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Effects of the Chinese Heart-Healthy Diet (Sichuan Cuisine Version) on the 10-year CVD risk and vascular age: a randomised controlled feeding trial.
Su, D, Chen, H, Guo, Y, Feng, Q, Yang, M, Cai, C, Zhang, Y, Wu, Y, Wang, Y, Zeng, G
The British journal of nutrition. 2024;(6):997-1006
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Abstract
Sichuan cuisine was previously fitted into the Chinese Heart-Healthy Diet (CHH) trial to verify the antihypertensive effect. Whether the modified Sichuan diet lessens cardiovascular disease (CVD) is not fully explored. We aimed to estimate the effects of the Sichuan version of CHH diet (CHH diet-SC) on the 10-year risk of CVD and vascular age. A single-blinded randomised controlled feeding trial was conducted. General CVD prediction model was used in manners of intention-to-treat and per-protocol set. After a 7-d run-in period, fifty-three participants with pre- and grade I hypertension from local communities were randomised and provided with either CHH diet-SC (n 27) or a control diet (n 26) for 4 weeks. Mean absolute and relative estimated CVD risks were reduced by 4·5 % and 27·9 % in the CHH diet-SC group, and the between-group relative risk reduction was 19·5 % (P < 0·001) using linear mixed-effects models. The sensitivity analysis with datasets and models showed consistent results, and pre-specified factors were not associated with the intervention effects. The vascular age of CHH-SC group was theoretically 4·4 years younger than that of the control group after intervention. Compared with a typical diet, adopting the CHH diet-SC over 1 month significantly reduced 10-year CVD risks and vascular ages among local adults with mild hypertension.
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COMPARISON OF THE EFFICACY AND SAFETY OF RANIBIZUMAB 0.5 MG VERSUS 1.0 MG WITH PARS PLANA VITRECTOMY FOR THE TREATMENT OF PROLIFERATIVE DIABETIC RETINOPATHY: A Randomized Controlled Trial.
Su, T, Lai, D, Wu, Y, Gu, C, He, S, Meng, C, Cai, C, Zhang, J, Luo, D, Chen, J, et al
Retina (Philadelphia, Pa.). 2024;(4):680-688
Abstract
PURPOSE To investigate the effectiveness of two regimens of ranibizumab-assisted pars plana vitrectomy in the treatment of patients with proliferative diabetic retinopathy. METHODS This is a prospective, 6-month, randomized controlled trial. Eighty patients with 87 eyes requiring pars plana vitrectomy treatment for proliferative diabetic retinopathy were included and randomly divided into a 1.0-mg injection group and a 0.5-mg injection group. The ranibizumab was delivered intraoperatively, at the close of surgery. The vitreous hemorrhage grade, best-corrected visual acuity, central macular thickness, and safety data were assessed to Month 6. RESULTS The 1.0-mg injection group had a milder grade and a lower reoccurrence rate of early postoperatively vitreous hemorrhage than the 0.5-mg injection group (35.0% and 63.4%, respectively, P = 0.0195). The mean best-corrected visual acuity of two groups was significantly improved from baseline to 6 months after surgery, 1.60 ± 0.72 Logarithm of the Minimum Angle of Resolution (LogMAR) (<20/200) to 0.47 ± 0.49 LogMAR (20/59) for the 1.0-mg injection group and 1.51 ± 0.69 LogMAR (<20/200) to 0.50 ± 0.31 LogMAR (20/63) for the 0.5-mg injection group, but there was no significant difference between the two groups ( P = 0.74). There was no significant difference in the mean decrease in central macular thickness and probability of postoperative adverse events between the two groups. CONCLUSION Intravitreal injection of 1.0 mg of ranibizumab after pars plana vitrectomy compared with the recommended dose of 0.5 mg significantly reduced the recurrence and severity of early postoperative vitreous hemorrhage in patients with proliferative diabetic retinopathy. It also contributed to the early recovery of visual acuity after surgery and did not increase postoperative adverse events.
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Conditioning therapy with N-acetyl-L-cysteine, decitabine and modified BUCY regimen for myeloid malignancies patients prior to allogeneic hematopoietic stem cell transplantation.
