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20 April 2018, Volume 15 Issue 4 Previous Issue    Next Issue

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Effects of TGF-β/Smad3 Pathway on Process of Fulvestrant Inhibiting Proliferation and Secretion of Prolactinoma MMQ Cells LIU Qian, LI Zhen-ye, CAO Lei, GAO Hua, LI Chu-zhong, ZHANG Ya-zhuo 2018, 15(4): 193-196.  Abstract ( 417 )   PDF (838KB) ( 147 )   Objective To study the effects of TGF-β/Smad3 pathway on process of fulvestrant inhibiting the proliferation and secretion of prolactinoma MMQ cells. Methods After treated with different concentrations of fulvestrant for 24, 48, 72 h, the proliferation of prolactinoma MMQ cells was determined by MTS. Simultaneously, the active TGF-β; 1 and prolactin(PRL) levels in the supernatant of MMQ cells treated with increasing doses of fulvestrant for 24 h were measured by ELISA. The Smad3 phosphorylation levels following 24 h exposure to fulvestrant in MMQ cells were detected by immunofluorescence staining. Results Fulvestrant caused significant cytotoxicity in MMQ cells with a dose- and time-dependent manner. At the same time, MMQ cells were treated with fulvestrant increased active TGF-β; 1 levels and decreased PRL levels in a dose-dependent manner. In addition, the activated Smad3 in MMQ cells was significantly increased in cell cytoplasm and nucleus (mainly in cell nucleus) after following exposure to fulvestrant. Conclusion Fulvestrant maybe inhibit the proliferation and secretion of prolactin in MMQ cells through TGF- /Smad3 signaling pathway. References | Related Articles | Metrics

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Protective Effects of 4-Methylcyclopentadecanone on Myocardial Ischemia/Reperfusion Injury WANG Yong-ling, XUE Yun, DAI Xiao-li, MA Yu-kui 2018, 15(4): 197-200.  Abstract ( 374 )   PDF (723KB) ( 161 )   Objective To investigate the effects and mechanism of 4-methylcyclopentadecanone(4-MCPC) on myocardial ischemia/reperfusion(MI/R) injury on rat model. Methods MI/R rat model was established by coronary artery ligation for 30 min followed with 2 h reperfusion. Muscone was selected as control. Myocardial ischemic infarction was calculated and the level of CK, LDH in serum, the activity of MPO and the content of TNF-α, IL-1β in heart homogenate were detected to evaluate the effects of 4-MCPC on MI/R rats. Results Compared with model group, the myocardial ischemic infarction, CK, LDH level in serum, the activity of MPO and the content of TNF-α, IL-1β in heart homogenate were dramatically decreased in 4-MCPC(20, 10 mg·kg-1) group rats. Conclusion 4-MCPC displayed certain protective effects on MI/R rat model. References | Related Articles | Metrics

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Study on Related Factors of Postoperative Nausea and Vomiting and Clinical Intervention in Patients with Intraspinal Anesthesia ZHAO Cui-hong, TAO Yi-xiu, WANG Sheng-hai, ZHAO Qiang, MENG Qing-yong, ZHANG Han-xiang, QING Ming-ying, MA Wen-xia, MI Man 2018, 15(4): 201-204.  Abstract ( 401 )   PDF (738KB) ( 136 )   Objective To study the relationship of PONV (postoperative nausea and vomiting) between opioids and 5-HT3 receptor antagonists to guide the clinical rational use of drugs. Methods Through the 530 cases of the use of opioids in spinal anesthesia patients, study the intervention and nonintervention effect on PONV and difference, and compare the effects of three differences kinds of 5-HT3 receptor antagonists in preventing nausea and vomiting. At the same time, the time characteristics of PONV after different opioids is also studied. Results There was a significant difference in the incidence of PONV between the use of opioids and 5-HT3 receptor antagonist (P <0.05). The effects of different 5-HT3 receptor antagonists on PONV was positive (P >0.05). The occurrence time of PONV by different opioids was basically the same, which occurred between 2~6 h postoperatively, accounting for 69.23%~76.92%. The incidence of PONV after 24 h was very small, accounting for 1.54%. Conclusion The efficacy of 5-HT3 receptor antagonist on intraoperative and postoperative nausea and vomiting prevention is good. The prevention effect of three kinds of 5-HT3 receptor antagonists on intraoperative and postoperative nausea and vomiting is similar. But take into account the economy, ondansetron is used for preventing postoperative nausea and vomiting in clinical. Different opioids lead to different levels of PONV. It is no need to use 5-HT3 receptor antagonists preventively without the high risk factor of PONV, so that to avoid overtreatment. References | Related Articles | Metrics

