Archive

08 August 2013, Volume 10 Issue 8 Previous Issue    Next Issue

---

For Selected:

Download Citations EndNote Ris BibTeX

Toggle Thumbnails

Select

The Safety Evaluation Study of C ASANT Sustained-release Anti-tumor Agent by Implanted Medication in the Lung of Beagle Dog TANG Lian -sheng JIA Qing -wen 2013, 10(8): 449-451.  Abstract ( 269 )   PDF (499KB) ( 207 )   Objective To evaluate the general toxicity of CASANT sustained-release anti-tumor agent by implanted medication in the lung of Beagle dog. Methods The test substance [1,2,4 mg/dog] was implanted into the lung of Beagle dog by using MyLabTwice ultrasonic diagnostic apparatus to guide positioning. After administration, the ani mals were continuously observed. The body temperature, urine, standard lead-ECG, hematology, serum chemistry indicators were detected, and the bone marrow examination, histological examination of major organs and tissues were conducted at 2,4,8,13 wk. Results There were no statistical significance between the test substance groups and control group in above indexes. The histological examination showed no tissue damage. Conclusion The CASANT does not have toxicity on Beagle dog. References | Related Articles | Metrics

Select

Experimental Study of Long-term Toxicity of Penyanxiao Enema in Rats ZHANG Lei ,FU Zheng-ying, CHEN Ning 2013, 10(8): 452-455.  Abstract ( 330 )   PDF (443KB) ( 150 )   Objective To observe the long-term toxicity and severity occurred after administration of Penyanxiao enema in rats. Methods SD rats were randomly divided into 4 groups. Each group was given Penyanxiao enema at dose of 50g·kg-1、25g·kg-1 and 12.5g·kg-1 daily for up to 12 weeks, respectively. Blank control group was given same bulk of distilled water. After the withdrawal of the drug for 2 weeks the rats' body weight, food intake, hematology, blood biochemistry analysis and organ coefficients were measured, and the histopathological changes were also observed. Results The outer appearance and behavior, body weights, organ coefficients, the indexes of hemstology and biochemistry analysis in rats of drug taking groups showed no significant difference from those of control group. Pathological examination discovered no obvious pathological changes related to drug toxicity and no delayed toxicity reaction after drug withdrawal. Conclusion Penyanxiao enema had no obvious toxicity in rats for long-term administration. References | Related Articles | Metrics

Select

The Revelation of Study on Drug Manufacture Post Marketing Surveillance System in the United States DONG Duo ,LIU Cui-li 2013, 10(8): 456-459.  Abstract ( 334 )   PDF (611KB) ( 232 )   By introducing the system of drug manufacture post marketing surveillance in the United States, it helped to know the general situation of manufacture adverse event reporting, supervision elements to strengthen manufacture post marketing surveillance and the coordination mechanism of internal organizations. It provided the example and reference for perfecting and developing adverse drug reaction reporting and monitoring system of drug manufacture in China. References | Related Articles | Metrics

Select

FDA's Requirements for Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Prescription Drug XIAO Hui-lai 2013, 10(8): 460-463.  Abstract ( 338 )   PDF (458KB) ( 226 )   The requirements for warnings and precautions, contraindications and boxed warning of labeling are described specifically in FDA's "Guidance for Industry Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products-Content and Format". There is no similar guidance in our country. The primary content of it is introduced in this article. It is expected to assist the writers and reviewers of labeling. Key words: Food and Drug Administration; guidance; labeling for prescription drug; warnings and precautions; contraindications; boxed warning References | Related Articles | Metrics

Select

Brief Introduction and Implication of the Package Leaflet Readability Guidelines of FDA and EMA TANG Ren, WANG Xiao-yan, YANG Yue 2013, 10(8): 464-467.  Abstract ( 350 )   PDF (613KB) ( 161 )   Objective To introduce the readability guidelines of package leaflet in FDA and EMA, and put forward suggestions on developing labelling readability of China. Methods Literature study were used to analyze the foreign materials, and contrast the differences between China and them. Results There is a big difference between foreign countries and China on labelling content and effect after readability tests of package leaflet. Conclusion s We should learn achievement from FDA and EMA to improve readability of labelling. References | Related Articles | Metrics

Select

Research Progress on Quality Control of Honghua Injection LIANG Xuan-ge, LIU Li-li ,ZHANG Ruo-yan 2013, 10(8): 468-472.  Abstract ( 286 )   PDF (550KB) ( 97 )   Objective To review the progress on study of quality control of Honghua injection in recent years, provide reference for the safety reevaluation of Honghua injection. Methods The literatures of Honghua injection published home and abroad were collated, analyzed and summarized. Results It can effectively control the quality of the Honghua injection from active ingredients, related substances, fingerprint chromatogram, stability, biological safety, quality standards, etc. Conclusion The safety reevaluation work still needs to be further strengthened to ensure the stable quality of Honghua injection,so as to be safe and effective. References | Related Articles | Metrics

