Objective:To explore the impact of recent changes in domestic policies and regulations on the development and appli-cation of generic drugs. Methods:Through the collation of the recent regulatory documents, the policy changes for generic drugs were analyzed, and the corresponding development proposals were provided. Results and Conclusion:According to the possible impact of current policy changes on generic drug development, the relative solutions are proposed with the aim to provide certain reference for ge-neric pharmaceutical R & D institutions.

OBJECTIVE To explore the risk factors of lower respiratory tract nosocomial infection in geriatrics patients after abdominal operation and the measures of prevention and control.METHODS The medical records of the 470 cases with abdominal operation from Jan 2003 to Sep 2006 were investigated retrospectively with prospective monitoring.RESULTS Among 470 cases,119 suffered from hospital infection,62 suffered from lower respiratory tract hospital infection,the infection rate being 13.19% and occupied 52.10% of the total number of the hospital infection in the abdominal operation.CONCLUSIONS Invasive operation,such as nasogastric tube,intubation,inhaling oxygen,sputum drawing out,cannulization,tracheotomy,and use of respirator after operation,lying in bed,vomit,using proton pump inhibitors,and underlying diseases are the causes of the lower respiratory tract hospital infection.To enhance the monitoring and control of the risk factors,we can decrease the rate of lower respiratory tract infection and mortality in geriatrics patients after abdominal operation.

OBJECTIVE To evaluate distribution and resistance of pathogens in patients with pulmonary infection after abdominal operation by stages,and provide reference to select antibiotics in clinics.METHODS Forty five patients with pulmonary infection after abdominal operation were included from Jan 2004 to Sep 2007.Their course was divided into 3 stages: onset stage,middle stage and last stage,at every stage to identify pathogens and to test drug sensitivity and the sputa and broncho-alveolar lavage fluid(BALF) were sampled.RESULTS A total of 189 strains of pathogens were isolated,from them 110(58.2%)were Gram-negative bacilli including Pseudomonas aeruginosa,Escherichia coli and Klebsiella pneumoniae;and 59(31.2%)were Gram-positive cocci including Staphylococcus aureus and Enterococcus;and 20(10.6%)were fungi,Candida albicans was the main fungus.At onset stage the most pathogens were Gram-negative bacilli;at middle stage the Gram-positive cocci increased distinctly;and the fungi were detected at middle and last stages.The mixed infection rate was high.The result of drug sensitive test showed that there were high rates of multidrug resistance in P.aeruginosa.The resistance rates of all isolates of Enterobacteriaceae to imipenem or meropenem were 0.The resistance rates of all Gram-positive cocci to linezolid or vancomycin were 0.CONCLUSIONS Distribution of pathogens in patients with pulmonary infection after abdominal operation is different at each stage.The most are multidrug resistant,and rationl use of antibacterial drug in clinics must be based on the distribution and drug-resistance of pathogens.

OBJECTIVE:To observe the efficacy and safety of tripterygium glycosides combined with mizolastine in the treatment of dermatitis and eczema. METHODS:138 patients with dermatitis and eczema were randomly divided into control group (69 cases) and observation group (69 cases). Control group received Mizolastine sustained release tablet 10 mg,orally,once a day. Observation group additionally received Tripterygium glycosides tablet 20-30 mg,orally taking after a meal,3 times a day. All patients treated for 3 weeks,patients’life way remained unchanged during treatment. Clinical efficacy,total score of symptoms, IL-2,IL-6,CRP levels and the incidence of adverse reactions in 2 groups were observed. RESULTS:The total effective rate in observation group was significantly higher than control group,with significant difference (P<0.01). After treatment,the total score of symptoms,IL-2,IL-6,CRP levels in 2 groups were significantly lower than before,and observation group was lower than control group,with significant differences(P<0.05 or P<0.01). The incidence of adverse reactions in observation group was significantly lower than control group,with significant difference (P<0.05). CONCLUSIONS:Tripterygium glycosides combined with mizolastine shows better efficacy than mizolastine alone in the treatment of dermatitis and eczema,with better safety.

