[Reflections on supervision strategies of new Tibetan drug registration].

Tibetan medicine is an essential part of Chinese medicine and has unique theoretical experience and therapeutic advantages. According to the development principle of inheriting the essence, sticking to the truth, and keeping innovative, the supervision department should give clear and reasonable guidance considering the characteristics of Tibetan medicine, establish a standard system for quality control, clinical verification and evaluation, and accelerate the research and commercialization of new drugs. In view of the needs of drug supply-side reform and the current situation of Tibetan medicine and new pharmaceutical research, we ponder and provide suggestions on the confusion faced by the current supervision of Tibetan drug registration, hoping to contribute to the supervision strategy of Tibetan drug registration and the high-quality development of Tibetan medicine industry.

Trial of Contralateral Seventh Cervical Nerve Transfer for Spastic Arm Paralysis.

BACKGROUND: Spastic limb paralysis due to injury to a cerebral hemisphere can cause long-term disability. We investigated the effect of grafting the contralateral C7 nerve from the nonparalyzed side to the paralyzed side in patients with spastic arm paralysis due to chronic cerebral injury. METHODS: We randomly assigned 36 patients who had had unilateral arm paralysis for more than 5 years to undergo C7 nerve transfer plus rehabilitation (18 patients) or to undergo rehabilitation alone (18 patients). The primary outcome was the change from baseline to month 12 in the total score on the Fugl-Meyer upper-extremity scale (scores range from 0 to 66, with higher scores indicating better function). Results The mean increase in Fugl-Meyer score in the paralyzed arm was 17.7 in the surgery group and 2.6 in the control group (difference, 15.1; 95% confidence interval, 12.2 to 17.9; P<0.001). With regard to improvements in spasticity as measured on the Modified Ashworth Scale (an assessment of five joints, each scored from 0 to 5, with higher scores indicating more spasticity), the smallest between-group difference was in the thumb, with 6, 9, and 3 patients in the surgery group having a 2-unit improvement, a 1-unit improvement, or no change, respectively, as compared with 1, 6, and 7 patients in the control group (P=0.02). Transcranial magnetic stimulation and functional imaging showed connectivity between the ipsilateral hemisphere and the paralyzed arm. There were no significant differences from baseline to month 12 in power, tactile threshold, or two-point discrimination in the hand on the side of the donor graft. RESULTS: The mean increase in Fugl-Meyer score in the paralyzed arm was 17.7 in the surgery group and 2.6 in the control group (difference, 15.1; 95% confidence interval, 12.2 to 17.9; P<0.001). With regard to improvements in spasticity as measured on the Modified Ashworth Scale (an assessment of five joints, each scored from 0 to 5, with higher scores indicating more spasticity), the smallest between-group difference was in the thumb, with 6, 9, and 3 patients in the surgery group having a 2-unit improvement, a 1-unit improvement, or no change, respectively, as compared with 1, 6, and 7 patients in the control group (P=0.02). Transcranial magnetic stimulation and functional imaging showed connectivity between the ipsilateral hemisphere and the paralyzed arm. There were no significant differences from baseline to month 12 in power, tactile threshold, or two-point discrimination in the hand on the side of the donor graft. CONCLUSIONS: In this single-center trial involving patients who had had unilateral arm paralysis due to chronic cerebral injury for more than 5 years, transfer of the C7 nerve from the nonparalyzed side to the side of the arm that was paralyzed was associated with a greater improvement in function and reduction of spasticity than rehabilitation alone over a period of 12 months. Physiological connectivity developed between the ipsilateral cerebral hemisphere and the paralyzed hand. (Funded by the National Natural Science Foundation of China and others; Chinese Clinical Trial Registry number, 13004466 .).

Body mass index and cancer risk among Chinese patients with type 2 diabetes mellitus.

