Chinese Journal of Pharmacovigilance

Protective Effects of Guanxindanshen Formula Different Components on Acute Myocardial Ischemia in Rats

DOU Li-wen, ， SUN Rong,

2015, 12(11): 641-644.

Abstract ( 303 )

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Objective To compare the protective effects of Guanxindanshen formula(GDF) different components with effectiveness by ligating coronary left descending artery with acute myocardial ischemia in rats. Methods The rat model of acute myocardial ischemia was established by ligating coronary left descending artery into sublingual vein. The incidence rates of VT and VF in rats after ligating coronary left descending artery were observed. Myocardial infarction size (MIS) of model rats was calculated and pathological examination of myocardial tissue was performed. Meanwhile, the levels of lactate dehyd rogenase (LDH), superoxide dismutase (SOD), malondialdehyde (MDA) in serum were determined by assay. Results Compared with model group, the GDF group significantly reduced infarct size, decreased the levels of LDH and MDA in serum, and increased the activities of SOD. In addition, MIS was reduced and myocardial cells were protected. The GDF group was the best to protect myocardial ischemia. Conclusion GDF different components with effectiveness can significantly inhibit acute myocardial ischemia in rats caused by ligating coronary left descending artery.

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Influence of Bicyclol on Survival Condition of Tumor-bearing Mice

WANG Shao-yuan, LIU Ning, YU Ling-hong, WEI Huai-ling, BAO Xiu-qi ZHANG Dan, SUN Hua

2015, 12(11): 645-648.

Abstract ( 311 )

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ObjectiveTo investigate the effect of bicyclol and combinative effect of bicyclol with anti-tumor drugs on survival condition of tumor-bearing mice. MethodsKunming mice transplanted with S180 sarcoma were administrated with 200 mg·kg^-1 bicyclol for 7 days, and simultaneously injected with 8 mg·kg^-1 adriamycin or 70 mg·kg^-1 cyclophosphamide at the first day and sixth day. After treatment, six mice of each group were sacrificed and the inhibitory rate of tumor growth was calculated. Animal death in the remaining animals was recorded. C57BL/6 mice were administrated with 150 mg·kg^-1 bicyclol for 14 days after 9 days transplanted with Lewis lung carcinoma. C57BL/6 mice were treated with bicyclol(50 mg·kg^-1,100 mg·kg^-1) for 18 days after 5 days transplanted with B16-F10 melanoma carcinoma. In these two models, the body weight and survival condition of mice were observed. ResultsIn S180 sarcoma and B16-F10 melanoma tumor-bearing mice models, bicyclol significantly prolonged the median survival time and decreased the mortality rate of tumor-bearing mice. However, there was no marked improvement effect at mice survival rate in C57BL/6 Lewis lung tumor-bearing mice models with bicyclol treatment. The combination of bicyclol with anti-

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Gaomo Therapy on Elimination of Psoas Fatigue of Weightlifter

LV Duan-lei, ZHAO Zhi-hui, Cheng Hu

2015, 12(11): 649-651.

Abstract ( 239 )

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ObjectiveTo explore the effect of the Gaomo therapy on improving psoas fatigue of weightlifter. Method40 athletes were randomly divided into control group and experimental group. The control group was given massage therapy, while the experimental group was given Gaomo therapy for 12 weeks. Contrast analysis of surface temperature, VAS fatigue, senior testosterone (T), cortisol (C), creatine kinase (CK) and blood urea nitrogen (BUN) before and after training were all recorded for change. ResultsThe surface temperature changes showed that Gaomo therapy group had a very significant difference compared with control group whenever it is before treatment and after treatment or before treatment and after treatment in 5 minutes(P <0.001). The results of VAS showed that Gaomo therapy group had a very significant difference compared with control group(P <0.001). The levels of T and C of Gaomo therapy had significant difference compared with control group in the 6th and 12th week(P<0.05), and the results of CK and BUN were meaningless(P>0.05).ConclusionGaomo therapy is effective for improving psoas fatigue of weightlifter and it is simple, economic and safe, so Gaomo therapy is deserving of the clinical expansion.

