Objective: To assess the safety and immunogenicity of freeze-dried rabies vaccine (Vero-cells) for human use on different immunization procedures in healthy people aged 9-65 years. Methods: A randomized, blind, positive-controlled clinical study was conducted in March 2015. The eligible residents aged 9-65 were recruited in Dengfeng city and Biyang County, Henan Province. A total of 1 956 subjects were enrolled. The subjects were randomly (1∶1∶1) assigned to 5-dose control group, 4-dose trial group and 5-dose trial group, with 652 subjects in each group. The subjects of 5-dose control group were immunized with control vaccine on days 0, 3, 7, 14 and 28. The subjects of 4-dose trial group were immunized with trial vaccine on days 0, 7 and 21 (2-1-1 phases) and the subjects of 5-dose trial group were immunized with trial vaccine on days 0, 3, 7, 14 and 28. A combination of regular follow-up and active reporting was used to observe local and systemic adverse reactions till 30 days after the first and full immunization, and the incidence rate of adverse reactions in three groups was analyzed and compared. The venous blood was collected before the first immunization, 7 days after the first immunization, 14 days after the first immunization and 14 days after the full immunization. The neutralizing antibody of rabies virus was detected by rapid fluorescent focus inhibition test (RFFIT), and the seropositive conversion rate and geometric mean concentration (GMC) of antibody were calculated. Results: The adverse reaction rates in 5-dose control group, 4-dose trial group and 5-dose trial group were 41.87% (273/652), 35.43% (231/652) and 34.97% (228/652), respectively. The adverse reaction rates of 4-dose trial group and 5-dose trial group were lower than those of the 5-dose control group (P<0.05). The local reactions were mainly pain, itching, swelling and redness in injection site, while the systemic reactions were mainly fever, fatigue, headache and muscle pain. The severity of adverse reactions was mainly mild (level 1), accounting for 85.33% (518/607), 89.02% (373/419) and 88.96% (427/480) of the total number of adverse reactions in each group. At 14 days after the first immunization and 14 days after the full immunization, the antibody positive conversion rates of three groups were all 100%. At 7 days, 14 days after the first immunization and 14 days after the full immunization, the GMCs of three groups were 0.60, 0.72, 0.59 IU/ml, 20.42, 23.99, 24.38 IU/ml and 22.95, 23.52, 24.72 IU/ml, respectively, with no significant difference (P>0.05). Conclusion: The freeze-dried rabies vaccine (Vero-cells) for human use has good safety and immunogenicity when inoculated according to 5-dose and 4-dose immunization procedures.
Humans ; Rabies Vaccines ; Antibodies, Viral ; Antibodies, Neutralizing ; Rabies virus ; Vaccination ; Rabies/prevention & control*

Objective::This study aimed to evaluate the major adverse cardiovascular and cerebrovascular events (MACCEs) and overall safety profile associated with iodixanol in Chinese patients undergoing percutaneous coronary intervention (PCI).Methods::Patients at 30 centers in China registered in the OpenClinic v3.6 database from October 30, 2013, to October 7, 2015, were included in the study. The primary endpoint was in-hospital MACCEs including target lesion revascularization (TLR), stroke, stent thrombosis, cardiac death, and PCI-related myocardial infarction (MI) within 72 h post-PCI. Secondary endpoints were MACCEs from 72 h to 30 d post-PCI and other safety events within 30 d post-PCI.Results::A total of 3,042 patients were enrolled. The incidence of MACCEs within 72 h post-PCI was 2.33% ( n = 71), including cardiac death (0.03%, n = 1) and PCI-related MI (2.30%, n = 70). The incidence of MACCEs from 72 h to 30 d post-PCI was 0.16% ( n = 5), including cardiac death (0.10%, n = 3), PCI-related MI (0.03%, n = 1), and TLR for stent thrombosis (0.03%, n = 1). The incidence of composite angiographic or procedural complications was 2.86% ( n = 87); 233 (7.86%) patients had results suggesting contrast-induced acute kidney injury. Conclusions::These findings indicate that the use of iodixanol in Chinese patients undergoing PCI is associated with a low incidence of MACCEs, confirming its safety in this population.

