal