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Comparison of safety and efficacy between calcipotriol plus betamethasone dipropionate gel and calcipotriol scalp solution as long-term treatment for scalp psoriasis in Chinese patients: a national, multicentre, prospective, randomized, active-controlled phase 4 trial.
Liu, L, Zhang, C, Wang, J, Chen, K, Ding, Y, Yan, G, Lu, Q, Li, W, Fang, H, Cheng, H, et al
European journal of dermatology : EJD. 2020;(5):580-590
Abstract
BACKGROUND The efficacy and safety of calcipotriol plus betamethasone dipropionate gel for the treatment of scalp psoriasis has previously been demonstrated in a four-week trial in a Chinese population. OBJECTIVE To evaluate the long-term safety and efficacy of two-compound gel in Chinese adult patients with scalp psoriasis. MATERIALS & METHODS A multicentre, prospective, randomized, active-controlled trial was established in which subjects were randomized (at a ratio of 4:1) to receive either two-compound gel once daily or calcipotriol scalp solution twice daily for 28 weeks. Incidence of adverse drug reactions (ADRs) of any type and adverse events (AEs) of concern associated with long-term corticosteroid use on the scalp were evaluated. RESULTS A total of 951 subjects were randomly assigned to receive either two-compound gel (n=760) or calcipotriol scalp solution (n=191). The incidence of ADRs was significantly lower in the two-compound gel group compared with the calcipotriol scalp solution group (11.7 vs. 22.2%, p<0.001). There was no significant difference in treatment-emergent adverse events (TEAEs) associated with long-term topical corticosteroid use on the scalp (1.1% vs. 0%, p=0.369) between the two groups. A statistically significant difference in the percentage of visits with treatment success according to the Subject's Global Assessment was observed (p=0.009); more subjects had visits with 100% treatment success (15.2 vs. 6.3%) and fewer subjects had visits with 0% treatment success (23.7 vs. 30.8%) using two-compound gel compared to calcipotriol scalp solution. CONCLUSION The two-compound gel was well tolerated and effective in the long-term management of scalp psoriasis in Chinese patients.
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Comparison of the preventive efficacy of rosuvastatin versus atorvastatin in post-contrast acute kidney injury in patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention.
Dai, Y, Huang, J, Zeng, L, Huang, Z, Duan, C, Shao, S, Chen, H, Xue, L, Chen, J, Tan, N, et al
Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie. 2020;:110336
Abstract
Statins have been shown to reduce the risk of post-contrast acute kidney injury (PC-AKI) in patients undergoing percutaneous coronary intervention (PCI). However, the preventive effect of rosuvastatin versus atorvastatin on PC-AKI in patients with ST-segment elevation myocardial infarction (STEMI) undergoing PCI remains unclear. Patients with STEMI undergoing PCI between January 2010 and May 2016 were consecutively enrolled. A total of 1300 included patients were divided into two groups according to the statin type (atorvastatin: n = 1040; rosuvastatin: n = 260). The primary endpoint was PC-AKI defined as an absolute increase of ≥ 0.5 mg/dL in the level of serum creatinine or an increase of ≥ 25 % over baseline within 48-72 h after contrast media exposure. In total, 245 (18.8 %) patients developed PC-AKI. The atorvastatin and rosuvastatin groups had similar rates of PC-AKI (19.1 % vs. 17.7 %, p = 0.595), in-hospital mortality (4.1 % vs. 3.8 %, p = 0.833), and major adverse clinical events (MACE). Multivariate logistic regression analysis revealed that rosuvastatin treatment had an effect similar to atorvastatin regarding PC-AKI (odds ratio [OR] = 0.97, 95 % confidence interval [CI], 0.66-1.43, p = 0.874). Propensity score analyses and subgroup analysis demonstrated similar results for PC-AKI. Kaplan-Meier survival curves and Cox proportional regression showed that the atorvastatin and rosuvastatin groups had no differences regarding follow-up mortality. Rosuvastatin exerted a similar preventive effect against PC-AKI and showed similar levels of in-hospital and follow-up all-cause mortality and in-hospital MACE compared with atorvastatin in patients with STEMI undergoing PCI.
