Chinese Journal of Pharmacovigilance

Effects of Salvia Miltiorrhiza and Exercise on Blood Stasis Aged Rat Model and Its Mechanism

JIA Jing-jing, MAO Xin, CHEN Ying, FU Ying-jie, HAN Shu-xian, WANG Zhi-min, LIAO Fu-long, YOU Yun

2016, 13(2): 65-69.

Abstract ( 264 )

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ObjectiveTo investigate the effects and possible interactions of Salvia miltiorrhiza combined exercise on blood stasis in aged rats. MethodsBlood stasis aged rat model was established by subcutaneously injecting D- galactose. 3×3 factor experimental design was used. Rats were randomly divided into nine groups, namely different levels of Salvia miltiorrhiza (0, 1.5, 3 g·kg^-1) and different levels of swimming (0, 20, 40 min). After seven weeks, Laser Doppler blood flow imaging system was used to monitor the change of microcirculation blood flow of rat lower limbs and detect the post-occlusion reactive hyperaemia (PORH) of rat lower limbs. The plasma samples of rats were collected to determine the content of platelet aggregation and fibrinogen (FIB). The serum samples were collected to detect the level of superoxide dismutase (SOD) and malondialdehyde (MDA). ResultsBoth Salvia miltiorrhiza and exercise could improve the microcirculation blood flow of model rat lower limbs (P<0.01, P<0.05) and they had interaction (P<0.05). Salvia miltiorrhiza could significantly enhance the hyperemia rate of model rat lower limbs (P<0.01). Both Salvia miltiorrhiza and exercise could reduce the rate of platelet aggregation of model rats (P<0.05, P<0.05), and lower the content of FIB of model rats (P<0.01, P<0.01) and they had interaction (P<0.01). Exercise could increase the level of SOD in model rats (P<0.05). Both Salvia miltiorrhiza and exercise could decrease content of MDA of model rats (P<0.01, P<0.05). ConclusionSalvia miltiorrhiza combined appropriate exercise could improve the microcirculatory disturbances of blood stasis aged rats through reducing the rate of platelet aggregation and the content of FIB and MDA, increasing the level of SOD and the microcirculation blood flow.

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Comparison Study on Acute Toxicity of the Aqueous Solution from Radix, Radix with Cortex and Cortex of Psammosilene Tunicoides

WU Min-xuan, GUO Jian-you, WANG Qian, ZHANG Bei-yue, WANG Sheng-nan, MA Xiao-jie, ZHENG Zhi-quan, SHI Jin-li

2016, 13(2): 70-73.

Abstract ( 273 )

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ObjectiveTo compare the acute toxicity of the aqueous solution from Psammosilenes radix, Psammosilenes radix with cortex and Psammosilenes cortex, in order to provide a basis for safe and reasonable medication in clinic. MethodsThree samples of Psammosilenes tunicoides were prepared and compared in accordance with classical acute toxicity test. The toxic symptom was observed, and the death and the change of body weight were recorded. The pathological morphology parameters of dead mice with high dose were performed. The experimental data are calculated LD₅₀ with the Bliss method. ResultsThe LD₅₀ (the 95% confidence interval) of Psammosilenes radix, Psammosilenes radix with cortex, Psammosilenes cortex are respectively 4.638 2 (4.004 6~5.439 6) g·kg^-1, 4.847 1 (4.325 1~5.450 8) g·kg^-1, 6.403 2 (5.720 7~7.210 3) g·kg^-1 (crude drug dose). The main toxic target organs are lung, spleen and stomach. ConclusionThe value of LD₅₀ of different fractions in Psammosilenes tunicoides is: Psammosilenes cortex >Psammosilenes radix with cortex> Psammosilenes radix. However, it has slight difference. The process of toxicity in vivo and toxicity mechanism need to be further studied.

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Effects of Kushenin Pellicle on Hypertrophic Scar and TGF-β/Smad Signal Transduction Pathway

WANG Ai-li, GU Yao-hui, HUANG Jing, JIA Qing, CHEN Bo, XU Shun

2016, 13(2): 74-77.

