The aim of this Post-Marketing Surveillance study was to assess efficacy,safety and acceptance of acarbose treatment in Chinese type 2 diabetic patients under day-to-day practice conditions.A total of 2 480 patients were enrolled by 231 physicians throughout China into an open,prospective,uncontrolled,non- randomised,multi-centre study.Main efficacy parameters were the changes in fasting and postprandial blood glucose concentrations as well as in HbA-(1C) levels after acarbose treatment.The majority of patients had been previously treated with other oral anti-diabetic medication or insulin and received concomitant anti-diabetics during the mean observation period of 13.5 weeks.Most patients started on a daily acarbose dose of 50 mg t.i.d. Acarbose treatment reduced fasting blood glucose concentrations by 56.1 mg/dl ( 18 mg/dl glucose = 1 mmol/L glucose) and 2h-postprandial values by 111.3 mg/dl over the study period.HbA-(1C) decreased by 1.9% and body weight by 0.9 kg.76 acarbose-relatod adverse events occurred;two patients experienced serious adverse events. The attending physicians assessed treatment efficacy as“very good”or“good”for 90.1% of the patients, tolcrability for 89.1% and acarbose acceptance for 87.1% of the patients.Acarbose is efficacious,safe and well accepted by Chinese type 2 diabetic patients under day-to-day routine conditions,both as anti-diabetic mono- therapy and in combination with other anti-dlabetic drugs.

OBJECTIVETo study the effects of extracts of root of kudzu vine on mammary gland and uterus development in rats.

METHOD40 Wistar rats weighting 65-85 g were randomly divided into 4 groups: control group, estrogen group, extracts of root of kudzu vine group of high dose, extracts of root of kudzu vine group of low dose. (10 rats in each group). After having been treated for 7 days, the rats were killed; mammary glands and uterus were removed and weighed. Serum was isolated and kept at 4 degrees C for determination of hormones.

RESULT1. Administration of the root of kudzu vine significantly increased the weigh of mammary gland and uterus in rats. 2. Administration of the root of kudzu vine increased serum FSH, LH, E2 and decreased PRL.

CONCLUSIONExtracts of root of kudzu vine could enhance the weight of mammary gland and uterus growth in rats, which may provide experimental evidence for the development of new drug used for promoting mammary gland and uterus.

Animals ; Drugs, Chinese Herbal ; isolation & purification ; pharmacology ; Estradiol ; blood ; Female ; Follicle Stimulating Hormone ; blood ; Luteinizing Hormone ; blood ; Mammary Glands, Animal ; anatomy & histology ; growth & development ; Organ Size ; drug effects ; Plant Roots ; chemistry ; Plants, Medicinal ; chemistry ; Prolactin ; blood ; Pueraria ; chemistry ; Rats ; Rats, Wistar ; Uterus ; anatomy & histology ; growth & development

OBJECTIVETo observe the effects of early goal-directed fluid therapy with hydroxyethyl starch 130/0.4 on intra-abdominal hypertension (IAH), multiple organ dysfunction and fluid balance in severe acute pancreatitis (SAP) patients.

METHODSAccording to the criteria of selection and exclusion, 120 SAP patients within 72 hours after the symptom occurred from 4 study sites were recruited. They were given standard medication according to "the guideline of diagnosis and treatment of SAP in China" in SICU or PICU. The patients were randomly divided into two groups with crystalloid (control group) and colloid plus crystalloid resuscitation (research group). The objective of fluid therapy was to keep steady hemodynamics for 8 days. IAP was measured three times daily by means of urinary bladder transduction. Function of liver, renal and lung were detected daily. APACHE II score and fluid balance were calculated daily.

RESULTSTotal 120 cases were recruited into research group (n = 59) and control group (n = 61). The demography and baseline data were comparable. IAP was lower in research group than that in control group at day 4 and day 5 (P < 0.05). There was no significant difference in APACHE II scores between two groups pre- and after admission. The decline of daily IAP to baseline (DeltaIAP) in research group was significantly higher than in research group from day 2 to day 8(P < 0.05), whilst the decline of daily APACHE II score to baseline (DeltaAPACHE II score) in research group were significantly higher from day 4 to day 8 (P < 0.05). Negative fluid balance emerged much earlier in the research group (P = 0.036). Percentage of patients with negative fluid balance within 8 days was significantly higher in research group than that in control group (94.9% vs. 62.3%). The amount of positive fluid balance was significantly lower in research group (P = 0.039). IAP correlated significantly with APACHE II score (r(2) = 0.322, P = 0.000). PaO2/FiO2 was significantly higer in research group at day 4 and day 8.

CONCLUSIONSIt is very important to pay close attention to IAP in early fluid therapy of SAP patients. Early goal-directed fluid therapy with HES130/0.4 shortens the duration of positive fluid balance, decreases the amount of positive fluid balance, reduces APACHE II score, relieves IAH, and improves PaO2/FiO2.

