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Wen F.,University of Sichuan | Tang R.,University of Sichuan | Sang Y.,University of Sichuan | Li M.,University of Sichuan | And 6 more authors.
Cancer Science | Year: 2013

This meta-analysis was performed to determine whether the addition of monoclonal antibodies (mAbs) of epidermal growth factor receptor (EGFR) to oxaliplatin-based chemotherapy treatment improves efficacy in KRAS wild-type metastatic colorectal cancer (mCRC), and whether infusional 5-fluorouracil (5-FU) and oxaliplatin is a preferred combination for EGFR mAbs. Oxaliplatin (including treatment), EGFR mAbs, first-line treatment, KRAS wild-type, and mCRC were used as key words. The PRIME, OPUS, COIN, and NORDIC VII trials were identified by two independent authors. Time-to-event outcomes of overall survival (OS) and progression-free survival (PFS) were analyzed using HRs (hazard ratios) with fixed effect, and response rate (RR) using odd ratios (OR) with fixed effect. A total of 1767 patients who were KRAS wild-type were included in this meta-analysis, with 866 patients in the mAbs and chemotherapy combination group and 901 patients in the chemotherapy alone group. The addition of mAbs to oxaliplatin-based chemotherapy in patients with KRAS wild-type mCRC as first-line treatment resulted in significant improvements in PFS (HR = 0.88; 95% confidence interval (CI), 0.79-0.99; P = 0.03) and response rate (RR) (OR = 1.38; 95% CI, 1.14-1.66; P = 0.009) compared with chemotherapy alone, but the difference in OS was not significant (HR = 0.96; 95% CI, 0.85-1.08; P = 0.48). However, the differences in OS and PFS were not significant when mAbs were added to bolus 5-FU or capecitabine-based regimens compared with chemotherapy alone, whereas PFS improved with an infusional 5-FU and oxaliplatin combination (P = 0.06; PFS, HR = 0.76; 95% CI, 0.65-0.86; P = 0.0002), and even OS was marginally significant, which was consistent with the subgroup analysis of cetuximab and panitumumab. EGFR mAbs combined with oxaliplatin and an infusional 5-FU regimen was associated with significantly improved RR, PFS and OS as first-line treatment in KRAS wild-type mCRC. © 2013 Japanese Cancer Association.

Li L.,University of Sichuan | Li S.,West China Hospita | Deng K.,University of Sichuan | Liu J.,University of Sichuan | And 17 more authors.
BMJ (Online) | Year: 2016

Objectives To examine the association between dipeptidyl peptidase-4 (DPP-4) inhibitors and the risk of heart failure or hospital admission for heart failure in patients with type 2 diabetes. Design Systematic review and meta-analysis of randomised and observational studies. Data sources Medline, Embase, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov searched up to 25 June 2015, and communication with experts. Eligibility criteria Randomised controlled trials, non-randomised controlled trials, cohort studies, and case-control studies that compared DPP-4 inhibitors against placebo, lifestyle modification, or active antidiabetic drugs in adults with type 2 diabetes, and explicitly reported the outcome of heart failure or hospital admission for heart failure. Data co llection and analysis Teams of paired reviewers independently screened for eligible studies, assessed risk of bias, and extracted data using standardised, pilot tested forms. Data from trials and observational studies were pooled separately; quality of evidence was assessed by the GRADE approach. Results Eligible studies included 43 trials (n=68 775) and 12 observational studies (nine cohort studies, three nested case-control studies; n=1 777 358). Pooling of 38 trials reporting heart failure provided low quality evidence for a possible similar risk of heart failure between DPP-4 inhibitor use versus control (42/15 701 v 33/12 591; odds ratio 0.97 (95% confidence interval 0.61 to 1.56); risk difference 2 fewer (19 fewer to 28 more) events per 1000 patients with type 2 diabetes over five years). The observational studies provided effect estimates generally consistent with trial findings, but with very low quality evidence. Pooling of the five trials reporting admission for heart failure provided moderate quality evidence for an increased risk in patients treated with DPP-4 inhibitors versus control (622/18 554 v 552/18 474; 1.13 (1.00 to 1.26); 8 more (0 more to 16 more)). The pooling of adjusted estimates from observational studies similarly suggested (with very low quality evidence) a possible increased risk of admission for heart failure (adjusted odds ratio 1.41, 95% confidence interval 0.95 to 2.09) in patients treated with DPP-4 inhibitors (exclusively sitagliptin) versus no use. Conclusions The relative effect of DPP-4 inhibitors on the risk of heart failure in patients with type 2 diabetes is uncertain, given the relatively short follow-up and low quality of evidence. Both randomised controlled trials and observational studies, however, suggest that these drugs may increase the risk of hospital admission for heart failure in those patients with existing cardiovascular diseases or multiple risk factors for vascular diseases, compared with no use. © BMJ Publishing Group Ltd 2015.

