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In 2019, Drug Administration Law of China was first time proposed that the country should establish pharmacovigilance system. In 2021, the first Pharmacovigilance Quality Management Standard of China was released. The proposal and implementation of pharmacovigilance were the initial stage in China, and it needed to improve the aspects of pharmacovigilance include institution, monitoring mechanism and database construction. The number of new diagnosed cancer patients in China ranked first in the world. In recent years, the marketing speed of novel antitumor drugs was accelerated, and there were many clinical trials. Therefore, antitumor pharmacovigilance was imperative. In this article, we summarized pharmacovigilance of the origin, clinical practice objectives, procedures, methods. We described the difficulties in antitumor pharmacovigilance and current characteristics of pharmacovigilance in China, aiming to provide reference for the development of antitumor pharmacovigilance. .
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China , Humans , Lung Neoplasms , PharmacovigilanceABSTRACT
BACKGROUND@#Cancer pain affect the physical activity, psychological state and quality of life seriously, and even shortened the survival time of patients. Rational and standard application of opioids could control cancer pain effectively. Since the high incidence of cancer pain in lung cancer patients, the status of opioids application should be analyzed to evaluate the rationality of analgesic application in lung cancer patients.@*METHODS@#The clinical data of 305 patients with lung cancer who were hospitalized in Department of Respiratory and Critical Care Medicine of Peking Union Medical College Hospital from June 2018 to June 2019 were analyzed retrospectively.@*RESULTS@#In the analysis of factors affecting the use of opioids in lung cancer patients, age and drug kinds were the main influencing factors. The proportion of male patients was higher than female. Moreover, male patients used more kinds of opioids and were mostly between 60 and 69 years old. The variety and structure of opioids used in lung cancer patients in our hospital met the requirements. Oxycodone hydrochloride prolonged-release tablet has the highest frequency of application, and defined daily cost (DDC) ranked the first with a serial number ratio of 1, which showed good synchronization. The quantity of morphine tablet and morphine injection were low, and the overall breakthrough cancer pain (BTcP) in lung cancer patients was well controlled. The overall application of opioids were reasonable (93.4%), and the unreasonable items mainly included the disposal of BTcP and the unreasonable frequency of opioids, as well as overdose.@*CONCLUSIONS@#The majority of patients with lung cancer who take opioids are male, and the cancer pain in elderly men are more difficult to control, which needs to pay more attention. The overall application of opioids in the patients with lung cancer pain in our hospital are reasonable, but there are still some problems to focus, such as the disposal of BTcP, the dosage of opioids and the medication of special groups.
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OBJECTIVE：To o ptimize the t ype of nervous system medicines in National Essential Medicine List of China. METHODS：Various editions of WHO Essential Medicine Model List （WHO EML ）were consulted ，the collection of nervous system medicines was analyzed statistically ，and 2017 edition of WHO EML was compared with 2018 edition of National Essential Medicine List of China （NEML）. RESULTS ：During 1977-2017，the total number of nervous system medicines and disease coverage included in each edition of WHO EML had little change. Compared with 2017 edition of WHO EML ，2018 edition of NEML contained more medicines for nervous system disease （54 medicines vs. 30 medicines），and covered more disease types ， such as dementia （huperzine A ）and neuralgia （pregabalin），etc. However ，for the treatment of multiple sclerosis ，neuralgia， dementia and other diseases ，there were not many medicines to choose ，and some similar medicines （with the same or similar mechanism of action ）were collected repeatedly and some medicines had serious adverse reaction. CONCLUSIONS ：It is suggested that National Essential Medicine List should be continuously optimized and perfected ，the varieties of essential medicines for the treatment of nervous system diseases should be increased appropriately ，for improving the treatment effect of such diseases and reducing the cost burden of patients.
