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20 May 2016, Volume 13 Issue 5 Previous Issue    Next Issue

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Study on Effect of Tetrandrine on Akt Activity in MCF-7 Cell Line WU Jian-yi, SHEN Qing, JIN Yun-jie, YAO Xiao-xiang, ZHU Ji-hua, ZHU Lin-yu, DING Zhao-heng, HUANG Xiao-dong 2016, 13(5): 257-259.  Abstract ( 306 )   PDF (3165KB) ( 173 )   Objective To study the cell signal mechanism of tetrandrine-induced apoptosis of human breast cancer cell line MCF-7. Methods The effects of tetrandrine-induced apoptosis of MCF-7 (1, 5, 10 μmol·L-1) was detected by flow cytometry. Western blot was performed to assess expression of Akt, p-Akt ser437 and p-Akt Thr308 in MCF-7. The activity of Akt was detected by Akt activity assay kit (KinaseSTAR). Results Different doses of tetrandrine (Tet) could induce apoptosis of MCF-7 in a dose-dependent manor. Tet could significantly inhibit expression of p-Akt ser437and p-Akt Thr308, but had no effect to expression of total Akt in MCF-7. Tet could down-regulate the activity of Akt of MCF-7. Conclusion Tet can induce apoptosis of MCF-7 cells through suppressing Akt activity. References | Related Articles | Metrics

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Phase I Clinical Trial on Safety and Tolerability of Levornidazole Disodium Phosphate for Injection in Chinese Healthy Volunteers CAO Jiang, CHEN Qian, MEI He-kun, BAI Nan, JIANG Xue-wei, WANG Jin, WANG Rui 2016, 13(5): 260-232.  Abstract ( 397 )   PDF (4613KB) ( 145 )   Objective To assess the safety and tolerability of levornidazole disodium phosphate for injection in Chinese healthy volunteers. Methods 24 healthy subjects were enrolled in the multi-dose trial (male:female=1:1). Subjects were equally divided into two groups, received intravenous infusion of 1 000 mg twice daily and 2 000 mg once daily for consecutive 7 days. The safety and tolerability were evaluated based on clinical symptoms, vital signs, physical examinations, ECG, laboratory tests and adverse events. Results Levornidazole disodium phosphate had no clinically significant effects on vital signs and ECG in total of 24 subjects who completed the tolerance test. 19 adverse events were observed in 12 subjects, including ALT elevation, AST elevation, LDH elevation and pain at the injection site, which were somewhat related to the study drug judged by investigator. But they were slight and temporary and completely relieved without any intervention. There was no serious adverse event or any adverse event leading to drop-out. Conclusion Levornidazole disodium phosphate for injection is well-tolerated in Chinese healthy subjects after administration of multi-doses (1 000 mg twice daily and 2 000 mg once daily). The main adverse reactions were ALT and AST mild increase, which were also consistent with previous reports that hepatic metabolism is the main elimination for ornidazole. In the multi-dose trial, safty and tderability of 2 000 mg once daily is bettert than that of the other. References | Related Articles | Metrics

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Analysis of Efficacy of S-1 Capsale Monotherapy Third-line Treatment in Elderly Patients with Advanced Colorectal Cancer LV Jian-hua, LV Jian-li, LI Yong-bing 2016, 13(5): 263-265.  Abstract ( 346 )   PDF (3332KB) ( 168 )   Objective To investigate the clinical efficacy of S-1 monotherapy third-line treatment in elderly patients with advanced colorectal cancer. Methods 66 cases of senile advanced colorectal cancer patients were selected in our hospital from August 2013 to August 2014, who were randomly divided into the observation group and the control group with 33 cases in each group. In observation group, third-line S-1 monotherapy was applicated, while the patients in control group were treated with capecitabine tablets. The efficacy and side effects of the drugs were observed and compared between the two groups of patients. Results In the observation group patients, the clinical effective rate was 45.45%, while it was 42.42% in the control group. There was no significant difference (P > 0.05) between the two groups of patients. Improvement of KPS score in the observation group was significantly higher than that of the control group with significant difference between the two groups (P < 0.05).Diarrhea and hand foot syndrom incidence in observation group was significantly lower than that of the control group, which was significantly different (P < 0.05). Conclusion In elderly patients with advanced colorectal cancer, S-1 capsule monotherapy third-line treatment is effective with less adverse reactions and dosing convenience. It can improve the life quality of patients, also with a higher tolerance. It is worthy to be further applicated and promoted in clinic. References | Related Articles | Metrics