Fluid Therapy ; Goals ; Humans ; Intra-Abdominal Hypertension ; Multiple Organ Failure ; Pancreatitis

OBJECTIVETo explore the diagnosis and treatment of penile verrucous carcinoma.

METHODSThe clinical and pathological data of 4 patients with penile verrucous carcinoma were analyzed.

RESULTSThe patients ranged in age from 42 to 76 years (average 52). All the tumors showed exophytic papillary lesions, the biggest being 2.1 to 5.8 cm in diameter. The lesions were confined to the glans penis in two cases and invaded the shafts in the other 2 (1 accompanied by syphilis). One patient, whose tumor was small (1.4 cm in diameter) and confined to the glans penis, underwent glandectomy. One with a larger tumor confined to the glans penis and the other 2 with the shafts involved underwent partial penectomy, including the one accompanied by syphilis, who underwent the operation after treated by Benzathine benzylpenicillin. Histopathological examination of the specimens showed that the tumor cells were mostly well-differentiated and the surgical margins were tumor free in all the 4 cases. HE stain was performed in all the specimens. Microscopic examination revealed papillomatosis and hyperkeratosis of the epithelium, with bulbous projections into the lamina propria consisting of well-differentiated squamous epithelial cells. Marked invasion of the stroma by lymphocytes was noted. Follow-up ranged from 3 to 7 years (average 4.6), revealing no recurrence. The result of the rapid plasma regain (RPR) test was negative but that of the Treponema pallidum passive-particle-agglutination (TPPA) test remained positive in the blood of the patient accompanied by syphilis after treatment.

CONCLUSIONVerrucous carcinoma of the penis is characterized by low malignant potential and locally aggressive nature. It seldom develops metastasis to regional lymphonodes or distant areas. Glandectomy or partial penectomy can be chosen for its treatment, with favorable prognosis.

Aged ; Carcinoma, Verrucous ; diagnosis ; pathology ; surgery ; Follow-Up Studies ; Humans ; Male ; Middle Aged ; Penile Neoplasms ; diagnosis ; pathology ; surgery

OBJECTIVETo explore the effects of Tongmai decoction on the perioperative changes of serum concentrations of tumor necrosis factor alpha (TNF-alpha) and interleukin (IL)-6 in patients with femoral fractures, and conform the effectiveness of Tongmai decoction on inflammatory factors in patients with femoral fractures, providing the theoretical evidence for the clinical use of Tongmai decoction.

METHODSFrom October 2007 to May 2009, 60 patients with closed traumatic femoral fractures were selected according to the inclusion criterias and exclusion criterias. All the patients were randomly divided into three groups (group A, group B and group C). Twenty patients in group A (Tpanax Notoginseng pill group), 13 patients were male and 7 patients were female; ranging in age from 20 to 45 years, averaged 32.0 years; the disease course ranged from 2.0 to 26.0 h, with an average of 9.5 h. Twenty patients in group B (Tpanax Notoginseng pills and Lornoxicam injection group),12 patients were male and 8 patients were female; ranging in age from 23 to 42 years, averaged 31.0 years; the disease course ranged from 3.5 to 25.0 h, with an average of 13.6 h. Twenty patients in group C (Tpanax Notoginseng pill, Lornoxicam injection and Tongmai decoction group), 14 patients were male and 6 patients were female; ranging in age from 21 to 44 years, averaged 31.5 years; the disease course ranged from 4.6 to 29.0 h, with an average of 13.3 h. Among all the patients, 42 patients with fractures were fixed with femoral intramedullary nailing, and other 18 patients with femoral locking plate fixation. The patients in group A took Tpanax Notoginseng pills orally, 4 g each time and twice daily; the patients in group B took Tpanax Notoginseng pills orally as group A, and at the same time received intramuscular injection of Lornoxicam, 8 mg each time and once daily; the patients in group C took Tpanax Notoginseng pills orally and received intramuscular injection of Lornoxicam as group B, and at the same time took Tongmai decoction (R ) orally, 200 ml each time and twice daily. The above medications were administered to the three groups on the second day after admission to hospital. Peripheral blood samples were taken for determination of pro-inflammatory cytokines of TNF-alpha and IL-6 in blood serum on the 2nd and 6th days before operation and on the 8th and 13th days after operation. And all the patients were evaluated liver and kidney function at the 2nd and 7th days after admission. Analysis of variance and least significant difference-test were done with the help of SPSS 17.0 statistic software.

