Objective:To analyze the current situation of Investigator-Initiated Trials in medical and health institutions in Shandong Province, the problems in the process of conducting clinical research, and put forward proposals for the establishment of a clinical research management system with effective supervision, sound systems and supporting services, taking into account the progress of the projects since the pilot work was carried out.Methods:A questionnaire was created, an online survey was conducted, a database was set up, a status analysis was conducted and a post-launch analysis of the progress of the pilot was carried out using the National Medical Research Registry Information System, culminating in recommendations using the literature summary method and empirical analysis.Results:Statistical analysis of the questionnaire found that 29.39% of the institutions have a dedicated clinical research management department, and 75.97% of the institutions have a management approach. 25.52%, 40.30%, and 43.07% of institutions established biobanks, clinical research centers, and follow-up centers. There was a statistically significant difference in the establishment of clinical research centers, biobanks, and follow-up centers in secondary and tertiary medical institutions ( P<0.05). The number of general clinical research projects filed, the number of submissions and the number of ethics committees filed in the filing system have all increased significantly after the pilot work, with growth percentages of 126%, 141% and 62% respectively. Conclusions:Shandong Province clinical research pilot work has begun to bear fruit, the current clinical research project still exists in the lack of special funding support, perfect service platform and system support and training system to be improved and other issues.

Objective:To explore the role played by clinical pharmacists in the formulation and pharmaceutical care of individual-ized administration of warfarin. Methods:Clinical pharmacists adopted maximum a posteriori Bayesian method to formulate the dosage regimen of patients treated with warfarin and monitored the implementation process. The increase of INR was timely identified on ac-count of drug interactions to avoid bleeding events,as well as the decrease of INR caused by patients' medication mistakes to avoid re-currence of thrombosis. Results:The maximum a posterior Bayesian estimation method could be used to estimate and guide clinical medication,which showed great reference value for individualized drug regimen. Conclusion:Clinical pharmacists should formulate in-dividualized administration plan according to genetic testing results and choose optimal treatment for patients. Moreover,the implemen-tation of dosage regimen should be monitored during the whole progress,so as to timely find INR abnormal fluctuations due to disease interactions,drug interactions,poor treatment compliance and so on,and consequently improve anticoagulant effect and reduce adverse reactions such as bleeding and thrombosis etc.

Objective: To explore the effects of genetic factors and non-genetic factors on warfarin dosage in pregnant women after heart valve replacement. Methods: Totally 68 pregnant women were treated with warfarin throughout pregnancy. PCR-chip method was used to detect the polymorphism of CYP2C9 and VKORC1 gene,and the clinical data were collected. The effects of genetic factors and non-genetic factors on stable dosage of warfarin were statistically analyzed. Results: CYP2C9, VKORCl genotypes and weight had sig-nificant effects on warfarin dosage. The three variables could explain 44. 6% of warfarin individual differences. Conclusion: Genetic factors have significant effect on warfarin dosage in pregnant patients, so the detection of genetic polymorphism of CYP2C9 and VKORCl can be applied to individualize warfarin dosage in pregnant patients with heart valve replacement.

Objective To study the characteristics of Chinese ischemic stroke subclassification (CISS) in relation with migration to different climatic zones in autumn and winter.Methods Ninety-six subjects who travelled from northeast China,northwest China and north China to Hainan Province from September 2012 to February 2017 and were admitted to our hospital due to cerebral infarction occurred within 3 weeks after they arrived at Hainan were included in this study.Their demographic data,risk factors for cerebrovascular disease,laboratory blood test and imaging parameters were recorded.The patients were classified according to their medical history,auxiliary examination findings and CISS.The recorded data were statistically analyzed.Results CISS showed that penetrating artery disease,large artery atherosclerosis,cardiogenic stroke,and undetermined etiology accounted for 50.0％,38.5％,4.2％,7.3％ respectively.Hypertension (70.8 ％) and abnormal glucose metabolism (61.5％) were the major risk factors for cerebral in farction.Conclusion The incidence of penetrating artery disease is the highest,followed by that of large artery atherosclerosis in cerebral infarction patients.Alert to cerebral infarction should thus be stressed for those with hypertension and abnormal glucose metabolism who are going to travel in autumn and winter.

Objective To systematically assess whether cilostazol can delay the progression or decrease the carotid intima-media thickness (clMT).Methods Papers on the effect of cilostazol on cIMT in randomized controlled trials and cohort studies were retrieved from a number of foreign and domestic databases.The data were analyzed by Review Manager 5.3.Results Six randomized controlled trials and two cohort studies were included in this study.A total of 1107 patients were divided into cilostazol therapy group (n=533) and control group (n=574).Meta-analysis showed that cilostazol therapy for 6 months,12 months,≥24 months could reduce the maximum cIMT with a mean difference of-0.04 mm (95％CI:-0.05--0.03,P=0.000),a mean difference of -0.04 mm (95％CI:-0.05--0.03,P=0.000) and a mean difference of-0.08 mm (95％CI:-0.11-0.05,P =0.000) respectively.Conclusion Cilostazol therapy for 6 months,12 months,24 months or more than 24 months can reduce the maximum cIMT,which is needed to be confirmed by studies with a large sample of clinical data.