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Effects of the Antianginal Drugs Ranolazine, Nicorandil, and Ivabradine on Coronary Microvascular Function in Patients With Nonobstructive Coronary Artery Disease: A Meta-analysis of Randomized Controlled Trials.
Zhu, H, Xu, X, Fang, X, Zheng, J, Zhao, Q, Chen, T, Huang, J
Clinical therapeutics. 2019;(10):2137-2152.e12
Abstract
PURPOSE The goal of this study was to investigate the effects of the antianginal drugs ranolazine, nicorandil, and ivabradine on coronary microvascular function. METHODS Electronic scientific databases were searched for randomized trials investigating the effects of antianginal drugs on coronary microvascular function. Primary outcomes were changes in the coronary flow reserve (CFR), index of microvascular resistance (IMR), and myocardial perfusion reserve index (MPRI). The secondary outcome was the Seattle Angina Questionnaire scores. The standardized mean difference or weighted mean difference (WMD) (95% CI) served as a summary statistic. FINDINGS The antianginal drugs ranolazine, nicorandil, and ivabradine did not increase the CFR compared with the control drugs (standardized mean difference, 0.39; 95% CI, -0.08 to 0.85; P = 0.10). Ranolazine did not increase the global MPRI compared with the control drugs (weighted mean difference [WMD], 0.11; 95% CI, -0.06 to 0.29; P = 0.21). However, in the subgroups with a baseline CFR <2.5 or a global MPRI <2, ranolazine increased the global MPRI (WMD, 0.19; 95% CI, 0.10 to 0.27; P < 0.0001). In addition, the subendocardial midventricular MPRI (mid-subendocardial MPRI) was improved after ranolazine treatment (WMD, 0.12; 95% CI, 0.03 to 0.20; P = 0.007). Moreover, nicorandil significantly reduced the IMR compared with the control drugs (WMD, -7.63; 95% CI, -11.82 to -3.44; P = 0.0004). In addition, ranolazine and ivabradine improved 3 of the 5 Seattle Angina Questionnaire scores. IMPLICATIONS Ranolazine improved the global MPRI in patients with definite coronary microvascular dysfunction and the mid-subendocardial MPRI with suspicious coronary microvascular dysfunction, and nicorandil reduced the IMR. In addition, ranolazine and ivabradine reduced angina. Moreover, it is possible that the IMR and mid-subendocardial MPRI are more sensitive than the CFR and global MPRI for evaluating coronary microvascular function.
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Differential efficacy of methylcobalamin and alpha-lipoic acid treatment on symptoms of diabetic peripheral neuropathy.
Han, Y, Wang, M, Shen, J, Zhang, Z, Zhao, M, Huang, J, Chen, Y, Chen, Z, Hu, Y, Wang, Y
Minerva endocrinologica. 2018;(1):11-18
Abstract
BACKGROUND Diabetic hyperglycemia damages peripheral nerves by triggering ischemia, oxidative stress, and inflammation. Alpha-lipoic acid (ALA) and methylcobalamin (MC) are known to improve signs of diabetic peripheral neuropathy (DPN), possibly by enhancing neural and vascular endothelial cell metabolism and antioxidant capacity. We evaluated differences in efficacy following short-term MC or ALA treatment on DPN symptoms to guide clinical drug selection. METHODS Forty DPN patients were randomly divided into MC and ALA treatment groups (both N.=20) and assessed by the Toronto Clinical Neuropathy Scoring System (TCSS), total symptom score (TSS), visual analog scale (VAS) of positive symptoms, and easy sensory test (EST) for negative symptoms before and after 2 weeks of treatment. Serum malondialdehyde (MDA) and superoxide dismutase (SOD) were also measured. RESULTS Neuropathy as measured by TCSS, TSS, and VAS scores was significantly reduced by both treatments (P<0.05) but magnitude varied by symptom. The VAS score reductions for burning and pain were significantly greater following ALA (P<0.01), while MC reduced numbness and paresthesia VAS scores to a slightly greater extent than ALA (P>0.05). Numbers of abnormal (low-response) points for pressure and pinprick sensation were reduced by MC but not by ALA, while both treatments induced a significant reduction in vibratory perception threshold (P<0.01). Neither MC nor ALA improved temperature sensation or tendon reflexes (P>0.05). Alpha-lipoic acid, increased SOD and reduced MDA (P<0.05), indicating enhanced antioxidant capacity, while MC had no effect. CONCLUSIONS Due to differences in efficacy, MC or ALA should be chosen according to the symptoms of individual patients.
