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20 December 2017, Volume 14 Issue 12 Previous Issue    Next Issue
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Interference Effect of Sodium Valproate on Hepatocyte Biofunctional Networks Based on Bioinformatics Analysis WU Shou-yan, HUANG Gui-hua,, ZHAO Wen-jing , WANG Bing-shun, GONG Li-kun 2017, 14(12): 705-710.  Abstract ( 390 )   PDF (1076KB) ( 182 )   Objective To investigate the interference of sodium valproate (VPA) on hepatocyte bioprocessing/pathways by using published original data of rat hepatocyte-derived gene microarrays and to provide a basis for further studies on the mechanism of VPA toxicity. Methods Data of GSE40338 from VPA-treated rat primary hepatocytes in NCBI database was analyzed by GCBI online platform. The data was divided into control group and experimental group for differential gene analysis, Gene Ontology analysis and pathway analysis. Results Gene microarray analysis showed that different doses and incubation times of VPA treatment induced different gene regulations on hepatocytes. Further analyses suggest that VPA might interfer with the processes of biological processes, metabolism, development and etc. Pathways associated with development mainly include vasculogenesis, embryonic development, neurodevelopment and organ development. And the enrichments of organ development and neurodevelopment were much stronger than others. Conclusion Genomic analysis of hepatocytes in vitro indicates that in addition to metabolism, VPA can interfere with a variety of biological processes, including disruption of developmental bio-functional networks, implying that it is associated with organ developmental and neurodevelopmental toxicities. This study indicates that in-depth analysis of bio-networks/processes of gene microarray data is of important value in predicting toxicity of a drug and understanding its mechanism. References | Related Articles | Metrics

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Protective Effects of Extracts from Pteris multifida Poir on α-naphthalene Isothiocyanate-induced Liver Injury in Mice LIU Wei , LI Fang-fang, LI Mei ,ZHANG Dan, BAO Xiu-qi , SUN Hua 2017, 14(12): 711-714.  Abstract ( 357 )   PDF (928KB) ( 191 )   Objective To investigate the protective effects of alcohol extracts from Pteris multifida Poir(EPMP) on cholestatic jaundice induced by α-naphthalene isothiocyanate (ANIT) in mice. Methods ICR mice were given EPMP 125, 250 and 500 mg·kg-1 for 5 days orally, once per day. 2 h after administration of medication on the 3rd day, the mice were given ANIT 80 mg·kg-1 orally once. All of the animals were fasted 12 h after the final administration of EPMP, and mice were treated to collect livers and blood. The levels of serum ALT, AST, ALB, ALP, TBIL, DBIL and TBA were measured by automatic biochemical analyzer, and liver tissues were taken for pathological examination. Results ANIT 80 mg·kg-1 significantly increased the activities of plasma ALT, AST, ALP, TBil, DBil, TBA, decreased the levels of ALB and injured liver compared with control group. Upon EPMP 125, 250 and 500 mg·kg-1, the transaminase activity was markedly decreased and the level of ALB was elevated. At the same time, serum bilirubin, TBA and ALP levels were significantly reduced. The HE staining results demonstrated that EPMP remarkably attenuated liver damage including degeneration, necrosis and infiltration of inflammatory cells. Conclusion The extracts from Pteris multifida Poir have significant protective effects on ANIT-induced liver injury and cholestatic jaundice. References | Related Articles | Metrics

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Effects of Nuciferine on Apoptosis of Human Hepatocellular Carcinoma Cell Line HepG2 and Its Mechanism LI Na ,SONG Jin-chun 2017, 14(12): 715-719.  Abstract ( 369 )   PDF (1118KB) ( 178 )   Objective To investigate the effects of nuciferine on apoptosis of human hepatocellular carcinoma cell line HepG2 and its mechanism. Methods The proliferation of nuciferine on HepG2 cells was determined by the assay of cell counting kit-8(CCK-8). The apoptotic morphology of HepG2 cells with Hoechst 33258 staining was observed under fluorescent microscope. Cell cycle distribution and apoptotic rate were evaluated by flow cytomety(FCM). Western Blot analysis was used to detect the protein expression of apoptosis. Results Nuciferine could inhibit the proliferation of human hepatocellular carcinoma cell line HepG2 in a dose and time dependent manner. Hoechst 33258 staining showed that the experimental group of cells shrank, apoptotic bodies formed, blue fluorescence deepened and flow cytometry (FCM) indicated that HepG2 cells were arrested in G0/G1 phase and the apoptotic rate increased with the increase of the concentration of nuciferine. Western Blot result showed that nuciferine inhibited the expression of NF- КB and Bcl-2 proteins while promoted the expression of Bax protein in a concentration-dependent manner. Conclusion Nuciferine could inhibit the growth and proliferation of HepG2 cells in a dose and time-dependent manner and induce the apoptosis of HepG2 cells. Also, HepG2 cells were arrested in G0/G1 phase. Furthermore, up-regulation of Bax protein as well as downregulation of NF-КB and Bcl-2 protein expression may be one of the important apoptotic inducing mechanisms. References | Related Articles | Metrics

