Quality assessment and its influencing factors of lung cancer clinical research registration: a cross-sectional analysis.

Background: A better understanding of the current features of lung cancer clinical research registration is important for improving registration quality and standardizing the registration. This study aimed to assess the registration quality of lung cancer studies on ClinicalTrials.gov and analyze the influencing factors. Methods: Lung cancer clinical researches registered in the ClinicalTrials.gov database were searched on 7 July 2021. The characteristics of trials that registered up to 7 July 2021 were assessed. The quality of completed and terminated lung cancer studies from 1 July 2007 to 7 July 2020 was assessed using a modified version of the World Health Organization (WHO) Trial Registration Data Set (TRDS, V.1.3.1). Multivariate logistic regression analysis was also used to analyze the factors influencing study registration quality. An above-average registration quality score represented a high registration quality. Results: A total of 6,448 clinical studies on lung cancer were used to summarise the registration characteristics. Most interventional studies were randomized (41.88%), single group (48.07%), and open-label (82.86%) studies, while most observational studies were cohort studies (59.08%). In total, 2,171 completed and terminated studies were assessed, with an average quality score (out of 54) of 36.76±5.69. None of the assessed studies had a 100% modified TRDS reporting rate, and missing summary results were the main factor affecting the quality scores. Multivariate logistic regression analyses showed that prospective registrations [adjusted odds ratio (aOR), 2.18; 95% confidence interval (CI), 1.79-2.65], multi-center studies (aOR, 1.73; 95% CI, 1.39-2.16), government-sponsored studies (aOR, 3.09; 95% CI, 1.48-6.42), and published studies (aOR, 1.43; 95% CI, 1.15-1.78) were more likely to be high quality research. Conclusions: To improve the quality of registration, awareness of prospective registration should be further improved and government investment should be increased. At the same time, more efficient and extensive data sharing after completion of the studies should be actively promoted.

Efficacy and safety of aflibercept plus chemotherapy in metastatic colorectal cancer: A systematic review and PRISMA-Compliant single-arm Meta-Analysis of noncomparative clinical studies and randomized controlled trials.

WHAT IS KNOWN AND OBJECTIVE: Aflibercept, a recombinant protein designed to suppress the vascular endothelial growth factor (VEGF) signalling pathway, has been used in patients with metastatic colorectal cancer (mCRC). We conducted the first meta-analysis to systematically review the efficacy and safety of aflibercept in mCRC. METHODS: PubMed Central/Medline, Embase and cochrane library were systematically searched for randomized controlled trials and single-arm clinical trials on aflibercept plus chemotherapy for the treatment of mCRC through 9 September 2021. RESULTS: Ten studies comprising 2049 patients met the inclusion criteria. The pooled estimate rates were 16.0% for 12mPFS, 64.4% for 12mOS, 32.5% for ORR, 83.5% for DCR, while the rates of III/IV AEs rate were 80.2% respectively. The pooled estimate rates were 16.8% for III/IV diarrhoea, 22.3% for III/IV hypertension, 29.5% for III/IV neutropenia, 7.3% for III/IV proteinuria and 8.6% for III/IV oral mucositis. CONCLUSIONS: Analysis of data from randomized controlled trials(RCT) and single-arm clinical trials confirmed the good efficacy of aflibercept plus chemotherapy in mCRC, while the safety of the treatment is concerning.

Metabolomic Study to Determine the Mechanism Underlying the Effects of Sagittaria sagittifolia Polysaccharide on Isoniazid- and Rifampicin-Induced Hepatotoxicity in Mice.

In this study, a non-targeted metabolic profiling method based on ultra-performance liquid chromatography-high resolution mass spectrometry (UPLC-HRMS) was used to characterize the plasma metabolic profile associated with the protective effects of the Sagittaria sagittifolia polysaccharide (SSP) on isoniazid (INH)-and rifampicin (RFP)-induced hepatotoxicity in mice. Fourteen potential biomarkers were identified from the plasma of SSP-treated mice. The protective effects of SSP on hepatotoxicity caused by the combination of INH and RFP (INH/RFP) were further elucidated by investigating the related metabolic pathways. INH/RFP was found to disrupt fatty acid metabolism, the tricarboxylic acid cycle, amino acid metabolism, taurine metabolism, and the ornithine cycle. The results of the metabolomics study showed that SSP provided protective effects against INH/RFP-induced liver injury by partially regulating perturbed metabolic pathways.

