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Effects of postoperative antioxidants on the salivary glands in patients with thyroid cancer undergoing radioactive iodine-131 treatment.
Tong, H, Yue, R, Fang, J, Li, X, Yang, S, Hou, Y, Wang, R, Zhang, B, Liu, H, Wu, Z, et al
Nuclear medicine communications. 2024;(4):312-320
Abstract
OBJECTIVE This study aimed to evaluate the effects of three antioxidants, selenium yeast capsule, vitamin E and vitamin C, alone or in combination, on the salivary glands of patients with differentiated thyroid cancer (DTC) treated with iodine-131 ( 131 I). METHODS A total of 69 postoperative DTC patients were randomly divided into three groups: vitamin E combined with vitamin C group (21 cases); selenium yeast group (23 cases); and selenium yeast combined with vitamin C group (25 cases). Salivary gland functional changes were assessed by salivary gland dynamic imaging functional parameters in the enrolled patients before and 1 month after 131 I treatment. RESULTS Comparison of salivary gland function parameters before and after 131 I treatment in the three groups were evaluated. In the vitamin E combined with the vitamin C group, the left parotid gland excretion fraction (EF) value was significantly higher than that before treatment. In the selenium yeast group, the left parotid gland excretion part, bilateral parotid gland excretion ratio (ER), left submandibular gland maximum uptake ratio within 20 min (UR20), and the right submandibular gland ER values were significantly higher than that before treatment, while in the selenium yeast combined with vitamin C group, the bilateral parotid gland EF, bilateral submandibular gland UR20, EF, and left submandibular gland ER values were significantly higher than that before treatment (all P < 0.05). CONCLUSION During high-dose 131 I treatment, vitamin E combined with vitamin C improved the excretory function of parotid glands in DTC patients; selenium supplementation had a protective effect on salivary glands; and the combination of selenium and vitamin C had a better effect.
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Dapagliflozin and Kidney Outcomes in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction: A Prespecified Analysis of the DELIVER Randomized Clinical Trial.
Mc Causland, FR, Claggett, BL, Vaduganathan, M, Desai, AS, Jhund, P, de Boer, RA, Docherty, K, Fang, J, Hernandez, AF, Inzucchi, SE, et al
JAMA cardiology. 2023;(1):56-65
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IMPORTANCE Sodium-glucose cotransporter 2 inhibitors are known to reduce heart failure events and slow progression of kidney disease among patients with heart failure and a reduced ejection fraction. OBJECTIVE To determine the effect of dapagliflozin on cardiovascular and kidney outcomes and the influence of baseline kidney disease among patients with heart failure and a mildly reduced or preserved ejection fraction enrolled in the Dapagliflozin Evaluation to Improve the Lives of Patients With Preserved Ejection Fraction Heart Failure (DELIVER) trial. DESIGN, SETTING, AND PARTICIPANTS This was a prespecified analysis conducted from July 1 to September 18, 2022 of the DELIVER randomized clinical trial. This was an international, multicenter trial including patients with ejection fraction greater than 40% and estimated glomerular filtration rate (eGFR) of 25 mL/min/1.73 m2 or higher. INTERVENTIONS Dapagliflozin, 10 mg, per day or placebo. MAIN OUTCOMES AND MEASURES Outcomes assessed were whether baseline kidney function modified the treatment effect on the primary outcome (cardiovascular death or worsening heart failure). Also examined was the treatment effect on the prespecified outcomes of eGFR slope and a post hoc composite kidney outcome (first ≥50% decline in eGFR from baseline; first eGFR <15 mL/min/1.73 m2; end-stage kidney disease; death from kidney causes). RESULTS A total of 6262 patients (mean [SD] age, 72 [10] years; 3516 male [56%]) had mean (SD) eGFR measurements available: 61 (19) mL/min/1.73 m2; 3070 patients (49%) had an eGFR less than 60 mL/min/1.73 m2. The effect of dapagliflozin on the primary outcome was not influenced by baseline eGFR category (eGFR ≥60 mL/min/1.73 m2: hazard ratio [HR], 0.84; 95% CI, 0.70-1.00; eGFR 45-<60 mL/min/1.73 m2: HR, 0.68; 95% CI, 0.54-0.87; eGFR <45 mL/min/1.73 m2: HR, 0.93; 95% CI, 0.76-1.14; P for interaction = .16). Over a median (IQR) follow-up of 2.3 (1.7-2.8) years, the overall incidence rate of the kidney composite outcome was low (1.1 events per 100 patient-years) and was not affected by treatment with dapagliflozin (HR, 1.08; 95% CI, 0.79-1.49). However, dapagliflozin attenuated the decline in eGFR from baseline (difference, 0.5; 95% CI, 0.1-0.9 mL/min/1.73 m2 per year; P = .01) and from month 1 to 36 (difference, 1.4; 95% CI, 1.0-1.8) mL/min/1.73 m2 per year; P < .001). CONCLUSIONS AND RELEVANCE Results of this prespecified analysis showed that baseline kidney function did not modify the benefit of dapagliflozin in patients with heart failure and a mildly reduced or preserved ejection fraction. Dapagliflozin did not significantly reduce the frequency of the kidney composite outcome, although the overall event rate was low. However, dapagliflozin slowed the rate of decline in eGFR compared with placebo. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT03619213.
