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Hu Y.,University of Sichuan | Hu C.,National Chengdu Center for Safety Evaluation of Drugs | Zhang H.,Hebei Medical University | Ping Y.,Hebei Medical University | Chen L.-Q.,University of Sichuan
Annals of Surgical Oncology | Year: 2010

Background: It is proposed by International Union Against Cancer (UICC) and American Joint Committee on Cancer (AJCC) that at least 6 lymph nodes (LN) should be removed during resection of esophageal cancer for an accurate N classification. However, large series evidence is needed. The aim of this study is to assess the impact of total number of removed LNs during esophagectomy on UICC-TNM staging and long-term survival. Materials and Methods: The clinicopathological data and follow-up results of 1098 patients with advanced esophageal carcinoma who underwent an esophagectomy were analyzed. Results: The survival experience of group A (removed LNs <6) was worse than that of group B (removed LNs ≥6). With the stratification analysis according to N and TNM stage, for patients with pN0 cancers, the survival in group A was worse than that in group B (P = .003), while in patients with 1 and ≥2 positive LNs, the survival experience was similar (P = .919 and .182, respectively). A significant difference in survival in patients at stage IIa was observed between group A and group B (P = .005). However, the survival in patients at stage IIb and stage III was not different between the two groups (P = .302 and 0.108, respectively). Conclusions: For advanced esophageal carcinoma, if the number of resected LNs per operation is less than 6, an occult positive regional LN might be missed, resulting in an inaccurate N classification. The minimum of 6 LNs removed for esophageal cancer recommended by UICC and AJCC is rational and should be complied with. © 2009 Society of Surgical Oncology.

Wang Y.-Q.,University of Sichuan | Li X.-L.,University of Sichuan | Li Y.-P.,University of Sichuan | Luo Q.-Q.,National Chengdu Center for Safety Evaluation of Drugs
Chinese Journal of Evidence-Based Medicine | Year: 2015

Objective To explore the effectiveness and safety of high-intensity focused ultrasound (HIFU) for bone tumors, so as to provide a reference for clinical decision. Methods PubMed, EMbase, The Cochrane Library, CNKI and VIP databases were systematically searched for clinical effectiveness and safety studies of HIFU for bone tumors up to August 2014. Study selection, data extraction and quality assessment were applied independently by two reviewers, and then RevMan 5.1 software was used for conducting meta-analysis. If the data cannot be synthesized, the research outcome was described with a qualitative analysis. Results A total of 10 case series including 257 patients (157 males, 100 females) were included. The current evidence indicated that overall survival rates for all primary bone malignancy at 1-, 2-, 3-and 5-year were 89.8%, 72.3%, 60.5% and 50.5%, respectively. For the patients with clinical stage IIb, the rates were 93.3%, 82.4%, 75% and 63.7%, respectively. For those with clinical stage III, the rates were 79.2%, 42.2%, 21.1% and 15.8%, respectively. The local recurrence rate of HIFU for bone tumors was 7% to 9%, and recurrences at 1-, 2-, 3-and 5-year were 0%, 6.2%, 11.8% and 11.8%, respectively. The amputation rate was 2% to 7%. The adverse reaction rate was 27.2% (70/257), and among them the main was mild skin burn (21/257, 8.2%), followed by I degree burns (16/257, 6.2%), nerve damage (10/257, 3.9%) and fracture (6/257, 2.3%). Conclusion HIFU provide an alternative choice for patients with bone malignancy, with a certain effectiveness and safety. However, high-quality, large-scale randomized controlled trials or cohort studies which may focus on vary kinds of tumors, clinical stage and site of lesions are urgently needed, so that clinicians can use sufficient evidence for their clinical decision-making. © 2015 Editorial Board of Chin J Evid-based Med.

Wang Y.,University of Sichuan | Luo Q.,National Chengdu Center for Safety Evaluation of Drugs | Li Y.,University of Sichuan | Deng S.,University of Sichuan | And 2 more authors.
PLoS ONE | Year: 2014