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Clinical Observation of Etanercept Combined with Methotrexate in Treatment of Patients with Rheumatoid Arthritis ZHU Shuai, HUANG Yu-peng, HE Yong, NIE Xin, WANG Wei-qing, DU Xiang-yang, GUO Ying, LI Gui-xing 2016, 13(5): 266-268.  Abstract ( 360 )   PDF (3330KB) ( 81 )   Objective To explore the efficacy and safety of etanercept combined with methotrexate in treatment of patients with rheumatoid arthritis. Methods 54 outpatient patients with rheumatoid arthritis (RA) from September 2015 to January 2016 were recruited to the open observational study. The control group included 30 patients who received methotrexate (10 mg, po, qw), and the treatment group included 24 patients who received etanercept (25 mg, sc, qw) and methotrexate (10 mg, po, qw). We observed the tender and swollen joint counts, patient visual analogue score (VAS) on disease condition, physician VAS on disease condition, patient VAS on joint pain, patient health questionnaire (HAQ) and erythrocyte sedimentation rate (ESR) at 4, 8 and 12 weeks of follow-up.Therapeutic efficacy was evaluated by the American College of Rheumatism (ACR) efficacy evaluation criteria. Results At 4th week, tender and swollen joint counts and ESR had been significantly improved compared with baseline. All the observation indexes were significantly improved compared with baseline at 8th week, and were significantly improved compared with baseline and the control group at 12nd week. The remission rates of ACR20 at 8th week and ACR20, ACR50, ACR70 at 12nd week of the treatment group were higher than that of the control group in the same period, and the differences were statistically significant (P<0.05 or P<0.01). No serious adverse events were noted during the observation. There was no significant difference in incidence of adverse events between the treatment group and the control group (P>0.05). Conclusion Etanercept combined with methotrexate has better efficacy and higher remission rate than methotrexate used only in treatment of rheumatoid arthritis. References | Related Articles | Metrics

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Preliminary Exploration for Construction of Adverse Drug Reaction/Event Sentinel Surveillance in Heilongjiang Province ZHAO Shi-dan, GAO Xu-guang, DAI Yun-peng, CAO Fei, LIU Li-min, LI Bai-qiang, LU Zhong-ping 2016, 13(5): 269-271.  Abstract ( 329 )   PDF (3289KB) ( 213 )   Objective To provide theoretical basis for the comprehensive construction of adverse drug reaction/event sentinel surveillance. Methods The article analyzed and researched the necessity, feasibility and construction of sentinel hospitals in our province. Results Adverse drug reaction/event sentinel construction is practicable as a result of promoting the quantity and quality of reports and data use. The reporting structure of adverse drug reaction/event is further optimized. Conclusion The construction of sentinel hospitals can effectively improve the ability and level of adverse drug reaction monitoring work. References | Related Articles | Metrics

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Thinking to Promote Adverse Drug Reaction Monitoring Work of Medical Institutions TIAN Chun-hua 2016, 13(5): 272-274.  Abstract ( 540 )   PDF (3321KB) ( 178 )   Medical institutions as the direct contact of adverse drug reactions and treatment, has played a positive role in the adverse drug reaction monitoring in China, but based on statistical data, there is still much room for improvement in the report quantity and quality of medical institutions currently. This article expounded the meaning of the medical institutions to carry out the adverse drug reaction monitoring work. Through influence factors analysis of adverse reaction reports, suggestions on how to strengthen the adverse drug reaction monitoring work in the medical institutions were put forward. At the same time, on the basis of some lessons drawn from foreign experience, combined with the characteristics of medical institutions in our country, several measures which can be taken at the national level were discussed. References | Related Articles | Metrics

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Possibility and Challenge of Non-production Enterprises in Our Country to Become a Marketing Authorization Holder REN Yu, LI Xiao-yu, TIAN De-long, YANG Yue 2016, 13(5): 275-281.  Abstract ( 349 )   PDF (6108KB) ( 202 )   Objective To explore the possibility of non-production enterprises to become the marketing authorization holder and its implementation path based on revision of the Drug Administration Law and marketing authorization holder (MAH) pilot program. Methods Through statistics of 1.1 class chemicals accepted by China Food and Drug Administration (CFDA) during August 2014 to August 2015, the basic situation of non-production enterprises listed applicants were analyzed, such as their nature, registration time and capital. As well, based on the rights and obligations stipulated in the MAH pilot program, the possibility of non-production enterprises to become the MAHs was analyzed. Results The non-production enterprises have accounted a large proportion in 1.1 class chemicals accepted by CFDA in nearly one year, the responsibility of drug safety and effectiveness will become a threshold for these enterprises to be MAHs. Conclusion To become MAHs, non-production enterprises should improve the quality management and monitoring departments. At the same time, our country still needs to improve MAH system, such as establishing the adverse drug event relief fund for compensation and other supporting policies to promise of smooth implementation for MAH pilot program. References | Related Articles | Metrics