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Efficacy of Early Enteral Immunonutrition on Immune Function and Clinical Outcome for Postoperative Patients With Gastrointestinal Cancer.
Luo, Z, Wang, J, Zhang, Z, Li, H, Huang, L, Qiao, Y, Wang, D, Huang, J, Guo, L, Liu, J, et al
JPEN. Journal of parenteral and enteral nutrition. 2018;(4):758-765
Abstract
BACKGROUND Nutrition support is crucial for patients with gastrointestinal (GI) cancer after the operation. However, the controversy over the application of parenteral nutrition (PN) and early enteral immunonutrition (EEIN) has no determinate conclusion. MATERIALS AND METHODS We compared the effects of PN and EEIN on the postoperative nutrition condition, immune status, inflammation level, long-term survival, and quality of life of the patients with GI cancer. Seventy-eight patients were randomly divided into the PN group (n = 44) or EEIN group (n = 34). After an 8-day nutrition treatment, clinical and immunological parameters were evaluated. RESULTS The EEIN group had a significantly shorter hospital stay and higher body mass index level on postoperative day 30 than those in the PN group (P < .05). However, total hospital cost and incidences of short-term postoperative complications had no significant difference (P > .05). The percentages of CD4+ , natural killer, and natural killer T lymphocyte cells and the ratio of CD4+ /CD8+ in peripheral blood were significantly increased. Compared with the PN group, the EEIN group had a higher expression of activated cell surface markers such as CD27 and CD28. In addition, the secretion of interleukin (IL)-2 and interferon-γ was significantly higher, and the secretion of tumor necrosis factor-α and IL-10 was lower. Complication-free survival in the EEIN group were longer than those in the PN group (P = .04). CONCLUSION EEIN is superior to PN in improving nutrition status, enhancing immune function, and elevating quality of life.
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Impact of lifestyle and psychological stress on the development of early onset breast cancer.
Li, P, Huang, J, Wu, H, Fu, C, Li, Y, Qiu, J
Medicine. 2016;(50):e5529
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Abstract
The present study aimed to investigate risk factors for early onset breast cancer that are related to lifestyle and psychological stress. A comparative case-control study was performed among patients from the Department of Breast Surgery in Shanghai Cancer Center of Fudan University. The information regarding risk factors associated with the development of early onset breast cancer was collected using a questionnaire in a face-to-face interview. The distribution of the risk factors associated with the development of early onset breast cancer between the patient group and the control group was analyzed with logistic regression. A total of 582 cases of young patients (≤40 years old) with breast cancer and 540 controls of young patients (≤40 years old) with benign breast disease were included in this study. The risk factors for breast cancer in young women include age at first birth (odds ratio [OR] = 0.93, 95% confidence interval [CI]: 0.88-0.98), history of breast cancer in an immediate family member (OR = 2.36, 95% CI: 1.14-4.89), history of genital surgery (OR = 2.11, 95% CI: 1.16-3.82), active and passive smoking in daily life or the environment (OR = 1.64, 95% CI: 1.19-2.25), weekly intake of soy products (OR = 1.24, 95% CI: 1.02-1.49), use of household cooking oil (OR = 2.04, 95% CI: 1.04-4.00), disharmonious marital status (OR = 1.16, 95% CI: 1.06-1.26), frequent depression (OR = 1.32, 95% CI: 1.00-1.75), and negative emotional experiences (OR = 1.15, 95% CI: 1.03-1.29). Our study could provide the basis for risk assessment and preventive interventions for early onset breast cancer.