BACKGROUND: Obesity and diabetes are two risk factors for cancer. To evaluate the association of body mass index (BMI) with cancer risk in diabetic patients may improve current understanding of potential mechanisms. METHODS: A retrospective cohort study was conducted in 51,004 newly diagnosed T2DM patients derived from an electronic health record (EHR) database of Minhang district in Shanghai, China. Incident cancer cases and all-cause deaths occurred before September 30, 2015 were identified by linking with the Shanghai Cancer Registry and the Shanghai Vital Statistics. To examine the potential non-linear and linear relationships of BMI and cancer risk, Cox proportional hazard models with and without restricted cubic spline functions were used, respectively. RESULTS: A non-linear association was observed between BMI and overall cancer incidence in men younger than 60 years old (p for non-linearity = 0.009). Compared with those having BMI of 25.0 kg/m2, the cancer risk increased in those with either lower or higher BMI. In women older than 60 years old, linear dose-response relationships were observed between BMI and the risk of both overall cancer and breast cancer. As each unit increase in BMI, the overall cancer risks elevated by 3% (95%CI: 1-5%) and the breast cancer risks increased by 7% (95%CI: 1-13%). No significant association was observed between BMI and other common cancer sites. CONCLUSIONS: Our results show that the effect of BMI on cancer risk in Chinese patients with T2DM may vary by gender, age and cancer subtypes, suggesting different underlying biological mechanisms.

Cancer incidence in patients with type 2 diabetes mellitus: a population-based cohort study in Shanghai.

BACKGROUND: Type 2 diabetes mellitus (T2DM) has been suggested to increase the risk of cancers. The aim of this study was to investigate the risk of common cancers in Chinese patients with T2DM. METHODS: A population-based retrospective cohort study including 36,379 T2DM patients was conducted in Minhang District of Shanghai, China, during 2004 to 2010. All T2DM patients were enrolled from the standardized management system based on local electronic information system. Newly-diagnosed cancer cases were identified by record-linkage with the Shanghai Cancer Registry. Standardized incidence ratios (SIR) and 95% confidence interval (CI) were used to estimate the risk of cancers among T2DM patients. RESULTS: Overall crude incidence rate (CIR) of cancers was 955.21 per 105 person-years in men and 829.57 per 105 person-years in women. Increased risk of cancer was found in both gender, with an SIR being 1.28 (95% CI = 1.17-1.38) in men and 1.44 (95% CI =1.32-1.55) in women. Increased risk of colon (SIR = 1.97; 95% CI = 1.49 to 2.46), rectum (1.72; 1.23 to 2.21), prostate (2.87; 2.19 to 3.56), and bladder cancers (1.98, 1.28 to 2.68) were observed in men and elevated risk of colon (1.67; 1.25 to 2.08), breast (1.66; 1.38 to 1.95), and corpus uteri cancers (2.87; 2.03 to 3.71) were observed in women. CONCLUSIONS: Our results indicate that Chinese patients with T2DM may have an increased risk of some cancers, and the increase may vary by sub-sites of cancers.

Glycated haemoglobin in diagnosis of diabetes mellitus and pre-diabetes among middle-aged and elderly population: Shanghai Changfeng study.

OBJECTIVE: To investigate the optimal glycated haemoglobin (HbA1c) cut off points and evaluate the impact of HbA1c on diabetes and pre-diabetes in middle-aged and elderly population. METHODS: Subjects were recruited from Shanghai Changfeng Study. A total of 1973 community-based participants (age ⋝45) without known diabetes underwent oral glucose tolerance test (OGTT) by using a 75-g oral glucose load and HbA1c was measured by using high performance liquid chromatography (HPLC). Subjects were classified as normal glucose tolerance (NGT), pre-diabetes(impaired glucose regulation, IGR) and new diagnosed diabetes (NDD) per 1999 WHO criteria. Two tests are compared with receiver operating characteristic curve (ROC). RESULTS: Among 1973 subjects, 271 (13.7%) were diagnosed as NDD and 474 (24.0%) as IGR by using OGTT. HbA1c was 5.7%±0.7% in this population. Use of 6.5% as the HbA1C cutoff point has sensitivity of 38.7% and specificity of 98.5%. We recommend 6.0% as a better cutoff value for diagnosis of diabetes in this population (AUC 0.829, 95% CI 0.798-0.860, P<0.001) with its sensitivity and specificity as 66.1% and 86.8%. For IGR, the results showed low sensitivity (44.9%) and specificity (66.7%) with an AUC of 0.571 for HbA1c when 5.8% was used as the cutoff point. Participants detected with HbA1c⋝6.0% were associated with nearly the same metabolic characteristics, including body mass index (BMI), blood pressure, lipid profile and urine albumin-creatinine ratio (uACR) compared with diabetic subjects detected by OGTT. CONCLUSION: The optimum HbA1c cutoff point for diabetes in our study population was lower than ADA criteria, and HbA1c may not be used to identify IGR.

