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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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Abstract
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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CSL112 (Apolipoprotein A-I [Human]) Strongly Enhances Plasma Apoa-I and Cholesterol Efflux Capacity in Post-Acute Myocardial Infarction Patients: A PK/PD Substudy of the AEGIS-I Trial.
Gibson, CM, Kazmi, SHA, Korjian, S, Chi, G, Phillips, AT, Montazerin, SM, Duffy, D, Zheng, B, Heise, M, Liss, C, et al
Journal of cardiovascular pharmacology and therapeutics. 2022;:10742484221121507
Abstract
INTRODUCTION Cholesterol efflux capacity (CEC) is impaired following acute myocardial infarction (AMI). CSL112 is an intravenous preparation of human plasma-derived apoA-I formulated with phosphatidylcholine (PC). CSL112 is intended to improve CEC and thereby prevent early recurrent cardiovascular events following AMI. AEGIS-I (ApoA-I Event Reducing in Ischemic Syndromes I) was a multicenter, randomized, double-blind, placebo-controlled, dose-ranging phase 2b study, designed to evaluate the hepatic and renal safety of CSL112. Here, we report an analysis of a pharmacokinetic (PK) and pharmacodynamic (PD) substudy of AEGIS-I. METHODS AMI patients were stratified by renal function and randomized 3:3:2 to 4, weekly, 2-hour infusions of low- and high-dose (2 g and 6 g) CSL112, or placebo. PK/PD assessments included plasma concentrations of apoA-I and PC, and measures of total and ABCA1-dependent CEC, as well as lipids/lipoproteins including high density lipoprotein cholesterol (HDL-C), non-HDL-C, low density lipoprotein cholesterol (LDL-C), ApoB, and triglycerides. Inflammatory and cardio-metabolic biomarkers were also evaluated. RESULTS The substudy included 63 subjects from AEGIS-I. CSL112 infusions resulted in rapid, dose-dependent increases in baseline corrected apoA-I and PC, which peaked at the end of the infusion (Tmax ≈ 2 hours). Similarly, there was a dose-dependent elevation in both total CEC and ABCA1-mediated CEC. Mild renal impairment did not affect the PK or PD of CSL112. CSL112 administration was also associated with an increase in plasma levels of HDL-C but not non-HDL-C, LDL-C, apoB, or triglycerides. No dose-effects on inflammatory or cardio-metabolic biomarkers were observed. CONCLUSION Among patients with AMI, impaired CEC was rapidly elevated by CSL112 infusions in a dose-dependent fashion, along with an increase in apoA-I plasma concentrations. Findings from the current sub-study of the AEGIS-I support a potential atheroprotective benefit of CSL112 for AMI patients.
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Effect of CSL112 (apolipoprotein A-I [human]) on cholesterol efflux capacity in Japanese subjects: Findings from a phase I study and a cross-study comparison.
Zheng, B, Goto, S, Clementi, R, Feaster, J, Duffy, D, Dalitz, P, Airey, J, Korjian, S, Tortorici, MA, Roberts, J, et al
Clinical and translational science. 2022;(10):2331-2341
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Abstract
CSL112 (apolipoprotein A-I [apoA-I, human]) is a novel drug in development to reduce the risk of recurrent cardiovascular events following acute myocardial infarction by increasing cholesterol efflux capacity (CEC). This phase I study aimed to compare the pharmacokinetics (PKs), pharmacodynamics (PDs), and safety of CSL112 in Japanese and White subjects. A total of 34 Japanese subjects were randomized to receive a single infusion of CSL112 (2, 4, or 6 g) or placebo and 18 White subjects were randomized to receive a single dose of 6 g CSL112 or placebo, followed by PK/PD assessment and adverse events monitoring. In addition, PK/PD parameters were compared across the CSL112 clinical development program. Plasma exposure of apoA-I increased in a dose-dependent but nonlinear manner in Japanese subjects receiving a single dose of CSL112. Mean baseline-corrected area under the curve from 0 to 72 h (AUC0-72 ) increased from 840 to 6490 mg h/dl, in the 2 and 6 g cohorts, respectively, followed by dose-dependent increase of CEC. The plasma PK profile of apoA-I and increases in total and ATP binding cassette transporter A1 dependent CEC were comparable in Japanese and White subjects. The geometric mean ratio (Japanese:White) for plasma apoA-I AUC0-72 and maximum plasma concentration (Cmax ) was 1.08 and 0.945, respectively. Cross-study comparison analysis demonstrated similar CSL112 exposure and CEC enhancement in Japanese and non-Japanese subjects (including patients with cardiovascular disease) and further confirmed consistent PKs/PDs of CSL112. This study suggests CSL112 acutely enhances CEC and is well-tolerated with no differences between Japanese and White subjects.
