BACKGROUND: Innovative coronavirus disease 2019 (COVID-19) vaccines, with elevated global manufacturing capacity, enhanced safety and efficacy, simplified dosing regimens, and distribution that is less cold chain-dependent, are still global imperatives for tackling the ongoing pandemic. A previous phase I trial indicated that the recombinant COVID-19 vaccine (V-01), which contains a fusion protein (IFN-PADRE-RBD-Fc dimer) as its antigen, is safe and well tolerated, capable of inducing rapid and robust immune responses, and warranted further testing in additional clinical trials. Herein, we aimed to assess the immunogenicity and safety of V-01, providing rationales of appropriate dose regimen for further efficacy study. METHODS: A randomized, double-blind, placebo-controlled phase II clinical trial was initiated at the Gaozhou Municipal Centre for Disease Control and Prevention (Guangdong, China) in March 2021. Both younger (n = 440; 18-59 years of age) and older (n = 440; ≥60 years of age) adult participants in this trial were sequentially recruited into two distinct groups: two-dose regimen group in which participants were randomized either to follow a 10 or 25 μg of V-01 or placebo given intramuscularly 21 days apart (allocation ratio, 3:3:1, n = 120, 120, 40 for each regimen, respectively), or one-dose regimen groups in which participants were randomized either to receive a single injection of 50 μg of V-01 or placebo (allocation ratio, 3:1, n = 120, 40, respectively). The primary immunogenicity endpoints were the geometric mean titers of neutralizing antibodies against live severe acute respiratory syndrome coronavirus 2, and specific binding antibodies to the receptor binding domain (RBD). The primary safety endpoint evaluation was the frequencies and percentages of overall adverse events (AEs) within 30 days after full immunization. RESULTS: V-01 provoked substantial immune responses in the two-dose group, achieving encouragingly high titers of neutralizing antibody and anti-RBD immunoglobulin, which peaked at day 35 (161.9 [95% confidence interval [CI]: 133.3-196.7] and 149.3 [95%CI: 123.9-179.9] in 10 and 25 μg V-01 group of younger adults, respectively; 111.6 [95%CI: 89.6-139.1] and 111.1 [95%CI: 89.2-138.4] in 10 and 25 μg V-01 group of older adults, respectively), and remained high at day 49 after a day-21 second dose; these levels significantly exceed those in convalescent serum from symptomatic COVID-19 patients (53.6, 95%CI: 31.3-91.7). Our preliminary data show that V-01 is safe and well tolerated, with reactogenicity predominantly being absent or mild in severity and only one vaccine-related grade 3 or worse AE being observed within 30 days. The older adult participants demonstrated a more favorable safety profile compared with those in the younger adult group: with AEs percentages of 19.2%, 25.8%, 17.5% in older adults vs. 34.2%, 23.3%, 26.7% in younger adults at the 10, 25 μg V-01 two-dose group, and 50 μg V-01 one-dose group, respectively. CONCLUSIONS: The vaccine candidate V-01 appears to be safe and immunogenic. The preliminary findings support the advancement of the two-dose, 10 μg V-01 regimen to a phase III trial for a large-scale population-based evaluation of safety and efficacy. TRIAL REGISTRATION http://www.chictr.org.cn/index.aspx (No. ChiCTR2100045107, http://www.chictr.org.cn/showproj.aspx?proj=124702).
Aged ; Antibodies, Viral ; COVID-19/therapy* ; COVID-19 Vaccines ; Double-Blind Method ; Humans ; Immunization, Passive ; Recombinant Fusion Proteins ; SARS-CoV-2

Objective:To evaluate the clinical efficacy and safety of the innovative topical ozone therapy for infantile atopic dermatitis.Methods:Sixty children with atopic dermatitis were divided into a treatment group and a control group.The treatment group was showered with ozonated water (3-5 times a week) and smeared with ozonated oil (twice a day),while the control group was washed with warm running water and smeared with base oil,adding moisturizer if necessary.The treatment course was 2 weeks.Efficacy and side effect were evaluated.Results:The skin exudation was reduced and erosion was healing after 3-5 days topical ozone therapy for infantile atopic dermatitis.The effective rates were 80.0％ and 20.0％ in the treatment group and control group for 1 week,and 89.6％ and 30.7％ for 2 weeks,respectively,with significant difference between the 2 groups (P＜0.001).Conclusion:Innovative treatment of infantile atopic dermatitis with topical ozone application is safe and effective,which is worth popularizing in clinic.

