| Objective:To analyze the clinical application and adverse drug reaction(ADR) of Bozhi Glycopeptide injection and explore the ADR rate and risk factor to provide reference for its rational use in clinic.Methods:Part I: Retrieved related literature of Bozhi Glycopeptide from the databases of CNKI, Wanfang and VIP. Search fields: “Title” or “Key words”. Search word: Bozhi Glycopeptide, Bozhi Glycopeptide injection, Bozhi Glycopeptide for injection. Search time: Januray 1, 1980 to October 20, 2015. Remove summary, duplicate and incomplete literature. All of literature was classified into “component analysis, basic pharmacology,clinical application, ADR case report and others”. The main clinical application(quantity of literature for same disease entities exceed 3) and ADRs were analyzed and evaluated.Part II: The patients who used Bozhi Glycopeptide in the psychiatry department,cardiology department and neurosurgery department from December 8, 2014 to December 8, 2015 were monitored. The patients' information included identification,medicines and ADR was collected. The patients' information was recorded in “the Questionnaire of Bozhi Glycopeptide Application”. Someone who had ADR still have to be recorded in “the Questionnaire of Bozhi Glycopeptide Adverse Reaction”. Finally, to analyze the information of patients by statistical methods.Results:Part I: A total of 163 literature were found, including 137 clinical application, 11 ADR case reports, 10 basic pharmacology, 2 component analysis and 3 others. The disease which quantity of literature exceed 3 included condyloma acuminatum(9literature), herpes zoster(6 literature), hand-foot-mouth disease(6 literature), psoriasis vulgaris(6 literature), lung cancer(5 literature), repeated respiratory infection(4literature), hepatitis B(9 literature), and 45 literature in total. The effective rate of conventional drugs combined with Bozhi Glycopeptide from 66.67% to 98.40% for condyloma acuminatum, from 90.00% to 97.14 for herpes zoster, from 90.00% to 100%for hand-foot-mouth disease, and from 75.0% to 91.1% for psoriasis vulgaris. The effective rate of combined drugs group was significantly higher than single conventional drugs group. The effective rate of conventional drugs combined with Bozhi Glycopeptide from 92.5% to 94.0% for repeated respiratory infection, from 44.7% to 89.3 for lung cancer. The effective rate of combined drugs group was significantly higher than single conventional drugs group. The HBe Ag and HBV-DNA negative conversion rate of conventional drugs combined with Bozhi Glycopeptide were significantly higher than single conventional drugs group(P<0.05).At the 45 literature of the clinical application, 32 literature(1772 cases) of these have mentioned yes/no ADR occurred. 49 cases(2.77%) from 32 literature(1772 cases)were reported ADR which mainly involved skin and its appendages damage(10 cases,20.0%), digestive system(9 cases, 18.0%), nervous system(9 cases, 18.0%), systemic lesions(6 cases, 12.0%), circulatory system(2 cases, 4.0%) and unknown(14 cases,28.0%).20 cases were included in 11 ADR case reports. There were 7 male and 11 female and 2 unknown. The average age was 46.0±22.8 years. 3 cases had allergic history. The clinical type of ADR involved systemic lessions(13 cases, 37.2%), skin and its appendages damage(6 cases, 17.1%), circulatory system(6 cases, 17.1%), respiratory system(3 cases, 8.6%), motor system(3 cases, 8.6%), nervous system(2 cases, 5.7%)and digestive system(2 cases, 5.7%).Part II: A total of 1087 cases were collected from December 8, 2014 to December 8,2015. There were 509 male(46.8%) and 578 female(53.2%). The average age was49.7 ± 17.3 years and the youngest and the oldest patient was 12 years and 88 years respectively. The number of patients with normal BMI were 621(57.1%), with abnormal BMI were 466(42.9%). 220 cases(20.2%) had bad habits and 98 cases(9.0%) had allergic history. There were 992 cases(91.3%) used Saisheng and 95 cases(8.7%) used Woertai. The single-dose of Bozhi Glycopeptide involved 4ml, 6ml and 8ml. The quantity of drug combination involved equal or less than 3(77 cases, 7.1%), 3 to 7(925cases, 85.1%), equal or greater than 7(85 cases, 7.8%).35 ADR cases were reported and the rate of ADR was 3.22%. There were 16 male(45.7%) and 19 female(54.3%). The average age was 52.8±19.7 and the youngest and the oldest patient was 44 years and 81 years. The number of patients with abnormal BMI were 18(51.4%). 7 cases(20.0%) had bad habits and 2(5.7%) cases had allergic history.The clinical type of ADR involved systemic lessions(11 cases, 29.7%), digestive system(8 cases, 21.6%), nervous system(7 cases, 18.9%), motor system(6 cases, 16.2%), skin and its appendages damage(2 cases, 5.5%), circulatory system(1 cases, 2.7%),respiratory system(1 cases, 2.7%), urinary system(1 cases, 2.7%). By univariate analysis, the rate of ADR had statistical significance in age, BMI and the quantity of drug combination(P<0.05). The rate of ADR was higher in cases whose age exceed 60 years,low weight or overweight, or the quantity of drug combination equal or less than 3. By multivariate analysis, the rate of ADR had statistical significant in the quantity of drug combination(P<0.05). The rate of ADR which quantity of drug combination equal or less than 3 was 3.138 times as much as the equal greater than 3.Conclusion:Part I: Bozhi Glycopeptide mainly combined with other drugs as an adjuvant enhanced conventional drugs' efficacy in clinical application. The rate of ADR was2.77%. The clinical type of ADR mainly involved skin and its appendages damage.Part II:1. The rate of Bozhi Glycopeptide's ADR by intensive monitoring was 3.22%.2. By univariate analysis, the rate of ADR had statistical significance in age, BMI and the quantity of drug combination. The rate of ADR was higher in cases whose age exceed 60 years, low weight or overweight, or the quantity of drug combination equal or less than 3. By multivariate analysis, the rate of ADR had statistical significant in the quantity of drug combination. The rate of ADR which quantity of drug combination equal or less than 3 was 3.138 times as much as the equal greater than 3. |
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