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Lenvatinib versus sorafenib for unresectable hepatocellular carcinoma: a cost-effectiveness analysis.
Cai, H, Zhang, L, Li, N, Zheng, B, Liu, M
Journal of comparative effectiveness research. 2020;(8):553-562
Abstract
Aim: To investigate the cost-effectiveness of lenvatinib and sorafenib in the treatment of patients with nonresected hepatocellular carcinoma in China. Materials & methods: Markov model was used to simulate the direct medical cost and quality-adjusted life years (QALY) of patients with hepatocellular carcinoma. Clinical data were derived from the Phase 3 randomized clinical trial in a Chinese population. Results: Sorafenib treatment resulted in 1.794 QALYs at a cost of $43,780.73. Lenvatinib treatment resulted in 2.916 QALYs for patients weighing <60 and ≥60 kg at a cost of $57,049.43 and $75,900.36, The incremental cost-effectiveness ratio to the sorafenib treatment group was $11,825.94/QALY and $28,627.12/QALY, respectively. Conclusion: According to WHO's triple GDP per capita, the use of lenvatinib by providing drugs is a cost-effective strategy.
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Vitamin D supplementation prior to in vitro fertilisation in women with polycystic ovary syndrome: a protocol of a multicentre randomised, double-blind, placebo-controlled clinical trial.
Hu, KL, Gan, K, Wang, R, Li, W, Wu, Q, Zheng, B, Zou, L, Zhang, S, Liu, Y, Wu, Y, et al
BMJ open. 2020;(12):e041409
Abstract
INTRODUCTION Polycystic ovary syndrome (PCOS) is one of the leading causes of female infertility, affecting around 5% of women of childbearing age in China. Vitamin D insufficiency is common in women with PCOS and is associated with lower live birth rates. However, evidence regarding the effectiveness of vitamin D supplementation in women with PCOS is inconclusive. This multicentre randomised, double-blinded, placebo-controlled trial aims to evaluate the effectiveness of vitamin D supplementation prior to in vitro fertilisation (IVF) on the live birth rate in women with PCOS. METHODS AND ANALYSIS We plan to enrol women with PCOS scheduled for IVF. After informed consent, eligible participants will be randomised in a 1:1 ratio to receive oral capsules of 4000 IU vitamin D per day or placebo for around 12 weeks until the day of triggering. All IVF procedures will be carried out routinely in each centre. The primary outcome is live birth after the first embryo transfer. The primary analysis will be by intention-to-treat analysis. To demonstrate or refute that treatment with vitamin D results in a 10% higher live birth rate than treatment with placebo, we need to recruit 860 women (48% vs 38% difference, anticipating 10% loss to follow-up and non-compliance, significance level 0.05 and power 80%). ETHICS AND DISSEMINATION This study has been approved by the Ethics Committee in Women's Hospital of Zhejiang University on 2 March 2020 (reference number: IRB-20200035-R). All participants will provide written informed consent before randomisation. The results of the study will be submitted to scientific conferences and a peer-reviewed journal. TRIAL REGISTRATION NUMBER NCT04082650.
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[Traditional Chinese and Western medicine treatment of mycoplasmal pneumonia in children and the serum cytokine changes].
Liu, DJ, Zheng, B, Cai, BH, Zhou, WM, Yu, BX
Nan fang yi ke da xue xue bao = Journal of Southern Medical University. 2010;(3):626-7, 630
Abstract
OBJECTIVE To observe the therapeutic effect of traditional Chinese medicine (TCM) and Western medicine (WM) treatments on mycoplasmal pneumonia in children and the changes in the serum cytokines. METHODS Ninety children with mycoplasmal pneumonia were randomly divided into the treatment group and the control group. TCM was given orally and azithromycin at the daily dose of 10 mg/kg was administered intravenously in the treatment group. In the control group, only intravenous azithromycin was given. After a 7-day treatment, the response rate, time of symptom disappearance, and serum levels of IL-6, IL-8 and TNF-alpha were observed. RESULTS The total response rate was 93.33% in the treatment group and 73.33% in the control group, showing a significantly better therapeutic effect in the treatment group (P<0.05). The combined treatments also showed better effects in alleviating fever, coughing and rales (P<0.05), and resulted in more obvious reduction in the serum levels of cytokines (P<0.05). CONCLUSION Combined treatment with TCM and WM produce good therapeutic effects in children with mycoplasmal pneumonia.
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Electrolyte intake and nonpharmacologic blood pressure control.
