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    20 September 2016, Volume 13 Issue 9 Previous Issue    Next Issue

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    Study on Antipyretic Effects in Rats and Its Mechanism of Water Extraction Components of Bupleurum
    SHI Liang, ZHANG Zhi-hui, LI Xiao-yu, LV Li-li, SUN Rong
    2016, 13(9): 513-516. 
    Abstract ( 310 )   PDF (1040KB) ( 194 )  
    Objective To study the antipyretic effects of water extraction of Bupleurum components for rat fever model and to investigate the antipyretic mechanism. Methods Rat fever model was established via the back injection of 2, 4-dinitrophenol (DNP). Different doses of water extraction of Bupleurum components were given to rats by gavage. The temperature was detected in anus once every 30 minutes, continuously determined for 4 hours, recorded anal temperature and observed the antipyretic effect. At the same time, the levels of IL-1β, IL-6, TNF-ɑ, PGE2 in serum were detected. The content of cyclic adenosine phosphate (cAMP) in hypothalamic and plasma as well as the arginine vasopressin (AVP) levels in brain ventral septal area and plasma. Results The modeling was successful because the rectal temperature of rats increased significantly (P<0.001) after injection of 2, 4-dinitrophenol. The high, medium, low dose of water extraction components of Bupleurum all can reduce the temperature and present a dose dependent relationship, and it was also found that they can decrease the levels of IL-1β, IL-6, TNF-ɑ, PGE2 in serum, the cAMP in hypothalamic and the AVP in brain ventral septal area. However, the content of AVP in plasma was increased, but there was no significant effect on plasma cAMP level. Conclusion Water extraction of Bupleurum components has the antipyretic effect to the rat fever model. The mechanism of antipyretic effect mainly relates to reducing the serum inflammatory mediators of IL-1β, IL-6, TNF-ɑ, PGE2 in serum and regulating the synthesis and secretion of cAMP and AVP in hypothalamus.
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    Rat Body Weight, Organ Index and Histopathological Changes in Long-term Toxicity Experiment of Kursi Kaknaq in SD Rats
    Rabigul·Islam, Abdujilil· Abdugheny, LENG Ying-li, WANG Jing
    2016, 13(9): 517-520. 
    Abstract ( 292 )   PDF (935KB) ( 245 )  
    Objective To discuss rat body weight, organ index and histopathological changes in long-term toxicity experiment of Kursi Kaknaq in SD rats. Methods A total of 120 healthy SD rats, half male and half female, were randomly divided into the control, low (0.32 g·kg-1·d-1), middle (1.6 g·kg-1·d-1) and high (3.2 g·kg-1·d-1) of Kursi Kaknaq. The drug was given orally, 6 days a week for 180 days, and the controls were given with 0.5% sodium carboxymethyl cellulose suspension. The body weight, organ index and histopathological changes were examined when those rats were treated 90 days, 180 days and stoped for 30 days. Results Compared with the control group, there was no significant difference in body weight and organ index changes of rats in each period (P >0.05). In the 3.2 g (crude drug)· kg-1·d-1 group, organs of rats did not show drug-induced obvious histopathological changes. There were also no obvious toxic target organs. Conclusion No obvious toxicity was observed in SD rats treated with Kursi Kaknaq at 0.32, 1.6, 3.2 g (crude drug)·kg-1·d-1 given orally for 180 days in rat body weight, organ index ,and no obvious toxic target organs in the dose of 3.2 g·kg-1·d-1 (equivalent to 50 times of the recommended adult clinical doses ). It indicated that this drug has no obvious toxicity.
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    Observation on Cardiovascular Safety of Extracorporeal Shock Wave Therapy in Orthopedic Chronic Overuse Syndrome
    LIU Ya-jun, JIANG Ji-le, TIAN Wei*, ZHANG Long-hao, ZHANG Yin, GUO An-yi
    2016, 13(9): 521-524. 
    Abstract ( 236 )   PDF (896KB) ( 245 )  
    Objective To observe the cardiovascular safety and efficacy of extracorporeal shock wave therapy in orthopedic chronic overuse syndrome. Methods Patients with chronic overuse syndrome in Orthopedic Extracorporeal Shock Wave Therapy Center in Jishuitan Hospital between May 2015 and March 2016 were prospectively selected. Parameters including breath rate, heart rate, blood pressure and oxygen saturation during therapy were documented in the patients’ first course of treatment. Visual Analogue Score (VAS) was also recorded. Data were collected and compared before, during and after treatment. Patients with hypertension were analyzed in a subgroup. Results A total of 628 patients were enrolled, with an average age of 45.3±14.6 years old (13~89), among which there were 94 patients with hypertension. There was an increase of VAS scores during therapy but no significant difference in heart rate, breath rate, blood pressure and oxygen saturation (P>0.05), and there was significant reduction between VAS before and after treatment (6.34±1.98 and 3.89±1.69, respectively) (P=0.000). There was no case of abnormally changed breath rate, heart rate, blood pressure and oxygen saturation. The results in hypertension subgroup were consistent with overall patients. Conclusion Extracorporeal shock wave therapy did not increase stress of cardiovascular system during therapy, even in patients with hypertension. It could relieve the pain of orthopedic chronic overuse syndrome significantly.
