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المؤلفون: Ya-Fei Liu, Jing-Liang Wu, Xiao-Yu Xu, Gui-Fan Li, Hongxing Pan, Wenling Wang, Jingxin Li, Jian-Kai Liu, Meng Wang, Baoying Huang, Kai Chu, Li Zhang, Wenjie Tan, Fengcai Zhu, Xian-Yun Chang, Dan-Dan Zhu, Wei-Jin Huang, Jialei Hu
المصدر: Chinese Medical Journal, Vol 134, Iss 11, Pp 1289-1298 (2021)
Chinese Medical Journalمصطلحات موضوعية: Adult, medicine.medical_specialty, COVID-19 Vaccines, Phases of clinical research, Placebo, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Double-Blind Method, law, Internal medicine, medicine, Humans, Seroconversion, Adverse effect, Inactivated vaccine, business.industry, SARS-CoV-2, COVID-19, General Medicine, Original Articles, Neutralizing antibody, Immunogenicity, Clinical trial, Regimen, Vaccines, Inactivated, 030220 oncology & carcinogenesis, Medicine, Safety, business, 030217 neurology & neurosurgery
الوصف: BACKGROUND: The significant morbidity and mortality resulted from the infection of a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) call for urgent development of effective and safe vaccines. We report the immunogenicity and safety of an inactivated SARS-CoV-2 vaccine, KCONVAC, in healthy adults. METHODS: Phase 1 and phase 2 randomized, double-blind, and placebo-controlled trials of KCONVAC were conducted in healthy Chinese adults aged 18 to 59 years. The participants in the phase 1 trial were randomized to receive two doses, one each on Days 0 and 14, of either KCONVAC (5 or 10 µg/dose) or placebo. The participants in the phase 2 trial were randomized to receive either KCONVAC (at 5 or 10 µg/dose) or placebo on Days 0 and 14 (0/14 regimen) or Days 0 and 28 (0/28 regimen). In the phase 1 trial, the primary safety endpoint was the proportion of participants experiencing adverse reactions/events within 28 days following the administration of each dose. In the phase 2 trial, the primary immunogenicity endpoints were neutralization antibody seroconversion and titer and anti-receptor-binding domain immunoglobulin G seroconversion at 28 days after the second dose. RESULTS: In the phase 1 trial, 60 participants were enrolled and received at least one dose of 5-µg vaccine (nâ=â24), 10-µg vaccine (nâ=â24), or placebo (nâ=â12). In the phase 2 trial, 500 participants were enrolled and received at least one dose of 5-µg vaccine (nâ=â100 for 0/14 or 0/28 regimens), 10-µg vaccine (nâ=â100 for each regimen), or placebo (nâ=â50 for each regimen). In the phase 1 trial, 13 (54%), 11 (46%), and seven (7/12) participants reported at least one adverse event (AE) after receiving 5-, 10-µg vaccine, or placebo, respectively. In the phase 2 trial, 16 (16%), 19 (19%), and nine (18%) 0/14-regimen participants reported at least one AE after receiving 5-, 10-µg vaccine, or placebo, respectively. Similar AE incidences were observed in the three 0/28-regimen treatment groups. No AEs with an intensity of grade 3+ were reported, expect for one vaccine-unrelated serious AE (foot fracture) reported in the phase 1 trial. KCONVAC induced significant antibody responses; 0/28 regimen showed a higher immune responses than that did 0/14 regimen after receiving two vaccine doses. CONCLUSIONS: Both doses of KCONVAC are well tolerated and able to induce robust immune responses in healthy adults. These results support testing 5-µg vaccine in the 0/28 regimen in an upcoming phase 3 efficacy trial. TRIAL REGISTRATION: http://www.chictr.org.cn/index.aspx (No. ChiCTR2000038804, http://www.chictr.org.cn/showproj.aspx?proj=62350; No. ChiCTR2000039462, http://www.chictr.org.cn/showproj.aspx?proj=63353).