[Ovarian ultrasonographic features in reproductive age females with polycystic ovary syndrome and the establishment of ultrasonographic criteria].

OBJECTIVE: To understand the ovarian ultrasound imaging features in the reproductive age females with polycystic ovary syndrome (PCOS). METHODS: A total of 396 PCOS patients aged 18 - 35 years were recruited from our gynaecology & endocrinology clinic, including obese (OB-PCOS group, n = 153) and non-obese (NOB-PCOS group, n = 241). And 635 reproductive period females with normal menstruation for the control group, including obese (OB-CON group, n = 72) and non-obese (NOB-CON group, n = 563). Questionnaire surveys were conducted on their menstrual history. Vagina or rectum ultrasound methods were employed to determine the values of ovarian follicle number (FN) and ovarian volume (OV). Also the clinical symptom scores and endocrine and metabolic indices were measured. RESULTS: (1) As compared to the control group, the values of ovarian FN and OV 95% site for physiological high limit were 10 and 9.5 ml respectively. (2) In PCOS patients, their ovarian volumes and the number of follicles were significantly higher than those of the control group (P < 0.01). (3) In 90.4% of these patients, their values were OV > 9.5 ml and/or FN ≥ 10. And in 66.9% PCOS patients of reproductive age, the polycystic ovarian changes of ultrasound imaging reached the Rotterdam consensus diagnostic criteria. CONCLUSION: The features of ovarian ultrasound imaging in reproductive period PCOS patients are enlarged ovarian volume and increased follicles numbers. The preliminary Chinese ovarian ultrasonographic diagnostic cut-off points have been proposed for reproductive period PCOS patients.

Antigenic and genetic variation in the hemagglutinins of H1N1 and H3N2 human influenza a viruses in the Shanghai area from 2005 to 2008.

Continued rapid evolution of the influenza A virus is responsible for annual epidemics and occasional pandemics in the Shanghai area. In the present study, the representative strains of A/H1N1 and A/H3N2 influenza viruses isolated in the Shanghai area from 2005 to 2008 were antigenically and genetically characterized. The antigenic cartography method was carried out to visualize the hemagglutination-inhibition data. Antigenic differences were detected between circulating A/H1N1 strains isolated from 2005 to 2006 and the epidemic A/H1N1 strains isolated in 2008, which were found to be associated with the amino acid substitution K140E in HA1. The present vaccine strain A/Brisbane/59/2007 is considered to be capable of providing sufficient immunity against most of the circulating A/H1N1 viruses isolated in 2008 from the Shanghai population. The study showed that there were significant antigenic differences between the epidemic A/H3N2 strains isolated in 2007 and 2008, suggesting that antigenic drift had occurred in the A/H3N2 strains isolated in 2008. The P194L mutation was thought to be responsible for the antigenic evolution of influenza A/H3N2 viruses isolated from Shanghai in 2008. Evidence of antigenic drift suggests that the influenza A/H3N2 vaccine component needs to be updated.

Liver fat content is independently associated with microalbuminuria in a normotensive, euglycaemic Chinese population: a community-based, cross-sectional study.

