Clinical Outcomes In Chinese Patients Research Articles

Annexin-1 Downregulation Is Associated with Clinical Outcome in Chinese Patients with Hilar Cholangiocarcinoma

Aims: Annexin A1 (ANXA1) is a calcium- and phospholipid-binding protein and has been implicated in regulating inflammatory responses, cell proliferation and apoptosis. The evidence of its importance in carcinogenesis increased rapidly. However, the status of ANXA1 in hilar cholangiocarcinoma remains unclear. Here, we detected ANXA1 expression and determined its clinical significance in Chinese patients with hilar cholangiocarcinoma. Methods: Tissue microarray blocks containing tumor specimens obtained from 61 patients were constructed. Expression of ANXA1 in these specimens was analyzed using immunohistochemical studies. Results: ANXA1 expression was observed in 27 cases (44.3%). Loss of ANXA1 expression was significantly associated with lymph node metastases and histopathologic grade. ANXA1 expression has a significant inverse correlation with recurrence and poor survival in univariate analyses.Multivariate analyses revealed that loss of ANXA1 expression was an independent predictor for future recurrence and overall survival in patients with cholangiocarcinoma. Conclusions: Decreased expression of ANXA1 is a common event in human hilar cholangiocarcinoma and is significantly correlated with the poor outcome of patients with cholangiocarcinoma, suggesting a potential role of ANXA1 in cancer development and progression.

Effect of coronary bifurcation angle on clinical outcomes in Chinese patients treated with crush stenting: a subgroup analysis from DKCRUSH-1 bifurcation study

Background Bifurcation angles may have an impact on the clinical outcomes of crush stenting. We sought to compare high (≥60°) with low (<60°) bifurcation angle in patients who underwent either classical or double kissing (DK) crush stenting for bifurcation lesions from the DKCRUSH-1 data base. Methods There were 212 patients with 220 lesions, some with low-angle (n=138) and some with high-angle (n=74). Angiography was indexed at 8-month after procedure. Primary endpoint was the occurrence of major adverse cardiac events (MACEs), defined as cardiac death, myocardial infarction and target lesion revascularization (TLR). Secondary endpoint included late lumen loss, the rate of restenosis, and final kissing balloon inflation (FKBI). Results At 8 months, clinical follow-up was 100%; angiographic follow-up was 75% in the low-angle group and 83.3% in the high-angle group. There were no significant differences in the FKBI between the high-angle group (91.43%) and the low-angle group (82.39%). In the high angle group, there was a significant difference in contrast volume used (P=0.005) but no significant difference in acute gain, minimum lumen diameter (MLD), late loss and diameter stenosis in the pre-bifurcation segment, post-bifurcation segment or side branch. When lesions were assigned into with-(n=133) and without-FKBI (n=42), significant side-branch late loss was seen in the group without-FKBI ((0.65±0.49) mm vs (0.47±0.62) mm, P=0.02), with a resultant greater restenosis rate (37.68% vs 18.32%, P=0.001). No difference was detected in the MACE free survival rate between the high and low angle groups (82.39% vs 82.36%, P=0.84). The rate of stent thrombosis tended to be higher in the lower-angle group although there was no significant difference (P=0.38). The TLR free survival rate was 87.2% in the with-FKBI group vs 73.5% in the without-FKBI group (P=0.001). Cox regression analysis showed that the independent predictors for target vessel revascularization were the side branch stent MLD post stenting (hazard ratios (HR) 1.028, 95% CI 2.357–16.233, P=0.002), lack of FKBI (HR 4.910, 95% CI 4.706–8.459, P=0.001) and unsatisfactory kissing (HR 3.120, 95% CI 2.975–5.431, P=0.001). Conclusions Bifurcation angles do not influence the clinical outcome of crush stenting. Successful final kissing balloon inflation, regardless of bifurcation angles, can predict TLR.

