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Autologous serum skin test (ASST) is commonly used as a screening test to assess immune subtypes of chronic spontaneous urticaria (CSU) in clinical practice, but its immunological mechanisms and associations with clinical features and prognosis of CSU are not yet clear. Studies have shown that positive ASST is associated with increased immunoglobulin G autoantibodies, decreased eosinophil and basophil counts, increased CD63 expression on basophils, and changes in circulating inflammatory cytokine levels in CSU patients, but not associated with age, disease duration, and personal or family history of CSU patients, and may be a predictor of severity of chronic urticaria. ASST-positive patients may respond poorly to second-generation H1 antihistamines, slowly to omalizumab, but respond well to cyclosporine and autologous whole blood/serum injections. This review summarizes the immunological and clinical characteristics of ASST-positive patients, and discusses the predictive value of positive ASST for the efficacy of different treatment regimens.
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The pathogenesis of rosacea has not been fully elucidated. It is currently believed that genetic factors, local skin immune imbalance, neuroimmune and neurovascular dysfunction, skin barrier function abnormalities, microbiota imbalance, etc., are all involved in the occurrence and development of rosacea. This review summarizes research progress in the pathophysiological pathogenesis of rosacea.
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Objective:To evaluate the efficacy and safety of baricitinib in the treatment of moderate-to-severe atopic dermatitis (AD) .Methods:From June 2020 to June 2021, patients with moderate-to-severe AD who were insensitive or intolerant to topical agents were enrolled from Department of Dermatology, Peking University First Hospital. Before treatment, the patients were evaluated by 4 scales, including the Investigator′s Global Assessment (IGA), Eczema Area and Severity Index (EASI), Itch Numeric Rating Scale (NRS), and Dermatology Life Quality Index (DLQI) ; meanwhile, photos of skin lesions were taken, routine blood test was performed, blood biochemical indices and total IgE levels were measured. After exclusion of contraindications, the patients were treated with oral baricitinib at a dose of 2 mg/d for 16 weeks. Regular follow-up was conducted at weeks 1, 2, 4, 8, 12, 16 and 20 after the start of treatment, clinical evaluation was carried out with the above 4 scales, and adverse events were recorded during the treatment.Results:A total of 24 patients were enrolled in the study, and all completed 16-week oral treatment and 20-week follow-up. All the 4 scale scores showed a continuous downward trend within 20 weeks after the start of treatment. At week 20, the patients′ IGA, EASI, NRS, and DLQI scores significantly decreased from 4.13 ± 0.61, 37.59 ± 14.86, 6.83 ± 2.26 and 18.67 ± 8.64 points respectively at baseline to 1.12 ± 0.49, 4.53 ± 3.78, 0.72 ± 0.58 and 1.39 ± 0.85 points respectively ( t = 22.70, 10.55, 10.69, 8.40, respectively, all P < 0.001). During the follow-up period, no serious adverse reactions were observed; 3 patients experienced gastric discomfort at the start of oral treatment, but the symptoms disappeared after the treatment continued; 3 developed acute allergic manifestations (1 case of allergic conjunctivitis, 2 cases of acute urticaria), which resolved rapidly after the use of antihistamines without recurrence. Conclusion:Baricitinib can provide a safer and more effective treatment option for patients with moderate-to-severe AD, especially those who are insensitive or intolerant to topical agents and need systemic treatments.