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[Objective] The biocompatibility between SGBG/PHBV and human PDLC were investigated to provide a basis for the choice of the scaff material of periodontal tissue engineering.[Methods] Human PDLC were cultured using tissue-explant technique.Seeding on 96 wells plate,9 wells for one group,Four different concentrations (100％,75％,50％,25％,0％) of maceration extract of SGBG/PHBV were added into the culture plantsafter 48-h cell seeding,the grades of the cytotoxicity of SGBG/PHBV was evaluated by MTT assay.Human PDLC cultured in vitro were collected and seeded on the three-dimensional scaffolds of SGBG/PH-BV,the cellular morphology and cell growth on the scaffolds were observed and photographed by scanning electronic microscope.HumanPDLC seeded on the three-dimensional scaffolds of SGBG/PHBV in the experimental group,and human PDLC seeded by DMEM in the control group,after 12-,24-,and 48-h cell seeding,got 27 simples for each group,and the affection of the SGBG/PHBV on cell secretory function was observed by spectrophotometry which assayed the biochemical indexes ALP in supinate.[Results] The grades of the cytotoxicity of SGBG/PHBV were 0 and 1.It was displayed that human PDLC adhered and proliferated well on the scaffold of SGBG/PHBV under the scanning electronic microscope.The significant difference of ALP in supinate between the experimental group and the control group (P ＜ 0.05).[Conclusions] SGBG/PHBV had no cytotoxicity to human PDLC.SGBG/PHBV is potential to further study as the scaffolds of periodontal tissue engineering since it displayed the satisfactory biocompatibility with human PDLC.
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The convenient measures for medicine taking of chronic patients mainly depend on a long-range medicine taking mode. The diversity of prescription re-dispensing and research focus in the future in America were analyzed through data analysis, the significance of prescription re-dispensing in enhancing the compliance of patients was evaluated from the perspective of management,and how to achieve the multi-win-win situation for doctors,pharmacists,nurses and medical technicians was discussed in the study. Although the operation process and technical support process of the long-range medicine taking are detailed and concreted,it is necessary to further improve the mode according to the situation of the United States.
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BACKGROUND: BACKGROUND: Studies have found that surface treatment agents containing 10-methacryloyloxy decyl dihydrogen phosphate may be chemical y bonded to the oxide on the surface of zirconia, thereby notably improving the bonding performance of zirconia. OBJECTIVE: To study the effects of Mondbond N and Single bond Universal Adhesive on microtensile bond strength between zirconia and composite resin. METHODS: Sixty pieces of zirconia were randomized into three groups: in group 1, conventional Bis-GMA resin cement was used to bond zironia and composite resin; in group 2, conventional Bis-GMA resin cement was used to bond zironia and composite resin fol owing Mondbond N treatment; in group 3, conventional Bis-GMA resin cement was used to bond zironia and composite resin fol owing surface treatment with Single Bond Universal Adhesive containing 10-methacryloyloxy decyl dihydrogen phosphate. Microtensile bond strength and microstructure on the bonding interface were compared among three groups. RESULTS AND CONCLUSION: (1) Microtensile bond strength was significantly higher in the groups 2, 3 than group 1 (P < 0.05), and there was no difference between the two former groups. (2) Scanning electron microscope observation of the bonding interface: before microtensile test, there were more fissures on the bonding interface of group 1; in the group 2, there were a few fissures on the bonding interface that was relatively even; in the group 3, the bonding interface was smooth and continuous with few fissures. After microtensile, cohesive failure and bonding interface failure were mainly seen in the three groups, but there was no simple interface failure in the groups 2 and 3. These findings indicate that Monobond N and Single Bond Universal Adhesive can both improve the bonding strength of zirconia with composite resin.