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    Clinical Observation of Alprostadil Injection in Treatment of Patients with Decompensated Hepatitis B Cirrhosis
    GAI Xing-wen, MA Yong, ZHANG Wen-xue
    2016, 13(9): 525-528. 
    Abstract ( 394 )   PDF (894KB) ( 191 )  
    Objective To evaluate the clinical efficacy and safety of alprostadil injection in treatment of patients with decompensated hepatitis B cirrhosis, and provide some reference for the clinical application of the scheme. Methods From August 2013 to August 2015, 176 patients with decompensated hepatitis B cirrhosis in our hospital were studied prospectively. The patients were randomly divided into two groups, including 88 cases who received conventional liver protective and symptomatic supportive treatment as the control group, while 88 patients who received conventional treatment supplementary alprostadil injection as the observation group, four weeks for a course of treatment in both of the two groups. The changes of liver function, renal function, prothrombin activity (PTA), total bilirubin (TBIL), ascites depth, abdominal circumference and 24 h urine before and after treatment were observed and compared, the adverse reactions of the patients were observed during the treatment. Results Compared with the levels before treatment, the ALT, TBIL, BUN, SCr in both of the two groups decreased significantly, and the ALB, PTA increased significantly after four weeks treatment, the changes of the observation group were more obvious, the differences were statistically significant (P < 0.05). After treatment, the classification of liver function, the combination of hepatic encephalopathy, ascites ratio in both of the two groups decreased significantly, the changes of the observation groups were more obvious, the differences were statistically significant (P < 0.05). After four weeks treatment, ascites depth, abdominal circumference and 24 h urine in both of the two groups decreased significantly, the changes of the observation groups were more obvious, the differences were statistically significant (P < 0.05). The total effective rate of observation group was 81.82%, which was higher than that in the control group of 55.68%, the difference was statistically significant (P < 0.05). 3 cases of the observation group complained site redness, pain during the treatment, and the symptoms disappeared after the slow drop. There were no obvious adverse reactions in the control group during the treatment. Conclusion Alprostadil can improve liver function of the patients with decompensated hepatitis B cirrhosis, further promote the ascites symptoms relief, enhance the clinical efficacy, and no serious adverse reactions were observed after administration.
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    Study and Enlightenment of Medicines Risk Management Plan in European Union
    TIAN Yi, YANG Yue, TIAN Li-juan
    2016, 13(9): 529-532. 
    Abstract ( 431 )   PDF (1005KB) ( 370 )  
    Objective To provide suggestions to conduct risk management plan in China by introducing the development, implementation elements and implementation effect of risk management plan (RMP) in European Union. Methods The material of RMP in European Union was summarized through analyzing literature and searching European Medicines Agency (EMA) official website. Results European Union regulations require marketing authorization applicant (MAA) / marketing authorization holder (MAH) develop RMP to ensure drug risk-benefit balance, with perfect regulations and guidelines and organization structure, and has achieved good results. Conclusion China could require companies to develop RMP from a legal perspective, and improve the relevant system, promote the development of RMP, so as to achieve full life-cycle drug risk management.
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    Study on Situation and Countermeasures of Traditional Chinese Medicine Patent Protection
    KOU Xue-fang, XU Wen
    2016, 13(9): 533-536. 
    Abstract ( 302 )   PDF (907KB) ( 340 )  
    Objective To explore the development and distribution of traditional Chinese medicine (TCM) patents, by analyzing patent application status of TCM. Methods Chinese Patent Database web was used to inquire the types and quantity of TCM patents from 2008 to 2015. Furthermore,the distribution of patents was also analyzed. Results The number of patent applications was rising continually, but the overall quality is not optimistic at present. The patents were mainly applied by individuals, while enterprises and research institutions shared a small proportion. Conclusion The working focuses of TCM patents should be changed from quantity to quality gradually in the future by multifaceted and multisectoral cooperation, so as to push the research achievement to the market and to enhance the international competitiveness comprehensively.
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    Research on Medical Device’s Post-marketing Surveillance between China and Japan
    ZHENG Li-jia, ZHAO Yan, DONG Fang
    2016, 13(9): 537-539. 
