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Comparison of 3 Paclitaxel-Based Chemoradiotherapy Regimens for Patients With Locally Advanced Esophageal Squamous Cell Cancer: A Randomized Clinical Trial.
Ai, D, Ye, J, Wei, S, Li, Y, Luo, H, Cao, J, Zhu, Z, Zhao, W, Lin, Q, Yang, H, et al
JAMA network open. 2022;(2):e220120
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Abstract
IMPORTANCE Multiple paclitaxel-based regimens are widely used in chemoradiation therapy against esophageal cancer, including regimens combining paclitaxel with fluorouracil, cisplatin, and carboplatin. However, which among these 3 regimens provides the best prognosis with minimum adverse events is still unknown. OBJECTIVE To compare the efficacy and adverse events of fluorouracil, cisplatin, and carboplatin in definitive chemoradiotherapy in patients with esophageal squamous cell carcinoma (ESCC). DESIGN, SETTING, AND PARTICIPANTS This randomized clinical trial of patients with ESCC was conducted in 11 treatment centers in China. Eligible patients were aged 18 to 75 years and had histologically confirmed ESCC stages IIa to IVa with no prior treatment, Eastern Cooperative Oncology Group performance status of 2 or lower, and adequate organ functions. The study was conducted between July 2015 and February 2018, and the cutoff date for data analysis was August 31, 2020. INTERVENTIONS Patients with locally advanced ESCC were randomly assigned (1:1:1) to groups combining paclitaxel treatment with fluorouracil, cisplatin, or carboplatin. Patients in the cisplatin group were treated with 2 cycles of concurrent chemoradiotherapy followed by 2 cycles of consolidation chemotherapy with monthly paclitaxel plus cisplatin. For the fluorouracil group, patients were administered 6 cycles of weekly paclitaxel plus fluorouracil in concurrent chemoradiotherapy followed by 2 cycles of monthly paclitaxel plus fluorouracil in consolidation chemotherapy. Patients in the carboplatin group were treated with 6 cycles of weekly paclitaxel plus carboplatin in concurrent chemoradiotherapy followed by 2 cycles of monthly paclitaxel plus carboplatin in consolidation chemotherapy. All patients received radiotherapy of 61.2 Gy delivered in 34 fractions. MAIN OUTCOMES AND MEASURES The primary end point was overall survival (OS). The secondary end points were progression-free survival and adverse events. RESULTS Overall, 321 patients (median [IQR] age, 64 years [59-69 years]; 248 [77.3%] men) with ESCC from 11 centers were randomized into fluorouracil, cisplatin, or carboplatin groups between July 2015 and February 2018. Over a median (IQR) follow-up time of surviving patients of 46.0 months (36.6-53.0 months), the 3-year OS rates were 57.2% in the fluorouracil group, 60.1% in the cisplatin group, and 56.5% in the carboplatin group, respectively (fluorouracil vs cisplatin: HR, 1.06; 95% CI, 0.71-1.60; P = .77; fluorouracil vs carboplatin: HR, 0.94; 95% CI, 0.63-1.40; P = .77). The cisplatin group had significantly higher incidences of acute grade 3 or 4 neutropenia (69 events [60.8%] vs 19 [17.8%] for fluorouracil and 37 [34.6%] carboplatin; P < .001), thrombocytopenia (14 events [13.1%] vs 4 [3.7%] for fluorouracil and 5 [4.7%] for carboplatin; P = .01), anemia (50 events above grade 2 [46.7%] vs 25 [23.4%] for fluorouracil and 37 [34.6%] for carboplatin; P = .35), fatigue (11 events [10.3%] vs 2 [1.9%] for fluorouracil and 1 [0.9%] carboplatin; P = .007), and vomiting (17 events above grade 2 [15.9%] vs 3 [2.8%] for fluorouracil and 5 [4.7%] for carboplatin; P < .001) than the other 2 groups. CONCLUSIONS AND RELEVANCE In this randomized clinical trial, paclitaxel plus fluorouracil did not show OS superiority over paclitaxel plus cisplatin or paclitaxel plus carboplatin regimens in definitive chemoradiation in patients with locally advanced ESCC. Higher rates of hematologic and gastrointestinal toxic effects were reported in the cisplatin group compared with those in the fluorouracil or carboplatin groups. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02459457.
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Comparison of Percutaneous Coronary Intervention, Coronary Artery Bypass Grafting and Medical Therapy in Non-ST Elevation Acute Coronary Syndrome Patients With 3-Vessel Disease.
