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20 June 2017, Volume 14 Issue 6 Previous Issue    Next Issue

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Hepatotoxicity of Short Time Oral Administration of Aqueous Extract of Polygoni Multflori Radix in Rats QUAN Zheng-yang, CHEN Jing, LI Deng-ke, FEI Zhan-yang, WANG Zi-jian, ZHOU Ming, LI Kai-ming, SUN Zhen-xiao 2017, 14(6): 321-325.  Abstract ( 308 )   PDF (1945KB) ( 61 )   Objective To investigate the sensitive hepatotoxicity related blood serum biochemical indicators in rats after short-time continuous oral administration of aqueous extract of Polygoni Multflori Radix (AEPMR). Methods Male SD rats were orally administered with low and high dose (10、30 g?kg-1) of AEPMR once a day for 14 d. During the administration period, observed the rat general condition and weighed rats every day, and calculated food utilization rate weekly. Detected the levels of ALT, AST, ALP, TBIL, DBIL, and IBIL in rats after 1 d and 14 d administration. 14 d AEPMR administration later, rats were euthanized and anatomized for general observation. The liver of rats was weighed to calculate liver coefficient and then made to slices stained with hematoxylin and eosin (HE staining) for histopathological analysis. Results Rats appeared tired, stool soft, urine color deepened and fur not bright after AEPMR administration. There was no significant difference among groups in liver coefficient, weekly food utilization and ALT, AST, ALP levels in serum after 1 d and 14 d administration. Compared with control group, TBIL of low-dose group (P<0.05) and TBIL and DBIL of high-dose group (P<0.01) were significantly increased after 1 d administration. TBIL, DBIL and IBIL of high-dose group were significantly increased after 14 d administration (P<0.01). Liver pathological analysis showed that in rats administered with high dose of AEPMR for 14 d, parts of the liver had observed vacuolization of hepatocytes and Kupffer cell hypertrophic hyperplasia, and fibroblasts hypertrophic hyperplasia in portal area. Conclusion Certain dose of AEPMR could induce increase of blood serum bilirubin and liver injury of hepatocyte injury in rats after short-time oral administration. References | Related Articles | Metrics

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Fertility and Early Embryo Developmental Toxicity of Arctigenin in Rats LI Chun-yan, YAO Jing-chun, WANG Hui-Ping, LIU Feng, WANG En-li 2017, 14(6): 326-330.  Abstract ( 303 )   PDF (5165KB) ( 77 )   Objective To observe the toxicity effect of arctigenin on rat fertility and early embryo development in SD rats. Methods SD rats were divided into solvent control group and arctigenin 4, 16, 64 mg?kg-1 three dose groups, 25 animals per sex per group. Prior to mating, male rats were treated 10 weeks and female rats were treated 2 weeks respectively by subcutaneous injection with volume 2 mL?kg-1 once a day. Within each treatment group, the male and female rats were co-housed (1:1) until evidence of mating was seen or for 2 consecutive weeks. During cohabitation period, total animals were continuously treated. After successful mating, female rats still were treated until day 6 of pregnancy and male rats were kept treating until euthanized. Clinical observations, body weights and food consumption were recorded routinely. Male rats were euthanized 1 week after successful mating, then sperm quality and reproductive organs were inspected; female rats were euthanized on day 15 of pregnancy, then the corpora luteum number, implantation number, viable fetuses number, absorbed fetuses number, dead fetuses number, uterus and ovary weight were inspected. Results During treating times, stimulation of drug delivery site were seen on all groups animals, arctigenin 16, 64 mg?kg-1 dose group caused 1 animal death respectively. Body weights and feed consumption in all arctigenin treatment groups were not significantly different when compared with the solvent group. There had no abnormal changes on animal precoital interval, mating index, gestation index, sperm quality of male rats and pregnancy outcome of female rats. Conclusion Under this experimental environment, arctigenin has no significant toxicity on rat fertility and early embryo development, and the no observed adverse effect level（NOAEL）is 64 mg?kg-1. References | Related Articles | Metrics

