1.Application of cluster randomization design in vaccine clinical trials
Shuyu GAO ; Jingxin LI ; Pengfei JIN ; Fengcai ZHU
Chinese Journal of Epidemiology 2021;42(12):2221-2225
When the coverage of the vaccinated people reaches a certain percentage of the population, the herd protection will protect the unvaccinated persons. However, the traditional clinical evaluation of vaccines performing individual randomized design fails to evaluate the herd protection of vaccines. Compared with the individual randomized design, the cluster-randomized design can determine the overall protection by the vaccine more comprehensively. It has become increasingly common to perform a cluster-randomized design in clinical trials of vaccines in Phase Ⅲ and Ⅳ clinical trials. However, little is known about the application of cluster randomized design in vaccine clinical trials in China. We, at this moment, do a review of the application of random cluster design in vaccine clinical trials and provide references for future research in China.
2.Exercise versus immobilization in the treatment of acute deep vein thrombosis during different clot-organized stage: an animal experiment.
Haoshan QI ; Fuxian ZHANG ; Yong LIU ; Fengcai YAN ; Yanyu LONG ; Gangzhu LIANG ; Zhimin GAO ; Dalin LI ; Kun ZHANG
Chinese Journal of Surgery 2014;52(7):529-532
OBJECTIVETo evaluate the corresponding influence on pulmonary embolism incidence between immobilization and exercise in different stage of thrombus after acute deep vein thrombosis in rabbits.
METHODSForty-eight New Zealand rabbits were randomly divided into three groups depending on the different organized stage of thrombus: the early, medium and later stage group.Each group was subdivided into two sub groups: the immobile and mobile subgroup. Rabbit modeling of deep vein thrombosis was made by ligating the right femoral vein. Among the early-stage group, rabbits of the immobile subgroup were fixed for 3 days, while that of the mobile subgroup were free to move for 3 days, then each was euthanized to extract the lungs for pathological examination. Among the medium-stage group, each of the immobile subgroup were fixed for 7 days, while the mobile subgroup ones were fixed for 3 days, then released free-moving for 4 days following the pathological extraction. Among the later-stage group, animals in the immobile subgroup were fixed for 14 days comparing the mobile subgroup fixed for 7 days and next free-moving for 7 days, then each was euthanized.
RESULTSAmong the early-stage group, pulmonary embolism incidence (PEI) of the immobile and mobile subgroup was 4/8 vs.3/8, the pulmonary lobe embolism incidence (PLEI) was 17.5% (7/40) vs. 15.0% (6/40). Among the medium-stage group, PEI of the immobile and mobile subgroup was 3/8 vs. 2/8, PLEI was 37.5% (7/40) vs. 25.0% (10/40). Among the later-stage group, PEI of the immobile and mobile subgroup was 3/8 vs. 3/8, PLEI was 12.5% (5/40) vs. 15.0% (6/40). There was no statistical difference between immobilization subgroup and mobilization subgroup among different stage group.
CONCLUSIONOn the premise of given anticoagulation treatment, early ambulation do not significantly increase pulmonary embolism incidence after acute deep vein thrombosis of lower extremity in rabbits.
Animals ; Disease Models, Animal ; Immobilization ; Lung ; pathology ; Motor Activity ; Pulmonary Embolism ; etiology ; Rabbits ; Time Factors ; Venous Thrombosis ; complications
3.Expressions of CD117 and CD28 in patients with newly diagnosed multiple myeloma and their clinical significances
Fangfang GE ; Wenliang TIAN ; Huimin SUN ; Fengcai GAO ; Hui SUN ; Ling SUN ; Rong GUO ; Dingming WAN ; Linxiang LIU ; Yanfang LIU ; Xinsheng XIE ; Zhongxing JIANG
Journal of Leukemia & Lymphoma 2019;28(5):263-267
Objective To investigate the expressions of CD28 and CD117 in patients with newly diagnosed multiple myeloma (MM) and their clinical significances. Methods The clinical data of 115 newly diagnosed MM patients in the First Affiliated Hospital of Zhengzhou University from May 2015 to December 2017 were retrospectively analyzed. The expressions of CD28 and CD117 were detected by using multiparameter flow cytometry. The relationship between the expressions of CD28 and CD117 and MM staging and clinical parameters was analyzed. The staging was performed according to the International Staging System (ISS). Results Among these 115 patients, there were 15 patients with CD117 positive and 30 patients with CD28 positive. Erythrocyte sedimentation rate (r = -0.481, P = 0.039), Cˉreactive protein level (r = -0.314, P=0.015), the proportion of plasma cells detected by bone marrow cytology (r=-0.027, P=0.001) were negatively correlated with CD117 positive expressions. CD28 positive expression was positively correlated with lactate dehydrogenase level (r = 0.249, P = 0.033) and ISS stage (r = 0.319, P = 0.017), while it was negatively correlated with hemoglobin level (r = -0.372, P = 0.026). CD28 positive was associated with light chain type, and nonˉsecretory type mostly occurred (P = 0.016). The incidence of osteolytic lesions in CD28 positive group and CD117 positive group was high, but there was no statistical difference between CD28 positive group, CD117 positive group and CD28 negative group, CD117 negative group (P = 0.052, P=0.479). Conclusions The positive expression of CD117 in the early stage of MM patients is higher than that in the advanced stage, and the expression of CD28 positive in the advanced stage of MM patients is higher than that in the early stage. CD28 and CD117 can be used as indicators of prognosis stratification in the patients with newly diagnosed MM.
4.Detection of neutralizing antibodies and DNA of human papillomavirus 16, 18 in women aged 18-45 years in Funing, Jiangsu province.
Wenyu LIU ; Feixue WEI ; Jie TANG ; Shangbo YANG ; Yachun GAO ; Ting WANG ; Yunfei JIANG ; Mei LI ; Ying HONG ; Kai CHU ; Wen CHEN ; Yuemei HU ; Fengcai ZHU
Chinese Journal of Epidemiology 2016;37(3):406-409
OBJECTIVETo understand the distributions of DNA and neutralizing antibodies of human papillomavirus (HPV)16, 18 in 18-45 year-old women.
METHODSTotally, 1494 women were enrolled through multistage random sampling in Funing, Jiangsu province. Cervical exfoliated cells were collected from them for HPV DNA testing, and serum samples were taken from them for the detection of HPV16, 18 neutralizing antibodies by using pseudovirion-based neutralization assay(PBNA).
RESULTSAmong the 1494 women, 28(1.9%) and 188(12.6%) were positive for DNA and neutralizing antibody of HPV16 respectively, and 15(1.0%) and 60(4.0%) were positive for DNA and neutralizing antibody of HPV18, respectively. There were no significant differences in the detection rates of DNA and neutralizing antibody of HPV16, 18 among different age groups. About 16.7% of the women were infected with HPV16, 18, or both.
CONCLUSIONIn Funing county of Jiangsu province, most women aged 18-45 years has no immunity to HPV16 and 18, indicating that they are appropriate targets for HPV 16/18 vaccination.
Adolescent ; Adult ; Antibodies, Neutralizing ; isolation & purification ; Antibodies, Viral ; isolation & purification ; China ; DNA, Viral ; isolation & purification ; Female ; Human papillomavirus 16 ; immunology ; Human papillomavirus 18 ; immunology ; Humans ; Middle Aged ; Papillomavirus Infections ; prevention & control ; Papillomavirus Vaccines ; Young Adult