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Experimental Comparison Study on Mice's Acute Toxicity of Xuezhining and Its Separated Prescriptions GUO Xin ,HUANG Na-na, LV Li-li , CAI Tao-tao , LI Xiao-yu, , SUN Rong 2017, 14(12): 720-726.  Abstract ( 351 )   PDF (1352KB) ( 136 )   Objective To compare the acute toxicity of Xuezhining and its separated prescriptions in mice and to explore the mechanism of prescription compatibility, so as to provide a foundation for safe and rational drug use in clinic. Methods Xuezhining was divided into seven combinations by referring to the combination of prescription, single flavor and the characteristics of lipid lowering effect, namely Cassiae Semen and Crataegi Fructus (group 1), Cassiae Semen and Nelumbinis Folium (group 2), Cassiae Semen and Polygoni Multiflori Radix Praeparata (group 3), Polygoni Multiflori Radix Praeparata and Nelumbinis Folium (group 4), Cassiae Semen and Crataegi Fructus and Nelumbinis Folium (group 5), Cassiae Semen and Crataegi Fructus and Polygoni Multiflori Radix Praeparata (group 6), Cassiae Semen and Crataegi Fructus and Polygoni Multiflori Radix Praeparata and Nelumbinis Folium (group 7). The classical method of acute toxicity was used to compare the difference of acute toxicity among Xuezhining and its separated prescriptions. Results The maximum dosage (MFD) of all components of seven groups were respectively 39.60, 34.80, 42.00, 21.60, 37.20, 38.40 and 39.60 g·kg-1, which were respectively equal to 19.05, 14.87, 16.15, 11.87, 12.49, 12.31 and 10.15 times of the clinical daily dosage in 70 kg humans. The MFD of water extracted components of all groups referred were respectively 192.00, 320.40, 192.00, 300.00, 218.40, 177.60 and 192.00 g·kg-1, which were respectively equal to 92.31, 136.92, 73.85, 164.84, 73.36, 56.92 and 49.23 times of the clinical daily dosage in 70 kg humans. The sequence of acute toxicity of all-components of all groups is group 4>group 2>group 5>group 6>group 1≈group 7>group 3; The sequence of acute toxicity of water extracted components of all groups is group 6>group 1≈group 3≈group 7>group 5>group 4>group 2. The main acute toxicity symptoms and signs are poor spirit, negligent action and prostrate. Conclusion The results of the acute toxicity of combinations mentioned above were less than Cassia Semen and Polygoni Multiflori Radix Praeparata which were previously reported in laboratory. It is suggested that the separated prescriptions of Xuezhining which divided according to the prescription structure of traditional Chinese medicine can reduce the degree of acute toxicity of Cassiae Semen and Polygoni Multiflori Radix Praeparata. It also proved that the compatibility of traditional Chinese medicine in safety control is scientific and reasonable. The mechanism of detoxification should be further researched. References | Related Articles | Metrics

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Effects of Water Extracts from Bupleuri Radix and Vinegar-baked Bupleuri Radix on L02 Cells in vitro ZHAO Xin-mei,ZHANG Zhi-yi ,LI Xiao-yu, ,SUN Rong 2017, 14(12): 727-729.  Abstract ( 403 )   PDF (680KB) ( 161 )   Objective To compare the effects of the water extracts from Bupleuri Radix and vinegar-baked Bupleuri Radix on L02 cells in vitro. Methods The effect of the water extracts from Bupleuri Radix and vinegar-baked Bupleuri Radix on the growth of L02 cells were tested by CCK8 method. ALT, AST and LDH in the culture supernatant were determined by biochemical method. Results CCK8 method showed that the water extracts of Bupleuri Radix and vinegar-baked Bupleuri Radix could inhibit the proliferation of L02 cells, and the cell viability was positively correlated with the dose which compared with the normal group. The cell inhibitory effect strength is the water extract of Bupleuri Radix > the water extract of the vinegar-baked Bupleuri Radix. IC50 of the water extract from Bupleuri Radix and vinegar-baked Bupleuri Radix which had acted 24 h, is respectively 1 173.87 and 1 205.59 mg·L-1. The results of biochemical assay showed that the content of ALT, AST and LDH increased. Conclusions The water extract of Bupleuri Radix and vinegar-baked Bupleuri Radix all have toxic effects on L02 cells, and the inhibitory effect of the water extract from Bupleuri Radix on the growth of L02 cells was stronger than that of the water extracts from vinegar-baked Bupleuri Radix. References | Related Articles | Metrics

