[Skin test: guide of post-marketed re-evaluation of clinical safety in traditional Chinese medicine injection].

Anaphylaxis is the most common adverse reaction caused by traditional Chinese medicine (TCM) injection, the most serious of which is type I, so post-marketed safety re-evaluation is necessary. Skin test can be used to screen type I allergy reaction, which is of great significance for TCM injection safe use. Skin test is not only able to find the population sensitization situation of TCM injection, but also is a way of understanding the mechanism of allergy reaction. TCM injection varieties that often occur type I anaphylaxis are applicable to skin test, and study population include healthy volunteers and patients whose disease is listed in the drug specification, intracutaneous test and prick test are the alternative method. The concentration of skin-test solution may influence the positive rate of skin test, penicillin skin-test solution preparation method can be used as the reference in TCM injection. Different doses of TCM injection skin-test solution,glucose injection and normal saline, histamine hydrochloride are comprised in comparison. Given the characteristics of type I allergy reaction,we should be pay close attention to skin test reaction in half an hour, and observation index need be designed based on post-marketed re-evaluation of clinical safety.