Objective To characterize the effects of AQP1 expression on kidney damage in rat disseminated intravascular coagulation(DIC) caused by lipopolysaccharide(LPS) dosing. Method Fifty male Wistar rats (clean grade) were randomly assigned into 5 groups of 10 rats. The 10 control rats were dosed with 10 ml of 0.9%NaCl solution by a drip via the vena caudalis within 4 h, and blood and tissues were obtained after treatment completion. In the DIC groups, the rats were dosed with LPS (30 mg/kg body weight in 10 ml of 0.9% NaCl solution) by a drip via the vena caudalis within 4 h, and blood and tissues were obtained at 4, 6, 8 and 10 h. The blood platelet(PLT) count, prothrombin time(PT) , activated partial thromboplastin time(APTT), fibrin(FIB) and D-dimer(D-D) were detected. Hematoxylin and eosin(HE) staining was used to examine the pathologic changes in the lung and kidney tissues of each group (both hematologic parameters and tissue pathologic changes were used to judge the course of DIC). The AQP1 gene expression levels in the kidney tissues from the groups were evaluated by the mRNA levels using RT-PCR. Statistical analyses were performed by the SNK- q method. Results The PLT count, PT, APTT, FIB and D-D examinations revealed remarkable changes in all DIC groups compared with the control group (P < 0.01). The AQP1 mRNA level was significantly decreased in the DIC group at 4 h compared with the control group (P < 0.01) , and further decreased to the minimum level in the DIC group at 6 h. Moreover, cloudy swelling of renal tubular cells was observed at 6 h and cell degeneration and necrosis were observed at 8 h among the DIC groups. Conclusions Downregulation of AQP1 mRNA expression occurred before damage to the renal tubular cells in DIC, indicating that AQP1 expression may be involved in the kidney damage observed in rat DIC.

Objective To investigate the effect of di-(2-ethylhexyl) phthalate (DEHP) on the postnatal lung development in newborn rats.Methods A total of 60 newborn Sprague-Dawley rats (weighing 5.0-8.0 g) in five age groups were studied in the first experiment.The rats were divided based on the different postnatal ages:postnatal day (PND)I,PND4,PND7 and PND14.A total of 45 newborn Sprague-Dawley rats (weighing 5.0-8.0 g) were randomly divided into three groups according to the dosage of DEHP administered in the second experiment.The newborn rats were administered DEHP through intraperitoneal injection at 10 (low-dose subgroup),100 (medium-dose subgroup) or 750 (high-dose subgroup) mg/kg daily from PND1 to PND13.The rats were sacrificed on PND14.Pups were sacrificed with lethal dose injection of pentobarbital sodium.The lung was removed.The right middle lobes were used for analysis.The tissue was processed for histology and lung sections were stained with HE for light microscopic (LM) morphometric measurement.The analysis was performed by means of a digital image analysis system,including pulmonary interstitial area ratio (IAR) and total length density of all segments.One-way ANOVA,LSD and Dunnet T3 methods were used for statistical analysis.Results In the normal controls,IAR decreased significantly by (31.97±5.03) ％,(30.05±3.57)％,(25.33± 1.83)％ and(22.01 ±2.19)％,respectively,from PND1 to PND14 (P＜0.05 or P＜0.01).IAR in medium-and high-dose subgroups increased significantly by (24.11 ±2.78)％ and (26.53± 3.42)％,respectively on PND 14.The total length density of all segments in unit area lung volume increased significantly by 0.047 8±0.003 7,0.050 0±0.002 9,0.071 2±0.003 0 and 0.084 4±0.004 3,respectively from PND1 to PND14 (P＜0.01).In the DEHP treated animals,when compared with the control group,IAR was significantly higher on PND14 (P＜0.05 or P＜0.01),while the total length density of all segments in unit area lung volume was significantly decreased (P＜0.05 or P＜0.01).Length density in medium-and high-dose subgroups were higher than that of low-dose subgroup by 0.082 9±0.001 8,0.077 2±0.002 0 and 0.071 3±0.003 7,respectively on PND14 (P＜0.05 or P＜0.01).Conclusions Medium-and high-dose DEHP affect the postnatal lung development in rats in a dose-dependent mode.

