Chinese herbal formulas can well present the characteristics of traditional Chinese medicine (TCM) with their simple, convenient, inexpensive and effective uses. However, due to the high cost of production, manufacturing pharmacies inside the hospital closed down one after another, which rendered the difficult situation of developing preparation of Chinese herbal formulas. The Pudong New Area of Shanghai, as a pilot region for comprehensive reforms on national development of TCM, vigorously explores the standardized research on and application of hospital-made Chinese herbal formulas. The Health Bureau of the Pudong New Area, based on the Shuguang Hospital, has established a clinical evaluation center for hospital-made Chinese herbal formulas. Through screening, manufacturing, quality control, unified allocation, and standardized clinical evaluation, the clinical evaluation center has summarized its experience on these processes.

Objective To compare the efficacy and safety ofetanercept injection 50 mg once weeklycombined with methotrexate (MTX) therapy for patients withactive rheumatoid arthritis.Methods This studyconsists of 2 parts：a 12-week double-blind treatmentperiod (part A) followed by a 12-week open-labelsafety study period (part B).The randomization oftreatments in double-blind treatment period was completedthrough the clinical operations randomization environment(CORE) system.During part A,the subjects wererandomly assigned to the etanercept 50 mg or placebo group. The dosage regimen for etanercept was 50 mgadministered subcutaneously once weekly while MTX wasadministered orally.All subjects who completed partA received 50 mg etanercept once weekly and MTX1 during theopen-label treatment.The primary endpointwas ACR 20 response at week 12.Secondary endpoint variablesincluded physician／patient global assessmentsof disease activities,duration of morning stiffness,painvisual analog scale (VAS),health assessment questi onnaire (HAQ),CRP level and tender and swollen joint counts .The results of safety between the two groupswere compared.The primary endpoint and other secondarybinary endpoints were analyzed using the Fisher’sexact test.For continuous endpoints.the change frombaseline was analyzed with analysis of covariance.Results One hundred and fifty six subjects satisfiedmodified intent-to-treat (mITT) population were enrolled during part A,of which 77 subjects were in theetanercept+MTX group,and 79 subjects were in theplacebo+MTX group respectively.A total of 149 subjectscompleted part A.As early as week 4.the ACR 20response achieved 39％ (30,77) in the etanerceptgroup,which was significantly higher than that of theplacebogroup [16％(13／79),P<0.001].At week 12,the ACR 20respouse achieved 62％(48,77)in the etanercept group and 23％(18／79) in the placebo group (P<0.01).Fromweek 4,other study endpoints including physician global assessment,patient globalassessment,duration of morning stiffness,painVAS,HAQ,CRPlevel,tender joint counts,swollen joint counts were alsocompared.The results showed that all above efficacyendpoints in the etanercept+MTX group were better than thoseof the placebo+MTX group(P<0.01).Butthere Was no significant difference in the total adverseeriects between the two groups.ConclusionEtanercept 50 mg once weekly + MTX treatment for 24 weeks iswell tolerated.During the first 12-weektreatment period,the etanercept group has shown a rapidefficacy onset and a significantly better therapeuticeffect compared to that of the placebo group.

Objective To investigate the accuracy,image quality and effective dose (ED)of the whole-heart CT scanner in infants with congenital heart disease.Methods Totally 86 consecutive pediatric patients younger than 2 years old with congenital heart disease were enrolled.They were divided into 2 groups:whole-heart CT scanner with low dose group,43 patients(28 males,15 females,aged 12 d -19 months)underwent CT acquisition by using the whole-heart CT,and the other 43 patients(23 males,20 females,aged 19 d-16 months)examined with volume helical shuttle (VHS)of high definition CT were assigned as VHS group.With surgical results as the standard,the sensitivity, specificity,positive predictive value (PPV),negative predictive value (NPV)and the diagnostic accuracy of the 2 groups for cardiovascular abnormalities were evaluated.Attenuation and noise of 2 groups of ascending aorta,main pul-monary artery,and muscle were measured,and the signal -to -noise ratio (SNR)and contrast -to - noise ratio (CNR)were calculated.The double blind method was used to evaluate the subjective image quality of the level of intra-cardiac,extra-cardiac and coronary artery.Both the volumetric CT dose index (CTDIvol)and dose-length product(DLP)of each child were recorded,and the ED was also estimated in both groups.Results By using surgical findings as the reference standard,a total of 124 and 113 separate cardiovascular anomalies were confirmed by the whole-heart CT scanner in the low dose group and the VHS group.The diagnostic accuracy in 2 groups was 99.2%and 98.8%,respectively,without significant difference(χ2＝0.035,P＝0.852).The sensitivity,specificity,PPV and NPV in 2 groups were 97.8%,99.7%,98.4%,99.6% and 95.2%,99.3%,98.2%,98.7%,respectively.No signifi-cant difference was found in the attenuation,image noise,SNR,and CNR between 2 groups in the same anatomic regions (all P＞0. 05).No significant difference was found in subjective image quality between 2 groups on the intra-cardiac and extra-cardiac structure(all P＞0.05).But the subjective image quality of coronary artery was significantly higher in whole-heart CT scanner in the low dose group than that of the VHS group(4.02 ± 0.91 vs.2.79 ± 0.74),and the differ-ence was significant(Z＝ -5.562,P＝0.000).ED was (0.59 ± 0.31)mSv in whole-heart CT scanner in the low dose group and (2.28 ± 1.07)mSv in the VHS group,reflecting dose savings of 74% by using the whole-heart CT scanner with high temporal resolution,and the difference was significant(t＝ -11.285,P＝0.000).Conclusions The whole-heart CT scanner with low dose can improve image quality with lower ED,especially for the image quality of coronary artery,which is an effective examination method for the diagnosis of congenital heart disease of children, especially for complex congenital heart disease.

Statistics show that 76.74% (4 688) of 6 109 patients with chronic wounds are those over 50 years of age; the proportion of patients with underlying diseases in all age groups above 50 years ranges from 78.25% to 100.00%; among the underlying diseases of chronic wound patients, the top four diseases are diabetes mellitus , cardiovascular and cerebrovascular diseases, hypertension, and respiratory diseases. The above underlying diseases and ages of patients are the susceptibility factors of corona virus disease 2019 released by National Health Commission of China. It is an unavoidable fact that patients with chronic wounds have to go to the hospital for treatment prescribed by the physician. At the same time, we found that there were not a few patients who go far afield because of various reasons when go to the hospital for treatment. During the period of epidemic prevention and control, this kind of "go far afield" style of seeking medical treatment may increase the exposure risk during transportation. Accordingly, we convened 36 wound care clinics in different regions in Shanghai to implement the "Five Measures" to encourage patients with chronic wounds to seek medical treatment proximately. The principle of this operation is that when seeking medical treatment, trying our best to reduce as much as possible the transportation distance for patients with chronic wounds to minimize the exposure risk during the epidemic period and eventually support the epidemic prevention and control campaign.