BACKGROUND AND OBJECTIVES: Intravenous immunoglobulin-SN (IVIG-SN) is a new human immunoglobulin product. Its safety is ensured by pathogen-elimination steps comprising solvent/detergent treatment and a nanofiltration process. This multicenter clinical study was designed to evaluate the efficacy and safety of combined aspirin and high-dose IVIG-SN therapy in pediatric patients with Kawasaki disease (KD). SUBJECTS AND METHODS: We evaluated coronary artery lesions (CALs) at 2 and 7 weeks after administering IVIG-SN; total fever duration; and variations in erythrocyte sedimentation rate, N-terminal pro B-type natriuretic peptide or B-type natriuretic peptide, and creatine kinase-myocardial band level before and after treatment with IVIG-SN (2 g/kg). Adverse events were monitored. RESULTS: Forty-five patients were enrolled, three of whom were excluded according to the exclusion criteria; the other 42 completed the study. The male:female ratio was 0.91:1, and the mean age was 29.11±17.23 months. The mean fever duration before IVIG-SN treatment was 6.45±1.30 days. Although most patients had complete KD (40 patients, 90.91%), four had atypical KD (9.09%). After IVIG-SN treatment, one patient (2.38%) had CALs, which was significantly lower than the incidence reported previously (15%) (p=0.022), but not significantly different from recent data (5%). There were no serious adverse events, though 28 patients (63.64%) had mild adverse events. Three adverse drug reactions occurred in 2 patients (eczema, anemia, and increased eosinophil count), all of which were transient. CONCLUSION: IVIG-SN treatment in patients with KD was safe and effective.
Anemia ; Aspirin* ; Blood Sedimentation ; Clinical Study ; Coronary Artery Disease ; Coronary Vessels ; Creatine ; Drug-Related Side Effects and Adverse Reactions ; Eosinophils ; Fever ; Humans ; Immunoglobulins ; Immunoglobulins, Intravenous ; Incidence ; Mucocutaneous Lymph Node Syndrome* ; Natriuretic Peptide, Brain

OBJECTIVETo investigate the clinical effect and safety of anti-D immunoglobulin (anti-D) in the treatment of children with newly diagnosed acute immune thrombocytopenia (ITP) through a Meta analysis.

METHODSPubMed, EMBASE, Cohrane Library, Ovid, CNKI, and Wanfang Data were searched for randomized controlled trials (RCTs) published up to April 2017. Review Manager 5.3 was used for the Meta analysis.

RESULTSSeven RCTs were included. The Meta analysis showed that after 72 hours and 7 days of treatment, the intravenous immunoglobulin (IVIG) group had a significantly higher percentage of children who achieved platelet count >20×10/L than the anti-D group (P<0.05). There were no significant differences in platelet count after 24 hours, 72 hours, and 7 days of treatment between the anti-D (50 μg/kg) group and the IVIG group (P>0.05), and there were also no significant differences in platelet count after 24 hours and 7 days of treatment between the 50 μg/kg and 75 μg/kg anti-D groups (P>0.05). The anti-D group had a significantly greater reduction in the hemoglobin level than the IVIG group after treatment, but did not need transfusion. No children in the anti-D group or the IVIG group experienced serious adverse reactions.

CONCLUSIONSIntravenous injection of anti-D may have a similar effect as IVIG in improving platelet count in children with acute ITP, but it may be slightly inferior to IVIG in the rate of platelet increase after treatment. The anti-D dose of 50 μg/kg may have a similar effect as 75 μg/kg. The recommended dose of anti-D for treatment of ITP is safe.

Humans ; Immunoglobulins, Intravenous ; adverse effects ; therapeutic use ; Platelet Count ; Purpura, Thrombocytopenic, Idiopathic ; blood ; drug therapy ; Rho(D) Immune Globulin ; adverse effects ; therapeutic use

OBJECTIVETo evaluate the immunotoxicological effects of genetically modified wheat with TaDREB4 gene in female BALB/c mice.