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BACKGROUND:Our previous studies have shown that the poly(hydroxybutyrate- co-hydroxyvalerate) - sol-gel bioactive glass (PHBV-SGBG) has good biocompatibility and promote bone tissue repair, but its specific role in periodontal tissue regeneration has not been investigated. OBJECTIVE:To investigate the periodontal regenerative effects of a PHBV-SGBG scaffold in beagle dogs. METHODS:Alveolar bone defects (5 mm×5 mm) were surgicaly created bilateraly at the buccal side of the mandibular third and fourth premolars of four beagle dogs. PHBV-SGBG scaffold was randomly filed in the defects as experimental group and nothing was put into the contralateral as control group. Histological and scanning electron microscopy observations, cone-beam CT evaluation and the Ca/P concentration ratio analysis were processed at 2, 4, 8 and 12 weeks after surgery. RESULTS AND CONCLUSION:After surgery, the height of the regenerated tissue increased with time in both groups, and the regenerated tissue height in the experiment group was higher than that in the control group (P 0.05), but higher than that of the control group (P < 0.05); the histological observation showed that the regenerated tissue of the experimental group was close to the normal tissue, and the regenerated tissue of the control group tended to be mature, with a smal amount of new blood vessels. Under the scanning electron microscope, no scaffold structure was visible in the experimental group with the presence of bone lacuna at 8 weeks after surgery, while in the control group, there was no bone lacuna and obvious osteoblasts; at 12 weeks after surgery, the structure of the regenerated tissue of experimental group was more regular and close to the normal tissue with no remarkable osteoblasts, and in the control group, the regenerated tissue was disordered, with several cavity. These results show that the PHBV-SGBG scaffold can enhance periodontal bone regeneration effectively.
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Objective To explore the distribution of inflam m atory cells and positive expression of P-se-lectin glycoprotein ligand-1 (PSG L-1) in infant brainstem tissue from hand-foot-m outh disease related fatal brainstem encephalitis. Methods Tw enty brainstem sam ples from infants suffered from brainstem en-cephalitis w ere collected as the experim ental group. Ten brainstem sam ples from infants died of non-brain diseases and injuries w ere collected as the control group. The distribution of inflam m atory cells and the expression of PSG L-1 in the tw o groups w ere exam ined by im m unohistochem ical m ethod. The characteristics of the positive cells w ere observed. Results In brainstem tissue of the experim ental group, there w ere sleeve infiltrations of inflam m atory cells around the vessels and in the glial nodule. Microglia was the m ost and following was neutrophils around the vessels and in the glial nodule. There was a significant statistical difference am ong m icroglias, neutrophils and lym phocytes (P<0.05). There was no sleeve infiltration in the control group. PSG L-1 protein was expressed w idely in inflam m atory cells in the experim ental group, especially in the inflam m atory cells around the vessels and in the glial nodule. B ut PSG L-1 positive staining could be observed significantly less in the control group com paring with the experim ental group (P<0.05). Conclusion Microglia is the m ain type of inflam m atory cells involved in the progress of the fatal disease. Moreover, PSG L-1 could participate in the pathogenesis of hand-foot-m outh disease related fatal brainstem encephalitis.
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BACKGROUND:The morphological structure of nanofiber scaffold which fabricated by electrospinning technique is similar to the natural extracelular matrix, which provides a good microenvironment for cel growth and proliferation, and can also enhance cel adhesion, migration, proliferation and differentiation. OBJECTIVE: To observe the biocompatibility of double-layer poly(L-lactic acid) electrospun nanofiber scaffold and human periodontal ligament cels. METHODS: Electrospinning technique was used to prepare double layers poly(L-lactic acid) electrospun nanofiber scaffold. The toxicity of different concentrations of (100%, 75%, 50%, 25%) double-layer poly(L-lactic acid) electrospun nanofiber scaffold extracts to human periodontal ligament cels was evaluated by MTT assay. The double-layer poly(L-lactic acid) electrospun nanofiber scaffold was co-cultured with human periodontal ligament cels. The cel adhesive capacity in early stage was determined by MTT assay. The growth of cels on the scaffold was observed by scanning electron microscopy. RESULTS AND CONCLUSION: Different concentrations of double-layer poly(L-lactic acid) electrospun nanofiber scaffold extracts did not create any toxicity to human periodontal ligament cels. After co-culture for 2, 6, 24 hours, human periodontal ligament cels were poorly adherent onto the double-layer poly(L-lactic acid) electrospun nanofiber scaffold. After 7 days of co-culture, human periodontal ligament cels adhered wel on the loose surface of scaffold, maintained the original shape, stretched wel, and interconnected processes were observed; on the dense surface of the scaffold, multi-layer cels were observed. The cels showed fusiform or polygonal appearance and were connected together. These results demonstrate that the double-layer poly(L-lactic acid) electrospun nanofiber scaffold has good biocompatibility with human periodontal ligament cels.