OBJECTIVE: Non-alcoholic fatty liver disease (NAFLD) is associated with microalbuminuria (MA) in patients with diabetes/pre-diabetes. Whether this association is mediated by blood glucose and blood pressure (BP) remains unclear. This study investigated whether liver fat content (LFC) was associated with MA in a normotensive and non-diabetic population. DESIGN: A cross-sectional substudy. SETTINGS: LFC was determined from the hepatic/renal echogenicity ratio at ultrasound. MA was defined as an albumin-to-creatinine ratio (ACR) of 30-300 µg/mg (early- morning urine sample). Multivariable logistic regression and receiver operating characteristic (ROC) curve analyses were used to evaluate LFC as a predictor of MA. PARTICIPANTS: Between May 2010 and June 2011, this cross-sectional, community-based study enrolled residents from Shanghai (China), aged ≥40 years and with normal glucose tolerance and BP. RESULTS: A total of 550 residents (median age, 57 years; 174 men) were enrolled and stratified according to LFC quartiles. ACR (p<0.001) and MA prevalence (p=0.012) increased across the LFC quartiles. Multivariable logistic regression showed that the OR for MA (per SD increase in LFC) was 1.840 (95% CI 1.173 to 2.887, p=0.008) after adjustment for potential confounders including age, gender, waist-hip ratio, blood urea nitrogen, systolic and diastolic BP, fasting blood glucose, postprandial glucose, low-density lipoprotein-cholesterol, triglycerides, high-density lipoprotein-cholesterol, total cholesterol, estimated glomerular filtration rate and lipid-lowering drugs. The ROC analysis revealed that the optimal LFC cut-off value for predicting MA was 6.82%. CONCLUSION: LFC is independently associated with MA in normotensive, euglycaemic middle-aged and elderly Chinese individuals. Screening for MA in people with NAFLD might facilitate early intervention to minimise kidney disease risk.

[The application study of community-based tele-screening system for diabetic retinopathy in Beixinjing Blocks, Shanghai].

OBJECTIVE: To design the community-based tele-screening system for diabetic retinopathy and evaluate the feasibility of it. METHODS: Cross-sectional study. The tele-screening system was based on non-mydriatic digital eye fundus camara photography and computer network technology. 109 type 2 diabetes mellitus residents were randomly selected for system evaluation, which included: (1) The consistency of the far visual acuity examined by an ophthalmologist and a trained inspector, evaluated by paired t-sample test; the consistency of diagnosis of diabetic retinopathy by tele-screening system and traditional screening method by ophthalmoscope, slit-lamp bimicroscope combined with non-contact lens after pupil dilation, evaluated by kappa value and intraclass coefficient correlation. (2) The proper compression ratio of the fundus photographs transferring through the internet, evaluated by intraclass coefficient correlation. (3) The working time for the tele-screening on the residents, comparing with the traditional screening method. RESULTS: The visual acuities of the 218 eyes in 109 residents examined by an ophthalmologist were < 0.05 in 13 eyes, between 0.05 and 0.3 in 61 eyes, > or = 0.3 in 144 eyes. No significant difference was found between the vision acuity given by different examiner (t = -0.572, P = 0.568). 52 eyes were diagnosed as DR by traditional screening method, while 51 eyes were diagnosed as DR by the tele-screening method, so in DR diagnosis, high consistency were found with kappa value as 0.885, 95%CI 0.807 to 0.963, and in DR degree diagnosis with ICC value as 0.91, 95%CI 0.85 to 0.94. The most compression ratio of fundus photographs was as low as 15% (526 x 350). It took 5 to 7 minutes for the tele-screening system to examining and giving diagnosis of a diabetes mellitus resident, a little bit sooner than traditional screening method. CONCLUSIONS: This community-based tele-screening system can meet the requirements of mass screening for diabetic retinopathy.

Etanercept biosimilar (recombinant human tumor necrosis factor-α receptor II: IgG Fc fusion protein) and methotrexate combination therapy in Chinese patients with moderate-to-severe plaque psoriasis: a multicentre, randomized, double-blind, placebo-controlled trial.

