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    08 June 2015, Volume 12 Issue 6 Previous Issue    Next Issue

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    Preclinical Safety Research of Epirubicin Hydrochloride Injection
    LIU Fen,XU Xin-chang,ZHAO Tao,LV Jin-gang,YAO Jing-chun,XUE Fang-xi
    2015, 12(6): 321-324. 
    Abstract ( 390 )   PDF (528KB) ( 406 )  
    Objective To study the safety of epirubicin hydrochloride injection and provide theoretical evidence for clinical application. Methods The safety of epirubicin hydrochloride injection was observed through vascular and bladder mucosa irritation test, hemolytic test in vitro and active systemic anaphylaxis(ASA). Results Epirubicin hydrochloride injection had no obvious vascular and bladder mucosa irritation, no allergic reaction, however it had hemolytic reaction. Conclusion The hemolysis phenomenon may occur when epirubicin hydrochloride injection is used in clinic, and dilution is recommended.
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    Experimental Study on Antivirus Effects of Junduqing Granule in Vitro
    GUO Shan-shan,BAO Lei,CUI Xiao-lan
    2015, 12(6): 325-329. 
    Abstract ( 483 )   PDF (1228KB) ( 707 )  
    Objective To observe the antivirus effects of Junduqing granule in vitro. Methods The cytopathic effect (CPE) method was adopted to study the inhibitory effect of Junduqing granule on respiratory syncytial virus (RSV), adenovirus (AdV) and coxsackie virus (CoxV) in vitro. The quantitative real-time PCR method was used to observe the inhibiting effect of Junduqing granule on EB virus BcLF and BARF1 genetic expression. Results Junduqing granule showed obvious inhibiting effect on the CPE induced by RSV, AdV and CoxV. And it also has obvious inhibiting effect on EB virus BcLF and BARF1 genetic expression. Conclusion Junduqing granule can inhibit respiratory virus, enterovirus and EB virus in vitro.
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    Experimental Study of Topical Homemade Extract of Lithospermum Erythrorhizon Treating Scalded Rats
    WANG Yong,WANG Shuang-yan,XIAO Yan-ying
    2015, 12(6): 330-331. 
    Abstract ( 298 )   PDF (400KB) ( 223 )  
    Objective To study the pharmacological effects of Lithospermum erythrorhizon on scalded rats in order to clarify its topical treatment function of burns. Methods 60 rats were randomly divided into 5 groups. We used the constant temperature water bath to manufacture rat burn model and measured the rat paw circumference with a soft tape measure. Foot swelling rate was evaluated with computer. Results Compared with the control group, there were significant differences in Lithospermum erythrorhizon high, low concentration group (P<0.05). Conclusion Homemade extract of Lithospermum erythrorhizon could treat hot water scaldand be suitable for clinical application.
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    Anesthesia Effect of Dexmedetomidine Combined with Propofol in Gastroscopy
    LIU Long-juan
    2015, 12(6): 332-334. 
    Abstract ( 369 )   PDF (463KB) ( 269 )  
    Objective To investigate the anesthesia effect of dexmedetomidine combined with propofol in gastroscopy. Methods 78 cases of patients were randomly divided into observation group and control group who received intravenous anesthesia painless gastroscopy. The control group received propofol,and the observation group received dexmedetomidine and propofol. Results Within groups, in T1, T2, T3 three time points, HR value of the observation group was significantly lower than the value at T0 (P <0.05), MAP and SpO2 values were significantly lower than T0 in control group (P <0.05). At T1, T2 two time points, MAP and SpO2 of the observation group was significantly higher (P <0.05). At T1, T2, T3 three time points, HR value of the observation group was significantly lower than in the control group (P <0.05). The observation group was significantly lower than the control group in total amount of propofol, anesthesia time, numerical aspects of recovery time and orientation recovery time (P <0.05). The overall incidence of adverse reactions was 15.4% and 35.9% in observation group and the control group, respectively. The observation group was significantly lower (P <0.05). In T1, T2 and T3 depth of anesthesia, the observation group was higher (P <0.05). Conclusion Dexmedetomidine combined with propofol showed a well anesthesia effect, could be used in gastroscopy.
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    Near Infrared Correlation Coefficient Method with Characteristic Spectral Band for Determination of Illegally Added Gliclazide and Hydrochlorothiazide in Capsule Preparations
    XIA Fang-liang
    2015, 12(6): 335-337. 
