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20 August 2016, Volume 13 Issue 8 Previous Issue    Next Issue

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Study on Efficacy and Mechanisms of Antipyretic of Sanhuangxiexin Decoction by Processing Compatibility MA Xiao-jing, WANG Lan, YIN, LI Li, LIU Ying, GONG Lei-lei, XIAO Yong-qing, LIANG Ri-xin 2016, 13(8): 449-451.  Abstract ( 284 )   PDF (1134KB) ( 236 )   Objective To observe the antipyretic efficacy of Sanhuangxiexin decoction by processing compatibility and explore the mechanisms preliminarily. Methods The fever models were established by subcutaneous injection with dried yeast suspension. Aspirin was used as the positive control (0.1 g•kg-1), and Sanhuangxiexin decoction was divided into three doses （1, 0.5, 0.25 g crude drug•kg-1), which was intragastrically administrated. Firstly the basal body temperature was measured before administration, then a measurement of the fever temperature was carried out after 0.5, 1, 2, 4 h, which was expressed as ΔT. The blood was sampled to separate and collecte the serum, and the hypothalamus tissues were taken to prepare supernatant from rats after the experiment. Finally, Elisa method was used to test the content of PGE2, cAMP, Cox-1, Cox-2 both in the serum and hypothalamus. Results All three doses of Sanhuangxiexin decoction could decrease the temperature and the content of PGE2, cAMP, Cox-1, Cox-2 in serum and hypothalamus. Conclusion The formula 8 of Sanhuangxiexin decoction has obvious antipyretic effect, and its mechanisms maybe relate to inhibition of the release of centric febrile mediators such as PGE2 and cAMP, etc. References | Related Articles | Metrics

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Analysis of Clinical Effects of Salvianolate Injection on Renal Function in Real Word WANG Hai-yang, XIE Yan-ming, JIANG Jun-jie, YANG Wei, ZHANG Hui, ZHUANG Yan 2016, 13(8): 452-455.  Abstract ( 355 )   PDF (1005KB) ( 434 )   Objective To explore the effects on renal function of salvianolate injection in real word. Methods Based on the data extracted from the hospital information system (HIS) of 18 large hospitals, the treatment group of salvianolate injection and the control group of not using were compared with the level of serum creatinine (SCr) and blood urea nitrogen (BUN) abnormal changes as the ending index. After using the generalized boosted models propensity score (GBM) to balance the confounding factors, the Logistic regression adopting the propensity score with covariate adjustment was used to analyze safety outcomes. Results The abnormal change of SCr had significant difference in the treatment group compared with the control group (P<0.05), And there was no significant difference on the abnormal change of BUN (P>0.05). Conclusion After a comprehensive analysis, it is not suggested that the kidney damage is caused by salvianolate injection based on existing data. In order to confirm the cause of the damage, a prospective randomized controlled trial was necessary. And in the clinic, the instructions to use salvianolate injection should be strictly followed, and non-standard medication should be avoided, so as to ensure the drug safety. References | Related Articles | Metrics

