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OBJECTIVE:To investigate the characteristics and rules of new and severe ADR induced by TCM for removing blood stasis and clearing heat in our hospital,and to provide reference for safe drug use in clinic. METHODS:New and severe ADR induced by TCM for removing blood stasis and clearing heat reported to national ADR monitoring center were collected from our hospital during Jan. 2006-Dec. 2016. Those ADR cases were analyzed retrospectively in respects of gender,age,allergic history,route of administration,drug type and dosage form,occurrence time,organs/systems involved and clinical manifestations, outcome. RESULTS:Among 298 reports,the incidence of ADR in female(70.13%)was higher male(29.87%),especially in patients aged 50-59(21.48%);there were 77 allergic cases(25.84%). Route of administration was mainly oral administration (57.37%),and dosage form was mainly injection(25.50%). Main ADR-inducing drug was Chinese patent medicine(53.53%). ADR mostly occurred over 1 d after medication(48.32%). Systems/organs involved in ADR were mainly lesion of skin and its appendants,systemic damage and gastrointestinal damage. Main clinical manifestations were rash,contact dermatitis,pruritus, infusion reaction,chills,fever,nausea,vomiting,diarrhea,etc.After drug withdrawal or symptomatic treatment,97.99% patients were revered and cured. There was no death case. CONCLUSIONS:TCM for removing blood stasis and clearing heat causes most new and severe ADR.Clinical drug use should be monitored closely to reduce the occurrence of ADR.
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OBJECTIVE:To provide reference for standardizing the names and definitions for the processing methods of"gener-al principles for processing"in reprinted Chinese Pharmacopoeia. METHODS:Comparing with the Processing of Chinese Mate-ria,Beijing Processing Specification for TCM Decoction Pieces,Shennong Bencaojing and National Processing Specification for Chinese Herbal Medicine,parts of the name and definition problems for processing methods of"general principles for processing"in Chinese Pharmacopoeia (2015 edition,Vol Ⅳ) were analyzed,and suggestions were put forward. RESULTS:The definitions of partial items in the"general principles for processing"in Chinese Pharmacopoeia remained to be normalized and operability re-mained to be improved. For example,the definitions of stir-frying,stir-frying with wine,stir-frying with vinegar,stir-frying with salt and stir-frying with honey were not accurate,so as the steaming. The name of the processing method under the term of decoc-tion pieces was not identified,there was deviation in the scope of crystallizing definition,and amount of pharmaceutic adjuvant was not worthy to be generalized. CONCLUSIONS:When generalizing and defining the processing methods for all TCM decoction pieces,Chinese Pharmacopoeia should give consideration to the popularity,accuracy and universality.
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OBJECTIVE:To systematically review the efficacy and safety of insulin glargine versus insulin detemir in the treat-ment of type 2 diabetes,and provide evidence-based reference for clinical treatment. METHODS:Retrieved from PubMed,EM-Base,Cochrane Library,CBM,CJFD,VIP and Wanfang database,randomized controlled trials (RCT) about the clinical efficacy and safety of insulin glargine versus insulin detemir in the treatment of type 2 diabetes were collected. Meta-analysis was performed by using Rev Man 5.2 software after data extraction and quality evaluation by Cochrane 5.1.0. RESULTS:A total of 18 RCTs,in-volving 3 638 patients were included. Results of Meta-analysis showed there was no significant difference in reducing glycosylated hemoglobin[MD=0.08,95%CI (-0.01,0.17),P=0.09];fasting blood glucose level in insulin glargine group was significantly lower thaninsulin detemir,the difference was statistically significant [MD=0.15,95%CI(0.03,0.27),P=0.02]. And there was no significant difference in the incidence of hypoglycemia [OR=0.97,95%CI(0.91,1.03),P=0.25];the degree of body mass gain ininsulin detemir was significantly lower than insulin glargine group [MD=-0.95,95%CI(-1.06,-0.85),P=0.003],but the in-cidence of injection site reactions was significantly higher than insulin glargine group [OR=2.28,95%CI(1.16,4.50),P=0.02],the differences were statistically significant. CONCLUSIONS:The insulin glargine has better efficacy,than insulin detemir with lower incidence of injection site reactions but higher degree of body mass gain than insulin detemir in the treatment of type 2 diabetes.
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Objective To investigate the effects of different methods of preparation on the contents of nuzhenide and oleanolic acid in Ligustri Lucidi Fructus. Methods The same batch of Ligustri Lucidi Fructus was under preparation and process. RP-HPLC was used to determine the contents of nuzhenide and oleanolic acid in crude samples, wine-prepared samples, vinegar-prepared samples, and salt-prepared samples. Results The contents of nuzhenide were in the order as follow:salt-prepared samples (1.997 5%)>crude samples (1.600 7%)>wine-prepared samples (1.144 6%)>vinegar-prepared samples (0.894 6%). The contents of oleanolic acid were in the order as follow:wine-prepared samples (1.120 2%)>salt-prepared samples (0.924 6%)>vinegar-prepared samples (0.913 2%)>crude samples (0.899 8%). Conclusion Different methods of preparation have certain effects on the contents of nuzhenide and oleanolic acid in Ligustri Lucidi Fructus.
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Objective To investigate the effects of different processing methods on contents of main chemical components isoferulic acid in Cimicifuga heracleifolia. Methods Cimicifuga heracleifolia from the same batch were prepared by processing method. HPLC were used to determine the contents of isoferulic acid in crudes samples, wine-prepared samples, vinegar-prepared samples, and carbonized samples. Results The contents of isoferulic acid of crudes samples and the three different processed products were in the order as follows:carbonized samples (0.404 7%)>vinegar-prepared samples (0.302 3%)>wine-prepared samples (0.262 4%)>crudes samples (0.231 3%). Conclusion Different processing methods had certain effects on the content of isoferulic acid in Cimicifuga heracleifolia.