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Determination of Psoralen and Isopsoralen in Compound Ziling Capsules by UPLC

JIANG Li , GONG Chun-yan

2015, 12(11): 652-655.

Abstract ( 394 )

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Objective To establish an ultra performance liquid chromatography (UPLC) method for the determination of psoralen and isopsoralen in compound Ziling capsules. Methods The separation was performed on ACQUITY UPLC BEH C18(2.1 mm× 100 mm, 1.7 m) with 0.05% formic acid：methamol (50∶ 50) mixture as mobile phase at a flow rate of 0.2 mL·min-1, and UV detection at 246 nm. Results The calibration curves for psoralen and isopsoralen were linear in the range of 10~200 mg·L-1 (rPsoralen=0.999 6, rIsopsoralen=1.000 0). The average recoveries of psoralen and isopsoralen were (100.69± 1.38)% and (100.67± 1.29)%, respectively. Conclusion The method was simple, accurate and reliable for the quality control of compound Ziling capsules.

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Study on Quality of Moutan Cortex from Different Areas and Extraction Process of Paeonol

QU Yun-ping, WANG Jiao, GAO Hui-qin, LI Fei, LI Long-long, LI Zhe, JIANG Guo-zhi, LI Zhen-jiang

2015, 12(11): 656-659.

Abstract ( 250 )

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ObjectiveTo analyze the quality of Moutan Cortex from different areas, and to study the extraction process of paeonol. MethodsMoutan cortex from seven different areas were assayed and the different effective factors on yield rate and percent conversion were analyzed by SPSS software. ResultsThe contents of paeonol in Moutan Cortex from different areas are significantly different. The continuous extraction and distillation temperature have a great influence for paeonol yield rate and percent conversion. ConclusionAmong the Moutan Cortex from seven different areas, the highest content occurs in the one from Tongling, Anhui province, but the highest percent conversion of paeonol occurs in the one from Shangluo, Shaanxi province.

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Opportunities and Challenges in Using Medical Big Data to Monitor and Evaluate Drug Safety

WANG, Ling

2015, 12(11): 660-664.

Abstract ( 410 )

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ObjectiveTo introduce the concept of big data, the characteristic and the effect of medical big data, describe the necessity and feasibility of drug safety monitoring and evaluation by using medical big data, give suggestions on the secondary use of observational data for maximizing the benefit and minimizing the risk of pharmaceutical, and provide thought and references for the promotion of risk management. MethodsSubject study on linking of hospital information system and the national adverse drug reaction monitoring system was conducted, studing the current status and the practical application by using electronic healthcare data for pharmacovigilance in US and EU, compariing and analysing the gap between developed countries and China. The limitations of spontaneous reporting system were summarized, and the opportunities and challenges in medical big data application were analysed. Resultsand ConclusionThe healthcare data is important data resource with the features and the potential value of big data. Spontaneous reporting has inherent limitation, it will be a new way to rational use of medical big data for improving drug safety monitoring and evaluation. We should draw lessons from foreign advanced experience, and further strengthen in ideology, regulations and technology level.

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Proposal and Practice of Building the Early Warning System on Cluster Adverse Drug Events Based on the Adverse Drug Reaction Monitoring

FENG Hong-yun, YANG Le, SONG Qiu-jie, HOU Yong-fang, ZHENG Ming-Jie

2015, 12(11): 665-668.

Abstract ( 435 )

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The cluster adverse events, which have serious impact and harm on public health and social stability, are concerned by drug regulators. To avoid more damages, the signals of the cluster adverse events need to be discovered, identified and controlled as earlier as possible. In order to discover the drug cluster events and control the risk, an early warning system of the cluster adverse drug events based on the adverse drug events monitoring was built. In this article, the feasibility of building the warning system on cluster adverse drug events was analyzed.

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Application of Animal Models for the Discovery and Efficacy Evaluation of Anti Acute Liver Injury in Chinese Medicine

HUANG Na-na, SUN Rong

2015, 12(11): 669-673.

