New registry classifications of chemical drugs redefined the concepts of new drugs and generic drugs. New drugs emphasize the international innovation including innovate new drugs and modified new drugs. Modified new drugs are improvement of drugs already on the market to achieve superior efficacy. With the advantages of high success rate,high return,low risk and long life cycle,modified new drugs have become the mainstream of new drugs research and development in the world. Modified new drugs R&D in China should be based on clinical demand and focused on the differentiation research in order to obtain new preparations with signif-icant clinical advantages to better serve the clinical practise. This paper states the concept and characteristics of modified new drugs in China,makes case analysis and shares the development history of blockbuster modified new drugs in the world,clarifies the opportuni-ties and challenges and provides ideas for the future development of modified new drugs in China.

Objective: To review the clinical effect of early enteral nutrition in patients with carcinoma of esophagus after operation.Methods: Nutrient canal was indwelt through Fresubin(TP) was given through the nasal-intestinal tube in 120 cases with carcinoma of esophagus after operation.Results: The complications such as anastomotic leakage,lung infection and incisional infection in the patients receiving early enteral nutrition were much less than those in control group.No death occurred.The time for bowel function recovery was much shorter.Conclusion: Early enteral nutrition can promote the recovery of gastrointestinal function,improve the nutrition,decrease the occurrence of complications and raise the successful rate of operation in operative patients with esophagus carcinoma.

In this paper, we propose an image-based key frame gating method to reduce motion artifacts in intravascular ultrasound (IVUS) longitudinal cuts. The artifacts are mainly caused by the periodic relative displacement between blood vessels and the IVUS catheter due to cardiac motion. The method is achieved in four steps as following. Firstly, we convert IVUS image sequences to polar coordinates to cut down the amount of calculation. Secondly, we extracted a one-dimensional signal cluster reflecting cardiac motion by spectral analysis and filtering techniques. Thirdly, we designed a Butterworth band-pass filter for filtering the one-dimensional signal clusters. Fourthly, we retrieved the extremes of the filtered signal clusters to seek key frames to compose key-frames gated sequences. Experimental results showed that our algorithm was fast and the average frame processing time was 17ms. Observing the longitudinal viewpictures, we found that comparing to the original ones, the gated sequences had similar trend, less saw tooth shape, and good continuity. We selected 12 groups of clinical IVUS sequences [images (876 +/- 65 frames), coronary segments length (14.61 +/- 1.08 mm)] to calculate vessel volume, lumen volume, mean plaque burden of the original and gated sequences. Statistical results showed that, on one hand, both vessel volume and lumen volume measured of the gated sequences were significantly smaller than those of the original ones, and there was no significant difference on mean plaque burden between original and gated sequences, which met the need of the clinical diagnosis and treatment. On the other hand, variances of vessel area and lumen area of the gated sequences were significantly smaller than those of the original sequences, indicating that the gated sequences would be more stable than the original ones.
Algorithms ; Artifacts ; Heart ; Humans ; Motion ; Ultrasonography, Interventional

Ursolic acid, a pentacyclic triterpene compound, naturally occurs in a large variety of plants, has at-tracted considerable interest owing to its significant biological activities. In recent years, more and more scientists have been working on the structural modification at the C-3 position , C_(12)-C_(13) double bond or C-28 position of ur-solic acid in order to improve their biological activities. Herein a brief introduction of the recent progresses on the chemical structural modification and the structure-activity relationship of ursolic acid and its derivatives are re-viewed.

Objective:To study the clinical efficacy of acupuncture for ischemic stroke and its effect on ET-1 levels in IS cases.Method:The 63 cases were randomized into a treatment group (31 cases),receiving acupuncture and routine method,and control group (32 cases),receiving routine method alone.Seven days constitute a course of treatment,a 2-day interval between two courses.The clinical efficacy and ET-1 level in two groups were compared after four weeks.Result:The total effective rate in the treatment group and control group were 96.8% and 75% respectively,with a statistical significance (P＜0.05);the ET-1 level in blood plasma also with a statistical significance after the treatment (P＜0.05);the pre-treatment and post-treatment ET-1 level in the treatment group showed a statistical significance (P＜0.01),whereas the control group didn't.Conclusion:Acupuncture is effective for ischemic stroke and can lower the ET-1 level in ischemic stroke cases.

