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20 May 2017, Volume 14 Issue 5 Previous Issue    Next Issue

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Study on Micronucleus in Bone Marrow and Peripheral Blood and Sperm Abnormality of Mice Induced by Semen Daturae PENG Xiao-ming, GAO Li, HUO Shi-xia, YAN Ming 2017, 14(5): 257-262.  Abstract ( 350 )   PDF (1443KB) ( 110 )   Objective To investigate the influence of semen daturae on micronuclei formation in bone marrow and peripheral blood polychromatic erythrocyte. Methods KM strain mice were randomly divided into negative control group, positive control group, semen daturae powder group and total alkaloids of semen daturae group. The negative control group mice were treated with 0.5% CMC-Na and positive control group with 0.02 mL·kg-1·d-1 CP. Semen daturae powder group were administered intragastrically by 2.5, 5 and 10 g·kg-1·d-1 of semen daturae powder, and total alkaloids of semen daturae group by 1.25、2.5 and 5 g·kg-1·d-1 of total alkaloids of semen daturae. Mice body weight was measured every three days, and micronucleus in bone marrow and peripheral blood were analyzed by Giemsa staining and sperm abnormality by Eosin staining. Results Compared with negative control group, semen daturae could significantly decrease the weight increments of mice, and increase the micronucleus in bone marrow and peripheral blood and sperm abnormality in mice. Conclusion 10 g·kg-1·d-1 of semen daturae powder and 1.25, 2.5, 5 g·kg-1·d-1 of total alkaloids of semen daturae may have genetoxicity to mice. References | Related Articles | Metrics

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Efficacy and Safety Comparison of Ambroxol Hydrochloride Between Aerosol Inhalation and Intravenous Injection In Acute Exacerbations of Chronic Bronchitis：A Prospective Randomized Controlled Clinical Study CHEN Nan, FANG Yuan, XU Ling 2017, 14(5): 262-265.  Abstract ( 413 )   PDF (419KB) ( 113 )   Objective To compare and analyze the efficacy and safety of different administration routes (aerosol inhalation and intravenous injection) of ambroxol hydrochloride in treating acute exacerbations of chronic bronchitis. Methods Patients with acute exacerbations of chronic bronchitis (n=120) were randomly assigned to two groups: observation group（n=60）and control group（n=60）.Two groups were treated with ambroxol hydrochloride by aerosol inhalation or intravenous injection respectively for 5~7 days. Clinical efficacy was measured by treatment outcomes and improvements of 5 symptom indicators: cough, sputum volume, sputum properties, expectoration difficulty and rales. Adverse events were also recorded. Results More overall improvements were observed in the observation group（96.7%） than in the control group（88.3%）(P<0.05). For the five symptom indicators, except for the treatment effect of cough, the observation group showed more significant improvements in the aspects of sputum volume(98.3%), sputum properties(100%), expectoration difficulty(98.3% ) and rales(98.3%) than those of the control group (88.3%、96.7%、85.0%、86.7%)( P<0.05). In the aspect of safety, adverse events were not observed in the observation group, meanwhile, 1 adverse effect was recorded in the control group(the incidence of adverse effects was 1.7%, P>0.05). Conclusion The result shows the better clinical effects of aerosol inhalation of ambroxol hydrochloride in the treatment of acute exacerbations of chronic bronchitis than those of the intravenous administration,especially in the improvements of sputum volume, sputum properties, expectoration difficulty and rales. References | Related Articles | Metrics