Abstract ( 274 )

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Objective To summarize the research progress on acute liver injury (ALI) caused by different factors of animal models in recent years, which will be used for TCM syndromes study and efficacy evaluation, and assess the degree of fit and accuracy between them, in order to seek better animal models of medical research adapted to different syndromes of ALI. Methods References about ALI model in the last decades at home and abroad were collated, analyzed and summarized. Results At present the common model is modern pathology model (model of ALI is mainly chemical, drug, alcohol and other autoimmune), but few studies have reported an animal model of TCM syndrome, and all of these failed to fully reflect the nature of these diseases in ALI, thus also affected the reasonable evaluation of drugs for acute liver injury. Conclusion In order to study the nature of ALI and liver medicine to provide better tools for evaluation. Under the guidance of Chinese medicine theory, on the basis of TCM clinical manifestations of ALI , combining modern etiology and pathogenesis study, we should research ALI animal model which is more in line with actual clinical syndromes and TCM theory.

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Literature Analysis of Adverse Drug Reaction on Central Nervous System Induced by Ertapenem

DONG Yue, HU Xin

2015, 12(11): 674-678.

Abstract ( 279 )

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ObjectiveTo analyze the situation and clinical characteristics of adverse drug reaction on central nervous system induced by ertapenem in order to provide references for rational drug use. MethodsErtapenem, adverse drug reaction, delirium, encephalopathy, antibiotic neurotoxicity, seizure, central nervous system toxicity and epilepsy were selected as the search words. PubMed,EMBASE,CBM,CNKI,VIP and WANFANG database were searched from 2001~2015. The literatures and case reports of adverse drug reaction on central nervous system induced by ertapenem were collected. The data were analyzed retrospectively including characteristics of patients, drug use as well as types, onset time, clinical manifestations, treatment and prognosis to adverse drug reaction. ResultsA total of 10 clinical research papers and adverse drug reaction reports(including 8 English papers and 2 Chinese papers )were selected.20 patients were enrolled in this study. They comprised 13 men(65.00%) and 7 women(35.00%) with average age of 40~89 years. The onset time to adverse drug reaction induced by ertapenem was within 5~7 days(65.00%)The clinical manifestations in most patients were mental disorder(55.00%) and epileptic seizures(40.00%). In total of 20 patients, 11 patients (55.00%) improved after receiving the drug discountinuation, 6 patients (30.00%) improved after receiving the drug discountinuation and symptomatic treatment, 3 patients (15.00%) died of non-drug reason. ConclusionErtapenem can lead to adverse effects on central nervous system in patients with risk factors of central nervous system toxicity, and such patients should avoid to use it or followed by a careful adverse drug reaction monitoring. The application of drugs should be ceased immediately once the adverse reactions were monitored, and meanwhile the relevant symptomatic therapies should be applied.

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Analysis of 719 Reports of Adverse Drug Reactions/Events Induced by Sofren Injection

LI Lei, WANG Li-jian, ZHU Xu, GUAN Yu, FAN Ruo-xi, JIN Feng

2015, 12(11): 679-682.

Abstract ( 453 )

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ObjectiveTo study the general pattern and characteristics of adverse drug reactions/events(ADR/ADE) induced by sofren injection to provide references for clinical rational use of drug. Methods719 cases of ADR/ADE related to the sofren injection from January 2004 to December 2014 in Jilin province were analyzed using retrospective study method. ResultsAmong 719 reports, the elderly accounted for 44.78%, the main ADR/ADE was systemic damage (36.92%), and the major clinical manifestations were anaphylactic shock, dyspnea, shiver and fever, etc, but there was no warning of these in the drug instructions. ConclusionIt's important to pay attention to the ADR/ADE caused by sofren injection, and perfect drug instructions, in order to improve rational use of medicines in clinic, ensure clinical medication safety.

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Literature Analysis of 61 Cases of Adverse Drug Reaction Induced by Troxerutin

FENG Ya-nan, LIU Xin-xin, LI Yong-hui, GUO Rui-feng, LV Jun-qing

2015, 12(11): 683-686.