Sustained disease remission after spontaneous HBeAg seroconversion is associated with reduction in fibrosis progression in chronic hepatitis B Chinese patients

Recently, controversies have arisen about whether hepatitis B e antigen (HBeAg) seroconversion can result in regression of fibrosis, thus improving the clinical outcome of Chinese patients with chronic hepatitis B. In this study, we determined if spontaneous HBeAg seroconversion is associated with regression of fibrosis in Chinese chronic hepatitis B patients. We evaluated the histology of liver samples from 128 HBeAg-positive treatment-naive Chinese patients who had undergone 2 liver biopsies over the years. Regression of fibrosis was defined as a decrease in fibrosis stage of at least 1 point. Sustained disease remission was defined as HBeAg seroconversion and hepatitis B virus (HBV) DNA < 10(4) copies/ml at follow-up liver biopsy. The mean duration (+/- standard error of the mean) between the initial and follow-up liver biopsies was 43.9 +/- 3.4 months. Regression of fibrosis was higher in patients with sustained disease remission (5 of 13 [38.5%] versus 22 of 115 [19.1%], P < 0.00005), patients who were younger (20-29 years old) at initial liver biopsy (17 of 54 [31.5%] versus 10 of 74 [13.5%], P = 0.0004), and patients with genotype B (17 of 43 [39.5%] versus 10 of 85 [11.8%], P = 0.004). On multivariate analysis, sustained disease remission (relative risk [RR] 3.00, 95% confidence interval [95% CI] 1.29-7.01, P = 0.01) and being 20-29 years old at initial liver biopsy (RR 2.94, 95% CI 1.01-8.62, P = 0.04) were independently associated with regression of fibrosis. The rate of fibrosis progression was lower in patients with sustained disease remission than in those who remained HBeAg positive (median 0 fibrosis units/year, range -2.00 to -0.70 fibrosis units/year, versus median 0.51 fibrosis units/year, range 0 to +2.03 fibrosis units/year, P = 0.02). Spontaneous sustained remission of disease is associated not only with little progression of fibrosis but also with regression of fibrosis.

Efficacy and Tolerability of Oxycodone Hydrochloride Controlled-Release Tablets in Moderate to Severe Cancer Pain

Oxycodone is a semisynthetic opioid analgesic drug classed as a strong opioid. The controlled-release oxycodone tablet formulation (OCRT) was approved in China in 2004 for management of moderate to severe cancer pain. Few data about the efficacy of OCRT and clinical outcomes in Chinese patients taking this drug are available. The purpose of this study was to evaluate the efficacy and tolerability of this drug for relief of moderate to severe cancer pain in Chinese patients. This was a prospective, open-label, multicentre clinical trial carried out in ten hospitals in Zhejiang Province, China. Patients with cancer pain with a score > or =4 (numerical rating scale) were enrolled. They received oral OCRT at an initial dosage of 5mg every 12 hours for patients scoring 4-6 and 10mg every 12 hours for patients scoring > or =7. Doses were then titrated on an individual basis. Onset of analgesic action, pain score and quality-of-life (QOL) scores - including items measuring family understanding and support, sleep, mental state, appetite, fatigue, and activities of daily life - were evaluated. Adverse effects were also documented. 216 patients (126 males and 90 females) aged 22-84 years were enrolled. The total mean OCRT dosage was 445.2 +/- 361.6mg (range 130-2320mg). The daily dosages of the vast majority of cases (89%) were between 10mg and 30mg. Onset of analgesic action occurred within 1 hour in 198 cases (91.7%) following administration of OCRT. 82.4% of cases were titrated to a steady dosage level within 2 days following administration of the first dose of medication. Pain score decreased significantly (p < 0.01) from 7.1 +/- 1.2 at baseline to 2.3 +/- 1.2 one week after starting medication and 1.8 +/- 0.9 four weeks after starting medication. Scores on all six QOL items increased significantly (p < 0.01) compared with baseline but showed varying rates of improvement. Adverse events included constipation, nausea, vomiting, drowsiness and dysuria. These were noted most frequently in the first week (25.5% of patients) and lessened over time. No severe adverse events were noted. We conclude that OCRT is well tolerated and effective in controlling moderate to severe cancer pain in Chinese patients.

