ABSTRACT
OBJECTIVE@#To evaluate whether skin tests are suitable to predict the allergy reactions induced by Chinese herbal injections (CHIs).@*METHODS@#The skin tests including skin prick tests (SPT), intradermal tests (IDT) and provocation tests including subcutaneous tests and intravenous tests were administered to 249 healthy subjects and 180 allergic patients for 3 CHIs, including ginkgolide injection, diterpene ginkgolide meglumine injection and Salvianolate lyophilized injection. The results of the provocation tests were used as the "gold standard" to determine the sensitivity and specificity of the skin tests.@*RESULTS@#The results did not show any significant differences between the healthy and allergy groups in both skin tests and provocation tests (P>0.05). The specificities of SPT and IDT were 0.976 and 0.797, respectively, and the sensitivities of both SPT and IDT were 0.@*CONCLUSION@#Skin tests are insufficient to predict the likelihood of allergic reactions resulting from CHIs. (ChiCTR-CPC-15006921).
Subject(s)
Humans , China , Hypersensitivity , Intradermal Tests , Sensitivity and Specificity , Skin TestsABSTRACT
Along with the increase of clinical application, the safety of traditional Chinese medicine gained more and more attentions. In particular, the safety evaluation of Chinese medical injections has become a mandatory task should be completed by pharmaceutical companies under the supervision of China Food and Drug Administration(CFDA). Due to the weak foundation of previous studies, the safety issues of Chinese medical injections have not been fully understood, and lack of scientific and rational risk management programs. Clinical safety centralized monitoring(CSCM) is an important method for post-market safety evaluation of Chinese medicine. Due to the lack of appropriate norms and procedures, the quality of similar research is uneven, and the results vary. Combined with practical experience with experts' suggestions, we developed this expert consensus on the design and implementation of CSCM from three stages (design, implementation and report) with 20 technical points, which will provide technical support for future CSCM studies.
ABSTRACT
Cocktail probe substrates approach is a fast, sensitive and high through put method to determine cytochrome P450 enzymes activity. It has been widely used to screen early drug development, analyze drug metabolism types and confirm the metabolism pathways, study drug-drug interactions, optimize clinical regimen, evaluate post marketing drugs and help liver/kidney pathological studies. This article reviewed characteristics of Cocktail probe substrates, focused on the application to traditional Chinese medicine to CYP450 system as follows: the metabolic pathway research of Chinese herb active ingredients; processing way and compatibility of medical herbs affect CYP450; find out the metabolic characteristic of Chinese patent medicine, study in pharmacy of national minority; do research in liver protective effect of traditional Chinese medicine and evaluate traditional Chinese medicine syndromes in animal models. This article make a summary of existing research results and also make a comparison of cocktail probe substrates approach application to western medicine and Chinese medicine.
ABSTRACT
<p><b>OBJECTIVE</b>To observe the therapeutic efficacy on chronic severe hepatitis B (CSH) patients of Yanghuang and Yinhuang syndrome type by principles of cooling-blood and detoxicating combined with clearing-heat and resolving dampness (PA) or with strengthening-Pi and warming-yang (PB), respectively.</p><p><b>METHODS</b>Forty-three patients with CSH were randomly divided into two groups, group A (22 cases) treated with PA and group B (21 cases) with PB. The therapeutic efficacy, laying stress on the effect in eliminating jaundice, was observed.</p><p><b>RESULTS</b>The efficacy in group B was effective in 19 cases (90.5%), and ineffective in 2 (9.5%), while in group A, effective in 16 (72.7%) and ineffective in 6 (27.3%). Levels of TBIL and ALT were significantly lower in both groups (P < 0.05 or P < 0.01), and the descending extent was greater, the thrombinogen activity was higher in group B than that in group A after treatment (P < 0.05), no significant difference in ALT was found between the two groups.</p><p><b>CONCLUSION</b>The efficacy of PB is better than that of PA on CSH with Yanghuang and Yinghuang syndrome.</p>