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Long-term Toxicity of Total Saponins from Medicago sativa L. in Beagle Dogs LI Xia, SUN Hui-ping, LIU Wen-xia, CAO Jun-ping, MA Yi 2017, 14(6): 331-333.  Abstract ( 300 )   PDF (365KB) ( 67 )   Objective To investigate the long-term toxicity of oral treatment of total saponins from Medicago sativa L. (TSM) on Beagle dogs. Methods Beagle dogs were divided into 4 groups at random (n=8), namely normal control, TSM high, medium and low dose groups (3.2, 1.6 and 0.8 g?kg-1, respectively). TSM was orally administered for 180 days. The body weight, behavior and food intake of animals were observed during the administration. The hematology and blood biochemistry analysis were carried out, and organ histopathological changes were observed under the microscope at the end of the administration and 30 days after the administration, respectively. Results The outer appearance, behavior and body weights in dogs of TSM groups showed no significant differences compared to those of normal control group. In hematology and blood biochemistry analysis, white blood cell count was increased while aminopherase activity was decreased in the blood of TSM high dose group. The levels of total protein and creatinine were significantly increased in TSM medium and low dose group, respectively. This may attribute to the stress response or individual difference of some Beagle dogs. In addition, no changes related to TSM among other indices were observed. TSM showed no apparent influence in organs of dogs in histopathological observation. In addition, no delayed toxicity reaction was showed 30 days after the administration. Conclusion TSM (0.8 to 3.2 g?kg-1) shows no obvious toxicity in Beagle dogs for long-term administration. References | Related Articles | Metrics

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Clinical Effect of Aerosol Inhalation of Budesonide in Children with Acute Laryngitis ZHAO Li-ying 2017, 14(6): 334-337.  Abstract ( 239 )   PDF (512KB) ( 89 )   Objective To explore the clinical effect of aerosol inhalation of budesonide in children with acute laryngitis. Methods Within 5y, 230 children with acute laryngitis in our hospital were selected. The subjects were randomly divided into control group and observation group. The control group received the intravenous injection of dexamethasone; the observation group took the aerosol inhalation of budesonide. The clinical effect for two groups was observed. Results The total effective rate of observation group (97.4%) was significantly higher than that of control group (84.2%); The disappearance time of clinical symptoms for observation group was shorter than that of control group(P < 0.05) Conclusion Compared with intravenous injection of dexamethasone, the aerosol inhalation of budesonide has a better effect in children with acute laryngitis, can improve the clinical symptoms, clinical effect and clinical feasibility. References | Related Articles | Metrics

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Effect of Rosuvastatin on Serum Leptin, Inflammatory Factors, Blood Lipid and Renal Function in Patients with Early Diabetic Nephropathy ZHANG Bei-hui 2017, 14(6): 338-340.  Abstract ( 292 )   PDF (433KB) ( 61 )   Objective To observe the effect of rosuvastatin on serum leptin, inflammatory factors, blood lipid and renal function in patients with early diabetic nephropathy. Methods 80 cases of diabetic nephropathy (DN) patients were selected and randomly divided into control group(40 cases) and observation group(40 cases). Two groups were treated with conventional treatment. The patients in the observation group were given 10 mg rosuvastatin every day on the basis of the conventional treatment. Two groups of patients were treated for 12 weeks. The changes of serum leptin, inflammatory factor, blood lipid and renal function were compared between the two groups before and after treatment. Results After treatment, the serum leptin, C reactive protein (hs-CRP), tumor necrosis factor-ɑ(TNF-ɑ), interleukin 6 (IL-6), triglyceride (TG), total cholesterol (TC), low density lipoprotein (LDL), blood urea nitrogen (BUN), serum creatinine (Scr) and 24 h urinary albumin excretion rate (UAER) level of the observation group were significantly lower than those of the control group and the same group before treatment (P<0.05). The high density lipoprotein (HDL) and glomerular filtration rate (GFR) of the observation group were significantly higher than those of the control group and the same group before treatment (P<0.05). Conclusion Besides decreasing the levels of serum leptin and inflammatory factors, rosuvastatin can significantly reduce the blood lipid level, and improve renal function, which have a certain clinical value for the diagnosis and treatment of DN. References | Related Articles | Metrics

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Application of Targeted Maximum Likelihood Estimation in Active Drug Safety Surveillance HAN He-Dong, GUO Wei, YE Xiao-Fei, XU Jin-Fang, GUO Xiao-Jing, ZHU Tian-Tian, SHI Wen-Tao, WANG-Meng, HOU Yong-Fang, HE Jia 2017, 14(6): 341-345.  Abstract ( 419 )   PDF (1353KB) ( 196 )   Objective Causal inference using observational data has long been the focus of epidemiologic researchers. In pharmacoepidemiologic studies, exploring effect of a drug or adverse drug reaction caused by a drug also fits into causal inference. Targeted maximum likelihood estimation (TMLE) proposed by van deer laan is proved of desirable properties, we introduce its principle and application in the study. Method The common methods for causal inference include inverse probability of treatment weighting (IPTW), G-formulation and some double robust estimators. We provide an overview of the theory, model, estimation, statistical inference and properties. Meanwhile, we also compare the performances of several causal effects estimators. Result Compared with other methods, TMLE has certain advantages. However, its implementation is difficult. Conclusion TMLE is a method with double robustness and could also produce efficient unbiased estimator of targeted parameter. There is potential value of TMLE enhancing drug risk management in active drug safety surveillance. References | Related Articles | Metrics