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Effects on Adherence to a Mobile App-Based Self-management Digital Therapeutics Among Patients With Coronary Heart Disease: Pilot Randomized Controlled Trial.
Li, Y, Gong, Y, Zheng, B, Fan, F, Yi, T, Zheng, Y, He, P, Fang, J, Jia, J, Zhu, Q, et al
JMIR mHealth and uHealth. 2022;(2):e32251
Abstract
BACKGROUND The adherence to secondary prevention treatment in patients with coronary heart disease (CHD) is low. Digital therapeutics (DTx) refers to an emerging branch of medicine that delivers medical interventions directly to patients using evidence-based, clinically evaluated, technology-based software algorithms or apps to facilitate disease management, which may be an efficient tool to optimize adherence. OBJECTIVE This paper aims to investigate the effect of mobile app-based self-management DTx on long-term use of secondary prevention medications in patients with CHD in China. METHODS This pilot study was a parallel-designed, open-labeled, single-center, randomized controlled trial. Hospitalized patients with CHD admitted to Peking University First Hospital between April 2016 and June 2017 were randomized before discharge on a 1:1 ratio. The intervention group received regular follow-up combined with DTx, which is a self-management mobile app already installed on an Android 5 (Mi Pad 1, Xiaomi Corporation) tablet. Structured data from the hospital informatics system were integrated automatically, and medication, lifestyle intervention plan, follow-up protocol, and patient education materials were also provided according to the diagnosis. Participants could use DTx for self-management at home. The control group was under conventional hospital-based follow-up care. Patients were followed up for 1 year, and the primary end point was the percentage of all guideline-recommended medications at 12 months. The secondary end points included the percentage adhered to standard secondary prevention medications at 6 months, the control rate of lipid profile, and blood pressure at 6 months and 1 year. RESULTS Among 300 randomized patients with CHD, 290 (96.7%) were included in the final analysis, including 49.3% (143/290) and 50.7% (147/290) of patients from the intervention and control groups, respectively. Baseline characteristics were similar between the 2 groups. There was a statistically significant improvement in the percentage of all guideline-recommended medications at 12 months in the intervention group compared with the control group (relative risk [RR] 1.34, 95% CI 1.12-1.61; P=.001), and there was no interaction with baseline characteristics. The intervention group had a significantly higher proportion of patients achieving blood pressure under control (systolic blood pressure <140 mm Hg and diastolic blood pressure <90 mm Hg) and low-density lipoprotein cholesterol <1.8 mmol/L (RR 1.45, 95% CI 1.22-1.72; P<.001 and RR 1.40, 95% CI 1.11-1.75; P=.004, respectively) at 12 months. Furthermore, on logistic regression, the intervention group had a lower risk of withdrawing from guideline-recommended medications (odds ratio 0.46, 95% CI 0.27-0.78; P=.004). CONCLUSIONS Among patients with CHD, using a mobile app-based self-management DTx in addition to traditional care resulted in a significant improvement in guideline-recommended medication adherence at 12 months. The results of the trial will be applicable to primary care centers, especially in rural areas with less medical resources. TRIAL REGISTRATION ClinicalTrials.gov NCT03565978; https://clinicaltrials.gov/ct2/show/NCT03565978.