METHODSFemale mice weighing 18-22 g were divided into five groups (10 mice/group), which were set as negative control group, common wheat group, parental wheat group, genetically modified wheat group and cyclophosphamide positive control group, respectively. Mice in negative control group and positive control group were fed with AIN93G diet, mice in common wheat group, non-genetically modified parental wheat group and genetically modified wheat group were fed with feedstuffs added corresponding wheat (the proportion is 76%) for 30 days, then body weight, absolute and relative weight of spleen and thymus, white blood cell count, histological examination of immune organ, peripheral blood lymphocytes phenotyping, serum cytokine, serum immunoglobulin, antibody plaque-forming cell, serum half hemolysis value, mitogen-induced splenocyte proliferation, delayed-type hypersensitivity reaction and phagocytic activities of phagocytes were detected.

RESULTSNo immunotoxicological effects related to the consumption of the genetically modified wheat were observed in BALB/c mice when compared with parental wheat group, common wheat group and negative control group.

CONCLUSIONFrom the immunotoxicological point of view, results from this study demonstrate that genetically modified wheat with TaDREB4 gene is as safe as the parental wheat.

Animals ; Antibody-Producing Cells ; immunology ; Body Weight ; Cytokines ; blood ; Female ; Genes, Plant ; Hemolysis ; Hypersensitivity, Delayed ; Immune System ; drug effects ; Immunoglobulins ; blood ; Mice ; Mice, Inbred BALB C ; Organ Size ; Phagocytosis ; Plants, Genetically Modified ; toxicity ; Spleen ; immunology ; Thymus Gland ; immunology ; Triticum ; genetics

OBJECTIVETo study the changes of serum complement C and immunoglobulin (Ig) in sensitized guinea pigs exposed to trichloroethylene.

METHODSThirty six white female guinea pigs (250 ∼ 300 g) were randomly divided into blank control group (5 guinea pig), solvent (olive oil) control group (5 guinea pig) and TCE treatment group (26 guinea pig). According to guinea pig maximization test (GPMT), guinea pigs were exposed to TCE. After stimulating contact for 24 h, the skin reactions of guinea pig back test area were recorded and scored. According to Skin sensitization integral, the guinea pigs treated with TCE were divided into the sensitized group (score ≥ 1) and un-sensitized group (score 0). The concentrations of serum C3, C4, IgA, IgG and IgM were detected in 24 and 72 h, respectively after the experiment.

RESULTSThe sensitization rates of group treated by TCE was 65.38%. The serum C3 levels of groups sensitized to TCE for 24 and 73h were 99.75 ± 1.45 and 93.28 ± 3.61g/ml, respectively, which were significantly lower than that (112.30 ± 9.10 g/ml) of solvent control group (P < 0.05). Also The serum C4 levels of groups sensitized to TCE for 24 and 73 h were 34.63 ± 2.53 and 33.82 ± 2.76g/ml, respectively, which were significantly lower than that (43.87 ± 3.65 g/ml) of solvent control group (P < 0.05). The serum IgA and IgM levels of groups sensitized to TCE and unsensitized to TCE for 24 and 72 h were significantly lower than those of solvent group (P < 0.05). as compared with unsensitized groups, the serum IgA levels of the groups sensitized to TCE for 24 and 72 h significantly decreased (P < 0.05).

CONCLUSIONAfter the guinea pig skin was sensitized to TCE, the serum C3, C4 levels decreased, the immune function disordered.

Animals ; Complement System Proteins ; metabolism ; Female ; Guinea Pigs ; Immunity, Humoral ; drug effects ; Immunoglobulins ; blood ; Skin ; drug effects ; Trichloroethylene ; toxicity

OBJECTIVETo determine the relation between the change of immunology indexes of serum and the occurrence of anaphylaxis in patients induced by Qingkailing injection, and to establish the method of detection of the type of anaphylaxis in patients induced by traditional Chinese medicine (TCM) injection.

METHODIn a prospective nested case-control study, we compared the concentration of IgE, IgG, IL-2, IL-4 of 20 cases in anaphylaxis induced by Qingkailing injection with those from 60 matched controls who remained normal after the using Qingkailing injection. The correlation between the change of IgE, IgG, IL-2, IL-4 of serum and the occurrence of anaphylaxis in patients induced by Qingkailing injection was determined, and we also evaluate the clinical values of IgE, IgG, IL-2, IL-4 of serum in diagnosis of anaphylaxis in patients induced by Qingkailing injection by Binary-Logistic regression analysis.