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Application of Improved Weighted Association Rule Algorithm in Identifying the Risk of Pharmaceutical Production Sun Yiyuan, Deng Jianxiong, Yang Yue 2017, 14(6): 346-349.  Abstract ( 275 )   PDF (469KB) ( 114 )   Objective To improve the weighted association rule algorithm, and establish enterprise risk monitoring model. Methods Based on the theory of Apriori association rule algorithm, the category of organ damage, such as "liver damage" and "kidney damage", is used as the association rule item, and the serious events or the new adverse events are used as the weight index of association rules, in order to further improve the weighted association rule algorithm. Besides, we use the ADR report data received by the Guangdong Provincial Adverse Reaction Monitoring Center from January to June 2006 to identify the risk of "Qiqihar Second Pharmaceutical Factory Drug Safety Event" and verify the feasibility of the enterprise risk monitoring model. Results In the case of minimum support of 0.05 and minimum confidence of 0.90, the improved weighted Apriori correlation algorithm identifies the risk of " Qiqihar Second Pharmaceutical Factory Drug Safety Event ", while the traditional Apriori correlation algorithm has no risk signal generation; reduces the minimum support to 0.02 , although the traditional algorithm come up to risk signal, but there have been a lot of mixed risk signal as well. Conclusion Compared with the traditional weighted correlation algorithm, the improved weighted correlation model is highly effective and accurate, and is more conducive to the early warning and monitoring of production risk. References | Related Articles | Metrics

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Application of Time-to-onset in Drug Safety Surveillance YAN Xin-yuan, WANG Yin-cheng, ZHANG Tian-yi, YE Xiao-fei, HOU Yong-fang, WU Gui-zhi, HE Jia 2017, 14(6): 350-352.  Abstract ( 555 )   PDF (308KB) ( 274 )   Objective Disproportionality analysis is the main method for signal detection and disproportionality analysis is based on the observed and expected values. Recently, time-to-onset (TTO) has been proposed as an effective tool in the adverse drug reactions surveillance. In this study, we aimed to introduce the principle and application of TTO method. Methods We discussed the theory, characteristic, signal detection performance of TTO method through literature review. Results TTO method has played role in signal detection, however, the performance result differed in different studies. Conclusion TTO method could act as an important complementary tool of disproportionality analysis for signal detection. References | Related Articles | Metrics

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Opportunities and Challenges for Real World Evidence Applied in Drug Regulation and Health Decision Making SUN Yu-xin, WEI Feng-fang , , YANG Yue, 2017, 14(6): 353-358.  Abstract ( 417 )   PDF (1923KB) ( 139 )   Objective To introduce the concept, characteristics and functions of relevant terms such as real-world evidence, expounded the opportunities and challenges of real-world evidence in drug regulation and health decision-making, and put forward some suggestions for realizing the life cycle monitoring of pharmaceutical products, so as to further strengthen the scientific nature of decision-making. Methods Based on comprehensive literature search at home and abroad, this paper studied the real-world study and its’ appliance in the development of drug safety, effectiveness and economic decision-making; summarized the present situation of China's development in this area; made the analysis of the opportunities and challenges of real world evidence. Results and Conclusion Real-world evidence can provide strong support for product lifecycle evaluation in decision-making. Developed countries such as Europe and the United States are currently conducting extensive application research and legislation in this area, while China has been still in the start stage. Therefore, more efforts should be made to further develop RWE in its value exploration and application range expanding, and further promote the establishment of proactive regulatory model of regulatory authorities. References | Related Articles | Metrics