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Prevalence and Impact on Stroke in Patients Receiving Maintenance Hemodialysis versus Peritoneal Dialysis: A Prospective Observational Study.
Fu, J, Huang, J, Lei, M, Luo, Z, Zhong, X, Huang, Y, Zhang, H, Liu, R, Tong, J, He, F
PloS one. 2015;(10):e0140887
Abstract
BACKGROUND Patients undergoing maintenance dialysis are at increased risk of stroke, however, less is known about the prevalence and impact on stroke in the patients. METHODS In this prospective cohort study, 590 patients undergoing hemodialysis (HD; n = 285) or peritoneal dialysis (PD; n = 305) from January 1, 2008 to December 31, 2012 were recruited. Baseline demographic, clinical, and laboratory data were collected. Timeline incidence data were analyzed using a Poisson model. The Cox proportional hazards regression assessed adjusted differences in stroke risk, a multivariate analysis was also performed. RESULTS 62 strokes occurred during 1258 total patient-years of follow-up. Stroke occurred at a rate of 49.2/1,000 patient-years with a predominance in HD patients compared with PD patients (74.0 vs. 31.8/1,000 patient-years). The cumulative hazard of developing stroke was significantly higher in HD patients (hazard ratio [HR], 1.75; 95% confidence interval [CI], 1.15-3.62; p = 0.046) after adjusting for potential confounders. HD patients had an increased risk of ischemic stroke (HR, 2.62; 95% CI, 1.56-4.58; p = 0.002). The risk of hemorrhagic stroke was not significantly different between PD and HD patients. On multivariate Cox analysis, risk factors of stroke in both HD and PD patients were older age, diabetes, and cardiovascular disease. Other independent risk factors of stroke were lower albumin-corrected calcium in HD patients and higher triglycerides in PD patients. CONCLUSIONS Patients undergoing PD were less likely to develop ischemic stroke than those undergoing HD. Comprehensive control of diabetes, cardiovascular disease, calcium-phosphorus metabolism, and triglyceride levels may be useful preventive strategies for stroke in dialysis patients.
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PCSK7 genotype modifies effect of a weight-loss diet on 2-year changes of insulin resistance: the POUNDS LOST trial.
Huang, T, Huang, J, Qi, Q, Li, Y, Bray, GA, Rood, J, Sacks, FM, Qi, L
Diabetes care. 2015;(3):439-44
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OBJECTIVE A common variant rs236918 in the PCSK7 gene has the strongest association with iron homeostasis and is related to insulin resistance. Dietary carbohydrate (CHO) modulates the genetic effect on insulin resistance. We examined whether 2-year weight-loss diets modify the effect of PCSK7 genetic variants on changes in fasting insulin levels and insulin resistance in a randomized, controlled trial. RESEARCH DESIGN AND METHODS Data were analyzed in the Preventing Overweight Using Novel Dietary Strategies (POUNDS LOST) trial, which is a randomized, controlled 2-year weight-loss trial using diets that differed in macronutrient proportions. PCSK7 rs236918 was genotyped in 730 overweight or obese adults (80% whites) in this trial. We assessed the progression in fasting insulin and glucose levels, and insulin resistance by genotypes. RESULTS During the 6-month weight-loss phase, the PCSK7 rs236918 G allele was significantly associated with greater decreases in fasting insulin levels in the high-dietary CHO group (P for interaction = 0.04), while the interaction for changes in HOMA-insulin resistance (HOMA-IR) (P for interaction = 0.06) did not reach significant levels in white subjects. The G allele was significantly associated with a greater decrease in fasting insulin levels and HOMA-IR in response to high dietary CHO levels (P = 0.02 and P = 0.03, respectively). From 6 months to 2 years (weight-regain phase), the interactions became attenuated due to the regaining of weight (P for interactions = 0.08 and 0.06, respectively). In addition, we observed similar and even stronger results in the whole-study samples from the trial. CONCLUSIONS Our data suggest that PCSK7 genotypes may interact with dietary CHO intake on changes in insulin sensitivity in the white Americans.