RESULTThe concentrations of IgE, IgG, IL-2, IL-4 of serum of 20 cases were significantly higher than those in controls (P < or = 0. 05). The concentrations of IgE, IgG, IL-2, IL4 of serum of 20 cases after the treatment with Qingkailing injection were significantly higher than those before the treatment with Qingkailing injection (P < or = 0.05). The Exp(B) of IgE, IgG, IL-2, IL-4 were 22. 018 (95.0% CI for EXP was 3.268-310.831), 11.271 (95.0% CI for EXP was 1.91-3.024), 23.612 (95.0% CI for EXP was 3.012-421.187), 16.486 (95.0% CI for EXP was 1.233-205.413), respectively.

CONCLUSIONThe allergic reaction caused by Qingkailing injection may be due to type I allergic reactions; The presence of IgE, IgG, IL-2, IL-4 can serve as clinical evaluation indicators in evaluation the damage degree of immune system caused by anaphylaxis in patients induced by Qingkailing injection. Cytokines are more likely to become the effective evaluation index in diagnosis of anaphylaxis in patients induced by TCM injection.

Adolescent ; Adult ; Aged ; Anaphylaxis ; blood ; etiology ; immunology ; Case-Control Studies ; Cytokines ; blood ; immunology ; Drug Hypersensitivity ; immunology ; Drugs, Chinese Herbal ; administration & dosage ; adverse effects ; Female ; Humans ; Immunoglobulins ; blood ; immunology ; Male ; Middle Aged ; Prospective Studies ; Young Adult

OBJECTIVETo study the impact and mechanism of Shengmai Injection (SMI) on the immunological function changes after cardiopulmonary bypass.

METHODSForty patients with rheumatic heart valve disease were selected and assigned randomly to two groups: 20 in the control group and 20 in the SMI group. Peripheral blood samples were taken at various time points, i.e. 3 days before operation (T1), 10 min after terminal of CPB (T2), the first (T3), third (T4), and seventh (T5) day after operation, for counting white blood cell (WBC), neutrophils and lymphocytes; percentage of T lymphocytes (CD3+ mononuclear cells) and its subsets (CD4+ and CD8+) to calculate CD4+/CD8+ ratio; and the serum content of immunoglobulins (IgG, IgA, IgM) as well as serum concentration of interleukin-8 (IL-8) and interleukin-10 (IL-10) were assayed.

RESULTSCompared with the control group, in the SMI group, WBC and neutrophil count were lower at T2 (P < 0.01); percentages of CD3+ and CD4+ lower at T4 and T5 (P < 0.05 or P < 0.01); percentage of CD8+ higher at T2 to T5 (P < 0.05 or P < 0.01); CD4+/CD8+ ratio lower at T3 to T5 (P < 0.05 or P < 0.01); IgG lower at T2 (P < 0.05); IgA higher at T3 (P < 0.05); IgM higher at T3 to T5 (P < 0.05); IL-8 lower at T2 to T4 (P < 0.05); and IL-10 higher at T2 (P < 0.05).

CONCLUSIONApplication of SMI in the perioperative period can enhance the humoral immunity and inhibit the cellular immunity after CPB, it could also reduce the systemic inflammatory reaction and improve the prognosis of patients.

Adult ; Cardiopulmonary Bypass ; adverse effects ; Drug Combinations ; Drugs, Chinese Herbal ; administration & dosage ; Female ; Heart Valve Prosthesis Implantation ; Humans ; Immunoglobulins ; blood ; Immunologic Factors ; administration & dosage ; Injections, Intravenous ; Interleukins ; blood ; Male ; Middle Aged ; Perioperative Care ; Phytotherapy ; Rheumatic Heart Disease ; immunology ; surgery ; T-Lymphocyte Subsets ; immunology

OBJECTIVETo investigate the effect and mechanisms of Compound Astragalus Recipe (CAR) for regulating cellular immune in patients with myasthenia gravis (MG).