Tang, Y, Zhang, Z, Liu, S, Yao, Y, Pan, T, Qi, J, Kang, H, Liu, Y, Cai, C, Zhou, M, et al
American journal of hematology. 2023;(6):881-889
Abstract
Conditioning therapy is an essential procedure prior to hematopoietic stem cell transplant (HSCT), imposing a great impact on the outcomes of recipients. We performed a prospective randomized controlled trial to assess the outcome of HSCT recipients with myeloid malignancies after receiving the conditioning therapy consisting of modified BUCY (mBUCY), N-acetyl-L-cysteine (NAC), and decitabine. Enrolled patients were randomly allocated to either Arm A (decitabine, day -12 to -10; NAC, day -9 to +30; mBUCY, day -9 to -2), or Arm B (mBUCY regimen followed by stem cells infusion). Seventy-six patients in Arm A and 78 patients in Arm B were finally evaluated. The results showed platelet recovery accelerate in Arm A, with more patients achieving a platelet count of ≥50 × 109 /L than Arm B at day +30 and +60 (p = .004 and .043, respectively). The cumulative incidence of relapse is 11.8% (95% CI 0.06-0.22) in Arm A, and 24.4% (95% CI 0.16-0.35) in Arm B (p = .048). The estimated 3-year overall survival rate was 86.4% (±4.4%) and 79.9% (±4.7%) in 2 arms, respectively (p = .155). EFS at 3 years was 79.2% (±4.9%) in Arm A and 60.0% (±5.9%) in Arm B (p = .007). Intracellular reactive oxygen species (ROS) level was found to be reversely correlated with platelet recovery, and fewer patients in Arm A displayed excessive ROS within hematopoietic progenitor cells compared to Arm B. In conclusion, the addition of decitabine and NAC to mBUCY is a feasible and promising conditioning therapy for myeloid malignancies patients.
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Pharmacokinetics and Safety of Single and Multiple Doses of Peficitinib (ASP015K) in Healthy Chinese Subjects.
Gao, X, He, X, Oshima, H, Miyatake, D, Otsuka, Y, Kato, K, Cai, C, Wojtkowski, T, Song, N, Kaneko, Y, et al
Drug design, development and therapy. 2022;:1365-1381
Abstract
OBJECTIVE To investigate the pharmacokinetics and safety of peficitinib (Janus kinase inhibitor for the treatment of rheumatoid arthritis) in healthy Chinese subjects following single and multiple doses. METHODS This open-label, randomized study was conducted at one site in China. Subjects received peficitinib 50, 100 or 150 mg as a single dose on Day 1 (fasted) and once daily from Days 8 to 13 in the multiple-dose period (fed). Blood samples were collected before administration each day, and up to 72h post administration. Pharmacokinetic assessments included area under the concentration curve (AUC), half-life (t1/2), maximum concentration (Cmax), and time to maximum concentration (tmax) of peficitinib and its metabolites (H1, H2 and H4). Treatment-emergent adverse events (TEAEs) were evaluated. RESULTS Thirty-six subjects were enrolled (12 per dose group). After a single dose of peficitinib, median tmax was 1.0-1.5h and mean t1/2 was 7.4-13.0h for all doses. In the multiple-dose period, median tmax was 1.5-2.0h. Dose-proportional increases in Cmax and AUC24h were observed for peficitinib and its metabolites following single and multiple doses, with minimal drug accumulation. The major metabolite was H2, with a systemic exposure of >150% of the parent AUC. Drug-related TEAEs were experienced by 5 (13.9%) and 12 (33.3%) subjects in the single- and multiple-dose periods, respectively. Following multiple doses of peficitinib, TEAEs were more frequent in higher than lower dose groups but were mild in severity with no related discontinuation or death. CONCLUSION Following single and multiple doses of peficitinib in healthy Chinese subjects, peficitinib demonstrated rapid absorption and was well tolerated at all doses. CLINICALTRIALSGOV IDENTIFIER NCT04143477.
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The effect of an intensive patients' education program on anxiety, depression and patient global assessment in diabetic foot ulcer patients with Wagner grade 1/2: A randomized, controlled study.
Chen, H, Cai, C, Xie, J
Medicine. 2020;(6):e18480
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Abstract
This study aimed to synthetically evaluate the impact of intensive patients' education program (IEP) on anxiety, depression and patient global assessment (PGA) in diabetic foot ulcer (DFU) patients.One hundred eighty DFU patients with Wagner grade 1 and Wagner grade 2 were consecutively recruited in this randomized, controlled study and randomly assigned to IEP group (N = 90) or control group (N = 90) as 1:1 ratio. In the IEP group, patients received the IEP and usual care, and patients in the control group received usual care only. IEP included educating patients and their family members, supervising patients' harmful habits and diets, psychological care for the patients and establishing a patient-physician-nurse WeChat group. Hospital Anxiety and Depression Scale-anxiety/depression (HADS-A/D) and Zung Self-Rating Anxiety/depression Scale (SAS/SDS) were applied to assess anxiety/depression at M0-M3. PGA score was also assessed at M0-M3.For anxiety assessment, IEP group presented decreased HADS-A/SAS scores at M2/M3 and increased HADS-A/SAS score changes (M3-M0) compared to control group. For depression assessment, IEP group displayed reduced HADS-D/SDS scores at M2/M3 and raised SDS score change (M3-M0) compared to control group. Moreover, IEP group exhibited reduced PGA score at M1/M2/M3 and elevated PGA score change (M3-M0) compared to control group. Further subgroup analyses disclosed that IEP reduced HADS-A/SAS/HADS-D/PGA scores at M3 and elevated these score changes (M3-M0) in patients with Wagener grade 2 but not Wagener grade 1.IEP ameliorates anxiety, depression and PGA in DFU patients with Wagner grade 2 but not Wagner grade 1.