ABSTRACT
OBJECTIVE：To analyze the clinical manifestations and characteristics of adverse drug reactions （ADR）induced by EGFR-TKI，and to provide reference for safe use of drugs in clinic. METHODS ：The relevant data of EGFR-TKI-induced ADR reports which were reported to Shandong ADR Monitoring Center from January 2018 to December 2020 were summarized ，and analyzed statistically in respects of age ，gender，drug variety ，ADR classification ，usage and dosage ，occurrence time ，involved organs/systems，clinical manifestations and prognosis of patients. RESULTS & CONCLUSIONS ：A total of 120 ADR reports induced by EGFR-TKI were included ，involving 120 patients. Among 120 patients，the female （60.83％）was more than the male （39.17％），and the age was mainly 50-79 years old （79.16％）. A total of 5 drugs including gefitinib ，ositinib，afatinib，ektinib and erlotinib were involved. ADR occurred in 72，11，15，6 and 16 patients using the above drugs respectively ；the main ADR was general ADR （70.83％），followed by severe ADR （22.50％），new general ADR （5.00％）and new severe ADR （1.67％）. All patients were given drugs orally ，off-label use was found in 2 patients who used ektinib ，and the rest met the medication requirements of the drug instructions. ADR occurred in 61 patients（50.83％）within 1 month after medication ，34 patients （28.33％）within 1-3 months after medication ，25 patients（20.83％）within 4-12 months after medication ，and no ADR occurred after 12 months. ADR of organs/systems involved were mainly the lesion of skin and its appendant injury，gastrointestinal system injury and hepatobiliary system injury. The main clinical manifestations were rash ，diarrhea and abnormal liver function ；in addition，some patients developed severe or new severe ADR such as interstitial pneumonia ，bone marrow suppression ，tongue swelling and cerebral infarction. Totally 102 patients recovered or improved after drug withdrawal or symptomatic treatment ，12 patients had unknown outcome ，and 6 patients did not improve. It is suggested that pharmaceutical care should be strengthened within 1 month after EGFR-TKI administration ，so as to guard against the occurrence of new and serve ADR and ensure the safety of clinical medication.
ABSTRACT
OBJECTIVE：To investigate the occurrence and characteristics of new adverse drug reactions （ADR）in Shandong province，so as to provide reference for the safety of drug use in the clinic. METHODS ：The data of new ADR reports were collected from Spontaneous Reporting System of Shandong ADR Monitoring Center during Oct. 2019 to Mar. 2020. Those reports were analyzed statistically in respects of report types ，reporting institution ，reporters’occupation，gender and age of patients ，drug type ，organs/ systems involved ，clinical manifestations. RESULTS & CONCLUSIONS ：A total of 8 566 new ADR reports were screened out ， accounting for 10.81％ of the effective ADRs. Among them ，there were 7 961 new and general ADR （92.94％）and 605 new and serious ADRs （7.06％）. For the new ADR ，the reporting institutions were mainly medical institutions （98.42％），and the reporters ’ occupation were mainly doctors （78.44％）. Female （4 860 cases）was slightly more than male （3 698 cases）；most of them were 45 years old and above （70.00％），and intravenous drip （47.67％）was the main route of administration. The top five ADR suspected drugs were TCM preparations （34.50％），anti-microbials（13.75％），circulatory system drugs （11.41％），nervous system drugs （6.39％）and blood system drugs （4.81％），involving 517，91，64，53，50 types，respectively，among which Levofloxacin injection caused the most serious ADR （24 cases）. The new and general ADR mainly involved gastrointestinal system ，skin and its appendant ； their clinical manifestations were nausea ，vomiting，rash，etc. New and serious ADR mainly caused systemic damage ；their clinical manifestations were anaphylactic shock ，chest tightness and shivering ，etc. It is suggested to strengthen the ADR monitoring of TCM preparations，anti-microbials，circulatory system drugs and other drugs ，so as to ensure the safety of clinical drug use.
ABSTRACT
Objective To analyze the characteristics of breast cancer blood supply before and after chemotherapy with low-dose CT perfnsion. Methods Fifteen patients with breast cancer underwent CT breast perfusion examination, which was performed before and after chemotherapy within 1 week on Siemens Sensation 4 scanner with 120 kV and 50 mAs, 50 ml of nonionic contrast agent (320 mg I/ml) was injected at a flow rate of 4 ml/s with a power injector, Scan started after 8 seconds delay and data acquisition duration was 50 seconds. The blood flow ( BF), blood volume (BV) and mean transfer time (MTT) of lesion and contralateral normal breast gland were calculated using Basama perfusion 3 software package before and after chemotherapy. At the same time, the tumor size before and after chemotherapy were measured and correlated with the BF values. The t test and non-parametric test were used for the statistics. Results ( 1 ) The mean BF、BV and MTT of breast cancer were (33.20±4. 17) ml · min-1 · 100 ml-1 , (8. 31±2.43) ml · 100 ml-1 and ( 15. 31 ± 4. 31 ) s respectively before chemotherapy, and ( 13.65 ± 6. 04) ml · min-1 100 ml-1, (5.04±2. 33) ml · 100 ml-1 and (25. 97±9. 07) s respectively after chemotherapy and there were statistically significant (P =0. 000). The mean BF、BV and MTT of normal breast were (4. 31 ± 2.23) ml · min-1 · 100 ml-1, (1.38±0.75) ml · 100 ml-1 and (19.25±3.94) s respectively before chemotherapy, and (4.03±2.35) ml · min-1 · 100 ml-1、(1.44±0.84) ml · 100 ml-1、(22.56 ± 7.71 ) s respectively after chemotherapy and there were not statistically significant (P >0. 05). (2)The BF of breast cancer was higher than the normal breast before chemotherapy ( P < 0. 01 ). (3) There was a positive correlation between the BF values and tumor size before and after chemotherapy ( r = 0. 902, P = 0. 000). Conclusion The BF value has a positive correlation with tumor size after chemotherapy, CT perfusion is more sensitive for the evaluation of chemotherapy response than morphologic assessment.