Chinese Journal of Pharmacovigilance

Comparative Study on Acute Toxicity of Different Extraction Methods of Cassia Semen on Normal Mice

HUANG Na-na, SUN Rong

2016, 13(11): 641-644.

Abstract ( 433 )

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Objective To compare the acute toxicity effect of different extraction methods of Cassia Semen on normal mice and observe/evaluate the acute toxicity of Cassia Semen, so as to provide a foundation for safe and rational drug use in clinic. Methods Preparing the all-components, water extracted components, alcohol extracted components and n-butyl alcohol extracted components then ig. all-components, water extracted components and alcohol extracted components of aconite to mice and the MLD, LD₅₀ were tested respectively by the classical methods of acute toxicity. Results The MTD of alcohol extracted components was 159.6 g·kg^-1·d^-1, which was respectively equal to 774.8 times of the clinical daily dosage in 70 kg humans. The MLD of all-components was 20.0 g·kg^-1·d^-1, the MLD of water extracted components was 76.6 g·kg^-1·d^-1 and the MLD of n-butyl alcohol extracted components was 1 493.6 g·kg^-1·d^-1, which was respectively equal to 93.3 times, 357.6 times and 6 969.7 times of the clinical daily dosage in 70 kg humans. By observing, we found that poor spirit, hypokinesia, prostrate motionlessness and loose stools were the main symptoms and signs of acute toxicity caused by aconite. Conclusion The sequence of acute toxicity of different extracts from Cassia Semen is alcohol extracted components > all-components > water extracted components > n-butyl alcohol extracted components. The toxical components and mechanisms should be further researched.

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Correlation between Activity of T Lymphocyte Subsets and NK Cells and Antibiotics Use in the Cancer Patients

ZHANG Hong-xu, HAN Feng, HUANG Jin-yue, LING Xin, LIU Guang-feng

2016, 13(11): 645-650.

Abstract ( 303 )

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Objective To study the correlation between the activity of T lymphocyte subsets, NK cells and antibiotics use in cancer patients. Methods The activity of T lymphocyte subsets and NK cells in the peripheral blood of the cancer patients and healthy controls were detected by using flow cytometry. The correlation between the activity of probiotics and antibiotics use in cancer patients was statistically analyzed by t-test, chi-square test, one-way analysis of variance ( F-test), Student-Newman-Keuls q-test and Pearson correlation analysis. Results Overall comparison: the percentage of CD3⁺, CD4⁺, NK cells, and CD4⁺/CD8⁺ ratio in peripheral blood of the cancer patients were decreased significantly, while the percentage of CD8⁺ was significantly increased, compared with the normal control group. The difference was statistically significant (each P < 0.05). Correlation analysis: there was weakly correlation between the percentage of CD3⁺, CD4⁺, CD8⁺, NK cells, and CD4⁺/CD8⁺ ratio in peripheral blood and the cumulative amount of antibiotics use of the case group ( r= -0.36, -0.40, 0.38, -0.38, -0.36, each P < 0.05). The effects of different factors on expression of T lymphocyte subsets and NK cells in peripheral blood of the healthy controls: the effect of both gender and age on the total number of bacteria and the number of lactobacillus in gastrointestinal tract of the healthy controls dose not reach statistical significance ( P > 0.05). Conclusion There is a weakly correlation between activity of T tymphocyte subsets, NK cells and antibiotics use in cancer patients after antibiotics cumulative use reaches a certain amount in a certain period of time.

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Clinical Efficacy and Safety of Low Molecular Weight Heparin Combined with Warfarin in Anticoagulant Treatment of Acute Submassive Pulmonary Embolism

CHEN Li-xiu

2016, 13(11): 651-654.

Abstract ( 402 )

