Intensive Hospital Monitoring Study Of Adverse Drug Reaction Of Cefoperazone Sodium And Tazobactam Sodium

Objective: The purpose of this study is to quantify and describe ADR of cefoperazone sodium and tazobactam sodium, in addition, to explore the methods of intensive hospital monitoring, by intensive monitoring cefoperazone sodium and tazobactam sodium. We hope provide support for clinical rational drug use.Methods: Part Ⅰ: Retrieved related literatures of cefoperazone sodium and tazobatam sodium from the databases of CNKI, WANFANG MED ONLINE. We analyzed and evaluated those literatures, which main related to clinical application、ADR and incompatibility. Part Ⅱ: 89 case reports of cefoperazone sodium and tazobatam sodium ADR were collected(2006-2014) from Shanxi province center for adverse drug reaction monitoring. We evaluated the 89 case reports by descriptive analysis, and found suspected ADR risk factors by chi-square test and conditional logistic regression. Part Ⅲ: Prospective observational study. All patients came from 5 departments include respiratory ward, general surgery department, infectious disease department, urology department and department of pediatrics. The information collected includes patient information(initials, age, sex, hospitalization costs), suspected adverse event(brief description of the reaction, onset date/stop date of occurrence of events, outcomes of events, treatment receive), medical history(past/present), concomitant medication, relevant test/laboratory data, other relevant history including pre-existing medical conditions, etc. In the end, observer reviewed the above information by descriptive analysis and statistic analysis.Results: Part : A total of 53 literatures about cefoperazone sodium and tazobatam sodium Ⅰwere found, including 12 ADR case reports( 22.6%), 23 compatibility taboo(43.4%) and 19 clinical application(34.0%). The 12 ADR case reports involve 93 cases of ADR, Serious adverse reactions included anaphylactic shock(7cases), disulfirom-like reaction(2cases), secondary epilepsy(1cases), anaphylactoid purpura(2 cases), airways spasm(1cases), prolong clotting time(1cases) and coagulation disorders(1 cases). Part Ⅱ: 1. The majority of ADRs had moderate severity(98.88%), only one ADR had severe(1.12%). About rate of adverse reaction report, Taiyuan city was significantly higher than other areas(32.58%), and medical institutions were higher than other departments(86.52%). ADRs were more frequent in male(69.66%) than in females(30.34%). The highest ADR rate(52.8%) was found in the geriatric(≥60 years), and the lowest ADR rate(4.5%) was found in children(≤18 years). There were 21 reports were unreasonable of dosage(23.6%). As expected, the most noticeable ADRs occurred in skin tissues(65.12%), with such ADRs are more obvious to medical staff, with rashes being the most common reactions. 2. Univariate analysis indicated that the occurrence of adverse reactions relate to the patient’s gender, age, the length of medication use, the original disease and past medical history. Male patients were more higher than female patients in adverse reaction rates( P﹤0.05,OR =2.327). ADR often occurred within 72 hours(OR(28)421.73). Patients who had history of adverse reactions are more likely had ADR(OR =4.257). The result of conditional logistic regression multivariable analysis indicated that age, personal history, medication time, and original disease are the ADR risk factors of cefoperazone sodium and tazobatam sodium. The lowest ADR rate was found in children group(OR(28)007.0). ADR of Cefoperazone sodium and tazobatam sodium more likely occurred in first 72 hours(OR(28)268.122). Patients who had history of adverse reactions are more likely had ADR(OR =0.042). Patients had orthopedic diseases are more likely had ADR(OR =67.798). Part Ⅲ:1. To carry out a descriptive analysis of intensive hospital monitoring study of cefoperazone and tazobatam: we found 54 probable adverse drug reactions out of a total of 1504 patients consecutively admitted to teaching hospitals during from December 2014 to December 2015. Advese reaction rate is 3.84%. There were only 2 cases of serious adverse reactions, one was disulfirom-like reaction, the other case was children with convulsions. The majority of cefoperazone and tazobatam of adverse reactions were lighter. Analysis of adverse reaction cases found no statistical differences in gender(P﹥0.05). The average age of the patients was 56.53. Pediatric has the highest rate of ADR than the other departments, the second was infectious department. There were not ADR occurred in urinary surgery during the monitoring period. The rate of ADR of general surgery was only 0.49%, probably because of short medication time. We found most ADR occurred taking medication more than one day, this result was different with the result of part II(ADR occurred in the first time use, 47.19%). Observer had found many no reported ADR led to the different. 2. We further analyzed and compared the suspected risk factors, such as gender, age, allergy, bad habits, medication time, BMI and drug combination. Univariate analysis indicated that the ovvurrence of adverse reactions relate to the age and medication time. The result of conditional logistic regression multivariable analysis indicated that age, drug combination and medication time were the ADR risk factors of cefoperazone and tazobatam.Conclusion: Part Ⅰ: We analyzed literatures and found that cefoperazone sodium and tazobatam sodium can effectively control infections. ADR rate of cefoperazone sodium and tazobatam sodium is low, skin and its accessories damage was most. Common serious ADR are anaphylactic shock and secondary epilepsy, convulsions. Part Ⅱ: We evaluated the 89 case reports by descriptive analysis and found: ADR risk factors of cefoperazone sodium and tazobatam sodium were medication time, dosage of administration and past medical history. Medical staff use cefoperazone sodium and tazobatam sodium according the instruction, should pay attention to the patient’s past medical history. Part Ⅲ: 1. ADR rate of cefoperazone sodium and tazobatam sodium is 3.84%. 2. ADR risk factors of cefoperazone and tazobatam were age and medication time, gender, drug combination.