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Analysis of 737 Reports of Adverse Drug Reactions Induced by Zedoray Turmeric Oil Injection and Literature Review CHANG Hong, , WU Shi-fu, LI Yu-ji, XU Kui, GUO Fan-ling, CHANG Guang-jin, TANG Dao-quan 2017, 14(6): 359-363.  Abstract ( 330 )   PDF (620KB) ( 139 )   Objective To study the features and contributing factors of adverse drug reactions(ADRs) induced by Zedoray turmeric oil injection and provide rational use of drugs in clinic. Methods 737 reports of ADRs induced by Zedoray turmeric oil injection were statistically analyzed from 2006 to 2016 in ADR monitoring database of Shandong province. Meantime, articles were reviewed and from different aspect，the possible influence links were explored. Results Occurring younger and faster, good prognosis were its feature. Group of children under 10-year-old accounted for the highest proportion of 51.42%, also, all patients were cured and no deaths occurred. Serious adverse reactions mainly included respiratory damage, of which dyspnea and cyanosis accounted for 84.35%, followed by systemic damage, skin damage and appendages damage, central and peripheral nervous system damage, gastrointestinal system damage and so on. Conclusion The causes of ADRs induced by Zedoray turmeric injection are complicated, what should be considered include raw materials, solubilizers used as accessories, production processes, clinical factors, storage and transportation . References | Related Articles | Metrics

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Literature Analysis of 1087 Cases of Adverse Reactions Induced by Different Rabies Immunoglobulin SHEN Jie, GU Hai-yan, ZHANG Wei 2017, 14(6): 364-368.  Abstract ( 272 )   PDF (661KB) ( 84 )   Objective To discuss the characteristics of adverse reactions(ARs) induced by different rabies immunoglobulin, in order to prevent and rescue these adverse reactions in time. Methods AR cases induced by rabies immunoglobulin reported in CNKI from 1956 to 2016 were retrieved and analyzed statistically. Results 75 standard literatures were retrieved, a total of 1087 cases. In these statistic cases, there were no significant differences in gender between anti-rabies serum and human rabies immunoglobulin, and most of the patients are under 20 years of age in anti-rabies serum. The adverse reactions of anti-rabies serum had a certain incubation period, up to a week. And the adverse reactions of human rabies immunoglobulin were more than 85.06% within 30 min after injection. There were 986 cases of anti-rabies serum, mainly serum disease. While human rabies immunoglobulin has lower incidence, only 101 cases showed more adverse reactions such as syncope and vasovagal reflections (VVRS). Conclusion The medical staff and the family members of the patients should be combined with the rabies immunoglobulin inoculated with the patients. The response of the patients should be closely observed before and after the inoculation, and rescue measures should be prepared before the vaccination. References | Related Articles | Metrics

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Investigation of Cognition on Drug Safety Knowledge and Drug Use Behavior and Intervention Research of Middle School Students in Remote Minority Areas ZHOU Li, LI Er-ping, WEI Jing-tu, BAN Bing-kun 2017, 14(6): 372-374.  Abstract ( 343 )   PDF (387KB) ( 61 )   Objective To understand the cognition on drug safety knowledge and drug use behavior of middle school students in remote minority areas, and to raise the cognition on drug safety knowledge and correct irrational drug use behavior by formulating effective interventions. Methods Cluster stratified random sampling method was adopted to investigate the cognition on drug safety knowledge and drug use behavior, according to the survey to formulate intervention measures, the intervention effect was evaluated. Results Before the intervention, students lacked knowledge of drug safety and reasonable medication. However, the cognition of students’ drug safety knowledge was increased after the intervention, more students chose to go to the hospital to buy drugs and paid more attention to the contents of the drug instruction, students’ self-protection awareness after the occurrence of adverse reactions and the rights consciousness after the purchase of counterfeit drugs were increased. Conclusion The interventions can raise the students’ cognition on drug safety knowledge and correct irrational drug use behavior. References | Related Articles | Metrics

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Some Suggestions on Standardizing the Toxicity of Toxic Traditional Chinese Medicine FAN Ying-ying, JIANG Qing-dan, ZHANG Pei-pei 2017, 14(6): 375-377.  Abstract ( 317 )   PDF (407KB) ( 77 )   Objective To explore the existing problems of new pharmacopoeia in defining the toxicity degree, toxic ingredients, active ingredients, usage and dosage of toxic traditional Chinese medicine, analyze the influence of the existing problems on clinical application, and put forward some suggestions. Methods The existing problems of new pharmacopoeia in defining the toxicity degree, active ingredients ,toxic ingredients, usage and dosage of Chinese traditional medicine were analyzed by demonstration. Results The toxic traditional Chinese medicine’s toxicity, active ingredients, toxic ingredients, usage and dosage are lack of objective theory data and there is no unified standard. Conclusion It is necessary to strengthen the study on toxic traditional Chinese medicine pharmacology and toxicology, scientifically determine the toxicity degree, active ingredients and toxic ingredients of the toxic traditional Chinese medicines of raw products and processed products, and standardize the usage and dosage. References | Related Articles | Metrics