Chinese quince seed gum and poly (N,N-diethylacryl amide-co-methacrylic acid) based pH-sensitive hydrogel for use in drug delivery.

In this investigation, a variety of innovative pH-sensitive polymers consisting of Chinese quince seed gum (CQSG) and poly (N,N-diethylacryl amide-co-methacrylic acid) were synthesized via free radical polymerization for controlled drug delivery. The resultant hydrogel polymers were characterized by scanning electron microscopy and X-ray diffraction, analyzed by Fourier-transform infrared spectroscopy, and confirmed with thermogravimetry. Results suggested the hydrogel polymers were composed of CQSG chains physically entangled in poly (N,N-diethylacryl amide-co-methacrylic acid) networks. Swelling properties of these hydrogels were strongly affected by the contents of CQSG and crosslinkers. The drug delivery applications of the hydrogels were evaluated using bovine serum albumin (BSA) as a model drug in vitro release. It was determined that BSA release from the hydrogels was pH-sensitive under simulated gastrointestinal conditions. All of these attributes imply that the new proposed CQSG/poly (N,N-diethylacryl amide-co-methacrylic acid) hydrogel polymers can be used as a good medium for oral delivery of proteinaceous drugs.

[Prior periodontal intervention lowers incidence of lower respiratory infection in patients receiving oral and maxillofacial tumor surgery].

OBJECTIVE: To investigate whether periodontal infection is a risk factor for lower respiratory infection patients receiving oral and maxillofacial tumor surgery. METHODS: Patients undergoing oral and maxillofacial surgery for tumors with concurrent periodontal disease between January, 2012 and December, 2016 were randomized into periodontal intervention group and control group (treated with gargle solution containing chlorhexidine gluconate). The one-time periodontal intervention was completed within 24 h in the intervention group and two-week mouthwash was prescribed in the control group before oral and maxillofacial tumor surgery. Five periodontal indexes were examined at baseline and at 6 weeks after the treatment. The clinical symptoms and incidence of lower respiratory infections were compared between the two groups at 6 weeks. RESULTS: The PLI, BOP, PPD, and CAL were significantly lower and GR was higher in the intervention group than in the control group (P<0.01). The periodontal status was significantly improved in the intervention group. The incidence of lower respiratory infection was significantly lower in the intervention group than in the control group (2.22% vs 7.11%, P<0.01). The incidences of cough and expectoration in the intervention group were significantly lower than those in control group (P<0.01). CONCLUSIONS: Periodontal infection is one of the risk factors for lower respiratory infection after oral and maxillofacial tumor surgery. The periodontal status can be effectively controlled and improved by periodontal intervention. Compared with mouthwash, periodontal intervention can significantly reduce the incidences of cough and expectoration and lower the incidence of lower respiratory infections.

Elevated thymidine kinase 1 in serum following neoadjuvant chemotherapy predicts poor outcome for patients with locally advanced breast cancer.

Patients with locally advanced breast cancer (LABC) commonly have an unfavorable prognosis. A molecular predictor for the identification of at-risk patients is urgently required. Thymidine kinase 1 in serum (S-TK1) is an enzyme involved in the synthesis of DNA precursors. In studies using immunohistochemistry, it was reported to be a more useful proliferation marker than Ki-67 in breast, lung and colorectal carcinoma. In the present study, we extended the research of prior breast carcinoma studies by postulating that in patients with LABC, overexpression of S-TK1 following neoadjuvant chemotherapy predicts cancer outcome. An experimental design consisting of 48 patients with LABC was prospectively constructed and analyzed. All patients received neoadjuvant chemotherapy and definitive surgical therapy. Study homogeneity was maintained by standardized treatment, surveillance and compliance protocols. The S-TK1 concentration was detected using the anti-TK1 chicken IgY antibody, using a dot-blot immuno-assay. After a median follow-up of 30 months, the results indicated a statistically significant trend (unadjusted). Patients with high S-TK1 overexpression had a significantly higher incidence of recurrence (P=0.006) and cancer death (P= 0.0128) than those with low S-TK1 overexpression. A multivariate analysis provided identical results. The hazards ratio for developing recurrence in patients with higher S-TK1 expression was 6-7 times higher than the hazards ratio in patients with lower expression. In conclusion, our results indicate that a high S-TK1 concentration in sera from LABC patients receiving neoadjuvant chemotherapy is predictive of cancer outcome.