    Abstract ( 389 )   PDF (890KB) ( 308 )  
    Objective Comparing medical device’s post-marketing surveillance between China and Japan, to provide reference for the medical device’s post-marketing monitoring in China. Methods Through the comparison between Chinese and Japanese medical device regulatory agency composition, medical device adverse event reporting system and procedures, treatment of medical device adverse event reports, combining with Chinese medical device regulatory status, the existing insufficiencies were analysed, so as to give advices. Results There are still insufficiencies in regulation, corporate responsibility awareness, the ability of hospital personnel, and public awareness. Conclusion By learning the medical device’s post-marketing surveillance in Japan, Chinese current regulation can be improved to promote the public safety of medical device’s use.
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    Bibliometric Analysis on Domestic and Foreign Studies of Pharmaceutical Service
    ZHANG Ya-tong, ZHAO Ming, ZHAO Zi-nan, DONG Fan, HU Xin
    2016, 13(9): 540-542. 
    Abstract ( 244 )   PDF (1154KB) ( 104 )  
    Objective To study the content and characteristics on literatures of pharmacy services, and to illustrate the development and trends on pharmaceutical service. Methods We searched the literature with the key words of pharmacy services or pharmaceutical care, analyzed the constitution ratio on the literature key words, subject name, journal name, research grant funds, research-level ,authors and so on. Results A total of 4 258 valid documents were retrieved in CHKD, 6 506 ones in WOS (web of science). Literature on pharmacy services increased significantly in China, but there was one obviously increasing trend a decade later than on abroad. Articles were contributed by many research units, but there was one relative concentration. The Domestic and foreign high-quoted documents have different focuses. Conclusion Domestic studies on pharmaceutical service started lately and has developed rapidly but need to be broadened and deepened in the contents.
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    Research Progress on Pharmacological Effects and Clinical Applications of Xinkeshu Tablets
    ZHANG Zhi-hui, YANG Qian, SUN Rong
    2016, 13(9): 543-546. 
    Abstract ( 458 )   PDF (919KB) ( 705 )  
    Xinkeshu tablet is a traditional Chinese medicine composed of five kinds of medicinal plants, Salvia Miltiorrhiza, Pueraria Lobata, Panax Notoginseng, Crataegus Pinnatifida, Aucklandia Lappa. Pharmacology studies have shown that Xinkeshu tablet has many activities, such as improving blood rheology and blood flow dynamics, lowering blood cipids, improving the heart rate variability, protecting hearts from ischemia-reperfusion injury, improving endothelial function, against coxsackie virus in vitro, inhibiting liver enzyme activity, and inflammatory response. Xinkeshu tablet is usually used to treat hyperlipemia, coronary heart disease, arrhythmia, hypertension, cardiac neurosis, double heart disease, cerebrocardiac syndrome. This paper reviewed the main progress on studies of pharmacological effects and clinical applications of Xinkeshu in recent years, so as to provide a reference for the further research and development of this drug.
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    Meta-analysis of Adverse Reactions of Zhengqingfengtongning Sustained Release Tablets
    XIE Zhi-Xin, WANG Mian, LONG Li-Ping, QIU Ping, WEN Ying-Yi
    2016, 13(9): 547-556. 
    Abstract ( 358 )   PDF (1010KB) ( 316 )  
    Objective To systematically review the characteristics of adverse reactions of Zhengqingfengtongning sustained release tablets, and to provide scientific evidence for related control and prevention work. Methods Databases such as CNKI, VIP, WanFang Data were searched for studies investigating the characteristics of adverse reactions of Zhengqingfengtongning sustained release tablets between 2000~2015. According to the inclusion and exclusion criteria, the data were extracted and the methodological quality of included studies was assessed. Then Meta-analysis was performed by using the RevMan 5.3 software. Results Forty-four studies involving 1 700 cases of treatment group and 1 688 cases of control group were included. The results of pooled analysis showed that the overall adverse reaction incidence of Zhengqingfengtongning was 14.2% and the risk was 0.83 times of the control group (RR: 0.83, 95% CI: 0.72~0.96). Sub-group analysis showed that the adverse reaction incidence of Zhengqinfengtongning alone group was 11.8%, 0.83 times of the risk for the control group (RR: 0.83, 95% CI: 0.62~1.10); the adverse reaction incidence of Zhengqinfengtongning combined use group(the control group treatments + Zhengqingfengtongning) was 14.8%, 0.91 times of the risk for the control group (RR: 0.91, 95% CI: 0.74~1.11); the types of adverse reactions mainly included rash reaction(8%), the risk was three times for the control group (RR: 3.00, 95% CI: 2.21~4.08); gastrointestinal reaction3.8% ,the risk was 0.58 times for the control group (RR: 0.58, 95% CI: 0.44~0.76); the other kind of adverse reactions 2.4%, the risk was 0.33 times for the control group (RR: 0.33, 95% CI: 0.24~0.44). Conclusion The treatment groups administrated Zhengqinfengtongning had a higher rash itchy reaction rate than the control groups, but the occurrence of gastrointestinal reaction and others were lower than the control groups. From the point of the overall adverse reactions, combined use of Zhengqinfengtongning had less adverse reaction incidences than the control group.
