Chinese Journal of Clinical Pharmacology and Therapeutics

Problems and countermeasures in the supervision of clinical trials of medical devices

LI Xiao, LIU Yang, WANG Xinyi

2018, 23(8): 841-845. doi:10.12092/j.issn.1009-2501.2018.08.001

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In recent years, China's clinical trial supervision of medical device has achieved certain results. However, there are still some problems in the supervision of medical device clinical trials. For example, there are a large number of medical device products for clinical trials, regulatory responsibilities are not clear, clinical trials lack technical guidance, and clinical trial sponsor, investigator, CRO lack Compliance awareness. This paper analyzes the problems found in the supervision level of medical devices clinical trials in China, and gives some suggestions to solve the problems based on the supervision subjects, which has certain guiding significance for the relevant parties of medical instrument registration.

Effects of miR-1-3p/206/613 on the expression of LXRα and OATP1B1 proteins and its mechanism

YE Rongfang, LIU Mingyi, XU Yu, ZHANG Yanli, ZHU Dandan, DING Wei, XIONG Yuqing

2018, 23(8): 846-854. doi:10.12092/j.issn.1009-2501.2018.08.002

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AIM: To explore the effect of miR-1-3p, miR-206 and miR-613 on the expression of LXRα and OATP1B1 proteins, and the effect of them on the transporting function of OATP1B1 and further to explore the molecular mechanisms underlying the above effects. METHODS: Bioinformatics databases were used to predict the potential miRNAs targeting on the 3'-UTR of LXRα and OATP1B1 mRNA; the levels of miR-1-3p/206/613,LXRα and OATP1B1 proteins were detected by RT-qPCR and Western blotting; the content of rosuvastatin in HepG2 cells was detected by LC-MS/MS; Dual-luciferase reporter assays was used to study the molecular mechanism in which miR-1-3p/206/613 affect the expression of LXRα and OATP1B1.RESULTS:The predicted results showed that miR-1-3p/206/613 has perfect complementary with 3′-UTR of LXRα and OATP1B1 mRNA, which has relatively high specificity,conservation and binding stability. Compared with the control group, miR-1-3p/206/613 mimics could significantly down-regulate LXRα protein level in HepG2 cells by 16.5%,16.0% and 25.1%, OATP1B1 protein level by 30.4%, 30.5% and 44.4%, respectively. On the contrary, miR-1-3p/206/613 inhibitors significantly upregulated LXRα protein level by 13.3%,13.3% and 16.0%,OATP1B1 protein level by 25.0%,25.6% and 30.4%. When the concentrations of RSV were 5,60 and 125 μmol/L, miR-1-3p/206/613 mimics significantly reduced the uptakes of RSV in HepG2 cells to 0.50,0.19,0.30 fold,0.49,0.24,0.23 fold,0.64,0.48,0.31 fold of the control group, respectively; In contrast,miR-1-3p/206/613 inhibitors upregulated the uptakes of RSV by 1.26,1.59,2.07 fold,1.97,2.44,2.63 fold,2.22,2.86,2.93 fold.Compared with the control group, miR-1-3p/206/613 mimics or miR-1-3p/206/613 inhibitors decreased the luciferase activities of pGL/LXRα-WT reporter gene by 38.5%,32.5%,2.8% or increased by 137.0%,75.8%,55.7%.But they had no obvious effect on the luciferase activity of pGL/LXRα-Mut reporter gene. As above, the luciferase activities of the pGL/OATP1B1-WT reporter gene decreased by 24.3%, 28.9%,32.1% or increased by 33.5%,48.3%,61.6%,respectively.But they had no obvious effect on the luciferase activity of the pGL/OATP1B1-Mut reporter gene. CONCLUSION: miR-1-3p/206/613 can regulate the expression of OATP1B1 protein and transporting function of OATP1B1 by directly targeting the 3'-UTR of OATP1B1 mRNA, and can also exert indirect regulation through targeting the 3'-UTR of LXRα mRNA.