METHODSSixty MG patients were equally assigned to two groups randomly, the test group administered with CAR and the control group with prednisone for 3 months. Changes of patients' symptoms and adverse reactions were observed. The peripheral lymphocyte subsets distribution was examined by flow cytometry, and the levels of immunoglobulins and complements in the peripheral blood were measured by immuno-turbidimetry before and after treatment.

RESULTSThe total effective rate in the test group after 12-week treatment reached 80% (24/30), while that of the control group reached 83.3% (25/30), difference between them showed no statistical significance (P > 0.05). CD4+ and CD4+/CD8+ ratio were lowered significantly in both groups, but the decrement of CD4+/CD8+ ratio in the test group was more significant than that in the control group, showing significance between groups (P < 0.05). While CD8+ in the test group after treatment was significantly increased as compared with that before treatment (P < 0.05), but with no significant difference in comparing with that in the control group (P > 0.05). Serum levels of IgM and IgA in MG patients were significantly higher than normal range (P < 0.01). Levels of C3 and C4 were significantly increased in both groups after treatment (P < 0.05). Moderate high level of ALT and AST revealed transiently at the 2nd week in 5 patients of the control group, while no adverse reaction was found in the test group.

CONCLUSIONOne of the mechanisms for CAR in playing its immuno-modulate effect may be its regulation on lymphocyte subsets distribution and humoral immune function.

Adolescent ; Adult ; Aged ; Astragalus membranaceus ; chemistry ; Child ; Complement System Proteins ; metabolism ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Humans ; Immunoglobulins ; blood ; Lymphocyte Subsets ; drug effects ; Male ; Middle Aged ; Myasthenia Gravis ; drug therapy ; immunology ; Phytotherapy ; Young Adult

OBJECTIVETo observe the therapeutic efficacy of Danggui Buxue Decoction No.1 in treating patients of non-small cell lung cancer (NSCLC) at the peri-operational stage and its impact on the patients' immune function.

METHODSEighty-two NSCLC patients were randomly assigned to two groups equally, the control group and the test group, they were given conventional treatment, while to the test group, DB1 were given additionally. The observation was conducted by testing the changes of T-lymphocyte subsets, natural killer (NK) cell activity, serum levels of immunoglobulin (IgA, IgM, IgG), interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-alpha), cytokeratin fragment 19 (CYFRA21-1) and carcinoembryonic antigen (CEA) in NSCLC patients before and after administration of DB1, and analyzing the patients' general condition.

RESULTSThe level of CD3(+), CD4(+), the ratio of CD4 and CD8(+), IgA, IgM, IgG and IL-2 decreased in patients with NSCLC on day 1 after operation, and the level of CD8 and TNF-alpha increased compared to pre-operation. While the levels of CD3(+), CD4(+), CD4 /CD8(+), NK cell activity, serum IgA, IgM, IgG, IL-2 began to elevate, CD8 and TNF-alpha levels began to decline in patients administered with DB1 on day 3 after the operation, earlier than patients who did not use the decoction. The level of CYFRA21-1 and CEA, was immediately decreased after operation in both groups.

CONCLUSIONSApplying DB1 to NSCLC patients at an early post-operational stage could alleviate the impairment and accelerate the recovery of immune function of patients to enhance their immunity. DB1 also shows an anti-tumor action to a certain degree.

Adult ; Aged ; Biomarkers, Tumor ; Carcinoma, Non-Small-Cell Lung ; drug therapy ; immunology ; surgery ; Combined Modality Therapy ; Drugs, Chinese Herbal ; administration & dosage ; Female ; Humans ; Immunoglobulins ; blood ; Integrative Medicine ; Killer Cells, Natural ; drug effects ; Lung Neoplasms ; drug therapy ; immunology ; surgery ; Male ; Middle Aged ; T-Lymphocyte Subsets ; drug effects

OBJECTIVETo explore and compare the clinical effects of three immuno-potentiators and their influence on immune function in preventing and treating recurrent respiratory tract infection (RRI).

