OBJECTIVE: To discuss the development of drug data protection in China. METHODS: The specific data protection measures taken by United States (US) and the European Union (EU) were compared and the drawbacks of China drug data protection were analyzed; then some suggestions were put forward. RESULTS & CONCLUSION: The drug data protection in China is still only in its infancy. The Chinese government and drug administration should work out definite drug data protection bylaws by drawing experiences from US and EU.

Objective To study the different periods of childhood bronchial asthma induced sputum of the percentage change of inflammatory cells,and to explore part of the pathogenesis of asthma in children.Methods 69 children with asthma(the age ≥5 years old) were selected.By clinical symptoms,they were divided into acute exacerbation and clinical remission of 3 months and 6 months.At the same time,in the same groups of hospital pediatric clinic,22 healthy children were chosen as control group.The percentage of neutrophils and eosinophils in induced sputum was detected.Through the comparison,we can explore the correlation between the two kinds of inflammatory cells in different periods of asthma.Results Comparing the percentage of neutrophils among the four groups,acute exacerbation group was compared with clinical remission three months group,clinical remission six months group and the normal control group,acute exacerbation group was higher than the clinical remission group of three months,clinical remission of six months and normal control group [(57.905 ± 11.615)％ vs (40.137 ± 11.668)％,(33.825 ± 12.457) ％,(23.836 ± 13.585) ％,P =0.039,0.000,0.000].The clinical remission of three months and clinical remission six months group were higher than the normal control group(P =0.000,0.032).The clinical remission of three months group and 6 months group had no significant difference (P =0.538).The percentage of eosinophils in acute exacerbation group was higher than the clinical remission of three months group,clinical remission of six months and normal control group [(4.090 ± 1.452) ％ vs (2.685 ± 1.190) ％,(2.151 ± 1.417) ％,(1.848 t 0.887) ％,P =0.002,0.000,0.000].The clinical remission of three months group and the normal control group had no significant difference (P =0.937).Conclusion Asthma in children induced sputum neutrophil percentage and eosinophil percentage are significantly higher in acute exacerbation.The study shows that neutrophils and eosinophils are involved in the part of the pathogenesis of bronchial asthma in children.

Objective To establish a method for the determination of Chrysophanol in Jiangzhiling Capsules. Methods RP-HPLC was used for samples separating on a Nova-Pak C18 column. The mobile phase consisted of methanol-0.1 %H3PO4(85 ∶15). The detection wavelength was 254 nm and the flow rate was 1 mL?min-1.Results The standard curve of Jiangzhiling Capsules was linear in the rang of 0.037 5～0.750 0 ?g (r=0.999 9) with average recovery of 98.31 %(RSD=1.36 %). Conclusion The method is simple,accurate and precise. It can be used effectively for the quality control of Jiangzhiling Capsules.

OBJECTIVE: To investigate the effects of carvedilol on blood pressure in hypertension patients and vascular endothelial function. METHODS: 100 inpatients with primary hypertension were collected from our hospital from Jan. 2008 to Jan. 2010 and randomly divided into treatment group and control group(n=50). Treatment group were given initial oral dose of carvedilol tablets 6.25 mg twice a day for 7～14 days if it was tolerated; the dose of carvedilol tablets increased to 12.5 mg or 25 mg twice a day according to blood pressure at trough concentration if it was necessary. Control group were given carvedilol tablets 6.25 mg twice a day if it was tolerated. After 1 week, control group received double dose of metoprolol with maximum dose of carvedilol of 50 mg. The treatment course was 3 months. The contents of NO and ET in serum of 2 groups were detected. Antihypertensive effect and effects of carvedilol on vascular endothelial dilatation and systolic function were observed and compared between 2 groups. RESULTS: After treatment, the systolic and diastolic blood pressure in both groups were decreased significantly(P

Objective To investigate the influence of t he mass screening on the diagnostic status of the conventional ordinary prostati c cancer (CaP). Methods Sixty seven cases of prostate ca ncer detected by mass screening (January 1996～December 2001) and 358 cases diag n osed at the outpatient of various hospitals in Changchun (January 1986～December 2001) were compared in terms of age distribution,clinical stages,level of serum prostate special antigen(PSA),pathological grade and treatment modalities,with a SPSS analysis system. Results The annual average incide nce of CaP during 1999 to 2001 increased 4.72 times when compared to the 1986 to 1989’s.In the screening group,the cases with clinical stage A and B accounted for 58.2%. In the clinical group, it was only 27.9%,and mostly detected incident ally.Furthermore,in the screening group the percentage of the cases beyond 20 ng /ml PSA and of poorly differentiated carcinoma were much lower compared to the c linical group.These differences were statistically significant.The cases of radi cal prostatectomy in the screening group increased 15.3% compared with that of t he clinical group. Conclusions Only the mass screening c an really reveal the actual prevalence of prostate cancer.It can markedly raise the number of prostate cancer,especially the cancer in the early stage.The mass screening is inevitable to detect the curable early stage prostate cancer.