OBJECTIVETo establish the Chinese Pediatric Evaluation of Disability Inventory (PEDI) norms in Chongqing, China.

METHODSPEDI (English version) was translated into Chinese and proof read by back-translation. A total of 1 140 children stratified by age were randomly selected from Chongqing and evaluated by the Chinese version of the PEDI. The obtained data were statistically analyzed.

RESULTSOf 1 140 questionnaires, 1 075 (94.3%) were valid. The data showed that the raw and scale scores of PEDI increased with age, but the standard scores did not increase with age. The raw, scale, and standard scores on self-care and social function scales were significantly lower than American PEDI norms in some age periods (P<0.05), but the raw, scale, and standard scores on mobility scale were not significantly different from American norms (P>0.05).

CONCLUSIONSThe PEDI norms in Chongqing have been successfully established, and can be used to assess the daily function in children, judge the degree of daily function impairment, evaluate the effect of rehabilitation training, and make the rehabilitation plan for disabled children.

Child ; Child, Preschool ; China ; Disability Evaluation ; Female ; Humans ; Infant ; Male ; Pediatrics

Optimization of sensor array is a significant topic in the application of electronic nose (EN). Stepwise discriminant analysis and cluster analysis combining with screening of typical index were employed to optimize the original array in the classification of 100 samples from 10 kinds of traditional Chinese medicine based on alpha-FOX3000 EN. And the identification ability was evaluated by three algorithm including principle component analysis, Fisher discriminant analysis and random forest. The results showed that the identification ability of EN was improved since not only the effective information was maintained but also the redundant one was eliminated by the optimized array. The optimized method was eventually established, it was accurate and efficient. And the optimized array was built up, that is, S1, S2, S5, S6, S8, S12.
Algorithms ; Biosensing Techniques ; methods ; Cluster Analysis ; Discriminant Analysis ; Drugs, Chinese Herbal ; classification ; isolation & purification ; Electronic Nose ; Medicine, Chinese Traditional ; Principal Component Analysis ; Reproducibility of Results ; Smell

OBJECTIVETo compare the enhanced recovery program after surgery (ERAS) with conventional perioperative management in patients undergoing radical resection for colorectal cancer.

METHODSThe ERAS protocol included a combination of evidence-based and consensus methodology. A total of 597 consecutive patients undergoing elective colorectal resection were randomized to either the ERAS(n=299) or the control group(n=298). Outcomes related to nutrition and metabolism index, stress index, and recovery index were measured and recorded.

RESULTSDemographics and operative parameters were similar between the two groups(P>0.05). The nutritional status of patients in the ERAS group was improved after surgery compared with that of the control group. On postoperative day (POD) 1, the HOMA-IR in the ERAS group was significantly lower than that in the control group(P<0.01). The cortisol level in the control group was elevated on both POD 1(P<0.01) and POD 5(P<0.01) compared to the preoperative level. However, the cortisol level was not increased until POD 5(P<0.01) in the ERAS group. The levels of TNF-α, IL-1β, IL-6, and IFN-γ were reduced in the ERAS group, indicating less postoperative stress responses compared with the control group. In addition, ERAS group was associated with accelerated recovery of gastrointestinal function. The postoperative length of stay [(5.7±1.6) d vs. (6.6±2.4) d, P<0.01] and expense[(15 998±2655) RMB vs. (17 763±3059) RMB, P<0.01] were reduced in the ERAS group. Twenty-eight patients(9.4%) in the control group and 29(9.7%) in the ERAS group developed complications, while the difference was not statistically significant(P>0.05).