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Research Development on Pharmacology and Toxicology of Cassiae Semen Related to Efficacy and Material Basis HUANG Na-na, DOU Li-wen, SUN Rong 2016, 13(5): 282-285.  Abstract ( 544 )   PDF (4326KB) ( 256 )   Objective To summarize a number of reaches of Cassiae Semen that were reported at home and abroad in recent years, look for the pharmacological and toxicological characteristics, the possible material basis and potential toxicity mechanism which play a role in its efficacy-toxicity. So as to provide literature evidence and ideas for the future pharmacology and toxicology research based on traditional Chinese medicine efficacy and material basis, especially confirming the safety standard and efficacy-toxicity material basis. Methods References in old days and in the last decades both at home and abroad about Cassiae Semen were collated, analyzed and summarized. Results Early references records of toxicity about Cassiae Semen were lacking. Recent researches were confined to the isolated aspect such as pharmacology, toxicology, chemical constituents and lacked the correlations of efficacy, toxicity and material basis. Consequently, blamelessly safely using standards should be made based on efficacy and material basis, and insured its toxicity could be scientifically controlled. Only by clarifying the indications, material basis, pharmacological toxicological characteristics and effect mechanism of efficacy-toxicity could we make rational use of the maximum effect of Cassiae Semen. In order to scientifically control the toxic side effects, it is necessary to formulate a reasonable safety standard of Cassiae Semen basing on the in vivo safety limit research of efficacy-toxicity material basis. Conclusion Only by studying toxicity and safely controlling the toxic material basis during the expression of effectiveness and the separation and quality controlling of efficacy material basis, could we put forward early-warning scheme and treatment measures of adverse reaction in clinical use, so as to ensure the safe and rational use of Cassiae Semen. References | Related Articles | Metrics

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Clinical Drug Interactions Related to CYP3A4 Enzyme WU Hua 2016, 13(5): 286-290.  Abstract ( 682 )   PDF (5121KB) ( 294 )   Objective To provide reference for rational use of strong inhibitors and strong inducers of CYP3A4 enzyme. Methods The related literatures at home and abroad with clinical research or case report about clinical drug interactions related to strong inhibitors and strong inducers of CYP3A4 enzyme were consulted and summarized. Results There are many clinical reports about strong inhibitors of CYP3A4 enzyme such as calcium channel blockers, clarithromycin, protease inhibitors and triazole antifungal agents particularly with statins, hormone drugs, tacrolimus, etc. There are also some clinical reports about strong inducers of CYP3A4 enzyme such as rifampin, carbamazepine and phenytoin with oral contraceptives, tacrolimus, ticagrelor, etc. Conclusion When strong inhibitors or strong inducers of CYP3A4 enzyme were used, attentions must be paid to their impact on CYP3A4 substrate, and regimen must be adjusted timely. References | Related Articles | Metrics

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Analysis of Influence of Bicyclol Tablets on Renal Function Based on Real World HOU Dao-rui, LI Yuan, XIE Yan-ming,* ZHAO Wei, ZHUANG Yan 2016, 13(5): 291-294.  Abstract ( 681 )   PDF (3426KB) ( 197 )   Objective To understand the effect of bicyclol tablets on serum creatinine and blood urea nitrogen in clinical practice through descriptively analyzing real world use data of bicyclol tablets, which used serum creatinine and blood urea nitrogen, the conventional test of renal function test, as final indicators, so as to provide evidence for further discussion on the safety to kidney. Methods The clinical use information of the bicyclol tablets from 18 hospitals in China was selected. The abnormal rates of serum creatinine and blood urea nitrogen in patients with or without the bicyclol tablets were analyzed by Chi-square test respectively. Results The abnormal rates of serum creatinine and blood urea nitrogen in patients with the bicyclol tablets were significantly lower than that without use (χ2=10.784 6, P=0.001 0; χ2=11.442 1, P=0.000 7). Conclusion In the real world, the bicyclol tablets have no significant damages to kidney. References | Related Articles | Metrics