Abstract ( 260 )

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ObjectiveTo investigate the effects of kushenin on hypertrophic scar and its effective mechanism. MethodsHuman hypertrophic scar tissues were subcutaneously transplanted into the back of 30 nude mice to create the animal models of hypertrophic scar. Ten days after the operation, the mice were distributed into the model control, kushenin pellicle and positive medicine group. Drugs were applied 2 times a day for 8 weeks. The growth of the scar was observed and photographed every week, and its size was measured after 10, 35, 49 and 56 d. RT-PCR and Western Blot assessment was used to detect the mRNA and protein expression of TGF-β1 and Smad3. ResultsThe growth of scars in the model control group was more rapid than that of the kushenin pellicle and positive medicine treatment group. The inhibition effect became more obvious with extended medication time. Compared with the model control group, the mRNA and protein expression of TGF-β1 and Smad3 were declined sharply in kushenin pellicle group. ConclusionThe mechanisms of anti-hypertrophic scar effects of kushenin maybe involve inhibiting the TGF-β/Smad signal transduction pathway.

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Optimal Selection of Base Composition of Ointment of Curcuma Oil by Orthogonal Design

HONG Bo, LI Wen-jing, NIU Ying-cai, LI Xiao-ming, LI Cheng-chong, ZOU Yu

2016, 13(2): 78-79.

Abstract ( 248 )

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ObjectiveTo determine the best formula of ointment of curcuma oil. MethodsThe best formula was determined by orthogonal design and high performance liquid chromatography methods, using appearance of the ointment and the contents of effective components as the test index. ResultsThe optimal formula was determined as followed: glyceryl monostearate 32 g, glycerin 70 mL, albolene 18 g, distilled water 500 mL. ConclusionThe ointment with high effective components obtained from this formula is stable.

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Discussion on How Drug Manufacturers Report Individual Case Adverse Drug Reactions

LI Ning, REN Jing-tian

2016, 13(2): 80-83.

Abstract ( 335 )

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This paper systematically reviewed laws and regulations in our country, relevant guidelines of ICH and ISPE, analyzed six different sources of adverse drug reactions/ adverse events, such as spontaneous reports, sourced from organized data collection scheme,literature,abroad, contractual agreements and other sources, put forward the minimum data elements, contents and time frames of individual report,specific reporting requirements of those sourced from organized data collection scheme and abroad,and put emphasis on the requirements on how to analyze individual report in summary report. It’s aimed to provide reference for manufacturers according to reporting requirements.

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Adverse Drug Reactions General Quantitative Indicator Researches

ZHANG Jin-peng, SHI Yuan-yuan, FENG Xiao-yuan, WANG Xiao-yi, WANG Ying, ZHU Wen-tao

2016, 13(2): 84-86.

Abstract ( 267 )

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ObjectiveTo analyze the applicability and limitation of the general indicators in ADR quantitative assessment researches. MethodsThe related literatures since 2000 in CNKI, WANFANG and VIP databases were searched, and the general indicators in ADR quantitative assessment researches were summarized. ResultsFive indicators in ADR quantitative assessment researches were involved: disability-adjusted life year, severity index of ADR, risk-benefit-ratio, number need to harm and quality-adjusted life year. ConclusionLimitation does exist in each indicator. Indicators can be used cooperatively to improve the scientific level in ADR quantitative assessment researches.

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Improvement and Evaluation of Adverse Drug Reactions Monitoring System in Our Hospital

XIA Yun, LU Yi-yan, FAN Bei-bei, CAO Shan, QU Hong

2016, 13(2): 87-89.

Abstract ( 267 )

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ObjectiveTo improve the ADR monitoring system and ensure this system to play an important role in drug safe use. MethodsThrough training and changing the mode of reward, the reporters’ enthusiasm was improved. Through clarifying responsibilities, clinical pharmacists played the guiding role in ADR monitoring. By developing the ADR monitoring platform the reporting process was simplified. ResultsThe quantity and quality of ADR reports, the percentage of new serious ADR reports and the effect of ADR early warning and intervention measures were enhanced greatly after ADR monitoring system had been improved. ConclusionThe methods of improving our hospital ADR monitoring system are correct and can provide a reference for other medical institutions.