Li C.C.,University of Sichuan | Wang Y.Q.,363 Hospital | Li Y.P.,University of Sichuan | Li X.L.,University of Sichuan
Journal of Evidence-Based Medicine | Year: 2015

Objectives: To evaluate the quality of pancreatic cancer guidelines with evidence-based methods based on the global burden of disease and to explore its status, distribution, characteristics of theme, and the difference of recommended therapies among various qualities of guidelines, so as to provide a reference for clinical decision. Methods: The PubMed, The Cochrane Library (Issue 11, 2013), Chinese Biomedical Database, China National Knowledge Infrastructure, and VIP databases, as well as the website of National Guidelines Clearinghouse, Guidelines International Network, and National Institute for Clinical Excellence were systematically reviewed through November 2013 for pancreatic cancer guidelines. The Appraisal of Guidelines for Research and Evaluation (AGREE II) were applied to assess the methodological quality of the guidelines. Results: A total of 14 relevant guidelines (including 5 evidence-based ones) were identified, involving four continents (Asia, Europe, North America, and Oceania), seven counties, and four international organizations. There were only two domains, namely 'scope and purpose' and 'clarity of presentations', getting high average scores (more than 60%) among all 14 guidelines. The mean AGREE domain score in guidelines varies among different areas, and the quality of 5 evidence-based guidelines was superior to that established by consensus. According to AGREE II, 11 guidelines were weakly recommended, while 3 were not recommended due to poor methodological quality. Their subjects of 14 guidelines covered six treatment categories, including chemotherapy, surgery, radiotherapy, support therapy, radiotherapy, and interventional therapy. Conclusion: The overall methodological quality of pancreatic cancer guidelines is suboptimal among different countries or regions. The qualities of evidence-based guidelines are significantly superior to consensus. The chemotherapy, surgery, radiotherapy, and support therapy were the predominant choices by guidelines. © 2015 Chinese Cochrane Center, West China Hospital of Sichuan University and Wiley Publishing Asia Pty Ltd.

Zhang P.,University of Sichuan | Yang Y.,University of Sichuan | Wen F.,University of Sichuan | He X.,First Peoples Hospital of Longquanyi District | And 5 more authors.
European Journal of Gastroenterology and Hepatology | Year: 2015

Objective Sorafenib has been shown to significantly improve the overall survival of patients with advanced hepatocellular carcinoma (HCC). This study aimed to assess the cost-effectiveness of sorafenib as a first-line treatment for patients with advanced HCC. Materials and methods To carry out the analysis, we collected the data on the efficacy and safety of patients treated with sorafenib from medical records and follow-up of these patients. A Markov model comprising three health states (progression-free survival, progressive disease, and death) was created to simulate the process of advanced HCC. We calculated the data on cost from the perspective of Chinese patients. Sensitivity analyses were also carried out to explore the impact of several essential variables. Results Overall, 94 patients with advanced HCC were included in our study: 70 in the Child-Pugh A group and 24 in the Child-Pugh B group. The median overall survival was 8.0 months (95% confidence interval: 7.21-8.50). In general, treatment with sorafenib was estimated to increase costs by $18 251.84 compared with best supportive care, with a gain of 0.18 quality-adjusted life years (QALYs). Thus, the incremental cost-effective ratio was $101 399.11/QALY for sorafenib versus best supportive care. In addition, in patients with Child-Pugh A liver function, the total costs and effectiveness were $20 643.06 and 0.48 QALYs, respectively, whereas in the Child-Pugh class B group, the total costs and effectiveness were $15 844.33 and 0.28 QALYs. Conclusion On the basis of the commonly accepted willingness-to-pay threshold ($20 301.00/QALY in China), sorafenib is not a cost-effective option as a first-line treatment for patients with advanced HCC. © 2015 Wolters Kluwer Health, Inc.

Hao N.,University of Sichuan | Xia W.,University of Sichuan | Tang Y.,University of Sichuan | Wu M.,University of Sichuan | And 4 more authors.
Epilepsy and Behavior | Year: 2015

Objective: The aims of this study were to investigate the implementation of guidelines on periconceptional folic acid supplementation among pregnant women with epilepsy (WWE) in China and to identify its potential correlations with selected sociodemographic and clinical factors. Methods: A detailed investigation was conducted in China using a structured questionnaire from December 2013 to May 2014. Data on the awareness and use of folic acid supplementation, as well as sociodemographic and clinical characteristics, were collected from 153 pregnant WWE. Descriptive analysis, followed by univariate and multivariate logistic regression analyses, was applied to the data from this survey. Results: Among the enrolled subjects, 67.3% became pregnant after the promulgation of the relevant guidelines. Only 26.2% of them knew the exact effects of folic acid, and 73.8% had taken folic acid at some point during periconception. In addition, the folic acid intake of most of these women (67.1%) did not exceed that of the average pregnant woman. The prevalence of folic acid supplementation for pregnant WWE three months before pregnancy was only 15.5%. There has been almost no improvement in the level of additional awareness and use of folic acid supplementation for WWE since the relevant guidelines were established in China. Pregnant WWE with higher education levels, those with a planned pregnancy, or those who live in urban areas were more likely to know about and implement folic acid supplementation during periconception. Moreover, pregnant WWE with a planned pregnancy or those living in cities seemed to have a higher folic acid intake and started folic acid supplementation earlier before conception. Conclusion: The extent of awareness and use of folic acid supplementation in pregnant WWE remains low in China. More efforts are needed to promote periconceptional folic acid supplementation for WWE, especially those with low education levels and those who live in rural areas. Planned pregnancy should be encouraged for WWE. © 2014.

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