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20 December 2016, Volume 13 Issue 12 Previous Issue    Next Issue
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Inhibitory Effect of Asarone Injection on P450 Enzyme Activities in Vitro YE Lin-hu, KONG Ling-ti, HE Mei, WANG Yu-qi, HE Ying-jun, Chen Cui 2016, 13(12): 705-707.  Abstract ( 344 )   PDF (974KB) ( 107 )   objective To evaluate inhibitory effect of asarone injection on the activities of human liver microsomes cytochrome P450 (CYP) enzymes including CYP2D6, CYP3A4, CYP2C19, CYP2E1 and CYP2C9 in vitro for predicting potential metabolic drug interactions.Methods Human liver microsomes and five probes were incubated with different concentrations of asarone injection at 37℃ in presence of NADPH. The concentrations of produced metabolites in the reaction solution were determined by an LC-MS/MS method, and compared for evaluating the activity of isoenzymes. Results The inhibitory effects of asarone injection on the isoenzymes were mainly dependent on the concentrations. The injection inhibited CYP2D6,CYP3A4,CYP2C19,CYP2E1 and CYP2C9 activities with IC50 values of 26.44, 36.16, 52.00, 102.40 and 55.86 μg·mL-1, respectively. Conclusion Asarone injection was found to have inhibitory effect on P450 activities. Extreme caution should be taken regarding the use of this injection to avoid the potential risks of metabolic drug interactions with conventional drugs in the clinic. References | Related Articles | Metrics

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Exploration on Reasonable Prescription of Guhong Injection in Improving Mitochondrial Function of Cerebral Ischemia-reperfusion Rats FENG Lu, ZUO Ping-ping, WANG Ming-yang, YANG Nan, FAN Si-yuan, CUI Li-ying 2016, 13(12): 708-711.  Abstract ( 284 )   PDF (975KB) ( 182 )   Objective To explore the difference of the expression of autophagy related proteins between Guhong injection and its main components acetylglutamine and safflower in rats with cerebral ischemia reperfusion injury. Methods The middle cerebral artery occlusion (MCAO) model of SD rats was made by thread embolization. The rats were randomly divided into sham operation group, model group, acetylglutamine group, safflower group and Guhong group (n = 8). Behavioral tests (modified Neurological Severity Score and adhesive-removal test) were performed at 14 d after MCAO. The expressions of Beclin1, Parkin, KIFC2 and UCP3 were detected by Western blot. Results Significant changes in Neurological Severity Score, somatosensory and motor behavior were found in model animals, but there were no obvious change in the groups of acetylglutamate and safflower. The treatment of Guhong could effectively reverse cortical mitochondria and autophagy function of the above-mentioned protein expression changes in ischemic rats (P <0.01), while the acetylglutamine group and safflower group had no significant change. Conclusion The effect of Guhong injection on function of mitochondria of cerebral ischemia reperfusion injury in rats was significantly stronger than acetylglutamine injection and safflower injection. References | Related Articles | Metrics

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Clinical Observation of Curative Effect and Safety Differences of Paclitaxel Liposome or Paclitaxel Injection Combined with Cisplatin Treatment for Cervical Cancer CHEN Shu-tong 2016, 13(12): 712-715.  Abstract ( 301 )   PDF (981KB) ( 147 )   Objective To observe the clinical effect and safety differences of paclitaxel liposome or paclitaxel injection combined with cisplatin in patients with middle and advanced cervical cancer. Methods 83 cases of patients with middle and advanced cervical cancer from June 2009 to June 2010 in our hospital were enrolled as study subjects and randomly divided into two groups, 42 cases in observation group and 41 cases in control group. Observation group was given paclitaxel liposome 135 mg·m-2 via intravenous drip on the first day, cisplatin 60 mg·m-2 was given via intravenous drip on the second day; control group was given paclitaxel injection 135 mg·m-2 via intravenous drip on the first day, cisplatin 60 mg·m-2 was given via intravenous drip on the second day. The two groups all took concurrent radiochemotherapy scheme. The clinical effect (recent curative effect and the forward curative effect) and safety differences between two groups in the treatment of cervical cancer were compared. Results The effective alleviation rates of observation group and control group were 83.33% and 68.29% respectively, the difference was statistically significant (P<0.05). The cervical cancer invasion and lymph node metastasis of observation group was significantly lower than control group, and the 5-year survival rate of the observation group was significantly higher than the control group (P<0.05). The adverse drug reaction such as alopecia, gastrointestinal reaction, anaphylactic reaction, myelosuppression and weakened immunity in observation group has significant differences compared with the control group (P<0.05). Conclusion In this study, paclitaxel liposome combined with cisplatin has good recent curative effect and forward curative effect and safety is relatively high in the treatment of cervical cancer. References | Related Articles | Metrics