CONCLUSIONERAS protocol alleviates surgical stress response and accelerates postoperative recovery without compromising patient safety.

Adult ; Aged ; Aged, 80 and over ; Colorectal Neoplasms ; surgery ; Female ; Humans ; Male ; Middle Aged ; Perioperative Care ; methods ; Prospective Studies ; Young Adult

OBJECTIVETo explore the clinicopathological correlation between CD4(+) T lymphocyte count and superficial lymphadenopathy HIV/AIDS patients.

METHODSA total of 1066 HIV/AIDS patients were included in this study. The incidence of superficial lymphadenopathy, peripheral blood CD4(+) T lymphocyte counts and histological features of superficial lymphadenopathy were analyzed.

RESULTSAmong 1066 patients, 126 cases (11.8%) presented with superficial lymphadenopathy. Of the 126 cases, there were 69 cases with CD4(+) T lymphocyte counts < 100/µl and clinical diagnoses including tuberculosis (37 cases), reactive hyperplasia (8 cases), AIDS-related lymphadenopathy (18 cases), penicillium diseases (12 cases), fungal infection (5 cases) and non-tuberculous mycobacterial infection (1 case). Twenty-six cases had CD4(+) T lymphocyte counts between 100/µl to 200/µl and clinical diagnosis including tuberculosis (12 cases), reactive hyperplasia (8 cases), AIDS-related lymphadenopathy(6 cases), penicillium disease (2 cases) and non-Hodgkin lymphoma (1 case). Twenty-nine cases had CD4(+) T lymphocyte counts > 200/µl and clinical diagnoses including tuberculosis (11 cases), reactive hyperplasia (12 cases), AIDS-related lymphadenopathy (3 cases), Penicillium diseases (1 case) and non-Hodgkin lymphoma (4 cases). The CD4(+) T lymphocyte counts among patients with tuberculosis, AIDS-related lymphadenopathy and Penicillium diseases were significantly different (χ(2) = 8.861, P = 0.012). A significant correlation between the incidence of superficial lymphadenopathy and CD4(+) T lymphocyte counts was found (χ(2) = 375.41, P = 0.000).

CONCLUSIONSThe most common cause of superficial lymphadenopathy in HIV/AIDS patients is tuberculosis, followed by lymph node reactive hyperplasia, AIDS-related lymphadenopathy and Penicillium disease. Low CD4(+) T lymphocyte count correlates with an increased incidence of superficial lymphadenopathy and the risk of opportunity infection. Therefore, determination of peripheral blood CD4(+) T lymphocyte count should become an integral marker for the early diagnosis and treatment of superficial lymphadenopathy in HIV/AIDS patients.

AIDS-Related Complex ; blood ; complications ; pathology ; AIDS-Related Opportunistic Infections ; blood ; complications ; pathology ; Acquired Immunodeficiency Syndrome ; blood ; complications ; pathology ; Adolescent ; Adult ; Aged ; Aged, 80 and over ; CD4 Lymphocyte Count ; Child ; Female ; HIV Infections ; blood ; complications ; pathology ; Humans ; Lymph Nodes ; pathology ; Male ; Middle Aged ; Tuberculosis ; blood ; complications ; pathology ; Young Adult

OBJECTIVETo evaluate the effect of thoracic radiation therapy (TRT) on patients with extensive stage small-cell lung cancer (SCLC).

METHODSOne hundred and fifty-four patients with extensive stage SCLC treated in our department between January 2003 and December 2006 were enrolled in this study. Eighty nine patients received chemotherapy and thoracic radiation therapy (ChT/TRT), and 65 patients were treated with chemotherapy alone (ChT without TRT). The chemotherapy was CE (carboplatin and etoposide), PE (cisplatin and etoposide) or CAO (CTX, ADM and VCR) regimens. The total dose of thoracic irradiation was 40-60 Gy with 1.8 - 2.0 Gy per fraction.