Effects and mechanisms of nicotinic acid curcumin on apoptosis induced by low shear stress in human umbilical vein endothelial cells

2018, 23(8): 855-861. doi:10.12092/j.issn.1009-2501.2018.08.003

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AIM: To investigate the effect of curcumin nicotinate（CN）on apoptosis of human umbilical vein endothelial cells (HUVECs) induced by low shear stress (LSS)and its mechanism. METHODS: A parallel plate flow chamber was used to establish a model of HUVECs apoptosis induced by low shear stress. Hoechst33258 fluorescence staining and flow cytometry were used to detect the effects of curcumin on the apoptosis of HUVECs. Western blot was used to detect the expression of proprotein convertase subtilisin/kexin type 9. RESULTS:Hoechst 33258 fluorescence staining showed that the number of HUVECs with apoptotic status in the LSS group was significantly higher than that in the static culture group. Compared with the LSS group, the HUVECs showing apoptotic status in the CN+LSS group were significantly reduced and showed a concentration-dependent manner. Among them, the least number of apoptotic cells was in 20 μmol/L CN+LSS group. Flow cytometry results showed that compared with the static culture group, the apoptosis rate of the LSS group was significantly increased, and the difference was statistically significant (P<0.01); compared with LSS group, the apoptosis rate of HUVECs in CN+LSS group was significantly reduced and showed a concentration-dependent manner. Among them, the decrease of apoptotic rate with 20 μmol/L CN+LSS group was the most obvious, the difference was statistically significant (P<0.01). Western blot results showed that compared with static culture group, PCSK9 protein expression was significantly increased in LSS group, and the difference was statistically significant (P<0.01). Compared with the LSS group, the expression of PCSK9 protein in the CN+LSS group was decreased and showed a concentrationdependent manner. The difference was statistically significant (P<0.05). Among them, the expression of PCSK9 protein was significantly decreased in 20 μmol/L CN+LSS group (P<0.01). CONCLUSION: CN inhibits the apoptosis of HUVECs induced by LSS, and its mechanism is related to down-regulation of the protein expression of PCSK9 in HUVECs under the action of LSS.

Expression of PKD1 and PKD3 genes in heart tissue during early embryonic development in mice

ING Ran,XIE Qiying,LI Fei,DENG Guiyuan,LONG Tianyi,ZOU Juanlin,OUYANG Kunfu

2018, 23(8): 862-866. doi:10.12092/j.issn.1009-2501.2018.08.004

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Effects of trichostatin A on CD14+ monocytes activation and TLR4 signal pathway

WANG Yang, DU Pei, GAO Keqin, YANG Shuang, JIA Sujie

2018, 23(8): 867-873. doi:10.12092/j.issn.1009-2501.2018.08.005

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AIM: To study the effects of trichostatin A (TSA) on CD14⁺ monocytes activation and TLR4 signal pathway. METHODS: CD14⁺ monocytes were isolated from healthy donors and cultured in 1640 medium with 20 nmol/L TSA. After 24 hours, cells were harvested to detect the expression of TLR4 and downstream cytokines by RT-qPCR and flow cytometry methods. ChIP-qPCR was used to detect histone H3 acetylation level TLR4 promoter. Transwell and adhesion experiments were performed to assess the motility and adhesion ability of CD14⁺ monocytes. RESULTS: TSA treatment can increase the motility and adhesion ability of CD14⁺ monocytes. Expression of TLR4 and down-stream cytokines, including TNF-α, MCP-1 and IL-6, were up-regulated in CD14⁺ monocytes after TSA treatment. Higher acetylation of histone H3 within TLR4 promoter region was also detected in CD14⁺ monocytes after TSA treatment. CONCLUSION: TSA activates CD14⁺monocytes, promotes the expression of genes in TLR4 signal pathway and increases the histone H3 acetylation of TLR4 promoter.