METHODSSeventy-two children with RRT were assigned to three groups, the 23 patients in the M group treated with milkvetch extract oral liquid, the 23 in the P group treated by P-transfer factor and the 26 in the U group treated by Utilins injection. Clinical effect was compared among three groups after treatment, and changes of T cell subgroups as well as immune antibodies were detected before and after treatment.

RESULTSThe markedly effective rate in the M, P, and U group was 69.6%, 65.2%, and 73.0% respectively, and the total effective rate 87.0%, 82.6%, and 92.3%, showing an insignificant difference among them (all P>0.05). After treatment, the levels of CD3+, CD4+ and CD4+/CD8+ rose obviously in the three groups (all P<0.05); levels of CD8+ in the M group and the P group lowered significantly (P<0.05, P<0.01), but with no significant difference among three groups in the changes of T cell subgroups (all P>0.05). Serum levels of IgG in all the three groups, IgA in the P group and the M group, and IgM in the M group and the U group rose significantly (P<0.05 or P<0.01), with statistical difference presented in comparing of IgA level in the P group with that in the other two groups (P<0.01).

CONCLUSIONThe clinical effects and the outcomes of immunological indexes' changing are similar in RRI patients treated by the three immuno-potentiators. They all can enhance the immunological function of the organism, strengthen the disease-resistant ability of patients, and reduce the incidence of RRI. Among them, the milkvetch extract oral liquid is worthy of spreading due to its lower cost, simple administration, exemption from painful injection, and good compliance.

Administration, Oral ; Astragalus Plant ; chemistry ; Child ; Child, Preschool ; Drugs, Chinese Herbal ; administration & dosage ; pharmacology ; therapeutic use ; Female ; Humans ; Immunoglobulins ; blood ; Infant ; Male ; Respiratory Tract Infections ; blood ; drug therapy ; immunology ; prevention & control ; Retrospective Studies ; Secondary Prevention ; T-Lymphocyte Subsets ; drug effects ; immunology ; Treatment Outcome

This study aimed to discover potential biomarkers for dioxynivalenol (DON) intoxication. B6C3F1 male mice were rally exposed to 0.83, 2.5 and 7.5 mg/kg body weight (bw) DON for 8 days and the differential protein expressions in their blood plasma were determined by SELDI - Time-of-Flight/Mass Spectrometry (TOF/MS) and the immunoglobulins (Igs) G, A, M and E in the serum were investigated. 11.7 kDa protein was significantly highly expressed according to DON administration and this protein was purified by employing a methyl ceramic HyperD F column with using optimization buffer for adsorption and desorption. The purified protein was identified as a haptoglobin precursor by peptide mapping with using LC/Q-TOF/MS and MALDI-TOF/MS and this was confirmed by western blotting and ELISA. IgG and IgM in serum were decreased in a dose-dependent manner and IgA was decreased at 7.5 mg/kg bw DON administration, but the IgE level was not changed. To compare the expressions of haptoglobin and the Igs patterns between aflatoxin B1 (AFB1), zearalenone (ZEA) and DON intoxications, rats were orally administered with AFB1 1.0, ZEA 240 and DON 7.5 mg/kg bw for 8 days. Haptoglobin was increased only at DON 7.5 mg/kg bw, while it was slightly decreased at ZEA 240 mg/kg bw and it was not detected at all at AFB1 1.0 mg/kg bw. IgG and IgA were decreased by DON, but IgG, IgA, IgM and IgE were all increased by AFB1. No changes were observed by ZEA administration. These results show that plasma haptoglobin could be a diagnostic biomarker for DON intoxication when this is combined with examining the serum Igs.
Aflatoxin B1/toxicity ; Animals ; Blood Proteins/drug effects/*metabolism ; Enzyme-Linked Immunosorbent Assay ; Haptoglobins/drug effects/*metabolism ; Immunoglobulins/*blood/drug effects ; Male ; Mass Spectrometry ; Mice ; Mice, Inbred Strains ; Rats ; Rats, Wistar ; Trichothecenes/*toxicity ; Zearalenone/toxicity