Objective To explore adverse event(AE)signals of sunitinib and to provide a reference for rational drug monitoring based on the Food and Drug Administration Adverse Event Reporting System(FAERS)database.Methods Report odds ratio method(ROR),proportional report ratio method(PRR),polynomial gamma Poisson distribution reduction method(MGPS),and Bayesian confidence interval progressive neural network method(BCPNN)were used to detect the data risk signal strength of sunitinib from the first quarter of 2006 to the third quarter of 2023.Results A total of 35 720 AE reports of sunitinib were retrieved,with 310 positive signals.Most AEs occurred in the first 30 days after treatment(39.71％).Serious AE accounted for 76.37％;27 system organ classifications(SOCs)were involved in positive signals,and the top three were systemic diseases,various reactions at the administration site,gastrointestinal system diseases,and various examinations.High frequency of death,diarrhea,disease progression,and fatigue;65％of the top 20 AEs were new adverse reactions,such as tumor rupture and diffuse proliferation of uveal melanocytes.Conclusion The evaluation of sunitinib should be improved,and medication monitoring should be strengthened to ensure the safety of patients.

Objective To explore adverse event(AE)signals of sunitinib and to provide a reference for rational drug monitoring based on the Food and Drug Administration Adverse Event Reporting System(FAERS)database.Methods Report odds ratio method(ROR),proportional report ratio method(PRR),polynomial gamma Poisson distribution reduction method(MGPS),and Bayesian confidence interval progressive neural network method(BCPNN)were used to detect the data risk signal strength of sunitinib from the first quarter of 2006 to the third quarter of 2023.Results A total of 35 720 AE reports of sunitinib were retrieved,with 310 positive signals.Most AEs occurred in the first 30 days after treatment(39.71％).Serious AE accounted for 76.37％;27 system organ classifications(SOCs)were involved in positive signals,and the top three were systemic diseases,various reactions at the administration site,gastrointestinal system diseases,and various examinations.High frequency of death,diarrhea,disease progression,and fatigue;65％of the top 20 AEs were new adverse reactions,such as tumor rupture and diffuse proliferation of uveal melanocytes.Conclusion The evaluation of sunitinib should be improved,and medication monitoring should be strengthened to ensure the safety of patients.

OBJECTIVE To establish a quantitative analysis method for the quality control components in Tenghuang jiangu capsules， and predict the possible action mechanism of the quality control components. METHODS Seven key quality control components in Tenghuang jiangu capsules were quantitatively analyzed by UHPLC-Q-Orbitrap HRMS. The “component-target” network was constructed based on network pharmacology， and the Kyoto Encyclopedia of Genes and Genomes （KEGG） pathway enrichment analysis and gene ontology （GO） function enrichment analysis were further conducted to find the key signaling pathways. RESULTS The average contents of succinic acid， hyperoside， gallic acid， kaempferol， naringin， naringenin and protocatechuic acid in 20 batches of Tenghuang jiangu capsules were 520.92， 67.67， 129.48， 4.74， 397.45， 5.66 and 376.62 μg/g， respectively. The results of network pharmacology showed that the 62 key target genes of the quality control components of the drug included AKT1， TNF， VEGFA， MMP9， PTGS2， etc. They were mainly enriched in cytokine receptor interaction， nuclear factor， tumor necrosis factor， interleukin 17， rheumatoid arthritis， Toll-like receptor and other signal pathways， involving inflammatory reaction， signal transduction， protein phosphorylation and other biological processes， kytoplasm， cell membrane and other cell components， as well as enzyme activity， energy activity and other molecular functions. CONCLUSIONS The established UHPLC- Q-Orbitrap HRMS method can be used for the quantitative analysis of the quality control components of Tenghuang jiangu capsule. Its quality control components may be mapped to inflammatory pathways related to bone diseases such as rheumatoid arthritis and Toll-like receptors through AKT1， TNF， VEGFA and other key targets， so as to play a therapeutic role.