    Abstract ( 300 )   PDF (544KB) ( 201 )  
    Objective To detect the illegally added gliclazide and hydrochlorothiazide in capsule preparations with the near infrared (NIR) correlation coefficient method. Methods The near infrared spectrum of the chemical reference substance of gliclazide and hydrochlorothiazide was used as reference spectrum, the specific spectrum was selected. According to the added amount of gliclazide and hydrochlorothiazide in capsule preparations, the threshold value of similarity coefficient in this spectral band of the tested sample spectrum and the reference spectrum was established. Whether the tested sample contained gliclazide or hydrochlorothiazide was qualitatively estimated. Results The spectral band 5 850~5 700 cm-1 was selected as the characteristic band for gliclazide, and the threshold value was set as 60%. The spectral band 6 150~5 950 cm-1 was selected as the characteristic band for hydrochlorothiazide, and the threshold value was set as 70%. Conclusion The two models have high accuracy and strong applicability, which may be used as a fast detection method to determine illegally added gliclazide and hydrochlorothiazide in traditional Chinese medicine and health food capsule preparations on market.
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    Determination of Martine, Belamcandin and Irisflorentin in Qiweiqingyan Aerosol by HPLC
    MENG Lei-lei
    2015, 12(6): 338-340. 
    Abstract ( 313 )   PDF (538KB) ( 336 )  
    Objective To develop a HPLC method for determination of martine, belamcandin and irisflorentin in Qiweiqingyan aerosol. Method The optimum HPLC condition was as follows: Agilent Zorbas Stablebond C18 column(4.6 mm×250 mm,5 μm) with gradient elution of acetonituile (A)- methanol(B)-0.1% phosphoric acid (C), detection wavelength:251 nm, column temperature: 30℃, flow rate:1mL?min-1. Results There were good linearity between peak areas and injection quantity of martine, belamcandin and irisflorentin within the range of 0.25~125 μg?mL-1, 0.10~101μg?mL-1, 0.12~234μg?mL-1.The average recoveries were between 98.5 %~100.6%. Conclusion The method could detect martine, belamcandin and irisflorentin in Qiweiqingyan aerosol. The HPLC measurement was reasonable, stable and accurate.
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    Study on Application of Data Organization and Common Data Model of the Observational Medical Outcomes Partnership in US
    WANG Ling
    2015, 12(6): 341-346. 
    Abstract ( 387 )   PDF (515KB) ( 303 )  
    Objective To provide thought and references for the promotion of ADR monitoring in China, suggestions on the secondary use of observational data for maximizing the benefit and minimizing the risk of drug use. Methods The data organization and access models of the Observational Medical Outcomes Partnership in US and the Common Data Model were studied and analyzed. Results and Conclusion The establishment and implementation of OMOP has obvious characteristics. In order to use existing multiple observational healthcare databases for active drug safety and benefit monitoring, the critical factor and the basis on the technical levels are the construction, improvement and unification of the medical information standards. The CDM design, development and evaluation can provide good thought and references for secondary use of observational data and active drug safety surveillance by establishing partnership and using a variety of data sources in China.
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    Analysis of 60 Cases of Acute Hepatic Injury Induced by Intravenous Infusion of Amiodarone
    MAO Min,XU Xiao-hua,ZHAO Jia-shu,MAO Jian-sheng,DU Jin-hang,LU Jin
    2015, 12(6): 347-351. 
    Abstract ( 330 )   PDF (628KB) ( 276 )  
    Objective To conclude intravenous infusion of amiodarone-induced acute hepatic injury cases, to analyze the causal factors and mechanisms of acute hepatic injury induced by intravenous infusion of amiodarone, and to find the way of prevention and treatment of acute hepatic injury. Methods The clinical feature, primary disease, indications and Methods of using amiodarone, characteristics of hepatic injury and functions of other organs, concomitant medicines and prognosis of patients were analyzed in 60 cases. One of the cases was the inpatient of our hospital in 2011, and the others were collected from foreign and domestic medical journals between 1988 to 2012. Results The dosage of intravenous amiodarone was 193.2~4 310(1 345.7±550.6)mg, the duration of administration was 6~29(34.0±17.9)h. The peak of AST was 122.3~17 471(3 798±3 982)U?L-1 and ALT was 225~12 426(3 206±1 788)U?L-1. After discontinuation of intravenous amiodarone and conventional liver adjuvant therapy, 52 cases of liver enzymes returned to normal, the average time was 21.6 ± 13.24 d, 4 cases died of acute renal failure or multi-organ failure, one case died of hepatic encephalopathy, three cases died of cardiogenic shock. The liver function of 15 cases who adopted oral amiodarone after stopping intravenous amiodarone continued to improve. Conclusion The relationship between incidence of acute liver injury induced by intravenous amiodarone and the total does of amiodarone, and the treatment time is unclear. However,the high concentration of cosolvent polysorbate 80 is the most critical factors to lead to acute liver injury. The patient with both acute liver injury and other organs damage would have poor prognosis. Intravenous infusion of amiodarone could be safely replaced by oral amiodarone when acute hepatic injury happened. Acute hepatic injury with acute renal failure induced high mortality, CBP is conducive to treatment as soon as possible.