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Short-term Efficacy and Influence on the Peripheral Blood MMP-9 Level by Early Stage Atorvastatin Intensive Treatment for Acute Cerebral Infarction ZHU Xuan, DENG Ben-qiang, CHEN Lei 2016, 13(12): 716-719.  Abstract ( 252 )   PDF (952KB) ( 141 )   Objective To investigate the short-term efficacy and influence on the level of (matrix metalloproteinase-9) MMP-9 in the peripheral blood by early stage atorvastatin intensive treatment for acute cerebral infarction (ACI). Methods 330 patients with acute cerebral infarction were collected from January 2015 to December 2015 in our hospital, and randomly divided into intensive statin treatment group (165 cases) and conventional dose of statin group (165 cases). Conventional dose of statin group was given atorvastatin calcium tablets 20 mg every day, intensive statin treatment group was given atorvastatin calcium tablets, 40 mg every day, both for 14 days. The Enzyme-linked immunosorbent assay (ELISA) method was used to detect the level of MMP-9 between two groups, and the Barthel Index, National Institutes of Health Stroke Scale (NIHSS) and Fugl-Meyer assessment scale (FMA) were compared before and 7 d, 14 d after given atorvastatin calcium tablets. Results The Barthel and FMA of intensive statin treatment group were higher than conventional dose of statin group, and the NIHSS of intensive statin treatment group was lower than conventional dose of statin group, the differences were statistically significant (P<0.05). Compared with the conventional dose of statin group, the level of MMP-9 of intensive statin treatment group significantly decreased after 7 d, 14 d given atorvastatin calcium tablets 40 mg/d (P<0.05),which indicated that the atorvastatin therapy could effectively improve neurological function in patients with acute cerebral infarction, improved the motor function and self-care ability. Conclusion Early stage atorvastatin intensive treatment can reduce the level of serum MMP-9 of acute cerebral infarction patients, promote the recovery of neural function, meanwhile, improve the ability of daily life and exercise, short term therapeutic effect is obvious. References | Related Articles | Metrics

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Effects of Hyperbaric Oxygen on the Pharmacokinetics of Gliclazide in Rats CAO Xiu-qin, SONG Dan-dan, SHEN Jia-wei, ZHOU Wei-li, SHI Hong, CHU Fei-fei, SONG Jin-bo 2016, 13(12): 720-723.  Abstract ( 270 )   PDF (1400KB) ( 106 )   Objective To investigate the effects of hyperbaric oxygen (HBO) on the pharmacokinetics of gliclazide (GL). Methods 16 rats were randomly divided into 2 groups, the HBO group and the control group. The 2 groups of animals received gavage of GL with a single-dose of 30 mg·kg-1. The animals in the HBO group were immediately put into the hyperbaric oxygen chamber and maintained at a pressure of 0.20 MPa for 20 min. The time used for compression and decompression was both 5 min. The animals in the control group were just given a single gavage of GL. The blood samples from the rats were taken at 0.67, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0, 24.0 h after drug administration. Concentrations of GL in serum were monitored with UPLC-MS/MS, and pharmacokinetic parameters were calculated accordingly. Results The main pharmacokinetic parameters of the HBO group were as follows: Cmax 119.81±25.19 µg·mL-1, tmax 2.69±0.80 h, t1/2 3.54±2.30 h, AUC 731.96±210.15 µg·mL-1·h, ke 0.26±0.13, while the corresponding results of the control group were Cmax 112.43±26.96 µg·mL-1, tmax 2.75±1.00 h, t1/2 2.55±1.10 h, AUC 653.60±184.20 µg·mL-1·h, ke 0.31±0.10. Conclusion Effects of hyperbaric oxygen on the pharmacokinetics of gliclazide in rats was not significant. References | Related Articles | Metrics

