Post-marketing evaluation is a process which evaluate the risks and benefits of drug clinical application comprehensively and systematically, scientific and systematic results of post-marketing evaluation not only can provide data support for clinical application of traditional Chinese medicine, but also can be a reliable basis for the supervision department to develop risk control measures. With the increasing demands for treatment and prevention of disease, traditional Chinese medicine has been widely used, and security issues are also exposed. How to find risk signal of traditional Chinese medicine in the early stages, carry out targeted evaluation work and control risk timely have become challenges in the development of traditional Chinese medicine industry.
Drug Evaluation ; methods ; Drugs, Chinese Herbal ; Humans ; Medicine, Chinese Traditional

The adverse reaction monitoring is important in warning the risks of traditional Chinese medicines at an early stage, finding potential quality problems and ensuring the safe clinical medication. In the study, efforts were made to investigate the risk signal mining techniques in line with the characteristics of traditional Chinese medicines, particularly the complexity in component, processing, compatibility, preparation and clinical medication, find early risk signals of traditional Chinese medicines and establish a traditional Chinese medicine safety evaluation system based on adverse reaction risk signals, in order to improve the target studies on traditional Chinese medicine safety, effective and timely control risks and solve the existing frequent safety issue in traditional Chinese medicines.
China ; epidemiology ; Drug Evaluation ; Drug-Related Side Effects and Adverse Reactions ; epidemiology ; etiology ; Drugs, Chinese Herbal ; adverse effects ; therapeutic use ; Humans ; Product Surveillance, Postmarketing

Traditional Chinese medicine Polygoni Multiflori Radix is dried roots of Polygonaceae Polygortum multiflorum Thunb. Its clinical application records were first discovered in literatures of the Tang dynasty. The origins, efficacy, toxicity, processing and taboos of Polygoni Multiflori Radix have been discussed in many ancient herb literatures. In recent years, with the increase in the public awareness in health, Polygoni Multiflori Radix admits preparations have been more widely applied in the treatment and prevention of diseases. However, there have been more and more reports about Polygoni Multiflori Radix induced liver injury, the safety of Polygoni Multiflori Radix has increasingly attracted attention of the society. In this paper, the authors summarized and analyzed the toxicity and medication risk factors of Polygoni Multiflori Radix recorded in ancient herb literatures, and proposed that more attention shall be given to the effect of the planting and processing methods on the components and toxicity of Polygoni Multiflori Radix in safety studies, which provides clues for the further studies.
China ; Drugs, Chinese Herbal ; adverse effects ; history ; History, Ancient ; Humans ; Medicine in Literature ; Medicine, Chinese Traditional ; history ; Polygonum ; adverse effects ; Risk Assessment

The renal toxicity and mutagenicity of aristolochic acid (AA) as well as its carcinogenicity on upper urinary tract transitional epithelial cells have been widely known. Since 2003, drug regulatory departments have successively cancelled the quality standards for AA-containing medicines such as Aristolochiae Radix, Aristolochiae Manshuriensis Caulis and Aristolchiae Fangchi Radix, and adopted measures for strengthening regulation and revising package insert or quality standards for other AA-containing medicines, including Aristolochia Cinnabarina Radix, Aristolochiae Fructus, Aristolochiae Mollissimae Herba, in order to control its safety risk. In recent years, domestic and foreign studies on AA have mainly involved action mechanism and clinical performance of AA toxicity, early-stage diagnosis and treatment method. In this paper, authors gave a brief summary and evaluation on risk factors for using AA-containing medicines, and offered measures and suggestions for preventing and controlling AA toxicity.
Animals ; Aristolochia ; adverse effects ; chemistry ; Aristolochic Acids ; analysis ; therapeutic use ; toxicity ; Drug Therapy ; Drug-Related Side Effects and Adverse Reactions ; epidemiology ; etiology ; Drugs, Chinese Herbal ; analysis ; therapeutic use ; toxicity ; Humans