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Changes of Serum Myocardial Enzyme Spectrum and Prognosis in Elderly Patients with Acute Myocarditis Treated by Trimetazidine SUN, Yu-sheng 2016, 13(8): 456-459.  Abstract ( 272 )   PDF (1043KB) ( 132 )   Objective To observe the change of serum myocardial enzyme in patients with senile viral myocarditis (VM) treated by trimetazidine, and analyze its effect on the prognosis, so as to provide reference for clinical diagnosis and treatment of VM. Methods 114 cases of elderly patients with VM were randomly divided into observation group and control group, 57 cases for each group. All patients were treated with conventional treatment, while trimetazidine 20 mg, tid, was added to the patients in observation group for 6 weeks. In the same period, 50 cases of healthy people were selected to normal group for reference. Then the levels of serum myocardial enzymes and the LVEF were compared between all groups, and the levels of serum myocardial enzymes and the change of LVEF were observed 1, 2, 3, 4, 5, 6 weeks after treatment to investigate the effect of trimetazidine on the serum myocardial enzymes. Results The levels of CK and CK-MB of VM patients were higher than normal group, and the differences were statistically significant (P <0.05). The levels of CK, CK-MB of control group and observation group were significantly decreased, but the changes in observation group were more obvious, the differences were statistically significant (P <0.05). The total effective rate of control group was lower than observation group (84.2% vs 96.5%), the difference was statistically significant (P <0.05). The 1 year survival rate was 93.0% (53/57) in control group,and 98.2% (56/57) in observation group, the difference was not statistically significant (P >0.05). The results of Pearson correlation analysis showed that the CK (r= -0.780) and CK-MB (r=-0.801) had negative correlation with LVEF (P<0.05), while CK (r= -0.791) and CK-MB (r= -0.764) were negatively correlated with 1-year survival (P<0.05). Conclusion Trimetazidine has positive significance to improve the prognosis of elderly patients with VM, and can help to predict the 1-year survival and the change of LVEF combining detection of serum myocardial enzymes. References | Related Articles | Metrics

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Effects of Low Dose Azithromycin on TNF-α, IL-8, CRP Levels in Peripheral Blood and Pulmonary Function of Elderly Patients with Stable Stage of Chronic Obstructive Pulmonary Disease LI Tao, LIU Xiang-qun, LIU Jing-shuang 2016, 13(8): 460-463.  Abstract ( 291 )   PDF (1088KB) ( 260 )   Objective To investigate the effects of low dose azithromycin on TNF-α, IL-8, CRP levels in peripheral blood and pulmonary function of elderly patients with stable stage of chronic obstructive pulmonary disease (COPD). Methods From January 2013 to December 2015, 100 patients with COPD in our hospital were involved in the study and randomly divided into two groups, including 50 cases who received conventional bronchiectasis and expectorant medicine as the control group, while 50 patients who received conventional therapy with supplementary low dose azithromycin as the observation group. Forced vital capacity in 1st second (FEV1), forced vital capacity (FVC), percentage of forced vital capacity in 1st second (FEV1%), tumor necrosis factor-α (TNF-α), interleukin-8 (IL-8), C-reactive protein (CRP) and arterial oxygen partial pressure (PaO2) were observed and recorded. Results Compared with the indexes before treatment, the PaO2, FEV1, FEV1/FVC and FEV1% were significantly higher, and the TNF-α, IL-8 and CRP were significantly lower after 6 months treatment in the observation group (P < 0.05). Compared with the control group, the indexes of pulmonary function and inflammatory factors in peripheral blood in the observation group were significantly improved after 6 months treatment, with statistically significant difference (P < 0.05). There was no significant difference between the two groups of MIC value of pathogenic bacteria and azithromycin in sputum samples before treatment and after treatment for 6 months (P >0.05). Conclusion Low dose azithromycin can significantly improve pulmonary function and reduce airway inflammation in elderly patients with stable stage of COPD, which is worthy of further clinical promotion. References | Related Articles | Metrics

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Establishment of Rapid Quantitative Analysis of Water in Salvia Miltiorrhiza by Near Infrared Diffuse Reflectance Spectroscopy HAO Lei, LI Jun-shan, PENG Xin-hua, WANG Xiao-kang, GAO Hui-qin, JIANG Guo-zhi, LI Zhen-jiang 2016, 13(8): 464-467.  Abstract ( 231 )   PDF (1296KB) ( 155 )   Objective To establish a quantitative model to determine the water in Salvia miltiorrhiza quickly by using near-infrared diffuse reflection technology and chemometrics method. Methods Near infrared spectra of the samples were measured by the integrating sphere. The partial least squares (PLS) calibration model was built with the first derivative spectra. Results The optimal number of the latent variables for the model was 6. The coefficient of determination (R2) for the model was 0.996 4. The root mean square error of cross-validation (RMSECV) was 0.442 and root mean square error of prediction (RMSEP) was 0.229. The relative standard deviation of the system and the method was 1.1% and 1.8% separately. Conclusion The NIRS model was proved to be a rapid and exact method for the quantitative determination of the water in Salvia miltiorrhiza. References | Related Articles | Metrics