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Near Infrared Spectral Quantitative Analysis for Active Component of Angelica Dahurica Radix and Saposhnikoviae Radix Based on Pharmacopoeia ZHAN Hao, FANG Jing, WU Hong-wei, TANG Li-ying, LI Hua, YANG Bin, FU Mei-hong 2016, 13(12): 724-729.  Abstract ( 262 )   PDF (1085KB) ( 154 )   Objective To establish the rapid detection method for imperatorin in Angelicae dahuricae Radix and the amounts of prim-O- glucosylcimifugin and 5-O-methylvisammioside in Saposhnikoviae Radix by near infrared spectroscopy (NIRS). Methods 100 batches of samples were collected from different regions, the content of label components were determined by high performance liquid chromatography (HPLC), and near infrared spectra of samples were also determined. Due to smaller differences between the spectral, it was needed to deal with spectrum by regression methods, pretreatment methods, bands as well as the numbers of principal components. The near infrared spectroscopy quantitative model were established for Angelicae dahuricae Radix and Saposhnikoviae Radix. Results In Angelicae dahuricae Radix, the calibration model of R2 was 0.975 5, RMSEC and RMSEP were respectively 0.011 2 and 0.011 6, the principal component number was 11. In Saposhnikoviae Radix, the calibration model of R2 was 0.977 3, RMSEC and RMSEP were respectively 0.054 5 and 0.051 4, the principal component number was 6. Conclusion The quantitative analysis models established in this research were more accurate and can be used to predict imperatorin in Angelicae dahuricae Radix and the amounts of prim-O-glucosylcimifugin and 5-O-methylvisammioside in Saposhnikoviae Radix, which have good application prospects. References | Related Articles | Metrics

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Research on Preparation Process Optimizing of Fluoxertine Hydrochloride Impurity LIU Bo, WANG Teng, WU Di, PANG Yu, SONG Yong-ji 2016, 13(12): 730-732.  Abstract ( 278 )   PDF (924KB) ( 238 )   Objective To develop a rapid and effective method for preparation of the fluoxertine hydrochloride related substanceⅢ in ChP 2015 by optimizing the preparation process. Methods Via verification of multiple factors (temperature, concentration and pH condition) and structure confirmation by NMR and HR-MS, finally, the optimum condition was founded. Results The process was an one-pot continuous method, the total yield was 82.05%. Conclusion An effective and rapid preparation route to synthesize compound hydrochloride N-menthyl-3-benzedrine was developed, which is the fluoxertine hydrochloride related substanceⅢ in ChP 2015. It also laid a foundation for the study of toxic mechanism, quality specification improvement and adverse reaction reducing of fluoxertine hydrochloride. References | Related Articles | Metrics

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Risk Analysis and Control of Compound Resorcinol Lotion in China Hospital Preparations Specifications WANG Li, MA Cong, LEI Jia-hao, ZHANG Yan, MA Jun-qiang, MA Pei-jie, ZHAO Ting 2016, 13(12): 733-736.  Abstract ( 266 )   PDF (952KB) ( 109 )   Objective To provide the reference for amending the risk control and quality standards of lotion by analyzing the risk of compound resorcinol lotion, including prescription, preparation, test and use. Methods Based on searching literatures from CNKI, the analysis showed that compound resorcinol lotion in China Hospital Preparations Specifications carried risk. Results The compound resorcinol lotion formula has excessive amounts of toxic substance. During its preparation, toxic substance can be absorbed by skin and respiratory tract. Toxic substance concentration can not be strictly controlled when testing compound resorcinol lotion. The risk can be added up when using this lotion for a long time. Conclusion It is necessary to evaluate the risk of compound resorcinol lotion and improve its quality standards. References | Related Articles | Metrics

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Ideas on the Project of Drug Safety Data Partner Cooperation in China SHEN Lu, LIU Wei, HOU Yong-fang, GUO Xue, PENG Li-li, KONG Fan-yao, LI Xin-ling 2016, 13(12): 737-739.  Abstract ( 329 )   PDF (976KB) ( 205 )   This article introduces the executive summary of sentinel initiative, the sentinel system vision, progress building the sentinel system. Then it analyses the practical meaning and inspiration for ADR monitoring in China by the sentinel system and tries to establish the fundamental principle and developmental trend of ADR monitoring in the current period. This article suggests the project of drug safety data partner cooperation in China, which includes China adverse drug reaction sentinel union and data source cooperation. References | Related Articles | Metrics

