No abstract

A high proportion of patients with stable angina remains symptomatic despite multiple treatment options. Di'ao Xinxuekang (XXK) capsule and Compound Danshen (CDS) tablet have been approved for treating angina pectoris for more than 20 years in China. We compare the anti-anginal effectiveness of XXK capsule and CDS tablet in patients with symptomatic chronic stable angina. A randomized, multicenter, double-blind, parallel-group, superiority trial was conducted in 4 study sites. 733 patients with symptomatic chronic stable angina were included in the full analysis set. The primary outcomes were the proportion of patients who were angina-free and the proportion of patients with normal electrocardiogram (ECG) recordings during 20 weeks treatment. Compared with CDS, XXK significantly increased the proportion of angina-free patients, but no significant difference was noted in the proportion of patients with normal ECG recordings. Weekly angina frequency and nitroglycerin use were significantly reduced with XXK versus CDS at week 20. Moreover, XXK also improved the quality of life of angina patients as measured by the SAQ score and Xueyu Zheng (a type of TCM syndrome) score. We demonstrate that XXK capsule is more effective for attenuating anginal symptoms and improving quality of life in patients with symptomatic chronic stable angina, compared with CDS tablet.

Aims Qishen Yiqi dripping pills (QSYQ) may be beneficial in patients with ischaemic heart failure (IHF). We aimed to assess the efficacy and safety of QSYQ administered together with guideline-directed medical therapy in patients with IHF. Methods and results This prospective randomized, double-blind, multicentre placebo-controlled study enrolled 640 patients with IHF between March 2012 and August 2014. Patients were randomly assigned to receive 6 months of QSYQ or placebo in addition to standard treatment. The primary outcome was 6 min walking distance at 6 months. Among the 638 IHF patients (mean age 65 years, 72% men), the 6 min walking distance increased from 336.15 ± 100.84 to 374.47 ± 103.09 m at 6 months in the QSYQ group, compared with 334.40 ± 100.27 to 340.71 ± 104.57 m in the placebo group (mean change +38.32 vs. +6.31 m respectively; P < 0.001). The secondary outcomes in composite clinical events, including all-cause mortality and emergency treatment/hospitalization due to heart failure, were non-significantly lower at 6 months with QSYQ compared with placebo (13% vs. 17%; P = 0.45), and the change of brain natriuretic peptide was non-significantly greater with QSYQ compared with placebo (median change À14.55 vs. À12.30 pg/mL, respectively; P = 0.21). By contrast, the Minnesota Living with Heart Failure Questionnaire score significantly improved with QSYQ compared with placebo (À11.78 vs. À9.17; P = 0.004). Adverse events were minor and infrequent with QSYQ, similar to the placebo group. Conclusions Treatment with QSYQ for 6 months in addition to standard therapy improved exercise tolerance of IHF patients and was well tolerated.

The aim of this study is trying to describe more details of superior mesenteric artery margin in pancreaticoduodenectomy for pancreatic ductal adenocarcinoma, to evaluate biological and prognostic implications of tumor budding in this margin, and to provide more evidence for evaluation of R0 surgery in pancreaticoduodenectomy. 46 patients in 5-years period are included in this study. Immunochemistry and immunofluorescence are used to analyze tumor budding and epithelial–mesenchymal transition. Superior mesenteric artery margin might be described from four aspects including location, gross appearance, microscopic appearance and tumor budding. We find that 1mm rule for R1 surgery is more appropriate to predict prognosis (P = 0.009) than 0mm rule (P = 0.141). Expression of cytokeratin in tumor budding is significantly lower than primary tumor (P = 0.001), and it suggests that tumor budding may participate the procedure of epithelial–mesenchymal transition. High-grade tumor budding and decreasing cytokeratin of tumor budding correlate with distant metastasis and has negative influence on prognosis. So superior mesenteric artery margin might be not only an area that tumor cells may invade, but also a pathway for distant metastasis. It is necessary to evaluate superior mesenteric artery margin in pancreaticoduodenectomy for pancreatic cancer.