Effects of Shenggu zaizao pills on VEGF and FLT-1 expression in steroid-induced avascular necrosis of femoral head in rabbits

CAO Linzhong, WANG Xiaomin, ZHANG Hulin, GUO Chenglong, SU Lianglei, LIU Xinyu

2018, 23(8): 874-880. doi:10.12092/j.issn.1009-2501.2018.08.006

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AIM: To explore the intervention mechanism of Shenggu zaizao pills on the steroid induced avascular necrosis of femoral head (SANFH) of rabbit by investigating its effect on vascular endothelial growth factor (VEGF) and its receptor FLT-1. METHODS: Ten Japanese rabbits were randomly selected as blank normal group (group A).The remaining 70 Japanese rabbits were chosen to establish SANFH model, and were administered with low doses of Escherichia coli endotoxin (LPS) combined with high dose of Hormone, four died during the modeling process. Two weeks after establishing model, six Japanese rabbits were randomly selected and sacrificed by air vein injection. HE staining was applied to the pathological sections, and the pathological change of femoral head tissue was observed under high power (×400) optical microscope. When it is confirmed that SANFH model was established successfully, the remaining Japanese rabbits were randomly divided into 4 groups: model group (group B), and low-, medium- and high- dose of Shenggu zaizao pills (group C, D, E), twelveJapanese rabbits in each group. RESULTS:HE pathological sections showed that the number of empty lacuna in B group was the highest at the same time point, and it was more significantly reduced in group C, D and E as compared with group B (P＜0.05)；With time passing，group C, D and E were more significantly reduced as compared with early weeks (P＜0.05). CONCLUSION: Shenggu zaizao pills can promote angiogenesis by up-regulating the expression of VEGF and its receptor FLT-1, which assists the repair of necrotic bone tissue.

Effects of the pirfenidone eye drops for rat corneal scarring after acute alkali burn

ZOU Zhikang, WU Gongfa, QIU Lizhen, LIU Yujun, HUANG Qiting, ZENG Yuting

2018, 23(8): 881-885. doi:10.12092/j.issn.1009-2501.2018.08.007

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AIM: To study the efficacy of pirfenidone on corneal scarring after acute alkali burn in rat model. METHODS: Thirty adult healthy SD rats were random selected for the experiment. Ten rats were used as control group. Twenty rats were used to make acute alkali burn model on the left eye, and divided into PFD and PBS group(10 rats each group) after successful modeling. The PFD group was treated with pirfenidone eye drops (3 mg/mL), and PBS group was treated with phosphate buffered saline, the treatments of the left eye were administered 4 times daily and continued for 14 days. At 14 d post-therapy, the corneal haze was analyzed by slit lamp microscope, and then all rats were killed and their left cornea was removed. HE staining was used to observe all groups of the structure of the corneal tissue. The presences of blood vessels in the corneal tissue were observed by immunohistochemical CD34 staining. The expressions of TGF-β1 protein in the cornea were examined by Western blot. RESULTS: The score of corneal haze in PFD group (0.30±0.48) was significantly lower than that in PBS group (3.40±0.52, P<0.05). HE staining showed that there were many inflammatory cell infiltrations and proliferation of fibrous tissue in the corneal tissue of PBS group, while the morphology and structure of corneal tissues in the PFD group had no significant pathological changes. PFD group showed lower microvessel quantity than the PBS group. PFD group down-regulated TGF-β1 protein expression as compared with PBS group. CONCLUSION: PFD can significantly inhibit corneal scarring after acute alkali burn in rat model by down-regulating TGF-β1 expression and inhibiting the corneal neovascularization.