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Telephone follow-up by clinical pharmacists can improve treatment outcomes in patients with peptic ulcers: A prospective randomized study.
Weng, A, Su, X, Yang, C, Zheng, B, Zheng, L, Jian, C, Fang, J
Medicine. 2022;(42):e31150
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OBJECTIVE The purpose of this study was to investigate the effect of pharmaceutical care by clinical pharmacists through telephone follow-up on the treatment outcomes in patients with peptic ulcers who had been discharged from the hospital. METHODS A total of 120 patients with peptic ulcers discharged from the hospital were randomly divided into an intervention group and a control group, with 60 patients in each group. The patients in the two groups received different services. RESULTS A total of 108 patients with peptic ulcers were enrolled in this study, including 53 in the intervention group and 55 in the control group. This study showed that the Helicobacter pylori eradication rate (19/23, 82.61% vs 13/29, 44.83%), awareness of peptic ulcer disease, medication compliance, diet compliance, and life compliance in the patients in the intervention group were higher than those in the patients in the control group. The H pylori eradication group had higher follow-up scores than the noneradication group. Sex and body mass index (BMI) did not affect the results in either group, but age did. In the control group, younger patients scored higher than older patients, whereas in the intervention group, this difference disappeared for diet compliance and life compliance, and significant differences remained for awareness of basic knowledge regarding peptic ulcer (AOKPU) and medication compliance. CONCLUSION As a form of clinical pharmaceutical care, telephone follow-up by clinical pharmacists is recommended for discharged patients with peptic ulcers because it can improve treatment outcomes after discharge.
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Effect of vitamin E and supragingival scaling on salivary gland function in patients with differentiated thyroid cancer treated with 131I.
Cheng, Y, Tong, H, Li, X, Zhang, X, Fang, J, Yue, R, Huang, N, Tian, J, Yu, F, Gao, Y
Nuclear medicine communications. 2022;(9):995-1003
Abstract
OBJECTIVE The aim of this study was to evaluate the effect of vitamin E and supragingival scaling with vitamin C on the salivary glands of patients with differentiated thyroid carcinoma after 131I treatment. METHODS A total of 89 prospective patients with differentiated thyroid carcinoma were enrolled and randomly divided into the following groups: vitamin E group (n = 30, group A), vitamin C group (n = 30, group B) and supragingival scaling with vitamin C group (n = 29, group C). Using functional indices (e.g. maximum uptake fraction, uptake index, excretion fraction, secretion time and excretion rate), changes in the salivary gland functions before and a month after 131I treatment were assessed by dynamic imaging of salivary gland. RESULTS We compared the before and after 131I therapy results of the three groups. In group A (P < 0.05), the excretion fraction and excretion rate of the left parotid gland were significantly higher, and the uptake index of the bilateral submandibular glands was significantly lower. No significant changes in salivary gland functional parameters were observed in group B (P > 0.05). The uptake index of the bilateral parotid glands and the excretion rate of the left parotid gland were significantly higher in group C (P < 0.05). The degree of serum amylase level reduction decreased significantly in group C (P < 0.05). CONCLUSION Vitamin E showed a protective effect on parotid excretion function in patients with differentiated thyroid carcinoma who underwent 131I treatment. Supragingival scaling may be a promising radiation protector because it is associated with a protective effect on the salivary gland functions.
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Impact of gum chewing on the quality of bowel preparation for colonoscopy: an endoscopist-blinded, randomized controlled trial.
Fang, J, Wang, SL, Fu, HY, Li, ZS, Bai, Y
Gastrointestinal endoscopy. 2017;(1):187-191
Abstract
BACKGROUND AND AIMS Gum chewing can accelerate motility in the GI tract; clinical studies suggested gum chewing can reduce postoperative ileus. However, no trial has investigated the effect of gum chewing on bowel preparation for colonoscopy in addition to polyethylene glycol (PEG). The objective of this study was to investigate whether gum chewing before colonoscopy can increase the quality of bowel preparation. METHODS This was a single-center, randomized controlled trial. Consecutive patients undergoing colonoscopy were randomized to the gum group or the control group. Patients in the gum group chewed sugar-free gum every 2 hours for 20 minutes each time from the end of drinking 2 L of PEG to the beginning of colonoscopy. Patients in the control group only received 2 L of PEG before colonoscopy. The quality of bowel preparation, procedure time, adenoma detection rate, patients' tolerance, and adverse events were compared. RESULTS Three hundred patients were included in the study (150 in the control group, 150 in the gum group). More than 90% of patients in both groups were satisfied with the process of bowel preparation, and the incidence of adverse events was comparable in the 2 groups (41.3% vs 46.0%, P = .42). The mean Boston Bowel Preparation Scale score was 6.2 ± 1.4 and 6.1 ± 1.2 in the control group and the gum group, respectively, and the difference between the 2 groups was not significant (P = .51). CONCLUSIONS This study indicates that gum chewing does not improve the quality of bowel preparation for colonoscopy, but it can improve patients' satisfaction with the process of bowel preparation and does not have negative effects on cleanliness. (Clinical trials registration number: NCT02507037.).