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Objective:To evaluate efficacy and safety of dupilumab in the treatment of atopic dermatitis (AD) .Methods:A retrospective study was conducted among patients with AD who showed poor response to topical agents and then received standardized injections of dupilumab for 16 weeks in Department of Dermatology, Peking University First Hospital from June 1, 2020 to September 1, 2021. Basic information on the patients was collected, so were the Investigator′s Global Assessment (IGA), Eczema Area and Severity Index (EASI), Itch Numeric Rating Scale (NRS), Dermatology Life Quality Index (DLQI), and Patient-Oriented Eczema Measure (POEM) scores recorded before and at weeks 2, 4, 8, 12, and 16 during treatment. Adverse reactions were recorded during treatment. Wilcoxon rank sum test was used to compare the scores of all patients at the end of follow-up with those before treatment.Results:A total of 57 patients were enrolled in the study, and all completed 16-week injections and follow-up. At week 16, the patients′ IGA, EASI, NRS, DLQI, and POEM scores significantly decreased from 4.0 (4.0, 5.0), 30.0 (17.2, 36.0), 9.0 (7.0, 10.0), 15.0 (11.5, 20.5), and 19.0 (15.5, 23.0) points respectively at baseline to 1.0 (1.0, 1.0), 4.0 (1.6, 7.3), 1.0 (0.0, 1.0), 3.0 (1.0, 4.0), and 4.0 (2.0, 4.0) points respectively ( Z = 6.65, 6.57, 6.59, 6.57, and 6.57 respectively, all P < 0.001). All the 5 scale scores showed a continuous downward trend within 16 weeks after the start of dupilumab treatment. During the follow-up period, no serious adverse reaction was observed, and only two patients developed conjunctivitis. Conclusion:Dupilumab shows marked efficacy in the treatment of AD, with favorable safety.
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Objective:To evaluate clinical efficacy and safety of omalizumab in the treatment of symptomatic dermographism by analyzing real-world data.Methods:Clinical data were collected from patients with symptomatic dermographism who completed 16-week treatment with omalizumab in Department of Dermatology, Peking University First Hospital from February 2018 to May 2021, and retrospectively analyzed. The analysis was done by comparing data obtained before and after the treatment, including critical friction thresholds (CFTs) , pruritus scores in a provocation test, as well as urticaria control test (UCT) , dermatology life quality index (DLQI) and chronic urticaria quality of life questionnaire (CU-Q2oL) scores. Adverse events reported by patients during the treatment were recorded. Wilcoxon signed-rank test was applied for the analysis of clinical data before and after the treatment.Results:A total of 27 patients with symptomatic dermographism who completed 16 weeks of omalizumab treatment were included. At baseline, the CFTs of all the 27 patients were 4, and their UCT, DLQI and CU-Q2oL scores were 7.0 (5.0, 8.0) , 9.0 (6.0, 10.0) , 63.0 (50.0, 72.0) points respectively. At week 4, the CFTs decreased from 4 to 0 in 9 patients (33.3%) , the UCT scores increased to 14.0 (12.0, 16.0) points ( Z = 4.548, P<0.05) , and the DLQI and CU-Q2oL scores decreased to 2.0 (0.0, 2.0) and 32.0 (25.0, 41.0) points respectively in the 27 patients ( Z = 4.513, 4.433, respectively, both P<0.05) . At week 6, the UCT scores increased to 15.0 (14.0, 16.0) points, and the DLQI and CU-Q2oL scores decreased to 0.0 (0.0, 1.0) and 25.0 (23.0, 30.0) points respectively in the 27 patients. No drug-related serious adverse events were reported during the treatment. Conclusion:Omalizumab can effectively improve the symptoms of symptomatic dermographism and patients′ quality of life with a good safety profile.
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Objective:To retrospectively evaluate efficacy and safety of omalizumab in the treatment of chronic spontaneous urticaria (CSU) , as well as recurrence after its withdrawal.Methods:Clinical data on patients with CSU, who received omalizumab treatment in Peking University First Hospital from February 2018 to January 2021, were collected and analyzed retrospectively. Through outpatient follow-up, urticaria control test (UCT) and dermatology life quality index (DLQI) were recorded to assess disease severity, and adverse events and recurrence after omalizumab withdrawal were monitored. Comparisons of normally distributed measurement data between groups were carried out using t test or analysis of variance, comparisons of non-normally distributed measurement data between groups using Mann-Whitney U test, Wilcoxon signed-rank test or Kruskal-Wallis H test, and comparisons of enumeration data between groups using chi-square test or Fisher′s exact test. Results:A total of 59 patients with CSU were included and treated with omalizumab for at least 3 months, of whom, 45 were