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Objective To analyze the clinical efficacy and safety of low molecular weight heparin combined with warfarin in anticoagulant treatment of acute submassive pulmonary embolism (ASPE), and investigate its application value.Methods 126 patients with ASPE from May 2011 to June 2016 in our hospital were involved in the study and randomly divided into two groups, including 63 patients who received the low molecular weight heparin combined with warfarin anticoagulant therapy as the observation group, while 63 cases who were treated with low molecular weight heparin and warfarin anticoagulant therapy combined with urokinase thrombolytic therapy as the control group. Changes of clinical indexes of patients before and after treatment were compared between the two groups, and the efficacy and safety of the two therapeutic strategies were analyzed. Results Compared with the levels before treatment, the PaO₂, PaCO₂, RVEF in both of the two groups increased, the P(A-a)O₂, RVESVI, RVEDVI, PS, PC, D-D, t-PA, PAI-1, TM decreased after treatment, the difference was statistically significant (P < 0.05). After treatment, there was no significant difference of the arterial blood gas indexes between the two groups (P > 0.05). The total effective rate of the observation group and the control group were 92.06% and 93.65% respectively, without statistical difference between the two groups (P > 0.05). The incidence of adverse reactions in the observation group was 6.35%, which was lower than that in the control group of 26.98%, the difference was statistically significant (P < 0.05). Conclusion Low molecular weight heparin combined with warfarin in anticoagulant treatment of patients with ASPE can obtain a similar effect as the strategy supplementary with thrombolytic therapy, and with lower incidence of adverse reactions and better safety.

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Observation on Efficacy of Extract from Rabbit Skin Inflamed by Vaccinia Virus in Limb Salvage Treatment of Diabetic Foot Infection

WANG Jun, QIU Yang, WANG Yi-cun, DAI Si-hui, WEI Chang-hui, SHI Ning-wen

2016, 13(11): 655-659.

Abstract ( 302 )

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Objective To observe the clinical effect of extract from rabbit skin inflamed by vaccinia virus (ERSIVV) in the limb salvage treatment of diabetic foot (DF). Methods From January 2013 to June 2015, 46 DF patients with infection who needed limb salvage treatment in our hospital were selected and divided into the observation group and the control group according to treatment program, 23 cases in each group. All of patients were graded according to the Wagner and accepted surgical treatment. Then observation group received the ERSIVV, the control group was given mecobalamin injection. The clinical efficacy and complications of the two groups were compared. Results The VAS scores of the two groups decreased after treatment, and the VAS scores 2 weeks and 3 weeks after treatment in the observation group were lower than those of the control group, the total effective rates of the pain improvement in the observation group were 82.61% and 86.96%, which were higher than those in the control group (69.57% and 73.91%) (P < 0.05). The scores of neurological symptoms and signs of the two groups decreased after treatment, and the scores in the observation group were lower than those in the control group, the difference was statistically significant (P < 0.05). After treatment, the nerve conduction velocity in the two groups all increased, and the change of the observation group was more obvious (P < 0.05). There were no obvious complication and adverse reaction in the two groups during the treatment period. Conclusion The ERSIVV can effectively improve the pain, neurologic symptoms and signs of the patients with DF infection after the limb salvage treatment, promote the recovery of nerve conduction speed, it has good clinical efficacy and safety.

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Clinical Observation of Combined Application of Somatostatin, Omeprazole and Thrombin in Treatment of Upper Gastrointestinal Ulcer Bleeding

RUI Ju-ping

2016, 13(11): 660-662.

Abstract ( 318 )

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Objective To evaluate the clinical efficacy and safety of combined application of somatostatin, omeprazole and thrombin in treatment of upper gastrointestinal ulcer bleeding, and lay a foundation for the application of the treatment.Methods 100 patients with upper gastrointestinal ulcer bleeding from March 2011 to March 2015 in our hospital were selected and divided into the observation group and the control group (50 cases in each group) by the random number table method. All of the patients were treated with omeprazole, while patients in the observation group were treated with the therapy supplementary somatostatin and thrombin. The changes of the hematology test, coagulation indicators and Blatchford scores between the two groups were observed and compared, and the clinical efficacy and safety of the two treatments were evaluated. Results The hemostatic time, hemorrhage volume and hospitalization time in the observation group were lower than those in the control group, the difference was statistically significant (P < 0.05). Compared with the levels before treatment, the Hb, RBC, PLT, Hct, FIB in both of the two groups increased, the WBC, PT, APTT, Blatchford scores decreased after 72 hours treatment, the changes of the observation group were more obvious, the difference was statistically significant (P < 0.05). The clinical total effective rate of the observation group was 82.00%, which was higher than that in the control group of 58.00%, the difference was statistically significant (P < 0.05). The incidence of adverse reactions in both of the two groups was 8.00%, showed no statistical difference (P > 0.05). Conclusion Combined application of somatostatin, omeprazole and thrombin in the treatment of upper gastrointestinal ulcer bleeding has curative effect and good safety, can positively improve the clinical symptoms and blood coagulation function of patients, and it’s worthy of promotion.

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Study of Pharmacokinetics and Bioequivalence of Single Oral Dose Ondansetron Dissolved Film in Healthy Volunteers

JIANG Jun-yi, LIN Hui, CAO Bei, QIAN Wei ,XIAO Da-wei

2016, 13(11): 663-669.