RESULTSFor the whole group, the median survival time (MST) was 13.7 months, the 2-year and 5-year overall survival rates were 27.9% and 8.1%, respectively. The MST, overall survival rates at 2 years and 5 years in the ChT/TRT group and ChT without TRT group were 17.2 months, 36.0%, 10.1% and 9.3 months, 16.9%, 4.6%, respectively (P = 0.001). The median progression-free survival (PFS) for all patients was 8.0 months, the 2-year and 5-year PFS were 13.6% and 8.2%, respectively. The median PFS, 2-year and 5-year PFS in the ChT/TRT group and ChT without TRT group were 10.0 months, 17.4%, 10.5% and 6.2 months, 9.8%, 4.9%, respectively (P < 0.001). The incidence of intra-thoracic local failure was 29.6% in the ChT/TRT group and 70.0% in the ChT/without TRT group (P = 0.000).

CONCLUSIONSChemotherapy plus thoracic radiation therapy can improve the overall survival, progress free survival and reduce local regional failure rate in patients with extensive stage SCLC compared with that by chemotherapy alone.

Antineoplastic Combined Chemotherapy Protocols ; therapeutic use ; Carboplatin ; therapeutic use ; Cisplatin ; administration & dosage ; Combined Modality Therapy ; Disease-Free Survival ; Etoposide ; administration & dosage ; Humans ; Lung Neoplasms ; drug therapy ; radiotherapy ; Prognosis ; Small Cell Lung Carcinoma ; drug therapy ; radiotherapy ; Survival Rate

OBJECTIVETo examine the chemopreventive effect of selective cyclooxygenase-2 (COX-2) inhibitor celecoxib for Barrett's esophagus in rats.

METHODSFifty 8-week-old male Sprague Dawley rats underwent esophagojejunostomy to induce Barrett's esophagus model. Four weeks after operation the animals were given celecoxib 10 mg/(kg*d(-1))(celecoxib group), or saline 1 ml (control group). Another 10 rats were sham operation group. All animals were sacrificed at 20 week after surgery. The degree of inflammation, Barrett's esophagus, adenocarcinoma, COX-2 expression and PGE(2) of animals were assessed.

RESULTAmong 60 rats, 6 rats died in celecoxib group, 8 rats died in control group, 1 rat died in sham operation group, and 45 (75%) rats completed the study. The incidence of mild, moderate and severe degree esophageal inflammation in celecoxib group and control group was 14/19(73.68%), 4/19(21.05%), 1/19(5.26%); 4/17(23.53%), 5/17(29.41%), 8/17(47.06%)(P<0.05), respectively. The incidence of Barrett's esophagus was 7/19(36.84%), 13/17(76.47%) in two group respectively(P<0.05); The incidence of Barrett's esophagus with dysplasia was 2/19(10.53%), 8/17(47.06%)(P<0.05), respectively. The expression of COX-2 was 1/7(14.29%), 10/13(76.92%)(P<0.05) in two groups. PGE2 content was significantly lower in the celecoxib group than that in control group(P<0.001). No esophageal pathological changes were found in sham operation group.

CONCLUSIONSelective COX-2 inhibitors celecoxib can inhibit inflammations, development of Barrett's esophagus and esophagus adenocarcinoma.

Animals ; Barrett Esophagus ; metabolism ; prevention & control ; Celecoxib ; Cyclooxygenase 2 ; metabolism ; Cyclooxygenase 2 Inhibitors ; therapeutic use ; Dinoprostone ; metabolism ; Male ; Pyrazoles ; therapeutic use ; Rats ; Rats, Sprague-Dawley ; Sulfonamides ; therapeutic use

OBJECTIVETo establish animal models of reflux esophagitis in rats.

METHODSSeventy male Sprague Dawley rats aged 8 weeks were randomly divided into 4 groups: in Group A (n=20) esophagojejunostomy was performed to induce a gastro-jejuno-esophageal reflux; in Group B (n=20) esophagoduodenostomy was performed to induce a gastro-duodeno-esophageal reflux; in Group C (n=20) total gastrectomy plus esophagojejunostomy was performed to induce a jejuno-esophageal reflux; in Group D (n=10) only was performed sham operation (control).

