Objective:To improve the quality standard for Kangshiming mixtures. Methods:The identification of Angelicae Sinen-sis Radix, Astragali Radix and Phellodendri Chinensis Cortex was carried out by TLC. The contents of puerarin and paeoniflorin in the preparations were determined by HPLC. Results:The spots displayed in TLC were clear without interference from the negative control. The linear range for puerarin was 1. 64-49. 20μg·ml-1(r=0. 999 9) and 4. 22-63. 30μg·ml-1(r=0. 999 6) for paeoniflorin. The average recovery was 99. 63%(RSD=2. 14%,n=9) and 99. 05%(RSD=2. 70%,n=9) for puerarin and paeoniflorin, respectively. Conclusion:The method is accurate, reliable and specific, and can be used in the quality control of Kangshiming mixtures.

Four impurities were isolated from raw material of clindamycin phosphate (CP), and their structures have been determined. LC-MS was used to determine the molecular weights of the impurities in the raw material of CP. Reversed-phase preparative HPLC was used to prepare them, and their chemical structures were identified by HR-MS and NMR. The four unknown impurities were determined as clindamycin-B-phosphate (1), clindamycin-2,4-diphosphate (2), 3',6'-dehydro clindamycin phosphate (3), epi-clindamycin phosphate (4). Impurity 1 has been included in BP and EP, while 2, 3 and 4 have not. The impurities 2, 3, 4 are first separated from raw material of CP.

OBJECTIVETo investigate the changes of the cardiac hemodynamics after acute high altitude exposure in healthy young males and the relationship with acute mountain sickness(AMS).

METHODSLeft ventricular function and oxyhemoglobin saturation (SaO2), heart rate (HR), blood pressure (BP) were measured in 218 healthy young males before and after high altitude exposure within 24 h respectively. According to the lake louise score criteria, the subjects were divided into two groups: acute mountain sickness group (AMS group) and non acute mountain sickness group (non-AMS group).

RESULTSHR, diastolic blood pressure (DBP), mean arterial pressure (MAP), left ventricular ejection fraction (LVEF), stroke volume (SV), stroke index (SI) cardiac output (CO), cardiac index (CI) were significantly increased upon acute high altitude exposure (P < 0.05). Whereas SaO2 and end-systolic volume (ESV) were significantly decreased (P < 0.05). In addition, HR, systolic blood pressure (SBP) and MAP in AMS group were significantly higher than those in non-AMS group (P < 0.05). But stroke index (SI) and end-diastolic volume (EDV) in AMS group were significantly lower than those in non-AMS group (P < 0.05).

CONCLUSIONCardiac function in healthy young males upon acute high altitude exposure was enhanced. EDV, HR and SI might become the indexes of predicting the acute mountain sickness in the future.

BACKGROUND: The dynamic changes of pneumocyte apoptosis and aspartate-specific cysteine proteases-3 (caspase-3) expression in lung tissue of rats during the process of lung ischemia/reperfusion (I/R) injury and the possible action mechanisms remain unclear.OBJECTIVE: This study was to observe the dynamic changes of pneumocyte apoptosis and caspase-3 expression in the rat lung tissue during the process of lung I/R injury, and to analyze the role of pneumocyte apoptosis and the possible action mechanism.DESIGN: A randomized controlled animal experiment.SETTING: Emergency Center, First Hospital, Nanjing Medical University.MATERIALS: This study was carried out in the Animal Laboratory of the First Hospital of Nanjing Medcial University and Nanjing Center for Radioimmunity between April 2006 and September 2006. Twenty-eight male healthy SD rats of clean grade, with body weight of 250 to 350 g, aged 49 to 76 days, were provided by the Experimental Animal Center of Nanjing Medical University. The involved rats were randomized into experimental group and control group, with 14 rats in each.METHODS: ①Experimental intervention: Rats in the experimental group were created into models of lung I/R injury according to the method of Eppinger et al. They were occluded for 45 minutes at the porta of lung (no systolic and diastolic reactions in lung tissue being considered as successful occlusion), and then they were reperfused (recovery of systolic and diastolic function being considered as successful reperfusion); After that, lung tissues were harvested at 3 and 6 hours after lung I/R injury, 7 rats at each time point. Each rat in the control group was subjected to a thoracotony only, but lung tissues were isolated at the same time point by the same method. ②Experimental evaluation: Apoptotic cells in the lung tissue were detected with a flow cytometer by Annexin-V-PI staining, and apoptosis rate was calculated. Caspase-3 expression in the lung tissue was observed by immunohistochemical method and image analysis. Wet to dry weight ratio(W/D) of lung tissue of rats in the two groups was calculated; the number of injured pulmonary alveoli at I/R 3 hours/that at I/R 6 hours was calculated for quantitative evaluation of injured lung tissue; Patho-morphological changes of lung tissue were observed by haematoxylin & eosin staining under an optical microscope.MAIN OUTCOME MEASURES: ①Pneumocyte apoptosis rate and caspase-3 expression in the lung tissue. ②W/D of lung tissue and quantitative evaluation of injured lung tissue. ③Patho-morphological changes of lung tissue.RESULTS: Twenty-eight rats were involved in the final analysis, without deletion. ①Pneumocyte apoptosis rates in the experimental group at I/R 3 and 6 hours were significantly increased as compared with control group (P＜0.01). In the experimental group, pneumocyte apoptosis rate was decreased a little at I/R 6 hours than at I/R 3 hours (P＜0.05). ②Caspase-3 expression in the lung tissue of rats of experimental group reached its top at I/R 3 hours, and was decreased a little at I/R 6 hours. At each time point, caspase-3 expression in the experimental group was increased as compared with control group (P＜0.01). ③In the experimental group, the number of injured pulmonary alveoli at I/R 3 hours/that at I/R 6 hours and W/D ratios of lung tissues were significantly increased as compared with control group (P＜0.01). In the experimental group, two ratios at I/R 6 hours were higher than those at I/R 3 hours (P＜0.05).④In the experimental group, the structure of pulmonary alveoli was destructed, collapsed and disappeared; lots of inflammatory cell infiltration was found; Patho-morphological changes of injured lung tissue at I/R 6 hours were severer than those at I/R 3 hours. No obvious changes were found in the control group.CONCLUSION: At the early stage of lung I/R injury, the alteration of caspase-3 maybe activate pneumocyte apoptosis and induce the apoptosis of lung tissue, and thereby leads to lung injury.