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Study on Acute Toxicity and Cytotoxicity of 5-Hydroxymethylfurfural LIN Lin, LIN Ni, LING Ya-hao, Li En-can, Fan Xiao-Yu, LIN Sheng, ZANG Qing-ce, HE Jiu-ming, JIN Hong-tao 2018, 15(4): 205-209.  Abstract ( 1200 )   PDF (1076KB) ( 275 )   Objective To investigate the acute toxicity of 5-hydroxymethylfurfural(5-HMF) on ICR mice and cytotoxicity on mast cell RBL-2H3 and P815. Methods ICR mice received tail vein injection of 8 different doses of 5-HMF. The mice were observed daily to record the number of death and body weight, then 50 % lethal dose of (LD50) was counted. Pathological examination was completed at the end of the observation period. The cytotoxicity of 5-HMF on mast cell: RBL-2H3 and P815 was measured by MTT assay and 50 % inhibitory concentration (IC50) was calculated. Results Ataxia, tonic convulsions and other phenomena appeared in low doses, and with the dose increasing the frequency of above phenomenon increased. 5-HMF significantly decreased the weight of all groups from d1~d14 compared with control group(P <0.01) and the LD50 value was 871.12 mg·kg-1 using Bliss method based on the mortality rate. Pathological examination showed that mice had chronic progressive nephropathy in all doses. The IC50 of 5-HMF solution on RBL-2H3 and P815 was respectively 4.96 mM and 7.43 mM. Conclusion 5-HMF has acute toxicity with LD50 871.12 mg·kg-1, and kidney is the toxic target organ. IC50 in RBL-2H3 and P815 is 4.96 mM and 7.43 mM respectively. It provided the experimental basis for the degranulation of mast cells and theoretical basis for its quality control and further safety research. References | Related Articles | Metrics

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Research Progress of Pharmacological Activity and Toxicity of 5-Hydroxymethylfurfural LI En-can, HE Jiu-ming, JIN Hong-tao, LIN Ni 2018, 15(4): 210-215.  Abstract ( 1775 )   PDF (711KB) ( 524 )   Objective To understand and summarize the recent progress in the pharmacology and toxicology research of 5-hydroxymethylfurfural(5-HMF). Methods The author listed the common pharmacological effects and toxicity of 5-HMF, and collected and analyzed the existing research data which showed the research direction of 5-HMF at the present stage, then emphasized the necessity of 5-HMF content detection and limited control. Results 5-HMF has both pharmacological activity and toxicity, and is widely present in food and medicine, and ultimately whether it is harmful to the human body or not depends on the route of exposure, the dose and frequency of exposure, therefore, people should pay more attention to the toxicity of 5-HMF. Conclusion The safety evaluation of 5-HMF may provide guidance for the quality control and safe application of 5-HMF-containing foods and drugs. References | Related Articles | Metrics

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Research Progress in Analytical Methods of Allergenic Components in Injection ZANG Qing-ce, JIN Hong-tao, ABLIZ Zeper, HE Jiu-ming 2018, 15(4): 216-220.  Abstract ( 397 )   PDF (624KB) ( 180 )   Injection has been frequently reported to cause anaphylaxis. Establishing sensitive, effective and practical analytical methods for safety evaluation and quality control of injection can help to improve the safety of injection in clinical applications. In this review, we summarize the main analytical techniques for the determination of allergenic components in injection, including liquid chromatography-mass spectrometry, cell membrance chromatography and enzyme-linked immunosorbent assays, and discuss the applications, limitations and trends of these analytical techniques, hoping to provide reference for the improvement of the safety of injections. References | Related Articles | Metrics

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Sequential Probability Ratio Analysis in Post-market Drug Safety Surveillance ZHANG Xin-ji, GUO Xiao-jing, YE Xiao-fei, PENG Xu-jiao, HE Jia 2018, 15(4): 221-225.  Abstract ( 478 )   PDF (743KB) ( 243 )   Objective To review currently used sequential probability ratio analysis methods in medical product safety surveillance. Methods The principles of continuous and group sequential probability ratio analysis methods were reviewed. The key features of these two kinds of sequential methods were compared, and the application status was summarized. Meanwhile, we discussed the areas needed further development. Results The use of sequential probability ratio analysis for post-market drug safety surveillance was quickly emerging. Continuous sequential methods were the preferred approach, but group sequential methods were also promising. ConclusionSequential probability ratio analysis is a feasible method to monitor the drug safety in real time, but methodological development is needed to improve success. References | Related Articles | Metrics