Aim To investigate the effect of Jinlida on cholesterol-related genes in skeletal muscle in fat-in-duced insulin resistance ApoE-/ - mice. Methods Ten male C57 BL/6 J mice were selected as normal group ( NF );50 male ApoE-/ - mice with a high-fat feeding after 16 weeks ( HF) were divided into model group, rosiglitazone ( LGLT ) , Jinlida low dose group ( JLDL, 0. 95 g · kg-1 · d-1 ) , Jinlida medium dose group ( JLDM, 1. 9 g·kg-1 ·d-1 ) , Jinlida high dose group (JLDH, 3. 8 g·kg-1·d-1), which were per-formed intragastric administration for 8 weeks. Oil red O staining of mouse skeletal muscle was used for fat ac-cumulation. Insulin receptor ( INSR) , insulin receptor body substrate-1 ( IRS-1 ) , low-density lipoprotein re-ceptor ( LDLR ) , cholesterol sensor ( SCAP ) mRNA and protein expression in mouse skeletal muscle were measured by quantitative reverse transcription PCR ( RT-PCR ) and Western blot. Results Compared with NF group, fasting blood glucose ( FBG) , choles-terol ( TC ) , triglyceride ( TG ) and low density lipo-protein cholesterol ( LDL-C ) of HF mice were signifi-cantly elevated, while high-density lipoprotein ( HDL-C ) significantly decreased ( P < 0. 05 ) . Compared with HF group, Jinlida group could reduce to varying degrees FBG, TC, TG and LDL-C in mice, and in-crease HDL-C ( P <0. 05 ) . Jinlida could downgrade fasting serum insulin ( FINS ) level, and improve the insulin sensitive index ( ISI ) ( P < 0. 05 ) . Jinlida could obviously improve skeletal muscle fat accumula-tion of mice. Compared with NF group, skeletal mus-cle INSR, IRS-1, LDLR mRNA and protein levels of HF group were significantly decreased ( P <0. 05 ) , while SCAP mRNA and protein level increased signifi-cantly (P<0. 05). Compared with HF group, Jinlida could increase to varying degrees INSR, IRS-1, LDLR mRNA and protein levels ( P < 0. 05 ) , and lower SCAP mRNA and protein levels ( P<0. 05 ) . Conclu-sion Jinlida can alleviate fat-induced insulin resist-ance in ApoE-/ - mice through regulation of cholester-ol-related gene expression.

Objective To compare the differences of lung pathological changes of acute lung injury in mice in-duced by lipopolysaccharide ( LPS) and graphite particles, and to explore the possible mechanisms of acute lung injury in-duced by fine particles of different origins.Methods 140 male specific-pathogen-free Kunming mice weighing 18-20 g were randomly divided into 7 experimental groups, in addition to the normal control group.The experimental groups were treated by intratracheal instillation of LPS solution or graphite powder suspension in different doses, respectively, to induce acute lung injury in the mice.The mortality of the mice was observed, and pathological changes of the lung tissues were ex-amined by light and transmission electron microscopy.Western blot was used to detect the protein expression of neutrophil elastase ( NE) in lung tissues , and real-time quantitative PCR was used to detect mRNA expression of monocyte chemotac-tic protein-1 ( MCP-1) in the lung tissue .Results Compared with the normal control group, some pathological changes were observed in the lung tissues of the groups L ( LPS) and G ( graphite) .There were numerous macrophages in the lung tissues in the group G mice, and exudate, mainly neutrophils, in the lung tissues of the group L.The NE protein expres-sion in the lung tissue was significantly higher than that of the normal control group ( P<0.05) , and there was also a sig-nificant difference between the groups L and G (P<0.05).The MCP-1 mRNA expression in lung tissues was higher in the control group (P<0.01), and there was also a significant difference between the groups L and G (P<0.01).Conclu-sions Diverse types of particulate matters induce different pathological changes in the lungs, therefore the mechanism may also be different in the inflammatory responses.It means that the lung injuries caused by fine particles of mixed composition may have complex mechanisms.

