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Clinical study on effect of HCL combined with Bromine Hydrochloride on infantile cough

hua Chun DU ; jin Jia LI ; hui Quan LIAO

Drug Evaluation Research.2017;40(8):1117-1121. doi:10.7501/j.issn.1674-6376.2017.08.016

Objective To investigate the clinical effect of ambroxol hydrochloride combined with cough syrupintegrated traditional Chinese and Western Medicine on infantile cough.Methods Selected 200 cases of patients with cough who were treated in our hospital from January 2012 to December 2015,divided into two groups randomly,100 cases in observation group,100 cases in control group.The observation group was treated with ambroxol hydrochloride combined with cough syrup,the control group were treated with ambroxol hydrochloride.To observe the clinical symptoms and clinical manifestations of the patients after treatment,recorded the time of cough and the disappearance of cough,and to determine the effect of treatment.The lung function indexes of the two groups were detected:peak expiratory flow,forced vital capacity,forced expiratory volume in one second,maximal expiratory flow rate of 50％ vital capacity and maximal expiratory flow rate of 25％ vital capacity.All the patients were followed up for 6 months by telephone or clinic,the recurrence rate of the two groups was observed,and the number of children with asthma were recorded.Results The time of cough and the disappearance time of cough in observation group were significantly shorter than that of the control group (P ＜ 0.05);the total effective rate of observation group was 93.00％ (93/100),significantly higher than that of the control group 74.00％ (74/100) (P ＜ 0.05).After treatment,expiratory flow peak,forced vital capacity,one second forced expiratory volume,vital capacity 50％ of maximum expiratory flow and 25％ of vital capacity maximal expiratory flow of two groups were significantly increased (P ＜ 0.05) and the observation group increased more significantly than the control group (P ＜0.05).After 6 months of follow-up,the control group had 22 cases of recurrence,the recurrence rate was 22.00％;the observation group had 6 cases of recurrence,the recurrence rate was 6.00％,the recurrence rate of the observation group was significantly lower than that of the control group (P ＜ 0.05);the control group had 14 cases of children with asthma,the change rate was 14％;the observation group had 2 cases of children with asthma,the change rate was 2％,the change rate of the observation group was significantly lower than that of the control group (P ＜ 0.05).Conclusion Ambroxol hydrochloride combined with cough syrup has better curative effect on infantile cough,can effectively improve children's lung function,reduce the rate of recurrence and change of asthma,which has high clinical application value.

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Effect of Xihuang Pill on curative effect of paclitaxel combined with platinum based neoadjuvant chemotherapy in patients with advanced cervical cancer after operation

li Xiu SANG ; yan Guo LIU

Drug Evaluation Research.2017;40(8):1112-1116. doi:10.7501/j.issn.1674-6376.2017.08.015

Objective To investigate the effect of Xihuang Pill on the curative effect of paclitaxel combined with platinum based neoadjuvant chemotherapy in patients with advanced cervical cancer after operation.Methods 80 cases of patients with advanced cervical cancer treated in our hospitalfrom January 2014 to January 2017 were enrolled in the study.By random number table method,the patients were divided into the observation group and the control group with 40 cases in each group,and all patients were treated with radical hysterectomy.After operation,the control group were treated with paclitaxel and platinum (cisplatin) based neoadjuvant chemotherapy,while the observation group were treated with Xihuang Pill and platinum based neoadjuvant chemotherapy.The effective rate of chemotherapy,survival rate and recurrence rate were compared between the two groups.The levels ofT lymphocyte subsets (CD3+,CD4+,CD8+) and immunoglobulin (IgA,IgG,IgM) in two groups were determined before and after chemotherapy.The quality of life and cancer pain degree were evaluated with the Kamofsky Performance Scale (KPS) and the numeric rating scale (NRS),and adverse reactions were recorded.Results The effective rate of chemotherapy was slightly higher in the observation group than the control group (87.50％ vs 77.50％).Three months and six months after chemotherapy,the survival rate and recurrence rate showed no significant difference between the two groups.After chemotherapy,percentages of CD3+ and CD4+,levels of IgA,IgG and IgM were significantly higher in the observation group than the control group (P ＜ 0.05),and the percentage of CD8+ was lower than the control group (P ＜ 0.05).After treatment,KPS score of the observation group was significantly higher than the control group,and NRS score was significantly lower than the control group (P ＜ 0.05).The incidence of adverse reactions was significantly lower in the observation group than the control group (7.50％ vs 25.00％) (P ＜ 0.05).Conclusion Xihuang Pill combined with cisplatin based neoadjuvant chemotherapy is effective in the treatment of advanced cervical cancer after operation.The regimen can improve the immune function and quality of life,relieve pain degree and reduce adverse reactions.It will not increase the short-term survival rate and recurrence rate,and long-term efficacy needs further study.