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Research Progress of Cardiac Toxicity of Loperamide NIE Zhi-guang, DING Chang-ling, TIAN Yue-jie 2016, 13(12): 740-744.  Abstract ( 282 )   PDF (962KB) ( 171 )   Objective To provide references for rational drug use through analyzing the cardiac toxicity of loperamide and the influencing factors. Methods References at home and abroad about the cardiac toxicity of loperamide were summarized and analyzed. Results The cardiac toxicity caused by loperamide hasn’t been reported in China. However, foreign literatures shows that higher than recommended doses of loperamide can cause serious cardiac events, including syncope, cardiac arrest, QT prolongation, torsades de pointes ventricular tachycardia and even death. Conclusion The main risk factors for cardiac toxicity of loperamide are the high dose abuse, combined with inhibitors of CYP3A4/CYP2C8 and/or P-glycoprotein, and the low age. Patients should only take loperamide in the dose prescribed by doctors or according to the label. Loperamide is not recommended for use in children under 2 years. More attentions should be paid to the risk of the combined medication. References | Related Articles | Metrics

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Automatic Surveillance for Hemocytopenia Caused by Cinepazide Maleate HU Peng-zhou, MA Liang, GUO Dai-hong, LIU Jia, WANG Xiao-yu, KOU Wei, JIA Wang-ping 2016, 13(12): 745-747.  Abstract ( 276 )   PDF (917KB) ( 118 )   Objective To study the incidence of cinepazide maleate related hematologic adverse drug reaction by monitoring software. Method The research objects were screened out by adverse drug events’ active surveillance and assessment system developed by our hospital. The collected data of the hospitalized patients in General Hospital of PLA who received cinepazide maleate between August 1, 2015 and July 31, 2016 were analyzed retrospectively. Alarm cases submitted by system were evaluated by 2 professionals. Results A total of 3 181 patients using cinepazide maleate were automatically monitored. The incidences of thrombocytopenia and leukopenia were 0.14% and 0.28%, respectively, which were consistent with the literature’s report, only 1 case without granulocytopenia in 8 cases of leukopenia. The incidence of anemia was 0.48%, it was a new ADR. The total incidence of hemocytopenia was about 0.72%, severe ADR was not observed. The average age is 69, there was no statistical difference in different age groups. Conclusion By using the automatic surveillance and assessment system, pharmacists can effectively and accurately screen the hematologic ADR induced by cinepazide. The incidence of hemocytopenia was between 0.1% and 1.0%, severe granulocytopenia was not observed. The incidence of anemia was relatively high. The ADRs caused by cinepazide can be prevented effectively and discovered as early as possible by fully understanding medication history and strengthening hemogram monitoring. References | Related Articles | Metrics

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Research on Compatibility of Cervus and Cucumis Polypeptide for Injection Combined with Different Injections GAO Sheng-chuan, LIU Mei-tong, FU Shi-yuan 2016, 13(12): 748-752.  Abstract ( 422 )   PDF (934KB) ( 284 )   Objective To research the compatibility of Cervus and Cucumis polypeptide for injection combined with different injections and to provide favorable experimental basis for the clinical application of the Cervus and Cucumis polypeptide for injection. Methods According to the current dosage of clinical medicine, the Cervus and Cucumis polypeptide for injection was added to the sterilized water for injection as control group. Cervus and Cucumis polypeptide for injection was added to 0.9% sodium chloride injection, 5% and 10% glucose injection and glucose-sodium chloride injection as experimental group.The combination solution change of color, pH value, and the number of particles were reseached at 0 h, 0.5 h, 1 h, 2 h, 4 h, 8 h which were detected by the method specified in China Pharmacopeia (2015 edition, No 4). Results The Cervus and Cucumis polypeptide for injection combined with the 0.9% sodium chloride injection solution at different time was light yellow liquid, The pH value remained stable and the number of particles was conforms to the 2015 edition of China Pharmacopoeia standards. The numbers of ≥10µm particles exceeded the limitation of China Pharmacopoeia after combinee with 5% and 10% glucose injection and glucose-sodium chloride injection. There were no significant changes in clarity and pH value. Conclusion The most suitable solvent compatibility for Cervus and Cucumis polypeptide for injection was 0.9% sodium chloride injection. In the clinical application, the transfusion must be slowly infusied and close observation should be given to the patients. References | Related Articles | Metrics

