The unwanted immunogenicity of biopharmaceutical is an adverse reaction caused by long-term medication.The primary concerns of immunogenicity would be critical for the efficacy and safety of biopharmaceutical.The immunogenicity assessments include validation of methodology,detection of anti-drug antibodies,characterization antibodies and their subtypes against biopharmaceuticals,determination of antibody neutralization as well as the analyses of relationship of antibody formation to pharmacokinetics and pharmacodynamics parameter and toxicities of drugs.The optimization of detection methods,the predictability of immunogenicity with available animal models and the standardization of evaluation method are currently the major challenges in the assessment of immunogenicity for biopharmaceuticals.

Objective To analyze the utilization of traditional Chinese medicine (TCM) injections for invigorating blood circulation and eliminating stasis in patients with acute cerebral infarction in Ezhou Central Hospital,and evaluate the rationality of drug use of this type of drugs.Methods Totally 480 patients with acute cerebral infarction from 2015 to 2016 were randomly stratified extraction,and evaluated by criteria according to drug information,drug utilization research and adverse drug reaction (ADR).Results A total of involving 12 kinds of TCM injections and 506 cases in 480.Drug utilization studies have shown that the top 3 drugs for aDDDs values respectively were Xuesaitong Injection,Shuxuetong Injection and Salvia Injection,and DUI values of all drugs were≤ 1.0.Evaluation of rational drug use showed irrational use of 81 cases and irrational rate of 16.0％.Mainly for a single dose or the type of solvent instructions for recommended of drug instructions,mixed other drug compatibility or same use of two kinds of TCM injection,irrational rate of Western medicine practitioners was significantly higher than Chinese medicine practitioners (P ＜ 0.01).ADR monitoring showed that ADR occurred in 11 cases,main clinical manifestations were skin and accessories damage.Conclusion The utilization of TCM injections for invigorating blood circulation and eliminating stas,is in patients with acute cerebral infarction in our hospital is basically rational yet it far from perfect.The clinical rational use of TCM injection needs to be further regulated.

Objective To investigate the effect of clopidogrel on platelet function and inflammation factor in treatment of severe carotid artery stenosis after stent-assisted angioplasty.Methods Patients (120 cases) with severe carotid artery stenosis after stent-assisted angioplasty were chosen and divided into two groups,the control group were given atorvastatin combined with aspirin,and the observation group were given atorvastatin combined with chlorine.The serum coagulants DD level,FIB level,inflammation factor P-chosen element level and restenosis event incidence of two groups were observed.Results D-double polymer of two groups had no significant difference;After surgery,the D-double polymer and FIB level of two groups were all higher (P ＜ 0.05).After surgery for 24 h,the D-double polymer and FIB level of observation group were higher,after 3 months of surgery,the D-double polymer and FIB level had no significant differences compared with before surgery,which were all in normal level.After 24 h,1 month,3 months of surgery,the D-double polymer and FIB level of observation group were all lower than control group (P ＜ 0.05).Before treatment,the P-chosen selectin of two groups had no significant differences,which were all decreased after surgery,and the observation group was lower than control group (P ＜ 0.05);The restenosis event of observation group was lower than control group (P ＜ 0.05).Conclusion Clopidogrel could control the platelet aggregation of severe carotid stenosis after surgery to prevent the thrombogenesis and decrease the restriction incidence,while control the inflammation factor expression to prevent the atherosclerosis.

Objective To explore the effect of lidocaine with intravenous infusion on the postoperative inflammatory factors and cognitive dysfumction for elderly patients undergoing spinal operation.Method 80 elderly patients undergoing spinal operation in Central hospital of Baoji were enrolled from Janua-y 2015 to January 2016,of which patients divided into two groups randomly,control group (n =40) accepted routine general anesthesia,and study group (n =40) adopted intravenous lidocaine based on the patiems in control group,comparing the MMSE score and the incidence of postoperative cognitive dysfunction (POCD) with before operation,detecting and analyzing the difference of inflammatory and immunity factors.Results The MMSE score of the study group after three days of operation was significantly lower than that of the control group,the difference was statistically significant (P ＜ 0.05).The incidence of POCD in the study group was significantly lower than that in the control group,the difference was statistically significant (P ＜ 0.05).The serum levels of IgA,IgM and IgG in the study group after seven days of operation were significantly higher than those in the control group,the difference was statistically significant (P ＜ 0.05).After three days and seven days postoperatively,the serum levels of interleukin-6 (IL-6) in the study group were significantly lower than those in the control group,the difference was statistically significant (P ＜ 0.05).And there was no significance of TNF-α between two groups at any time point.Conclusions Intravenous lidocaine for patients undergoing spinal operation could inhibit the inflammatory response,improve the function of immunity,and decrease the incidence of POCD,which deserved popularization in clinic.

