Drug-coated balloon angioplasty with provisional stenting versus primary stenting for the treatment of de novo coronary artery lesions: REC-CAGEFREE I trial rationale and design.

BACKGROUND: Percutaneous coronary intervention (PCI) with primary stenting, which stands for stent implantation regardless of obtaining satisfactory results with balloon angioplasty, has superseded conventional plain old balloon angioplasty with provisional stenting. With drug-coated balloon (DCB), primary DCB angioplasty with provisional stenting has shown non-inferiority to primary stenting for de novo coronary small vessel disease. However, the long-term efficacy and safety of such a strategy to the primary stenting on clinical endpoints in de novo lesions without vessel diameter restrictions remain uncertain. STUDY DESIGN: The REC-CAGEFREE I is an investigator-initiated, multicenter, randomized, open-label trial aimed to enroll 2270 patients with acute or chronic coronary syndrome from 43 interventional cardiology centers in China to evaluate the non-inferiority of primary paclitaxel-coated balloons angioplasty to primary stenting for the treatment of de novo, non-complex lesions without vessel diameter restrictions. Patients who fulfill all the inclusion and exclusion criteria and have achieved a successful lesion pre-dilatation will be randomly assigned to the two arms in a 1:1 ratio. Protocol-guided DCB angioplasty and bailout stenting after unsatisfactory angioplasty are mandatory in the primary DCB angioplasty group. The second-generation sirolimus-eluting stent will be used as a bailout stent in the primary DCB angioplasty group and the treatment device in the primary stenting group. The primary endpoint is the incidence of Device-oriented Composite Endpoint (DoCE) within 24 months after randomization, including cardiac death, target vessel myocardial infarction, and clinically and physiologically indicated target lesion revascularization. DISCUSSION: The ongoing REC-CAGEFREE I trial is the first randomized trial with a clinical endpoint to assess the efficacy and safety of primary DCB angioplasty for the treatment of de novo, non-complex lesions without vessel diameter restrictions. If non-inferiority is shown, PCI with primary DCB angioplasty could be an alternative treatment option to primary stenting. TRIAL REGISTRATION: Registered on clinicaltrial.gov (NCT04561739).

Characterization of extracellular polymeric substances of Bacillus amyloliquefaciens SQR9 induced by root exudates of cucumber.

Bacillus amyloliquefaciens SQR9 is a plant growth-promoting rhizobacterium (PGPRs) that forms biofilm on the roots of plants and protects them from a variety of pathogens. In this study, we reported the effect of root exudates produced by cucumber (Cucumis sativus L.) at different developmental stages on the biochemical composition of the biofilm matrix of SQR9. The results showed that the amino acids present in the root exudates of cucumber were responsible for triggering biofilm formation of SQR9. In addition, when root exudates harvested at different growth phases of cucumber were used as carbon sources for biofilm formation, the resulting biofilm matrixes differed both quantitatively and qualitatively. The biofilm matrix was mostly composed of amino groups observed by confocal laser scanning microscope (CLSM) hence the proteins formed the major component of the resulting extracellular polymeric substances (EPS). The potential use of amino acid-based dietary supplements to control biofilm formation in the plants may be a viable option to improve agricultural productivity by recruiting beneficial association with PGPRs in the manufacture of bio fertilizers or bio controls.

Pegylated filgrastim is comparable with filgrastim as support for commonly used chemotherapy regimens: a multicenter, randomized, crossover phase 3 study.

The purpose of this study was to compare the efficacy and safety of a single subcutaneous injection of pegylated filgrastim with daily filgrastim as a prophylaxis for neutropenia induced by commonly used chemotherapy regimens. Fifteen centers enrolled 337 chemotherapy-naive cancer patients with normal bone marrow function. All patients randomized into AOB and BOA arms received two cycles of chemotherapy. Patients received a single dose of pegylated filgrastim 100 µg/kg in cycle 1 (AOB) or cycle 2 (BOA) and daily doses of filgrastim 5 µg/kg/day in cycle 1 (BOA) or cycle 2 (AOB). Efficacy and safety parameters were recorded. The primary end point was the rate of protection against grade 4 neutropenia after chemotherapy [defined as the rate at which the absolute neutrophil count (ANC) remained >0.5×10(9)/l throughout the entire cycle]. Ninety-four percent of patients receiving pegylated filgrastim or filgrastim did not develop grade 4 neutropenia. The incidence of ANC<1.0×10(9)/l was 16.0% (50/313) after support with either pegylated filgrastim or filgrastim. The incidences of febrile neutropenia and antibiotic administration were similar in both groups. Notably, faster ANC recovery was observed with pegylated filgrastim support. The ANC nadir was also earlier with pegylated filgrastim (day 7) support than with filgrastim support (day 9), although the depth of nadir was not significantly different. A single subcutaneous injection of pegylated filgrastim 100 µg/kg provided adequate and safe neutrophil support comparable with daily subcutaneous injections of unmodified filgrastim 5 µg/kg/day in patients receiving commonly used standard-dose mild-to-moderate myelosuppressive chemotherapy regimens.