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Aim To investigate the anti-proliferating effect of tetrandrine ( Tet ) on colon cancer cells and its possible molecular mechanism. Methods We intro-duced crystal violet staining and flow cytometry to ana-lyze the effect of Tet on proliferation in LoVo cells. Flow cytometry was used to detect the effect of Tet on apoptosis in LoVo cells. Western blot assay was taken to analyze the effect of Tet on the expression of insulin-like growth factor binding protein 5 ( IGFBP5 ) . Final-ly, luciferase reporter assay, recombinant adenovirus mediated over-expression or silence of IGFBP5 were used to analyze the possible role of IGFBP5 in the anti-proliferating effect of Tet on colon cancer cells. Re-sults Crystal violet staining and flow cytometery anal-ysis results showed that Tet could exert an anti-prolifer-ating effect and induce apoptosis in LoVo cells. Tet de-creased the expression of IGFBP5 in a concentration-dependent manner. Tet inhibited the transcriptional ac-tivity of pTOP-luc reporter, which could be reversed by exogenous expression of IGFBP5 mostly. Similar results were found in the expression of c-Myc, but IGFPB5 knockdown couldn’ t reverse this effect. Conclusion Tet can inhibit the proliferation of colon cancer cells, and this effect may be mediated by down-regulating the expression of IGFBP5 to inhibit Wnt/β-catenin signa-ling transduction partly.
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This study is to investigate the anti-tumor activities of a novel cyclophosphamide derivate 4, 6-diphenyl cyclophosphamide (9b) in vivo and in vitro, and its possible mechanism of action. The inhibitory effects of 9b on human hepatoma cell line HepG2, human breast carcinoma cell line MCF-7 and human myeloid leukemia cell line K562 were measured by MTT assay in vitro. Cell cycle distribution and apoptotic rate were evaluated by flow cytometry. To evaluate the anti-tumor effect of 9b in vivo, mouse model bearing inoculated H22 tumor was established. The results indicated that 9b could inhibit the proliferation of HepG2, MCF-7 and K562 cells in a dose and time dependent manner. The ICo50 values of 9b were 32.34 micromol.L-1 to HepG2 cells, 87.07 micromol.L-1 to MCF-7 cells and 149.10 micromol.L-1 to K562 cells after incubation for 48 h. The results of flow cytometry indicated that after being treated for 48 h with different concentrations of 9b, the ratios of HepG2, MCF-7 cells at the Go/G1 phase and K562 cells at the G0/Gl phase and G2/M phase increased significantly compared with control group, and the apoptotic rate increased with the increase of the concentration of 9b. 9b could significantly reduce tumor weight of H22 solid tumor mouse model in vivo. To summarize, 9b showed significantly anti-tumor activity in vivo and in vitro, of which the mechanism might be associated with the change of cell cycle distribution and induction of tumor cell apoptosis.