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Fasting serum CGRP levels are related to calcium concentrations, but cannot be elevated by short-term calcium/vitamin D supplementation.
Hu, F, Chen, L, Che, H, Fang, J, Lv, F, Li, H, Zhang, S, Guo, C, Yin, H, Zhang, S, et al
Neuropeptides. 2015;:37-45
Abstract
Calcitonin gene-related peptide (CGRP) is an important cardioprotective neuropeptide. Few studies have shown that calcium supplementation may increase CGRP levels transiently. However, the relationship between CGRP and calcium is poorly known. This study was to explore the correlation between serum calcium and CGRP in coronary artery disease (CAD), and observe whether short-term calcium/vitamin D supplementation would increase fasting serum CGRP. A randomized, placebo-controlled and double-blind clinical trial, and a supplementary study for further analysis of the correlations were conducted. The results showed that the correlation between serum calcium and CGRP was positive in CAD without myocardial infarction (MI) (r = 0.487, P = 0.029), but negative in acute and healing MI (r = -0.382, P = 0.003). Moreover, we found a positive correlation between lg (amino-terminal pro-B-type natriuretic peptide, NT-proBNP) and CGRP (r = 0.312, P = 0.027), but a negative correlation between lg (NT-proBNP) and serum calcium (r = -0.316, P = 0.025) in acute and healing MI. As to the clinical trial, participants subjected to CAD but without evolving or acute MI, together with blood calcium ≤ 2.4 mmol/L, were randomized into three groups. Among the groups of placebo, caltrate (600 mg elemental calcium; 125 IU vitamin D3, per tablet) 1 tablet/d and caltrate 2 tablets/d, there were no significant differences in baseline characteristics. After short-term (5 days) treatments, the results indicated that the effect of grouping was not statistically significant (P = 0.915). In conclusion, the correlations between serum calcium and CGRP in different types of CAD are inconsistent, and the main reason may be associated with elevated natriuretic peptides after acute MI. Further, our study shows that short-term calcium/vitamin D supplementation cannot significantly increase fasting serum CGRP levels.
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Dietary sodium adherence is poor in chronic heart failure patients.
Basuray, A, Dolansky, M, Josephson, R, Sattar, A, Grady, EM, Vehovec, A, Gunstad, J, Redle, J, Fang, J, Hughes, JW
Journal of cardiac failure. 2015;(4):323-9
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BACKGROUND We sought to determine the rates and predictors of dietary sodium restriction and to evaluate the reliability of 24-hour urine collection as a tool to estimate dietary sodium intake in heart failure (HF) patients. METHODS AND RESULTS We evaluated the 24-hour urinary sodium excretion of 305 outpatients with HF and reduced ejection fraction who were educated on following a <2 g sodium diet. The mean sodium excretion according to a single sample from each participant was 3.15 ± 1.58 g, and 23% were adherent to the <2 g recommendation. One hundred sixty-eight participants provided 2 samples with urinary creatinine excretion within normative range. Averaging both resulted in a mean sodium excretion of 3.21 ± 1.20 g and lower adherence rates to the <2-gram diet: 14% versus 23% (P = .019). Multivariate logistic regression showed only male sex and higher body mass index (BMI) to be associated with nonadherence (male: odds ratio [OR] 2.20, 95% confidence interval [CI] 1.25-3.88; 1 unit BMI: OR 1.05, 95% CI 1.01-1.10). Bland-Altman plots of urinary sodium and creatinine showed poor reproducibility between samples. CONCLUSIONS In this chronic HF population, sodium consumption probably exceeds recommended amounts, particularly in men and those with higher BMI. Urine analyses were not highly reproducible, suggesting variation in both diet and urine collection.