Etanercept biosimilar recombinant human tumour necrosis factor-α receptor II: IgG Fc fusion protein (rhTNFR-Fc, trade name Yisaipu) has shown good efficacy in the treatment of moderate-to-severe plaque psoriasis. To compare the efficacy and safety of rhTNFR-Fc plus methotrexate (MTX) and rhTNFR-Fc plus placebo in Chinese patients with moderate-to-severe plaque psoriasis. In this multicentre, randomized, placebo-controlled trial, patients with moderate-to-severe plaque psoriasis were enrolled and randomly assigned in a 1:1 ratio to receive rhTNFR-Fc plus MTX or rhTNFR-Fc plus placebo. The primary endpoint was the proportion of patients achieving Psoriasis Area and Severity Index improvement of at least 75% (PASI 75) from baseline at week 24. Adverse events (AEs) were recorded to evaluate safety. Efficacy analysis was performed using the intent-to-treat principle. A total of 466 patients were enrolled and randomly received rhTNFR-Fc plus MTX (combination group, n = 233) or rhTNFR-Fc plus placebo (monotherapy group, n = 233). PASI 75 at week 24 was significantly higher in the combination group than in the monotherapy group (81.86% vs. 65.50%, p < 0.001). Similar results were observed in other PASI improvement scores at week 12 [PASI 75, 62.39% vs. 44.54% (p < 0.001); PASI 50, 87.17% vs. 75.55% (p = 0.001); and PASI 90, 34.07% vs. 18.78% (p < 0.001)] and week 24 [PASI 50, 92.48% vs. 85.59% (p = 0.019); and PASI 90, 64.16% vs. 42.36% (p < 0.001)]. Significantly more patients had a static Physicians' Global Assessment of clear or almost clear in the combination group than in the monotherapy group at week 12 (26.46% vs. 12.50%, p < 0.001) and week 24 (62.38% vs. 40.83%, p < 0.001). The most common AEs in the two groups were upper respiratory tract infection and abnormal liver function. The combination therapy of rhTNFR-Fc plus MTX was an effective therapy for moderate-to-severe plaque psoriasis with an acceptable safety and tolerability profile, indicating that it was feasible and well tolerated for patients.

[Development and evaluation of an inquiry scale for diagnosis of heart system syndromes in traditional Chinese medicine].

OBJECTIVE: To develop an inquiry scale for diagnosis of heart system syndromes, and to discuss the provisional standardization of the inquiry method in traditional Chinese medicine (TCM). METHODS: Based on scale-making method, Chinese medicine theory and literature searching, an inquiry scale for diagnosis of heart system syndromes in TCM was developed. Statistics method, frequency counting and Delphi method were used for analysis. The inquiry scale was revised and tested repeatedly to check the test reliability, internal consistency reliability, and content validity, etc. RESULTS: The inquiry scale for diagnosis of heart system syndromes mainly covered basic data, chief complaint, history of present illness (accompanying symptoms) and past history, with appendix of inspection and palpation information as well as diagnosis made according to traditional Chinese and Western medicine. Among them, general inquiries covered fever and chills, sweating, head-body and chest-belly symptoms, taste and diet, stool and urine, sleep, mood, and gynecologic symptoms, which were scaled in 8 dimensions. And 66 symptom variables were screened finally. The scale had a good content validity and its coefficient alpha was 0.82. For the results of test-retest reliability, the Kappa values of using the scale for diagnosis of heart-qi deficiency, heart-yang deficiency, turbid phlegm, and cold coagulation twice by the same doctor ranged from 0.74 to 1, showing that the consistency of the scale was relatively high. The Kappa values of evaluation of scorer reliability in diagnosis of heart-qi deficiency, heart-yang deficiency, and heart-yin deficiency were also high, which were 0.63, 0.72, 1 and 0.48 respectively. Other results of diagnosis had low-consistency or even no diagnostic agreement. CONCLUSION: The research on the scale for inquiry in TCM indicates that it is feasible for the standardization of inquiry scale for diagnosis of heart system syndromes in TCM, offering a reference for research on the inquiry scales for other systems.

Polymorphisms in phase I and phase II metabolism genes and risk of chronic benzene poisoning in a Chinese occupational population.

