Objective To put forward suggestions for improving the writing standards of package inserts of Chinese patent drug in China. Methods Totally 84 package inserts of Chinese patent drug were chosen randomly. The labeled items in them would be investigated and analyzed according to legal documents in China. Results The rate of complete labeled items was 0%. Meanwhile, many problems existed in the items which affected medication safety seriously. In addition, there were defects in expression of the content, revision of package inserts of Chinese patent drug and so on. Conclusion It is urgent to improve the writing standards and the completeness of the labeled items as well as the scientificalness on the expressions of package inserts of Chinese patent drug.

Objectives To determine the predictive effect of the transvaginal ultrasonographic cervical measurement in induction of labor among the nulliparous. Methods This prospective observational study recruited women with singleton gestation scheduled for induction of labor at ≥37 weeks. All the pregnancy women were nulliparous. Transvaginal ultrasonographic cervical measurement was performed and Bishop score was detemined, each by operators masked to the other measurement. Data were collected on parity, gestational age, mode of delivery, induction agent, induction onset of labor interval, Bishop score and cervical measurement. Results A total 121 women were included. A stepwise regression model identified cervical length was the best linear predictor of induction to onset of labor interval. ( r=0.67, P

Objective To evaluate the clinical effect of hepatocellular carcinoma treatment with a combination therapy of transcather arterial super liquefied lipiodol embolization and cytokine-induced killer cell(CIK) infusion.Methods There were 3 groups in this study,group 1:38 cases of HCC patients treated with a combination therapy of transcather arterial super liquified lipiodol embolization and CIK infusion;group 2:80 cases of HCC patients treated with a combination therapy of transcather arterial super liquefied lipiodol embolization and percutaneous intratumoral ethanol injection;group 3:134 cases of HCC patient treated with transcather arterial super liquefied embolization.Finally,the outcomes of the 3 groups were compared.Results The short term effective rates of group 1,2 and 3 were 76.1%,41.3% and 14.9% respectively,simultaneously with significant difference of changes concerning AFP value among the three groups especially in group 1 the AFP decrease to normal level while those of the other two groups still remain in higher levels.Conclusions The living quality and survival rate of HCC patients could be improved by a combination therapy of transcather arterial super liquefied lipiodal embolization and CIK infusion.(J Intervent Radiol,2007,16:235-239)

Objective To investigate the impact of the gestational diabetes mellitus and abnormal glucose challenge test (GCT) on macrosomia. Methods Clinical data of 8656 pregnant women who had antenatal care and delivered in the Department of Obstetrics and Gynecology of the First Hospital of Peking University from Jan 1995 to Mar 2001 were retrospectively analyzed. All of them underwent 50 g GCT. Results The incidence of macrosomia was 8.1% (700/8656). The incidence of macrosomia in GDM or IGT women was 12.5%(69/552), which was significantly higher than that of other women with normal glucose level 7.8%(631/8104, P

Objective To observe the changes of cervix in women between 16 and 35 weeks of gestation using transvaginal ultrasound and to determine the value of the cervix length in predicting preterm delivery among the women with threatened preterm labor Methods Transvaginal sonography were performed in 154 normal single nulliparous pregnant women between 16 and 35 weeks of gestation and 58 women with threatened preterm labor but without premature rupture of membrane Results (1) There is no definitely change in either cervical length or internal diameter of cervix among the pregnant women over the studied period There was also no funneling to be observed The mean cervical length is (36?5) mm,and the mean cervical internal diameter is (4?1) mm (2) Eleven preterm deliveries occured among the 58 pregnancy women with threatened preterm labor The cervical length by sonography of 11 preterm deliveries was (18?6) mm,and was significant shorter than the women without preterm deliveries whose mean cervical length was (32?6) mm ( P

Objective To prepare 5-aminolevulinic acid (ALA) and hematoporphyrin monomethyl ether (HMME) hydrogel suppositories and to evaluate their photosensitizer transfer efficiencies in rectal tumor tissue.Methods The BALB/c mice implanted SW837 rectal cancer cells subcutaneously were randomly divided into four groups:intrarectal suppository administration group,cutaneous administration group,intratumoral injection group and intravenous injection group.Fluorescence spectrophotometry was used to measure the concentration of protoporphyrin Ⅸ (PpⅨ) and HMME in rectal wall,skin and tumor tissue.The distribution of photosensitizer was determined by a fluorescence spectroscopy system.Results The concentration of PpⅨ in the ALA suppository administration group was 9.76 times (1 h) and 5.80 times (3 h) higher than that in the cutaneous administration group,and the differences were statistically significant (all P＜0.05).The maximal penetration depth of ALA in tumor tissue was about 3-6 mm at 2 h after the cutaneous administration.After the HMME suppository administration,the concentration of HMME in the rectal wall was very low.The maximal penetration depth of HMME in tumor tissue was less than 2 mm after the cutaneous administration.Conclusions ALA is more likely to penetrate mucosal barrier compared to skin tissue.The hydrogel suppository based rectal administration is expected to be a new administration method for the rectal cancer photodynamic therapy using ALA.