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In vivo patterns of resistance to the HIV attachment inhibitor BMS-488043.
Zhou, N, Nowicka-Sans, B, Zhang, S, Fan, L, Fang, J, Fang, H, Gong, YF, Eggers, B, Langley, DR, Wang, T, et al
Antimicrobial agents and chemotherapy. 2011;(2):729-37
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Attachment inhibitors (AI) are a novel class of HIV-1 antivirals, with little information available on clinical resistance. BMS-488043 is an orally bioavailable AI that binds to gp120 of HIV-1 and abrogates its binding to CD4(+) lymphocytes. A clinical proof-of-concept study of the AI BMS-488043, administered as monotherapy for 8 days, demonstrated significant viral load reductions. In order to examine the effects of AI monotherapy on HIV-1 sensitivity, phenotypic sensitivity assessment of baseline and postdosing (day 8) samples was performed. These analyses revealed that four subjects had emergent phenotypic resistance (a 50% effective concentration [EC(50)] >10-fold greater than the baseline value) and four had high baseline EC(50)s (>200 nM). Population sequencing and sequence determination of cloned envelope genes uncovered five gp120 mutations at four loci (V68A, L116I, S375I/N, and M426L) associated with BMS-488043 resistance. Substitution at the 375 locus, located near the CD4 binding pocket, was the most common (maintained in 5/8 subjects at day 8). The five substitutions were evaluated for their effects on AI sensitivity through reverse genetics in functional envelopes, confirming their role in decreasing sensitivity to the drug. Additional analyses revealed that these substitutions did not alter sensitivity to other HIV-1 entry inhibitors. Thus, our studies demonstrate that although the majority of the subjects' viruses maintained sensitivity to BMS-488043, substitutions can be selected that decrease HIV-1 susceptibility to the AI. Most importantly, the substitutions described here are not associated with resistance to other approved antiretrovirals, and therefore, attachment inhibitors could complement the current arsenal of anti-HIV agents.
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All-trans retinoic acid/As2O3 combination yields a high quality remission and survival in newly diagnosed acute promyelocytic leukemia.
Shen, ZX, Shi, ZZ, Fang, J, Gu, BW, Li, JM, Zhu, YM, Shi, JY, Zheng, PZ, Yan, H, Liu, YF, et al
Proceedings of the National Academy of Sciences of the United States of America. 2004;(15):5328-35
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Both all-trans retinoic acid (ATRA) and arsenic trioxide (As(2)O(3)) have proven to be very effective in obtaining high clinical complete remission (CR) rates in acute promyelocytic leukemia (APL), but they had not been used jointly in an integrated treatment protocol for remission induction or maintenance among newly diagnosed APL patients. In this study, 61 newly diagnosed APL subjects were randomized into three treatment groups, namely by ATRA, As(2)O(3), and the combination of the two drugs. CR was determined by hematological analysis, tumor burden was examined with real-time quantitative RT-PCR of the PML-RAR alpha (promyelocytic leukemia-retinoic acid receptor alpha) fusion transcripts, and side effects were evaluated by means of clinical examinations. Mechanisms possibly involved were also investigated with cellular and molecular biology methods. Although CR rates in three groups were all high (> or =90%), the time to achieve CR differed significantly, with that of the combination group being the shortest one. Earlier recovery of platelet count was also found in this group. The disease burden as reflected by fold change of PML-RAR alpha transcripts at CR decreased more significantly in combined therapy as compared with ATRA or As(2)O(3) mono-therapy (P < 0.01). This difference persisted after consolidation (P < 0.05). Importantly, all 20 cases in the combination group remained in CR whereas 7 of 37 cases treated with mono-therapy relapsed (P < 0.05) after a follow-up of 8-30 months (median: 18 months). Synergism of ATRA and As(2)O(3) on apoptosis and degradation of PML-RAR alpha oncoprotein might provide a plausible explanation for superior efficacy of combination therapy in clinic. In conclusion, the ATRA/As(2)O(3) combination for remission/maintenance therapy of APL brings much better results than either of the two drugs used alone in terms of the quality of CR and the status of the disease-free survival.