OBJECTIVE: To explore the predictive value of four items of new thrombus markers combined with conventional coagulation tests for thrombosis in antiphospholipid syndrome. METHODS: A total of 121 antiphospholipid syndrome (APS) patients who hospitalized at Peking University People's Hospital from March 2022 to January 2023 were selected and divided into thrombus group (50 cases) and nonthrombus group (71 cases) according to whether thrombosis occurred. The differences of laboratory characteristics including antiphospholipid antibodies were compared between the thrombotic and non-thrombotic groups. Chemiluminescent immunoassay was used to detect thrombomodulin (TM), thrombin-antithrombin complex (TAT), Plasmin-α2 plasmin inhibitor complex (PIC), and tissue plasminogen activator inhibitor complex (t-PAIC) in plasma from venous. The independent risk factors of thrombosis in patients with APS were determined using binary Logistic regression. Receiver operating characteristic (ROC) curve analysis was applied to evaluate the efficacy of each index on the prediction of thrombosis. RESULTS: Compared with the patients without thrombosis, the patients with thrombosis were older [49 (32, 64) years vs. 36 (32, 39) years, P < 0.05]. The percentages of male, smoking, hypertension, and global antiphospholipid syndrome score (GAPSS)≥10 in the patients with thrombosis were significantly higher than those in the patients without thrombosis (P < 0.05). The positive rates of anticardiolipin antibody (aCL) and lupus anticoagulant (LA) in the thrombotic group were significantly higher than those in the non-thrombotic group (P < 0.05), and the levels of prothrombin time, activated partial thromboplastin time, fibrinogen, fibrin degradation product in the thrombotic group were significantly higher than those in the non-thrombotic group (P < 0.05).Among the thrombosis group, venous thrombosis accounted for 19 (38.00%), including deep vein thrombosis (16, 84.21%) and pulmonary embolism accounted (5, 26.32%); Arterial thrombosis accounted for 35 (70.00%), including myocardial infarction (6, 17.14%) cerebral infarction (30, 85.71%). The patients in the thrombotic group had significantly greater TM levels than those in the non-thrombotic group (P < 0.05).There were no significant dif-ferences between the two groups in TAT (Z=-1.420, P=0.156), PIC (Z=-0.064, P=0.949), and t-PAIC (Z=-1.487, P=0.137). Univariate and binary Logistic regression analysis of relevant variables showed that advanced age [OR=1.126, P=0.002], elevated TM [OR=1.325, P=0.048], prolonged prothrombin time (PT) [OR=4.127, P=0.008] were independent risk factors for thrombosis in the patients with APS. ROC curve analysis of the above three independent risk factors showed that the combined detection of age, PT and TM had the highest Yoden index (0.727) and sensitivity (83.0%), with a specificity of 89.7%. CONCLUSION TAT, PIC, TM, and t-PAIC may reflect thrombus formation from the coagulation system, fibrinolysis system, and endothelial system. The combined of age TM and PT is superior to the application of a single marker, which has diagnostic value for the early identification of APS thrombosis.
Humans ; Male ; Antiphospholipid Syndrome/diagnosis* ; Tissue Plasminogen Activator ; Thrombosis/etiology* ; Antibodies, Antiphospholipid/analysis* ; Blood Coagulation Tests/adverse effects*

BACKGROUND AND METHODS: To evaluate the role of specific antibodies to corn dust (CD) and their relationship to respiratory dysfunction, we detected serum specific IgE(slgE) and IgG4(slgG4) antibodies by ELISA in 42 employees working in the animal feed industry and 27 unexposed controls. RESULTS: Our survey revealed that 15 (34.9%) subjects had work-related respiratory dysfunction associated with or without nasal symptoms. Among these subjects, eight had airway hyper-responsiveness to methacholine. Significant differences were noted in slgE and slgG4 between exposed and unexposed groups (p = 0.04, p = 0.00 respectively), but no difference was noted in slgG (p = 0.1). Although there was no significant differences in the prevalence of specific IgE antibody between symptomatic (29%) and asymptomatic groups (19%, p = 0.55), the specific IgE levels were significantly higher in symptomatic workers than in asymptomatic workers (p = 0.03). Specific IgG antibody was detected in 1 (6%) symptomatic and 4 (15%) asymptomatic workers (p = 0.46). Specific IgG4 antibody was detected in 11 (73%) of symptomatic and 21 (78%) of asymptomatic workers (p = 0.90). The higher prevalence of slgG4 antibody was noted in workers with slgE antibody (p = 0.001). The correlation between slgG and exposure duration was significant (r = 0.36, p = 0.02). There was no association between the prevalence of slgE, slgG, and slgG4 to exposure intensity, smoking or atopic status. CONCLUSION: These results suggested that the existence of slgG and slgG4 might represent a response to CD exposure, and that some unexposed subjects had slgG to CD. Specific IgE might play a role in the development of respiratory symptoms.
Analysis of Variance ; Antibodies, Anti-Idiotypic/analysis* ; Asthma/immunology* ; Asthma/epidemiology ; Chi-Square Distribution ; Comparative Study ; Corn/adverse effects* ; Dust/adverse effects* ; Enzyme-Linked Immunosorbent Assay ; Human ; IgE/analysis* ; IgG/analysis* ; Male ; Occupational Diseases/immunology* ; Occupational Diseases/epidemiology ; Occupational Exposure/adverse effects ; Reference Values ; Respiratory Hypersensitivity/immunology* ; Skin Tests ; Smoking/immunology ; Substances: IgE ; Substances: IgG ; Substances: Antibodies, Anti-Idiotypic

