Study On Safety Reevaluation Of Antineoplastic Drugs Based On The Automatic Surveillance System

Objective:To investigate the characteristics and rules of adverse drug reaction(ADR)caused by antineoplastic drugs.Studying the incidence and related factors of ADR caused by the key antineoplastic drugs in clinical practice based on the automatic surveillance system and providing references for rational drug use.Method:(1)To analyze the ADR spontaneous reports of PLA ADR Monitoring Center retrospectively and have a preliminary understanding of the incidence of ADR caused by antineoplastic drugs.Key antineoplastic drugs would be screened out according to clinical medication.(2)The data of the hospitalized patients who received chemotherapy of gemcitabine and albumin-bound paclitaxel,were screened out by adverse drug events’active surveillance and assessment system(automatic surveillance system).The suspected cases were reviewed manually for further study.(3)To study the related ADRs caused by docetaxel(Taxotere)based on the automatic surveillance system.To compare the incidence of hematologic ADR related to domestic and imported docetaxel in the treatment of breast cancer and analyze the related factors.(4)To analyze the incidence and related factors of cutaneous ADR/ADE caused by kanglaite injection based on the automatic surveillance system.Results:(1)In the ADR spontaneous reports,a total of 8 categories of 117 kinds of antineoplastic drugs were involved.The number of serious ADR reports in the top three were docetaxel,gemcitabine and paclitaxel.The largest number of serious ADR reports were related to hematological system.The main clinical manifestations of ADR are nausea,vomiting,myelosuppression,skin rash and fever.(2)Positive alarm rate of each monitoring module is relatively high.The hematologic ADRs caused by gemcitabine and albumin-bound paclitaxel were very common.Hepatic dysfunction and acute kidney injury caused by albumin-bound paclitaxel were respectively very common and not common.The occurrence of hematologic ADRs caused by albumin-bound paclitaxel was significant difference in the BMI(P<0.05)and Group ADR was lower in the BMI.(3)The incidence of severe leukopenia,neutropenia,thrombocytopenia and anemia caused by docetaxel(Taxotere)were 5.14%,4.67%,0.32%and 0.The incidence of hepatic dysfunction was 17.84%and its severe ADR occurred in one patients.The incidence of acute kidney injury and dermal allergic reaction were 0.31%and 0.30%respectively and no severe ADRs occurred.Pleural and peritoneal metastasis(OR:0.940,95%CI:0.885-0.999)and renal dysfunction before administration(OR:2.005,95%CI:1.022-3.933)were independent risk factors of hematologic ADRs caused by docetaxel.The severe ADRs caused by domestic and imported docetaxel were both leukopenia and neutropenia which were no significant differences(P=0.252,P=0.840).Neither induced severe thrombocytopenia and anemia.BMI(OR:0.940,95%CI:0.885-0.999)and lung metastasis(OR:2.005,95%CI:1.022-3.933)were independent influencing factors of hematologic ADRs caused by docetaxel.(4)The incidence of cutaneous ADR in normal drug use is 0.20%and the incidence of cutaneous ADE beyond the normal course of medication is 2.13%.And there was 1 patient suffered from severe ADE.The medication duration over 2 weeks was independent risk factors for cutaneous ADR/ADE caused by kanglaite injection(OR=12.831,95%CI:1.378-119.473).Conclusion:Target drugs were determined by the results of spontaneous reports analysis.In this study,we acquired trusted data of target monitoring ADR for the first time by means of computer information monitoring,took lead in carrying out a comparative study on hematologic ADRs caused by domestic and imported docetaxel and improved the dispensatory of kanglaite injection.The performance of automatic surveillance system was verified.By using the system,Pharmacists can study on related ADRs caused by the key antineoplastic drugs efficiently and accurately and make a guidance for rational drug use.