Objective::This study aimed to evaluate the major adverse cardiovascular and cerebrovascular events (MACCEs) and overall safety profile associated with iodixanol in Chinese patients undergoing percutaneous coronary intervention (PCI).Methods::Patients at 30 centers in China registered in the OpenClinic v3.6 database from October 30, 2013, to October 7, 2015, were included in the study. The primary endpoint was in-hospital MACCEs including target lesion revascularization (TLR), stroke, stent thrombosis, cardiac death, and PCI-related myocardial infarction (MI) within 72 h post-PCI. Secondary endpoints were MACCEs from 72 h to 30 d post-PCI and other safety events within 30 d post-PCI.Results::A total of 3,042 patients were enrolled. The incidence of MACCEs within 72 h post-PCI was 2.33% ( n = 71), including cardiac death (0.03%, n = 1) and PCI-related MI (2.30%, n = 70). The incidence of MACCEs from 72 h to 30 d post-PCI was 0.16% ( n = 5), including cardiac death (0.10%, n = 3), PCI-related MI (0.03%, n = 1), and TLR for stent thrombosis (0.03%, n = 1). The incidence of composite angiographic or procedural complications was 2.86% ( n = 87); 233 (7.86%) patients had results suggesting contrast-induced acute kidney injury. Conclusions::These findings indicate that the use of iodixanol in Chinese patients undergoing PCI is associated with a low incidence of MACCEs, confirming its safety in this population.

【Objective】 To analyze the cause of single-ELISA reactive of four blood screening items in 18 blood stations in Henan, so as to provide the basis for improving the quality of blood screening. 【Methods】 The single-ELISA reactive rate of HBsAg, anti-HCV, HIV Ag/Ab and anti-TP of 18 blood station laboratories in Henan throughout 2019 was calculated, and the causes were analyzed according to different ELISA reagent combinations and gray area settings in each laboratory. 【Results】 The overall single-ELISA reactive rates of HBsAg, anti-HCV, HIV Ag/Ab and anti-TP were 1.740(2 154/1 237 789), 0.564‰(698/1 237 789), 1.421‰(1 759/1 237 789) and 1.561‰(1 932/1 237 789), respectively, showing significant differences by detection items (P <0.05). Person correlation analysis showed that the single-ELISA reactive rate was independent of the gray area settings.but dependent on laboratories and reagent combinations. The single-ELISA reactive rate of HBsAg, anti-HCV, HIV Ag/Ab and anti-TP in D laboratory was the highest and higher than that in other labs using the same reagent.The laboratories with high HBsAg single-ELISA reactive rate were mostly those using a combination of imported reagents and domestic reagents, including the top 6 laboratories. The laboratories with high anti-HCV single-ELISA reactive rate were mostly those using certain domestic reagents. No obvious rules was noticed by single-ELISA reactive for anti-HIV. Laboratories with high anti-TP single-ELISA reactive rate were mostly those using combination 4. 【Conclusion】 The HBsAg single-ELISA reactive rate was the highest in the four blood screening items of blood station laboratories in Henan. The single-ELISA reactive rate is related to the laboratory itself and the reagent manufacturer, suggesting that laboratory quality control should be strengthened and proper reagent combination should be selected to reduce the waste of blood.

【Objective】 To analyze the HIV-, HCV- and HBV- NAT yield rate in different areas of Henan province, so as to provide the basis for disease prevention and control as well as the establishment of a unified quality control standard for nucleic acid testing(NAT) in the Henan province. 【Methods】 The number and prevalence of NAT yielding samples with isolated infectious virus, namely HIV, HCV and HBV, in 18 blood stations in Henan province from 2017~2019, as well as the trends were analyzed. The NAT quality of each laboratory and each testing system was analyzed according to the ratio of reactive individual donation(ID) results to reactive minipools(MP). 【Results】 The HBV, HCV and HIV ID-NAT yield numbers in 3 501 251 blood donations were HBV 2 606(74/100 000), HCV 21 (0.63/100 000), and HIV 34(1.00/100 000). The HBV ID-NAT yield rate showed an upward trend in the whole province from 2017 to 2019, while the prevalence of HIV and HCV ID-NAT yield didn′t differ significantly during three years. 5 kinds of NAT detection systems were applied in 18 blood centers. among which Ⅰ, Ⅱ, Ⅳ and Ⅴ were triplex detection systems. 2661 ID-reactive samples were implicated in 5 595 MP-reactive samples, with a resolution rate of 47.56%. The resolution rate of triplex NAT system Ⅰ, Ⅱ, Ⅳ and Ⅳ was 39.63%~47.95%, 40.43%~54.36%, 51.61% and 70.00%~45.45%, respectively. An upward trend in triplex NAT resolution rate was observed in 8 laboratories, i. e.B, D, E, F, I, K, L and Q, and an descending trend in A and C. The NAT system Ⅲ, a ID-NAT system, was used only by laboratory C, presenting a NAT-yield rate of 0.19% (282/145 474) and resolution rate of 46.45% (131/282). 【Conclusion】 The majority of NAT-yield of one infectious virus in Henan province is HBV, presenting annual increasing trend. The quality management of NAT laboratories should be strengthened as the divergence was seen in the performance of different NAT laboratories.

