Some conclusions drawn from explanatory randomized controlled trial (ERCT) lack practical value in application under real-world clinical settings, and there are also some limitations on the generalization of pragmatic randomized controlled trial (PRCT) results. In some countries, real-world studies (RWSs) have been conducted to explore the effectiveness and safety of clinical interventions or postmarketing drugs, which is a new tendency in clinical researches. By reviewing some RWSs carried out in Western countries, we sum up the basic characteristics of the research design, and discuss the differences and connections between PRCT and RWS. The design ideas of RWS are different from PRCT. Researchers in RWS tend to perform long-term evaluation based on large quantities of subjects and quite large sample and focus on outcome measures which are clinically meaningful. Strict control on data collection, management and analysis are very important to RWS and PRCT. Owing to the complexity of clinical interventions and evaluation, PRCT is not completely suitable for clinical researches in traditional Chinese medicine (TCM). It is an inevitable tendency to apply RWS in clinical trials of TCM. We can explore the efficacy of TCM interventions through PRCT, and better understand the effectiveness through RWS. RWS will become a powerful approach to TCM clinical trials and postmarketing evaluation of Chinese medicines.

Objective: To evaluate the effect of RBa-I, an extract of Rosa bracteata Wend1, against withdrawa1 syndrome in morphine-dependent rats and to explore its mechanism. Methods: The mode1 rats of morphine dependent were established. The scores of withdrawa1 syndrome,?-EP level in hypotha1amus and pituitary body were observed to evaluate the effect of RBa-I in rats. Results: RBa-I can antagonize the urging withdrawa1 syndrome in morphine-dependent rats (ora1ly, 5 mg?kg -1 ), and the effect was inferior to chlonidine (oral1y, 0.2 mg?kg -1 ). It can a1so antagonize the natural withdrawal syndrome, decrease the tota1 scores of withdrawa1 syndrome and inhibit the decreasing of body weight. After a seven-day treatment course, the tota1 scores of withdrawa1 syndrome were decreased remarkab1y. The content of ?-EP in hypotha1amus and pituitary body were increased. Conclusion: RBa-I can antagonize the withdrawa1 syndrome of morphine-dependent rats and this may be related to the increase of ?-EP level in hypothalamus and pituitary body in rats.

Objective To observe the changes of lung function before and after radiotherapy with the lung perfusion of single-photon emission computed tomography and compare the difference between radiotherapy plans conducted by functional imagines and anatomical imagines in radiotherapy of patients with non-small-cell lung cancer.Methods A total of 36 patients (26 males and 10 females,aged 36-80 years) with lung cancer diagnosed as stage Ⅰ to stage Ⅲ non-small cell lung cancer confirmed by histological proof were selected.The lung perfusion image was delivered to radiotherapy planning system and the two plan (plan1 and plan 2) were made by lung perfusion image fusion.Plan 1 was only based on the anatomical informations and no lung perfusion images of SPECT considering.Plan 2 was optimized based on the lung perfusion image to reduce the irradiation dose of the normal tissues.The differences of protecting lung function between plan 1 and plan 2 were compared.Results 36 patients were stratified for clinical stage.FV10,fV20,fV30,MLD and PTV90/fV20 were decreased significantly after optimized with IMRT (all P =0.000).FV20,fMLD were decreased by (4.89±2.0) ％,(1.74 ±0.9)％.The IMRT plan based on the lung perfusion fusion images of SPECT could reduce the irradiation dose of normal lung tissues and the incidence of radiation pneumonitis.Conclusions Radionuclide pulmonary perfusion imaging can assess effectively the effect of tumor to regional pulmonary artery perfusion function before radiotherapy and reduce the irradiation dose of normal lung tissue in lung cancer patients undergoing IMRT.