Objective To investigate antimicrobial resistance of Escherichia coli (E.coli)and Klebsiella pneumoniae (K.pneumoniae),antimicrobial use density(AUD),as well as relation between antimicrobial resistance and AUD in a ter-tiary first-class hospital.Methods Antimicrobial resistance rates of clinically-isolated E.coli and K.pneumoniae,AUD of carbapenems and quinolones,as well as relation between resistance and AUD in 2013-2015 were statistically analyzed. Results Correlation analysis of antimicrobial resistance of bacteria and AUD showed that the decrease in resistance rate of E.coli to levofloxacin was related to the decrease in the use density of quinolones(r=0.61,P=0.03);increase in resist-ance rate of K.pneumoniae to imipenem was related to the increase in the use density of carbapenems(r=0.78,P<0.01). Conclusion Antimicrobial use is one of the causes of bacterial resistance,management on antimicrobial use needs to be strengthened to reduce the threat of bacterial resistance to human health.

The nursing experience of one hemaphagocytic syndrome patient with skin damage complication who underwent haploidentical hematopoietic stem cell transplantation were summarized. The patients gradually appeared ulceration of elbow joint skin, perianal mucosa, and bilateral axillary skin during the phase of agranulocytopenia and immune inhibition after transplantation. The overall skin ulceration area was accounted for 13% of total body surface area. We chose different dressings, combination anti-infection with promoting wound healing for nursing and achieved great effect. The skin lesions gradually healed and the patient went to the general ward successfully.

This study was aimed to reveal the material basis on different diseases of the same syndrome damp-heat syndrome from the level of metabonomics.The typical damp-heat syndrome patients diagnosed as chronic viral hepatitis B,non-alcoholic fatty liver disease,or chronic glomerulonephritis were included,with 30 cases in each disease.There were 30 healthy volunteers in the control group.The serum samples were detected by UPLC-QTOFMS and GC-TOFMS.And then,the results were analyzed by variance analysis in order to find out the generality and specificity of metabolic material in three different diseases with damp-heat syndrome.The results showed that through comparisons of different diseases with damp-heat syndrome,as well as the healthy group as control,it was revealed that inosine,uridine,aspartic acid,oleic acid glyceride and lactate were the same substances of three diseases of damp-heat syndrome.It was concluded that based on metabonomics,as for three different diseases with damp-heat syndrome,there were different substances among different diseases,but common substances related to damp-heat syndrome.Thus,it provided objective evidences for the theory of different diseases of the same syndrome in traditional Chinese medicine (TCM) from the level of metabonomics.

This study was aimed to analyze compatibility rules of Chinese drugs and prescription design in the pre-vention and treatment of scleroderma. The database of scleroderma treated by Chinese medicine was set up. And then, association rules were used to analyze the prescription compatibility rules. The results showed the highest fre-quency of drugs in the treatment of scleroderma were Astragalus, Angelica sinensis and Salvia. The tonifying and re-plenishing medicinal, blood-activating and stasis-resolving medicinal and exterior-releasing medicinal were with the highest frequency. The commonly used formula in the treatment of scleroderma was Y ang-He decoction. For herbal groups, occurrence of the highest was the combinations of Ramulus Cinnamomi-Astragalus and Carthamus tinctorius L.-Astragalus. Three kinds of herbals were commonly coupled, such as Polygonum multiflorum Thunb. and Caulis Spatholobi with Salvia, P. multiflorum Thunb. and R. Cinnamomi with Salvia, P. multiflorum Thunb. and Astragalus with Salvia, prepared Radix Rehmanniae and Codonopsis with C. tinctorius L., prepared Radix Rehmanniae and Codonopsis with R. Cinnamomi, Codonopsis and Radix paeoniae rubra with R. Cinnamomi. Four kinds of herbals such as R. Cinnamomi, Glycyrrhiza uralensis Fisch., Astragalus and Codonopsis were commonly coupled. It was con-cluded that compatibility rules of Chinese medicine in the prevention and treatment of scleroderma laid the founda-tion for herbal medicine selection and prescription design.

This study was aimed to prepare the spraying agent of prescriptions of Miao nationality herb and investigate the effect of Miao nationality herbs spray for serum SOD, MDA, and expression of Fas and Caspase-3 mRNA in lung tissues of silica-treated rats. The healthy SD rats were divided into 5 groups. Silica dust suspension was used in the model establishment of 4 groups. After the model was successfully established, 3 groups were randomly selected and given glucocorticoids atomization inhalation, Miao nationality herbs spray, Miao nationality herbs spray combined with intragastric administration of herbal medicine, respectively. After 40-day treatment, water-solubletetrazolium salt (WST-1) was used in the detection of serum superoxide dismutase (SOD). Thiobarbituric acid (TBA) was used in the detection of malondialdehyde (MDA). The mRNA expression variance of the Fas and Caspase-3 were detected by RT-PCR. The results showed that compared with the silica dust suspension group, the SOD activity of serum in the Miao nationality herbs spray group was significantly increased (P< 0.05). MDA content and the mRNA of Fas and Caspase-3 were significantly lower in the Miao nationality herbs spray group (P< 0.05). It was concluded that Miao nationality herbs spray group was able to increase the SOD activity of serum, decrease MDA content, and obviously decrease the expression of Fas and Caspase-3 of lung tissues among silica dust suspension rats.