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Overview and Application in Establishing Animal Models against Fatty Liver Disease for Active Discovery and Efficacy Evaluation of Chinese Medicine

SUN Xiao-qian, SUN Rong

2016, 13(2): 90-93.

Abstract ( 252 )

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ObjectiveTo establish the animal model of fatty liver with the basis of etiology and pathogenesis of fatty liver disease and the clinical practice of TCM, which is stable and reliable and is suitable for the activity and efficacy evaluation of TCM. MethodsReferences in the last decades at home and abroad about the animal model of fatty liver were collected, summarized and analyzed. ResultsThere are many models of fatty liver at present, though the mechanisms and applications of models are different and there are many problems in the study of the efficacy evaluation and pathological mechanism of TCM, such as sensitivity, reliability and stability of the model. ConclusionWith the development of modern medicine and the improvement of experimental technology, especially the early metabolic target of fatty liver discovered, the fatty liver model caused by varieties of inducements is possible. Cognition of fatty liver model with TCM and modern medicine is consistency, but also which is own characteristics of viscera. The fatty liver model is established by the study of etiology and pathogenesis and disease-syndrome development regularity, which is suitable for evaluating the activity and efficacy of TCM anti-fatty liver and accords with the disease-syndrome development regularity of TCM, for providing methodology and technology of screening and discovering anti-fatty liver drugs.

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Literature Analysis of 437 Cases of Adverse Drug Reactions/Events Induced by ATP

YUAN Xing-dong, XU Jin, ZHONG Chang-ming, ZHOU Juan, XU Yu-ming

2016, 13(2): 94-97.

Abstract ( 288 )

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ObjectiveTo probe into the characteristics and influencing factors of ADR cases induced by adenosine triphosphate (ATP), so as to provide a reference for clinical treatment. MethodsBy retrieving published ADR cases caused by ATP in the Chinese Journal Full-text Database between 1975 and 2015, 30 valid documents were obtained, 437 literatures were screened and analyzed retrospectively. ResultsThe main ADR manifestations were chest distress, flushing, dyspnea, headache, arrhythmia, nausea, limb numbness, etc. ConclusionThe ADRs of intravenous administration and non intravenous administration were different, the occurrence of adverse reactions may be related to the drug dosage, the clinical use dose of ATP is not unified, there are many differences in the method of administration between home and abroad.

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Literature Analysis of 82 Cases of Adverse Drug Reactions Induced by Gefitinib

XIA Hui-hong

2016, 13(2): 98-102.

Abstract ( 269 )

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ObjectiveTo investigate the characteristics and mechanism of adverse reactions induced by gefitinib, and to find its risk factors and provide technical support for safe and rational use of the drugs in clinic. Methods“Gefitinib”, “adverse reaction” and “caused by” were used as key words to retrieve articles in CNKI and VIP database. 57 literatures which met the inclusion and exclusion criteria were extracted and analyzed. ResultsThere were 82 cases of ADR in literatures, which mainly involved the gastrointestinal system, skin and appendages, respiratory system. Diarrhea, acne-like rash, cough, interstitial pneumonia were most common and some cases were serious even to death. The majority cases were senile male patients. ConclusionIt is important to pay attention to the adverse reactions caused by gefitinib, especially to strengthen post-marketing surveillance for elderly lung cancer patients, so as to prevent severe and rare adverse drug reactions.

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Intervention Analysis and Improvement Measures on Irrational Outpatient Prescriptions between 2012 and 2014

ZHANG Xian, LU Jin, YANG Shu-gui

2016, 13(2): 103-106.