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Investigation of hypertension special crowd antihypertensive drug choice

liang Shao WU ; sai Bao LI

Drug Evaluation Research.2017;40(8):1107-1111,1129. doi:10.7501/j.issn.1674-6376.2017.08.014

Hypertension is a common chronic cardiovascular disease,which is a serious threat to patient's health.The choice of antihypertensive drugs are multiple,different doctors hold the different views.The research surveyed our hospital's clinicians in order to understand the selection of drugs in hypertension prevention and treatment.According to the research,we intended to regulate the clinical drug use,improving the rational use of drugs,and benefit patients.

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Establishment of hanging drop 3D cell culture model in cell culture plate and comparison of cell viability detection methods

He LIN ; qiu Wan WANG ; yuan Jia JIAO ; shen Hao YANG ; xiang Li REN ; guo Li XING

Drug Evaluation Research.2017;40(8):1103-1106. doi:10.7501/j.issn.1674-6376.2017.08.013

Objective To establish a hanging drop 3D cell culture model of human colon cancer cell (HT29) in 48-well cell culture plate,at the same time,through the comparison of several cell viability detection methods to determine the appropriate one for this cell culture way.Methods HT29 cells of 2 375,3 164,4 218,5 625,7 500 and 10 000/well were seeded in the bottom of the 48-well culture plate to form droplets.After 2 d of inversion culture,the cell spheroids were formed and incubated in medium for another 3 d.The volume of cell spheroids were measured,and the absorbance (A) values were detected through APH assay,MTT assay,MTT assay after digestion,CCK-8 assay and CCK-8 assay after digestion.The results were compared among different methods.Results After 5 d of culture,the cell spheroids were formed perfectly at the density of 2 375-10 000/well,and the volumes were in good linear with the original cell inoculation number at the density of 2 375-7 500/well.The A values of APH assay,MTT assay after digestion and CCK-8 assay after digestion increased with the increase of cell inoculation amount;But the cell ball digestion process was complex,and the cell viability was damaged.However,the A values of MTT and CCK-8 assay increased slowly.Conclusion The method of a hanging drop 3D cell culture model in 48-well culture plate combining with APH assay to detect cell viability is economical,accurate and easy to operate.

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Correction of matrix effect in determination of heavy metal elements in iron dextran by icp-oes internal standard method

Chao MA ; Ce MENG ; xia Cai ZHANG ; yi Xin CHENG ; Bo WANG ; wen Xia REN

Drug Evaluation Research.2017;40(8):1098-1102. doi:10.7501/j.issn.1674-6376.2017.08.012

Objective To establish a method for the determination of 8 heavy metal elements of Pb,Cd,As,Hg,Co,V,Se,Mo in iron dextran by inductively coupled plasma optical emission spectrometry (ICP-OES).Method Through selection of detection wavelengths,optimization of instrument parameters,verification of matrix effect interference and investigation of internal standard for correction of matrix effect interference,the 8 heavy metal elements were analyzed by ICP-OES.Results The recovery rate of the detected elements were increased from 83％-90％ to 94％-100％,after correction of matrix effect interference by internal standard method.The accuracy of the method were good.The spiked recoveries of the detected elements were from 94.3％ to 101.5％.The precision of the method were good (RSD ＜ 3.5％,n =6).The linearities of the detected elements were good,and the correlation coefficients were all greater than 0.999.The detection limits were from 0.22 to 8.54 ng/mL.The quantization limits were from 0.68 to 25.73 ng/mL.Conclusion The established method was accurate,sensitivity,rapid and reliable,which can be applied to the determination of contents of 8 heavy metal elements in iron dextran.

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Immunosuppressive effect of curcumin on skin transplantation in mice

guo Hong ZHANG ; ping Jun CAO ; lian Jun SHU ; xia Wen LIU ; Yi MA

Drug Evaluation Research.2017;40(8):1082-1085. doi:10.7501/j.issn.1674-6376.2017.08.008

Objective To investigate the immunosuppressive effect ofcurcumin on xenogenic skin transplantation in mice.Methods The skin transplantation model was established by an operation,tergal skin flaps from BALB/c donor mice transplanted to the back of C57BL/6 recipient mice.Then recipient mice were divided into five groups at random,namely sham,model,curcumin (50 mg/kg),Cyclosporin A (10 mg/kg) and curcumin + Cyclosporin A (50 mg/kg + 5 mg/kg).All mice were ip administered once daily for 10 d.The survival days of skin graft were recorded in all groups.The interleukin-2 (IL-2) levels in plasma of all mice were determined by ELISA 4 and 8 d after the operation,respectively.Results The mean survival time of skin graft in curcumin,Cyclosporin A and curcumin + Cyclosporin A groups were 14.77,16.81 and 19.96 d,respectively,which showed significant.differences comparing with 12.10 d of model group (P ＜ 0.01).Combination of curcumin and Cyclosporin A administration showed a longer mean survival days than curcumin or Cyclosporin A group (P ＜ 0.05 or 0.01).The IL-2 levels in plasma of mice in curcumin,Cyclosporin A and curcumin + Cyclosporin A groups on postoperative day 4 were 3.68,2.05 and 2.70 ng/mL,respectively,which were significantly reduced than 4.76 ng/mL of model group (P ＜ 0.05 or 0.01).The IL-2 levels in plasma of mice in curcumin,Cyclosporin A and combination of curcumin and Cyclosporin A groups on postoperative day 8 were 4.06,2.11 and 2.95 ng/mL,respectively,which were significantly reduced than 5.85 ng/mL of model group (P ＜ 0.01).Conclusion Curcumin may have a good immunosuppressive effect on mice with xenogenic skin transplantation.