Selective mercury adsorption and enrichment enabled by phenylic carboxyl functionalized poly(pyrrole methane)s chelating polymers.

Mercury decontamination from water requires highly effective and efficient methods for maintaining public health and environmental protection. Herein, based on the coordination theory between functional groups and metal ions, we proposed phenylic carboxyl group-based poly(pyrrole methane)s (PPDCBAs) as highly efficient mercury removal materials for environmental remediation applications. It was found that PPDCBAs can efficiently adsorb and remove mercury(II) from aqueous solutions by functionalizing the molecular structure with phenylic carboxyl groups. Among the as-prepared PPDCBAs, poly[pyrrole-2, 5-diyl (4-carboxybenzylidane)] (PPD4CBA) with the carboxyl group at the para position can not only adsorb mercury over 1400 mg⋅g-1 but also achieve a 92.5 % mercury(II) uptake within 100 min by a very low dosage of 0.1 g⋅L-1. In addition, PPDCBAs exhibited excellent adsorption selectivity for mercury(II) compared with copper(II), cadmium(II), zinc(II) and lead(II). Furthermore, as determined by Fourier transform infrared (FT-IR) spectra, X-ray photoelectron spectroscopy (XPS) and the density functional theory (DFT) calculation, the mercury removal was found to be mainly dependent on the high density of chelating sites, the phenylic carboxyl moieties, which helped us to realize an ultra-trace amount mercury removal (from 10.8 µg⋅L-1 to 0.6-0.8 µg⋅L-1) for meeting drinking water standard requirements (1.0 µg⋅L-1).

Insight into the ion exchange in the adsorptive removal of fluoride by doped polypyrrole from water.

In this study, the polypyrrole (PPy) samples doped with Cl- (PPy-Cl), SO42- (PPy-SO4) and SO42-+Cl- (PPy-SO4+Cl) were synthesized by chemical polymerization for the adsorptive removal of fluoride ion from water. The structure and morphology of the as-prepared PPy samples were characterized by FT-IR, BET, SEM, XPS, and zeta potential. The adsorption experiments revealed that the PPy-Cl exhibited faster kinetics and higher adsorption capacity (13.98 mg/g), more than 4 times that of PPy-SO4 (3.08 mg/g) and PPy-SO4+Cl (3.17 mg/g). The kinetics of the adsorption followed the pseudo-second-order model and the adsorption isotherm data fitted well to the Langmuir model. FT-IR, EDX, and XPS tests for PPy samples before and after fluoride adsorption demonstrated that anion exchange between F- and Cl- or SO42- was the prior mechanism for fluoride ion removal from water. Cl- was more favorable than SO42- in the ion exchange with F-. Meanwhile, the Cl- or SO42- exchanged with F- was mainly bound to the active nitrogen that accounts for 6% of the total nitrogen in PPy molecular matrix. Further study of zeta potential and pH influence experiment demonstrated the electrostatic interaction is auxiliary interaction for the fluoride removal by doped PPy samples.

NIR triggered PLGA coated Au-TiO2 core loaded CPT-11 nanoparticles for human papillary thyroid carcinoma therapy.

MDR (multi-drug resistance) is one of the significant deterrents of effective chemotherapy for malignant growth. One of the powerful ways to deal with defeat of the MDR is to utilize inorganic nanoparticle-intervened tranquilize conveyance to build the medication aggregations in cancerous growth cells. In this work, we have developed the presentation that is accurately made of medication conveyance framework dependent on the TiO2 nanoparticles stacked CPT-11 to defeat the thyroid malignancy cells. The synthesized nanoparticles are characterized by spectroscopy methods (UV-vis, XPS, SEM, TEM, and DLS). The TEM results suggested that the shape of PLGA-Au-TiO2@CPT-11 of nanoparticles is ∼250 nm. After successful synthesis, we have evaluated the MTT of PLGA-Au-TiO2@CPT-11 nanoparticles with and without NIR radiations. Further, the morphological changes were observed using various biochemical stainings, such as acridine orange and ethidium bromide (AO-EB) and nuclear staining through Hoechst-33258. Also, migration and cell invasion were examined. The results show that these PLGA-Au-TiO2@CPT-11 and PLGA-Au-TiO2@CPT-11 + NIR nanoparticles exhibited promising antimetastatic property and reduced the cell invasion activity in B-CPAP and FTC-133 thyroid cancer cell lines. Based on the above findings, these PLGA-Au-TiO2@CPT-11 and PLGA-Au-TiO2@CPT-11 + NIR nanoparticles can be used as a promising candidate for the malignant thyroid cells.