No abstract

ObjectivesTo evaluate the efficacy, safety, and tolerability of guselkumab (GUS), a fully human monoclonal antibody against the p19 subunit of IL-23, in patients (pts) with active psoriatic arthritis (PsA).MethodsIn this double-blind, placebo-controlled, multicenter study, pts with active PsA and ≥3% body surface area (BSA) of plaque psoriasis despite current or previous treatment with standard-of-care therapies, including those previously exposed to anti-TNFα agents, were randomized 2:1 to receive GUS 100 mg subcutaneously (SC) or placebo (PBO) at wks 0, 4, and every 8 wks (q8w) thereafter through wk44. At wk16, pts from either group with <5% improvement from baseline in both swollen and tender joint counts were eligible for early escape to open-label ustekinumab. At wk24, all remaining PBO pts crossed-over to receive GUS 100 mg, and then received GUS at wk28, and q8w thereafter through wk44. The primary endpoint was ACR 20 response at wk24. Major secondary endpoints were PASI 75 and ACR 50 responses, change from baseline in HAQ-DI, and improvement in enthesitis (Leeds enthesitis index) and dactylitis score (by a 0–3 scoring system) at wk24; and ACR 20 response at wk16. Other secondary endpoints included change from baseline in SF-36 and proportion of pts achieving Minimal Disease Activity (MDA). Through wk24, efficacy analyses were performed in a modified Intent-to-Treat (mITT) population. Pts who met treatment failure criteria, early escaped or had missing data at wk24, were considered non-responders for ACR and MDA endpoints at wk24.Results149 pts were randomized to receive study agent (PBO: 49, GUS: 100). Baseline demographics and ACR component measures were generally similar between the two groups. Four [8.2%] pts in PBO and 9 [9.0%] pts in GUS were previously exposed to TNFα agents. The study met its primary and all secondary endpoints. Significantly more GUS pts achieved ACR 20/50/70 responses and PASI 75/90/100 responses at wk24 (Table 1). Significant treatment effect on ACR20 response was observed as early as wk4 (21% vs 0, p<0.001), and the effect increased over time reaching the maximum by wk16 (60.0% vs. 16.3%, p<0.001) vs. PBO. Results for other secondary efficacy endpoints are summarized in Table 1.Through wk24, proportions of pts with ≥1 AE were comparable between the two groups (PBO: 32.7%; GUS: 36.0%, respectively). Infections were the most common AEs (PBO: 20.4%; GUS: 17.0%, respectively). Two pts had SAEs (knee injury, n=1; myocardial infarction, n=1). There were no serious infections, malignancies, or deaths through wk24.ConclusionsIn pts with active PsA and ≥3% BSA of psoriasis, GUS demonstrated significant improvement on joint symptoms, physical function, psoriasis, enthesitis, dactylitis and quality of life. GUS was well tolerated with no unexpected safety findings in this population.Disclosure of InterestA. Deodhar Grant/research support from: Janssen, Abbvie, Pfizer, Novartis, UCB, Eli Lilly, Glaxo, Consultant for: Janssen, Eli Lilly, Pfizer, Novartis, UCB, A. Gottlieb Grant/research supp...

SILRC may provide a safe and feasible alternative to CLRC with similar short-term outcomes and aesthetic advantage of less skin incision. Well-designed randomized controlled trials, involving large cases and carrying long-term outcomes, are needed.

AIMTo investigate the long-term prognosis in peptic ulcer patients continuing taking antithrombotics after ulcer bleeding, and to determine the risk factors that influence the prognosis.METHODSAll clinical data of peptic ulcer patients treated from January 1, 2009 to January 1, 2014 were retrospectively collected and analyzed. Patients were divided into either a continuing group to continue taking antithrombotic drugs after ulcer bleeding or a discontinuing group to discontinue antithrombotic drugs. The primary outcome of follow-up in peptic ulcer bleeding patients was recurrent bleeding, and secondary outcome was death or acute cardiovascular disease occurrence. The final date of follow-up was December 31, 2014. Basic demographic data, complications, and disease classifications were analyzed and compared by t- or χ2-test. The number of patients that achieved various outcomes was counted and analyzed statistically. A survival curve was drawn using the Kaplan-Meier method, and the difference was compared using the log-rank test. COX regression multivariate analysis was applied to analyze risk factors for the prognosis of peptic ulcer patients.RESULTSA total of 167 patients were enrolled into this study. As for the baseline information, differences in age, smoking, alcohol abuse, and acute cardiovascular diseases were statistically significant between the continuing and discontinuing groups (70.8 ± 11.4 vs 62.4 ± 12.0, P < 0.001; 8 (8.2%) vs 15 (21.7%), P < 0.05; 65 (66.3%) vs 13 (18.8%), P < 0.001). At the end of the study, 18 patients had recurrent bleeding and three patients died or had acute cardiovascular disease in the continuing group, while four patients had recurrent bleeding and 15 patients died or had acute cardiovascular disease in the discontinuing group. The differences in these results were statistically significant (P = 0.022, P = 0.000). The Kaplan-Meier survival curve indicated that the incidence of recurrent bleeding was higher in patients in the continuing group, and the risk of death and developing acute cardiovascular disease was higher in patients in the discontinuing group (log-rank test, P = 0.000 for both). Furthermore, COX regression multivariate analysis revealed that the hazard ratio (HR) for recurrent bleeding was 2.986 (95%CI: 067-8.356, P = 0.015) in the continuing group, while HR for death or acute cardiovascular disease was 5.216 (95%CI: 1.035-26.278, P = 0.028).CONCLUSIONAfter the occurrence of peptic ulcer bleeding, continuing antithrombotics increases the risk of recurrent bleeding events, while discontinuing antithrombotics would increase the risk of death and developing cardiovascular disease. This suggests that clinicians should comprehensively consider the use of antithrombotics after peptic ulcer bleeding.