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Research on Determination of Illegal Additive Abietic Acid in Xiaoerhuadu Series Preparations WU Jia-li, QU Fan-na, ZHANG Qing-bo, BI Xue-yan 2016, 13(8): 468-471.  Abstract ( 266 )   PDF (1354KB) ( 130 )   Objective To establish a method for detection of illegal additive abietic acid in Xiaoerhuadu series preparations. Methods Illegal additive abietic acid in Xiaoerhuadu series preparations was determined by HPLC-UV method. The HPLC method was carried on C18 column using acetonitrile, tetrahydrofuran and 0.1% formic acid (45:25:30) as the mobile phase to gradient elution, and the flow rate was 1.0 mL·min-1, the column temperature was 30℃ and the detection wavelength was 241 nm. Then the positive results were confirmed by HPLC-DAD detector and HPLC-MS. Results The linear range of abietic acid was 25.72 ~321.5 ng. The regression equation was Y=0.038 1X+1.698 1 while the correlation coefficient was 0.999 7. The detection limit was 18.4 μg·g-1. Abietic acid was found in five out of fifty-six batches of samples. Conclusion The method is convenient, sensitive and effective in screening for illegal additive abietic acid in Xiaoerhuadu series preparations. References | Related Articles | Metrics

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Research of the Risk Factors and Practice of Drug Risk Management on Drug-induced Progressive Multifocal Leukoencephalopathy FENG Hong-yun, FAN Yan, WU Gui-zhi, DONG Duo 2016, 13(8): 472-475.  Abstract ( 260 )   PDF (1037KB) ( 152 )   Objective To investigate the etiology and risk factors, to control effectively the risk of the drug-induced progressive multifocal leukoencephalopathy (PML). Methods The etiology and pathogenesis of PML, the risk factors of drug-induced PML, and the practice of risk management were analyzed. Results The JC virus infection is etiology base of drug-induced PML, the patients who are immunosuppressed or have malfunction of the immune system are at higher risk of developing PML. Immunosuppressive medications used for long time or combination with immunomodulators could increase the risk of drug-induced PML. Conclusion The reasonable risk managements could control effectively the risk of drug-induced PML. The individual serious case report of drug-induced PML is few now, so we should enhance the abilities of monitoring and drug risk management on drug-induced PML. References | Related Articles | Metrics

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Research on USA and EU Regulations of Post-approval Drug Manufacturing Changes LI Xiao-yu, CHAI Qian-wen, TIAN De-long, YANG Yue 2016, 13(8): 476-481.  Abstract ( 345 )   PDF (1224KB) ( 820 )   Objective To put forward some suggestions on post-approval drug manufacturing changes for our country. Methods The USA and EU regulations of post-approval drug manufacturing changes were studied, and our deficiencies on post-approval drug manufacturing changes were analyzed. Results Both USA and EMA classify manufacturing changes based on risks, pay more attention to supervision of changes with high risks, and use post-approval change management protocol to give manufacturers who understand the risks of their products with more flexibility. Conclusion We should apply the risk-based approach to drug manufacturing changes to substitute the present unified regulatory way, thereby alleviate the burden of CFDA and corporations, and use post-approval change management protocol to increase more flexibility on manufacturing changes and promote manufacturs, continuous improvement and innovation. References | Related Articles | Metrics