Preparation and characterization of active and intelligent packaging films based on cassava starch and anthocyanins from Lycium ruthenicum Murr.

Lycium ruthenicum Murr. is a functional food with abundant anthocyanins. Since anthocyanins can change colors under different pH conditions, pH-sensitive packaging films were developed based on cassava starch and L. ruthenicum anthocyanins (LRA). Effect of LRA content on the physical, structural, antioxidant and pH-sensitive properties of starch-LRA films were evaluated. In addition, starch-LRA films were applied to monitor the freshness of pork. Spectroscopic analysis showed LRA contained six kinds of anthocyanins. The incorporation of LRA significantly enhanced the water vapor and ultraviolet-visible light barrier ability, tensile strength and antioxidant potential of starch film. Moreover, the barrier, antioxidant and pH-sensitive properties of starch-LRA films were closely related with LRA content. However, the thermal stability of starch film was not affected by LRA. Fourier transform infrared and X-ray diffraction analyses revealed intermolecular interactions (hydrogen bonds) formed between starch and LRA in the films. Starch-LRA films are pH-sensitive and could change their colors in different buffer solutions (pH 2-13). When applied to monitor the freshness of pork, starch-LRA films exhibited remarkable color variations with the quality change of pork. Our results suggested starch-LRA films could be used as active and intelligent packaging films in food industry.

Development of active packaging based on chitosan-gelatin blend films functionalized with Chinese hawthorn (Crataegus pinnatifida) fruit extract.

The fruits of Chinese hawthorn (Crataegus pinnatifida) have been used as the functional food and folk medicine due to potent antioxidant activity. In this study, polyphenols were extracted from the fruits of Chinese hawthorn and further added into chitosan-gelatin blend films to develop active packaging. The microstructure, physical, mechanical, barrier and antioxidant properties of the films were investigated in details. Results showed epicatechin, chlorogenic acid and procyanidin B2 were the main polyphenols in the extract of hawthorn fruits. The inner microstructure of chitosan-gelatin blend films became more compact when the extract was incorporated. The intermolecular interactions between film matrix and the extract were through hydrogen bonding and electrostatic interactions. The incorporation of the extract remarkably increased the thickness, tensile strength and elongation at break of chitosan-gelatin blend films. However, the moisture content, water vapor permeability and light transmittance of chitosan-gelatin blend films were significantly reduced by the addition of the extract. Moreover, chitosan-gelatin blend films containing the extract exhibited potent free radical scavenging ability. Our results suggest Chinese hawthorn fruit extract can be used as a natural antioxidant to improve the mechanical, barrier and antioxidant properties of chitosan-gelatin blend films.

Preparation and characterization of antioxidant and antimicrobial packaging films based on chitosan and proanthocyanidins.

The antioxidant and antimicrobial food packaging films were prepared by using chitosan (CS) and proanthocyanidins (PA). Effect of PA content (0, 5, 10, 15 and 20 wt% of PA on CS basis) on the physical, antioxidant and antimicrobial properties of CS-based films were determined. The prepared CS-PA films showed a brown color. PA incorporation remarkably increased the thickness, water solubility, water vapor permeability, opacity, tensile strength and thermal stability of CS film; whereas significantly reduced the moisture content, oxygen permeability, UV-vis light transmittance, elongation at break and crystallinity of CS film. Scanning electron microscopy showed PA was evenly distributed in the CS film matrix, making the films more compact. Some spontaneous agglomeration of PA was observed in the films when PA contents exceeded 5 wt%. Infrared spectra indicated the intermolecular interactions between PA and CS were through hydrogen bonds. Notably, CS-PA films exhibited improved antioxidant and antimicrobial activity in comparison with plain CS film. Our results suggested CS-PA films could be applied as active packaging materials in food industry.

Efficacy of Thalidomide in Preventing Delayed Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase III Trial (CLOG1302 study).