Jia, S, Zhang, C, Jiang, L, Xu, L, Tian, J, Zhao, X, Feng, X, Wang, D, Zhang, Y, Sun, K, et al
Circulation journal : official journal of the Japanese Circulation Society. 2020;(10):1718-1727
Abstract
BACKGROUND The aim of this study is to compare the long-term prognosis of non-ST elevation acute coronary syndrome (NSTE-ACS) patients with 3-vessel disease (3VD) who underwent percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG) or medical therapy (MT).Methods and Results:Overall, 3,928 NSTE-ACS patients with 3VD were consecutively enrolled from April 2004 to February 2011 at Fu Wai Hospital. Patients were followed up for a median of 7.5 years, and were divided into PCI, CABG or MT groups according to their treatment. Compared with patients undergoing PCI, CABG patients had lower rates of myocardial infarction (MI), unplanned revascularization, major adverse cardiovascular and cerebrovascular events (MACCE) and a higher rate of stroke (all P<0.05). Compared with MT, PCI and CABG had lower incidences of all adverse outcomes (all P<0.05), except for a similar rate of stroke between PCI and MT. Kaplan-Meier analysis showed similar results. After adjusting for confounders, CABG was independently associated with a lower risk of cardiac death, revascularization and MACCE compared with PCI (all P<0.05). Compared with MT, PCI reduced long-term risk of death, whereas CABG reduced long-term risk of death, revascularization and MACCE events (all P<0.05). CONCLUSIONS In NSTE-ACS patients with 3VD, CABG is independently associated with a lower risk of long-term cardiac death, revascularization and MACCE compared with PCI. Patients who received MT alone had the highest risk of long-term MACCE.
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A comparison between whole grain and pearled oats: acute postprandial glycaemic responses and in vitro carbohydrate digestion in healthy subjects.
Zhu, R, Fan, Z, Li, G, Wu, Y, Zhao, W, Ye, T, Wang, L
European journal of nutrition. 2020;(6):2345-2355
Abstract
PURPOSE To compare the glycaemic response of whole grain oat kernels and pearled oats cooked under normal pressure or higher pressure and examine whether replacing half of the rice in a given meal with either of the two oat grains could make a difference in acute glycaemic responses. METHODS In a randomised crossover trial, ten healthy subjects consumed two groups of test meals: (1) oat grain-only, including whole grain oats cooked under normal pressure (WONP) and higher pressure (WOHP) as well as their pearled oat counterparts, PONP and POHP; and (2) mixed meals of aforementioned oat grains and cooked rice (OG + R), including WONP + R, WOHP + R, PONP + R and POHP + R. A postprandial blood glucose test, texture profile analysis and in vitro carbohydrate digestion assay were carried out for each test meal. RESULTS Compared with the rice reference, oat grain-only meals induced lower glucose levels at all time points, lower peak values and smaller glucose excursions at 120 min (P < 0.05), but OG + Rs did not have the abovementioned effects. The oat grain-only meals had glycaemic indexes (GIs) ranging from 51 to 58, while those of OG + Rs ranged from 59 to 70. WONP + R had a 21% lower iAUC0-60 and a 40% lower iAUC60-120 value than those of rice (P < 0.05). Oat-rice mixed meals had lower iAUC0-60 values compared with that of the rice control (P < 0.05), except for POHP + R. Excellent consistency between the hydrolysis index and the GI was observed (r = 0.969, P < 0.001) in oat grain-only meals. CONCLUSIONS All oat grain-only meals could be included in the glycaemic management diet, regardless of the oat grain type or cooking treatment. In oat-rice mixed meals, whole grain oats and normal pressure cooking ensured a favourable glycaemic effect.
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Lamivudine versus telbivudine in the treatment of chronic hepatitis B: a systematic review and meta-analysis.
Jiang, H, Wang, J, Zhao, W
European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology. 2013;(1):11-8
Abstract
The purpose of this study was to evaluate the efficacy of lamivudine (LAM) versus telbivudine (LdT) in the treatment of chronic hepatitis B (CHB). Randomized controlled studies (RCTs) involving the use of LAM versus LdT in CHB patients were included in the study. Data were obtained from the Cochrane-controlled trials register, EMBASE and MEDLINE databases (1/1990 to 12/2011). Two reviewers performed quality assessment and extracted data independently. Eight RCTs were included in the main analysis. Eight eligible trials were included in the analysis. At the end of one-year treatment, LdT was better than LAM at the virological response (RR = 1.43, 95 % CI = 1.12-1.84, P = 0.005), while less than LAM at the viral breakthrough (RR = 0.34,95 % CI = 0.25-0.48, P < 0.00001), viral resistance (RR = 0.41,95 % CI = 0.28-0.58, P < 0.00001), but there was no statistically significant difference in the biochemical response (RR = 1.13,95 % CI = 0.99-1.29, P = 0.06), HBeAg seroconversion (RR = 1.13,95 % CI = 0.92-1.39, P = 0.25), therapeutic response (RR = 1.22,95 % CI = 1.00-1.50, P = 0.05) and adverse events (RR = 1.07,95 % CI = 1.00-1.14, P = 0.05). The creatine kinase (CK) elevation occurred more frequently in the LdT group than in LAM group (RR = 2.43,95 % CI = 1.57-3.75, P < 0.0001). When treatment prolonged to 2 years, LdT was better than LAM at the HBeAg seroconversion (RR = 1.29,95 % CI = 1.12-1.50, P = 0.0007) and therapeutic response (RR = 1.34,95 % CI = 1.21-1.49, P < 0.00001). LdT was more effective in inhibiting HBV replication and promoting HBeAg seroconversion than LAM for CHB patients, whereby adverse effects such as CK elevation must be paid attention to.