Background Climate change leads to frequent heavy rainfall events, and higher incidences of bacillary dysentery after heavy rainfall have been observed. The impacts of heavy rainfall and its antecedent rainfall conditions on the disease are worth paying attention to. Objective To quantitatively analyze how the relationship between heavy rainfall events and bacillary dysentery occurrence is modified by antecedent rainfall conditions in Anhui Province and explore the different moderation effects in urban and rural contexts. Methods CN05.1 meteorological data of Anhui Province and cases of bacillary dysentery of the same area were collected from January 1, 2006 to August 31, 2017. An exposure-response Poisson regression model of heavy rainfall events and the number of daily cases was constructed to explore the moderation effect of antecedent rainfall conditions on the incidence of bacillary dysentery, and further stratified by urban and rural areas. Results This study included 129 459 cases of bacillary dysentery, with a daily average of 30.39. Compared with dry antecedent conditions without heavy rainfall, dry antecedent conditions with heavy rainfall had no obvious different effect on the incidence of bacillary dysentery for the whole province (P>0.05). But wet antecedent conditions significantly increased the risk of bacillary dysentery for the whole province after heavy rainfall (wet antecedent conditions without heavy rainfall: RR=1.281, 95%CI: 1.264-1.298; wet antecedent conditions with heavy rainfall: RR=1.267, 95%CI: 1.167-1.376). After urban and rural stratification, antecedent rainfall conditions also showed a significant moderation effect on the incidence of bacillary dysentery following heavy rainfall events. Compared with dry antecedent conditions without heavy rainfall, dry antecedent conditions with heavy rainfall had no obvious effect on the incidence of bacillary dysentery for the urban and the rural populations (P > 0.05). However, wet antecedent conditions without heavy rainfall (urban: RR=1.391, 95%CI: 1.362-1.421; rural: RR=1.222, 95%CI: 1.201-1.243) and wet antecedent conditions with heavy rainfall (urban: RR=1.364, 95%CI: 1.193-1.559; rural: RR=1.218, 95%CI: 1.098-1.352) significantly increased the risk of bacillary dysentery in both rural and urban areas. Conclusion In the influence of heavy rainfall on the incidence of bacillary dysentery in Anhui Province, antecedent rainfall conditions have a certain moderation effect in the whole province and in both urban and rural areas, and the risk of bacillary dysentery is increased under wet antecedent conditions.

Background and purpose:Single drug of docetaxel and pemetrexed as second line treatment is standard treatment of advanced non-small cell lung cancer (NSCLC). Whether combined with platinum can increase the response and survival is still not elucidated. This study was designed to investigate the treatment response, overall survival (OS) and the safety of combined with oxaliplatin or cisplatin regimens as second line in treating NSCLC patients. Methods:Advanced NSCLC inpatients, failure of cisplatin or carboplatin in initial treatment, were divided into three groups at random in 3∶2∶1 rate. Control group:who received docetaxel, 75 mg/m2 (for all patients), d1 or pemetrexed 500 mg/m2 (for non-squamous carcinoma);Cisplatin group:who received cisplatin 25 mg/m2, d1-3 and docetaxel/pemetrexed; Oxaliplatin group: who received oxaliplatin 130 mg/m2 d1 and docetaxel/pemetrexed. Every 3 weeks were repeated as one cycle. The side effect was assessed every cycle and treatment efifcacy was investigated every two cycles. Follow-up examination was taken every 3 months after treatment. Results:There were no differences in treatment response, progress free survival (PFS), OS and toxicity among the three groups (P>0.05). Old patients (≥60 years) had a better PFS than that of patients less than 60 years (HR=0.56, 95%CI:0.35-0.90, P=0.015). Patients with performance score 0-1 had a better PFS and OS (HR=1.52, 95%CI:1.01-2.30, P=0.048;HR=1.90, 95%CI:1.17-3.09, P=0.009). Treatment response had relation to PFS and OS (HR=2.93, 95%CI:2.01-4.26, P=0.000;HR=2.03, 95%CI:1.37-3.01, P=0.000). Patients with anemia after treatment tended to have a worse PFS and OS (HR=1.59, 95%CI:0.97-2.61, P=0.066;HR=1.60, 95%CI:0.94-2.75, P=0.085). Patients with thrombocytopenia after therapy had a worse OS (HR=2.97, 95%CI:1.01-8.78, P=0.049). Patients with neural toxicity after chemotherapy tended to have a worse PFS (HR=3.36, 95%CI:0.92-12.25, P=0.066). Patients received post treatment after second line therapy had a better OS (HR=0.36, 95%CI:0.22-0.61, P=0.000). Conclusion:Combined with oxaliplatin or cisplatin as second line treatment can’t improve the response and survival in NSCLC patient. Treatment response and PS are prognostic factors to NSCLC patients’ PFS and OS. Patients with treatment related anemia might have a worse survival. Post therapy after failure to second line chemotherapy can prolong the survival.