Objective: To observe the effects of different frequencies of pricking-bloodletting at auricular points plus auricular point sticking therapy on the levels of the serum immunoglobulin G (IgG), immunoglobulin M (IgM), testosterone (T), and insulin-like growth factor-1 (IGF-1) in patients with acne vulgaris (AV). Methods: Ninety patients with AV were randomly assigned to treatment group 1, treatment group 2, and treatment group 3 according to the random number remainder grouping method, with 30 cases in each group. All three groups received pricking-bloodletting at auricular points plus auricular point sticking therapy. Treatment group 1 was treated once a week, treatment group 2 was treated twice a week, and treatment group 3 was treated 3 times a week. Four-week treatment was taken as 1 treatment course, and 3 treatment courses were observed. On the day before the start of the study and on the day next to the end of each course, the global acne grading system (GAGS) score was recorded, and 3 mL of blood from the median cubital vein was collected to test the serum levels of IgG, IgM, T, and IGF-1. After 3 courses of treatment, the efficacy index was calculated according to the GAGS score, and the serum indicators in patients with effective treatment (efficacy index ≥20％) and complete sampling were analyzed. Results: A total of 60 patients were included in the final blood indicator analysis. After 3 courses of treatment, the intra-group comparisons showed that the serum IgG level increased significantly in patients in treatment group 1 (P<0.01); the serum T level decreased significantly in the female patients in treatment group 2 (P<0.05); the IGF-1 level significantly decreased in the patients in all three groups (P<0.05 or P<0.01). There were no significant differences in the serum levels of IgG, IgM, T, and IGF-1 among the three groups at each time point (P>0.05). Conclusion: Pricking-bloodletting at auricular points plus auricular point sticking therapy can affect the levels of serum IgG, T, and IGF-1 in AV patients. The level of the serum IGF-1 can be reduced by treatment once a week, twice a week, or 3 times a week. Treatment once a week can increase the patients' serum IgG level, and treatment twice a week can significantly decrease the serum T level in female patients. Reducing the serum IGF-1 level may be one of the action mechanisms of pricking-bloodletting at auricular points plus auricular point sticking therapy in treating AV.

OBJECTIVE: To assess the value of chromosomal microarray analysis (CMA) for fetuses with choroid plexus cysts (CPC) detected by prenatal ultrasonography. METHODS: Amniotic fluid chromosomal karyotype was analyzed in 104 fetuses with CPC, and copy number variations (CNVs) among the fetuses were detected by using CMA. RESULTS: Ten fetuses (9.62%) were found to have an abnormal karyotype, and 14 additional CNVs were detected in those with a normal karyotype. The fetuses were divided into isolated CPC group (n = 87) and non-isolated CPC group (n = 17) based on the presence of additional ultrasonographic abnormalities. The detection rates for karyotypic abnormalities of the two groups were 4.6% and 35.3%, respectively, whilst those for the CMA were 4.6% and 47.1%, respectively. The detection rates for karyotypic abnormalities and CMA of the non-isolated CPC group were significantly higher than those of the isolated CPC group (P < 0.05). The detection rate for CMA in the non-isolated group was significantly higher than chromosomal karyotype abnormalities (P < 0.05). Among the 8 fetuses with abnormal CMA, 4 had single umbilical artery, 3 had abnormal cardiac structure, and 2 had enhanced intestinal echo. CONCLUSION CPC is closely associated with chromosomal abnormalities. Chromosome karyotype analysis in combination with CMA can effectively detect fetal chromosomal abnormalities and provide a basis for genetic counseling.
Humans ; Female ; Pregnancy ; DNA Copy Number Variations ; Choroid Plexus/diagnostic imaging* ; Microarray Analysis ; Karyotype ; Chromosome Aberrations ; Amniotic Fluid ; Cysts