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    Literature Analysis of 121 Cases of Anaphylactic Shock Induced by Cephalosporin Injection with Negative Skin Test
    YAO Xiao-ying,MENG Xian-min*
    2015, 12(6): 352-356. 
    Abstract ( 369 )   PDF (693KB) ( 292 )  
    Objective To understand the characteristics and relevant factors of anaphylactic shock induced by cephalosporin injection with negative skin test, in order to provide a reference for safe medication in clinic. Methods The case reports of anaphylactic shock induced by cephalosporin with negative skin test, reported in domestic medical journal in the last ten years, were searched and filtered. Patient's age, gender, primary diseases, allergic history, skin test, drug use, routes of administration, selection of solvent, time of occurrence of anaphylactic shock, and clinical manifestations, were collected and analyzed. Results 121 cases with anaphylactic shock were collected, of which the youth was the most common (45.45%), followed by the old (19.01%). 75.21% of the cases had no drug allergic history, 15.70% unclear. 90.91% of skin tests were done using diluted cephalosporin, and 9.09% using penicillin or cefazolin. The most common drugs leading to anaphylactic shock were the third generation cephalosporin. There were also problems in the medication of patients, for example single drug dosages for some patients were too large. The percentage of patient with immediate anaphylactic shock was 81.82%, while 18.2% with delayed anaphylactic shock. 72.73% anaphylactic shock occurred within 30 min after administration. Clinical symptoms mainly involved respiratory system, circulation system and central nervous system. The total mortality was 10.74%. Conclusion The use of cephalosporin and skin test need to be further standardized in China. Patients treated with cephalosporin need to be monitored closely, even if the skin test Results are negative, so as to ensure the safety of drug use.
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    Analysis of 23 cases of Qiliqiangxin Capsules in Relation to Digitalis Overdose
    LI Lin LI Qi,WANG Jin-hui,ZHAO Pei-yong
    2015, 12(6): 357-359. 
    Abstract ( 381 )   PDF (733KB) ( 193 )  
    Objective To provide reference for safe, effective and reasonable use of Qiliqiangxin Capsules in clinic. Methods Serum digoxin concentration was determined by chemiluminescence immune inspection technology, and the monitoring Results were subjected to statistical analysis. Results Of the total 258 cases who were treated with Qiliqiangxin Capsules, 91.09% serum digoxin concentrations were below 2 ng?mL-1, 8.91% were above 2 ng?mL-1, with 7 cases(2.71%) having symptoms of poisoning. The concentration in the group above the age of 60 years old was higher than that in the group under 60 years old (P<0.05). Sex had no perfect statistical mean(P>0.05). Conclusion To ensure clinical efficacy and reduce incidence of Qiliqiangxin Capsules, it's important to monitor the serum digoxin concentration.
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    Analysis of 110 Cases of Adverse Drug Reactions Induced by Tanreqing Injection
    YU Li,QIU Zhao-juan*,TAN Xi-ying
    2015, 12(6): 360-362. 
    Abstract ( 431 )   PDF (675KB) ( 824 )  
    Objective To analyze the characters of ADR induced by Tanreqing injection so as to promote the rational use of the drugs. Methods 110 cases of ADR related to Tanreqing injection from 2008 to 2012 in Jiangsu Province Hospital of Traditional Chinese Medicine were analyzed statistically in terms of adverse reaction time, clinical manifestation, dosage and administration,etc. Results Most of the reports (n=75) involved both of the skin system and its appendages, accounting for 62.5%. Most of the cases occurred within 60 minute. Conclusion Doctors and pharmacists should pay more attention to the ADR of Tanreqing injection. The process of drug use should be monitored to reduce the incidence of ADR.