It is widely accepted that the cytotoxicity and genotoxicity of benzene results from the action of reactive metabolites. Therefore, genetic variation in metabolic enzyme genes may contribute to susceptibility to chronic benzene poisoning (CBP) in the exposed population. Using a case-control study that included 268 benzene-poisoned patients and 268 workers occupationally exposed to benzene in South China, we aimed to investigate the association between single-nucleotide polymorphisms in genes with phase I and II of metabolism and risk of CBP. The TaqMan technique was used to detect polymorphisms of CYP1A1, CYP1A2, CYP1B1, ADH1B, EPHX1, EPHX2, NQO1, MPO, GSTP1 and UGT1A6 genes. We also explored potential interactions of these polymorphisms with lifestyle factors such as cigarette smoking and alcohol consumption. A weak positive association was found between glutathione S-transferase pi-1 (GSTP1) rs1695 polymorphism and the risk of CBP (P = 0.046), but this association was not statistically significant (P = 0.117) after adjustment for potential confounders. Further analysis showed that the risk of CBP increased in the subjects with EPHX1 GGAC/GAGT diplotype (P = 0.00057) or AGAC/GAGT diplotype (P = 0.00086). In addition, we found that alcohol drinkers with the EPHX1 rs3738047 GA + AA genotypes and non-alcohol drinkers with the GSTP1 rs1695 AA genotype tended to be more susceptible to benzene toxicity. Our results suggest that genetic polymorphisms in EPHX1 may contribute to risk of CBP in a Chinese occupational population.

Polymorphisms and haplotypes of DNA repair and xenobiotic metabolism genes and risk of DNA damage in Chinese vinyl chloride monomer (VCM)-exposed workers.

In this case-control study, we investigated the association between DNA damage and genetic susceptibility among vinyl chloride monomer (VCM)-exposed workers. The cumulative exposure dose of VCM was calculated based on the workers' duration of exposure and the geometric mean concentration of VCM in the workplace. DNA damage to peripheral blood lymphocytes was measured by single cell gel electrophoresis (SCGE) assay, and single nucleotide-polymorphisms (SNPs) in xenobiotic metabolism and DNA repair genes were detected by the polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP) methods. Univariate analysis showed that the CYP2E1 c1c2/c2c2 and XPD751 Lys/Gln and Gln/Gln genotypes were significantly associated with the levels of DNA damage (P<0.01 and 0.05, respectively). Further logistic regression analysis showed a significant association between CYP2E1 c1c2/c2c2 and DNA damage, and risk of having increased levels of DNA damage was more pronounced in those individuals having XRCC1 194 mutant genotypes and/or XPD751 Lys/Gln and Gln/Gln genotypes. Although most of the XPD and XRCC1 haplotypes did not show any significant difference, the XRCC1 haplotype Trp194-Arg280 was significantly over-represented in the case group (P<0.05; OR 2.09; 95% CI: 1.07-4.06) than in controls. Overall, our data suggest that the genotypes of CYP2E1, XRCC1 194, and XPD 751 were associated with the level of DNA damage and may contribute to individual sensitivity to DNA damage induced by VCM in the workplace.

A case-control study of the relationship between hepatitis B virus DNA level and risk of hepatocellular carcinoma in Qidong, China.

AIM: To investigate the role of hepatitis B virus (HBV) replication in the development of hepatocellular carcinoma (HCC), a nested case-control study was performed to study the relationship between HBV DNA level and risk of HCC. METHODS: One hundred and seventy cases of HCC and 276 control subjects free of HCC and cirrhosis were selected for this study. Serum HBV DNA level was measured using fluorescein quantitative polymerase chain reaction at study entry and the last visit. RESULTS: In a binary unconditional logistic regression analysis adjusted for age, cigarette smoking, alcohol consumption and family history of chronic liver diseases, the adjusted odds ratios (95% confidence intervals) of HCC in patients with increasing HBV DNA level were 2.834 (1.237-6.492), 48.403 (14.392-162.789), 42.252 (14.784-120.750), and 14.819 (6.992-31.411) for HBV DNA levels > or = 10(4) to < 10(5); > or = 10(5) to < 10(6); > or = 10(6) to < 10(7); > or = 10(7) copies/mL, respectively. Forty-six HCC cases were selected to compare the serums viral loads of HBV DNA at study entry with those at the last visit. The HBV DNA levels measured at the two time points did not differ significantly. CONCLUSION: The findings of this study provide strong longitudinal evidence of an increased risk of HCC associated with persistent elevation of serum HBV DNA level in the 10(4)-10(7) range.

[Efficacy of protein-free calf blood extract for mechanical corneal epithelial defects in human eyes].