Abstract ( 270 )

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ObjectiveTo probe into how to improve prescription quality and play the role of pharmacists in clinical treatment by means of prescription intervention. MethodsThe retrospective study was used to analyze data from the whole outpatient prescriptions between 2012 and 2014. The examples of irrational prescriptions were classified and analyzed. The reasons of errors were given, and the countermeasures were suggested. ResultsThere were 455 irrational prescriptions intervened from 2012 to 2014. The rate of the irrational prescriptions was reduced from 2.4 to 0.6 (P=6.6×10^-32, P<0.05). Dermatology, cardiology internal, endocrinology, otolaryngology and gastroenterology were most frequently involved in irrational prescriptions. ConclusionInterventions are effective. There were still problems in prescription writing and rational drug use, which need further improvement in order to ensure the patient’s safety. Pharmacists must play the role of professionals.

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Literature Analysis of 66 Cases of Adverse Drug Reactions Induced by Xingnaojing

LIU Hong-ming, XU Li-li, CUI Ran, ZHAI Shu-yu

2016, 13(2): 107-110.

Abstract ( 359 )

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ObjectiveTo investigate the rules and characteristics of ADRs, explore the influence factors of adverse drug reactions (ADRs) induced by Xingnaojing injection, and put forward reasonable suggestions for clinical application. MethodsDemographic characteristics, solvent, primary disease of patients, occurrence time and appearance of adverse reactions, and outcomes were analyzed by retrieving literature. ResultsXingnaojing injection was characterized, as suggested in literature, by speedy development, multi system damage, and presented problems such as exceeding indications, lacking usage and dosage for children in dispensatory. ConclusionIn clinic, this drug should be used strictly according to the indications for doctors and forbidden exceeding indications. For pharmaceutical enterprise, this drug should not be used for children until its usage and dosage for children was added in directions. The disposable precise infusion apparatus should be used in clinical as far as possible. Simultaneously, intensive care and controlling dropping speed should be practiced.

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Clinical Comparison and Analysis on Influence of Azole Antifungal Agents on Anticoagulation Activity of Warfarin

ZHAO Ming, LIANG Liang, ZHANG Ya-tong, CHEN Di, ZHU Yuan-chao

2016, 13(2): 111-114.

Abstract ( 307 )

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Objective To investigate the influencing frequency and degree of azole antifungal agents on anticoagulation activity of warfarin in order to reduce potential bleeding risk and provide reference for safe drug use. Methods Inpatient cases from January 1st 2010 to November 1st 2015 were screened to identify those who used warfarin in combination with azole antifungal agents, and relevant clinical data was extracted for analysis. Results Totaled 27 cases were included among which 21 cases received fluconazole and 6 cases received voriconazole in combination with warfarin therapy. 22 cases (81.48%) had INR values higher by 20% after co-administration than baseline levels with warfarin alone. Compared with the INR values with warfarin alone, INR values increased by 2.18 folds (P<0.000 1) and 2.59 folds (P=0.006 9) respectively after co-administration with fluconazole and voriconazole. Warfarin sensitivity index (WSI) was also calculated in order to diminish the influence of warfarin dosage adjustment on INR values. Compared with the WSI values with warfarin alone, INR values increased by 2.07 folds (P<0.000 1) and 3.28 folds (P=0.009 6) respectively after co-administration with fluconazole and voriconazole. INR values in some cases rose significantly as early as 2 days after co-administration and reached peak values on the 7th day. Conclusion Co-administration of warfarin and azole antifungal agents can significantly enhance anticoagulation activity of warfarin by 2 folds and INR values should be closely monitored within 1 week after co-administration in order to prevent bleeding events.

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CHENG Zheng-bo, WANG Yan, ZHANG Jian, ZHOU Ya-nan

2016, 13(2): 115-118.

Abstract ( 591 )

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Objective To investigate the incidence, causes and remedial measures of adverse events after tracheal intubation. Methods The incidence and outcomes of adverse events of ICU inpatients after tracheal intubation from 2011 to 2013 were retrospectively analyzed.Results After tracheal intubation, there were 32 cases of adverse events, of which one case of sudden cardiac arrest leaving neurological sequelae after a successful recovery. One case gave up treatment due to tracheal stenosis, another case was improved after treatment in superior hospital, and no obvious impact on treatment outcomes was found during the left 29 cases. Conclusion The adverse event incidence of ICU inpatients was higher, and it can be prevented by active prevention and reasonable treatment.

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