Inhibition of isofraxidin from sarcandra glabra on the breast cancer stem cells via Bcl-2 and Caspase signaling pathway

LI Hong, CHEN Jing, LI Dan, YU Wentao, LIU Zhengwei, NI Feng

2018, 23(8): 886-892. doi:10.12092/j.issn.1009-2501.2018.08.008

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AIM: To investigate the effects of isofraxidin from sarcandra glabra on the expression levels of Bcl-2, Caspase-3 and Caspase-8 which are related with the apoptosis in breast cancer stem cells. METHODS: The breast cancer stem-like cells were enriched from MDA-MB-231 cell lines using the serum-free culture method, and the CD44⁺/CD24 ^-/low subpopulation was sorted using the flow cytometry. After 0, 17, 50, 150 and 450 μmol/L isofraxidin were administrated to each group, the cell viability were detected using CCK-8 reagent, the width of cell wound was continuously recorded via microscopic photograph, and the total cell apoptosis rates were recorded using Annexin V-FITC/PI staining. The mRNA and protein levels of Bcl-2, Caspase-3 and Caspase-8 were measured using Real-time quantitative PCR and Western blot, respectively. RESULTS: Significantly lower rates of proliferation were observed in 50, 150, and 450 μmol/L isofraxidin group at 24, 48 and 72 h. 50, 150 and 450 μmol/L isofraxidin given for 48 h results in the decline of cell migration and increase in the rate of apoptotic. For the levels of mRNA and protein, Bcl-2 gene of 50, 150 and 450 μmol/L group was higher than that of the control, nevertheless, caspase-3 and caspase-8 gene of these groups were lower than those of the control. All the data showed a clear-cut dose-effect relationship. CONCLUSION: The up-regulation of Bcl-2 and the down-regulation of Casepase-3/8 genes are related with the apoptosis, proliferation inhibition and reduced migration of breast cancer stem cells after isofraxidin treatment.

Effects of beta-adrenergic receptor blockers and COX-2 inhibitors on liver metastasis of colorectal cancer

LI Minjiang, CHEN Dong, CHEN Wenbin

2018, 23(8): 893-899. doi:10.12092/j.issn.1009-2501.2018.08.009

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AIM: To study the role and potential mechanism of β-adrenergic receptor blockers and COX-2 inhibitors in liver metastasis of colorectal cancer. METHODS: The effect of different concentrations of β-adrenoceptor blockers and COX-2 inhibitors on colon cancer cell proliferation, VEGF secretion and ROS expression were investigated by in vitro colorectal cancer cell experiments. Then, animal models of liver metastasis of colorectal cancer were performed. The tumor metastasis rate, tumor number, maximum tumor weight, maximum tumor diameter, and VEGF mRNA were measured. RESULTS:β-adrenergic receptor blockers and COX-2 inhibitors had significant proliferation-inhibitory effects on colon cancer cells in a dose-dependent manner. When the concentration of β-adrenergic receptor blocker was 200 μmol/L, the tumor cell proliferation inhibition rate was (39.00±2.00)% and the VEGF secretion was (55.44±7.65) pg/mL. And the tumor cell proliferation inhibition rate was (33.67±1.15)%, and the VEGF secretion was (37.75±4.08) pg/mL when the concentration of COX-2 inhibitor was 2 μmol/L. The difference was statistically significant in each group (P<0.05). Compared with the use of β-adrenergic receptor blockers, the use of COX-2 inhibitors significantly inhibited the growth of liver metastases, the difference was statistically significant (P<0.05).Combining β-adrenergic receptor blockers with COX-2 inhibitors could effectively reduce tumor maximal weight, size, and VEGF mRNA expression levels ［（0.20±0.13）g, （1.98±0.33）mm and 0.22±0.06］ as compared with the control group ［（0.88±0.13）g, （5.45±0.88）mm and 1.03±0.14］ and the β-adrenergic receptor blocker group ［（0.50±0.16）g,（3.45±0.45）mm and 0.75±0.08］ and the COX-2 inhibitor group ［（0.34±0.09）g, 2.73±0.24）mm and 0.50±0.08］, the difference was statistically significant (P<0.05). CONCLUSION: In the process of hepatic metastasis of colorectal cancer, β-adrenergic Receptor blocker and COX-2 inhibitors promote tumor cell apoptosis by regulating tumor expression of ROS, regulating VEGF secretion in tumor cells through synergistic action, and inhibiting neovascularization and migration of tumor cells.