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Analysis on Influencing Factors of Quality of Adverse Drug Reaction Reports in China BAO Hui-ling, LI Jiang-fan, WU Zhi-ang 2018, 15(4): 226-229.  Abstract ( 605 )   PDF (869KB) ( 325 )   Objective To screen and rank factors affecting quality of adverse drug reaction(ADR) reports, provide a reference for improving the reporting system for adverse drug reactions. Methods The theory of total quality management, "4M1E" five factors theory and analytic hierarchy process(AHP) were used to analyze influencing factors. Results The ranking of importance of factors affecting the quality of ADR reports is personnel, method and regulation, software and hardware, material and environmental factors in order. Conclusion The ranking of importance of influencing factors can be used as a reference for improving the reporting system for ADR. References | Related Articles | Metrics

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Inspiration from EU EndraVigilance WU Nan, YANG Yue 2018, 15(4): 230-233.  Abstract ( 801 )   PDF (703KB) ( 581 )   Objective To intruduce the legal framework, working mechanism, responsibilities and access rights of various stakeholders of EudraVigilance, provide reference for pharmacovigilance database system in China. Methods Using literature analysis and comparative research methods, on the basis of understanding the EudraVigilance, examining the inadequacy of China's ADR System. Results EudraVigilance has clear statutory requirements for the responsibilities and authorities of various stakeholders, the function is perfect to realize the collection, management and analysis of EU drug safety information. Conclusion The adverse reaction monitoring system in China still needs to be strengthened in terms of legislation, access rights, data scope and information utilization. References | Related Articles | Metrics

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Analysis of 652 Cases of Adverse Drug Reactions Induced by Lithium Carbonate ZHANG Shu, LIN Qiang, SUN Li-wei, WU Li-ling, ZHANG Long-ying, WU Xu-chen, HONG Shan 2018, 15(4): 234-239.  Abstract ( 391 )   PDF (812KB) ( 408 )   Objective To investigate the general characteristics and relative factors of the adverse drug reactions caused by lithium carbonate, so as to provide references for clinical rational and safe use of drug. Methods By retrospective study method, 652 cases of adverse drug reactions/events by lithium carbonate from the adverse reaction network platform of Pan-Pearl River Delta during 2003-2016 were analyzed. We analyzed the patient's age, gender, past history, the purpose of drug use, occurrence time, symptoms of adverse drug reactions, the systems-organs involved etc. Results 652 cases were collected that involved 1 002 cases of clinical manifestation. Multiple systems were affected by lithium carbonate including the damage to digestive system, nervous system, and general disorders etc. Conclusion Adverse reactions of lithium carbonate were correlated with individual differences, strictly controlled the indications, the rational drug use, monitoring lithium concentration in blood, in order to ensure drug safety. References | Related Articles | Metrics

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Analysis of 97 Cases of Adverse Drug Reactions Induced by Thioctic Acid Injection and Its Related Factors YU Heng-cai, ZHANG Wen, JIN Xiao-long, XU Ji-ping, SHEN Cheng-wu 2018, 15(4): 240-243.  Abstract ( 624 )   PDF (745KB) ( 163 )   Objective To analyze 97 cases of adverse drug reactions (ADRs) and related factors in thioctic acid injection, prevent or reduce the incidence of ADRs and promote the safety of clinical medication. Methods 97 cases of ADRs induced by thioctic acid injection from May 2014 to April 2017 in our hospital were retrospectively investigated and analyzed. Results ADR mainly affected the skin and its appendages (45.57%), followed by local injection damage (17.09%), digestive system (17.09%) and central and peripheral nervous system (9.49%). The ADRs mainly occurred on the first day of medication and most improved after 60 minutes with discontinuation or symptomatic treatment. ADRs were related to the patient's food and drug allergy history, off-label uses (including indications, usage, dosage, speed of infusion), the impurities and excipients of thioctic acid injection. Conclusion It is recommended that clinicians should strictly follow the instructions of thioctic acid injection in terms of indications, daily dose, solvent, concentration, drip rate and light avoidance, and the manufacturers should purify thioctic acid injection further so as to reduce the occurrence of ADRs. References | Related Articles | Metrics

