1.Etelcalcetide: A new drug for secondary hyperparathyroidism of chronic kidney disease
Fei ZHENG ; Yanli ZHANG ; Qian ZHANG ; Ying GONG ; Yuanyuan GU ; Guodong HUA
Drug Evaluation Research 2017;40(3):428-432
Etelcalcetide (ParsabivTM) is a second generation calcimimetic agent newly developed by Amgen,mainly used for the treatment of secondary hyperparathyroidism.Etetcalcetide not only decreases calcium concentration by directly binding with the calcium sensing receptor,but also reduces the parathyroid hormone level.The European Union has approved for chronic kidney disease patients with secondary hyperparathyroidism in dialysis with Etelcalcetide injection.This paper summarized the pharmacological effects,pharmacokinetics,clinical trials,and adverse reaction of Etelcalcetide.
2.Research progress on nucleoside drugs combination used in clinic against chronic hepatitis B
Can CUI ; Lina ZHAO ; Lin WANG
Drug Evaluation Research 2017;40(3):424-427
Hepatitis B is a serious hazard to human health.This paper describes the current clinical use of several nucleoside antiviral drugs combination,and introduces the candidate drugs which are able to effectively inhibit the hepatitis B virus replication in vivo and in vitro in two years,which provides reference for the research and development of new anti-HBV drugs.
3.Anesthetic effect of intravenous anesthesia with propofol, ketamine, and remifentanil for pediatric orchiopexy
Jinwen GAO ; Meiyu LIN ; Jielian HUANG ; Qunfei ZOU
Drug Evaluation Research 2017;40(3):389-392
Objective To discuss the anesthetic effect of iv injection with propofol for pediatric orchiopexy.Methods Totally 80 children who needed orchiopexy were selected,and were divided into two groups randomly.The control group (39 cases) were iv given propofol and ketamine for anesthesia.The observation group (41 cases) were iv given propofol,ketamine,and remifentanil.The anesthetic effect of propofol for pediatric orchiopexy was evaluated by HR,MAP,SpO2,recovery time,dosage of propofol and ketamine,and postoperative adverse reaction.Results Before the injection and injection for 5 min,there was no statistical significance on MAP,HR,and SpO2 between two groups.Pulling the testicles,the MAP and HR in observation group were lower than those in control group (P < 0.05).There was no statistical significance on SpO2.The recovery time of observation group was shorter than that of control group (P < 0.05).And the dosages of propofol and ketamine in observation group were also less than those in control group (P < 0.05).There was no statistical significance on postoperative adverse reaction between two groups.Conclusion The iv anesthesia with propofol has a good anesthetic effect on the pediatric orchiopexy.The anesthesia is stable and has little effect on vital signs,rapid postoperative recovery without increasing adverse reaction,which is worthy of clinical use.
4.Curative effect of oxaliplatin combined with S-1 in treatment of advanced colorectal cancer
Anmin LI ; Rong SHENG ; Jianfeng XIN
Drug Evaluation Research 2017;40(3):385-388
Objective To analyze the curative effect of oxaliplatin combined with S-1 in the treatment of advanced colorectal cancer.Methods Totally 90 cases of patients with advanced colorectal cancer in Shangluo No.2 Provincial People's Hospital from January 2013 to August 2015 were divided into observation group and control group,45 cases in each group.Patients in control group were treated with oxaliplatin combined with fluorouracil,4 weeks for one cycle of treatment,and patients in observation group were treated with oxaliplatin combined with S-l,21 d for one cycle.The curative effects,adverse reactions,life quality,and one year survival rate were compared between two groups.Results After treatment,the total remission rate of observation group was higher than that of control group,and the disease control rate was lower than that of the control group,but there was no significant difference between the two groups.During the treatment,there were no significant differences in Ⅰ degree and Ⅱ degree adverse reactions between two groups;But the adverse reactions of level Ⅲ and level Ⅳ of gastrointestinal reaction,liver function damage,reduce the incidence of white blood cells in observation group were significantly lower than that of control group (P < 0.05).There was no significant difference between the two groups in the SF-36 scale scores.The one year survival rate of observation group was (21/45),and the survival rate of the control group after treatment was 42.22% (19/45) in the control group,and there was no significant difference between the two groups in the one year survival rate.Conclusion Compared with oxaliplatin combined with fluorouracil,oxaliplatin combined with S-1 has equivalent efficacy and life quality,but the adverse reactions in gastrointestinal tract,liver,and marrow were better.