Purpose We examined the efficacy and safety of thalidomide (THD) for the prevention of delayed nausea and vomiting in patients who received highly emetogenic chemotherapy (HEC). Patients and Methods In a randomized, double-blind, active-controlled, phase III trial, chemotherapy-naive patients with cancer who were scheduled to receive HEC that contained cisplatin or cyclophosphamide-doxorubicin/epirubincin ≥ 50 mg/m2 regimens were randomly assigned to a THD group (100 mg twice daily on days 1 to 5) or placebo group, both with palonosetron (0.25 mg on day 1) and dexamethasone (12 mg on day 1; 8 mg on days 2 to 4). Primary end point was complete response to vomiting-no emesis or use of rescue medication-in the delayed phase (25 to 120 h). Nausea and anorexia on days 1 to 5 were evaluated by the 4-point Likert scale (0, no symptoms; 3, severe). Quality of life was assessed by the European Organization for Research and Treatment of Cancer QLQ-C30 version 3 questionnaire on days -1 and 6. Results Of 656 patients, 638 were evaluable: 317 in the THD group and 321 in the control group. Compared with placebo, delayed and overall (0 to 120 h) complete response rates to vomiting were significantly higher with THD: 76.9% versus 61.7% ( P < .001) and 66.1% versus 53.3% ( P = .001), respectively. Rates of no nausea were also higher in the THD group (delayed: 47.3% v 33.3%; P < .001; overall: 41% v 29.6%; P = .003), and mean scores of anorexia were lower overall (0.44 ± 0.717 v 0.64 ± 0.844; P = .003). Adverse effects were mild to moderate. The THD group had increased sedation, dizziness, constipation, and dry mouth, but experienced better quality of life after chemotherapy. Conclusion Thalidomide combined with palonosetron and dexamethasone significantly improved HEC-induced delayed nausea and vomiting prevention in chemotherapy-naive patients.

[Treatment of chemotherapy-induced neutropenia pegylated recombinant human granulocyte colony-stimulating factor: a multi-center randomized controlled phase II clinical study].

OBJECTIVE: To compare the efficacy and safety of daily administration of recombinant human granulocyte colony-stimulating factor (rhG-CSF), and a single subcutaneous injection of pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF), a sustained-duration rhG-CSF, in chemotherapy-induced neutropenia. METHODS: In the present randomized, open-label, match and cross-over study, enrolled 104 patients with previously untreated non-small cell lung cancer (NSCLC), breast cancer or non-Hodgkin's lymphoma and with normal bone marrow function from 13 centers were randomly divided into 2 matched groups, AB and BA group. Each patient received two cycles of chemotherapy of identical regimen. In the study cycle, the patients received a single subcutaneous injection of PEG-rhG-CSF 100 microg/kg on day 3; and in control cycle, daily subcutaneous infection of rhG-CSF 5 microg x kg(-1) x d(-1) began on day 3 and continued for 14 days or until the absolute neutrophil count (ANC) became > or = 5.0 x 10(9)/L twice after it decreased to the nadir. Efficacy and safety parameters were monitored. RESULTS: The incidence rates of ANC < 1.5 x 10(9)/L in the 103 evaluable study cycles and 100 evaluable control cycles were 30.00% and 20.00% with the duration of 2.39 days and 2.35 days respectively. The incidence rates of grade 3 neutropenia were 7.77% and 7.00%; and that of grade 4 neutropenia were 5.80% and 4.00% respectively in the trial and control cycles. However, all the difference mentioned above did not reached statistical significance. None of the patients experienced febrile neutropenia. The ANC nadir was (7.55 +/- 5.25) x 10(9)/L and (8.42 +/- 5.57) x 10(9)/L (P = 0.257) respectively after receiving PEG-rhG-CSF and rhG-CSF. Compared with that of rhG-CSF group, the ANC profile of PEG-rhG-CSF group exhibited limited "overshoot" of neutrophils after the nadir. Subgroup analysis according to disease type yielded similar results. The safety profiles of the PEG-rhG-CSF and rhG-CSF groups were similar. Musculoskeletal pain or arthralgia occurred in 16.5% of the study cycles and 26.00% of the control cycles (P = 0.963), mostly mild or moderate. Other adverse effects such as fever, fatigue, dizziness, gastrointestinal effects and injection-site pain, were transient and easily manageable. CONCLUSION: A single subcutaneous injection of PEG-rhG-CSF 100 microg/kg provides neutrophil support and a safety profile comparable to regimen of daily subcutaneous injection of rhG-CSF 5 microg x kg(-1) x d(-1) in Chinese patients receiving a variety of myelosuppressive chemotherapy regimens.