Abstract ( 389 )

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Objective To explore the causes and regularity of the adverse reactions (ADRs) of troxerutin , in order to provide the scientific references for safe drug use in clinic. Methods 61 cases of the ADRs of troxerutin reported in domestic literature were analyzed. Results Among 61 cases of the ADRs of troxerutin, more than 80% occurred in the age group above 45 years and 55.7% happened after the drug was taken beyond indications showed in the instructions. Futhermore, among 57 cases accepting intravenous drop infusion, 68% used glucose injection as solvent, and the ADRs of the solvent were more risky than that of other solvents. In addition, 22% occurred when troxerutin was used combining with other drugs in the same infusion bottle. 77% happened within 30 minutes after the drug was taken. Finally, the main ADRs were anaphylactic and anaphylactoid reactions. Conclusion Medical staff should well know instructions of the drugs, use it in accordance with the indications and doses labeled in the instructions strictly, and be cautious of drug combination. Furthermore, it is prohibited to use the drug combining with other drugs in the same infusion bottle. Meanwhile, the drug should be used under strict monitoring to reduce the damage caused by ADRs to a minimum.Pharmaceutical manufacturers should strengthen researches on preparation quality control and safety of troxerutin, so as to revise and improve the instructions on safety of the drugs.

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Some Topics about the Serious Adverse Drug Reaction Surveillance in Taiwan Area of China

CHEN Zhi-dong

2015, 12(11): 687-689.

Abstract ( 364 )

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Objective To introduce some topics about serious adverse drug reaction (SADR) surveillance in Taiwan area of China. Methods Based on the related data and the author's learning experience in Taiwan area of China, some issues about SADR surveillance, such as the results, related act, relief act, and preventive measures are all introduced. Results Now the percentage of SADR report is more than 38.7%, Pharmaceutical Affairs Act, Procedure for Reporting SADR, and Drug Injury Relief Act are the important guarantee of SADR surveillance, the studies for allele-drug-induced injuries are the major feature in Taiwan area of China. Conclusion Taiwan area of China has reached the level of developed countries in SADR surveillance.

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Literature Analysis of 40 Cases of Adverse Drug Reactions of Nonprescription Chinese Patent Medicines for Diseases of Throat Department

WANG Pei-jie, WANG Jia-lun, YI Zhi-wei, Dong Yan-fei, WANG Pu

2015, 12(11): 690-692.

Abstract ( 264 )

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ObjectiveTo analyze the occurrence of adverse drug reactions of nonprescription Chinese patent medicines which commonly used in diseases of throat department, in order to provide a reference for the safe use of such medicines. MethodsUsing a retrospective study method, the related literatures in CNKI were searched, collected and analyzed. ResultsThere were 14 varieties of nonprescription Chinese patent medicines involved, in which adverse reactions caused by andrographis tablet and compound Caoshanhu tablet were more than others. ConclusionThe safe use of nonprescription Chinese patent medicines still needs to be highly concerned.

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Analysis of Adverse Drug Reactions/Events Induced by Azithromycin

LI Yu, LIU Lei, FU Cun-ji

2015, 12(11): 693-696.

Abstract ( 402 )

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ObjectiveTo explore the regularity and characteristics of adverse drug reaction/event (ADR/ADE) induced by azithromycin and search for risk factors in order to provide a reference for safe clinical use. Methods1 353 cases of azithromycin ADR/ADE reports were analyzed in terms of the patient's condition, original disease, ADR/ADE occurring time, organ function, clinical manifestation and outcome by using retrospective study method. Results 81.95% cases of azithromycin ADR/ADE occurred for the treatment of infectious diseases, 18.05% for non-infectious diseases. 75.16% cases of ADR/ADE occurred between 14~55 years old. 55.82% cases with intravenous drip occurred within 1 h after using medicine, 50.73% cases with oral medicine occurred in 10 min~24 h after drug use. The involved systems and organs included digestive system (56.05%), skin and accessories (15.78%), systemic damage (10.91%), nervous system (6.71%), cardiovascular system (4.87%), not in detail (2.61%), respiratory system (1.69%), auditory and vestibular apparatus(0.51%), kinetic system apparatus (0.46%) and urogenital system (0.41%). After active symptomatic treatment, recovery and improvement rate was 98.57%. ConclusionThe unreasonable use of azithromycin is one of the important factors of ADR/ADE. During the period of clinical application of azithromycin, we should strengthen the monitoring of ADR/ADE involving nervous system and cardiovascular system in order to reduce or avoid the occurrence of severe ADR/ADE.

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