Risk monitoring of new Chinese patent anti-hepatoma drugs is tracking recognized risks and residual risks, identifying emerging risk and ensure the implementation of the plan, estimating the process of reducing effectiveness. The paper is mainly through understanding the status of Chinese patent anti-hepatoma drugs, the content, characteristic and analysis method of dynamic risk monitoring, and then select the risk control indicators, collect risk information. Finally, puts forward the thought of anti-hepatoma drugs listed evaluation in our country, and try to establish the model of dynamic risk management of anti-hepatoma drugs.
Antineoplastic Agents, Phytogenic ; adverse effects ; economics ; therapeutic use ; Carcinoma, Hepatocellular ; drug therapy ; Drug Discovery ; economics ; legislation & jurisprudence ; organization & administration ; Drug and Narcotic Control ; economics ; legislation & jurisprudence ; organization & administration ; Drugs, Chinese Herbal ; adverse effects ; economics ; therapeutic use ; Humans ; Liver Neoplasms ; drug therapy ; Product Surveillance, Postmarketing

Objective To evaluate the value of ultrasound elastography score and strain ratio index in the differential diagnosis of thyroid solid nodules. Methods Eighty-six thyroid solid nodules of 69 patients were divided into 2 groups based on their pathologic results: benign nodules group and malignant nodules group.Compared with pathological results, each thyroid solid nodules' elastographic scores and strain ratio index were respectively analyzed. The sensitivity, specificity and accuracy of elasticity score and strain ratio index were calctlated.The receiver operator characteristic (ROC) curves were drawn according to the results, to choose the best cut-off value.Results There were 67 nodules in benign nodules group and 19 nodules in malignant nodules group. The diameter of benign nodules was (2.05 ± 0.21)cm, malignant nodules was (1.62 ± 0.12)cm. There were no significant differences in the elasticity score and strain ratio index between benign and malignant nodules(t= - 1.736, P ＞ 0.05). Malignant lesions had a higher score and strain ratio index(median 3, 3.97, respectively) than benign ones(median 2, 1.66,respectively, Z = - 5.290, - 5.450, all P ＜ 0.05). If the cut-off value of the elastographic scores was equal or more than 3, the sensitivity, specificity and accuracy were 84.2%(16/19) ,86.6%(58/67) and 86.0%(74/86), respectively,with an area under ROC curve of 0.854. If the cut-off value of the strain ratio index was equal or more than 2.50,the sensitivity, specificity and accuracy were 89.4%(17/19),86.6%(58/67) and 87.2%(75/86), respectively, with an area under ROC curve of 0.911. Conclusion Elasticity score and strain ratio index are helpful in differentiating benign and malignant lesions of thyroid with high clinical value.

Traditional Chinese ancient prescriptions have been used for treatment of liver cancer for a long history and the scientific and rational compatibility is a great wealth for modern research and development (R&D) of new drugs. The research and development of new drugs are often accompanied with a large investment, a long cycle and a high risk, especially for the anti-tumor drugs R&D which are facing more risks and lower successful rate. In this research, the regularity of compatibility of drugs was analyzed from 124 anti-hepatoma ancient prescriptions by computer program. The results can offer help to the R&D of anti-hepatoma new drugs and reduce the risk of drug screening. In addition, we surveyed 22 companies in this field from six provinces such as Beijing, Shanghai, Tianjin and so on and obtained 240 risk assessment questionaires. Then we used qualitative analysis method to interpret the greatest impacts for the risks in the process of R&D, production and sales of anti-hepatoma new drugs. The study provides a basis for anti-liver cancer drugs R&D researchers, who can take effective measures to reduce the R&D risks and improve successful rate.
Carcinoma, Hepatocellular ; drug therapy ; history ; China ; Drug Discovery ; history ; Drug Incompatibility ; Drug Prescriptions ; history ; Drugs, Chinese Herbal ; history ; therapeutic use ; History, Ancient ; Humans ; Liver Neoplasms ; drug therapy ; history ; Research ; history

Humans ; Siblings ; Forensic Medicine ; Forensic Genetics

OBJECTIVETo investigate the risk factors of lung cancer in Tianjin and to provide evidence for further monitor there of.

METHODSA case-control study involving interviews with 193 new cases and 259 controls aged 30 - 76 years was carried out. Structured questionnaires were used to collect information on general condition, living environment, living style, disease and family history, etc. Logistic regression model univariate and multivariate analysis were used to pick out the significant lung cancer risk factors.

RESULTSBy monovariate analysis, risk factors such as smoking, passive smoking, drinking, history of malignancy in family and occupation were found. By multivariate analysis, smoking, passive smoking, higher body mass index (BMI) and average income and living space per capita ten years earlier were ascertained, their operations research (OR) values were 3.302, 1.193, 1.003, 1.067 and 0.913.

CONCLUSIONSmoking and passive smoking are independent risk factors of lung cancer. Monthly income per person and living space per person 10 years earlier are associated with elevated risk of lung cancer. Higher body mass index has protective effects on lung cancer risk.