Select

Overview of Drug Benefit-Risk Assessment Research Progress LU Yu –mei, ZHANG Ming –hui, WU Zhi -ang 2013, 10(8): 473-477.  Abstract ( 281 )   PDF (566KB) ( 179 )   Benefit-risk assessment is an important means of ensuring drug safety, so it is particularly important to establish scientific, comprehensive and unified evaluation method and framework. In order to understand the foreign research situation of drug benefit-risk assessment, this article describes the hot topics and research progress among regulatory agencies, industry organizations, as well as enterprise, and further summerises the challenges and prospects of current research areas. Moreover, based on the present situation of our country, the article provides reference for domestic drugs benefit-risk assessment. References | Related Articles | Metrics

Select

Literature Analysis of 55 Cases of Adverse Drug Reaction by Glucoside Tripterygium Total YIN Cheng-xia 2013, 10(8): 478-482.  Abstract ( 371 )   PDF (676KB) ( 186 )   Objective Through analysing 55 adverse drug reaction(ADR) cases of Glucoside Tripterygium Total(GTT), explore the rules and causes of ADR, providea reference for clinical rational use of drugs. Methods By searching literature in Chinese Journal Full-text Database from 1984 to 2013, 28 ADR literatures of Glucoside Tripterygium Total(GTT) involving 55 cases, were statistically analyzed. Results The involving disease types included 16 rheumatoid arthritis ( RA ) cases , 6 nephritis cases , 11 nephrotic syndrome cases , systemic lupus erythematosus ( sle ) cases ,2 oral squamous moss cases, 1 psoriasis case, 1 neurodermatitis case, 1 nodular regression febrile and non suppurative panniculitis case. The adverse reaction incidence of women was more than men, the 20~39 years old patients with the highest incidence; the appeared time of ADR was from 1 day to half one year; the adverse reactions involved many systems and organs, the blood system was the first, followed by the gastrointestinal system, reproductive system, etc. The most adverse reactions were slight, even if some symptoms were severe, through withdrawing the drugs timely or symptomatic drug treatment, the most symptoms could be improved and disappeared. Conclusion The doctors and pharmacists should pay attention to the adverse reactions caused by Glucoside Tripterygium Total(GTT). The dosages were strictly controlled according to the disease conditions. The routine blood, routine urine and hepatic function were detected before and during taking the medicine. The clinical care should be strengthened so as to prevent the occurrence of adverse reactions. References | Related Articles | Metrics

Select

Literature Analysis of Adverse Drug Reaction Induced by Shenqifuzhen Injection CHEN Jie 2013, 10(8): 483-485.  Abstract ( 343 )   PDF (640KB) ( 493 )   Objective To discuss the general characteristics of the ADRs induced by Shenqifuzhen injection, provide reference for rational drug use in clinic. Methods The China Hospital Knowledge Database(CHKD) and Chinese Medical Journal Database(CMJD) were searched to get the cases of the adverse drug reactions induced by Shenqifuzhen injection that reported from 1999 to 2012, then statistical analysis was conducted. Results Among the 21 ADR cases, the proportions of the male and female patients were 80.95% and 19.05%. Most of the ADRs induced by Shenqifuzhen injection occurred within 30 minutes after medication. The skin and adnexa damage(22%) and circulatory system damage(20%) occupied the major part in ADR cases. The original diseases of the patients who had ADR are mainly cancer. Ten patients received combination therapy. Only one patient has allergic history. The treatment and prognosis of adverse drug reactions is good. Conclusion Attention should be paid to the characteristics of adverse drug reactions induced by Shenqifuzhen injection in clinical use, and the monitoring of medication should also be strengthened to ensure the safe medication. References | Related Articles | Metrics

Select

Adverse Reactions and Precautions of Imatinib Mesylate in the Treatment of Chronic Myelocytic Leukemia LI Dan-li ,LI Xi-na ,YANG Li-jie ,MA Man-ling 2013, 10(8): 486-487.  Abstract ( 260 )   PDF (631KB) ( 270 )   Imatinib mesylate is a new kind of oral tyrosine kinase inhibitor and has become a first-line treatment of chronic myelocytic leukemia. The main adverse reactions of imatinib mesylate are haematological and nonhaemato logical. The haematological adverse reactions include bone marrow suppression ( the decrease of white blood cells, hemoglobin and platelet). The nonhaematological adverse reactions include nausea, vomiting, diarrhea, edema(mainly periorbital edema), myalgia and muscle cramps. The main adverse reactions and precautions of imatinib mesylate in the treatment of chronic myeloid leukemia were reviewed in this paper. References | Related Articles | Metrics