OBJECTIVE: To evaluate the clinical efficacy between protein-free calf blood extract eye drops and recombinant human epidermal growth factor (rhEGF) eye drops for mechanical corneal epithelial defects in human eyes. METHODS: A multi-center, randomized and double-blind study with a parallel, positive-control designation was carried out from April to November in 2005 at Department of Ophthalmology, Eye Ear Nose and Throat Hospital of Fudan University, Xinhua Hospital of Shanghai Jiaotong University, the First Hospital of Zhejiang University, the Second Hospital of Zhejiang University and Qingdao Municipal Hospital. 240 patients (240 eyes) with confirmed diagnosis of corneal epithelial defects at that six hospitals were enrolled in this study and were randomly arranged into two groups in average. One group (120 eyes) were treated by 20% protein-free calf blood extract eye drops which was defined as the experimental group while the other (120 eyes) by 5000 IU/ml recombinant human epidermal growth factor (rhEGF) eye drops as the positive control group. The drug was delivered in both groups 4 times per day, one drop each time in the 14 days duration. The symptoms and signs were scored and the safety was evaluated on the pre-delivery day, the third post-delivery day (day 3), day 7 and day 14. The variants in the study were tested for the different efficacy and safety between the two drugs using non-inferiority test, paired t-test, Wilcoxon signed-rank test, chi-square test, continuity correction chi-square test, Fisher's exact probabilities, analysis of variance, Cochran-Mantel-Haenszel chi-square test and so on. The criterion for statistical significance was P < 0.05. RESULTS: There was no significant difference in efficacy between the protein-free calf blood extract group and the recombinant human epidermal growth factor group (day 3: X2 = 1.5677, P = 0.4566, day 7: X2 = 1.7152, P = 0.4242, day 14: X2 = 3.0814, P = 0.2142). The total scores of symptoms and signs in experimental group had a obvious descending (6.009 +/- 3.030) compared with the positive control group with a descending of (5.177 +/- 2.582), which reached the significant level (t = 2.2367, P = 0.0263). Ocular local stimulates and general side effect were not observed within the treatment course. There was no significant difference between the two groups in the comparison of pre- and post-therapy visual acuity. The difference was not significant when comparing the uncomfortable feelings, including eye burning and eye itching (eye burning: day 3: X2 = 0.4394, P = 0.932, day 7: X2 = 1.4710, P = 0.479,day 14: X2 = 2.1875, P= 0.335, and eye itching: day 3: X2 = 2.1045, P = 0.349, day 7: X2 = 2.0192, P = 0.364, day 14: X2= 0.6863, P = 0.407). And the positive control group gave priority to the experimental group in comfortability. A better comfortableness was reported in the protein-free calf blood extract group on the third day post-delivery (X2 = 6.626, P = 0.0100). However, no obvious difference was examined on day 7 and day 14 post-delivery. CONCLUSION: Protein-free calf blood extract eye drops has confirmed efficacy, good safety, quick effect and better comfortableness.

Epidemiology of schistosomiasis in the People's Republic of China, 2004.

Results from the third nationwide cluster sampling survey on the epidemiology of schistosomiasis in the People's Republic of China, conducted by the Ministry of Health in 2004, are presented. A stratified cluster random sampling technique was used, and 239 villages were selected in 7 provinces where Schistosoma japonicum remains endemic. A total of 250,987 residents 6-65 years of age were included in the survey. Estimated prevalence rates in the provinces of Hunan, Hubei, Jiangxi, Anhui, Yunnan, Sichuan, and Jiangsu were 4.2%, 3.8%, 3.1%, 2.2%, 1.7%, 0.9%, and 0.3%, respectively. The highest prevalence rates were in the lake and marshland region (3.8%) and the lowest rates were in the plain region with waterway networks (0.06%). Extrapolation to all residents in schistosome-endemic areas indicated 726,112 infections. This indicates a reduction of 16.1% compared with a nationwide survey conducted in 1995. However, human infection rates increased by 3.9% in settings where transmission is ongoing.

A time series analysis of outdoor air pollution and preterm birth in Shanghai, China.