Objective To investigate the clinical efficacy of alprostadil combined with butylphthalide on patients with acute ischemic stroke and its effect on hs-CRP.Methods Eighty-five patients with acute ischemic stroke admitted into our hospital were divided randomly into observation group (n =42) and control group (n =43).Patients in control group were treated with alprostadil,and those in observation group were treated with alprostadil combined with butylphthalide.The neurologic impairment score (NIHSS),ADL score,hs-CRP,coagulation function,and clinical efficacy in the two groups were observed and compared.Results After 14 days of treatment,the NIHSS and ADL score in both groups were improved,and NIHSS in observation group were much lower than control group,ADL were much higher,and hs-CRP were markedly lower than that of control (P ＜ 0.05).And the coagulation function indexes in both groups were obvious lowered,and DD and FIB in observation group were conspicuously lower than those in control group,and PT were much higher (P ＜ 0.05).In addition,observation group with effective rate of 90.5％ were significantly higher than that of control group with 72.1％ (P ＜ 0.05).Conclusion Compared with only alprostadil treatment,alprostadil combined with butylphthalide had a better capability of treating patients with acute ischemic stroke by improving coagulation function and neurologic function,and inhibiting levels of hs-CRP.

Objective To explore the influence of inhaled corticosteroids on the curative effect and fiactional exhaled nitric oxide and endothelial function for patients with stable COPD.Methods Totally 90 patients with stable COPD were collected in Xinxiang Central Hospital from July 2014 to July 2016,and divided into two groups randomly.The control group (n =45) was treated with conventional Western medicine,the observation group (n =45) were given fluticasone propionate inhalation atomization of 250 g per time,twice daily.The two groups received 6 months of treatment.The pulmonary function indexes including forced vital capacity (FVC),1 s forced expiratory volume (FEV1),maximal mid expiratory flow (MMEF) and peak expiratory flow (PEF),inflammatory factors such as lnterleukin-6 (IL-6),interleukin-8 (IL-8),tumor necrosis factor-α (TNF-α) and C reactive protein (CRP) levels,and vascular endothelial function indexes including flow-mediated vasodilation (FMD),soluble intercellular adhesion molecule-1 (SICAM-1),endothelin 1 (ET-1),and fractional exhaled nitric oxide (FENO) were compared and analyzed.Results After treatment,the pulmonary function indexes were improved significantly (P ＜ 0.05),and the FEV1,FEV1/FVC,MMEF,and PEF of observation group were higher significantly than those patients in control group (P ＜ 0.05).The levels of inflammatory factors decreased than before treatment remarkably (P ＜ 0.05),and the levels of IL-6,IL-8,TNF-α,and CRP in observation group were lower than those in control group,and which difference was significance (P ＜ 0.05).The FMD of patients in study group was higher than those in control group significantly (P ＜ 0.05).The levels of SICAM-1 and ET-1 in observation group were decreased significantly than those before treatment,and were lower than control group (P ＜ 0.05).The FENO of all patients decreased than before treatment,and reduced amplitude in observation group was more than those in control group significantly (P ＜ 0.05).Conclusion Inhaled corticosteroids for patients stable COPD could improve pulmonary functions and inhibit inflammatory response,specially,which improves endothelial function and reduces the amount of exhaled NO and occurrence of cardiovascular events.

Objective To discuss the effect of Yanhuning Injection combined with amoxicillin and clavulanate potassium in treatment of infantile pneumonia.Methods Totally 1 00 infants with pneumonia were selected.They were randomly divided into two groups,the observation group (52 cases) were given Yanhuning Injection combined with amoxicillin and clavulanate potassium.The control group (48 cases) were given Yanhuning Injection.The effect of Yanhuning Injection combined with amoxicillin and clavulanate potassium in treatment of infantile pneumonia was evaluated using efficacy,cough,pulmonary rales disappeared time,pyretolysis time,pulmonary function indexes and adverse reaction during treatment as indexes.Results The effective rate was 92.3％ in the observation group and 75.0％ in the control group.The effective rate in the observation group was higher than that of the control group (P ＜ 0.05).The cough,pulmonary rales disappeared time of the observation group was shorter than that of the control group (P ＜ 0.05).There was no statistical significance on pyretolysis time between two groups.Before treatment,there was no statistical significance on FVC,FEV1 and FEV1/FVC％ between two groups.After treatment,the FVC,FEV1 and FEV1/FVC％ were increased and higher in the observation group (P ＜ 0.05).During treatment,there was no statistical significance on adverse reaction between two group.Conclusion Yanhuning Injection combined with amoxicillin and clavulanate potassium has a good effective on infantile pneumonia.It could improve the symptoms of pneumonia and lung function while inhibiting inflammation with good safety.It was worthy of clinical application.