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Clinical Effect and Security in Treatment of Postherpetic Neuralgia by Different Administration Route of Extracts from Rabbit Skin Inflamed by Vaccinia Virus for Injection MA Li-min, SHI Dong-ping, LI Chan, LI Lin-gen 2017, 14(5): 266-269.  Abstract ( 360 )   PDF (455KB) ( 80 )   Objective To explor the clinical effect and safty in the treatment of postherpetic neuralgia (PHN) by different administration route of extracts from rabbit skin inflamed by vaccinia virus for injection (ERSIVVI). Methods PHN patients were selected for study, all patients were divided into parapharyngeal administration group (PA group) and intravenous administration group (IV group) , which has 45 patients, The PA group treated by paravertebral administration with 45 mL ERSIVVI (3mL: 3.6 IU) + 195 mL 0.9% NS with 2 mL·h-1, and the IV group treated by ERSIVVI 9 mL intravenous infusion. Likert pain scale and QS sleep index were used to evaluate pain and sleep improvement before treatment, 1 day after treatment, at discharge, and after discharge. Results 90 cases of PHN patients were selected for study, which had been treated in our hospital during Sep 2014 to Nov 2016 and were divided into two group randomly, each group of 45 cases. Likert pain scores of two groups of patients one day after treatment, at discharge and one month after discharge were significant lower than before treatment (P <0.05). Compared with the IV group, the Likert pain score of PA group one day after treatment was significantly decreased (P <0.05). QS sleep index score of two groups of patients one day after treatment, at discharge and one month after discharge were significant higher than before treatment (P <0.05). Compared with the IV group, the QS sleep index score of PA group,after 1day of treatment was significantly increased (P<0.05). The clinical efficacy of the PA group was significant higher than IV group, the significant efficiency of PA group was significant higher (P<0.05). During treatment periods, there was one case of dizziness, nausea and slight increase of blood pressure in the IV group. After 15 min of withdrawal, the above symptoms were relieved. In the course of subsequent treatment the patients did not show any of the above symptoms. Conclusion The efficacy of ERSIVVI in the treatment of herpes zoster by paravertebral injection is clear, with few adverse reactions. References | Related Articles | Metrics

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Clinical Efficacy and Safety of Paliperidone Palmitate in The Treatment of 200 Cases Young and Middle-aged Patients with Schizophrenia ZHU Yun-qian, CHEN Yun-ren 2017, 14(5): 270-273.  Abstract ( 390 )   PDF (524KB) ( 68 )   Objective To observe the clinical efficacy and safety of paliperidone palmitate in treatment of 200 cases of young and middle-aged patients with schizophrenia. Methods All patients were divided into research group (paliperidone palmitate) and control group (risperidone) in accordance with registration order. The whole treatment cycle lasted for 24 weeks. Psychotic symptoms, quality of life, social function and drug safety were tested respectively at these time points, including before treatment, treatment of 1, 4, 8, 16, 24 weeks. The positive and negative symptoms scale (PANSS), clinical global impression-severity (CGI-S), personal and social performance scale (PSP) and treatment emergent symptom scale (TESS) were regarded as the evaluation indicators. Results 200 patients participated in the study, 191 cases finished the research, 96 cases in paliperidone palmitate group, 95 cases in risperidone group. Before treatment, PANSS, CGI-S and PSP showed no significant difference between two groups. After 24-week treatment, PANSS and TESS were improved, but the comparative differences between two groups were not meaningful. CGI-S and PSP were improved at each time point of treatment, and improvement was more obvious in paliperidone palmitate group. Meanwhile, differences between two groups were statically significant (P<0.05). Conclusion Paliperidone palmitate, which has few adverse drug reactions, can effectively improve the symptoms of the youth patients with schizophrenia, and enhance their social function. References | Related Articles | Metrics

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Effect of SLCO1B1 Gene Polymorphism on Lipid - Lowering Effect of Atorvastatin ZHANG Ya-tong, ZHU Kong-cai, ZHAO Ming, ZHAO Zi-nan, LI Zheng, HE Yi-jun 2017, 14(5): 274-277.  Abstract ( 330 )   PDF (457KB) ( 79 )   Objective To study the effect of SLCO1B1 gene polymorphism on the lipid-lowering effect of atorvastatin. Methods Patients who had been taking atorvatatin for more than 15 days with complete clinical records were recruited ,and patients taking other lipid-lowerring medicines or with other lipid-related factors were excluded. The clinical data and serum lipid levels before and after atorvastatin treatment were collected, and SLCO1B1 -521T> C （rs4149056） and -388A> G （rs2306283） gene polymorphisms were detected. Results The results showed that the genotype distribution of patients was consistent with the Hardy-Weinberg equilibrium （P>0.05）. The reduction of TC, LDL-C and TG in SLCO1B1 -388GG genotype subgroup was significantly higher than that in AA+AG genotype subgroup. Conclusion SLCO1B1 polymorphism, especially -388A>G had significantly effect on the lipid-lowering effect of atorvastatin. References | Related Articles | Metrics

