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ObjectiveTo construct the evidence body for revision of safety information on package inserts of Chinese patent medicines in post-marketing by taking Xiaoke'an capsules as an example， so as to provide reference for the revision of instructions of Chinese patent medicines in post-marketing. MethodThe construction of the evidence body was guided by the theory of traditional Chinese medicine（TCM） and the Technical Guiding Principles for Revision of Safety Information Items in Instructions for TCMs After Marketing， and 8 categories and 25 specific items were taken as the main body of the evidence body， and information inclusion， integration， screening and improvement were carried out， then expert demonstrations were conducted， and finally modifications were made based on the opinions of the Center for Drug Evaluation to complete the revision of the safety information in the instructions of Xiaoke'an capsules. Result［Adverse reactions］ of Xiaoke'an capsules was revised to "monitoring data show that the following adverse reactions can be seen with this product：individual hypoglycemic reaction reports". ［Contraindications］ was revised to "contraindicated for those allergic to this product and its ingredients". ［Precautions］ was revised to "（1）pregnant women should use with caution， （2）elderly people should consult a physician， （3）people with spleen deficiency and dampness， spleen and stomach deficiency and cold， or those who eat less and have diarrhea should use with caution， （4）this product contains ginseng， should not be taken at the same time with TCM prescriptions or patent medicines containing veratrum and Wulingzhi， （5）pay attention to monitoring blood sugar during medication， （6）if any other discomfort occurs during medication， you should seek medical attention in time". The warning was revised to "use with caution by pregnant women， and pay attention to regular monitoring of blood sugar". ConclusionIn accordance with the content and process of the evidence body for the revision of safety information in the instructions， the revision of the safety information in the instructions of Xiaoke'an capsules has been completed， providing a strong basis for the rational and safe use of medication in the clinic.
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Objective:To evaluate the application effect of mini-clinical exercise assessment (Mini-CEX) in clinical teaching of pediatrics of Chinese medicine, further optimize Mini-CEX scale with characteristics of pediatrics of Chinese medicine, and improve teachers' understanding of its connotation.Methods:A total of 50 pediatric clinical practice undergraduates were randomly divided into Mini-CEX group and control group, 25 in each group, with a total of 4 weeks of practice. The application effect of Mini-CEX was evaluated by clinical comprehensive ability assessment, and the students' evaluation on the introduction of Mini-CEX in clinical teaching was understood through questionnaire survey on the recognition, advantages and existing problems of various contents of Mini-CEX. SPSS 17.0 was used for t test and chi-square test. Results:Total scores and sub-item scores of clinical comprehensive ability examination in Mini-CEX group were higher than those in control group ( P < 0.05), and the satisfaction with teaching in Mini-CEX group was significantly higher than that in control group ( P < 0.05). Through the questionnaire, it was found that the students had a high degree of recognition for the items in the improved Mini-CEX scale, and thought it was more suitable for the internship study and effect evaluation of pediatrics of Chinese medicine, especially in the aspects of clinical communication skills and humanistic care. Conclusion:Mini-CEX has many advantages, such as improving the clinical comprehensive ability of undergraduates, teaching effect, flexible teaching methods, objective evaluation methods and focusing on the cultivation of doctor-patient communication skills, which is worthy of clinical promotion.
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Objective To provide theoretical and experimental proof for selecting and implying Tourette's syndrome(TS) animal models, validities of four TS models induced by chemical factors were compared. Methods Four TS models,namely AMP model,APO model,DO1 model and IDPN model were built up by using different chemical modeling agents. Through detecting spontaneous movement, climbing time and monoamine transmitters levels in striatum, four TS animal models were compared and evaluated from three levels of validities-face, prediction,construct. Results Compared with control group, spontaneous movement times raised ( t = 4. 746, P =0. 000) and level of DOPAC ( (0.99 ± 0. 177 ) ng/mg) in striatum increased (P = 0.029 ), and level of NE in striatum decreased in AMP model group( (0.11 ± 0.033 )ng/mg, P = 0.012). Compared with control group, climbing time prolonged (P = 0. 004) and levels of DA ( ( 10. 19 ± 1.23 ) ng/mg), 5-HT ( ( 0. 54 ± 0.08 ) ng/mg) in striatum raised(P=0. 019, P=0. 002),at the same time ,levels of DOPAC( (0.63 ±0.11 )ng/mg),HVA ((0.45 ±0.04 ) ng/mg) in striatum reduced (P ＜ 0.01 ) in APO model group; Compared with control group, levels of DA ( ( 13.66 ± 1.55 ) ng/mg), DOPAC( (0.80 ±0. 11 ) ng/mg), HVA( ( 1.04 ± 0.14) ng/mg) grew downwards in striatum of DOI model mice(P=0.029,P=0.001, P= 0.004). Compared with control group, level of 5-HT in striatum increased in IDPN300 group ( (0.77 ± 0.09) ng/mg, P = 0.031 ). ConclusionFace validity of AMP model is temporal and that of IDPN model is steady and persistent. AMP model,APO model and DOI model possess predictive validity. AMP model,APO model,DOI model and IDPN model have potentiality of becoming construct validity model.
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0.05). Compared with model group, levels of DA and DOPAC in striatum reduced in Xieqing group (P