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المؤلفون: Rui-Lin Ma, Yan Deng, Yan-Fang Wang, Shi-Yang Zhu, Xue-Song Ding, Ai-Jun Sun, Yan-Jie Yin, Xiu-Yuan Hao
المصدر: Chinese Medical Journal
Chinese Medical Journal, Vol 134, Iss 23, Pp 2882-2889 (2021)مصطلحات موضوعية: medicine.medical_specialty, Overweight, Gastroenterology, Insulin resistance, Weight loss, Diabetes mellitus, Internal medicine, medicine, Humans, Obesity, Polycystic ovary syndrome, business.industry, Original Articles, General Medicine, medicine.disease, Polycystic ovary, Metformin, Exenatide once-weekly, Medicine, Exenatide, Female, medicine.symptom, business, Body mass index, medicine.drug
الوصف: Background:. Obesity and insulin resistance (IR) are common features of polycystic ovary syndrome (PCOS). Metformin (MET) increases insulin sensitivity, but it is associated with unsatisfactory weight loss. The glucagon-like peptide-1 receptor agonist exenatide has been shown to reduce weight and IR in patients with diabetes. This study aimed to explore the therapeutic effects of exenatide once-weekly (QW) combined with MET on body weight, as well as metabolic and endocrinological parameters in overweight/obese women with PCOS. Methods:. Fifty overweight/obese women with PCOS diagnosed via the Rotterdam criteria were randomized to one of two treatment groups: MET (500 mg three times a day [TID]) or combination treatment (COM) (MET 500 mg TID, exenatide 2 mg QW) for 12 weeks. The primary outcomes were anthropometric changes associated with obesity, and the secondary outcomes included changes in reproductive hormone levels, glucose and lipid metabolism, and C-reactive protein. Results:. Forty (80%) patients completed the study. COM therapy was superior to MET monotherapy in reducing weight (P = 0.045), body mass index (BMI) (P = 0.041), and waist circumference (P = 0.023). Patients in the COM group on an average lost 3.8 ± 2.4 kg compared with 2.1 ± 3.0 kg in the MET group. In the COM group, BMI and waist circumference decreased by 1.4 ± 0.87 kg/m2 and 4.63 ± 4.42 cm compared with 0.77 ± 1.17 kg/m2 and 1.72 ± 3.07 cm in the MET group, respectively. Moreover, levels of fasting glucose, oral glucose tolerance test (OGTT) 2-h glucose, and OGTT 2-h insulin were significantly lower with COM therapy than with MET (P
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المؤلفون: Wei Lu, Yaxin Wang, Lei Zhang, Lei Chen, Yun Shen, Tian Xia, Jian Zhou, Wei Zhu, Gang Hu, Chunfang Wang, Jingyi Lu
المصدر: Chinese Medical Journal
مصطلحات موضوعية: Blood Glucose, China, medicine.medical_specialty, HbA1c, Range (biology), Cancer mortality, Type 2 diabetes, digestive system, Neoplasms, Internal medicine, parasitic diseases, Humans, Medicine, Prospective Studies, Prospective cohort study, business.industry, Blood Glucose Self-Monitoring, Original Articles, General Medicine, biochemical phenomena, metabolism, and nutrition, medicine.disease, Hepatocellular cancer, Diabetes Mellitus, Type 2, Time in range, Cohort study, business
الوصف: Background: Little was known about the association among time in range (TIR), time above range (TAR), time below range (TBR), and cancer mortality among patients with type 2 diabetes. We aimed to investigate the association among TIR, TAR, TBR, and the risk of cancer mortality among patients with type 2 diabetes. Methods: A total of 6225 patients with type 2 diabetes were prospectively recruited in Shanghai, China. TIR was measured with continuous glucose monitoring at baseline and was defined as the average percentage of time in the target glucose range during a 24 h period. Cox proportion hazard regression analysis was used to determine the association between TIR and the risk of cancer mortality. Results: During a mean follow-up of 7.10 years, we confirmed 237 death events related to cancer. The multivariable-adjusted hazard ratio (HR) for cancer mortality was 1.32 (95% confidence interval [CI]: 1.01–1.75) in patients with TIR ≤70% compared with those with TIR >70%. When TIR was considered as a continuous variable, the multivariable-adjusted HR for cancer mortality associated with each 10% decrease in TIR was 1.07 (95% CI: 1.02–1.14). In the site-specific analysis, a significant association between TIR as a continuous variable and the risk of hepatocellular cancer was found (HR: 1.24; 95% CI: 1.09–1.41). However, no relationship between hemoglobin A1c and cancer mortality was observed (HR: 1.04; 95% CI: 0.97–1.10). Conclusions: The present study found an inverse association of TIR with the risk of cancer mortality among patients with type 2 diabetes. New evidence of TIR was added into the clinical practice that TIR may be an optimal target of glycemic control among patients with type 2 diabetes.