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BACKGROUND:At present, col agen as a material in periodontal tissue engineering has some disadvantages such as poor mechanical strength and rapid degradation speed. Col agen combined with chitosan can improve above-mentioned problems. OBJECTIVE:To evaluate the biocompatibility of a novel chitosan-col agen scaffold in vitro. METHODS:Cytotoxicity of the extract of chitosan-col agen scaffold in different concentrations (100%, 75%, 50%, 25%) was evaluated by 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide assay. Human periodontal ligament cel s at 4-6 passages were cocultured with the chitosan-col agen scaffold. Cel growth on the scaffold was observed. Changes in alkaline phosphatase activity were detected in periodontal ligament cel s before and after coculture. RESULTS AND CONCLUSION:The novel chitosan-col agen scaffold was made up of double layers with one dense layer and another loose layer. The grade of the cytotoxicity of the scaffold was from 0 to 1. Scanning electron microscope and histological observation demonstrated that cel s grew wel on the chitosan-col agen scaffold;the dense layer could prevent cel s to migrate into the scaffold. There were no significant differences in alkaline phosphatase activity in human periodontal ligament cel s before and 24 hours after combined culture (P>0.05). Alkaline phosphatase activity in human periodontal ligament cel s was greatly higher at 48 and 72 hours after combined culture compared with that before culture (P<0.05). Above results indicated that the novel chitosan-col agen scaffold has a good biocompatibility and barrier function, and potential as a scaffold for periodontal tissue engineering.
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Aim To observe the effects of amlodipine on cell cycle,cell cycle-related genes and cyclin expression of human breast carcinoma MCF-7 cells.And to probe effects of amlodipine on cell cycle and its mechanism of human breast carcinoma MCF-7 cells.Methods In vitro growth inhibitory effects of amlodip-ine on human breast carcinoma MCF-7 cells were determined by MTT assay,cell cycle distribution was detected by flow cytometry,the Mrna expression levels of cell cycle-related genes cyclinD1 and p21 were treated by RT-PCR,and the protein expression of cell cycle protein cyclinD1 and p21 were assessed by Western blot.Results With dose and time dependently,amlodipine could inhibit the proliferation of human breast carcinoma MCF-7 cells in vitro.The IC_(50) was 14.439 μmol·L~(-1).When breast cancer cells MCF-7 were treated with 7.22 μmol·L~(-1)(1/2 IC_(50)),14.439 μmol·L~(-1)(IC_(50))and 28.88 μmol·L~(-1)(2IC_(50))amlodipine for 48 h,the ratios in the G_0/G_1 phase were significantly increased as compared with control group(P<0.05).Amlodipine inhibited the expression of Mrna and protein of cyclinD1,while increased the expression of Mrna and protein of p21.Conclusions Amlodipine exhibits obvious anti-tumor activities on human breast carcinoma MCF-7 cells and arrest cell cycle in G_1 phase.The mechanism of G_1 phase arresting may be related to modulating the Mrna and protein expression of cell cycle-related gene cyclinD1 and p21.
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Objective To study the influence of RNA interference Caspase-3 gene on apoptosis of transformed human embryonic kidney 293 cells induced by cadmium in vitro. Methods Transformed human embryonic kidney 293 cell were treated with siRNA for 36 h. The treated cells were incubated with 40 ?mol/L CdCl2 for 12-24 h and the cells viability were measured with methyl thiazolyl tetrazolium(MTT) assay. In addition,the expression of caspase-3 gene in 293 cells was detected by the methods of reverse transcription polymerase chain reaction (RT-PCR) and Western-blot analysis,and the occurrence of apoptosis was determined by flowcytometry with Annexin-V and propidium iodide (PI) double labeling method. Results The results of RT-PCR and Western-blot analysis revealed that in incubated cells with 40 ?mol/L cadmium 12 h,the expression of Caspase-3 mRNA and 20 kDa protein significantly increased when compared with controls(n=4,P
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0.05), the same results were seen in the interferential experiment groups and the positive group. There were no alternating effects between nano red elemental selenium and CCl4. Conclusion In the present paper, nano red elemental selenium does not show an adverse effect on the liver of rats and a protective effect on liver injury induced by CCl4.