Effects of polymorphism of vascular endothelial growth factor A on the prognosis of colorectal cancer patients received fluorouracil based adjuvant chemotherapy

LI Xiaojie,ZHANG Shengwei,WANG Huasheng,WANG Dong, MEI Jiazhuan, DENG Yewei

2018, 23(8): 900-904. doi:10.12092/j.issn.1009-2501.2018.08.010

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AIM: To investigate the association between VEGF-A gene polymorphism and prognosis in patients with colorectal cancer. METHODS: This study was a retrospective analysis involved 149 patients with colorectal cancer who were underwent surgical treatment and received fluorouracil based adjuvant chemotherapy. Peripheral blood of the CRC patients was collected before surgery used to extract genomic DNA and the genotyping of -94C>G was carried out with PCR-RFLP. The genotype results of 149 patients were further verified and included in the final analysis. The correlation of -94C>G genotype and other variables was analyzed by logistic regression model. The univariate analysis of genotype and prognosis was carried out by Kaplan-Meier survival analysis, and multivariates were adjusted by Cox regression analysis.RESULTS:The prevalence of -94C>G in VEGF-A among the Chinese population are as follows: the GG genotype 62 cases (41.6%), CG genotype 61 cases (40.9%) and CC genotype 26 cases (17.4%), minimum allele frequency was 0.38. The distribution of three genotypes in accordance with Hardy-Weinberg Equilibrium (P=0.113). There were no statistical differences in the distribution of the three genotypes in baseline clinical data. The survival analysis of patients with different genotypes found that the 5 years OS rates of patients with CC genotype was significantly lower, which was statistically significant compared with those of GG/CG genotypes (P=0.022). Adjusted in multivariate Cox regression analysis, CC genotype was an independent factor for OS (OR=3.76, P=0.015). CONCLUSION: Among patients with colorectal cancer, the mutant homozygous CC genotype of VEGF-A -94C>G has independent influence on the prognosis of CRC patients.

Pharmacokinetic of piperacillin/tazobactam in patients with sepsis during continuous venovenous hemodiafiltration

CAI Yun, XU Jinlong, ZHANG Mao

2018, 23(8): 905-911. doi:10.12092/j.issn.1009-2501.2018.08.011

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AIM: To evaluate the pharmacokinetic of piperacillin/tazobactam in patients with sepsis during continuous venovenous hemodiafiltration and to analyse the influencing factors. METHODS: The patients with sepsis requiring CRRT in the intensive care units in a general hospital during June 2014 to May 2016 were enrolled as the subjects. First dose of piperacillin-tazobactam（4.5 g） was administered intravenously over 30 min. Blood samples were taken at 0, 15, 30, 45, 60, 90, 120, 180, 240, 360, 480 min after infusion.The concentrations of piperacillin and tazobactam were determined by high-performance liquid chromatography（HPLC）, PK analysis was conducted using a non-compartmental approach, the DAS 3.2.1 software was used to calculate pharmacokinetic parameters, Linear regression analysis was used to analyze the relationship between patient characteristics/CRRT parameters and pharmacokinetics.Blood concentration maintained above the minimum inhibitory concentration (MIC) for 50%(f%T_＞MIC＞50%) as a pharmacodynamic target. RESULTS: Eight patients with sepsis receiving CVVHDF were included in the investigation. The maximum concentration (C _max) of piperacillin and tazobactam was 116.11（98.03-152.29）and 21.60（15.9-29.69）mg/L,respectively; The volume of distribution (V_d) was 1.05（0.70-1.56）and 0.69（0.56-0.78）L/kg, respectively; The elimination half-time (t_1/2) was 4.79（3.30-8.27）and 4.38（3.35-5.52）h, respectively; The total clearance rate (CL) was 7.67（5.66-9.71）and 6.11（4.36-10.03）L/h, respectively. In the multivariate analysis, the most significant factor associated with Cmax of piperacillin was replacement flow rate (β：-0.854，95%CI：-0.148--0.036，P=0.007), the most significant factor associated with CL of piperacillin was effluent flow rate（β：0.883，95%CI：0.133-0.433，P=0.004）.When MIC≤16 mg/L, all patients reached pharmacodynamic target, when 16 mg/L＜MIC＜32 mg/L, just 5 patients (62.5%) reached the target, while MIC≥64 mg /L, no patient reached the target. CONCLUSION: Both piperacillin and tazobactam for patients with sepsis receiving CVVHDF show significantly lower C _max, significantly longer t_1/2, and decreased CL. CL and t_1/2 remain consistent. When germ's MIC＞32 mg/L, the first dosage of 4.5 g piperacillin/ tazobactam may be not enough.