Objective To investigate the related risk factors for small artery occlusion (SAO) and its 2 subtypes. Methods The clinical and imaging data in 291 patients with first-ever stroke who met the TOAST criteria of large artery atherosclerotic stroke (LAA) or SAO were collected from the Nanjing Stroke Registry Prog-am from December 2009 to November 2010. All the patients were divided into a LAA group (n = 120) and a SAO group (n = 171). The latter was redivided into either a lacunar infarction with ischemic leukoaraiosis (ILA) subgroup (n = 84)or an isolated lacunar infarction (ILI) subgroup (n = 87). The risk factors of the LAA group and SAO group and its subgroups were compared. Multivariate logistic regression analysis was conducted and the independent risk factors were screened. Results The mean age in the SAO group was larger than that in the LAA group. The proportion of the patients with hypertension and the serum homocysteine (Hcy) level were significantly higher than those in the LAA group (all P ＜0. 05). Multivariate logistic analysis showed that the advanced age (odds ratio, [OR] = 1.041,95% confidence interval [CI] 1.02-1.06, P = 0.045), hypertension (OR = 2. 912,95% CI 1. 11-6. 46, P =0. 031) and increased plasma Hcy (OR = 1. 109, 95% CI 1. 11-1. 32, P =0. 001) were the independent risk factors for SAO. The advanced age (OR = 1. 047,95% CI 1.00-1.09, P = 0.043), hypertension (OR = 2. 632, 95% CI 1.08-6.41, P= 0.033) and increased plasma Hcy (OR = 1. 211, 95% CI 1. 11-1. 32, P ＜0. 001) were the independent risk factors for ILA, while the hypercholesterolemia (OR =0. 136, 95% CI 0. 05-0. 37, P ＜0. 001) was the independent risk factor for ILI. Conclusions The advanced age, hypertension and increased plasma Hcy level may play important roles in the pathogenesis of SAO. The hypercholesterolemia is an independent risk factor for ILI, while advanced age, hypertension and increased plasma Hcy level are the independent risk factors for ILA.

Objective To investigate the changes and prognostic significance of bone marrow(BM) oil drop and megakaryocyte counts after chemotherapy in acute myeloid leukemia (AML) patients (non-M3).Methods Ninty-nine adult patients with denovo AML (non-M3) were retrospectively analyzed to evaluate the change of BM oil drop and megakaryocyte counts and their influences on overall survival(OS) and disease free survival (DFS) during all stages of standardized therapy.Results The median DFS and OS were 21 (2-88);months and 70 (4-89) months,respectively; and 3-year predicted DFS and OS were 47.3 ％ and 55.8 ％,respectively.After AML patients (non-M3) achieving complete remission (CR) by induction therapy,BM oil drop tended to increase along with postremission chemotherapy cycle accumulation, while megakaryocyte counts tended to decrease.The univariate analysis indicated that megakaryocyte counts decreased after the second course of postremission therapy. BM oil drop increased after the first to the third course of postremission therapy.Grade of myelofibrosis in BM biopsy,serum lactate dehydrogenase (LDH) level at diagnosis,flow cytometric immunophenotyping, the percentage of BM blast cells at diagnosis and the percentage of residual leukemic cells (RLC) during aplasia (7-10 days after the end of induction therapy) had prognostic significance.Multivariable COX analysis indicated the percentage of BM blast cells at diagnosis and change of BM oil drop after the third postremission therapy were independent prognostic factors for DFS (P =0.010,0.018 respectively),and RLCs during aplasia and change rate of the megakaryocyte counts after the second postremission therapy were independent prognostic factors for OS (P =0.009, 0.038respectively).Conclusion After AML patients (non-M3) achieving CR by induction therapy,BM oil drop tends to increase along with postremission chemotherapy cycles accumulation,while the megakaryocyte counts tend to decrease.Dynamic observations of bone marrow oil drop and megakaryocyte counts are helpful for assessing the prognosis of acute myeloid leukemia (non-M3).