RESULTSThe differences among three groups of TNF-alpha and IL-6 in blood serum at the 2nd day after admission and 2 days after operation had no statistical significance (P > 0.05). The TNF-alpha and IL-6 levels among 3 groups had statistical differences at the 7th day after admission and at the 7th day after operation (P < 0.05, P < 0.01). There were significant differences of TNF-alpha and IL-6 levels between the 7th day after admission and the 2nd day after admission, the 7th day after operation and the 2nd day after admission (P < 0.01). There were also significant differences of TNF-alpha and IL-6 levels between group C compared with group A and B at the 7th day after admission and the 7th day after operation(P < 0.05, P < 0.01).

CONCLUSIONThe serum concentrations of TNF-alpha and IL-6 level significantly increased in perioperative period. The results indicate that the Tongmai decoction may play an important role in inhibiting the release of TNF-alpha and IL-6 into the blood stream and decreasing the incunabula complication at early traumatic stage.

Adult ; Drugs, Chinese Herbal ; administration & dosage ; Female ; Femoral Fractures ; blood ; drug therapy ; immunology ; Fractures, Closed ; blood ; drug therapy ; immunology ; Humans ; Interleukin-6 ; blood ; Male ; Middle Aged ; Perioperative Care ; Tumor Necrosis Factor-alpha ; blood ; Young Adult

To compare the efficacy and safety of Lamivudine (LAM) plus Adefovir dipivoxil (ADV) combination therapy and Entecavir (ETV) monotherapy for chronic hepatitis B patients. 120 patients with chronic hepatitis B managed in a single-centre clinical practice (median 96 weeks) were split into 2 cohorts, one was treated with de-novo combination Lamivudine (100 mg/day) plus Adefovir (10 mg/day) (LAM+ADV), the other with Entecavir (0.5 mg/day) monotherapy. Serum levels of ALT, creatinine, HBsAg, HBeAg and HBV viral load, together with genotypic resistence were analyzed at 0, 12, 24, 48, 96 weeks, respectively. HBV DNA was determined by real-time PCR. HBsAg and HBeAg were assessed by chemiluminescence. Serum levels of ALT and creatinine were detected by automatic biochemical analyzer. HBV genotypic resistence was tested by direct sequencing. (1) At the time point of 96 weeks, a total of 99 patients (51 cases in combination therapy cohort and 48 case in monotherapy cohort) were compared. The baseline characteristics as for HBV viral load, median age, serum levels of ALT and creatinine were compatible between combination therapy cohort and monotherapy cohort. (2) The rates of HBV DNA values is less than 300 copies/ml and HBV DNA values is less than 1000 copies/ml had no significant difference between LAM + ADV and ETV cohorts by the 12 and 24 weeks (P more than 0.05). (3) At the time point of 48 weeks, the rates of HBV DNA is less than 1000 copies/ml, HBeAg seroconversion, and ALT normalization were similar in both cohorts, though the rate of HBV DNA values is less than 300 copies/ml was obviously higher in combination therapy cohort than that of monotherapy cohort (90.7% vs 76%, P values is less than 0.05). (4) At the time point of 96 weeks, the rates of HBV DNA values is less than 300 copies/ml (96.1% vs 79.2%), HBV DNA values is less than 1000 copies/ml (98% vs 87.5%) and the HBeAg seroconversion (41.7% vs 16.7%) were markedly higher in combination therapy cohort than those of monotherapy cohort statistically (P values is less than 0.05 for all). The mean values of decreases for HBV viral loads and HBsAg levels were smilar in both cohorts at 48 and 96 weeks. (5) Elevated serum creatinine not be found in both cohorts at the end of treatment. (6) No virological breakthrough occurred in combination therapy cohort at the end of treatment. Four patients in monotherapy cohort were found with virological breakthrough at 96 weeks and three cases among were confirmed to be of variants associated with ETV resistance (rtL180M + T184L + M204V). Present study suggests that Lamivudine plus Adefovir dipivoxil de-novo combination therapy was more efficacious than Entecavir monotherapy for CHB patients and the tolerance is compatible.

OBJECTIVETo determine the pathogen of an unexplained epidemic event of infectious diarrhea by laboratory diagnosis of suspected cases samples.

METHODS28 samples from 28 suspected cases (22 fecal samples, 3 vomitus samples, 3 anus swab samples) were tested for Norovirus by RT-PCR. Sequencing and phylogenetic analysis were acomplished of 5 positive samples.

RESULTS160 of 5694 population were ill with an attack rate of 2.81%. The peak period was 7-9, March. 14 of 28 samples were tested Norovirus positive.Sequencing and phylogenetic analysis showed Norovirus type GII/4 was the causative agent and it had highest identity (97. 9%) with epidemic strain 2006b.

CONCLUSIONThe epidemic event ofinfectious diarrhea were caused by GII/4 Norovirus strains.