Background Retinal development continues during the early postnatal period in mammals.Correct arrangement of layers and precise location of various cells in the retina are vital for forming normal visual function during critical period plasticity.Spectral-domain optical coherence tomography(SD-OCT)provides highquality in vivo retinal imaging and the possibility to measure retinal thickness longitudinally. Objective The present study was to investigate the changes of retinal thickness during critical period plasticity in rats. Methods In vivo consecutive scanning of retinal image was performed in 10 SPF Sprague-Dawley rats at postnatal day 14(P14),P18,P21,P24 and P42 with SD-OCT,and retinal histopathological examination was used to detect retinal morphologic changes at the same postnatal ages in 20 matched rats.The whole retinal thickness,the thickness from inner limiting membrane(ILM)to inner plexiform layer(IPL),the thickness of inner nuclear layer(INL)and the thickness from outer nuclear layer(ONL)to retinal pigment epithelium(RPE)were measured using Cirrus HD-OCT system and HMIAS-2000 Imaging System in retinal sections.The measurement parameters by Cirrus HD-OCT and those by hematoxylin-eosin staining were compared.The use of animals followed the Statement of National Institute of Health (USA). Results In vivo high-resolution images of rat retinas with SD-OCT compared well with histology,which enabled quantitative comparison of the SD-OCT and histological data during critical period plasticity in rats.From P14 to P42,the retinal thickness gradually decreased with the increase of rat ages(F=15.425,P=0.000),and so were the thickness from ILM to IPL,the thickness of INL and the thickness from ONL to RPE(F=3.973,P=0.007;F=17.529,P=0.000;F=7.038,P=0.000).The retinal thickness,thickness of INL.thickness from ONL to RPE measured by Cirrus HD-OCT were significantly correlated with those measured by retinal sections among P14,P18,P21,P24 and P42 rats(r=0.794,P=0.000;r=0.784,P=0.000;r=0.681,P=0.000). Conclusion SD-OCT is a demonstratably valuable technology to study the structure of retinas in rats.The retinal thickness is shown to reduce in thickness throughout the development of the retina during critical period plasticity due to the decrease in thickness of INL and the distance from the ONL to RPE,as illustrated by OCT scanning.

Objective:To assess the effect of isokinetic muscle strength training on cognitive function and motor function of patients with Alzheimer's disease (AD).Methods:Forty patients with AD were randomly assigned to trial group and control group.All patients in both groups received conventional treatment,while the patients in the trial group received isokinetic muscle strength training at the same time.After two months,the cognitive function and motor function were assessed.Results:After two months,the trial group showed improvement in cognition CAMCOG whereas the control group declined.Compared to the control group,the trial group presented significant improvement on the functional capacity such as Berg balance,timed-up and go,as well as Functional reach.Conclusion:Isokinetic muscle strength training may be recommended as an augmentation treatment for patients with AD.

Objective:To evaluate the impact of sample pooling strategy on 2019-nCoV RNA detection results.Methods:Ten negative swabs were stored in 6 ml virus transport medium, mixed thoroughly and diluted 1∶2 and 1∶10. Inactivated 2019-nCoV culture medium was added to simulate pooling samples: 10 pooling samples, 5 pooling samples and 1 swab sample. Extraction and amplification were made using three nucleic acid extraction reagents a, b, and c with different extraction methods and systems, as well as five 2019-nCoV detection reagents A-E with various template loading volumes and sensitivities respectively.Results:For the same sample, the Ct values of extracted templates a were 2.10±0.47 and 3.46±0.62 earlier than extracted templates b and c. For samples with identical amplifying, the Ct valves of N and ORF1ab gene of A reagent were 1.16±0.48 and 2.36±0.54 earlier than that of reagent B. Adding nucleic acid of 10 negative swabs to the amplification system lagged the Ct values of reagent A by about 1.36±0.32 Ct, while Ct values of reagent B were not affected. Extracted by regent a, a lag of 1.66±0.39 Ct on average was observed in C, D, and E reagents in detecting pooling samples of ten swabs as compared with one swab sample. When extracting 400 copies/ml pooling samples of ten swabs by reagent a, N gene could be detected by reagents C and E, but not by reagent D.Conclusion:Large amount of extraneous DNA is introduced by sample pooling, which could interfere the effiency of extraction and amplification. Strategies of using extraction reagents with large loading volume and high effiency, together with amplification reagents with large template volume and low limit of detection are helpful for ensuring detection sensitivity of pooling samples, and greatly reducing the risk of false negative results.

Objective To study the sensitivity and specificity of a double monoclonal antibody sandwich enzyme-linked immunosorbent assay (DMcAbS-ELISA)for the detection of F1 antigen of Yersinia pestis (Y.pestis).Methods Viscera (viz.liver and spleen)specimens of infected mice with virulent Y.pestis and negative control mice were detected by bacteriological test,DMcAbS-ELISA and reverse indirect hemagglutination assay (RIHA) for the F1 antigen.Results The 225 control specimens were all negative tested by plague bacteriology testing,DMcAbS-ELISA and RIHA.A total of 308 plague-infected mouse organ specimens were tested,and the positive detection rate was 92.21％ (284/308),90.91％(280/308) and 89.61％ (276/308),respectively,with germiculture,DMcAbS-ELISA and RIHA,and the difference was not statistically significant(x2=5.65,P＞0.05).The coincidence rate of DMcAbS-ELISA and bacterial culture was 97.00％[(274+243)/533],Kappa =0.940;RIHA in line with the rate was 99.25％[(276+253)/533],Kappa =0.985.Authenticity comparison of F1 antigen detection in viscera specimens:sensitivity,specificity,positive predictive value,negative predictive value,adjusted agreement and Youden's index was 96.48％(274/284),97.59％(243/249),97.86％ (274/280),96.05 ％(243/253),96.99％[1/4×(274/280+274/284+243/253+243/249)]and 0.9407,respectively,for DMcAbS-ELISA and 96.13％(273/284),98.80％(246/249),98.91％(273/276),95.72％(246/257),97.39％[1/4×(273/276+273/284+246/257±246/249)]and 0.9492,respectively,for RIHA.The detection sensitivity of DMcAbS-ELISA and RIHA was 2.7×104 cfu/ml and 2.2×105 cfu/ml,for Y.pestis,respectively,and was 10 μg/L for F1 antigen.Conclusions DMcAbS-ELISA assay is a sensitive,specific,simple and fast method for detection of the F1 antigen,and it has a potential application value in rapid diagnosis of plague.