Clinical effect of Bailing capsule in children with diabetic renal injury

ZHU Tingfu, ZOU Chaochun

2018, 23(8): 912-915. doi:10.12092/j.issn.1009-2501.2018.08.012

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AIM: To evaluate the clinical effect of Bailing Capsule in children with diabetic renal injury. METHODS: Forty-eight cases of children with diabetic renal injury were randomly divided into control group and treatment group, 24 cases in each group. On the basis of routine treatment, the control group was given insulin, 0.5 U/kg, 3 times/d, subcutaneous injection; on the basis of the control group, the treatment group was treated with Bailing capsule, 1.0 g/time, 3 times/d, oral. Serum creatinine (SCr), blood urea nitrogen (BUN), beta2 microspheres (beta2-MG), bone morphogenetic protein 7 (BMP-7) and urinary albumin excretion rate (UAER) levels, and efficiency of treatment were compared between groups before and after treatment. RESULTS: After treatment, compared with the control group, the serum levels of SCr, BUN and UAER were lower in the treatment group (P<0.05); the serum level of β2-MG was lower and the serum level of BMP-7 was higher in the treatment group (P<0.05); the treatment efficiency of the treatment group (91.67%) was significantly higher than that of the control group (70.83%), the results were statistically significant. CONCLUSION: Bailing capsule can significantly reduce the serum level of β2-MG and improve the serum level of BMP-7 renal function and clinical efficacy in children with diabetic renal injury.

Analgesia effect of small amount of buprenorphine on children undergoing laparoscopic hernia repair under general anesthesia

YING Haifeng, ZHANG Weiping, YOU Kuangzhang, CHEN Lingyang

2018, 23(8): 916-921. doi:10.12092/j.issn.1009-2501.2018.08.013

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AIM: To investigate the analgesia effect of small amount of buprenorphine on children undergoing laparoscopic hernia repair under general anesthesia. METHODS: From January 2016 to June 2017, sixty-two children undergoing laparoscopic hernia operation under general anesthesia in our hospital were randomly divided into control group and study group, with 31 cases in each group. The study group received buprenorphine 3 μg/kg on the induction of anesthesia, and the control group received equal amount of saline. Inflammatory cytokines, immune function were detected at Pre infusion (T₀), postoperative 6 h (T₁), 12 h (T₂), and 24 h (T₃), and pain and sedation scores as well as the clinical index and agitation classification were observed and compared after the operation. RESULTS: Compared with T₀, levels of serum CRP, TNF-α and Cor in the control group increased at T₁, T₂, and T₃; levels of CD₄⁺, CD₈⁺, CD₄⁺/CD₈⁺ decreased; levels of serum CRP, TNF-α and Cor in the study group increased at T₂, and T₃; levels of CD₄⁺, CD₈⁺,CD₄⁺/CD₈⁺decreased (P＜0.05). Compared with the control group, levels of serum CRP, TNF-α and Cor in the study group at T₁, T₂, and T₃ were lower; levels of CD₄⁺, CD₈⁺,CD₄⁺/CD₈⁺were higher (P＜0.05). Compared with T₁, RASS scores in the control group decreased at T₂ and T₃; pain scores and RASS scores in the study group decreased at T₂, T₃. Compared with the control group, pain scores and RASS scores in the study group at T₂, T₃ were lower (P＜0.05), the cough response and agitation scores in the study group were lower than those of the control group (P＜0.05). CONCLUSION: Small amount of buprenorphine has a good analgesic and sedative effects on pediatric laparoscopic hernia repair under general anesthesia by reducing inflammation and improving immune function.