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Application of JCI Certification Standards in the High-risk Drugs Management in Hospitals ZHANG Hong-xu, YANG Qing, GUO Hui 2016, 13(8): 482-483.  Abstract ( 295 )   PDF (976KB) ( 255 )   Objective To establish a management model for the high-risk drugs in our hospital in order to ensure the safety of clinical medication. Methods By comparing the high-risk drugs classification management catalog of Cpahp and the definition of high-risk drugs of JCI certification standards, combining with the specific cases of falling out of bed, death, and so on that we found in checks in the past caused by using high-risk drugs, measures for high-risk drugs management in our hospital were worked out by refering to JCI standards, and the processes of the high-risk drugs use were optimized, of course, the risks of high-risk drugs use were reduced. Results Establishing and improving the safe use and management of high risk drugs, grasping the variety of high-risk drugs, strengthening the effective communication among doctors, pharmacists, nurses and patients are an effective way to reduce the risks of high-risk drugs. Conclusion JCI high-risk drugs management system can effectively reduce the risks of high-risk drugs use and ensure the safety of clinical medication. References | Related Articles | Metrics

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Research on the Differences and Correlation Between‘Serious’ and ‘Severe’ Adverse Drug Reactions/Events YUAN Li, YANG Yue 2016, 13(8): 484-488.  Abstract ( 1575 )   PDF (1045KB) ( 3344 )   Objective To ravel out the concept,connotation and significance of ‘serious’ and ‘severe’ adverse drug reactions (ADRs) /adverse events (AEs), clear out the differences and correlation between the two concepts, and lay a foundation for accurate use in the actual work. Methods Literature research and comparative analysis were introduced to compare and summarize the differences and relationship between the concepts and connotation. Results ‘Serious’ ADR/AE is based on outcome, it is a guidance in determining responsibility in drug safety monitoring, ‘severe’ adverse drug reaction/event is a class of ADR/ADE marked as ‘severe’. Conclusion ‘Serious’ and ‘severe’ ADRs/AEs are not the same and often confused in use, the former is more likely a concept of administration, and the latter is more likely a technical concept. The existence of the two plays a different role, it should be paid attention when use. References | Related Articles | Metrics

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Analysis of 193 Cases of Adverse Drug Reactions Induced by Zhengqingfengtongning Sustained Release Tablets WU Zhao-zhao, LONG Li-ping, CHEN Xi, CHEN Guang-jian 2016, 13(8): 489-491.  Abstract ( 328 )   PDF (1100KB) ( 432 )   Objective To investigate the incidence of adverse drug reactions and clinical symptoms of Zhengqingfengtongning sustained release tablets. Methods 4 064 cases of patients who used Zhengqingfengtongning sustained release tablets were collected (including outpatients and inpatients from 7 hospitals in Hunan province). The frequency and constituent ratio were described by SPSS software. The incidence rate of different affecting factors was compared by chi-square test. Results The incidence of Zhengqingfengtongning sustained release tablets adverse events was 4.75% (193 in 4 063). The main ADR/ADE damages involved skin and its accessories (41.23%), gastrointestinal system (35.53%). The clinical symptoms of ADR were various, of which the erythra and itching occurred the most. Conclusion The lesions of skin and its accessories and gastrointestinal system are the predominant presentation of ADRs of Zhengqingfengtongning sustained release tablets. Clinicians should be familiar with the common ADRs of Zhengqingfengtongning sustained release tablets, discover and deal with the ADRs in time in order to ensure clinical drug safety. References | Related Articles | Metrics

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Clinical Medication Analysis of Sophorae Tonkinensis Radix et Rhizoma in a Hospital in 2015 PAN Shuang-feng, HUA Bi-chun 2016, 13(8): 492-495.  Abstract ( 243 )   PDF (996KB) ( 407 )   Objective To investigate the medication and compatibility of Sophorae tonkinensis Radix et Rhizoma in prescriptions of traditional Chinese medicine from a hospital, so as to provide guidance for medication safety and rationality in clinic. Methods Prescriptions with Sophorae tonkinensis Radix et Rhizoma in 2015 were selected from the hospital, and the medication dosage, department distribution, clinical application, single ingredient as well as the category were then statistically analyzed respectively. Results The prescriptions with Sophorae tonkinensis Radix et Rhizoma, of which the dosage was 6~9 g, were mainly used for 3 or 7 days, applied in otolaryngological department and pediatrics for the treatment of acute or chronic laryngopharyngitis, tonsillitis and cold. Besides, medicines used compatibly with Sophorae tonkinensis Radix et Rhizoma were those of heat-clearing medicine, dispelling phlegm drug, deficiency-supplementing medicine, drugs for relieving exterior syndrome, respectively by a ratio from high to low. What’s more, single ingredient used compatibly with Sophorae tonkinensis Radix et Rhizoma were Glycyrrhizae Radix et Rhizoma, Scutellariae Radix,Belamcandae Rhizoma, Platycodonis Radix, Scrophulariae Radix, respectively by a ratio from high to low. Conclusion Clinical medication of Sophorae tonkinensis Radix et Rhizoma prescriptions in this hospital is rather unreasonable. Thus, supervision and administration should be strengthened to raise the rationality and reduce the side effects. References | Related Articles | Metrics