OBJECTIVETo investigate the efficacy and toxicity of recombinant humanized anti-Her-2/neu antibody (Herceptin) and Taxol for patients with Her-2/neu overexpressing metastatic breast cancer.

METHODSSixty patients with Her-2/neu overexpressing metastatic breast cancer were investigated. Of the 60 cases, 22 were treated with Herceptin and Taxol and 38 with Taxol and doxorubicin.

RESULTSThe total response rate (RR) of Herceptin and Taxol was 68.2%, and that of Taxol and doxorubicin was 44.7%. The RR of patients with Her-2/neu(+++) was 75%, while that of patients with Her-2/neu(++) was 50%. The major adverse effects were gastro-intestinal tract reactions, myopathy, bone marrow suppression and alopecia.

CONCLUSIONThe treatment with Herceptin and Taxol is effective and safe for patients with Her-2/neu overexpressing metastatic breast cancer. The therapeutic effect is related to the degree of Her-2/neu overexpression.

Adult ; Aged ; Antibodies, Monoclonal ; administration & dosage ; adverse effects ; Antibodies, Monoclonal, Humanized ; Antineoplastic Combined Chemotherapy Protocols ; therapeutic use ; Breast Neoplasms ; chemistry ; drug therapy ; Female ; Humans ; Middle Aged ; Paclitaxel ; administration & dosage ; adverse effects ; Receptor, ErbB-2 ; analysis ; Trastuzumab

Liposoluble cape jasmine proteins were used to immunize BALB/C mice. Indirect ELISA was utilized to develop one monoclonal antibody by integrating SP2/0 cells and spleen cells from immunized BALB/C mice. The subclass of the monoclonal antibody was identified as IgG2b, with Kappa chain as its light chain. The ascite titer of 2H8 monoclonal antibody was 1:204 080. Western-blot analysis proved that 2H8 reacted with cape jasmine proteins to identify specific liposoluble protein with molecuar weight of around 58.5 kDa. Dot-ELISA was established with 2H8 ascites as the primary antibody, showing the minimum detectable amount of 19.5 ng. This study lays a foundation for the development of protein kits of Reduning injection.
Animals ; Antibodies, Monoclonal ; analysis ; immunology ; Antibody Specificity ; Drug Hypersensitivity ; immunology ; Drugs, Chinese Herbal ; adverse effects ; analysis ; Enzyme-Linked Immunosorbent Assay ; methods ; Female ; Humans ; Mice ; Mice, Inbred BALB C ; Plant Proteins ; analysis ; immunology ; Reagent Kits, Diagnostic

Antibodies, Monoclonal ; therapeutic use ; Antibodies, Monoclonal, Murine-Derived ; Antigens, CD20 ; analysis ; Antineoplastic Agents ; therapeutic use ; Humans ; Liver Transplantation ; adverse effects ; Lymphoproliferative Disorders ; drug therapy ; pathology ; Male ; Middle Aged ; Postoperative Complications ; drug therapy ; Rituximab

