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

Antimony ; blood ; Humans ; Spectrophotometry, Atomic ; methods

Objectives To investigate the effect of leptomeningeal anastomoses (LMA) compensation of anterior cerebral artery (ACA) on the size of cerebral infarction in patients with chronic middle cerebral artery occlusion (CMCAO) and to analyze the correlation between middle cerebral artery (MCA) velocity and cerebral infarction area.Methods From June 2014 to June 2016,35 consecutive patients with CMCAO from the Department of Neurology,Yanbian University Hospital and 74 with CMCAO from the Department of Neurology,Beijing Xuanwu Hospital,Capital Medical University were enrolled retrospectively.All patients were diagnosed as CMCAO on one side and MCA was normal on the other side with transcranial Doppler (TCD) or transcranial color-coded sonography (TCCS) and confirmed by digital subtraction angiography (DSA).They were divided into either a LMA group (n=49) or a non-LMA (NLMA) group (n=60) according to the DSA revealed ACA.TCCS and/or TCD were used to measure and record the peak systolic velocity (PSV) and mean flow velocity (MFV) of the contralateral and ipsilateral MCA,and the ratios of bilateral PSV were calculated.They were divided into 4 grades,including normal brain tissue,cerebral lacunar infarction,small and moderate cerebral infarction,and large cerebral infarction according to the findings of diffusion-weighted imaging (DWI).Mann-Whitney test was used to compare the differences of cerebral infarction areas between the LMA group and the NLMA group,and Spearman rank correlation analysis was used to analyze the correlation between the MCA blood flow parameters of the ipsilateral side and the cerebral infarction area.Results (1) The patients with stroke accounted for 90.0% (n=54) in the NLMA group,and it was significantly higher than 71.4% (n=35) in the LAM group.There was significant difference between the two groups (P<0.05).(2) The severity of cerebral infarction in the NLMA group was significantly higher than that in the LMA group.DWI revealed that the LMA group was mainly lacunar infarction (51.0%,n=25),the NLMA group was mainly small and moderate infarction (45.0%,n=27),the incidence of large infarction (21.7%,n=13) was higher than that in the LMA group (4.1%,n=2).The difference between the two groups was statistically significant (P<0.01).(3) The cerebral infarction area in patients of the NLMA group showed moderately negative correlation with PSV of MCA (r=-0.736,P<0.01),and increased with the increase of contralateral side of PSV/ipsilateral side of PSV,there was a high positive correlation (r=0.849,P<0.01).Conclusion The compensatory function of meningeal branches of the anterior cerebral artery in patients with CMCAO was associated with the severity of cerebral infarction.The decreased MCA blood flow velocity on the ipsilateral side had a significant correlation with cerebral infarction area.

Objective To compare the dosimetry and toxicities between postoperative fixed-field intensity-modulated radiotherapy (FF-IMRT) and image-guided radiation therapy/volumetric modulated arc therapy (IGRT-VMAT) for cervical cancer.Methods A total of seventy patients with stage I b-Ⅱa postoperative cervical cancer who had high risk factors,were divided into FF-IMRT (FF-IMRT group,n =35)and IGRT-VMAT (IGRT-VMAT group,n =35),to compare the difference of target dose and adverse reaction between the two groups.Results In the IGRT-VMAT group,the interfractional setup errors in the x,y,and z axes were (0.25±0.14) cm,(0.26±0.16) cm,and (0.24±0.18) cm,respectively;the intrafractional setup errors in the x,y,and z axes were (0.1±0.09) cm,(0.12±0.09) cm,and (0.11±0.09) cm,respectively;the margins in the x,y,and z axes were 0.75 cm,0.84 cm,and 0.78 cm,respectively.Under the same dosimetric conditions,the IGRT-VMAT group was superior to the FF-IMRT group in terms of conformity index,treatment time,and number of monitor units (P=0.000).The Dmean and volume receiving high-dose irradiation for the bladder,rectum,and small intestine were significantly lower in the IGRT-VMAT group than in the FF-IMRT group (P=0.000).Compared with the FF-IMRT group,the IGRT-VMAT group had a significantly reduced incidence of acute and chronic gastrointestinal,urinary,and hematologic toxicities (P＜ 0.05).Conclusions IGRT-VMAT can correct setup error online,shorten the treatment time,reduce the dose to organs at risk,and alleviate acute and chronic toxicities,and is especially suitable for patients with postoperative small bowel position changes.