treated for more than 6 months, and 15 for more than 12 months. After the start of omalizumab treatment, UCT scores increased from 3.0 (1.0, 6.0) points at baseline to 11.0 (3.0, 14.0) points at 1 month and 15.0 (12.0, 16.0) points at 3 months (both P < 0.05) ; DLQI scores decreased from 16.0 (12.0, 20.0) points at baseline to 7.0 (1.0, 13.0) points at 1 month and 1.0 (0.0, 4.0) points at 3 months (both P < 0.05) . The proportion of patients achieving partial or complete disease control increased from 0 at baseline to 44.1% at 1 month, 78.0% at 3 months, and 88.9% at 6 months. The proportion of patients whose quality of life was severely or extremely severely affected by CSU decreased from 84.7% at baseline to 30.5% at 1 month, 15.3% at 3 months, and 4.4% at 6 months. The disease duration was significantly shorter in the complete response group and partial response group than in the non-response group ( t = -2.894, -2.511, P = 0.011, 0.036, respectively) ; the treatment duration was significantly longer in the complete response group than in the partial response group and non-response group ( t = 2.479, 2.677, P = 0.039, 0.022, respectively) . Compared with the rapid response group, the slow response group showed higher DLQI scores ( Z = -2.622, P = 0.009) and lower UCT scores ( Z = -2.746, P = 0.006) at baseline. Nineteen patients withdrew omalizumab after complete control of CSU, of whom 13 (68.4%) experienced relapse 7.0 (5.0, 8.0) weeks after the withdrawal, and showed significantly higher UCT scores at relapse than at baseline ( Z = 3.172, P = 0.001) . The disease duration was significantly longer in the recurrence group than in the non-recurrence group ( Z = -2.635, P = 0.007) . After recurrence, 5 patients restarted omalizumab treatment, and all of them regained partial or complete disease control. The adverse events reported during the treatment were all mild to moderate. Conclusions:Omalizumab can effectively and safely control symptoms of CSU and improve the quality of life of patients with CSU. However, recurrence frequently occurs after omalizumab withdrawal, and reinitiating omalizumab treatment after recurrence is still effective.
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Chronic spontaneous urticaria (CSU) greatly affects the quality of life of patients. Currently, no sensitive and convenient biomarkers are available to assess the severity of CSU and efficacy of drug therapies. It is particularly important to apply patient-reported outcome assessment tools with good reliability and validity in daily management of CSU, such as urticaria activity score, urticaria control test and chronic urticaria quality of life questionnaire. This review outlines the existing CSU assessment tools, analyzes their strengths, limitations and clinical application, aiming to establish a CSU clinical scoring system, and to facilitate personalized treatment and efficacy evaluation.
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Purpose@#The purpose of this study was to evaluate the diagnostic value of soluble Axl (sAxl) in hepatocellular carcinoma (HCC) in comparison with serum α-fetoprotein (AFP). @*Materials and Methods@#Eighty HCC patients, 80 liver cirrhosis patients (LC), 80 patients with hepatitis B virus (HBV) infection, and 80 healthy controls (HC) were enrolled. sAxl levels were measured by an enzyme-linked immunosorbent assay, serum AFP levelswere measured by an electrochemiluminescence immunoassay. Receiver operating characteristic (ROC) curves were used to evaluate diagnostic performances. @*Results@#The results show that levels of sAxl were high expression in patients with HCC (p LC > HC > HBV. Logistic regression and ROC curve analysis identified the optimal cut-off for sAxl in differentiating all HCC and non-HCC patients was 1,202 pg/mL (area under the receiver operating characteristic [AUC], 0.888; 95% confidence interval [CI], 0.852 to 0.924) with sensitivity 95.0%, specificity 73.3%. Furthermore, differential diagnosis of early HCC with non-HCC patients for sAxl showed the optimal cut-off was 1,202 pg/mL (AUC, 0.881; 95% CI, 0.831 to 0.931; sensitivity, 94.1%; specificity, 73.3%). Among AFP-negative HCC patients with non-HCC patients, the cut-off was 1,301 pg/mL (AUC, 0.898; 95% CI, 0.854 to 0.942) with a sensitivity of 84.6%, a specificity of 76.3%. The optimal cut-off for sAxl in differentiating all HCC and chronic liver disease patients was 1,243 pg/mL (AUC, 0.840; 95% CI, 0.791 to 0.888) with sensitivity 93.8%, specificity 61.9%. The combination of AFP and sAxl increased diagnostic value for HCC. @*Conclusion@#sAxl outperforms AFP in detecting HCC, especially in early HCC and in AFP-negative HCC. Combination sAxl with AFP improved the specificity for early HCC diagnosis. In summary, sAxl is a candidate serum marker for diagnosing HCC.