BACKGROUND: Data on the immunogenicity and safety of heterologous immunization schedules are inconsistent. This study aimed to evaluate the immunogenicity and safety of homologous and heterologous immunization schedules. METHODS: Multiple databases with relevant studies were searched with an end date of October 31, 2021, and a website including a series of Coronavirus disease 2019 studies was examined for studies before March 31, 2022. Randomized controlled trials (RCTs) that compared different heterologous and homologous regimens among adults that reported immunogenicity and safety outcomes were reviewed. Primary outcomes included neutralizing antibodies against the original strain and serious adverse events (SAEs). A network meta-analysis (NMA) was conducted using a random-effects model. RESULTS: In all, 11 RCTs were included in the systematic review, and nine were ultimately included in the NMA. Among participants who received two doses of CoronaVac, another dose of mRNA or a non-replicating viral vector vaccine resulted in a significantly higher level of neutralizing antibody than a third CoronaVac 600 sino unit (SU); a dose of BNT162b2 induced the highest geometric mean ratio (GMR) of 15.24, 95% confidence interval [CI]: 9.53-24.39. Following one dose of BNT162b2 vaccination, a dose of mRNA-1273 generated a significantly higher level of neutralizing antibody than BNT162b2 alone (GMR = 1.32; 95% CI: 1.06-1.64), NVX-CoV2373 (GMR = 1.60; 95% CI: 1.16-2.21), or ChAdOx1 (GMR = 1.80; 95% CI: 1.25-2.59). Following one dose of ChAdOx1, a dose of mRNA-1273 was also more effective for improving antibody levels than ChAdOx1 (GMR = 11.09; 95% CI: 8.36-14.71) or NVX-CoV2373 (GMR = 2.87; 95% CI: 1.08-3.91). No significant difference in the risk for SAEs was found in any comparisons. CONCLUSIONS: Relative to vaccination with two doses of CoronaVac, a dose of BNT162b2 as a booster substantially enhances immunogenicity reactions and has a relatively acceptable risk for SAEs relative to other vaccines. For primary vaccination, schedules including mRNA vaccines induce a greater immune response. However, the comparatively higher risk for local and systemic adverse events introduced by mRNA vaccines should be noted. REGISTRATION PROSPERO; https://www.crd.york.ac.uk/PROSPERO/ ; No. CRD42021278149.
Adult ; Humans ; BNT162 Vaccine ; 2019-nCoV Vaccine mRNA-1273 ; Network Meta-Analysis ; Immunization Schedule ; COVID-19/prevention & control* ; COVID-19 Vaccines/adverse effects* ; Viral Vaccines ; mRNA Vaccines ; Antibodies, Neutralizing ; Antibodies, Viral

OBJECTIVETo evaluate the efficacy and toxicity in patients with HER2 overexpressing metastatic breast cancer.

METHODSTwenty-one patients with HER2 overexpressing metastatic breast cancer entered into the study. Trastuzumab (8 mg/kg day 1, then 6 mg/kg every 21 days or 4 mg/kg, then 2 mg/kg every week) and vinorelbine (25 mg/m(2)) was given on days 1 and 8 every 21 days.

RESULTSOverall 56 cycles were given to the 21 patients enrolled into the study (mean 2, range 1-6). All can be evaluated. The response rate was 33.33% (7/21), one patient achieved complete response (CR), six patients achieved partial response (PR), four patients achieved stable disease (SD), ten patients achieved progressive disease (PD)]. The median time to progression was 3.5 months. One year overall survival was 33%. The major toxicity was myelosuppression and peripheral neuritis. A few patients were observed with fever and lower grade cardiac failure.

CONCLUSIONThe combination of trastuzumab and vinorelbine is an effective and well tolerated therapy in patients with pretreated metastatic breast cancer.

Adult ; Aged ; Anemia ; chemically induced ; Antibodies, Monoclonal ; administration & dosage ; adverse effects ; Antibodies, Monoclonal, Humanized ; Antineoplastic Combined Chemotherapy Protocols ; adverse effects ; therapeutic use ; Breast Neoplasms ; drug therapy ; metabolism ; pathology ; Carcinoma, Ductal, Breast ; drug therapy ; metabolism ; pathology ; Female ; Humans ; Middle Aged ; Nausea ; chemically induced ; Neoplasm Metastasis ; Receptor, ErbB-2 ; metabolism ; Survival Analysis ; Thrombocytopenia ; chemically induced ; Trastuzumab ; Treatment Outcome ; Vinblastine ; administration & dosage ; adverse effects ; analogs & derivatives ; Vomiting ; chemically induced

We report a case of cytomegalovirus (CMV) retinitis after intravitreal bevacizumab injection. A 61-year-old woman with diabetic macular edema developed dense vitritis and necrotizing retinitis 3 weeks after intravitreal bevacizumab injection. A diagnostic vitrectomy was performed. The undiluted vitreous sample acquired by vitrectomy was analyzed by polymerase chain reaction and culture. Polymerase chain reaction of the vitreous was positive for CMV DNA. Other laboratory results did not show evidence of other infectious retinitis and systemic immune dysfunction. Human immunodeficiency virus antibodies were also negative. After systemic administration of ganciclovir, retinitis has resolved and there has been no recurrence of retinitis during the follow-up period of 12 months. Ophthalmologists should be aware of potential risk for CMV retinitis after intravitreal bevacizumab injection.
Angiogenesis Inhibitors/administration & dosage/adverse effects ; Antibodies, Monoclonal, Humanized/administration & dosage/*adverse effects ; Cytomegalovirus/genetics ; Cytomegalovirus Retinitis/diagnosis/*etiology/immunology ; DNA, Viral/analysis ; Diagnosis, Differential ; Female ; Humans ; Immunocompetence/*drug effects ; Intravitreal Injections ; Macular Edema/diagnosis/*drug therapy ; Middle Aged ; Polymerase Chain Reaction ; Vascular Endothelial Growth Factor A/antagonists & inhibitors