Adult ; Aged ; Humans ; Logistic Models ; Lung Neoplasms ; etiology ; genetics ; Middle Aged ; Occupations ; Risk Factors ; Smoking ; adverse effects

Objective The aim of this study was to investigate the effect of TSP-1 gene on angiogenesis in human osteosar-coma and its mechanism of action. Methods MG-63 cells were transfected with constructing pBPLV-shRNA-TSP-1 vector and pBPLV-TSP-1 expression vector. Cell viability was measured by CCK8,and its invasive ability was measured by Transwell assay. The expression of CD36 in intracells was detected by immunofluorescence. The expression levels of TSP-1,CD36,p38MAPK,VEGF, VEGFR-1,EGF and PDGF were detected in MG-63 cells by qRT-PCR and Western blot. Results The cell viability and inva-sion ability were significantly increased after transfected pBPLV-TSP-1 vector compared with the empty vector group(P<0. 05), and significantly decreased after transfected pBPLV-shRNA-TSP-1 vector( P<0. 05). The expression of TSP-1,EGF,P38, PDGF,VEGF and VEGFR -1 at mRNA and protein levels was significantly increased after transfection pBPLV -TSP -1 ( P <0. 05),and significantly decreased after transfection pBPLV-shRNA-TSP-1 vector(P<0. 05). Conclusion TSP-1 gene can promote the proliferation and invasion of MG-63 cells,and promote the formation of human osteosarcoma,indicating its mechanism related to the increase of growth factors EGF,VEGF,PDGF and activation of P38-MAPK pathway.

In the present investigation, antagonistic action of cholecystokinin octapeptide (CCK-8)against morphine on the electrical and contractile activity of rat jejunum in vitro was studied. The results showed that the potentiation of acetylcholine (ACh) on both the burst of spike and the contractility were inhibited by morphine, which could be completely antagonized by CCK-8. The CCK-8 effect, again, could be suppressed by CCK-A receptor antagonist devazepide ( 10 nmol/L), but partially by CCK-B receptor antagonist L-365,260 at 10 nmol/L or completely at concentration of 30 nmol/L. The above results demonstrated that the antagonism of CCK-8 on morphine was mediated by both CCK-A and CCK-B receptors.

Objective To study the tolerability and safety of single and multiple doses of Picika oral solution in healthy volunteers.Methods A single center, randomized, single -blind, placebo -controlled, dose -escalation study was designed.50 patients were given single dose, and 10 cases were given multiple doses.All of them had half male and fe-male.Single -dose group: 20 mL(4 subjects), 40 mL(6 subjects), 60 mL(10 subjects; 2 using placebo), 90 mL(10 subjects; 2 using place-bo), 120 mL (10 subjects ; 2 using placebo), 160 mL (10 subjects; 2 using placebo); multiple doses group: 10 subjects(2 using placebo), 40 mL? times-1 , tid, continuous medication for 10 days.Results Of the sixty healthy subjects enrolled , 58 finally completed the trial, and two shed.One case (female) of adverse event in single -dose 160 mL group was reported: her ctivated partial thromboplastin time (APTT) was ab-normal with clinical significance.It may not be associated with the medi-cation.In multiple doses group, one case of abdominal pain (female) was reported, may not be associated with the medication.Conclusion Single and multiple doses of Picika oral solution are safe and well tolera -ted in healthy subjects.

Objective To investigate the prognosis of patients with hepatitis B virus(HBV)-related intrahepatic cholangiocarcinoma(ICC)whose HBV DNA was negative before surgical.Methods A retrospective analysis was conducted on the clinical data of 97 ICC patients who underwent surgery resection at the Fifth Medical Center of Chinese PLA General Hospital between October 2010 and January 2017.All patients were divided into HBV-related ICC(HBV-ICC)group(n=62)and non-HBV-related ICC(Con-ICC)group(n=35).HBV-ICC group included 34 patients with HBV core antigen positive(HBcAb+)and HBV surface antigen positive(HBsAg+),and 28 patients with HBcAb positive and HBsAg negative.Kaplan-Meier analysis was used to plot survival curves and compare the overall survival(OS)and postoperative recurrence-free survival(RFS)among patients in Con-ICC,ICC patients with HBsAg+/HBcAb+,and ICC patients with HBsAg-/HBcAb+.Univariate and multivariate Cox proportional hazard models were used to analyze independent influencing factor for OS,RFS and early postoperative recurrence among gender,age,pathogenic factor,liver cirrhosis,Child-Pugh grade,carbohydrate antigen 19-9(CA199),alpha-fetoprotein(AFP),glutamine transferase(GGT),alkaline phosphatase(ALP),total bilirubin(TBil),direct bilirubin(DBil),American Joint Committee on Cancer(AJCC)stage,tumor size,tumor number,tumor differentiation,microvascular invasion,lymph node metastasis,hepatectomy procedure,cholecystectomy,and follow-up treatment.Results Of the 97 patients,the median age was 56 years,and 79(81.4%)of them were male.The median follow-up time was 92.2 months.Eighty-eight(90.7%)patients presented with tumor recurrence and 73(75.3%)died.In multivariate analyses,HBV-ICC and CA199>37 kU/L were independent predictors of OS(HR=0.45,95%CI 0.26-0.77,P=0.003;HR=2.10,95%CI 1.24-3.57,P=0.006),RFS(HR=0.43,95%CI 0.27-0.68,P<0.001;HR=1.78,95%CI 1.12-2.81,P=0.014),and postoperative early recurrence(HR=0.42,95%CI 0.26-0.70,P=0.001;HR=2.02,95%CI 1.20-3.39,P=0.008).AJCC stage Ⅲ was an independent risk factor for postoperative RFS(HR=1.81,95%CI 1.04-3.14,P=0.037).Multiple tumor lesions was an independent risk factor for postoperative RFS and early recurrence(HR=1.73,95%CI 1.07-2.77,P=0.024;HR=1.90,95%CI 1.12-3.24,P=0.017).There was no statistically significant difference in OS,RFS,and early recurrence between HBV-ICC patients with HBsAg-/HBcAb+and Con-ICC patients(P<0.05),whereas HBsAg+/HBcAb+was a significant factor affecting postoperative OS(HR=0.32,95%CI 0.16-0.62,P=0.001),RFS(HR=0.32,95%CI 0.18-0.55,P<0.001),and early recurrence(HR=0.29,95%CI 0.15-0.54,P<0.001)in ICC patients.Conclusions The prognosis of HBV-ICC patients with preoperative HBV-DNA-is better than that of Con-ICC patients.The prognosis of HBV-ICC patients with HBcAb+/HBsAg-is worse than that of HBV-ICC patients with HBcAb+/HBsAg+,but similar to Con-ICC patients.Therefore,the postoperative stratified management of HBV-ICC patients should be emphasized.