Objective The survival and prognosis factors of thoracic esophageal squamous cell carcinoma patients after radical resection was investigated.Methods 1923 patients of thoracic esophageal squamous cell carcinoma after radical resection were included in our study from January 1th 2000 to January 1th 2010 in Zhejiang Cancer Hospital,1 670 male and 253 female.the age in the majority with 40 to 59 years old(1 076/1 923,56.0％).Eighteen prognosis factors were collected.A multivariate analysis of these selected variables was performed using Cox proportional model and prognosis index.We used life table for accumulated survival rate.Results The accumulated survival rate for all patients were 82％,48％ and 35％ in 1 year,3 years and 5 years,respectively.Median survival time was 35.42 months.The significant prognosis factors included body mass index,length of tumor,depth of invasion,differentiation degree,lymph node metastatic degree and region,complication of surgery.Conclusion The prognosis of thoracic esophageal squamous cell carcinoma was affected by multi-factors and prognosis index can predict survival condition.

Objective To evaluate the antitumor effect of oncolytic adenovirus expressing human IL-18 gene on malignant melanoma implanted in nude mice.Methods BALB/c nude mice were subcutaneously inoculated with A375 cells to establish a model of malignant melanoma.When the volume of implanted tumor reached 100-150 mm3,murine models were randomly divided into three groups to receive a 3-day intratumoral injection of IL-18 gene-expressing human oncolytic adenovirus named ZD55-IL-18,IL-18 gene-expressing adenovirus named Ad-IL-18,phosphate buffer saline(PBS),respectively.The tumor size was measured at an interval of 4 days for 9 weeks.Hematoxylin and eosin (HE)staining was performed to observe the morphological changes of tumor cells.The protein expression of IL-18 and E1A.microvessel density in tumor tissue,and apoptosis of tumor xenografts were detected by immuno fluorescence assay,immunohistochemistry and in situ end labeling technique (TUNEL).respectively.Results The treatment with ZD55-IL-18 significantly inhibited the growth of tumor.Forty-four days after the treatment,the mean tumor volume was 1039.378±29.67 mm3 in ZD55-IL-18-treated mice.significantly smaller than that in Ad-IL-18 treated mice(2900.46±62.65 mm3)and PBS-treated mice(3980.24±63.78 mm3).HE staining showed that the nuclei of tumor cells were heavily stained with few nucleoli in ZD55-IL-18-treated mice.Increased positivity rate of IL-18 was noticed in ZD55-IL-18-treated mice vs.AD55-IL-18-treated mice(83.4%±3.2%vs 24.4%±2.1%.P＜0.01).Moreover,immunofluorescence assay revealed the presence of E1A protein in tumor tissue.A decrease was found in the microvessel density in ZD55-IL-18-treated mice compared with the PBS-treated mice(P＜0.01).The apoptosis rate in tumor cells from high to low was 86.28%±3.25%in ZD55-IL-18-treated mice,43.67%±3.46%in Ad-IL-18-treated mice,and 10.73%±2.48%in PBS-treated mice;there was a significant difference between the three groups(all P＜0.05).Conclusion The oncolytic adenovirus expressing human IL-18 gene,ZD55-IL-18,has a significant inhibitory effect on the growth and metastasis of malignant melanoma implanted in nude mice.