Effects of trimetazidine on serum-homocysteine and serum-gamma-glutamyl transferase level in the cases of stable angina cordis

SHENG Yang, ZHANG Tianjie

2018, 23(8): 922-926. doi:10.12092/j.issn.1009-2501.2018.08.014

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AIM: To investigate the effect of trimetazidine on serum-homocysteine and serum-gamma-glutamyl transferase level in the cases of stable angina cordis. METHODS: A total of 80 cases of stable angina cordis patients were included into this study. Conventional drug therapy for coronary heart disease was used for all the patients. In the treatment group, the additional therapy of 6-month trimetazidine was used. Serum-homocysteine and serum-gamma-glutamyl transferase levels were detected before and after treatment. RESULTS:Compared with data collected before treatment, serum-homocysteine and serum-gamma-glutamyl transferase levels in all the patients were significantly decreased after the 6-month therapy. However, more decreases were found in serum-homocysteine and serum-gamma-glutamyl transferase levels in the patients with additional 6-month trimetazidine as compared with the control group.CONCLUSION: Routine treatment plus trimetazidine can effectively reduce the serum-homocysteine and serum-gamma-glutamyl transferase levels and improve patients-outcomes for the patients with stable angina cordis.

Efficacy and safety of recombinant human interferon alfa2b oxygen inbreathe for bronchiolitis

MAO Qingdong

2018, 23(8): 927-931. doi:10.12092/j.issn.1009-2501.2018.08.015

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AIM: To evaluate the efficacy and safety of recombinant human interferon alfa2b oxygen inbreathe for bronchiolitis. METHODS: Eighty-six children with bronchiolitis were divided into control group and observation group, with 43 cases in each group. The two groups were generally treated in the same way, while the observation group was additionally inhaled with recombinant human interferon alfa2b oxygen drive. At end of the treatment period, the total effective rate, clinical symptoms and signs, hospital stay, adverse reactions, and blood routine and biochemical indexes were observed and compared between the two groups. RESULTS: The total effective rate (95.35%) of the observation group was significantly higher than that of the control group (83.72%) (P<0.05); the duration of clinical symptoms and signs of the treatment group was less than those of the control group (P<0.05); There was no significant difference between the two groups of children in the blood routine, blood biochemical indicators and regarding adverse reactions (P>0.05). CONCLUSION: Recombinant human interferon α2b oxygen inbreathe can improve the clinical cure rate, shorten the hospital stay of bronchiolitis with safety.

Pharmaceutical care on one case of hypobrinogenemia induced by hemocoagulase

YANG Bo, SHI Dawei, ZHENG Zaoqian

2018, 23(8): 932-936. doi:10.12092/j.issn.1009-2501.2018.08.016

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AIM: To investigate the pharmaceutical care of patients with cirrhosis decompensated in the application of hemocoagulase. METHODS: By participating in the treatment of 1 case of cirrhosis with hypofibrinogenemia, clinical pharmacist conducted a pharmacy evaluation according to the evaluation criteria of the National Center for ADR Monitoring. The result indicated an ADR caused by the hemocoagulase. It is recommended to avoid using the relevant drugs and to perform pharmacological monitoring on the patient.RESULTS: Clinical pharmacist provided rational suggestions with professional knowledges, accepted by clinicians, timely and effective treatment of adverse drug reactions, so that patients can be discharged after effective treatment. CONCLUSION: Clinical pharmacists participate in the treatment process of patients with cirrhosis and carry out pharmacy services, which can provide reasonable and effective medication recommendations to ensure the safety of patients.