Objective To improve the acknowledge of diagnosis and therapy of aggressive systemic mastocytosis (ASM).Methods One ASM patient was reported and the literatures were reviewed.Results As a rare subtype of SM,ASM is characterized by multiple organs involvement,and often accompanied by bone marrow dysfunction,osteolytic lesions and palpable hepatomegaly or splenomegaly which usually indicate the high mast cell burden.Conclusion ASM meets criteria for SM and has one or more C findings.Variable factors affect the prognosis of ASM patients and the formulation of the clinical treatment strategy which leads to the highly individualized therapies.

Data quality management system is essential to ensure accurate, complete, consistent, and reliable data collection in clinical research. This paper is devoted to various choices of data quality metrics. They are categorized by study status, e.g. study start up, conduct, and close-out. In each category, metrics for different purposes are listed according to ALCOA+ principles such us completeness, accuracy, timeliness, traceability, etc. Some general quality metrics frequently used are also introduced. This paper contains detail information as much as possible to each metric by providing definition, purpose, evaluation, referenced benchmark, and recommended targets in favor of real practice. It is important that sponsors and data management service providers establish a robust integrated clinical trial data quality management system to ensure sustainable high quality of clinical trial deliverables. It will also support enterprise level of data evaluation and bench marking the quality of data across projects, sponsors, data management service providers by using objective metrics from the real clinical trials. We hope this will be a significant input to accelerate the improvement of clinical trial data quality in the industry.

Objective To explore the clinical characteristic of rapidly progressive glomerulonephritis(RPGN) induced by the antithyroid agents[propylthiouracil(PTU) and methimazole(MMI)].Methods The analysis was made according to the drug histories,clinical manifestation,serology investigations,renal biopsy in 2 children.Results Two cases presented with gross hematuria,proteinuria and renal dysfunction.One case with antineutrophil cytoplasmic antibody(ANCA)-positive and vasculitis lesion with cresent in the renal biopsy;another presented with mesengial proliferation and cresent.They both had been diagnosed RPGN induced by antithyroid agents for 5 years because of Graves disease.The treatment included that PTU and MMI were withdrawn and then combined prednisone with mycophenolate mofetil(MMF)were applied.One year after treatment,the urine analysis and renal function returned to normal.Conclusions The antithyroid agents may induce RPGN.A early diagnosis and immunosuppressive therapy can improve its prognosis of the disease.

Objective To investigate the clinical features,treatment response and prognosis in children with Takayasu′s arteritis(TA) in order to improve the understanding of TA.Methods A retrospective study of 10 children with TA was performed.All of them were admitted and diagnosed in Peking University First Hospital from Jan.1998 to Oct.2008.The clinical features,laboratory tests,imaging modalities,treatment response and prognosis were all collected and evaluated.Results There were 3 boys and 7 girls in the 10 patients with TA,and the ratio of male to female was 12.3.The onset was from 4 months to 9 years old,with average age at 5.5 years old.The average duration of diagnosis was 7.6 months.The incidences of hypertension,vascular bruits,albuminuria,convulsion were present in 100%,100%,70% and 40%,respectively.The clinical types included typeⅡ(60%),type Ⅲ(10%) and type Ⅳ(30%).The acute phase inflammatory indices of activity such as erythrocyte sedimentation rate(ESR),C-reactive protein(CRP) and white blood cell(WBC) were not evidently increased.Tuberculosis infection was found in 6 out of 10 patients and anti-tuberculosis treatment was performed.Six patients were treated with steroids and 3 cases of them were also given immunosuppressives cyclophosphamide or methotrexate.Three of the 10 patients received anti-hypertensive and vasodilator.Two patients received percutaneous translurminal angioplasty and 1 patient received nephrectomy.One patient died of renal failure,heart failure and shock.Conclusions The patients with TA had high prevalence of tuberculosis infection,diagnosis as often late because of lack of specific clinical features at the acute inflammatory period.When organic ischaemia occurred,treatment response was usually unsatisfactory.Patients with multi-systemic and multi-viscera lesions should have comprehensive examination,especially for those with hypertension,pulseless and vascular bruits,in order to rule out TA.Early ultrasonography,computed tomography and magnetic resonnance image methods are valued in eariler diagnosis and they are the key factors to improve prognosis.