5.Clinical effect of single use or combination of dydrogesterone and progestin in treatment of threatened abortion caused by uteal phase defect
Lili FAN ; Xiuzhen XUE ; Yongyong ZHANG ; Na JIAO
Drug Evaluation Research 2017;40(3):381-384
Objective To explore the clinical effect of single use or combination of dydrogesterone and progestin in treatment of threatened abortion caused by uteal phase defect.Methods Totally 186 patients with threatened abortion caused by uteal phase defect accepted in The First Affiliated Hospital of Henan from April 2015 to April 2016 were selected and randomly divided into groups A,B,and C with 62 cases in each group.Patients in group A were given dydrogesterone,those in group B were given progestin,and those in group C were given dydrogesterone combined with progestin.Then the clinical effect,expression of hormones,treatment outcome,and adverse reaction were observed and compared.Results The total effective rates of groups A and B were 72.58% and 66.13%,respectively,which were obviously lower than 90.32% of group C with statistically significance (P <0.05).The expression levels of P,E2,and hCG of three groups after treatment were higher than those before,those in group C were the highest among them (P < 0.05).The successful treatment rates of groups A,B,and C were 83.87%,82.26%,and 95.16%,respectively,which had no great difference.Conclusion Combination use of dydrogesterone and progestin has better effective rate in treatment of threatened abortion caused by uteal phase defect compared to single use of these two drugs,which has good safety and worth of clinical application.
6.Curative effect and safety of romethamine combined with dexamethasone on the postpartum hemorrhage for patients with high risk pregnancy
juan Ya SHANGGUAN ; liang Yu ZOU ; jun Chao LI
Drug Evaluation Research 2017;40(10):1472-1476
Objective To explore the curative effect and safety of romethamine combined with dexamethasone on the postpartum hemorrhage for patients with high risk pregnancy.Methods 80 patients with high risk pregnancy were enrolled in our hospital from June 2014 to June 2016,of which patients divided into two group randomly,Group A (n =40) accepted romethamine for hemostasis treatment,and Group B (n =40) adopted romethamine combined with dexamethasone treatment.The clinical effect and hemorrhage of patients with postpartum hemorrhage were compared,and the adverse reactions were recorded and analyzed in the period of treatment.Results After treatment,the difference of total effective rate for postpartum hemorrhage from two groups was no significance.After given medicines 0.5 h respectively in delivery process,the SBP,DBP and HR of all parturient women were rising compared with before medicine administration remarkably (P < 0.05),but the difference of those between two groups was no significance.Within 24 h after delivery,the hemorrhage of Group B was lower significantly than those patients in Group A (P < 0.05).The difference of shock index (SI) from Group A and Group B was no significance.The incidence of nausea and vomiting in Group B was lower than those Group A significantly (P < 0.05),and the case of total adverse reactions in group B was fewer significantly than those Group A (P < 0.05).Conclusions The romethamine combined with dexamethasone for the postpartum hemorrhage in patients with high risk pregnancy deserved popularization in clinic,of which not only possessed remarkably clinical effect and well safety,but also controlled the postpartum hemorrhage effectively and decreased the incidence of the adverse reactions in the period of treatment.
7.Comparison of analgesic effect of ropivacaine and bupivacaine in painless childbirth and effects on maternal stress response
Drug Evaluation Research 2017;40(10):1468-1471
Objective To investigate analgesic effect of ropivacaine and bupivacaine in painless childbirth and response to maternal stress.Methods The voluntary labor analgesia maternal 210 cases in The Fifth People's Hospital of Baoji City from June 2015 to December 2016 were randomly divided into A group and B group.105 cases collected during the same period to take maternal painless childbirth as the control group,A group was given ropivacaine combined with fentanyl anesthesia,B group received bupivacaine combined with fentanyl anesthesia,observe the analgesic effect and the effect on maternal stress response.Results The difference between the groups before anesthesia score VAS was not statistically significant.After anesthesia compared with before anesthesia,A group and B VAS scores were reduced,the control group increased,the difference was statistically significant (P < 0.05).And VAS in A and B group was significantly lower than the control group,the difference was statistically significant (P < 0.05).After evaluation,there was no statistical difference between the two groups in MBS score.1,5 min,Apgar scores were not statistically significant in the 3 groups.Compared with the 1 rain Apgar score,Apgar scores in 3 and 5 min were increased,the difference was statistically significant (P < 0.05).Blood glucose levels in B group and control group were increased (P < 0.05).Cortisol levels in group A and group B before anesthesia were higher than the control group (P < 0.05);A~er anesthesia,cortisol levels in group B was higher than the control group,A group was lower than that in group B (P < 0.05).Before anesthesia,the ratio of insulin/blood glucose in the A group and the B group was lower than that in the control group (P < 0.05),and that in A group and B group afder anesthesia was higher than that in the control group,and the level of A group was lower than that of the B group (P < 0.05).Conclusion maternal analgesia with patient-controlled infusion effect,and can reduce maternal stress reaction,it is worthy of recommendation.