OBJECTIVE: To investigate the relation between air pollution exposure and preterm birth in Shanghai, China. METHODS: We examined the effect of ambient air pollution on preterm birth using time-series approach in Shanghai in 2004. This method can eliminate potential confounding by individual risk factors that do not change over a short period of time. Daily numbers of preterm births were obtained from the live birth database maintained by Shanghai Municipal Center of Disease Control and Prevention. We used the generalized additive model (GAM) with penalized splines to analyze the relation between preterm birth, air pollution, and covariates. RESULTS: We observed a significant effect of outdoor air pollution only with 8-week exposure before preterm births. An increase of 10 microg/m3 of 8-week average PM10, SO2, NO2, and O3 corresponded to 4.42% (95%CI 1.60%, 7.25%), 11.89% (95%CI 6.69%, 17.09%), 5.43% (95%CI 1.78%, 9.08%), and 4.63% (95%CI 0.35%, 8.91%) increase of preterm birth. We did not find any significant acute effect of outdoor air pollution on preterm birth in the week before birth. CONCLUSION: Ambient air pollution may contribute to the risk of preterm birth in Shanghai. Our analyses also strengthen the rationale for further limiting air pollution level in the city.

Interaction between ambient particles and ozone and its effect on daily mortality.

OBJECTIVE: To examine the effect of particulate matter (PM) less than 10 microns in diameter (PM10) and ozone (O3) on daily mortality in Shanghai, China. METHODS: A generalized additive model with penalized spline function was used to observe the acute effect of PM10 and O3 on daily mortality. RESULTS: Higher PM10 significantly increased the effect of O3 on total mortality, and O3 also increased the effect of PM10 although the estimated increment was statistically insignificant. CONCLUSION: Our findings provide further evidence for the effect of PM10 and O3 on daily mortality.

[The relationship between adiponectin and coronary heart disease metabolic risk factors in non-diabetic male patients].

OBJECTIVE: To investigate the correlation between adiponectin and metabolic risk factors of coronary heart disease in non-diabetic male patients. METHODS: 215 non-diabetic males aged (59 +/- 9) underwent coronary angiography (CAG) and then divided into coronary heart disease group (n = 127) and control group (n = 88) according to the CAG results. The anthroposomatologic parameters were measured. Blood sugar and lipids were examined. Adiponectin levels was detected with radioimmunoassay. RESULTS: The mean adiponectin level of the coronary heart disease group was 7.9 (5.7 - 11.6) mg/L, significantly lower than that of the control group [10.0 (7.0 - 13.5) mg/L, P = 0.014]. The adiponectin level of females was lower than those of the males, no matter whether with coronary heart disease. Partial correlation analysis showed that the adiponectin level was negatively correlated with the serum triglyceride, total cholesterol, post-challenge glucose level and body mass index (r = -0.250, -0.169, -0.167, -0.246, and -0.198, all P < 0.05), and positively correlated with HDL-C (r = 0.201, P = 0.001) after the age factor was controlled. Logistic multivariable stepwise regression analysis demonstrated levels of triglyceride and adiponectin independently associated with the presence of coronary heart disease (OR = 2.277 and 0.533 respectively). CONCLUSION: Adiponectin is influenced by metabolic disorders. Higher adiponectin level is a protective factor of coronary heart disease.

Time series analysis of the association between ambient temperature and cerebrovascular morbidity in the elderly in Shanghai, China.

Research on the association between ambient temperature and cerebrovascular morbidity is scarce in China. In this study, we applied mixed generalized additive model (MGAM) to daily counts of cerebrovascular disease of Shanghai residents aged 65 years or older from 2007-2011, stratified by gender. Weighted daily mean temperature up to lags of one week was smoothed by natural cubic spline, and was added into the model to assess both linear and nonlinear effects of temperature. We found that when the mean temperature increased by 1 °C, the male cases of cerebrovascular disease reduced by 0.95% (95% Confidence Interval (CI): 0.80%, 1.10%) or reduced by 0.34% (95% CI: -0.68, 1.36%) in conditions of temperature was below or above 27 °C. However, for every 1 °C increase in temperature, the female cases of cerebrovascular disease increased by 0.34% (95% CI: -0.26%, 0.94%) or decreased by 0.92% (95% CI: 0.72, 1.11%) in conditions of temperature was below or above 8 °C, respectively. Temperature and cerebrovascular morbidity is negatively associated in Shanghai. MGAM is recommended in assessing the association between environmental hazards and health outcomes in time series studies.