As a characteristic tumor therapy in China, Chinese medicine (CM) plays an important position in comprehensive treatment of tumor. It's a critical issue of objective realization, analysis and evaluation of CM safety for scientific decision-making in tumor safe medication and it also is a pivotal issue which affects the international communication. The safety evaluation of CM includes three phases: pre-clinical safety evaluation, clinical trials (micro-dose studies and traditional clinical trials) and post-marketing CM safety assessment. The key point of evaluation should be distinguished among different stages and various types of CM (such as classic formulas, Chinese herbal extracts, etc). Emphasis should be given to chronic toxicity when evaluating oral Chinese herbal , microdose studies and quality control must be underlined while injection is evaluated and more attention should be pay to the dose-effect relationship and time-effect relationship when turned to toxic Chinese medicine , and so as for the toxicity grading study. Moreover, we should constantly improve CM safety assessment method in various stages of tumor treatment, such as introducing the concept of syndrome classification theory, bringing in metabonomics and real-world research method which are similar to the CM therapeutic concept. Most importantly, we must keep its own feature of CM theory when we learn the concept of safety evaluation from abroad. Actively exploring the anti-tumor medicine safety evaluation methods and strategies is of great significance for clinical and experimental research, and it can provide supportability platform to CM's international communication.
Animals ; Combined Modality Therapy ; Humans ; Medicine, Chinese Traditional ; adverse effects ; methods ; Neoplasms ; therapy ; Safety

ObjectiveTo investigate the relationship between microalbuminuria (MAU) and short-term outcome in patients with acute ischemic stroke.MethodsThe consecutive patients with acute ischemic stroke admitted to hospital were enrolled prospectively.The first urine specimen was taken on the following morning after admission for detecting urine albumin/creatinine ratio (UACR).UACR 30-300 mg/g was defined as MAU positive.Stroke severity was evaluated with the National Institutes of Health Stroke Scale (NIHSS) at admission and the modified Rankin Scale (mRS) was used to evaluate functional outcome at discharge, and good outcome was defined as mRS score of 0 to 2.ResultsA total of 244 patients with acute ischemic stroke were enrolled, including MAU positive in 53 patients (27.12%), and poor outcome in 67 patients (27.50%).Univariate analysis showed that age, baseline NIHSS score, systolic blood pressure, fasting blood glucose, globulin, D-dimer, white blood cell count, neutrophils, and the proportions of ischemic heart disease in patients of the MAU positive group were significantly higher than those of the MAU negative group (all P<0.05).Multivariate logistic regression analysis showed that MAU (odds ratio [OR] 1.520, 95% confidence interval [CI] 1.151-1.794;P=0.031), baseline NIHSS score (OR 1.570,95% CI 1.357-1.808;P<0.001) were the independent risk factors for short-term poor outcome in patients with acute ischemic stroke.ConclusionsThe incidence of MAU is high in patients with acute ischemic stroke.MAU positive can be used as one of the independent predictors of short-term poor outcome in patients with acute ischemic stroke.

OBJECTIVE:To compare the curative effect of domestic cefoperazone/sulbactam and imported one for lower respiratory infection. METHODS:The curative effects of domestice vs. imported cefoperazone/sulbactam in 201 vs. 198 patients with lower respiratory infection in recent two years in our hospital were analyzed retrospectively. RESULTS:The effective rate was 61.6% for imported product and 51.7% for domestic product. Significant difference was noted between 2 groups statistically(P

Objective To investigate the effect of hyperbaric oxygen therapy on T-lymphocyte subpopulations in rats with acute pancreatitis. Methods 56 rats were randomly divided into three groups the sham group ( n = 8 ),control group( n = 24) and hyperbaric oxygen therapy group( treatment group, n = 24), then the control group and treatment groups were divided into three subgroups of 8 rats each undergoing euthanasia on days 1,3,7 after the acute pancreatitis induction. The CD4+ ,CD8+ subpopulations of T-lymphocytes in peripheral blood were detected respectively at the fist day and each day of the euthanasia. The sham group was used to make sure that the model was successfully induced. After euthanasia the pancrea was examined using electron microscopy. Results In the control group, the CD4+ cells in AP rats was significantly decreased and the ratio of CD4+/CD8+ also decreased. After 7days of HBO therapy,compared with the control group, the CD4+ lymphocytes of peripheral blood in the treatment group markedly increased( P ＜0.01 ). The CD8+ lymphocytes also increased to a certain extent. And the CD4+/CD8+ ratio of peripheral blood was obviously increased(P ＜0. 01 ). Also more severe pathological changes appeared in the untreated group than in the treatment group. Conclusion Hyperbaric oxygen therapy could improve the oxygen supply in acute panereatitis, regulate T cell immune function.