One hundred and nine consecutive coronary heart disease (CHD) patients with obstructive sleep apnea (OSA) undergoing percutaneous coronary intervention (PCI) during February 2016 to August 2018 were enrolled in the study. After treatment the quality of sleep was improved in 35 cases (observation group) and was not improved in 74 patients (control group). The basic characteristics, coronary lesions of patients were compared between two groups. Compared with the control group, patients in observation group had significant higher proportion of males [80.0%(28/35) vs. 59.5%(44/74), χ²=4.471, P=0.035], smoking history [85.7% (30/35) vs. 63.5% (47/74), χ²=5.647, P=0.018], lower body mass index [(25.8±3.1) kg/m² vs. (27.4±3.2) kg/m², t=2.461, P=0.033]. Compared with control group, the observation group had lower coronary Gensini score[(35.4±5.7) vs. (38.7±6.5), t=2.571, P=0.011], less number of stent[ (1.4±0.4) vs. (1.6±0.4), t=2.427, P=0.016]. And the lesions were mostly distributed in the right coronary artery in observation group (61.9%, 26/35) (χ²=11.759, P=0.003).Conclusion The improvement of sleep quality by PCI depends on the clinical features and coronary artery lesions of CHD patients with OSA.

Objective To evaluate the efficacy and safety of combined use of ticagrelor and cilostazol for patients with acute coronary syndrome (ACS) complicated with upper digestive tract diseases following percutaneous coronary intervention ( PCI).Methods A total of 262 consecutive ACS patients complicated with upper digestive tract diseases followed-up for one-year after PCI were included in this study.The patients were allocated into control group (combined use of ticagrelor and aspirin , n＝184) and cilostazol group ( combined use of ticagrelor and cilostazol , n ＝78) for antiplatelet treatment.The basic characteristics of the patients , change of the treatment regimens , cardiovascular events and hemorrhagic events were compared between two groups .Results After one year of follow-up, 16.8%(31/184)patients in control group and 3.8%(3/78)in cilostazol group changed antiplatelet regimens (χ2＝8.200,P＝0.004).There was no statistical difference in use of statins and ACEI/ARB between two groups(P＞0.05).The rate of proton pump inhibitor use in control group was significantly higher than that in cilostazol group [82.1%(151/184) vs.52.6%(41/78), χ2＝24.35, P＝0.000].However, the dosage of β-blockers in cilostazol group was significantly higher than that in control group [(39.1 ±12.4) mg vs.(28.6 ±10.1) mg, t ＝7.174,P＝0.000].No statistical difference was found in total cardiovascular events between two groups [21.7%(40/184) vs.12.8%(10/78),χ2＝2.822,P＝0.121].The incidence of gastrointestinal hemorrhage in control group was significantly increased compared with cilostazol group [12.0%(22/184) vs.2.6%(2/78),χ2＝5.807,P ＝0.018], however, there was no significant difference in hemorrhagic events concerning the thrombolysis for myocardial infarction between two groups [17.4%(32/184) vs.9.0%(7/78), χ2＝3.063,P＝0.089].Conclusion Combined use of cilostazol and ticagrelor is effective and safe for ACS patients with gastrointestinal hemorrhage or a higher risk of hemorrhage .