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Neuroprotective effects and mechanisms of Cerebroprotein Hydrolysate for Injection (Ⅰ) on vascular dementia in rats

long Xiao JING ; Li MA ; ming Lei REN ; bao Yan HOU ; Yan HUANG ; yong Shuang SUN ; Jing LIU ; ping Xiu SHEN

Drug Evaluation Research.2017;40(8):1078-1081. doi:10.7501/j.issn.1674-6376.2017.08.007

Objective To investigate the neuroprotective mechanisms of Cerebroprotein Hydrolysate for Injection (Ⅰ) on vascular dementia in rats.Method The rat vascular dementia model was prepared using an improved two-vessel occlusion method,and the common carotid artery was only isolated but not blocked in sham group.Rats were randomly divided into sham group,model group,Cerebroprotein Hydrolysate for Injection (Ⅰ) groups with low,medium and high dose (5,10,20 mg/kg) and Cerebroprotein Hydrolysate Injection group (Cerebrolysin,Positive drug,10 mg/kg).The drug was administered by iv injection of rat tail vein once a day for two weeks,while the same volume of saline was administered in sham and model group.At the end of administration,the plasma was collected through abdominal aorta to separate serum,and rat cortex was isolated to prepare homogenate.The levels of nerve growth factor (NGF) and insulin-like growth factor 2 (IGF-2) in serum and level of gamma-aminobutyric acid (GABA) in cortex were detected by ELISA.Level of glutamate (Glu) in cortex of VaD rats was detected by colorimetry.Results Compared with model group,levels of NGF and IGF-2 in the serum of VaD rats and level of GABA in cortex were significantly increased,while level of Glu in cortex was significantly decreased after administration of Cerebroprotein Hydrolysate for Injection (Ⅰ).The increased IGF-2 and GABA levels by Cerebroprotein Hydrolysate for Injection (Ⅰ) were significantly higher than that of Cerebrolysin at same dose.Conclusion The mechanisms underlying the increased leaming and memory ability of VaD rats by Cerebroprotein Hydrolysate for Injection (Ⅰ),are possibly related to the increased levels of NGF and IGF-2 in body and a regulation of the balance between excitatory and inhibitory amino acid neurotransmitters.

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Study on intestinal absorption of aqueous extract from Chaihu Shugan San

Yang LIU ; Yang ZHAO ; Meng YU ; mei Hong JIA ; yan Li MA ; mei Zhong ZOU

Drug Evaluation Research.2017;40(8):1059-1066. doi:10.7501/j.issn.1674-6376.2017.08.004

Objective To evaluate the intestinal absorption of main components (paeoniflorin,ferulic acid,narirutin,naringin,neohesperidin,and glycyrrhizic acid) in aqueous extract of Chaihu Shugan San (CSS).Methods UPLC method was established to simultaneously determine the concentrations of the six components in the test samples of everted gut sacs and in situ single pass intestinal perfusion (SPIP) models.Absorption kinetics parameters were calculated for describing their absorption characteristics.Results In SPIP model,the results indicated that ferulic acid was the well-absorbed ingredient in whole small intestine,while other ingredients presented moderate or poor absorption.In everted gut sacs model,paeoniflorin in jejunum,ferulic acid,naringin,and neohesperidin in duodenum,narirutin in duodenum and jejunum,had the best absorption,while there was no significant difference in absorption of glycyrrhizic acid in the intestine.Condusion In vivo model indicated that the main constituents in CSS could be absorbed in intestinal wall of rat,ferulic acid could be much more easily penetrated intestinal wall into the blood circulation than the other five components.Ex vivo model could further articulate that six index components could be absorbed selectively in different intestinal segments.

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Technology development of immunogenicity assessment for biopharmaceuticals

Ying HUANG ; Hua JIANG ; lu Lu LI ; Wei LI ; Xin WANG ; Yan HUO

Drug Evaluation Research.2017;40(7):999-1004. doi:10.7501/j.issn.1674-6376.2017.07.025

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.

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Utilization of traditional Chinese medicine injections for invigorating blood circulation and eliminating stasis with acute cerebral infarction in Ezhou Central Hospital from 2015 to 2016

Wei LI ; Jian SHEN ; wei Hong HOU ; Hua LIAO

Drug Evaluation Research.2017;40(7):993-998. doi:10.7501/j.issn.1674-6376.2017.07.024

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.

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