Branchio-Oto-Renal Syndrome ; Child ; Humans ; Male

Objective:To explore the levels of serum adiponectin,insulin growth factor Ⅰ (IGF-Ⅰ) and prealbumin in preterm infants,and analyze their correlation with preterm EUGR infant.Methods:321 cases of preterm infants who were born in our hospital and transferred to neonatal department in 24 hours from January,2014 to January,2016 were enrolled in the present study.According to the weight at discharge,they were divided into the EUGR group and the non EUGR group,the growth and development as well as the levels of serum adiponectin,IGF-Ⅰ and PA in the two groups were compared.Results:The occurrence rate of EUGR was 55.76％ (179/321) in the 321 cases ofpreterm infants;the weight of EUGR group was significantly lower than that of the non EUGR group at 42 th days and three months after birth(p＜0.05).The SDS of both groups were all negative,and that of EUGR group was significantly lower than non EUGR group (p＜0.05).The levels of serum adiponectin,IGF-Ⅰ and PA of both groups were significantly lower than the control group at seventh days of birth,and the PA level of EUGR group was significantly lower than non EUGR group (p＜0.05).There was no significant difference in the serum adiponectin and PA levels between 7 days and 14 days in EUGR group (P ＞ 0.05),however,the serum adiponectin and PA levels in the non EUGR group was obviously increased and significantly higher than that of the EUGR group (p ＜ 0.05).The level of IGF-Ⅰ in both groups keep unchanged during two weeks (P＞0.05).Conclusion:The lower levels of serum adiponectin,IGF-Ⅰ and PA were closely related to the EUGR of preterm infants,which could be used as biochemical indexes to early diagnosis of EUGR.

Fluorogenic quantitative polymerase chain reaction(FQ-PCR) is an emerging technique with high specificity,susceptibility,automatism and has been widely used for the detection and quantification of microorganism,some genetic diseases and cancer.The design and establishment of standard FQ-PCR laboratory are required not only by gene expansion and diagnosis but also by biosafty and veracity.The aim of the paper is to introduce the structural characteristics,instruments requirement and comfort parameters of FQ-PCR laboratory.

Objective　To observe the effects of Ang-Ⅱ on expressions of c-fos mRNA and pro-α1［Ⅰ］mRNA in fibroblasts (FBC) of rat embryo in the course of collagen synthesis.Methods　The change of free Ca2+(［Ca2+］i) was tested in fluorometry and the expressions of c-fos mRNA and pro-α1［Ⅰ］mRNA were tested by RT-PCR method in incubated FBC.Results　The level of［Ca2+］i in FBC and the expressions of c-fos mRNA and pro-α1［Ⅰ］mRNA were enhanced with the increase of Ang-Ⅱ concentration(10-8～10-5and 10-7～10-6mol/L).Conclusions　The expressions of c-fos mRNA and pro-α1［Ⅰ］mRNA were induced by Ang-Ⅱ activating signal system in FBC.

Objective To analyze the incidence of invasive fungal infection and the risk factor in primary acute leukemia patients.Methods Retrospectively analysis of clinical data from Jan 2007 to Jun 2008 about 80 newly diagnosed patients with acute leukemia primary treated in Peking University People's hospital.Results The incidence of invasive fungal infection is 13.8%,elderly patients、higer WBC counts and longer antibiotics treatment are the risk factor for the fungal infection.Conclusion There are high incidence of invasive fungal infection in induction therapy for primary acute leukemia,the prophylaxis therapy should be consider in high risk patients.

OBJECTIVETo investigate the effect of component I from agkistrodon acutus venomon (AAVC-I) the migration of human umbilical vein endothelial cells (HUVECs), and to elucidate the possible anti-angiogenic mechanism of AAVC-I.

METHODSThe effect of AAVC-I on the migration of HUVECs which was cultivated in vitro and treated with AAVC-1 at four concentrations: 0, 20, 40, 80 microg/ml, was observed by methods of scratch wound-healing and Transwell assay. The expression level of mRNA and protein of P-selectin and intercellular cell adhension molecule-I (ICAM-1) were examined by RT-PCR and Western blot assay.

RESULTSCompared with the blank group, the migration ability of HUVECs in each AAVE-I treated group was reduced in a dose-dependent manner, and the expression level of the mRNA and protein of P-selectin and ICAM-1 were decreased.

CONCLUSIONAAVC-I inhibits the migration of endothelial cell, which is acted by down-regulation of the expression content of mRNA and protein of P-selectin and ICAM-1.

Cell Movement ; drug effects ; Cells, Cultured ; Crotalid Venoms ; pharmacology ; Down-Regulation ; Human Umbilical Vein Endothelial Cells ; drug effects ; Humans ; Intercellular Adhesion Molecule-1 ; metabolism ; P-Selectin ; metabolism ; RNA, Messenger