Objective: To evaluate the effect and safety of neoadjuvant chemotherapy combined with PA-MSHA injection for breast cancer patients. Methods: An open randomized controlled clinical trial was con-ducted. Fourty patients with breast cancer were randomly assigned to neoadjuvant chemotherapy group (the control group, n=20) and neoadjuvant chemotherapy combined with PA-MSHA injection group (the experi-ment group, n=20). The evaluation of therapeutic effect was carried out when the treatment was completed. Kamofsky score was recorded before and after therapy. Venous blood was drawn before and after therapy and immune function (IFN-γ, IL-2, IL-4, and IL-10) and other indicators (Caspase-3, VEGF, MMP-2 and MMP-9) were measured by double antibody ELISA test. Adverse effects of PA-MSHA during therapy were ob-served and recorded. Results: The overall response rate (RR) in the experiment group was significantly higher than that in the control group (P<0.05). No significant difference was found in the pathologic complete remis-sion (pCR) between the experiment group and the control group (P>0.05). In the experimental group, pCR was significantly different before and after therapy (P<0.01). The score in the experimental group was signifi-cantly higher than that in the control group after therapy (P<0.01). With the treatment of chemotherapy and PA-MSHA injection, IFN-γ and IL-2 levels were significantly higher while IL-4 and IL-10 levels were significant-ly lower in the experiment group (P<0.05). A significant increase in serum Caspase-3 and a significant de-crease in serum VEGF, MMP-2 and MMP-9 (P<0.05) after therapy were also observed in the experimental group. The level of serum MMP-9 was decreased significantly (P=<0.05) after therapy in the control group. Con-clusion: Neoadjuvant chemotherapy combined with PA-MSHA injection can significantly improve the RR of breast cancer patients, enhance their cellular immune function, induce the apoptosis and restrain the metasta-sis of breast cancer cells. The PA-MSHA has been proved to be an ideal supplementary therapy for breast cancer.

Objective To analyze the composing experience of Menghe physician Ma Peizhi for cough by TCM inheritance support system. Methods The prescriptions for cough of Ma Peizhi were collected, frequency and association of drugs were analyzed by using data mining methods such as revised mutual information, complex system entropy cluster and unsupervised hierarchical cluster. Results Based on the analysis of 57 prescriptions, the frequency of each herb and association rules among the herbs were computed, 18 core combinations and 9 new prescriptions were mined from the database. Conclusion Menghe physicians Ma Peizhi is well experienced in expelling wind and opening the inhibited lung, dissolving phlegm and relieving cough. TCM inheritance support system can be used to analyze clinical experience of old TCM doctor.

Objective To investigate the medication rules for the treatment of hepatopathy by national medical masters. Methods The prescriptions for hepatopathy were collected to build a database based on Traditional Chinese Medicine (TCM) inheritance assist system. After analyzed by the data mining, such as apriori algorithm and complex system entropy cluster, the frequency of single medicine and drug combinations that used in prescriptions, and the association rules among drugs were obtained. Results The most frequently used drugs were Herba Artemisiae Capillaris, Tuckahoe, Radix Salviae Miltiorrhizae, Rhizoma Atractylodis Macrocephalae, and Radix Bupleuri, et al. The most frequently used drug combinations were “Radix Salviae Miltiorrhizae, Tuckahoe”, “Rhizoma Atractylodis Macrocephalae, Tuckahoe”, and “Radix Salviae Miltiorrhizae, Herba Artemisiae Capillaris”, et al. And when the confidence of drug association rules was 1, the drug combinations were“Radix et Rhizoma Rhei, Giant Knotweed→Herba Artemisiae Capillaris”,“Radix et Rhizoma Rhei, Radix curcumae→Herba Artemisiae Capillaris”, “Giant Knotweed, Gardenia→Herba Artemisiae Capillaris” and so on. Conclusion The medicines were often with the actions of clearing heat, removing dampness, regulating qi and activating blood circulation, which were used for the treatment of hepatopathy by national medical masters.

Objective To analyze the rules of property of the drugs used by State Medical Master Yan Zhenghua in clinical.Methods The prescriptions used by Pro. Yan were collected to build a database, which was based on traditional Chinese medicine inheritance assistant software. After analyzed by the software, such as using the module to analyze the prescriptions, the medication characters of the prescriptions can be got from the database.Results Drugs of warm nature were used with the highest frequency 7998 times, followed by the cool 7866 times, leveling 6763 times, cold 3942 times, and hot 95 times. From the property of five flavors, the most used flavor of drugs was bitter 15260 times, followed by sweet 10810 times, pungent 10453 times, sour 2794 times, salty 1651 times, mild 1203 times, and astringency 186 times. In the frequency of the channel tropism involved, the highest is of liver channel 14237 times, followed by lung 10452 times and spleen 10061 times.Conclusion Pro. Yan was accustomed to using the drugs that were of warm and cool natures, and sweet and pungent flavors, and also the drugs that have action on the collateral channels of liver, lung and spleen, which were the same as the experience from Pro. Yan.