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Objective:To assess the reliability and validity of the Chinese version of chronic urticaria quality of life questionnaire (CU-Q2oL) .Methods:The original English version of CU-Q2oL was translated into Chinese after forward-backward translation and cultural adaption, and items of the Chinese version of CU-Q2oL were determined. From January to December 2019, 195 chronic spontaneous urticaria patients with or without chronic inducible urticaria were enrolled from Department of Dermatology and Venereology, Peking University First Hospital, and followed up every 2 weeks. A total of 2 follow-ups were carried out, and a questionnaire survey was conducted by using the Chinese version of CU-Q2oL, dermatology life quality index (DLQI) and urticaria activity score over 7 days (UAS7) during each follow-up. After each follow-up, the treatment protocol for each patient was adjusted by clinicians based on the patient′s condition. The number of questionnaire factors was extracted by exploratory factor analysis, convergent validity was estimated by analyzing correlations of CU-Q2oL with DLQI and UAS, and the internal consistency reliability of CU-Q2oL was evaluated by calculating Cronbach′s α coefficient; the sensitivity of CU-Q2oL was assessed by analyzing correlations of changes in UAS7 scores with changes in CU-Q2oL scores.Results:Four factors were extracted from the Chinese version of CU-Q2oL, namely "symptoms", "daily functional activities", "sleep problems" and "restrictions" factors. There were 23 items in total, and the cumulative variance contribution rate was 74.011%. The Cronbach′s α coefficient of all items in CU-Q2oL was 0.961, and the Cronbach′s α coefficient of the 4 factors ranged from 0.804 to 0.933, suggesting excellent internal consistency. The total score of CU-Q2oL was moderately correlated with DLQI and UAS7 scores, with correlation coefficients of 0.437 and 0.560, respectively (both P < 0.01) . A total of 71 patients completed the second follow-up. The change in the total score of CU-Q2oL was moderately correlated with that in the UAS7 score, with a correlation coefficient of 0.392 ( P < 0.01) . Conclusion:The Chinese version of CU-Q2oL has excellent internal consistency, good reliability and validity, and can be used to evaluate the quality of life of patients with chronic spontaneous urticaria in China.
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Objective:To evaluate the reliability, validity and sensitivity of the Chinese version of pruritus-specific quality of life instrument (ItchyQoL) .Methods:Based on the English version of ItchyQoL, items of the Chinese version of ItchyQoL were determined after forward-backward translation and cultural adaption. Totally, 218 patients with pruritus caused by skin diseases were enrolled from Department of Dermatology, Peking University First Hospital from January to December 2019, and a questionnaire survey was conducted. At the time of enrollment and 2 weeks after enrollment, the Chinese version of ItchyQoL, dermatology life quality index (DLQI) and numerical rating scale (NRS) were used to evaluate the effect of pruritus on the quality of life of patients. Confirmatory factor was used to assess the structural validity of the Chinese version of ItchyQoL, and Cronbach′s α coefficient was used to estimate its internal consistency reliability. Spearman correlation coefficient was used to analyze correlations (convergent validity) of the Chinese version of ItchyQoL score with DLQI and NRS scores, and correlations (sensitivity) of changes in the Chinese version of ItchyQoL score with changes in DLQI and NRS scores.Results:The Chinese version of ItchyQoL contained a total of 22 items, including 3 dimensions, i.e., "symptoms", "functions" and "emotions", with the Cronbach′s α coefficients being 0.946, 0.883 and 0.953 respectively, suggesting excellent internal consistency. At 2 weeks after enrollment, the NRS score was strongly correlated with the total ItchyQoL score ( rs = 0.700, P < 0.01) , and moderately correlated with the subscores of "emotions", "functions" and "symptoms" ( rs = 0.452, 0.673, 0.692 respectively, all P < 0.01) ; the DLQI score was also strongly correlated with the total ItchyQoL score ( rs = 0.887, P < 0.01) and the subscores of "functions" and "symptoms" ( rs = 0.886, 0.750 respectively, both P < 0.01) , and moderately correlated with the "emotions" subscore ( rs = 0.674, P < 0.01) . Compared with the scores at the time of enrollment, the change in the total ItchyQoL score after 2 weeks was moderately correlated with the change in the NRS score ( rs = 0.642, P < 0.01) , and strongly correlated with the change in the DLQI score ( rs = 0.757, P < 0.01) ; the changes in "symptoms" and "functions" subscores were moderately correlated with the change in the NRS score ( rs = 0.648, 0.549 respectively, both P < 0.01) , while there was a weak correlation between the changes in "emotions" subscore and NRS score ( rs = 0.225, P < 0.01) ; the changes in "symptoms" and "functions" subscores were strongly correlated with the change in the DLQI score ( rs = 0.755, 0.703 respectively, both P < 0.01) , while the change in "emotions" subscore was moderately correlated with the change in the DLQI score ( rs = 0.401, P < 0.01) . Moreover, the total score of the Chinese version of ItchyQoL and subscores of "symptoms", "functions" and "emotions" all significantly differed among different NRS and DLQI score groups at 2 weeks after enrollment (all P < 0.05) . Conclusion:The Chinese version of ItchyQoL has good reliability and validity, and can be used to evaluate the quality of life of patients with pruritus caused by skin diseases in China.