Select

Analysis of 28 Adverse Drug Reaction Cases of Protamine after Cardiopulmonary Bypass in Children ZHAO Yu –dong, LI Xiao -feng 2013, 10(8): 488-491.  Abstract ( 263 )   PDF (679KB) ( 250 )   Objective To analyze the clinical features and treatment in ADR cases of protamine after cardiopulmonary bypass in children, in order to provide a reference for clinical safe medication. Methods 28 ADR cases of protamine after cardiopulmonary bypass in children with age, sex, dose, route of administration, clinical manifestations of adverse reactions, adverse reaction time, the management of adverse reaction, effect of ultrafiltration on incidence of adverse reaction were analyzed retrospectively. Results 28 patients were caused hypotension after protamine injection. After emergency treatment, 27 cases returned to normal blood pressure, while 1 patient got better in 30min cardiopulmonary bypass rebuilt, no clinical death happened. The incidence of adverse reactions of protamine with ultrafiltration was lower than no ultrafiltration(P=0). Conclusion Protamine may cause severe ADR after cardiopulmonary bypass in children. Ultrafiltration may be the key to lower the incidence of severe ADR. References | Related Articles | Metrics

Select

The Situation and Countermeasure of Current Children's Medicine WANG Chun-ting, LI Yu-ji, XIA Dong-sheng ,TIAN Chun-hua 2013, 10(8): 492-496.  Abstract ( 707 )   PDF (756KB) ( 778 )   Through analysing the current situation of pediatric drugs and pediatric characteristics to identify the current problems of pediatric drugs and adverse consequences caused by incorrect drug use, as well as to clarify the necessity of clinical research for pediatric drugs, the development of drugs for children and standardization of drug use. Combined with national laws and regulations on children's medication abroad, we provide a reference for China to formulate relevant policies and measures. References | Related Articles | Metrics

Select

Rustic Opinion on Common Problems in the Clinical Use of Ceftriaxone Sodium Injection LIU Cui -li,LIU Tai -yu ,TIAN Chun -hua 2013, 10(8): 497-500.  Abstract ( 275 )   PDF (763KB) ( 313 )   Through the description and analysis of frequently asked questions about ceftriaxone sodium injection such as whether need skin test before use, the compatibility of calcium solution, serious adverse reaction/event and unreasonable medication, some suggestions were put forward aiming to remind the medical staff should pay attention to the prob lems in the clinical use of ceftriaxone, in order to promote the rational use of drugs and reduce the risks of ceftriaxone. References | Related Articles | Metrics

Select

The Role of Pharmacists in Management of the High-alert Medications REN Shuang ,LIANG Jian-hua 2013, 10(8): 501-504.  Abstract ( 283 )   PDF (754KB) ( 368 )   Objective To study and analyze the role of pharmacists in management of high-alert medications in hospital and the Methods which can be used. Methods Refer to the ISMP's and CPAHP's lists of high-alert medications in 2012, and some management strategies and experiences of high -alert medications in medical institutions in China. Results The concept, background and classification of high -alert medications up to date were illustrated; the latest management ideas, technologies and measures of high -alert medications in hospital were summarized; the role of pharmacists in management of the high-alert medications in hospital was analyzed; and some management experiences in our hospital were introduced. Conclusion It is important to establish safety management system of high -alert medications for medical institutions. We advised that hospitals should make the lists and management systems of high-alert medications of their own according to each professional specialties, and attach importance to the pharmacists. References | Related Articles | Metrics

Select

Clinical Application of Meropenem in the Treatment of Severe Infection with Evidence-based Pharmacy CHEN Xu-zhao 2013, 10(8): 505-507.  Abstract ( 305 )   PDF (589KB) ( 338 )   Objective To find the evidence of evidence -based pharmacy to solve the problem of clinical use of meropenem, and at the same time, to explore the improvement of the meropenem infusion. Methods We searched the VIP Database, Wanfang Database, Knowledge Database, Chinese Biomedical Literature Database, Dutch EMBASE, Chinese Biomedical Literature Database and Chinese Science Citation Index Expanded Version, found the relevant reports and randomized controlled trials published in the literatures, conducted quality of liver function during the process. evaluation on the Results , and then modified the therapeutic regimen of inpatients to observe the effectiveness. Results Three randomized controlled trials on meropenem and imipenem clinical use safety showed that the main adverse reactions of meropenem included liver enzyme increase, nausea, vomiting, diarrhea and skin rash, and liver damage incidence was slightly higher than that of imipene, but the difference was not statistically significant, and the incidence of adverse reactions was not associated with dose. Two randomized controlled trials on meropenem infusion showed that 1g or 2g meropenem intravenous infusion by infusion pump for 3h could increase the antibacterial effect. Based on the above evidences, good Results were achieved in the clinical practice of this study. Conclusion For the refractory drug-resistance bacteria, 3h continuous intravenous infusion of meropenem can improve the therapeutic effect, but attention should be paid on the monitoring References | Related Articles | Metrics