Abstract ( 264 )

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Objective To develop and validate a sensitive and reliable liquid chromatography-tandem mass/mass spectrometry (LC-MS/MS) method for the determination of ondansetron in human plasma and evaluate the bioequivalence of oral ondansetron dissolved film. Methods The method involved the addition of internal standard solution to plasma samples, followed by liquid-liquid extraction with 0.5 mL of ethyl acetate. After vortexing and centrifugation, supernatant was transferred and evaporated to dryness in a slight stream of nitrogen. The residue was dissolved in 100 µL of mobile phase, and 10 µl of it was used for LC-MS/MS analysis. The separations were performed on a ZORBAX SB-C18 2.1 mm×50 mm 3.5 µm, with 0.1% formic acid and methyl alcohol as mobile phase, and the detection was performed on tandem mass/mass spectrometry by the multiple-reaction monitoring via an electrospray ionization source. Results The standard curve was linear over the concentration range from 0.2 to 80 ng·mL^-1. The lower limit of quantification was 0.2 ng·mL^-1 using 100 μL of human plasma sample. The intra- and inter-assay precision and accuracy were found to be less than 5.94% and 6.22%, respectively. Conclusion This developed analytical method was successfully applied to the pharmacokinetics and bioequivalence study of ondansetron in healthy Chinese volunteers.

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HPLC Determination of Ephedrine Hydrochloride in Shexiangzhuifeng Ointmen

JIANG Xiao-wen

2016, 13(11): 670-672.

Abstract ( 263 )

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Objective To determine the content of ephedrine hydrochloride in Shexiangzhuifeng ointmen by HPLC. Methods HPLC with Welch polar ether linked phenyl column (5 µm, 150 mm×4.6 mm) was employed by using methyl cyanide-0.092% H₃PO₄(0.04% triethylamine and 0.02% dibutylamine) (1.5:98.5) as the mobile phase. The flow rate was 1.0 mL·min^-1. The detection wavelength was set at 210 nm. The sample size was 10 µL. Results Ephedrine hydrochloride was in good linear relationship within the rage of 1.66×10^-4~0.244 µg, r=0.999 9. The mean recovery rate was 101.8% and RSD was 1.2%. Conclusion The HPLC method established here for analyzing the ephedrine hydrochloride in Shexiangzhuifeng ointmen is accurate, convenient and specific, which can be used for the quality control (QC).

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Discussion on Vaccine Active Surveillance in China

ZHANG Qian-ting, WANG Ya-li, QU Yi

2016, 13(11): 673-675.

Abstract ( 338 )

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Objective To provide thoughts and references for improving vaccine post-marketing surveillance in China. Methods Through introducing the experiences of other countries and analyzing the situation in China, to find the gap between China and advanced countries in vaccine post-marketing surveillance. Results Active surveillance is one of the import methods of post-marketing safety monitoring of vaccine. Using active surveillance, it is not only to ascertain the potential signals detected from passive surveillance data, but also to verify the safety hypothesis by combining proper epidemiological study. Conclusion Vaccine active surveillance in China is still in its infancy. Vaccine pharmacovigilance system should be strengthened according to our own situation by using international advanced experience, utilizing existing data platform and information technique, and establishing long-term cooperation partnership with research institutions.

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Finding and Excluding Strategies for Duplicated Cases in National Adverse Drug Reaction Database

HOU Yong-fang, LIU Wei, WU Gui-zhi, YE Xiao-fei

2016, 13(11): 676-677.

Abstract ( 328 )

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Objective To study the finding and excluding strategies for duplicated cases in National ADR Database (NADRDB). Methods Using variable matching method to find duplicated cases in NADRDB (only 2014 data), and classify and analyze duplicated cases. Results 3 914 sets of duplicated cases were found. 3 966 duplicated cases, accounting for 0.3% of research data. Conclusion Duplicated cases in NADRDB can be found and excluded.

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Introduction to Cosmetic Product Safety Report in European Union

SHEN Lu, KONG Fan-yao, LU Chang-fei, LI Xin-ling

2016, 13(11): 678-681.

Abstract ( 287 )

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Objective To study the requirements and actions for cosmetic safety in EU and to offer the reference and help on the safety management in China. Methods This article introduced the Cosmetic Product Safety Report and related regulations to analyze the logic and methods of cosmetic administration in EU. Results To ask the manufacturer to submit the Cosmetic Product Safety Report is very important in learning and evaluating the safety of cosmetics. Conclusion It is meaningful for cosmetics’ administration and cosmetic adverse reaction monitoring in China.