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Study on Stability of Propylgallate Injection Combined with Different Transfusions ZHANG Jing-yi, LIU Yang, LIU Mei-tong, GAO Sheng-chuan 2016, 13(8): 496-499.  Abstract ( 297 )   PDF (1029KB) ( 104 )   Objective To study the stability of the solution after compatibility of the propylgallate injection with different transfusions, so as to provide favorable experimental basis for the clinical application of the propylgallate injection. Methods According to the requirements for simulation of clinical medicine, the transfusions were divided into experimental group and control group, and the changes of color, pH values, and particle numbers of compatible solutions at 0, 0.5, 1, 2, 4 h and 8 h were investigated. The numbers of particles were detected by light blockage method specified in Chinese Pharmacopeia (2015 edition, No 4). Results The compatible solutions of propylgallate injection at different time were transparent liquid, no obvious change, and there were no differences between the groups. The pH value remained stable. The numbers of particles increaseed or decreaseed with time, which reached the minimum floating when propylgallate injection combined with 5% and 10% glucose injection, conformed to the 2015 edition of Chinese Pharmacopoeia standards. The numbers of≥10 µm particles quickly increased and exceeded the limitation of the Chinese Pharmacopoeia after combined with 0.9% sodium chloride injection. The numbers of≥10 µm particles reached the maximum floating at 0 hour when propylgallate injection combined with glucose-sodium chloride injection. At other times, the numbers of insoluble particles were qualified. Conclusion The most compatible suitable solvents for propylgallate injection were 5% glucose injection and 10% glucose injection. References | Related Articles | Metrics

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Stability Study of Rifampin for Injection in Six Solvents HOU Wen-jie, DING Hong-zi, ZHOU Qiu-yun, WANG Jie 2016, 13(8): 500-502.  Abstract ( 332 )   PDF (1098KB) ( 227 )   Objective To investigate the stability of rifampin in six solvents. Methods After the samples of rifampin were dissolved in six solvents, RP-HPLC was employed to analyze the contents at different time and temperature. Results The concentration of rifampin had no significant change in 0.9% NS and 5% GS with the volume of 500 mL. However, the decline of the content of rifampinin was observed with increased temperature and extended time. Conclusion It may be beneficial to make up rifampin in 0.9% NS and 5% GS with the volume of 500 mL. References | Related Articles | Metrics

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Medical Device Adverse Events Monitoring and Risk Analysis on Ventilators ZHENG Li-jia, ZHAO Yan, DONG Fang 2016, 13(8): 503-504.  Abstract ( 342 )   PDF (977KB) ( 677 )   Objective To strengthen the monitoring of ventilators, and ensure the correct and safe use of the products. Methods By introducing the classification,common use, suspected medical device adverse event (MDE) and analyzed of the MDE causes of ventilators, the risk factors of ventilators were anlyzed. The analysis of the risk factors was based on three aspects, including design factors, use factors and patients factors. Some advices to the risk control were suggested. Results The unreasonable design of products and improper use were the common risks about ventilators. Conclusion Manufacturers need to improve the product design, operators need to improve training to control the risks of ventilators. References | Related Articles | Metrics