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Experimental Comparison Study on Acute Toxicity of Different Processing Methods of Psoraleae Fructus on Normal Mice CAI Tao-tao, HUANG Na-na,WANG Liang,SUN Xiao-qian,LI Xiao-yu,, SUN Rong 2017, 14(12): 730-736.  Abstract ( 343 )   PDF (1189KB) ( 278 )   Objective To compare the acute toxicity of Psoraleae Fructus in normal mice prepared by different processing methods. Methods The method of preparing salt-processed Psoraleae Fructus was according to salt process of the Chinese Pharmacopoeia 2015. The water extracts of raw Psoraleae Fructus and salt-processed Psoraleae Fructus were prepared by extraction with 8 times the amount of water three times for 1 hour each. The all components of raw Psoraleae Fructus and salt-processed Psoraleae Fructus were prepared by crushing and making powder through 120 mesh sieve. HPLC method and the classical method of acute toxicity were used to determine the content of psoralen and isopsoralen and the acute toxicity in the above samples, and compare the content and the acute toxicity. Results The content of psoralen on the water extracts of raw Psoraleae Fructus and salt-processed Psoraleae Fructus was separately 0.0739%, 0.0727%, the content of psoralen on all components of raw Psoraleae Fructus and salt-processed Psoraleae Fructus was separately 0.3980%, 0.4813%, and the content of isopsoralen in the above samples was separately 0.0565%, 0.0511%, 0.3646%, 0.4541%. The LD50 and 95% confidence limit of water extraction components in raw Psoraleae Fructus and salt-processed Psoraleae Fructus are 49.212 g·kg-1·d-1(47.773～50.696 g·kg-1·d-1) and 56.028 g·kg-1·d-1(54.074～58.067 g·kg-1·d-1), which was respectively equal to 344.5 times and 392.2 times of the clinical daily dosage in 70 kg humans. The MFD of all components in raw Psoraleae Fructus and salt-processed Psoraleae Fructus was 40.032 g·kg-1·d-1 and 31.560 g·kg-1·d-1, which was respectively equal to 280.2 times and 220.9 times of the clinical daily dosage in 70 kg humans. The main acute toxicity symptoms and signs are poor spirit, negligent action, prostrate motionlessness, convulsions and unsteady walk. Conclusion The acute toxicity intensity in Psoraleae Fructus by different processing methods on normal mice is: water extraction components in raw Psoraleae Fructus > water extraction components in salt-processed Psoraleae Fructus > all components in salt-processed Psoraleae Fructus > all components in raw Psoraleae Fructus, The acute toxicity intensity of Psoraleae Fructus prepared by different processing methods in normal mice increases with increasing content of psoralen and isopsoralen, suggesting that there is a positive correlation between the toxicity and content of psoralen and isopsoralen, the toxic substances, toxicity characteristics and toxicity mechanism are all to be further studied. References | Related Articles | Metrics

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Research Progress of Psoraleae Fructus Compatibility Rule Based on Properties and Flavors Theory GUO Wen-he,LI Xiao-yu,,HUANG Na-na,SUN Rong 2017, 14(12): 737-741.  Abstract ( 411 )   PDF (829KB) ( 481 )   Objective Applying properties and flavors theory which provides guidance for clinical patterns identification and treatment to the analysis of Psoraleae Fructus's formulations, so as to provide theoretical basis and clinical application practice for security research of Psoraleae Fructus from the perspective of properties and flavors compatibility. Methods "Psoraleae Fructus", "poguzhi", "guzi", "heihuzi", "buguzhi" were used as key words. All the prescriptions containing Psoraleae Fructus were collected from the Dictionary of Traditional Chinese Medicine Prescription. The compatibility relationship between Psoraleae Fructus and different flavor herbs were evaluated and analyzed. Combined with relevant experimental results, compatible rules were explored based on properties and flavors theory. Results The common compatibility of Psoraleae Fructus in the aspects of four properties included homoflavor compatibility on behalf of Myristicae Semen, which could enhance efficacy and reduce toxicity. The combination of warm and hot could enhance efficacy with Cinnamomi Cortex as the representative. The way of toxicity-reducing included combining cold with warm, for example, Rehmanniae Radix. The common compatibility in the aspects of five flavors included combining pungent taste with sweet taste, which could reduce toxicity and enhance efficacy, for example, Polygoni Multiflori Radix. The means of toxicity-reducing included using sour taste to constraint pungent powder, for example, Schisandra Chinensis Fructus. The common means of properties and flavors compatibility included combining pungent taste with cold, which could reduce toxicity and enhance efficacy and be manifested as Salvia Miltiorrhiza Radix. The compatibility of efficacy-enhancing included pungent taste and warm, sweet taste and warm, such as Eucommia Cortex, Jujubae Fructus. Conclusion The formulation of Psoraleae Fructus had certain rule to follow in terms of properties and flavors of TCM. The way of toxicity-reducing included combining cold with warm and using sour taste to constraint pungent powder. The compatibility of efficacy-enhancing included warm and hot, pungent taste and warm, sweet taste and warm. The combination of toxicity-reducing and efficacy-enhancing included warm and warm, pungent taste and sweet taste, pungent taste and cold. References | Related Articles | Metrics