Disease Outbreaks ; Dysentery ; diagnosis ; epidemiology ; genetics ; Feces ; virology ; Gastroenteritis ; epidemiology ; virology ; Humans ; Molecular Epidemiology ; Norovirus ; classification ; genetics ; isolation & purification ; Phylogeny ; RNA, Viral ; analysis ; Reverse Transcriptase Polymerase Chain Reaction

The aim of study was to establish the packaging system of the recombinant lentiviral vector encoding Gfi1 gene for eukaryotic expression and to realize the efficient, stable expression of Gfi1 32D cells so as to provide effective platform for further studying the development of Gfi1 gene in hematologic malignancies. The three-plasmid recombinant lentiviral vector consisting of transfer plasmid (pLOX-Gfi1/pLOX), the packaging plasmid (pCMVDeltaR8.2) and the envelop plasmid (pMD.G) was prepared and purified. Human embryonic kidney 293T cells were cotransfected with the three plasmids by lipofectamine 2000. After transfection for 48 hours, the viral supernatant was collected and the target cell 32D was transfected with the recombinant lentivirus; the Gfi1 integration and expression in 293T and 32D cells were detected by Western-blot. The results showed that the three plasmids of lentivirus could be transfected into 293T with high efficiency and packaged successfully, and the Gfi1 protein could be detected by fluorescent microscopy. The recombinant lentiviruses carrying Gfi1 could transfer and deliver Gfi1 gene to 32D cells, and the Gfi1 expression in 293T and 32D cell could be detected by Western blot. It is concluded that the recombinant lentivirus carrying Gfi1 can deliver target gene to 32D cells with high efficiency, and the expression of Gfi1 protein is stable in 32D.
Cell Line ; DNA-Binding Proteins ; genetics ; Genetic Vectors ; Humans ; Lentivirus ; genetics ; Plasmids ; Transcription Factors ; genetics ; Transfection

OBJECTIVETo investigate the mechanism of hyperlipidemia- and imflammation-induced functional impairment of the endothelium.

METHODSThe experiment was conducted using 3 groups of rats fed for 20 weeks with standard chow (control group), high-fat diet and high-fat diet with daily fenofibrate treatment (10 mg/kg, starting since the fifth week), respectively. After 4 and 20 weeks of feeding, respectively, serum lipid level and NO concentration were measured in the rats, and the epithelial vascular cell adhesion molecule-1 (VCAM-1) expression and cell adhesiveness to the aortic endothelium were observed.

RESULTSCompared with the control group, the rats with hyperlipidemia induced by long-term high-fat diet feeding showed lower NO concentration and increased leukocyte accumulation on the endothelial surface, exhibiting also stronger and more extensive endothelial expression of VCAM-1. In contrast, the hyperlipidemic rats with fenofibrate treatment shoed significantly decreased VCAM-1 expression and leukocyte adhesion with recovery of the NO level.

CONCLUSIONNO deficiency and activation of inflammation are involved in vascular impairment in rats with high-fat diet-induced hyperlipidemia, and fenofibrate can effectively prevent atherosclerosis by restoring NO concentration and down-regulating VCAM-1 expression in these rats.

Animals ; Atherosclerosis ; prevention & control ; Cell Adhesion ; Endothelium, Vascular ; drug effects ; metabolism ; Fenofibrate ; pharmacology ; Hyperlipidemias ; drug therapy ; metabolism ; Inflammation ; Leukocytes ; cytology ; Nitric Oxide ; metabolism ; Rats ; Rats, Sprague-Dawley ; Vascular Cell Adhesion Molecule-1 ; metabolism

Objective To explore the relationship between blood pressure variability and worsening functional outcomes of patients upon discharge from the hospitals.Methods The study cohort consisted of 404 patients who presented to Second Affiliated Hospital of Harbin Medical University with ischemic stroke during March 2012-March 2013.Systolic BP and diastolic BP were measured for each patient from admission to the fifth day and coefficient of variation blood pressure calculated.Disability at discharge was measured by the modified Rankin score(mRs).Chi-square test,t-test and multivariate logistic regression analysis were performed.Results After adjustment for potential confounding factors including age,sex,activity,smoking,alcohol intake,BMI,heart rate,hypertension,diabetes mellitus,stroke history,lipid parameters,homocysteine and FPG,results from the multivariate logistic regression analysis showed that when DBP variability was greater than 9,it was associated with a significantly worse functional outcome at hospital discharge compared with those less than 9,with the odds ratio as 1.70(95％CI:1.02-2.84).When comparing the ones that DBP variability more than 10 with the ones less than 10,the odds ratio was 1.86 (95％CI:1.11-3.13).However,there was no significant association seen between SBP variability and the worse functional outcome at hospital discharge.Conclusion Blood pressure variability might be associated with ischemic stroke outcome at hospital discharge but needed more evidence to approve.