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Analysis of 156 Cases of Adverse Drug Reactions/Medical Device Events Induced by Levonorgestrel-releasing Intrauterine System ZHANG Min, SUN Zhi-ming, XU Hao-qin, YANG Yue-hua 2016, 13(5): 295-297.  Abstract ( 383 )   PDF (2913KB) ( 124 )   Objective To explore the characteristics of adverse drug reactions（ADRs）/medical device events（MDEs）caused by the levonorgestrel-releasing intrauterine system (LNG-IUS). Methods 156 cases of ADRs/MDEs caused by LNG-IUS were analyzed via retrospective study in terms of ages, time distribution and manifestation. Results The LNG-IUS was mainly placed in hospital, 85 cases were menstruproblems (54.49%), of which 31 cases were absence of menstruation (36.47%). Conclusion The most information on LNG-IUS was from hospital and doctor. Recommendation of doctor was important for using LNG-IUS. The main ADR/MDE of LNG-IUS was the change of menstruation. Informed consent should be done before using LNG-IUS. The LNG-IUS has the characteristics of drug and medical device, once taken out because of the drug, both ADR and MDE reports should be sabmitted. References | Related Articles | Metrics

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Clinical Study on Compatibility of Sodium Nitroprusside for Injection and Sodium Chloride Injection after Prolonged Use to 26 h LIN Xiao-ming, HUANG Min, XIE Pei-de 2016, 13(5): 298-302.  Abstract ( 321 )   PDF (3979KB) ( 123 )   Objective To provide scientific basis for clinical rational compatibility of sodium nitroprusside (SNP) for injection and sodium chloride (NS) injection. Methods The compatible solution of SNP and NS injection was given intravenously in three ways for the patients in 3 different groups of hypertensive crisis. The solution was given within 4 h, 12 to 14 h, and 24 to 26 h after preparation for each group of patients respectively. The blood contents of cyanide (CN) were measured, and blood gas analyses were performed at the same time, and the amounts of the SNP used were recorded. The contents of CN and the degradation of sodium nitroprusside in the compatible solution of SNP and NS injection were also measured 26 h after its preparation. Results As conventional preparation, the compatible solution of SNP and NS injection used within 26 h is safe and effective. Conclusion It is scientific to use the compatible solution of SNP and NS injection until 26 h after its preparation in clinic. References | Related Articles | Metrics

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Literature Review of 77 Cases of Adverse Drug Reactions Induced by Lamotrigine HE Xin, ZHANG Yong, XU Jin, XU Jing 2016, 13(5): 303-305.  Abstract ( 333 )   PDF (4143KB) ( 136 )   Objective To investigate the general rules of lamotrigine(LTG)-related adverse drug reactions(ADRs) and clinical characteristics, and to promote rational use of LTG. Methods Literatures of LTG-induced ADRs reported in domestic and overseas pharmaceutical journals from 1994 to 2014 were retrieved and analyzed. Results 77 cases were collected in which three patients died for Stevens-Johnson syndrome and one for acute liver failure. Most of LTG-related ADRs were skin lesions which may relate to the gender, age and combination use of drugs. Conclusion It is recommended to consider the gender, age, dose, and combination use of drugs when using LTG. More attention should be paid to LTG-related ADRs to promote its rational use. References | Related Articles | Metrics

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Analysis of Utilization of Hormone Drugs in Perimenopausal Women in Outpatient of Our Hospital SONG Xiao-dan, ZHANG Jing, MA Man-ling 2016, 13(5): 306-308.  Abstract ( 300 )   PDF (2909KB) ( 180 )   Objective To evaluate the status and issues of drugs related to hormone replacement therapy(HRT) in perimenopausal women in outpatient of our hospital. Methods The utilization of drugs related to HRT in perimenopausal women in outpatient of our hospital in the first quarter of 2013 was analyzed retrospectively in terms of varieties, consumption sum, DDDs, DDC, etc. Results The consumption sum of homone drugs in perimenopausal women, the total consumption sum and the ratio of the former to the latter in February 2013 were all lower. Duphaston, Climen, Progynova and Livial steadily dominated the first place on the consumption and constituent ratio lists in every month. The constituent ratio of Progynova showed an upward trend by month, while Livial was downward. Progynova, Climen, Duphaston and Ovestin were always on the top of the DDDs list in all months. In terms of DDC, Progesterone capsules and Duphaston ranked at the top 2 places in each month, followed by Livial. Conclusion Progynova, Climen, Duphaston and Ovestin were general drugs for HRT in perimenopausal women in our hospital. Progesterone capsules and Duphaston might be the heavy economic burden of patients. References | Related Articles | Metrics