Objective To compare the curative effect of tissue-selecting therapy stapler and procedure for prolapse and hemorrhoids in the treatment of patients with stage Ⅲ to Ⅳ hemorrhoids.Methods The patients with stage Ⅲ to Ⅳ hemorrhoids who underwent prolapse and hemorrhoids or tissue-selecting therapy stapler surgery in the department of General Surgery,Shanghai Ninth People's Hospital and Xinhua Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,Chongming Branch,from Jan.2013 to Jun.2014 were accepted and allocated to prolapse and hemorrhoids or tissue-selecting therapy stapler group.The peri-operative parameters about operative time,blood loss,postoperative hospital stay and the time required to return to normal activity were compared by t test,The postoperative complications including pain assessment and the incidence of postoperative bleeding,urine retention,faecal urgency,fecal incontinence,anal stenosis,rectovaginal fistula and recurrence rate were compared by t test and chi-square test.Rank sum test was used to compare the recurrence rate and patient's satisfaction between the two groups.Results The operation time,intraoperative bleeding volum,postoperative hospital stay and the time required to return to normal activity in the procedure for prolapse and hemorrhoids group were signifcantly higher than those in the tissue-selecting therapy stapler group (P =0.021,P =0.003,P =0.001,P ＜0.001).The pain score of procedure for prolapse and hemorrhoids group were all higher than those of the tissue-selecting therapy stapler group in the first post-operative defecation and in post-operative 24 hours and 72 hours (all P ＜ 0.001).The incidence of faecal urgency of the procedure for prolapse and hemorrhoids group in post-operative 1 month (18.6％) was higher than that of the tissue-selecting therapy stapler group (6.6％) (P =0.036).There were no statistically significant differences in the incidence of postoperative bleeding,urinary retention,recurrence rate and patient's satisfaction between two group (P ＞ 0.05).Conclusion Tissue-selecting therapy stapler was superior to the procedure for prolapse and hemorrhoids in operation time,intraoperative blood loss,postoperative pain and the incidence of faecal urgency.Long-term results demonstrate that tissue-selecting therapy stapler and prolapse and hemorrhoids have similar effectiveness.

Background:Gastroesophageal reflux disease( GERD)that does not respond satisfactorily to standard proton pump inhibitor is defined as refractory gastroesophageal reflux disease( rGERD). Combined therapy is used to treat rGERD, however,the addition of baclofen is rarely studied. Aims:To investigate the efficacy of baclofen combined with esomeprazole and mosapride on rGERD. Methods:Seventy-two patients with rGERD from March 2013 to April 2014 at the First Hospital of Putian City were enrolled and randomly divided into group A and group B. Patients in group A were orally administrated with esomeprazole 20 mg bid + mosapride 5 mg tid + baclofen 5 mg tid. Patients in group B were treated with esomeprazole 20 mg bid + mosapride 5 mg tid. The treatment course was 8 weeks. The efficacy on symptoms, esophagitis under endoscopy and adverse effects were compared between the two groups. Results:After 8-week treatment, score of heartburn,regurgitation,retrosternal pain,dysphagia and overall symptom were significantly decreased in the two groups than before the treatment. The overall symptom alleviating rate was significantly higher in group A than in group B (90. 6% us. 70. 0%;χ2 =4. 585,P=0. 032). Esophagitis under endoscopy in the two groups was significantly improved, the effective rate was significantly higher in group A than in group B(93. 8% us. 75. 0%;χ2 =4. 500,P=0. 034). The main adverse effects of baclofen were somnolence,dizziness and fatigue,all the patients were well tolerated. Conclusions:Baclofen combined with esomeprazole and mosapride is an efficient option for rGERD.

Objective To investigate the effects of telmisartan on the expression of angiotensin converting enzyme2 (ACE2) mRNA in monocyte-derived macrophages of hypertensive patients companied with diabetes.Methods 62 essential hypertensive patients companied with diabetes were randomly divided into two groups:regular treatment group,and telmisartan group.Then the content of ACE and ACE2 in serum was detected by ELISA,and the expression of ACE mRNA and ACE2 mRNA in monocyte-derived macrophages of patients was detected by RT-PCR before and after having been treated.Results (1) After having been treated for 4 weeks and 12 weeks,the blood pressure of the patients in two groups were decreased significantly,Comparing with regular group,telmisartan group seemed to have more obvious therapeutic effect (P ＜ 0.05) ; (2) After having been treated for 12 weeks,glycosylated hemoglobin diseased in both group,but there was no significant difference between the two group (P ＞ 0.05) ; (3) In telmisartan group,the content of ACE2 in serum was increased after having been treated for 12 weeks than that in regular treatment group,[(23.9 ± 8.2) U/L vs (16.3 ± 8.9) U/L,P ＜ 0.05] ; and the expression of ACE2 mRNA in monocyte-derived macrophages in telmisartan group was obviously increased after 12 weeks comparing with regular treatment group (0.73 ±0.06 vs 0.51 ±0.04,P ＜0.01).Conclusion The role of telmisartan in decreasing blood pressure and it's advantage to the metabolism of glucose are partly related with the up-regulation of ACE2 mRNA.