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To compare the quality of Schisandra formula particles from different manufacturers CHANG Yun-feng, HAO Lei, ZHANG Xiao-jian, LI Xue-li, GAO Han, LI Jun-shan 2017, 14(5): 278-282.  Abstract ( 349 )   PDF (1104KB) ( 79 )   Objective Comparison and analysis of the quality of Schisandra formula particles produced by different manufacturers, provide the basis for the establishment of a unified quality control method .Methods According to the granular requirement by the 2015 edition of "Chinese pharmacopoeia" , determinating and comparing samples from five different manufacturers ,Including it’s properties, particle size, moisture content, melting, loading quantity, extract and content, drug induced wettability,fingerprint. and then investigating its quality. Results The properties, particle size, moisture content, melting, loading quantity from five different manufacturers formula particles all meets the requirement ,but there is a big difference in the extract and content, drug induced wettability,fingerprint. Conclusion There is a big difference in the quality of Schisandra formula particles from different manufacturers,so it is urgent that establish uniform quality standards for formula particles. References | Related Articles | Metrics

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Consideration on Implementation and Reference Through FDA Risk Evaluation and Mitigation Strategy BAO Cheng-cheng, WANG Hong-wei, YANG Yue 2017, 14(5): 283-288.  Abstract ( 443 )   PDF (1550KB) ( 211 )   Objective This article makes an introduction of the FDA's Risk Evaluation and Mitigation Strategy and development process to provide suggestions to conduct Risk Evaluation and Mitigation Strategies (REMS) in China. Methods Studying material of REMS in US Food and Drug Administration (FDA) official website and analyzing related literature. Results application ensures that the benefits of a drug outweigh the risks of the drug by developing REMS,and U.S publishes a series of regulation and guidance to ensure REMS implement .Conclusion REMS could give some references for risk control measures. References | Related Articles | Metrics

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Investigation on the Situation of Cognition and Reporting of Adverse Drug Reactions in 1 109 Basic Medical Institutions LI Ang, ZHANG Bing, ZHANG Xiao-meng, SUN Xiao-xia, YANG Xue, LI Fan 2017, 14(5): 289-294.  Abstract ( 295 )   PDF (856KB) ( 115 )   Objective To know the cognition degree and reported condition on adverse drug reactions (ADR) of the basic medical institutions in China, analyze the problems of ADR reporting in it, and to provide references for training scheme. Methods With the anonymous survey questionnaires, we investigated the grassroots medical staff which from 1 109 basic medical institutions in 29 provinces. The contents of questionnaires included the basic information of respondents, the cognition of ADR, the situation of ADR reporting and feedback. Then we made classification, induction, statistics and analysis to survey questionnaire information. Results 1 109 questionnaires were distributed, and the recovery was 100%. 53.02% of the people who had been investigated was western medicine professional, 13.44% was Chinese medical professional and 29.76% was integrated Chinese and western medical professional and 86.30% had technical secondary school or college degree. There were 428 basic medical institutions who reported ADR, accounting for 38.59% of the total. 69.79% of basic medical institutions could understand concept of ADR, 70.87% could distinguish the type of ADR, but only 10.82% could understand the occurrence reason of ADR, 68.71% didn’t know reporting requirement of ADR. Besides, rewards could promote basic medical institutions to report ADR. Conclusion Many basic medical institutions have lower cognition, and lack of understanding in reporting process of ADR. Having bonus rewards can improve the positivity in reporting ADR. It is necessary for basic medical institutions to implement systematic trains of ADR cognition and reporting, and adopt proper measures of help and rewards to promote basic medical institutions to report ADR better. References | Related Articles | Metrics