Espeland, MA, Kumanyika, S, Yunis, C, Zheng, B, Brown, WM, Jackson, S, Wilson, AC, Bahnson, J
Annals of epidemiology. 2002;(8):587-95
Abstract
PURPOSE To characterize relationships between sodium and potassium intakes and blood pressure control. METHODS We analyzed repeated 24-hour diet recalls and 24-hour urine assays from 873 elderly participants with established hypertension in a 3-year clinical trial of lifestyle interventions. Pooled estimates of electrolyte intakes were developed using hierarchical measurement error models and related to nonpharmacologic blood pressure control. RESULTS Relative decreases in sodium and increases in potassium intakes each had graded relationships with better blood pressure control. After adjustment for measurement error, a 100 mmol/24-hour decrease in sodium intake was associated with an odds ratio of 2.93 [95% confidence interval: 1.83, 4.64] for maintaining nonpharmacologic blood pressure control throughout follow-up. A 50 mmol/24-hour increase in potassium intake was associated with an odds ratio of 2.00 [1.12, 3.55]. These relationships were independent of each other and of baseline levels of intakes. Blood pressure control was most strongly associated with sodium intake for participants with lower systolic blood pressures and longer duration of hypertension, and with potassium for those with elevated diastolic blood pressures. CONCLUSIONS Sodium and potassium intakes exert independent graded influences on nonpharmacologic blood pressure control. Correlated measurement error may spuriously introduce a dependency among these relationships.
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A randomized, controlled clinical trial on meropenem versus imipenem/cilastatin for the treatment of bacterial infections.
Hou, F, Li, J, Wu, G, Zheng, B, Chen, Y, Gu, J, Wang, H, Huo, L, Xue, X, Jia, C, et al
Chinese medical journal. 2002;(12):1849-54
Abstract
OBJECTIVE To evaluate the efficacy and safety of meropenem in Chinese patients, we conducted a study for the treatment of patients with lower respiratory tract infections, urinary tract infections and other infections. METHODS A total of 182 hospitalized patients were enrolled in the study. 90 patients received 500 mg meropenem every 12 hours (or 1 g every 12 hours if necessary) and 92 patients received imipenem/cilastatin 500 mg/500 mg every 12 hours (or 1 g every 12 hours if necessary) by intravenous infusion. The duration of treatment was 7 - 14 days for both groups. RESULTS Seventy of 90 cases receiving meropenem and 70 of 92 cases receiving imipenem/cilastatin were assessable for clinical efficacy. The overall efficacy rates were 90% for the meropenem group and 87% for the imipenem/cilastatin group, and the bacterial eradication rates were 86% in both groups. 93 (76%) of 123 strains isolated from patients produced beta-lactamases. Adverse drug reactions were evaluated in 72 cases in the meropenem group and 70 cases in the imipenem/cilastatin group. The adverse drug reaction rates were 9.7% and 8.6%, respectively. The results showed that there were no statistical differences between these two groups (P > 0.05). CONCLUSION Meropenem is effective and safe for the treatment of bacterial infections caused mainly by beta-lactamase-producing strains.
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Lifestyle interventions influence relative errors in self-reported diet intake of sodium and potassium.
Espeland, MA, Kumanyika, S, Wilson, AC, Wilcox, S, Chao, D, Bahnson, J, Reboussin, DM, Easter, L, Zheng, B
Annals of epidemiology. 2001;(2):85-93
Abstract
PURPOSE To characterize the distribution of errors in self-reported sodium and potassium dietary intakes relative to more objective urine measures among participants receiving lifestyle interventions. METHODS We analyzed longitudinal data from 900 individuals with hypertension who had been enrolled in a randomized controlled clinical trial to establish whether usual care or three lifestyle interventions (weight loss, sodium reduction, and combined weight loss and sodium reduction) could effectively substitute for phamacotherapy. Repeated standardized 24-hour diet recalls and 24-hour urine collections were collected over up to three years of follow-up to estimate sodium and potassium intakes. By contrasting self-reported and urine-based sodium and potassium data collected before and during interventions, we examined the relative impact of intervention assignment on estimated intakes, repeatability, and multivariate measurement error. RESULTS Relative to urine-based measures, mean self-reported sodium intakes were biased about 10% lower among participants assigned to combined weight loss and sodium reduction, but were unaffected by the other interventions. The repeatability of self-report measures increased slightly with time, particularly among participants assigned to sodium interventions. Errors in self-reported sodium and potassium intakes were correlated before the start of the intervention, but became uncorrelated among individuals assigned to sodium restriction interventions. CONCLUSIONS Lifestyle interventions may influence not only diet intake, but also the measurement of diet intake.