Analysis of rational usage of meropenem in our hospital

WANG Mengzhi, WEI Yuguang, HUANG Xiaoling

2018, 23(8): 937-941. doi:10.12092/j.issn.1009-2501.2018.08.017

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AIM: To analyze the situation of clinical usage of meropenem in our hospital and to promote the rational usage of meropenem. METHODS: Ninety-seven medical records of meropenem hospitalized in our hospital from January 2016 to December 2017 were retrospectively analyzed for the drug usage, clinical efficacy, adverse reactions, and rationality of medication. RESULTS:Of the 97 patients, the top 3 departments using meropenem were surgical intensive care unit (23 cases, 23.71%), internal medicine intensive care unit (14 cases, 14.43%), and respiratory medicine department (11 cases, 11.34%). Seventy-six cases were cultured with bacteria, the submission rate was 78.35%, the defined daily doses (DDDs) of meropenem were 756.8, the drug utilization index (DUI) was 1.16, the adverse reaction rate was 15.46%, the total effective rate of clinical treatment was 85.57%, and the rational drug usage rate was 87.63%. The irrational drug usage rate was 12.37%, of which the non-indicative drug usage accounted for the highest proportion in all unreasonable drug usage cases. CONCLUSION: The clinical application of meropenem in our hospital is basically reasonable, but there are also cases of irrational usage. Clinical prescribes of meropenem should strictly follow the regulations to reduce experience-directed drug usage, improve the submission rate in order to enhance the efficacy of rational drug usage.

Research progress of PD-1/PD-L1 pathway inhibitor in the immunotherapy of digestive system neoplasm

MENG Qiuhua, TIAN Jing, QIN Feizhang, QIN Yang, DONG Min

2018, 23(8): 942-948. doi:10.12092/j.issn.1009-2501.2018.08.018

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Programmed cell death-1(PD-1) is an important co-inhibitory molecule expressing on T cell that has negative regulations on immune responses. When PD-1 bound to its ligand programmed cell death-ligand (PD-L1), PD-1/PD-L1 pathway can restrain the immune microenvironment, leading to the down-regulation of tumor-specific T cell activity, and contribute to tumor cells avoiding the immune surveillance and immune escape. PD-1/PD-L1 inhibitors may block its signaling pathway and enhance immune responses, thus inhibiting the growth of tumor cells. In this review, we discuss the therapeutics use of PD-1/PD-L1 monoclonal blocking antibodies in the immunotherapy of digestive system neoplasm.

Advances of the ion channels related to depression

WU Mengyao, ZHAO Hongqing, WANG Yuhong

2018, 23(8): 949-954. doi:10.12092/j.issn.1009-2501.2018.08.019

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Depression is a central nervous system disorder characterized by emotion, cognition, neuroendocrine and somatic dysfunction, and is one of the most common mental diseases. Currently, the treatment mechanism of antidepressants mainly focuses on the concentrations of monoamine neurotransmitters in the brain such as serotonin, norepinephrine and dopamine, but depression is still not fully treated. In this paper, the ion channel as the starting point, the depression-related voltage-gated ion channels (such as sodium, potassium and calcium ions, etc.) and ligand-gated ion channels (such as glutamic acid receptor, γ-aminobutyric acid receptor and serotonin receptor, etc.) were reviewed respectively, to provide new ideas for the development of new antidepressants.

Farnesoid X receptor is an important target in lipid metabolism

LIU Xiaohong, LI Ling, QI Zhenhua, CHEN Binyao, ZHAO Huijia, HAO Zhuowen, YUE Jiang, YE Qifa，WU Jianguo

2018, 23(8): 955-960. doi:10.12092/j.issn.1009-2501.2018.08.020

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Farnesoid X receptor (FXR) is a kind of nuclear receptors of bile acid activation. FXR influences lipid in the liver, small intestine, and other important organs of various metabolic processes through regulating the expression of target genes such as CYP7A1. This review focuses on the influence of FXR in lipid metabolism on the basis of the related research reviews in recent years, and hopes to provide a scientific basis for prevention and treatment of clinical diseases as FXR is becoming the expected drug-target for diseases such as fatty liver, high blood triglycerides, etc.

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