The human papillomavirus (HPV)-16/18 AS04-adjuvanted cervical cancer vaccine has been demonstrated to be highly efficacious and immunogenic with a favorable safety profile. This study assessed the immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine in healthy Korean girls aged 10-14 yr. This multi-center, observer-blind trial randomly assigned 321 healthy girls to receive three doses (0, 1, 6-month schedule) of HPV-16/18 AS04-adjuvanted vaccine or hepatitis A vaccine. Immunogenicity against vaccine antigens was assessed one month post-Dose 3. Solicited and unsolicited adverse events (AEs) and serious AEs (SAEs) were recorded. In the according-to-protocol analysis, all initially seronegative subjects vaccinated with the HPV-16/18 AS04-adjuvanted vaccine had seroconverted at Month 7, with a peak geometric mean titer (GMT) that was 600-fold higher than the natural infection titer of 29.8 EU/mL for HPV-16 and a peak GMT that was 400-fold higher than the natural infection titer of 22.6 EU/mL for HPV-18. The vaccine was well tolerated with no increase in reactogenicity with subsequent doses and no reports of vaccine-related SAEs. In conclusion, the HPV-16/18 AS04-adjuvanted vaccine is shown to be highly immunogenic and generally well-tolerated in Korean girls aged 10-14 yr.
Adjuvants, Immunologic/administration & dosage ; Adolescent ; Aluminum Hydroxide/administration & dosage ; Antibodies, Viral/analysis ; Child ; Female ; Hepatitis A/immunology ; Hepatitis A Vaccines/administration & dosage/adverse effects/immunology ; Humans ; Lipid A/administration & dosage/analogs & derivatives ; Papillomavirus Infections/*prevention & control ; Papillomavirus Vaccines/administration & dosage/adverse effects/*immunology ; Republic of Korea ; Seroepidemiologic Studies ; Uterine Cervical Neoplasms/*prevention & control

BACKGROUND: Heparin-induced thrombocytopenia (HIT) is an adverse drug reaction caused by antibodies to the heparin/platelet factor 4 (PF4) complex, resulting in thrombocytopenia and prothrombotic state. HIT diagnosis is challenging and depends on clinical presentation and laboratory tests. We investigated the usefulness of clinical scores and heparin/PF4 ELISA optical density (OD) as a diagnostic marker and thrombosis predictor in HIT. METHODS: We analyzed 92 patients with suspected HIT. The heparin/PF4 antibody was measured using a commercial ELISA kit (GTI, USA). For each patient, the 4 T's score and Chong's score were calculated. RESULTS: Of the 92 patients, 28 were anti-heparin/PF4-seropositive. The 4 T's score and Chong's score showed good correlation (r=0.874). The 4 T's score and OD values showed good performance for diagnosis of the definite and unlikely HIT groups; however, OD levels showed better sensitivity (93.8%) than the 4 T's score used alone (62.5%). Of the 92 patients, 26 developed thrombosis. The OD values were significantly higher in patients with thrombosis than in those without thrombosis (0.52 vs. 0.22, P<0.001). Patients with high OD values (OD>0.4) had an increased risk of thrombosis (adjusted odds ratio 9.44 [3.35-26.6], P<0.001) and a shorter 250-day thrombosis-free survival (32.1% vs. 54.7%, P=0.012). CONCLUSIONS: ELISA OD values in combination with clinical scoring can improve the diagnosis of and thrombosis prediction in HIT. More attention should be paid to the use of clinical scores and OD values as thrombosis predictors in HIT.
Adolescent ; Adult ; Aged ; Aged, 80 and over ; Antibodies/adverse effects/analysis ; Area Under Curve ; Child ; Child, Preschool ; Enzyme-Linked Immunosorbent Assay/*methods ; Female ; Heparin/immunology ; Humans ; Infant ; Male ; Middle Aged ; Platelet Factor 4/immunology ; Risk ; Sensitivity and Specificity ; Survival Analysis ; Thrombocytopenia/chemically induced/*diagnosis/mortality ; Thrombosis/*diagnosis/etiology