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Ideas on Trend of ADR Monitoring Model in China SHEN Lu, LIU Wei, GUO Xue, PENG Li-li, KONG Fan-yao, LI Xin-ling 2017, 14(5): 295-297.  Abstract ( 678 )   PDF (705KB) ( 221 )   Objective To research and explore the trend of post-marketing pharmacovigilance in China. Methods The status analysis method was adopted, in view of the existing problems, the trend of post-marketing pharmacovigilance in China was conceived. Results In view of the uneven quality reports,corporate responsibility not in position, the main channel of medical institutions advantage not obvious,and other current situations,this article suggested that we should strengthen the existing ADR monitoring system, establish national ADR monitoring sentinel union, study data source cooperation, train and inspect enterprise, upgrade PSUR model, research on enterprise drug safety monitoring and evaluation system, and other methods to constantly deepen work of the post-marketing pharmacovigilance. Conclusion It would be the inevitable trend of post-marketing pharmacovigilance in China to constantly strengthen corporate responsibility, enhance the ability of enterprise, implementing the responsibility of enterprise, and raise up the monitoring system of their own ability of drug safety monitoring and evaluation. References | Related Articles | Metrics

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Systematic Review and Meta-analysis of Adverse Effects FENG Xue, LIU Jian-ping, CHEN Wei 2017, 14(5): 298-303.  Abstract ( 643 )   PDF (717KB) ( 274 )   Nowadays, the evaluation of drug adverse effects has gained more and more attention. Due to the inconsistent incidence of adverse effects reported by different studies and the wide variety of drugs, it is not scientific to draw a conclusion based on single clinical studies or large surveys. Systematic review / meta-analysis comprising all available studies can provide better evidence on drug adverse effects in general. This assay is to introduce the basic concept and the characteristics of drug adverse effects and the steps of making a systematic review/ meta-analysis for evaluating the drug adverse effects, involving the proposal of questions, searching strategy, methods of pooling of data, and the modification and update of review. References | Related Articles | Metrics

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Literature Analysis of 433 Cases of Drug-induced Pulmonary Diseases MA Li, HAN Xiao-nian, HUANG Jing, PENG Li-rong 2017, 14(5): 304-308.  Abstract ( 360 )   PDF (666KB) ( 95 )   Objective To investigate the drugs leading to drug-induced pulmonary diseases and discuss their clinical characteristics, so as to provide reference for rational drug use in the clinic. Methods Literatures of drug-induced pulmonary diseases publicly reported in domestic medical journals from 1979 to 2015 were collected and analyzed statistically. Results A total of 227 relevant articles were identified, which reported 433 cases of drug-induced pulmonary diseases, involving cardiovascular drugs, anticancer drugs, non-steroidal anti-inflammatory drugs, anti-microbial agents and traditional Chinese medicine injections. The main syndromes were asthma, interstitial pneumonia, drug-induced pulmonary edema, pulmonary fibrosis,etc. Most cases improved after drug withdrawal and symptomatic treatment, but 53 patients died. Conclusion A variety of drugs can induce drug-related lung damages. It is necessary to be vigilant, so as to reduce the incidence of adverse reactions. References | Related Articles | Metrics

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Clinical Characteristics of Patients with Interstitial Lung Disease Induced by Gefitinib and Erlotinib BIE Zhi-xin, DING Li 2017, 14(5): 309-312.  Abstract ( 301 )   PDF (468KB) ( 88 )   Objective To explore the clinical characteristics of interstitial lung disease (ILD) induced by gefitinib and erlotinib. Methods The reports of ILD induced by gefitinib and erlotinib from January 2004 to December 2016 were collected and analyzed from Web of Science and Wanfang databases. Results A total of forty-six patients were entered. Forty-five patients were diagnosed as non-small cell lung cancer and one patient was diagnosed as pancreatic cancer. Several patients has a history of radioactive pneumonia, interstitial lung lesion or chronic bronchitis. Gefitinib was given 250 mg/d in twenty-four patients (52.17%) and erlotinib was given 150 mg/d in twenty-two patients (47.83%). The ILD occurred during two to seven hundred and thirty days after medication, and 57.78% of ILD occurred during the first month after medication. The major clinical manifestations of ILD were dyspnea, cough and fever. Ground glass opacity, patchy consolidation or reticular opacity were found during chest X-ray or CT examination. The patients who were diagnosed as ILD were withdrawn immediately and forty-three patients were treated with symptomatic steroids such as dexamethasone, meprednisone and prednisone. Twenty-four patients’ symptoms and imaging features improved. Twenty patients died, and fourteen patients died during the first month after the diagnosis of ILD. Conclusion Gefitinib or erlotinib induced ILD is an acute and fatal complication. Respiratory symptoms should be monitored carefully after medication and high resolution CT is essential for diagnosis of ILD. Once the diagnosis of ILD is con?rmed, management includes discontinuation of EGFR-TKI, administration of steroids and provision of supportive care including antibacterial agents if appropriate. References | Related Articles | Metrics