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المؤلفون: Yu-Chun Jin, Jun-Xian Du, Shao-Mei Fu, Qin Chen, Yi-Ran Qiu, An Pei, Yi-Jing Yao, Wei Zhu, Ke-Jin Wu, Yan-Jie Yin
المصدر: Chinese Medical Journal, Vol 134, Iss 18, Pp 2186-2195 (2021)
Chinese Medical Journalمصطلحات موضوعية: Adult, China, medicine.medical_specialty, Breast surgery, medicine.medical_treatment, Breast Neoplasms, Abortion, Pregnancy-associated breast cancer, Breast cancer, Pregnancy, medicine, Humans, Stage (cooking), Survival analysis, Retrospective Studies, Clinicopathological feature, business.industry, Obstetrics, Incidence (epidemiology), Retrospective cohort study, Original Articles, General Medicine, Prognosis, medicine.disease, Treatment, Medicine, Female, Neoplasm Recurrence, Local, business, Pregnancy Complications, Neoplastic
الوصف: Background:. Pregnancy-associated breast cancer (PABC) is a special type of breast cancer that occurs during pregnancy and within 1 year after childbirth. With the rapid social development and the adjustment of reproductive policies in China, the average age of females at first childbirth is increasing, which is expected to lead to an increase in the incidence of PABC. This study aimed to accumulate clinical experience and to investigate and summarize the prevalence, diagnosis, and treatment of PABC based on large multicenter samples in China. Methods:. According to the Chinese Society of Breast Surgery, a total of 164 patients with PABC in 27 hospitals from January 2016 to December 2018 were identified. The pregnancy status, clinicopathological features, comprehensive treatment methods, and outcomes were retrospectively analyzed. Survival curves were plotted using the Kaplan-Meier method. Results:. A total of 164 patients of PABC accounted for 0.30% of the total number of cases in the same period; of which, 83 patients were diagnosed during pregnancy and 81 patients during lactation. The median age of PABC was 33 years (24–47 years). Stage I patients accounted for 9.1% (15/164), stage II 54.9% (90/164), stage III 24.4% (40/164), and stage IV 2.4% (4/164). About 9.1% (15/164) of patients were luminal A. Luminal B patients accounted the most (43.3% [71/164]). About 15.2% (25/164) of patients were human epidermal growth factor receptor 2 (Her-2) overexpression and 18.9% (31/164) of patients were triple-negative breast cancer. For pregnancy breast cancer, 36.1% (30/83) of patients received direct surgery and 20.5% (17/83) received chemotherapy during pregnancy. About 31.3% (26/83) chose abortion or induction of labor. The median follow-up time was 36 months (3–59 months); 11.0% (18/164) patients had local recurrence or distant metastasis and 3.0% (5/164) died. Conclusions:. It is safe and feasible to standardize surgery and chemotherapy for PABC.
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المؤلفون: Chen-Xi Wang, Yi-Chu Zhang, Qi-Lin Kong, Zu-Xiang Wu, Ping-Ping Yang, Cai-Hua Zhu, Shou-Lin Chen, Tao Wu, Qing-Hua Wu, Qi Chen, Peng Lyu
المصدر: Chinese Medical Journal
Chinese Medical Journal, Vol 134, Iss 19, Pp 2333-2339 (2021)مصطلحات موضوعية: Artificial intelligence, medicine.medical_specialty, Hypokalemia, Retrospective data, Electrocardiography, Deep Learning, Internal medicine, medicine, Humans, cardiovascular diseases, Internal validation, Lead (electronics), Retrospective Studies, Receiver operating characteristic, business.industry, External validation, Original Articles, General Medicine, Confidence interval, Electrocardiogram, Cardiology, Medicine, Ecg lead, medicine.symptom, business
الوصف: Background::A deep learning model (DLM) that enables non-invasive hypokalemia screening from an electrocardiogram (ECG) may improve the detection of this life-threatening condition. This study aimed to develop and evaluate the performance of a DLM for the detection of hypokalemia from the ECGs of emergency patients.Methods::We used a total of 9908 ECG data from emergency patients who were admitted at the Second Affiliated Hospital of Nanchang University, Jiangxi, China, from September 2017 to October 2020. The DLM was trained using 12 ECG leads (lead I, II, III, aVR, aVL, aVF, and V 1- 6) to detect patients with serum potassium concentrations
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المؤلفون: Liang Yu, Tian-Lei Xu, Lin Zhang, Shuo-Hao Shen, Yue-Lu Zhu, Hui Fang, Hai-Zeng Zhang, Pei-Fang Wei
المصدر: Chinese Medical Journal, Vol 134, Iss 18, Pp 2196-2204 (2021)