Objective To observe the expression of proinflammatory factors messenger RNA (mRNA) in periretinal membrane of proliferative vitreoretinopathy. Methods Fourteen specimens of periretinal membrane were collected during vitrectomy, and they were made into paraffin sections.The presence of mRNA coding for IL-1,IL-6,IL-8 and TNF alpha was observed by in situ hybridization(ISH) with biotin labeled oligonuclotide probes respectively.The eyeball after corneal grafting was made as normal control. Results No expression of proinflammatory factors mRNA was found in normal human retina.Positive staining was present in 5 specimens.In these specimens, IL-1? mRNA was found in 3 specimens and TNF? mRNA was found in 3 specimens,there is 1 specimen expressed IL-8 mRNA and 3 specimens expressed IL-6 mRNA.In these positive specimens, one contained cells expressing mRNA for IL-1 ? beta and IL-6, and one exhibited cells expressing mRNA for IL-1??IL-8 and TNF ?,two membranes possessed positive cells for IL-6 and TNF? mRNA, one membrane contained IL-1? mRNA positive cells only. Conclusion These findings suggest that these cytokines may be locally produced by cells infiltrating epiretinal membranes. The expression of IL-1?, IL-6, IL-8 and TNF? mRNA within retinal membranes provides further evidence of a pathogenic role of these cytokines in proliferative vitreoretinopathy.

Objective To investigate the potential factors which have impact on the working space for surgeons in gasless laparoscopic cholecystectomy and to probe into the specifications of gasless surgeries.Methods Clinical data of 49 cases of gasless laparoscopic cholecystectomy between March 2007 and July 2010 were summarized.The impacts of body mass index,bowel preparation and means of anesthesia on operation time and conversion to laparotomy were analyzed.Results For patients with body mass index ≤25and ＞ 25,operation times were (43.0 ± 5.4) min,and (52.8 ± 7.4 ) min,respectively,and rates of conversion to laparotomy were 0/34 and 4/15,respectively.Both indices in the first group were higher.For patients with and without bowel preparation,operation times were (44.5 ± 5.4) min and (46.1 ± 8.0)min,respectively,and rates of conversion to laparotomy were 2/26 and 2/23,respectively.For patients with epidural anesthesia and lumbar/epidural anesthesia,operation times were (46.5 ± 7.9) min and (44.1 ±6.8) min,respectively,and rates of conversion to laparotomy were 2/24 and 2/25,respectively.Conclusions The operation time of gasless laparoscopic cholecystectomy could be affected by many factors,such as body mass index.Gasless operations can be improved by evaluating the conditions of patients correctly and by selecting suitable operation methods,anesthesia means and bowel preparation.

Objective To elucidate the airway inflammation status in mice infected with respiratory syncytial virus (RSV), and whether the inflammation could be alleviated by small interference RNA (siRNA) targeting specific RSV gene. MethodsBALB/c mice were infected with RSV via intranasal instillation of RSV suspension, and were then treated with specific siRNA targeting RSV-M2 gene. ELISA assay was used to detect the levels of IFN-γ, IL-12 and IL-10 and Microscope was used to count white blood cells in bronchoalveolar lavage fluid(BALF). ResultsAfter RSV infection, a significant increase in leukocytes count was observed in BALF. Differential count showed a rise in the percentage of neutrophils, eosinophil, especially lymphocytes and a reduction of the percentage of monocytes and macrophages( P＜0.05 ).The levels of IFN-γ, IL-12 and IL-10 were also increased(P＜0.05). Furthermore, the leukocytes count,the percentage of lymphocytes, neutrophils and eosinophil, and the levels of IFN-γ, IL-12 and IL-10in BALF were decreased accordingly while the mice were given higher concentrations of siRNA ( P＜0.05 ).Conclusion RSV caused airway inflammation in BALB/c mice, which may be alleviated by RNAi technology.

Objective The purpose of this study is to study the clinical and pathological features of neurilemoma .Methods We observed the clinicopathologic features and immunohistochemical staining from eight patients with orbital neurilemoma between 2010.1~2012.12.Results Eight patients with classic neurilemoma were included in the study ,in which there were five males and three females ,aged between 21 and 63,mean age 35.The main symptom of the patients was exophthalmos ,including five cases of right eyes and three left eyes;2 cases of orbital floor and six above orbit ,lasting for one to ten years .The tumor diameter ranged between 1cm and 5 cm,an average of 3 cm,being pale and light yellow color .There were five cases of type Antoni A and one case of type was Antoni B among the six classic type neurilemoma .Two cases of ancient were neurilemoma ,in which one case was the histological structure of the classic type neurilemoma ,but there were more hypertrophy tumor cells , chromatin was coarse block atypia cells .The other one case with cells arranged disorderly ,which was mainly fine striated cells with scattered deeply stained atypia cells ,stromal transparent degeneration ,cystic degeneration .Im-munohistochemistry results showed that S -100(+),vimentin(+),ki67(-).Conclusion Antoni type B and ancient schwannoma are rare ,with complicated histologic characteristics .Combined with clinical features and im-munohistochemistry staining ,it can be diagnosed .