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Comparison of Blood Pressure, Pulse Pressure, Heart Rate and Adverse Reaction Between Different Dosage of Etomidate-induced Anesthesia in Adolescents WANG Lei, Wang chun-xue 2017, 14(5): 313-316.  Abstract ( 278 )   PDF (507KB) ( 62 )   Objective To observe and compare the differences of blood pressure, pulse pressure, heart rate and adverse reactions at different doses of etomidate during anesthesia induction in adolescents. Methods 150 cases patients with general anesthesia in our hospital were collected from February 2013 to April 2016, the age of 17 to 40 years old, according to the different dose and induced drugs were randomly divided into 5 groups: E3 (etomidate 300 g·kg-1), E4 (etomidate 400 g·kg-1), E5 (etomidate 500 g·kg-1), E6 (etomidate 600 g·kg-1), P (propofol 2 mg·kg-1). The changes of systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR), Brain electric dual frequency index (BIS) and adverse reactions at T0, T1, T2,T3, T4 and T5 timing were observed and recorded. Results Compared with T0, the patients of BIS were significantly decreased in the five groups after induction, (P<0.05), SBP, DBP, MAP of E6 group were significantly decreased (P<0.05), after intubation, the SBP, DBP, MAP of E3 group were significantly increased, E4 and E5 group were relatively stable. Compared with the P group, BIS, SBP, DBP and MAP in the E3 group were significantly higher than those in the P group (P <0.05), and HR was significantly higher than that of P group at T1 (P < 0.05).The BIS, DBP and MAP of E6 group were significantly lower than those of P group (P <0.05), SBP was significantly lower than that of P group at T1 (P <0.05), HR and P group were no difference (P> 0.05). The difference of BIS, DBP and HR between E4 group and P group was not significant (P> 0.05). SBP was significantly higher at T1, T3, T4 and T5 than that in group P (P <0.05), MAP at T1, T4 and T5 was significantly higher than that of P group (P <0.05). There was no significant difference between E5 group and P group (P> 0.05). Conclusion The concentration of etomidate within the scope of 400 μg·kg-1~500 μg·kg-1 has good effect in adolescents anesthesia induction, and the indicators change is relatively stable. References | Related Articles | Metrics

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Literature Analysis of 101 Cases of Adverse Reactions Induced by Huoxiangzhengqi Liquid LIU Song-song XIE Yi-ming 2017, 14(5): 317-320.  Abstract ( 533 )   PDF (558KB) ( 147 )   Objective Through investigating the characteristics and mechanism of adverse drug reactions (ADR) induced by Huoxiangzhengqi liquid, to find its risk factors and provide technical support for safe and rational use of drugs in clinic. Methods The keywords “Huoxiangzhengqi liquid”, “adverse reaction”, “side effect” and “induced” were used to search and retrieve articles in the CNKI databaseto extract and analyze literature data about Huoxiangzhengqi liquid. Results 33 references which met the inclusion and exclusion criteria including 101 cases. The ADRs mainly occur in the middle and young individuals. The primary diseases were acute gastroenteritis. 85.15% of ADRs happened in 1 h after administration. Systems and organs mainly involved in ADRs were systematic disorders, neurological and psychiatric system disorders, cardiovascular system disorders, skin and its appendages disorders, etc. The systematic disorders were the most common reported ADRs, including red hot, anaphylactic shock, double sulfur shimron reaction, anaphylactoid reaction, etc. Conclusion It is important to pay attention to the ADRs caused by Huoxiangzhengqi liquid, strengthen clinical rational use of drugs, and improve the medical instructions. References | Related Articles | Metrics