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    Research and Countermeasure for Information Safety of Intelligent Medical Devices
    ZHANG Chen-guang,LIU Yan,XU Wei
    2015, 12(6): 363-365. 
    Abstract ( 436 )   PDF (613KB) ( 390 )  
    Objective To study the challenges of information safety problems on intelligent medical devices, analyze industry development tendency and two information safety cases, so as to put forward countermeasure and suggestion on how to improve information safety of intelligent medical devices. Methods Terminal medical systems, wearable medical devices, implantable medical devices, intelligent artificial limbs were deeply studied.An adverse event reporting from FDA and a simulation from the safety service company Cardinal were also analyzed. Results Network attacks, computer viruses, software defects and government regulation defects were the root causes of the safety problems. Conclusion Government regulation should be strengthened and improved, the 3rd party safety company should be fully involved in the R&D and application processes of intelligent medical device life cycle.
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    Risks and Suggestions of Appliance in Orthodontics
    ZHANG Zhao-hui
    2015, 12(6): 366-367. 
    Abstract ( 356 )   PDF (747KB) ( 182 )  
    Objective To analyze the risk factors of appliance in orthodontics, in order to provide a reference for clinical safe handling. Methods By understanding the mechanism of action and clinical classification of appliance, analyze the common risk factors during clinical handling, and then put forward the suggestions. Results Although appliance has risks during clinical handling, they are able to be controlled. Conclusion By patients and physicians making great efforts together, appliance will play further important therapeutical effect in orthodontics.
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    Stability of Cefazolin Sodium Pentahydrate Mixed with Tinidazole in Vitro
    HAO Hao-hua,SONG Jin-chun,YANG Xiao-qing,XIE Shun-lan
    2015, 12(6): 368-372. 
    Abstract ( 412 )   PDF (708KB) ( 337 )  
    Objective To investigate the compatibility and stability of cefazolin sodium pentahydrate in sodium chloride injection and tinidazole glucose injection at 4 ℃ and 25 ℃. Methods The initial solutions are cefazolin sodium pentahydrate dissolving in tinidazole glucose injection and sodium chloride injection and stored at 4 ℃ and 25 ℃. The initial drug concentrations are 10 mg?mL-1 for cefazolin sodium pentahydrate and 4 mg?mL-1 for tinidazole. Samples were withdrawn from each container immediately after preparation and at predetermined intervals (0, 2, 4, 8, 24, 48, 72, 120, 168, 240 and 360 hours after preparation). The solutions were visually inspected for precipitation, cloudiness, and discoloration at each sampling interval. New high performance liquid chromatography (HPLC) method was used to detect the drug concentration. Results After 15 days of storage, the samples stored at 4 ℃ were tested retained >90 % of the initial concentrations of both drugs. The drug mixtures were clear in appearance, and no precipitation, not muddy, no clouds, no bubbles ,no discoloration. Throughout this period, pH values remained stable, but salt solution samples stored at 25 ℃ were tested low, 48 h later, it started to turn yellow, and after 72 h, the color deepened. The pH values of sugar and salt solution all increased significantly. Conclusion Admixtures of cefazolin sodium pentahydrate 10 mg?mL-1 and tinidazole 4 mg?mL-1 were stable for at least 15 days or more at 4 ℃ and under the condition of dark.
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    Reasonability Analysis of Proton Pump Inhibitors for Stress Ulcer in a Hospital
    SHEN Chi,LIU Na
    2015, 12(6): 373-375. 
    Abstract ( 337 )   PDF (598KB) ( 283 )  
    Objective To analyze the situation of proton pump inhibitors for stress ulcer in a hospital and instruct the rational application of the drug. Methods 240 medical records of patients from 8 clinical departments including department of gastroenterology which used PPIs from January to June 2014 were randomly chosen. What used for preventing stress ulcer were sampled for the evaluation of indications in prophylactic medication, the variety of drug, usage and dosage, course of treatment. Results There were 115 copies(47.91%)which used PPIs for preventing stress ulcer, 59 copies of them(51.30%)were unreasonable. No indications and long course of treatment were the main problems. Conclusion There are still some unreasonable situations on the prophylactic use of PPIs in a hospital, the related departments should strengthen the supervision and management.
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