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Objective:To translate the Urticaria Control Test (UCT) into Chinese, and to assess reliability, validity, sensitivity and screening accuracy of the new-version scale.Methods:After forward-backward translation and cultural adaption, items of the Chinese version of UCT were determined. The scale was used in 51 patients with chronic spontaneous urticaria (CSU) , 41 with chronic inducible urticaria (CIndU) , and 11 with CSU complicated by CIndU. Within 8 weeks after enrollment, 81 patients were treated with antihistamines, 8 with omalizumab, and 14 with antihistamines combined with omalizumab. At the time of enrollment and 4 and 8 weeks after enrollment, dermatology life quality index (DLQI) and urticaria activity score (UAS) were used to assess the quality of life impairment and disease activity. The internal consistency reliability of the questionnaire was estimated using Cronbach′s α coefficient. By comparing with DLQI and UAS28 scores, the Chinese version of UCT was tested for convergent validity, known-group validity, sensitivity and screening accuracy.Results:The Chinese version of UCT contained 4 items, and could be used to retrospectively evaluate clinical symptoms and signs of the disease, impact on quality of life, treatment effects and overall disease control in the past 4 weeks. The Cronbach′s α coefficient of each item in the UCT scale was 0.886 - 0.945 in the CSU group, and 0.834 - 0.958 in the CIndU group. At the time of enrollment, the UCT score was significantly negatively correlated with the DLQI score in both the CSU group and CIndU group ( rs = -0.672, -0.578, respectively, both P < 0.01) . At 4 and 8 weeks, the UCT score was significantly negatively correlated with UAS28 and DLQI scores in the CSU group (4 weeks: rs = -0.654, -0.829, respectively, both P < 0.01; 8 weeks: rs = -0.717, -0.765, respectively,both P < 0.01) , and it was also significantly negatively correlated with the DLQI score in the CIndU group ( rs = -0.834, -0.778, respectively, both P < 0.01) . In the CSU group, the change in the UCT score between weeks 4 and 8 was significantly negatively correlated with the change in UAS score ( rs = -0.569, P < 0.01) ; compared with the baseline, the change in the UCT scores was also significantly negatively correlated with the change in the DLQI scores at weeks 4 and 8 ( rs = -0.693, -0.447, respectively, both P < 0.01) . In the CIndU group, compared with the baseline, the change in the UCT scores at weeks 4 and 8 also showed a significant correlation with the change in DLQI scores ( rs = -0.615, -0.408, respectively, both P < 0.01) . The UCT score significantly differed among different UAS and DLQI score groups (all P < 0.05) . Conclusions:The Chinese version of the UCT is a valid and reliable tool for the clinical management of patients with CSU/CIndU. It can be used to evaluate disease control, and reflect disease activity and disease-related quality of life to a certain extent.