8.Clinical effect of fasudil in heart failure induced by chronic pneumocardial disease and the influence in serum level of NO and ET-1
jun Long MAO ; Ying LI ; Hua QIANG
Drug Evaluation Research 2017;40(10):1441-1444
Objective To investigate the clinical effect of fasudil in heart failure induced by chronic pneumocardial disease and the influence in serum level of NO and ET-1.Methods 100 cases of patients with heart failure induced by chronic pneumocardial disease in our hospital from September 2013 to September 2016 were selected and divided into observation group and control group,50 cases in each group.Patients in the control group were treated with conventional therapy,and in the observation group were treated with fasudil based on the conventional therapy.Compared the clinical effect,blood oxygen partial pressure (PaO2),CO2 partial pressure (PaCO2),tricuspid regurgitation speed,fight ventricular outflow tract inside diameter(RVOT),left ventricular ejection fraction (LVEF) and serum biochemical indexes (NO and ET-1) levels.Results After treatment,the total effective rate of the observation group was significantly higher than control group (P < 0.05).PaO2,LVEF,serum level of NO of the two groups were significantly higher,PaCO2,tricuspid regurgitation speed,RVOT,serum level of ET-1 significantly lower than before treatment (P < 0.05),and the PaO2,LVEF,serum level of NO of observation group were significantly higher,PaCO2,tricuspid regurgitation speed,RVOT,serum level of ET-1 of observation group were significantly lower than control group (P < 0.05).Conclusion Fasudil had remarkable clinical effect in heart failure induced by chronic pneumocardial disease,and improve the patient's clinical symptoms,adjust the serum level of NO and ET-1.
9.Inhibition of Water extract from Jiangtang Decoction on inflammation in KK-Ay mice by PI3K/Akt/NF-κB signaling pathway
ni Jin HONG ; wei Wei LI ; Ning ZHANG ; Hong FU ; mei Xue WANG
Drug Evaluation Research 2017;40(10):1389-1396
Objective To study the effect and mechanism of Water extract from Jiangtang Decoction (WEJTD) on diabetes mellitus and diabetic nephropathy (DN) in spontaneous type 2 diabetes mellitus model KK-Ay mice.Methods Totally 50 KK-Ay mice were randomly divided into five groups:model group,metformin (positive drug,250 mg/kg) group,WEJTD low,medium and high dose (2,4,and 8 g/kg) group,with 10 C57BL/6J mice as normal group.The relative drugs were ig administered once a day for 12 weeks,and mice in control group and model group were perfused with distilled water of equal volume.After 12 weeks' oral administration,mice were put into metabolism cages,and the food-intake,water-intake and urine volume were calculated and collected.Blood were collected to detect the concentration of IL-6,ICAM-1 and TNF-α.Then mice were executed,and HE staining and PASM staining were used to check the effect of WEJTD on kidney.Western blotting and qRT-PCR were used to detect the concentration of PI3K,Akt,NF-κB,IL-6,ICAM-1 and TNF-α in kidney.Results WEJTD can alleviate the symptoms of diabetes,such as food ration,polydipsia and polyuria (P < 0.05,0.01,and 0.001);Relief the pathological changes of kidney and significantly decreased glycogen deposition (P < 0.001),down-regulate the increase of IL-6,ICAM-1 and TNF-α in serum and kidney (P < 0.05,0.01 and 0.001),up-regulate the phosphorylation of PI3K and Akt (P < 0.05,0.01,and 0.001),and inhibit the phosphorylation of NF-κB (P < 0.001).Conclusion WEJTD had positive effects on kidney morphology of KK-Ay,and the underlying mechanism might be related to the regulation of PI3K-Akt and NF-κB-mediated inflammation.
10.Key technologies of clinical study of traditional Chinese medicine on pediatric functional abdominal pain
yan Yu LI ; yuan Si HU ; ting Jian WU
Drug Evaluation Research 2017;40(10):1386-1388
Functional abdominal pain is one of the most common problems in functional gastrointestinal disorders,and it's also one of the diseases benefit most from traditional Chinese medicine (TCM) treatment.This paper illustrates some key considerations on the study design of traditional Chinese medicine intended for the treatment of FAP based on the latest treatment and evaluation guidelines,technical guidance,professional authority works as well as the latest clinical studies,and combined with experience of clinical trial design.It hopes to offer helps for research designers in this genera.

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