Objectives: To evaluate the efficacy and safety of radiofrequency ablation (RFA) versus hepatic resection (HR) for early hepatocellular carcinoma (HCC) meeting the Milan criteria. Methods: A meta-analysis was conducted, and PubMed, Web of Science, the Cochrane Library, CBM, CNKI and VIP databases were systematically searched through November 2012 for randomized and nonrandomized controlled trials (RCTs and NRCTs). The Cochrane Collaboration's tool and modified MINORS score were applied to assess the quality of RCTs and NRCTs, respectively. The GRADE approach was employed to evaluate the strength of evidence. Results: Three RCTs and twenty-five NRCTs were included. Among 11,873 patients involved, 6,094 patients were treated with RFA, and 5,779 with HR. The pooled results of RCTs demonstrated no significant difference between groups for 1- and 3-year overall survival (OS), recurrence-free survival (RFS) and disease-free survival (DFS) (p.0.05). The 5-year OS (Relative Risk, RR 0.72, 95% CI 0.60 to 0.88) and RFS (RR 0.56, 95% CI 0.40 to 0.78) were lower with RFA than with HR. The 3- and 5-year recurrences with RFA were higher than with HR (RR 1.48, 95% CI 1.14 to 1.94, and RR 1.52, 95% CI 1.18 to 1.97, respectively), but 1-year recurrence and in-hospital mortality showed no significant differences between groups (p.0.05). The complication rate (RR 0.18, 95% CI 0.06 to 0.53) was lower and hospital stays (Mean difference -8.77, 95% CI 210.36 to 27.18) were shorter with RFA than with HR. The pooled results of NRCTs showed that the RFA group had lower 1-, 3- and 5- year OS, RFS and DFS, and higher recurrence than the HR group (p,0.05). But for patients with very early stage HCC, RFA was comparable to HR for OS and recurrence. Conclusion: The effectiveness of RFA is comparable to HR, with fewer complications but higher recurrence, especially for very early HCC patients. © 2014 Wang et al.

Liu Q.,National Chengdu Center for Safety Evaluation of Drugs | Li H.,National Chengdu Center for Safety Evaluation of Drugs | Xia Q.,National Chengdu Center for Safety Evaluation of Drugs | Liu Y.,National Chengdu Center for Safety Evaluation of Drugs | And 2 more authors.
International Journal of Nanomedicine | Year: 2015

The growing potential of quantum dots (QDs) in biomedical applications has provoked the urgent need to thoroughly address their interaction with biological systems. However, only limited studies have been performed to explore the effects of surface charge on the biological behaviors of QDs. In the present study, three commercially available QDs with different surface coatings were used to systematically evaluate the effects of surface charge on the cellular uptake, cytotoxicity, and in vivo biodistribution of QDs. Our results demonstrated that charged QDs entered both cancer cells and macrophages more efficiently than neutral ones, while negative QDs internalized mostly. Upon entry into cells, QDs were localized in different subcellular compartments (eg, cytoplasm and lysosomes) depending on the surface charge. Interestingly, inconsistent with the result of internalization, positive QDs but not negative QDs exhibited severe cytotoxicity, which was likely due to their disruption of cell membrane integrity, and production of reactive oxygen species. Biodistribution studies demonstrated that negative and neutral QDs preferentially distributed in the liver and the spleen, whereas positive QDs mainly deposited in the kidney with obvious uptake in the brain. In general, surface charge plays crucial roles in determining the biological interactions of QDs. © 2015 Liu et al.

Huang Y.,University of Sichuan | Huang Y.,National Chengdu Center for Safety Evaluation of Drugs | Gao H.,University of Sichuan | Gou M.,University of Sichuan | And 8 more authors.
Mutation Research - Genetic Toxicology and Environmental Mutagenesis | Year: 2010

In the present study, we prepared poly(ε-caprolactone)-poly(ethylene glycol)-poly(ε-caprolactone) (PCL-PEG-PCL, PCEC) nanomaterials by solvent-extraction method. The obtained PCEC nanomaterials were studied extensively for acute toxicity and genotoxicity using bacterial reverse mutation test (Ames test), chromosomal aberration test and mouse micronucleus test. All of the Sprague-Dawley rats did not show any mortality and clinical signs of toxicity after intravenous injection at the level of 2.4 g/kg body weight. Thus, the LD50 of PCEC nanomaterials was determined to be greater than 2.4 g/kg. In Ames test, PCEC nanomaterials were negative in Salmonella typhimurium strains TA97, TA98, TA100, TA102, and TA1535 with or without metabolic activation. PCEC nanomaterials did not induce chromosomal aberrations in cultured Chinese hamster lung cells up to 5000 μg/mL with or without metabolic activation. Micronucleus assay demonstrated that PCEC nanomaterials did not significantly increase micronucleated polychromatic erythrocytes (MNPCE) in the bone marrow of ICR mice or suppress bone marrow, indicating they did not cause chromosome aberrations. In conclusion, our results indicated that PCEC nanomaterials did not cause any acute toxicity and genotoxicity in our experimental conditions. Its potential to be a candidate of drug carrier is worth being further investigated. © 2010 Elsevier B.V. All rights reserved.

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