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    Analysis of the Perception of Risk on Drug-induced Progressive Multifocal Leukoencephalopathy
    FENG Hong-yun, FAN Yan, WU Gui-zhi, DONG Duo
    2016, 13(9): 557-562. 
    Abstract ( 279 )   PDF (964KB) ( 194 )  
    Objective To investigate the perception ability of risk on drug induced progressive multifocal leukoencephalopathy (PML) in China, and to provide support to treat and prevent PML reasonably. Methods The literatures in domestic and overseas bibliographic databases, the individual adverse drug reaction cases in Vigibase and China adverse drug reaction database were analyzed. Results Health professionals and Regulators in other countries have paid great attention on the diagnose, individual cases report and risk management of drug induced PML. But in our country, the perception of risk on drug induced PML is insufficient. Conclusion The risk of drug induced PML will exist for a long time, while the monitoring ability in our country lags behind other countries. In order to improve the monitoring and risk management ability on drug induced PML, several departments, such as manufactures, health professionals and regulators need to do more efforts and communication.
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    Analysis of Digoxin Dose of Elderly Outpatient Prescriptions Based on 2015 Beers Criteria
    MA Li-ping, YANG Fei, CAI Jin-rui, ZHANG Wen-xiang, WEN Cheng, WANG Hai-ying
    2016, 13(9): 563-566. 
    Abstract ( 344 )   PDF (923KB) ( 97 )  
    Objective To provide a basis for prescribing the rational digoxin dose for elderly outpatients. Methods All outpatients in Peking University shougang hospital who had been prescribed digoxin during 1 Jun. 2015 to 31 Aug. 2015 were eligible for the study. The samples were limited to adults aged 65 and older. The 2015 American Geriatrics Society (AGS) Beers Criteria was used to evaluate the doses of digoxin, which is recommended no more than 0.125 mg per day. The actual dosages of digoxin were confirmed with the included people by phone. Results Of 94 digoxin prescriptions, there are 62 prescriptions for elderly outpatients. Prescriptions of digoxin doses including 0.50 mg·d-1, 0.25 mg·d-1 and≤0.125 mg·d-1 account for 3.22%, 90.32% and 6.46%, respectively. However, by telephone interviewing some patients, we found that the actual doses of digoxin including 0.50 mg·d-1, 0.25 mg·d-1 and≤0.125 mg·d-1 account for 0%, 15.62% and 84.38%, respectively. We also found that the inconsistency between the doctor’s prescription doses (0.25 mg·d-1 or 0.5 mg·d-1) and the recommended doses (≤0.125 mg·d-1) was associated with the inconsistent dosage between the prescription doses of doctors and actual doses of patients. Conclusion Digoxin’ single strength, no unbundled dispensing medications of outpatient pharmacy and without limitation of digoxin dose for elderly outpatients in hospital information system are the main reasons of outpatient prescription digoxin doses higher than the recommended dose. Hence, the rationality of prescribing digoxin dose requires manufacturers, outpatient pharmacy, hospital information system and medical professionals to work together to make it.
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    Investigation and Analysis on Usage of Antibiotics in Inpatients of Psychiatric Hospital
    LI Huan-fen, ZHU Li-fang, CHU Liu-jie
    2016, 13(9): 567-569. 
    Abstract ( 379 )   PDF (882KB) ( 179 )  
    Objective To investigate the usage of antibiotics in psychiatric hospital so as to promote the rational use of antimicrobial drugs. Methods The medical records of 802 patients discharged from our hospital from September 1st to September 30th of 2015 were sampled for retrospective review of their basic conditions and the application of antibacterial drugs. Results From them 95 cases were administrated with antibacterial drugs, and the usage rate was11.85%, among which the preventive administration accounted for 9.47%, the therapeutic use 73.68%, and the ones using antibiotics with no indications 16.84% (P < 0.001), single medication accounted for 84 cases (88.42%), double medication 11 cases (11.58%) (P < 0.000 1). The bacterial exeamination rate was 21.05%. Conclusion There exist irrational phenomena in our psychiatric hospital in terms of indications of antibacterial drugs, preventative medication, combination medication, etc. So the training education and inspective management should be strengthened.
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