Following more and more new drugs are authorized into market, new, serious or unexpected adverse drug reactions appear frequently, which is a serious threat to people health and life. Through making laws and guidelines, governments of various countries aim to strengthen and standardize the surveillance and reporting of postmarketing drugs. The drugs management department of our country are doing related jobs positively, but there are some problems, such as drug risk-menagement is not emphasized well, and the management department lacks clarity on operating related regulations. This article tries to explore foreign countries' laws and regulations on the surveillance and reporting of postmarketing drugs, aiming to provide reference for our courtry.
Adverse Drug Reaction Reporting Systems ; legislation & jurisprudence ; organization & administration ; China ; Humans ; Internationality ; legislation & jurisprudence ; Legislation, Drug ; Marketing of Health Services

Objective:To observe the effect of "Qishen Yiqi Droplet" on serum concentrations of high sensitivity C reactive protein(hs-CRP),plasminogen activator inhibitor-1(PAI-1),endothelin-1(ET-1)in patients with acute coronary syndrome(ACS)after percutaneous coronary intervention (PCI).Methods:A total of 100 consecutive ACS patients ready to receive PCI therapy in our hospital from june 2007 to August 2008 were randomly assigned into two groups:Qishen group,n=50,with Qishen Yiqi Droplet 5.0 g three timee a day+conventional therapy after PCI;and Control group,n=50 with conventional therapy after PCI.The concentrations of hs-CRP,PAI-1 and ET-1were detected and compared 24 hours before PCI,and 24 hours,4weeks after PCI between two groups respectively.Results:There were no obvious differences of hs-CRP,PAI-1 and ET-1 24 hours after PCI in two groups.The levels of hs-CRP,PAI-1,ET-1 were lower in Qishen group than in Control group 4 weeks after PCI (0.219±0.143)ng/dl vs.(0.366±0.132)ng/dl,P<0.001,(104.252±26.038)ng/dl vs.(118.419±28.849)ng/ml,P<0.05,and (37.411±12.977)ng/dl vs.(45.755±12.305)pg/ml,P<0.01,respectively.Conclusion:Qishen Yiqi Droplet could decrease the levels of hs-CRP,PAI-1 and ET-1 in ACS patients who underwent PCI,and it might have the protective role in preventing the neointimal hyperplasia and thrombogenesis after stent implantation.

Objective To study the distribution of surfactant protein A2 (SP-A2) haplotype and its association with preterm respiratory distress syndrome (RDS) susceptibility in a local Chinese cohort.Methods Using population base and case-control study cohorts,genotyping for four single nucleotide polymorphism (SNP) was performed,rs1059046,rs17886395,rs1965707,rs1965708,in 80 term infants,50 preterm infants with RDS (RDS group) and 50 preterm infants without RDS(control group) by using TaqMan (R) real-time polymerase chain reaction.Infants in RDS group and control group were matched according to gender and gestational age.Frequency of each haplotype was compared between preterm infants with RDS and without RDS,term infants and preterm infants without RDS.Results Most common haplotypes in term infants were 1A0,1A5,1A1.In each preterm infants groups with RDS and without RDS,1A0,1 A5,1 A1 were also the most common haplotypes.Among these three common haplotypes,frequency of 1A0 was lower in preterm infants,including RDS group and control group,than that in term infants.No significant difference was found between preterm groups with RDS and without RDS (P ＞ 0.05),neither in preterm infants with gestational age ≥32 or ＜ 32 weeks.Haplotype 1A0 frequency(0.542) in term infants was significantly higher than that in preterm infants ＜ 32 weeks without RDS (0.329) (x2 =6.06,P =0.01).Conclusions SP-A2 haplotype distribution in a local Chinese population shows ethnic characteristics to some extent.Only SP-A2 does not contribute to the susceptibility for preterm RDS.