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Assessment of Rationality, Safety and Adherence in Warfarin's Clinical Application GU Xin, SUN An-xiu, ZHANG Xin-jiang, TANG Tie-yu, HU Yue 2016, 13(12): 753-756.  Abstract ( 362 )   PDF (928KB) ( 195 )   objective To evaluate the rationality of warfarin application in hospitalized patients, as well as the safety and adherence when they leaved hospital, obtain foundation for further research. Methods A sophisticated research was conducted on all patients who were admitted to the department of cardiology from Jan. 1st, 2015 to Dec. 31st, 2015 and had record of warfarin usage. In the research, we analyzed their cases retrospectively and systematically, assessing the rationality of their warfarin application in hospital. We also investigated their specific warfarin usage and their intervals of repeated International Normalized Ratio (INR) testing by telephone follow-up method, assessing the safety and adherence of their warfarin application at discharge time. Results A total of 139 patients (65 males and 74 females, ages ranging from 36 to 74, average age (68.52±10.02)) were enrolled in this research. When hospitalized, 38.30% of the patients had large-range warfarin dose adjustment, 76 patients had reasonable INR testing results and 63 had unreasonable results. When leaving the hospital, only 32.59% of the patients met the INR intensity goals, 42.98% of the patients were advised by their doctors to determine blood coagulation function on specific dates at discharge time. Among the 122 patients (17 patients unable to contact) who were investigated by phone calls at discharge time, 9 patients stopped taking pills without doctors' instructions, 8 patients had adverse reactions, and 64.76 % of patients' latest INR met targets. Conclusion The main problems of warfarin application are as follows: determined INR infrequently when hospitalized, low ratio of meeting target INR intensity when leaving hospital, and weak adherence of regular INR monitoring. Medication education and long-term telephone follow-up on patients may improve the safety and adherence of warfarin application. References | Related Articles | Metrics

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Pharmaceutical Care for One Advanced Non-small Cell Lung Cancer Complicated with Severe Anemia ZHOU Dian-you, XI Jia-xi, GONG Qian 2016, 13(12): 757-760.  Abstract ( 273 )   PDF (972KB) ( 153 )   Objective To explore clinical pharmacists participating in the anti-tumor drug treatment methods and thoughts. Methods Through a case of advanced non-small cell lung cancer chemotherapy leading to severe anemia, the reasons of anaemia were analyzed, and the pharmacist experiences of helping physicians improve relevant treatment methods, paying attention to drug adverse reactions and guiding medication were introduced. It was considered that the rapidly progressing of disease was related to recombinant human erythropoietin by searching literatures, and relevant information was provided to the clinician. Results Clinical pharmacists participated in antitumor drug therapy with professional skills so that anemia of the patient relieved. It was acknowledged by the healthcare professionals, and the rational drug use was promoted. Conclusion In the process of clinical practice, clinical pharmacists should fully disclose the benefits and risks of drugs to the doctors and patients, and provide good drug information for clinicians, so as to ensure patients' medication to be safe, effective and reasonable. References | Related Articles | Metrics

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Thoughts about the Clinical Use Safety of Disposable Latex T-shape Catherter LI Sui, DENG Xiao-yun, LUO Pei, ZHOU Juan 2016, 13(12): 761-763.  Abstract ( 230 )   PDF (920KB) ( 86 )   Objective To observe the risk of disposable latex T-shape catherter in the clinic, so as to explore the measures to improve the safety of clinical use. Methods 698 cases with disposable Latex T-shape Catherter clinical observation between October 2014 and June 2015 were retrospectively analyzed. Results 138 cases involved the application scope of product overused, 20 cases were suspected medical devices adverse events, the catherter indwelling time up to 180 days. Conclusion Generally, medical devices have risks, the weak awareness of security easily leads to a variety of risks. Therefore, raising awareness of the safe use of medical staff and enhancing risk management ability of manufactarers are the main routes to improve product safety. References | Related Articles | Metrics