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Objective:To investigate clinical application of critical temperature threshold (CTT) measurement by using a temperature tester in the diagnosis of cold contact urticaria, and to explore relationships of CTTs with disease activity, disease control condition and quality of life in patients with cold contact urticaria.Methods:A total of 20 patients with cold contact urticaria were collected from Department of Dermatology, Peking University First Hospital from October 2017 to March 2019. Disease activity was assessed by the patients themselves at the first visit; the CTT was measured, and dermatology life quality index (DLQI) was evaluated by the patients themselves at the first visit and subsequent 2 follow-up visits. At the second follow-up visit, disease control condition was evaluated in the patients. Spearman correlation analysis was used to analyze correlations of CTTs with disease activity, CTT improvement and disease control condition. Friedman test was used to compare the improvement of CTTs and DLQI during treatment, and Bonferroni multiple test was used for multiple comparisons.Results:Based on the patients′ self-assessed disease activity, there were 3 patients with mild cold contact urticaria, 8 with moderate cold contact urticaria, and 9 with severe cold contact urticaria, and the disease activity was positively correlated with CTTs ( r s = 0.573, P = 0.008) . Clinician assessment of disease control condition showed 3 patients with poor disease control, 6 with fair disease control and 9 with good disease control, and the disease control condition was positively correlated with the improvement of CTTs ( r s = 0.516, P = 0.020) . The CTTs were (20.10 ± 4.67) ℃, (10.75 ± 5.30) ℃, and 5.50 (4.00, 10.75) ℃ (expressed as median[ P25, P75]) at the first visit and 2 follow-up visits respectively, and significantly differed among different visits ( χ2 = 34.16, P < 0.001) ; meanwhile, the DLQI scores were 19.75 ± 3.81, 8.45 ± 6.27, 0.50 (0, 9.00) (expressed as median[ P25, P75]) respectively, and there was a significant difference among different visits ( χ2 = 35.23, P < 0.001) ; the CTT and DLQI were significantly lower at the 2 follow-up visits than at the first visit (all P < 0.001) . Conclusion:CTTs can reflect disease activity in patients with cold contact urticaria, and are correlated with the quality of life and disease control condition.
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Objective The aim of this study is to explore the mechanism of canonical Wnt signaling pathway in type 2 diabetes mice peripheral neuropathy. Methods Male C57BL6 mice were randomly assigned to three groups. One group treated with normal diet as control. And the rest were used to establish the diabetic model through the combination of 60 kcal% high fat diet and an administration of multipleand low dose of streptozotocin on 5 consecutive days. When the model of type 2 diabetes mice peripheral neuropathy was successfully established, one group was injected with the canonical Wnt signaling pathway inhibitor XAV 939 ( T2DM-XAV 939 group) and the other one was injected with phosphate buffer saline (PBS) as control (T2DM-PBS group). The 21stweek was the end point of the experiment, and fasting blood glucose, insulin level, homeostasis model assessment for insulin resistance (HOMA-IR), plantar test, and exercise tolerance were measured, realtime PCR were adopted to detect the related mRNA expression of the canonical Wnt signaling pathway. Results T2DM-XAV 939 group had higher total cholesterol, triglyceride, fasting blood glucose, and HOMA-IR than T2DM-PBS group, but showed no statistical difference. The enzymatic activity of glutamic oxaloacetic transaminase was lower level than that in T2DM-PBS group (P＜0.05); T2DM-XAV 939 group had significantly higher plantar test and poorer exercise tolerance than those in T2DM-PBS group (P＜0.05). The mRNA levels of genes in canonical Wnt signaling pathway such as β-catenin, c-myc, mitochondrial transcription factor A (TFAM) had slightly lower level than those in T2DM-PBS group, without statistical difference, and the protein expression of c-myc was lower than that of T2DM-PBS group (P＜0.05). The insulin receptor substeate 2 (IRS-2) mRNA expression was higher than that in T2DM-PBS group (P＜0.05). With the development of the experiment, we found that the survival rate of the T2DM-XAV 939 group was significantly reduced compared with the other groups. Conclusion Inhibition of the canonical Wnt signaling pathway may aggravate diabetic peripheral neuropathy.