Objective To explore the killing effect of dielectric barrier discharge (DBD) plasma on tumor cells and to analyze the DBD-induced apoptosis mechanism.Methods Thiazolyl blue tetrazolium bromide (MTT) assay method was used to detect the killing effect of low temperature plasma on the cytotoxicity of normal spleen leukocytes and acute promyelocytic leukemia cells (LT-12) at different doses.The changes of reactive oxygen species (ROS) level were measured after plasma treatment.The cell apoptosis rate was detected by Annexin V/PI double staining at different doses.The expression of apoptosis-related genes and proteins was detected by qRT-PCR and Western Blot.Results MTT results showed that the killing effect of plasma treatment was dose-dependent and time-dependent.The cell survival rate after 8 hours of treatment decreased from 98％ to 63％ with the dose increasing from 30 s to 240 s.The survival rate decreased from 78％ (2 h) to 39％ (24 h) after the treatment with a same dose (e.g.240 s).Annexin V/PI double staining results demonstrated that the plasma effect can induce apoptosis,and the apoptosis rate was not only positively correlated with the plasma dose,but also with the post-plasma time.The longer the post-plasma time,the higher was the apoptosis rate.The apoptotic rate of the 60 s dose treatment after 12 h was 48％ that increased to 55.3％ with the dose of 120 s.The production of reactive oxygen species (ROS) detected by flow cytometry also showed a time correlation of the plasma treatment.After the plasma treatment,the ROS level immediately increased to 1.24 times,and sharply increased to 5.39 times after 20 h post-plasma.The experimental results of qRT-PCR and Western blot showed that the expression of the genes and proteins of Caspase family and Bcl-2 family was very active at 8 to 12 h post-plasma treatment.Conclusions Low-temperature plasma can effectively kill tumor cells,and apoptosis is the main mechanism of death.The molecular mechanism of apoptosis of tumor cells induced by low temperature plasma was preliminary confirmed.

Objective To investigate radiological features of patients with heroin spongiform leukoencephalopathy(HSLE)of different clinical stages and discuss the evolutional characteristics of the disease.Methods Thirty two patients with HSLE underwent precontrast MRI and postcontrast MRI.The history of addiction,clinical presentations,and brain MRI were analyzed and summarized according to the patient's clinical staging.There are 6 cases in Ⅰ stage,21 cases in Ⅱ stage,5 cases in Ⅲ stage.Results All patients had history of heroin vapor inhalation.Most of the cases developed subacute cerebellar impairment in earlier period.Brain MRI revealed symmetrical lesion within bilateral cerebellum in all patients.Splenium of the corpus callosum,posterior limb of the internal capsule,deep white matter of the occipital and parietal lobes,were gradually involved with progressive deterioration of HSLE.The brain stem and deep white matter of the frontal and temporal lobes were involved in some cases.Conclusions The history of heated heroin vapor inhalation was the prerequisite for the diagnosis of HSLE.Brain MRI presented the characteristic lesion and its evolution of HSLE.Brain MRI was very important for accurate diagnosis and helpful to judge the clinical stages according to the involved brain region.

Objective To evaluate the influence of dosage,operation method,adverse reaction of endoscopic photodynamic therapy (EPDT) on its therapeutic efficacy in rabbit models of in-situ rectal cancer,so as to provide preclinical basis of photodynamic therapy for rectal cancer.Methods 20 rabbits with in-situ VX2 rectal cancer were randomly divided into control group,PDT low dose group,intermediate dose group,and high dose group.At 24 h before PDT,photosensitizer (hermimether) was intravenously injected into rabbits.630 nm semiconductor laser was used as light source.The growth of the tumor was observed by conventional endoscopy and endoscopic ultrasonography,and the survival time,general conditions and adverse reactions were recorded.The histopathological changes were observed by hematoxylin-eosin staining.Results At 7 d after PDT,the total response rates of low dose,intermediate dose and high dose group respectively were 40％ (slight),80％ (60％ remarkable and 20％ slight),100％ (20％ remarkable and 80％ slight).The average survival times of the three groups were 14 d,10 d and 5 d,respectively.The main adverse reactions were inflammation,intestinal obstruction,intestinal peristalsis loss and death.Conclusions The dosage of PDT is an important factor to influence the curative effect.The appropriate dose of PDT will have a better effect on the treatment of rectal cancer.A thorough study of these problems is helpful to the clinical application of PDT in the treatment of rectal cancer.

Animals ; Bromodeoxyuridine ; metabolism ; Cerebral Cortex ; injuries ; Immunohistochemistry ; Male ; Nerve Regeneration ; Rats ; Rats, Sprague-Dawley