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Evaluation of Post-marketing Drugs and Regulatory Experiences in US WU Gui-zhi, FENG Hong-yun,FAN Yan, DONG Duo 2017, 14(12): 742-745.  Abstract ( 577 )   PDF (663KB) ( 375 )   Objective Through introducing and analyzing regulatory history and evaluation experiences for post-marketing drugs, to provide valuable reference to reevaluation of post-marketing drugs in China. Methods By introducing Drug Efficacy Study Implementation (DESI) which performed in 1960s in US, and interpreting Marketed Unapproved Drugs-Compliance Policy Guide, the evaluation of post-marketing drugs and regulatory experiences obtained in US has been discussed following the updates of regulations and the improvement of cognitive level. Results and Conclusion Experiences obtained from DESI and actions taken for marketed unapproved drugs by FDA in US could provide valuable reference to reevaluation of post-marketing drugs in China. References | Related Articles | Metrics

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Overview of Opioid Abuse in United States and Its Governance's Interventions YANG , Yu-hui , XU Xiu-li ,ZHU Zhu 2017, 14(12): 746-751.  Abstract ( 945 )   PDF (721KB) ( 904 )   Objective This article is mainly about the profile and challenge of opioid abuse in the US and also introduce the targeted intervention strategies of the government and the health institutions of US in recent years. Methods By consulting domestic and foreign documents and accessing to the official website of the US government and the health institutions, information of opioid abuse was retrieved. Results and Conclusion Through the efforts of the US government, the US Food and Drug Administration, the US Drug Enforcement Administration and the US Centers for Disease Control and Prevention, significant contribution was made to the reduction of opioid abuse in the United States, but they still face many challenges. References | Related Articles | Metrics

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Multiple Criteria Decision Analysis-Based Methodologies for Pharmaceutical Product Risk-Benefit Assessment XIONG Wei-yi, DONG Duo 2017, 14(12): 752-754.  Abstract ( 532 )   PDF (570KB) ( 335 )   Benefit-risk assessment is a critical issue throughout the whole life-cycle for pharmaceutical products. The importance of quantitative assessment has arisen. Assessment methodologies based on multiple criteria decision analysis (MCDA) are highly recommended by international regulatory authorities. In 2016, a task force from the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) published an operational framework of MCDA application in health decisions and elaborated the key steps involved in implementing MCDA-based assessments. This paper aims to introduce MCDA and ISPOR framework to provide references to similar practices in China. References | Related Articles | Metrics

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Study on Hematologic Adverse Drug Reactions Related to Domestic and Imported Docetaxel in the Treatment of Breast Cancer by Automatic Surveillance KOU Wei,GUO Dai-hong, ZHAO Bo-yu, JIA Wang-ping, TIAN Xiao-yan,WANG Xiao-yu, HU PENG-zhou 2017, 14(12): 755-759.  Abstract ( 434 )   PDF (739KB) ( 360 )   Objective To compare the incidence of hematologic adverse drug reactions caused by domestic and imported docetaxel in the treatment of breast cancer and research its influencing factors. Methods This research was analyzed retrospectively. The hospitalized patients in our hospital, who suffered from breast cancer and received chemotherapy of domestic and imported docetaxel between Jan 1, 2015 and Dec 31, 2016 were screened out by adverse drug events' active moniroring and assessment system. The suspected cases were reviewed manually for further study. Results The incidence of hematologic ADRs related to domestic and imported docetaxel was 47.10% and 53.67% respectively. And there was no significant difference in incidence of hematologic ADRs caused by domestic and imported docetaxel (P =0.232).Their severe ADRs were both leukopenia and neutropenia. The incidence of leukopenia and neutropenia induced by domestic docetaxel was 4.52% and 3.23%, while the incidence of imported docetaxel was 2.26% and 2.26%, and no significant differences existed between them(P =0.252, P =0.840). Neither of them induced severe thrombocytopenia and anemia. BMI (OR:0.940, 95% CI:0.885-0.999, P =0.047) and lung metastasis (OR:2.005, 95% CI:1.022-3.933, P =0.043) were independent influencing factors of hematologic ADRs caused by docetaxel. Conclusion The incidence of hematologic ADRs caused by domestic and imported docetaxel was high and both should be closely monitored in the course of clinical use to prevent the occurrence of severe ADRs and treat timely. The safety study on key drugs and related ADRs can be accomplished efficiently by the system, and it's worth popularizing. References | Related Articles | Metrics