Objective: To explore the clinical effects of pulsed dye laser (PDL) dynamically combined with triamcinolone acetonide (TAC) in the treatment of keloids. Methods: A retrospectively observational study was conducted. From April 2015 to October 2020, 34 keloid patients (46 keloids) who met the inclusion criteria were admitted to Huaihe Hospital of Henan University. The patients were divided into TAC group and dynamic treatment group according to their treatment methods. There were 18 patients (26 keloids) in TAC group, including 8 males and 10 females, aged (30±12) years, who were treated with TAC injection alone. There were 16 patients (20 keloids) in dynamic treatment group, including 6 males and 10 females, aged (26±11) years, who were treated with TAC injection, PDL, or PDL combined with TAC injection according to the Vancouver scar scale (VSS) score before each treatment. Before the first treatment (hereinafter referred to as before treatment) and 12 months after the first treatment (hereinafter referred to as after treatment), the keloids were assessed by VSS, patient and observer scar assessment scale (POSAS), and the effect of keloids on the quality of life of patients was evaluated with dermatology life quality index (DLQI) scale. Twelve months after treatment, the curative effect of keloid was evaluated according to the VSS score and the effective rate was calculated. The first effective time and the cumulative times of TAC injection at the first effective time, the number of follow-up and the occurrence of adverse reactions of keloids within 12 months after treatment were recorded, and the incidence of adverse reactions was calculated. Data were statistically analyzed with paired sample t test, independent sample t test, Wilcoxon rank-sum test, Mann-Whitney U test, chi-square test, and Fisher's exact probability test. Results: The total VSS scores of patients' keloids in TAC group and dynamic treatment group 12 months after treatment were significantly lower than those before treatment (with t values of 7.53 and 8.09, respectively, P<0.01), and the total scores of pigmentation and vascularity in VSS and POSAS, the total POSAS score, and the DLQI scale score were significantly lower than those before treatment (with Z values of -3.71, -4.04, -4.21, -4.11, -3.76, -3.73, -3.92, and -3.93, respectively, P<0.01). The total scores of pigmentation and vascularity in VSS and POSAS of patients' keloids in dynamic treatment group 12 months after treatment were significantly lower than those in TAC group (with Z values of -2.03 and -2.12, respectively, P<0.05). Twelve months after treatment, the effective rate of patients' keloids in dynamic treatment group was significantly higher than that in TAC group (χ²=3.88, P<0.05). The first effective time of patients' keloids in dynamic treatment group was 5.5 (2.0, 6.0) months, which was significantly shorter than 6.0 (2.3, 10.3) months in TAC group (χ²=4.02, P<0.05). The cumulative times of TAC injection at the first effective time of patients' keloids in dynamic treatment group was 3.2±1.7, which was significantly less than 4.2±1.8 in TAC group (t=2.09, P<0.05). The number of follow-up of patients' keloids within 12 months after treatment in dynamic treatment group was significantly more than that in TAC group (t=-2.94, P<0.01), and the total incidence of adverse reactions was lower than that in TAC group but without statistically significant difference (P>0.05). Conclusions: Compared with TAC injection alone, PDL dynamically combined with TAC in the treatment of keloid can shorten the effective time, reduce the number of TAC injection, and improve the patient's compliance and clinical efficacy.
Female ; Humans ; Keloid/pathology* ; Lasers, Dye/therapeutic use* ; Male ; Quality of Life ; Retrospective Studies ; Treatment Outcome ; Triamcinolone Acetonide/therapeutic use*