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Fasting capillary blood glucose: an appropriate measurement in screening for diabetes and pre-diabetes in low-resource rural settings.
Zhao, X, Zhao, W, Zhang, H, Li, J, Shu, Y, Li, S, Cai, L, Zhou, J, Li, Y, Hu, R
Journal of endocrinological investigation. 2013;(1):33-7
Abstract
OBJECTIVE To evaluate the efficiency of fasting capillary blood glucose (FCG) measurement as compared with fasting venous plasma glucose (FPG) measurement in screening diabetes and pre-diabetes in low-resource rural settings. SUBJECTS AND METHODS In 2010, 993 participants were randomly selected from 9 villages in Yunnan province using cluster sampling method. Samples for FCG and FPG test were obtained after demographics and physical examination. The oral glucose tolerance test was performed in parallel as gold standard for diagnosis. Diagnostic capacities of the FCG measurement in predicting undiagnosed diabetes and pre-diabetes were assessed. The performance of FCG and FPG tests was compared. RESULTS Fifty-seven individuals with undiagnosed diabetes and 145 subjects with pre-diabetes were detected. The concordance between FCG and FPG levels was high (r = 0.75, p < 0.001). The area under the curve (AUC) for FCG test in predicting diabetes was 0.88 [95% confidence interval (CI) 0.82-0.93] with the optimal cutoff value of 5.65 mmol/l, sensitivity of 84.2%, and specificity of 79.3%. The corresponding values in FPG tests were 0.92 (95% CI 0.88-0.97) (AUC), 6.51 mmol/l (optimal cutoff point), 82.5% (sensitivity) and 98.3% (specificity), respectively. No significant difference was found in the AUC for the two screening strategies. CONCLUSION FCG measurement is considered to be a convenient, practicable screening method in low-resource rural communities with acceptable test properties.
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Comparison of Xilei-san, a Chinese herbal medicine, and dexamethasone in mild/moderate ulcerative proctitis: a double-blind randomized clinical trial.
Zhang, F, Li, Y, Xu, F, Chu, Y, Zhao, W
Journal of alternative and complementary medicine (New York, N.Y.). 2013;(10):838-42
Abstract
BACKGROUND Xilei-san is a traditional Chinese herbal medicine that has proven to be of possible use in the treatment of ulcerative proctitis (UP) in a pilot study. OBJECTIVES This study was intended to compare Xilei-san with dexamethasone enemas in subjects with mild-to-moderate active UP. METHODS A double-blind randomized study was performed in 35 subjects. During the initial 8 weeks, the subjects received an enema of Xilei-san or dexamethasone at bedtime, then discontinued the treatment and were followed for 12 weeks. All of the subjects received 3 g/day oral mesalazine during the entire study. The disease activity was assessed at inclusion and at weeks 4, 8, and 20. RESULTS Both treatments showed significant improvement in clinical, endoscopic, and histological grades in comparison with the baseline. CONCLUSIONS Xilei-san enemas are comparable to dexamethasone enemas in this study. This medicine is safe, well accepted, and may be an alternative drug in the treatment of mild-to-moderate active UP.
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Comparison of transcutaneous contrast-enhanced ultrasound-guided injected hemostatic agents with traditional surgery treatment for liver, spleen and kidney trauma: a retrospective study.
Wang, D, Lv, F, Luo, Y, An, L, Li, J, Xie, X, Tian, J, Zhao, W, Tang, J
Hepato-gastroenterology. 2012;(119):2021-6
Abstract
BACKGROUND/AIMS: There is lack of studies on the effectiveness of transcutaneous contrast-enhanced ultrasound-guided injections of hemostatic agents for liver. spleen and kidney trauma. We compared treatment by hemostatic agents to surgical treatment in a retrospective interventional human study. METHODOLOGY The study enrolled a total of 135 subjects from emergency unit of the Chinese People's Liberation Army General Hospital in Beijing. Within the cohort, 62 patients received contrast enhanced ultrasound-guided injection of hemostatic agents and the rest received surgical treatments. RESULTS The injury severity score was lower in the hemostatic agent treatment group than surgical treatment group (p<0.05), but Glasgow coma scale scores did not reach statistical significance. The patients in the surgical treatment group had significantly higher hospital fees than those in the hemostatic treatment group (p<0.05), although the length of hospitalization did not significantly differ between two groups. Safety outcome variables pre- and post-treatment remained within normal limits in both groups. CONCLUSIONS Hemostatic agents were more cost-effective than surgery to treat patients with liver, spleen and kidney trauma. However, given the limited sample size, subsequent studies drawing upon larger populations from multiple medical centers are necessary for follow-up.