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Research Advance on Pharmacological Effects and Metabolism of Fufangdanshen Dripping Pills

CHANG Hong, LI Zheng-guo, YANG Qing-guo, WU Shi-fu

2016, 13(11): 682-685.

Abstract ( 376 )

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Objective To summarize the current states of pharmacological effects and metabolic research about Fufangdanshen dripping pills. Methods By combing articles published at home and abroad in recent 20 years, the research progress of the effective components and quality control methods, metabolism and pharmacological effects were summarized, the effects of Fufangdanshen dripping pills on drug metabolizing enzymes were described specially. Results and Conclusion Chemical constituents and quality control methods of Fufangdanshen dripping pills have been maturely studied. Its main pharmacological effects are enhancing cell viability, improving tissue ischemia, inhibiting platelet aggregation and so on. Most of the main monomer components in the dropping pills inhibit CYP450s, only a very small part has an induction effect, and the overall effect of the preparation is not a simple addition. It is a difficult and hot topic to further expound the action mechanisms about the effects of Fufangdanshen dripping pills on drug metabolizing enzymes.

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Pharmaceutical and Clinical Comprehensive Evaluation of Baicaofuyanqing Suppository

TIAN Wen-yang, ZHAI Ye

2016, 13(11): 686-690.

Abstract ( 282 )

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Objective To provide evidence for promoting clinical safe and rational use of Baicaofuyanqing suppository and enhancing its efficacy by making a comprehensive review and analysis on the pharmaceutical researches and clinical studies. Methods We searched the researches of Baicaofuyanqing suppository in China Biology Medicine disc (CBMdisc) and Chinese Journal Full Text Database (CJFD), selected the researches we needed and made a systematic review and analysis in terms of pharmacology, efficacy and safety. Results According to the researches,we found that the Baicaofuyanqing suppository has certain therapeutic effectiveness and safety, but the level of evidence, quality control and the design of research should be strengthened. Conclusion The Baicaofuyanqing suppository has certain therapeutic effectiveness and relative safety. It’s needed to enhance the level of evidence by developing more well-designed post-marketing clinical research.

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Literature Analysis of 193 Cases of Adverse Reactions of Xanthii Fructus

YANG Xue, XIA Dong-sheng, GAO Jian-chao, TIAN Chun-hua, LI Lan, ZHANG Bing

2016, 13(11): 691-696.

Abstract ( 301 )

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Objective To explore the clinical toxicity characteristics and risk factor, in order to offer literature basis for clinical safety medication. Methods The adverse reactions of Xanthii Fructus on literatures between January 1st, 1953 April 1st, 2016 were summarized, the toxicity characteristics and risk factors for clinical use were analyzed. Results Oral and external use of Xanthii Fructus can lead to adverse reactions. Oral use of Xanthii Fructus caused multiple organ damage, the main damages are digestive damage and liver damage. External use of Xanthii Fructus caused skin lesions, the main damage was contact dermatitis. The main risk factors of adverse reactions/events of Xanthii Fructus were misuse in children, inappropriate drug processing, overdosage, using out of the direction of doctor, using folk prescription and patients, physique. Conclusion Toxicity of Xanthii Fructus should be paid attention in the clinical use, so as to control the risk factors and prevent the happening of adverse drug reactions.

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Strengthening Key Drug Monitoring to Enhance the Adverse Drug Reactions Reporting Rate

WANG Hua, LI Xin, YU Qian

2016, 13(11): 697-700.

Abstract ( 385 )

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Objective To enhance the reporting rate of adverse drug reactions through monitoring the actual occurrence of clinical drug adverse reactions. Methods We determined the related specific drugs like first-aid medicines and antiallergic drugs when the adverse reactions occurred. In addition, we extracted the clinical use of drugs specific cases to identify the purpose of usage and screened underreporting of adverse reactions. Results Through the specific drug use screening and monitoring of our hospital from June to December in 2015, the number of reported adverse drug reactions accounted for 91.16% of screening out number, significantly higher than clinical subjective reporting proportion (25.47%) in 2014, and clinical subjective reporting proportion (30.24%) from January to May 2015. Conclusion The method of intensively monitoring the usage of several specific drugs is simple and efficient, which can effectively enhance the reporting rate of adverse drug reactions. Therefore, it is worth to promote in hospital.

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