Chinese Medical Journalمصطلحات موضوعية: Oncology, Metastases pattern, medicine.medical_specialty, Colorectal cancer, medicine.medical_treatment, Metastasis, Propensity score matching, Internal medicine, medicine, Humans, Propensity Score, Locally advanced rectal cancer, Neoadjuvant therapy, Neoplasm Staging, Retrospective Studies, Rectal Neoplasms, business.industry, Distant metastasis, Retrospective cohort study, Chemoradiotherapy, Original Articles, General Medicine, medicine.disease, Neoadjuvant Therapy, Neoadjuvant chemoradiotherapy, Treatment Outcome, Medicine, Neoplasm Recurrence, Local, business
الوصف: Background:. Previous studies have demonstrated different predominant sites of distant metastasis between patients with and without neoadjuvant chemoradiotherapy (NCRT). This study aimed to explore whether NCRT could influence the metastasis pattern of rectal cancer through a propensity score-matched analysis. Methods:. In total, 1296 patients with NCRT or post-operative chemoradiotherapy (PCRT) were enrolled in this study between January 2008 and December 2015. Propensity score matching was used to correct for differences in baseline characteristics between the two groups. After propensity score matching, the metastasis pattern, including metastasis sites and timing, was compared and analyzed. Results:. After propensity score matching, there were 408 patients in the PCRT group and 245 patients in the NCRT group. NCRT significantly reduced local recurrence (4.1% vs. 10.3%, P = 0.004), but not distant metastases (28.2% vs. 27.9%, P = 0.924) compared with PCRT. In both the NCRT and PCRT groups, the most common metastasis site was the lung, followed by the liver. The NCRT group developed local recurrence and distant metastases later than the PCRT group (median time: 29.2 [18.8, 52.0] months vs. 18.7 [13.3, 30.0] months, Z = –2.342, P = 0.019; and 21.2 [12.2, 33.8] vs. 16.4 [9.3, 27.9] months, Z = –1.765, P = 0.035, respectively). The distant metastases occurred mainly in the 2nd year after surgery in both the PCRT group (39/114, 34.2%) and NCRT group (21/69, 30.4%). However, 20.3% (14/69) of the distant metastases appeared in the 3rd year in the NCRT group, while this number was only 13.2% (15/114) in the PCRT group. Conclusions:. The predominant site of distant metastases was the lung, followed by the liver, for both the NCRT group and PCRT group. NCRT did not influence the predominant site of distant metastases, but the NCRT group developed local recurrence and distant metastases later than the PCRT group. The follow-up strategy for patients with NCRT should be adjusted and a longer intensive follow-up is needed.
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المؤلفون: Ben-Long Shi, Yang Li, Ze-Zhang Zhu, Sai-Hu Mao, Zhen Liu, Xu Sun, Yong Qiu, Ning-Ning Wang
المصدر: Chinese Medical Journal, Vol 134, Iss 16, Pp 1983-1987 (2021)
Chinese Medical Journalمصطلحات موضوعية: medicine.medical_specialty, Neurofibromatosis 1, Scoliosis, Early-onset scoliosis, Internal medicine, Humans, Medicine, Curve progression, Neurofibromatosis, Child, Retrospective Studies, Early onset, Modulation, Braces, Curve evolution, Cobb angle, business.industry, Incidence (epidemiology), Retrospective cohort study, Original Articles, Bracing treatment, General Medicine, medicine.disease, Treatment Outcome, Rapid curve progression, Child, Preschool, Disease Progression, Cardiology, business, Neurofibromatosis type 1
الوصف: Background:. Scoliosis secondary to neurofibromatosis type 1 (NF1) in children aged 10°/year) were identified. The age at modulation and the AV before and after modulation were obtained. Patients with (n = 18) and without rapid curve progression (n = 10) were statistically compared. Results:. Twenty-eight patients with a mean age of 6.5 ± 1.9 years at the initial visit were reviewed. The mean Cobb angle of the main curve was 41.7° ± 2.4° at the initial visit and increased to 67.1° ± 8.6° during a mean follow-up of 44.1 ± 8.5 months. The overall AV was 6.6° ± 2.4°/year for all patients. At the last follow-up, all patients presented curve progression of >5°, and 20 (71%) patients had progressed by >20°. Rapid curve progression was observed in 18 (64%) patients and was associated with younger age at the initial visit and a higher incidence of modulation change during follow-up (t = 2.868, P = 0.008 and 10°/year is associated with younger age at the initial visit, and modulation change indicated the occurrence of the rapid curve progression phase.