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Effect of drinking on all-cause mortality in women compared with men: a meta-analysis.
Wang, C, Xue, H, Wang, Q, Hao, Y, Li, D, Gu, D, Huang, J
Journal of women's health (2002). 2014;(5):373-81
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BACKGROUND Alcoholic beverages are consumed by humans for a variety of dietary, recreational, and other reasons. It is uncertain whether the drinking effect on risk of all-cause mortality is different between women and men. We conducted a meta-analysis to evaluate the effect of drinking on the risk of all-cause mortality in women compared with men. METHODS We selected cohort studies with measures of relative risk (RR) and 95% confidence interval (CI) for all-cause mortality for drinkers versus nondrinkers by sex. Sex-specific RR and 95% CI were used to estimate the female-to-male ratio of RR (RRR) and 95% CI. Pooled estimates of RRR across studies were obtained by the fixed-effects model or the random-effects model (if heterogeneity was detected). Second-order fractional polynomials and random effects meta-regression models were used for modeling the dose-risk relationship. RESULTS Twenty-four studies were considered eligible. A total of 2,424,964 participants (male: 1,473,899; female: 951,065) were enrolled and 123,878 deaths (male: 76,362; female: 47,516) were observed. Compared with nondrinkers, the pooled female-to-male RRR for drinkers was 1.07 (95% CI: 1.02, 1.12). Subgroup analyses showed that the increased risk among female drinkers appeared to be consistent. J-shaped dose-response relationship was confirmed between alcohol and all-cause mortality in men and women, respectively. Moreover, the female-to-male RRR of all-cause mortality were 1.52 (95% CI: 1.01, 2.29), 1.95 (95% CI: 1.08, 3.49), and 2.36 (95% CI: 1.15, 4.88), respectively, for those who consumed 75, 90, and 100 g/day of alcohol. CONCLUSIONS Females had an increased risk for all-cause mortality conferred by drinking compared with males, especially in heavy drinkers. The present study suggested that female drinkers, particularly heavy drinkers, should moderate or completely reduce their level of consumption to have a health benefit.
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Effect of remote ischaemic preconditioning on renal protection in patients undergoing laparoscopic partial nephrectomy: a 'blinded' randomised controlled trial.
Huang, J, Chen, Y, Dong, B, Kong, W, Zhang, J, Xue, W, Liu, D, Huang, Y
BJU international. 2013;(1):74-80
Abstract
OBJECTIVE To evaluate whether remote ischaemic preconditioning (RIPC) reduces renal injury in patients undergoing laparoscopic partial nephrectomy (LPN). PATIENTS AND METHODS In all, 82 patients undergoing LPN were randomly assigned to either the RIPC or control group, with 40 and 38 patients, respectively completing 6-months follow-up. RIPC was conducted after induction of anaesthesia, which consisted of three 5-min cycles of right lower limb ischaemia and 5 min of reperfusion during each cycle. The primary outcome was the absolute change in glomerular filtration rate (GFR) of the affected kidney by renal scintigraphy from baseline to 6 months. The secondary outcomes included urinary retinol-binding protein (RBP) levels measured at 24 and 48 h, serum creatinine, and estimated GFR (eGFR) at 1 and 6 months, and changes in GFR by renal scintigraphy. RESULTS There were no differences in the change of GFR of the affected kidney at 6 months, while it was significantly decreased by 15.0% in the control group vs 8.8% in the RIPC group at 1 month (P = 0.034). The urinary RBP levels increased 8.4-fold at 24 h in the control group compared with a lower increase of 3.9-fold in the RIPC group (P < 0.001). There were no differences in the serum creatinine level or eGFR at 1 and 6 months between the two groups. CONCLUSIONS In patients undergoing LPN, RIPC using transient lower limb ischaemia may reduce renal impairment in the short term, but failed in the longer term despite a non-significant trend in favour of RIPC. These novel data support the need for a larger study of RIPC during LPN surgery.