[A multicenter, randomized, controlled, phase â ¢ clinical study of PEG-rhG-CSF for preventing chemotherapy-induced neutropenia in patients with breast cancer and non-small cell lung cancer].

OBJECTIVE: To explore the safety and efficacy of pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) in preventing chemotherapy-induced neutropenia in patients with breast cancer and non-small cell lung cancer (NSCLC), and to provide the basis for clinical application. METHODS: According to the principle of open-label, randomized, parallel-group controlled clinical trial, all patients were randomized by 1∶1∶1 into three groups to receive PEG-rhG-CSF 100 µg/kg, PEG-rhG-CSF 6 mg, or rhG-CSF 5 µg/kg, respectively. The patients with breast cancer received two chemotherapy cycles, and the NSCLC patients received 1-2 cycles of chemotherapy according to their condition. All patients were treated with the combination chemotherapy of TAC (docetaxel+ epirubicin+ cyclophosphamide) or TA (docetaxel+ epirubicin), or the chemotherapy of docetaxel combined with carboplatin, with a 21 day cycle. RESULTS: The duration of grade 3-4 neutropenia in the PEG-rhG-CSF 100 µg/kg and PEG-rhG-CSF 6 mg groups were similar with that in the rhG-CSF 5 µg/kg group (P>0.05 for all). The incidence rate of grade 3-4 neutropenia in the PEG-rhG-CSF 100 µg/kg group, PEG-rhG-CSF 6 mg group, and G-CSF 5 µg/kg group were 69.7%, 68.4%, and 69.5%, respectively, with a non-significant difference among the three groups (P=0.963). The incidence rate of febrile neutropenia in the PEG-rhG-CSF 100 µg/kg group, PEG-rhG-CSF 6 mg group and G-CSF 5 µg/kg group were 6.1%, 6.4%, and 5.5%, respectively, showing no significant difference among them (P=0.935). The incidence rate of adverse events in the PEG-rhG-CSF 100 µg/kg group, PEG-rhG-CSF 6 mg group and G-CSF 5 µg / kg group were 6.7%, 4.1%, and 5.5%, respectively, showing a non-significant difference among them (P=0.581). CONCLUSIONS: In patients with breast cancer and non-small cell lung cancer (NSCLC) undergoing TAC/TA chemotherapy, a single 100 µg/kg injection or a single fixed 6 mg dose of PEG-rhG-CSF at 48 hours after chemotherapy show definite therapeutic effect with a low incidence of adverse events and mild adverse reactions. Compared with the continuous daily injection of rhG-CSF 5 µg/kg/d, a single 100 µg/kg injection or a single fixed 6 mg dose of PEG-rhG-CSF has similar effect and is more advantageous in preventing chemotherapy-induced neutropenia.

Development and application of 3-chloro-1,2-propandiol electrochemical sensor based on a polyaminothiophenol modified molecularly imprinted film.

In this work, a novel electrochemical sensor for 3-chloro-1,2-propandiol (3-MCPD) detection based on a gold nanoparticle-modified glassy carbon electrode (AuNP/GCE) coated with a molecular imprinted polymer (MIP) film was constructed. p-Aminothiophenol (p-ATP) and 3-MCPD were self-assembled on a AuNP/GCE surface, and then a MIP film was formed by electropolymerization. The 3-MCPD template combined with p-ATP during self-assembly and electropolymerization, and the cavities matching 3-MCPD remained after the removal of the template. The MIP sensor was characterized by cyclic voltammetry (CV), differential pulse voltammetry (DPV) and scanning electron microscopy (SEM). Many factors that affected the performance of the MIP membrane were discussed and optimized. Under optimal conditions, the DPV current was linear with the log of the 3-MCPD concentration in the range from 1.0 × 10(-17) to 1.0 × 10(-13) mol L(-1) (R(2) = 0.9939), and the detection limit was 3.8 × 10(-18) mol L(-1) (S/N = 3). The average recovery rate of 3-MCPD from spiked soy sauce samples ranged from 95.0% to 106.4% (RSD < 3.49%). Practically, the sensor showed high sensitivity, good selectivity, excellent reproducibility, and stability during the quantitative determination of 3-MCPD.