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المؤلفون: Hu-Da-Chuan Jiang, Yan-Yang Tao, Si-Yue Jia, Jing-Xin Li, Feng-Cai Zhu, Jing Ni
المصدر: Chinese Medical Journal
Chinese Medical Journal, Vol 134, Iss 17, Pp 2037-2044 (2021)مصطلحات موضوعية: medicine.medical_specialty, COVID-19 Vaccines, Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Global studies, Pandemic, Humans, Severe acute respiratory syndrome coronavirus 2, Medicine, Intensive care medicine, Review Articles, Vaccines, SARS-CoV-2, business.industry, Public health, COVID-19, Outbreak, General Medicine, Immunogenicity, Clinical trial, Vaccination, Safety, business, Vaccine
الوصف: With the outbreak of the coronavirus disease 2019 (COVID-19) pandemic, the importance of vaccines in epidemic prevention and public health has become even more obvious than ever. However, the emergence of multiple severe acute respiratory syndrome coronavirus 2 variants worldwide has raised concerns about the effectiveness of current COVID-19 vaccines. Here, we review the characteristics of COVID-19 vaccine candidates in five platforms and the latest clinical trial results of them. In addition, we further discuss future directions for the research and development of the next generation of COVID-19 vaccines. We also summarize the serious adverse events reported recently after the large-scale vaccination with the current COVID-19 vaccines, including the thromboembolism caused by the AstraZeneca and Johnson & Johnson vaccines.
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المؤلفون: Xin-Yun Zhu, Hong-Bin Wang, Ye-Han Zhu, Yan-Bin Chen, Bei-Lei Zhang, Cheng Chen, Pei-Fang Wei
المصدر: Chinese Medical Journal
Chinese Medical Journal, Vol 134, Iss 14, Pp 1735-1737 (2021)مصطلحات موضوعية: Clinical Observations, medicine.medical_specialty, Carbapenem resistant Klebsiella pneumoniae, Klebsiella pneumoniae, Bacteremia, Drug resistance, law.invention, Risk Factors, law, Internal medicine, Bloodstream infection, Drug Resistance, Bacterial, medicine, Humans, In patient, Cross Infection, biology, business.industry, Pneumonia, General Medicine, biology.organism_classification, medicine.disease, Intensive care unit, Anti-Bacterial Agents, Klebsiella Infections, Intensive Care Units, Carbapenems, Medicine, business
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المؤلفون: Hong-Yan Zhao, Ling Sun, Ye-Qian Zhu, Qiu-Shi Chen, Wen-Wu Zhu, Mohammad Bilaal Toorabally, Xin-Guang Chen, Feng-Xiang Zhang, Li-Shao Guo.
المصدر: Chinese Medical Journal, Vol 133, Iss 18, Pp 2170-2176 (2020)
Chinese Medical Journalمصطلحات موضوعية: Cardiomyopathy, Dilated, medicine.medical_specialty, Dilated cardiomyopathy, Cardiomyopathy, Thyrotropin, lcsh:Medicine, Thyroid Function Tests, Gastroenterology, Thyroid function tests, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Internal medicine, medicine, Humans, Blood urea nitrogen, Creatinine, medicine.diagnostic_test, business.industry, Proportional hazards model, Hazard ratio, lcsh:R, Free triiodothyronine, Original Articles, General Medicine, Prognosis, All-cause mortality, medicine.disease, Confidence interval, Thyroxine, chemistry, 030220 oncology & carcinogenesis, Triiodothyronine, business, 030217 neurology & neurosurgery
الوصف: Background. The association between free triiodothyronine (FT3) and long-term prognosis in dilated cardiomyopathy (DCM) patients has not been evaluated. The purpose of this study was to determine whether the level of FT3 could provide prognostic value in patients with DCM. Methods. Data of consecutive patients diagnosed with DCM were collected from October 2009 to December 2014. FT3 was measured by fluoroimmunoassay. Other biochemical markers, such as free thyroxin (FT4), thyroid-stimulating hormone, red blood cell, hemoglobin, blood urea nitrogen, and serum creatinine, were tested at the same time. Follow-up was performed every 3 months. The primary endpoint was all-cause mortality. Pearson analysis was used to evaluate the correlation of FT3 and other lab metrics with DCM patients’ prognosis. The association of long-term mortality in DCM and FT3 was compared using Cox hazards model. Results. Data of 176 patients diagnosed with DCM were collected. Of them, 24 patients missed FT3 values and six patients were lost to follow-up. Altogether, data of 146 patients were analyzed. During the median follow-up time of 79.9 (53.5–159.6) months, nine patients lost, 61 patients died (non-survival group), and 85 patients survived (survival group). FT3 was significantly lower in non-survival group than that in survival group (3.65 ± 0.83 pmol/L vs. 4.36 ± 1.91 pmol/L; P = 0.003). FT3 also showed a significantly positive correlation with red blood cell and hemoglobin, negatively correlated with age, blood urea nitrogen and serum creatinine (P
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