Objective To analyze the influence of different factors and their relating correlation results on platelet transfusion during the bone marrow empty window period on the patients who have undergone allogeneic peripheral blood stem cell transplantation (allo-HSCT) with retrospective analysis of case-control data.Methods Clinical data of 153 cases were collected by the clinical blood management and evaluation information system with discharge diagnosis of allo-HSCT in the hematology department of The First Affiliated Hospital of Nanchang University within a time frame from January 2014 to December 2016.A total of 90 cases were considered valid for retrospective analysis according to the case exclusion criteria.The average transfusion dose for patients with allo-HSCT during the bone marrow empty window period was defined as the threshold value which divided the 90 cases into the observation group of 38 cases receiving more than 6 Units of platelet transfusion and the control group of 52 cases with less than 6Units of platelet transfusion.The amount of platelets transfused during the bone marrow empty window period,clinical indexes include Hb,ANC,Plt,SF before pretreatment,platelet engraftment time and the number of mononuclear cells implanted were compared and analyzed by Logistic regression.Results (1) There was no significant difference between the two groups in gender,age,primary diagnosis,HLA matching,Hb before pretreatment and the number of mononuclear cells implanted (P＞0.05).The ANC(×109/L) (1.24±0.57 vs 3.36±1.33) and Plt(×109/L) (43.55±68.29 vs 126.62±84.73) counts before pretreatment in the observation group were significantly lower than those in the control group(P＜0.05).SF(μg/L) (2351.05 ± 1 587.96 vs 1 000.96± 362.97)before pretreatment and P LT recovery time (d) (16.84± 2.47 vs 12.73 ± 1.65)was significantly higher than that in the control group(P＜0.05).Donor-recipient ABO blood group typing incompatibility (15 vs 10) was significantly higher than the control group (P＜0.05);(2) Single factor Logistic regression analysis showed that ABO blood group matching,clinical indexes include ANC,Plt,SF before pretreatment,PLT recovery time were statistically significant,Only ANC before pretreatment and PLT recovery time had significant effect on the platelet transfusion during bone marrow empty window period in patients with allo-HSCT in multivariate Logistic regression analysis(P＜0.05).Condusion The ANC before pretreatment and PLT recovery time are independent factors for platelet transfusion of the bone marrow empty window period in patients with allo-HSCT.The PLT recovery time is an independent risk factor,which indicates that the longer the duration of PLT implantation,the greater the amount of platelet transfusion will be needed.Besides,the ANC before pretreatment is the independent protective factor,which indicates that the greater the ANC,the smaller the amount of platelet transfusion is required.

Objective To optimize the preparation of nanoparticles (NP) encapsulating antisense oligodeoxynucleotides (ASODN) and investigate the effects on inhibition of C6 glioma cells. Methods ASODN coated in NT were prepared by interfacial polymerization of butyleyanoacrylate (BCA). Inverted microscope was used to observe the viability of C6 cells transfected by free ASODN, ASODN in NP, ASODN-NP (ASODN sticking to NP) and BCA-NP, respectively. Cell cycle of C6 cells was studied by flow cytometry (FCM), and CCK-8 assay was performed to examine the cytotoxicity and proliferation of C6 cells. Results Compared with the control group, all groups, except BCA-NP group, after transfection with NPs appeared cell morphological changes; C6 cells were detached from the matrix, the cell density was reduced and the cell viability was poor; ASODN in NP group was most significant in a time-dependent manner. The cell cycle in ASODN-in-NP group varied obviously compared with the BCA-NP group, and the number of the cells in the GO/GI phase was increased and the cell number in S phase was decreased significantly (P<0.05). The results of CCK-8 assay showed that all groups, but BCA-NP group, produced the inhibition of the cell proliferation to different degrees, and the inhibitory effect was increased with the final concentration increment, especially remarkably in ASODN-in-NP group (P<0.05). Conclusion ASODN in NP can inhibit the proliferation and cause cell cycle changes of C6 cells effectively after transfected with ASODN in NP, exerting significantly growth inhibitory effect on C6 glioma cells.