Prognostic Effect of Insertion/Deletion Polymorphism of the ACE Gene on Renal and Cardiovascular Clinical Outcomes in Chinese Patients With Type 2 Diabetes

The insertion/deletion (I/D) polymorphism of the ACE gene has been reported to be associated with diabetic microvascular or macrovascular complications. The aim of the present study was to investigate the prognostic effect of I/D polymorphism on renal and cardiovascular clinical outcomes in Chinese patients with type 2 diabetes. A consecutive cohort of 1,281 Chinese patients with type 2 diabetes were followed for 41.3 +/- 21.6 months. Renal end points were defined as renal death and events (need for dialysis, plasma creatinine >/=500 micromol/l, or doubling of plasma creatinine of baseline value >/=150 micromol/l). Cardiovascular end points were defined as cardiovascular death and events, which included ischemic heart disease, heart failure, cerebrovascular accident, and revascularization requiring hospital admission. The I/D polymorphism of the ACE gene was examined by PCR followed by agarose gel electrophoresis. The frequencies of ACE gene I/D polymorphisms were in Hardy-Weinberg equilibrium. Patients who developed a renal end point (n = 98) had higher frequencies of DD genotype (19.4 vs. 10.8%, P = 0.018) and D allele (41.3 vs. 31.8%, P = 0.006) compared with subjects who did not (n = 1,183). The cumulative rates of renal end points were 10.0, 19.2, and 24.4% in the II (n = 595), DI (n = 539), and DD genotype carriers (n = 147), respectively (log rank P = 0.004). In multiple Cox regression analysis, the occurrence of renal end points remained significantly influenced by I/D polymorphism with a dominant deleterious effect of the DD genotype (DD versus II, adjusted hazard ratio 2.80 [95% CI 1.49-5.29]). There was no prognostic effect of I/D polymorphism on cardiovascular end points. The DD genotype of the ACE I/D polymorphism was an independent risk factor for renal but not cardiovascular end points in Chinese patients with type 2 diabetes.

Cytogenetic Abnormalities Predict Disease Progression in Primary Myelodysplastic Syndrome: A Multicentric Study in 508 Chinese Patients.

Myelodysplastic syndrome (MDS) is a clonal stem cell disorder characterized by ineffective hematopoiesis and frequent leukemia progression. Cytogenetic abnormalities are presented in MDS patients and predict poor prognosis. To better define their relevance to clinical outcome in Chinese patients with primary MDS, cytogenetic analysis was performed in 508 cases and retrospectively compared with clinical data. The median age was 49 years which was 10 years younger than that of western patients. The median overall survival was 34 (range 1–161) months, with the 2-year and 5-year survival rate of 50.0% and 15.0%, respectively. Among 367 cases with evaluable karyotype in bone marrow mononuclear cells, cytogenetic abnormalities were found in 136 of them (37.1%), including 56 cases (15.3%) of numeric abnormality and 80 cases (21.8%) of structural abnormality. Higher incidence of cytogenetic abnormality was found in RAEB-T (43/86, 50.0%) and RAEB (44/106, 41.5%) patients than that of RA patients (38/143, 26.6%). RAEB and RAEB-T had more cases of non-hypodipoidy, double aberrations with translocation, and complex aberrations. In RA, the most frequent aberrations were duplication and numeric changes. This study also showed RAEB appears to be the course of MDS that genome turbulence was under the evolution pressure. In RAEB-T, the genome abnormalities tend to be uniform and behaved as special translocation, which is in accordance with the clinical behavior of AL. Poor prognosis and early leukemia transformation were observed in the patients with cytogenetic abnormalities, especially with complex cytogenetic aberrations and chromosome translocations. In conclusion, cytogenetic abnormalities possess strong predictive value on disease outcome in primary MDS patients.