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Objective To explore the effects of air pollution on children's nonspecific immune function,and find the sensitive indexes reflecting the earlier damages of human health induced by air pollution.Methods The data on air pollution were provided by Benxi and Shenyang environment protective bureaus. 300 children in grade 1 and grade 6,half for girls and half for boys were selected from area with slight air pollution and area with heavy air pollution in Shenyang and Benxi respectively by cluster sampling method.The contents of SIgA and the activities of bacteriolytic enzyme in saliva of children were measured by radioimmunoassay and agar spread assay respectively.Results The difference of the contents of saliva SIgA was observed in children in grade 1 between area with heavy air pollution(70.60 ?g/ml)and area with slight air pollution(97.77 ?g/ml),P
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Objective To Study the antitumor activity of Zhongjiefeng injection(ZJF)on FC in mice with precancer of stomach and its toxicity.Methods The model mice transplanted with pre cancer of stomach was established an d the effects of ZJF on inhibitory rate,body weigh t,thymus index and spleen index,whi te blood cell(WBC)count and FC cell strain in model mice were observed.Results ZJF had an obvious antitumor effect.The inhibitory rates of ZJF ip 0.2g /k g,1g /kg and 2g /kg were 39.83%,64.41%and 53.39%respectively.ZJF increased the indexes of spleen and thymus,the amount of WBC and body weight.The inhibitory rates of ZJF ip 100mg /mL,50mg /mL,25mg /mL,12.5mg /mL and6.25mg /mL were 65%,63%,57%,55%and44%respectively.Conclusion ZJF exerts an in -vitro and in -vivo antitumor effect for precancer of stomach in mice and increase the indexes of immune organs and amount of WBC.
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Objective To study the effects of inorganic arsenic on the activities of GS and AChE in the central nervous system of the offspring rats. Methods Wistar rats were exposed to arsenitc through drinking water at doses of 10, 50 and 100 mg/L respectively from gestation day 6 until F1 pups 42 days old. The activities of AChE, GS in rat brain regions such as cortex and hippocampus were separately determined in F1 pups 0, 28, 42 days old. Results On the postnatal day 0, there were not any significant changes in AChE and GS activities in arsenic group rats compared with the control rats. An increase of AChE in 100 mg/L arsenic group rats hippocampus was showed on the postnatal day 28.These changes also appeared on the postnatal day 42. Conclusion Consecutive arsenic exposure from embryo to postnatal may induce the activity changes of GS,AChE in the pups brain,which may cause results in the related neurotransmitter concentration changes.
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AIM: To study the effect of ginsenoside Rg 2 on cardiac hemodynamics in dog. METHODS: The parameters of cardiac hemodynamics were determined by using anesthetized open chest dog. RESULTS: In dogs treated with ginsenoside Rg 2 in a dose of 0.5、 1.0、2.0mg?kg -1 respectively, the heart rate (HR) slowed, the diastolic blood pressure (DBP)、 left ventricular systolic pressure (LVSP) and maximum decreasing rate ( dp/dtmax) increased; the cardiac output (CO)、 cardiac index (CI) and stroke index (SI) decreased; The coronary vascular resistance (CVR)、 the renal vascular resistance (RVR) and total periphery resistance (TPR) increased. CONCLUSION: Effect of ginsenoside Rg 2 on cardiac hemodynamics in dogs is similar to strophanthin K(SK), and can support the blood circulation of important organs.
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Objective: To study antitumor activity of Zhongjiefeng Injection (Herba sarcandrae) on mice liver cancer Hep A 22 in vivo, in vitro and its toxic reaction in mice with Hep A 22 tumor Methods: The antitumor activity and toxicity of Zhongjiefeng Injection were determined in the mice with transplantable tumor (mice liver cancer Hep A 22), and the antitumor effect of Zhongjiefeng Injection on Hep A 22 cells in vitro were determined with MTT method. Conclusion: The experiment indicates that Zhongjiefeng Injection shows significant antitumon effect increase the indexes of immune organs and amounts of WBC.