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TCM variety derived from classical or proved prescriptions and was improved through the innovation and development of clinical practices,controlling of medicinal raw material and producing process.The current protection system of TCM variety does not match the developing rule of TCM,in that there is no particular article to regulate traditional classical or proved prescriptions,self-made TCM preparations in hospitals,the genuineness of medicinal raw material and manufacturing techniques,and also lacks the relevant investment return mechanism.It was recommended of creating TCM protection category,protecting self-made TCM preparations in hospitals,regulating genuineness of medicinal raw material and establishing know-how protecting mechanisms,while protecting test data were suggested to be introduced for perfecting the protection system of TCM variety.
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OBJECTIVE:To provide reference for the effective integration of standardization strategy of traditional Chinese medicine (TCM) and intellectual property. METHODS:Through analyzing the conflict between standardization requirement of TCM and intellectual property system,the coordination between TCM standards and intellectual property especially the trade secret rights was explored. RESULTS:The information disclosure of TCM standards and intellectual property strategy especially protec-tion of TCM trade secrets faced confrontation and conflict in system and design. For the suggestions to solve it,one is to reconfirm the role and positioning of the government on the adaption of standardization in public law field;another is to establish coordina-tion principle of information disclosure and confidentiality in private law field,and achieve difference open and moderate open of information. CONCLUSIONS:The TCM standardization is not absolute,the pros and cons is the precondition to solve the conflict between the standardization strategy and trade secret system in TCM in terms of protection of information freedom and secret infor-mation.
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Aiming at the application of big data of biobank , this paper briefly analyzed the ethical and legal is-sues.Combined with the potential legal attribute of biobank namely creditor ' s right, virtual property right , and new intellectual property right , this paper also detailed the legal basis of biobank .Regarding the disputes existing in the big data ' s ownership of biobank and non -establishment of the sharing system of big data , this paper mean-while put forward some planning assumptions and suggestions .Firstly, the boundary between privacy protection and the development of big data should be determined .Secondly , the legal attribute and ownership of the big data of biobank should be confirmed .Finally, it should establish a sharing system of biobank when strengthen the protec-tion of intellectual property right .
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Aiming at the application of big data of biobank , this paper briefly analyzed the ethical and legal is-sues.Combined with the potential legal attribute of biobank namely creditor ' s right, virtual property right , and new intellectual property right , this paper also detailed the legal basis of biobank .Regarding the disputes existing in the big data ' s ownership of biobank and non -establishment of the sharing system of big data , this paper mean-while put forward some planning assumptions and suggestions .Firstly, the boundary between privacy protection and the development of big data should be determined .Secondly , the legal attribute and ownership of the big data of biobank should be confirmed .Finally, it should establish a sharing system of biobank when strengthen the protec-tion of intellectual property right .
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Patent legal system is a part of civil law,while protection system for the varieties of traditional Chinese medicines is involved in the market regulation law.Both of them emphasize on different aspects compiementarily in protecting traditional Chinese medicine (TCM) with advantages and disadvantages.To meet the requirements of the development of TCM in the new era,protection scope of the protection system for varieties of traditional Chinese medicines should be promoted,examination system and elimination mechanisms should be improved through the inheritance and innovation of TCM,which may be conducive to protect rights and interests of TCM enterprises and improve the quality of varieties of traditional Chinese medicines.
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Chinese genuine regional herbs are a combination of nature resource and traditional knowledge. Although we can make it to be an intellectual property product through applying geographical indication or certification mark, the value realization of Chinese genuine regional herbs should be supported by the merchant capital. Meanwhile, the merchant capital also disturbs the reasonable market price of Chinese genuine regional herbs. We should combine the merchant capital with Chinese genuine regional herbs, apply permission for sale and set up a new professional cooperation mode to maintain the market credibility and reasonable price of Chinese genuine regional herbs.
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Intellectual property protection is an indispensable management measure in the process of knowledge innovation in the National Traditional Chinese Medicine (TCM) Clinical Research Bases. Longhua Hospital, a National TCM Clinical Research Base , has actively participated in studies and construction of TCM intellectual property policy , laws and regulations , and endeavored to enhance international research cooperation and broaden the international repercussions of TCM . Longhua Hospital made great efforts to strengthen management on intel-lectual property management team and measures, advocacy training, property rights formation and transactions. Intellectual property protection played an important role in the construction of the National TCM Clinical Re-search Base in Longhua Hospital .