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Analysis of 45 Cases of Adverse Drug Reactions Induced by Lamiophhmis Rotata (Benth.) Kudo Preparations FANG Yan-xue, MA Dan 2018, 15(4): 244-247.  Abstract ( 461 )   PDF (796KB) ( 260 )   Objective To provide reference for the rational use of drugs in clinic and the development of their dosage forms through analyzing 45 cases of adverse drug reactions (ADRs) induced by Lamiophlomis rotata Kudo. Methods A descriptive study was used to retrospectively analyze 45 cases of adverse drug reactions reported from 2007 to 2016 in Gansu province. Results There were four kinds of dosage forms related to the side effects, which were Lamiophlomis rotata capsule, soft capsule, dispersible tablet and granule.45 cases of adverse reactions occurred in the preparations of Lamiophlomis rotata Kudo, of which Lamiophlomis rotata capsule had 28 cases, accounting for 62.22%; 13 cases of Lamiophlomis rotata soft capsules, accounting for 28.89%; 2 cases of Lamiophlomis rotata dispersible tablet and granule respectively, accounting for 4.44%. Lamiophlomis rotata capsule 's and Lamiophlomis rotata soft capsule 's main adverse reactions were gastrointestinal tract reaction, nausea and abdominal pain. The common adverse reactions of the four formulations were gastrointestinal reaction and pruritus. The sequence of adverse reactions in the four formulations is as follows: Lamiophlomis rotata capsule > Lamiophlomis rotata soft capsule > Lamiophlomis rotata granule > Lamiophlomis rotata dispersible tablet. Conclusion The paper is aimed at strengthening the monitoring and reporting of adverse reactions, grasping the possible adverse reactions timely and effectively. Through the study, it is significant to find out the risk so that maximization of the prevention of risk expansion can be reached, improve the safety of clinical drug use, and provide a new idea for the rational development of the drug. According to the adverse reactions of Lamiophlomis rotata capsule and soft capsule, it can be used with gastrointestinal protection drugs to reduce the stimulation of gastrointestinal tract caused by Lamiophlomis rotata capsule. References | Related Articles | Metrics

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Characteristics and Risk Factors Analysis of Liver Injury induced by Gukang Capsule ZHU Lan, PANG Yu, YANG Le, HU Jin-yan 2018, 15(4): 248-250.  Abstract ( 373 )   PDF (714KB) ( 273 )   Objective To investigate the characteristics and risk factors of liver injury induced by Gukang capsule, provide technical support for safe and rational use of drugs in clinic. Methods References and reports of liver injury caused by Gukang capsules were summarized and adverse drug reaction monitoring data was collected, and relevant cases were reviewed. The characteristics and causes were also analyzed through studying the potential risk of psoraleae fructus or drugs in the same class in Gukang capsule. Results Liver injury, being the main serious adverse reaction of Gukang capsule, was related to psoraleae fructus. The risk factors may include long-term usage, aged patients, previous history of hepatitis etc. Conclusion The risk of liver injury should be paid attention to. Reference is provided to the clinical usage of Gukang capsule. The drug manufacturers should strengthen pharmacovigilance and risk management to ensure drug safety. References | Related Articles | Metrics

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Systematic Review of the Safety of the Heart Rate Lowering Drug Ivabradine JIANG Huan, WANG Yao, YAN Hong, JIANG Ying 2018, 15(4): 251-254.  Abstract ( 392 )   PDF (902KB) ( 145 )   Objective To evaluate the safety of ivabradine in decreasing heart rate. Methods The randomized controlled trials of ivabradine in decreasing heart rate, which had been published from the time of library foundation to October, 2017 were collected from Pubmed, CNKI database according to the including criteria. The results of studies were analyzed through Stata 14.1 software and Rev Man 5.3 software. Results Ten randomized controlled trials were included. Meta-analysis showed that there was significant difference between ivabradine and controls in bradycardia (RR=4.16, 95% CI: 2.61-6.63, I2=92%, P<0.00001) and phosphenes (RR=5.07, 95% CI: 3.31-7.77, I2=68%, P <0.00001). Conclusion Meta-analysis proved that ivabradine was associated with a significant increase in the risk of bradycardia and phosphenes. Therefore, clinicians need to take these risks into account in treatment. References | Related Articles | Metrics

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One Case of Toxic Epidermal Necrolysis Induced by Vancomycin Hydrochloride for Injection WANG Wei-bo, WANG Hai-ying, SHI Chun-huan, GAO Xue-de, CHEN Xiao-yuan, LI Zhen-qing, WANG Ji -mei, ZHANG Cui-fang 2018, 15(4): 255-256.  Abstract ( 394 )   PDF (544KB) ( 198 )   References | Related Articles | Metrics