RESULTAmong 70 rats, 6 died in Group A, 7 died in Group B, 6 died in Group C, and 72.9 %(51/70) animals were completed in the study. After 12 weeks the incidence of esophageal inflammation was 100.0%; in Groups A, B and C erosion occurred in 11/14 (78.6%), 10/13 (76.9%), 3/14 (21.4%) of animals, respectively; squamous dysplasia was in 10/14 (71.4%), 10/13 (76.9%), 5/14 (35.7%) of rats, respectively; Barrett's esophagus was in 6/14 (42.9%), 5/13 (38.5%), 1/14 (7.1%), respectively. One esophageal adenocarcinoma was found in Group A; no histological changes were observed in Group D.

CONCLUSIONThe animal models of reflux esophagitis can be induced by esophagojejunostomy, esophagoduodenostomy or total gastrectomy plus esophago-jejunostomy in rats; and the former two surgical modalities are better than the later.

Animals ; Barrett Esophagus ; Disease Models, Animal ; Esophagitis, Peptic ; classification ; Esophagus ; surgery ; Male ; Random Allocation ; Rats ; Rats, Sprague-Dawley

OBJECTIVETo summarize our experience and evaluate the prognostic factors of locally advanced non small cell lung cancer (LA-NSCLC) treated with three dimentional conformal radiotherapy (3D-CRT).

METHODS118 patients with stage IIImA/IIIB non small cell lung cancer were treated with 3D-CRT from Nov. 2001 to Mar. 2005. 113 patients with complete clinical data were eligible for analysis, 45 of them received radiotherapy alone; 39 were treated by concurrent chemoradiation with paclitaxol plus carboplatin in 32 patients and topotecan in 7 patients, and 29 by sequential chemoradiation with platinum-based regiment in most of them. The dose of radiation for the thoracic field ranged from 26 Gy to 75 Gy with a median dose of 60 Gy. GTV and PTV were collected from the 3D treatment plans in 79 and 101 patients, respectively. Overall survival (OS) was calculated using the Kaplan-Meier method. Comparisons among the curves were made using a two-tailed long-rank test. The Cox model was used for multivariate analysis.

RESULTSThe 1-, 2- and 3-year overall survival rate was 60.7%, 31.6% and 22.4%, respectively, with a median survival time of 17 months. In univariate analysis, the following characteristics were significantly associated with longer survival: absence of chest pain, good karnofsky performance status (KPS), albumin > 4.2 g/L, hemoglobin > or = 140 g/L (male) or 130 g/L (female), response to radiotherapy and GTV < 100 cm3. However, multivariate analysis revealed that only good KPS was an independent risk factor predicting the survival.

CONCLUSIONThree-dimensional conformal radiotherapy is effective in the treatment of locally advanced non-small cell lung cancer with acceptable complications. Karnofsky performance status is the only independent prognositic factor.

Adult ; Aged ; Aged, 80 and over ; Antineoplastic Combined Chemotherapy Protocols ; therapeutic use ; Bone Neoplasms ; secondary ; Brain Neoplasms ; secondary ; Carboplatin ; administration & dosage ; Carcinoma, Non-Small-Cell Lung ; drug therapy ; pathology ; radiotherapy ; secondary ; Combined Modality Therapy ; Female ; Follow-Up Studies ; Humans ; Karnofsky Performance Status ; Lung Neoplasms ; drug therapy ; pathology ; radiotherapy ; Male ; Middle Aged ; Neoplasm Staging ; Paclitaxel ; administration & dosage ; Particle Accelerators ; Proportional Hazards Models ; Radiotherapy Dosage ; Radiotherapy Planning, Computer-Assisted ; methods ; Radiotherapy, Conformal ; methods ; Remission Induction ; Survival Rate