Objective To investigate the clinical effect of Spleen Aminopeptide Oral Lyophilized Powder on mycoplasma pneumonia in children and its influence in immune function.Methods Totally 103 cases of children infected with mycoplasma pneumonia from May 2013 to June 2016 were selected and divided into observation group and control group,with 53 cases in each group.The control group were treated with azithromycin,and observation group were treated with azithromycin combined with Spleen Aminopeptide Oral Lyophilized Powder.The clinical effect,T cell subgroup (CD4+,CD8+,CD4+/CD8+) levels,serum cytokine levels (IL-10,IL-17,TGF-β1) and safty were compared.Results The total effective rate of the observation group was 94.39％,which was significantly higher than that of the control group of 79.25％ (P ＜ 0.05).After treatment,the levels of CD4+,CD4+/CD8+ in two groups were significantly higher than those before treatment (P ＜ 0.05),and the levels of CD4+,CD4+/CD8+ in observation were higher than those in control group significantly (P ＜ 0.05).The levels of CD8+,IL-10,IL-17,TGF-β1 in two groups were significantly lower than before treatment (P ＜ 0.05),and those indexes in observation were lower than those in control group,the difference was statistically significant (P ＜ 0.05).Conclusion Azithromycin combined with Spleen Aminopeptide Oral Lyophilized Powder has remarkable clinical effect on mycoplasma pneumonia in children,which is cecurity and reliable,and can improve the cellular immune function and reduce the immune injury.

Objective To observe the curative effect of mouse nerve growth factor and its influence on levels of BDNF,IGF-1,and IL-33 in patients with acute cerebral infarction.Methods Totally 106 cases of patients with acute cerebral infarction were chosen as the research objects between October 2015 and February 2017 in Fourth People's Hospital of Langfang City.According to digital list method,the patients were randomly divided into treatment group and control group,53 cases in each group.The patients in two groups were treated with conventional medicine of acute cerebral infarction,and the patients in treatment group were added to mNGF on the basis of conventional drugs,im injection,18 μg each time,once daily.The patients in control group were not added to NGF treatment,and the patients in two groups were treated for 14 d.Before and after treatment,the degrees of neural function defect in two groups were scored according to NIH Stroke Scale (NIHSS),serum levels of brain-derived neurotrophic factor (BDNF),insulin-like growth factor-1 (IGF-1) and interleukin-33 (IL-33) were determinated using enzyme-linked immunosorbent method.Results Compared with those before treatment,NIHSS scores decreased (P ＜ 0.05) after 14 d of treatment in two groups,but the reduced value in treatment group was obviously higher than that in control group (P ＜ 0.05).After treatment,the total effective rate (93.4％) of treatment group was better than that of control group (46.6％),and the difference was statistically significant (P ＜ 0.05).Compared with before treatment,serum levels of BDNF and IGF-1 rised (P ＜ 0.05),IL-33 decreased (P ＜ 0.05) after 14 d of treatment in two groups,but the changes in treatment group were significantly greater than those in control group (P ＜ 0.05).Conclusion mNGF can effectively reduce the severity of nervous functional defects,and effectively increase expression levels of BDNF and IGF 1 and decreasedexpression level ofIL-33.

Objective To develop a method of quantitative analysis of multi-components by single marker (QAMS) for simultaneously determining four compounds in Calonyction muricatum.Method An HPLC method was developed as QAMS to determine ipalbidine,ipalbidinium,and ipalbinium in C.muricatum,using ipalbine as the intermal reference substance,the relative correction factor (RCF) of the three components was determined by HPLC with good reproducibility.Their contents in six batches of samples were determined by both extemal standard method and QAMS.Result No significant differences were found in the quantitative results of three alkaloid compounds in six batches of C.muricatum determined by external standard method and QAMS.Conclusion It is feasible and suitable to evaluate the quality ofcurcuma aromatic by QAMS.