BACKGROUND: Both MRI and transcranial Doppler can be used for ultra-early assessment of acute cerebral infarction (ACI), the former is considered as a reliable diagnostic means mainly for the morphological changes of ACI, however the latter is often used before obvious morphological changes appeared, but their combined diagnostic value is still uncertain. OBJECrIVE: To investigate the value of combined MRI and transcranial Doppler in ultra-early assessment of highly suspected ACI.DESIGN: Case analysis and double-blind design.SETTING: MRI Department of Daqing Oil-field General Hospital and Department of Clinical Epidemiology of West China School, and Medical-Economic Department of Public Health College, Sichuan University.PARTICIPANTS: From May 2000 to July 2001, totally 225 highly suspected ACI patients with stoke-like onset, 121 males and 104 females,aged of 33-86 years old with the means of (62±12), within 12 hours after onset, informed of the experiment, were selected from Daqing Oil-field General Hospital.METHODS: All cases subjected to transcranial Dopller examination and following MRI examination with interval of no more than 1 hour, then received follow-up MRI examination at 15 days later (as golden diagnostic standards for CI). MRI was performed to detect the position, morphology,size and signal of pathological changes. Transcranial Doppler was used to determine the blood flow velocity, peak value of systolic and diastolic stage, frequency spectrum and sound spectrum of blood flow of bilateral cerebral anterior, middle and posterior arteries, internal carotid artery and basal vertebral artery.MAIN OUTCOME MEASURES: The sensitivity, specificity and accuracy in the diagnosis of ACI with MRI, transcranial Doppler and the combination of MRI and transcranial Doppler.RESULTS: Totally 225 cases were selected, and 5 excluded for not accordant to the inclusion standards, finally 220 statistical analyzed. The diagnostic sensitivity of MRI was 79.3%,. specificity of 98.4% and accuracy of 90.5%, comparing to corresponding 80.4%, 81.3% and 80.9% of transcranial Doppler, and 96.7%, 80.5%, 87.3% of the combination of MRI and transcranial Doppler.CONCLUSION: The combination of MRI and transcranial Doppler can be used to make rapid and accurate assessment of ACI due to higher sensitivity and specificity.

Objective To study the repeatability and consistency of normal female pelvic floor structure using transperineal real‐time three‐dimensional ultrasound .Methods Forty‐two cases of normal adult female were evaluated by two different experience operator ,using the real‐time three‐dimensional ultrasound diagnostic apparatus .The bladder neck movement degrees and the levator hiatus area were observed after Valsalva condition .Differences between the groups were compared .Intraclass correlation coefficient (ICC) ,the coefficient of variation (CV) and Bland‐Altman analysis of consistency were evaluated . Results The bladder neck movement degrees and the levator hiatus area measured by the experienced operator (operator 1) and less experienced operator(operator 2) were (18 4.8 ± 5 8.4)cm and (17 7.9 ± 5 4.8) cm ,(17 5.3 ± 3 9.5)cm2 and (17 3.1 ± 4 3.2)cm2 ,respectively .There was no significant difference between the two operators ( P > 0 0.5) .The intra‐ICC were 0 8.9 and 0 9.0 ,CV were 7 2.6% and 3 0.3% .Experienced operator repeatability (ICC= 0 9.9 ,0 9.4) was slightly higher than the less experienced researchers (ICC 0 9.2 ,0 8.1) .The analysis results of Bland‐Altman image showed good consistency between two different operators .Conclusions The current study proves real‐time three‐dimensional ultrasound is a reproducible method for female pelvic floor structure assessment ,and the reproducibility is very well .The detection performance of experienced operator slightly better than the one with less experience ,strengthen the training of junior doctors may further improve the accuracy of measurement .

Objective To investigate the accuracy of CTVision image-guided stereotactic body radiation therapy (SBRT) for non-small cell lung cancer (NSCLC).Methods 10 lung SBRT patients were imaged with CTVision before and after irradiation for acquiring and analyzing the three-dimensional set-up error data sets in our department from October 2010 to May 2012.Gross tumor volumes (GTVs) were contoured on pre-and post-SBRT CT sets and combined for generating internal gross tumor volumes (IGTVs).Planning target volume (PTV) margin was calculated,and IGTVs and PTVs were compared for off-line verification of accuracy of SBRT.A paired t-test statistical analysis was conducted with the datasets using SPSS 17.0.Results 80 CT image sets were totally obtained.Setup errors was significant difference before and after radiotherapy in the left-right,superior-inferior and anterior-posterior directions,that were (-0.10±1.30) mmand (-0.15±1.31) mm (P=0.720),(0.18±1.32) mm and (0.18±1.43) mm (P =1.000) and (-0.08 ± 1.19) mm and (-0.13 ± 1.18) mm (P =0.750),respectively.IGTVs of ten patients were smaller than corresponding PTVs (13.53 cm3 and 37.84 cm3,P =0.000).Conclusion Accuracy and safety of SBRT could be verified by imaging with CTVision before and after delivery for non-small cell lung cancer.