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Analysis of Medication Errors in a Tertiary General Hospital QI Xian-fang , ZHANG Long, CHEN Xiao-meng, SUN Jun 2017, 14(12): 760-763.  Abstract ( 360 )   PDF (598KB) ( 193 )   Objective To determine the nature and types of medication errors and prevent potential errors. Methods Medication incidents reported from October 2012 to December 2016 in a tertiary general hospital were assessed and analysed by a clinical pharmacist. Analysis projects included category, type, triggering factor of ME, and proportion of persons who triggered or detected ME. Results 251 medication errors were reported, proportions of ME of category A, B, C, D, E, and F were respectively 3.98%, 33.86%, 45.42%, 11.95%, 3.98%, and 0.80%, ME of category G, H, and I have not been reported. 251 errors of type were noted. Therein, wrong patient was the highest proportion which reached 23.51%, the errors of omitted administration, dosage, wrong medication and indication respectively accounted for 23.11%, 11.16%, 8.37% and 7.17%. In 251 reports of ME, 329 triggering factors were noted. The most important factor was staff-related factors which reached 42.24%, the main reasons were inadequate training and inexpert skill. Omission error was the most common factor, accounted for 21.58%. In terms of the persons that triggered ME, the proportion of nurse was 84.47%, especially for student nurses and primary nurses (76.10%). Nurses and patient's family members were the main persons who detected medication errors, respectively accounted for 63.75% and 21.91%. Conclusion Medication errors are frequent, the identification of its determinants helps to undertake designed interventions. There is a need to establish ME reporting system to reduce its incidence and improve patient care and safty. References | Related Articles | Metrics

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Effects of Extended Pharmaceutical Care in and out of Hospital on Therapeutic Effect and Adverse Reactions in Patients with Type 2 Diabetes Mellitus PAN Feng-zhen ,ZHANG Ping , ZHANG Jin-mei 2017, 14(12): 764-768.  Abstract ( 315 )   PDF (690KB) ( 129 )   Objective To explore the effects of extended pharmaceutical care in and out of hospital on blood glucose control, medication compliance and adverse reactions in patients with 2 type diabetes mellitus. Methods 142 patients with type 2 DM in our hospital from January 2016 to January 2017 were enrolled and randomly divided into study group and control group, 30 cases in each group. The control group received routine pharmaceutical care; the study group additionally received extended pharmaceutical care in and out of hospital as medication education, telephone follow-up, etc. The levels of glycosylated hemoglobin, fasting blood glucose, rate of blood glucose compliance, medication compliance and rate of adverse reactions were compared between the two groups of patients before and after intervention. Results There was no statistical difference in the levels of glycosylated hemoglobin, fasting blood glucose, rate of blood glucose compliance and medication compliance between the two groups before intervention (P >0.05). After intervention, the levels of glycosylated hemoglobin and fasting blood glucose of patients in the two groups were significantly decreased (P<0.05); the rate of blood glucose compliance was significantly increased (P <0.05); those in the study group were significantly better than the control group (P <0.05); the blood glucose control effect in patients ＜ 60 years old were significantly better than patients ≥ 60 years old (P <0.05). After intervention, the rate of good medication compliance was significantly increased in the two groups (P <0.05); that in the study group was significantly better than the control group (P <0.05); the improvement of medication compliance in patients ＜ 60 years old was significantly better than patients ≥ 60 years old (P <0.05). After intervention, the rate of adverse reactions in the study group was significantly lower than the control group (P <0.05). Conclusion The extended pharmaceutical care in and out of hospital could contribute to blood glucose control, improve the medication compliance, decrease the rate of adverse reactions, especially for patients ＜ 60 years old. References | Related Articles | Metrics