Objective To further confirm the Efficacy and safety of tadenan (Pygeum africunum extract) in the treatment of benign prostatic hyperplasia (BPH) in larger population in China. Methods In this open multicenter study,a total of 3 508 patients with symptomatic BPH received oral tadenan of 50 mg twice daily for 8 weeks. Results IPSS,maximum urinary flow and post voiding volume were 19.57? 14.93 ,(13.52?5.36)ml/s and (44.58?30.95)ml four weeks after the treatment of tadenan and were 13.31?11.86,(15.58?5.98)ml/s and (32.64?24.23)ml eight weeks after the treatment,both improved significantly comparing to those before the treatment ( P

0.05).The ultramicrostructure of cells detected by electron microscope showed that GJIC function in transfected group was higher than that in the other two groups.While in migration assay,the numbers of cells in lower chamber passing through the membrane in transfected group,blank control group and negative control group were 112?23,306?49 and 322?91, respectively;with significant differences among 3 groups(P

Objective To investigate the brain protective effect of isoflurane preconditioning on the rat liver against ischemia-reperfusion through determining the content of S-100β protein in peripheral blood in combination with mitochondrial ultrastructure in rat brain.Methods A total of 45 SD rats were randomly divided into three groups,sham group (group S):the only separation of the hepatoduodenal ligament,but did not block the hepatic portal blood supply; ischemia-reperfusion group (group I/R):liver ischemia 60min,reperfusion 120 min; isoflurane preconditioning group (group ISO):60 min before liver I/R,ISO pretreatment for 30 min,elution in the air after 30 min; 24 h after recirculation the forebrain tissues were rapidly removed.The changes of mitochondrial ultrastructure were observed by electron microscopy.The content of S-100β protein in serum was measured before ischemia and reperfusion 120 min through the application of Elisa kit.Results Marked swelling of mitochondria with disrupted cristae and damaged matrix were observed in group I/R,while relative intact mitochondria were seen in sham and ISO groups.The content of S-100β protein in serum was significantly higher in I/R group [(1.52 ±0.26) μg/ml] than in sham [(0.31 ±0.05)μg/ml] and ISO [(0.79 ± 0.21) μg/ml] groups (P ＜0.05).Conclusions The liver ischemia-reperfusion may injure the brain of the rat and isoflurane preconditioning can protect the rat brain from injury.

Objective To comprehend the status and risk factors of overweight and obesity among urban and rural inhabitants of Shenchi county.Methods With stratified cluster sampling,two residents" committees were selected as investigation spots from each town of Longquan,Yijing,Bajiao and Hezhi of Shenchi county.Permanent inhabitants aged 20 to 74 yrs were investigated on their status of overweight and obesity and its realted risk factors.Results In this study,2231 inhabitants were investigated,among which male 871 and female 1 360.The prevalence rate of overweight and obesity were 28.6%(standardized rate was 26.7%) and 5.1% (standardized rate was 4,5%).There was a statistic significance in prevalence rate of overweight between male and female(X~2=4.595, P0.05).It was discovered that the age,the degree of education, the annual income of family,drinking,exercise status,alimentary control status,family history and so on had the relation with BMI, the exercise and diet control status assumed negative association by multiple linear regression.Conclusion There is a high prevalence rate of overweight and obesity among residents in Shenchi county in Shanxi province.We should make the comprehensive intervention measures according to its status and risk factors,and make the prevalence rate decreased.

Adolescent ; Amblyopia ; genetics ; Child, Preschool ; Female ; Finger Joint ; pathology ; Hearing Loss, Conductive ; congenital ; genetics ; Humans ; Male ; Pedigree ; Young Adult

Background The cryptochrom 2 (Cry2)in mammalian retina is a main influential factor of circadian clock.Objective Purpose of this study was to investigate the effect of light exposure rhythm on expression of Cry2 in retina.Methods Thirty clean healthy Sprague Dawley(SD)rats were collected and divided into two groups randomly.The rats of the control group exposed to natural light with the normal rhythm for 30 days,but rats of the experimental group exposed to the artificial light (light: dark =18 hours:6 hours) for 3 months with the light intensity of(533± 16)lx.The histopathological change and ultrastructural alteration of rat retina in both groups were examined under the light microscope and transmission electron microscope at the end of the experiment.Expressions of Cry2 protein and its mRNA were assayed by immunohistochemistry and quantitative PCR(Q-PCR).Results The rat retinal morphology and ultrastructure were clear and order-arranged under the light microscope and transmission electron microscope in the control group.However,atrophy and disorganization of retina were found under the light microscope,and liquefaction and vacuole of outer segments of photoreceptors were observed.The vacuolar degeneration of mitochondria in the inner segments of photoreceptors,cellular nuclear shrinkage,chromatin margination,nuclear notch and destruction were seen in the outer nuclear layer under the transmission electron microscope.Immunohistochemistry showed that the expression of Cry2 protein located in cytoplasm and nuclei membrane of the retinal ganglion cell layer and inner nuclear layer in both normal rats and experimental rats.The scores of Cry2 protein expression were 0.833±0.197 in the experimental group,and 1.700±0.245 in the control group,with a significant difference between them (P=0.009).The quantities of Cry2 mRNA were 0.962 ± 0.125 in the control group and 0.615±0.100 in the experimental group,showing a significant difference between the two groups (P =0.006).Conclusions Long-term light exposure under the 533 lx leads to retinal structural and functional damage probably by down-regulating Cry2 expression in retina.Whether the regulation of Cry2 expression is helpful for stabilizing the biorhythm or not is a worthy question to explore.