OBJECTIVE:To study the legislative evolution and causes of biologics data protection system in the United States, and provide reference for designing biologics data protection system in China. METHODS:Started from analyzing the features of biologics data protection in the United States,through analyzing the legislative struggle of biologics data protection in the United States,the caused and its enlightenment to China were explored. RESULTS & CONCLUSIONS:After legislative discussion evolu-tion and struggle,the United States enacted the Biologics Price Competition and Innovation Act in 2010,established the world's firststrong protectionstandard of biologics data protection system,and determined the 12-year data protection period. The legisla-tive basis was to stimulate the strategic needs of innovation,the direct cause was that a biological analogue simplified application was established in the United States,and the key factors included biologics technical attributes and patent protection features. Cur-rently,biologics data protection system is not suitable for China,and China should implement the system from nothing,from weak to strong when the national condition matches or strategic choice needs. Meanwhile,a mature registration approval system is the ba-sis of establishing data protection system.

Objective To observe the clinical efficacy and inflammation of tangential excision within 24 hours after burn with massive deep Ⅱdegree burn wounds for elderly patients. Methods From Jan. 2010 to Dec. 2013, a total of 82 elderly patients with massive deepⅡdegree burn wounds were divided into the observation group ( giveing tangential excision within 24 hours after burn) and the control group ( giveing tangential excision within 3~5 d after burn) according the time of tangential excision treatment. The amount of infused fluid, u-rine, levels of serum inflammatory factors, survival rate of skin grafts, wound healing time, hospitalization time and the complications were compared between the two groups. Results There was no significant difference in the amount of infused fluid, plasma and urine between the two groups in the first day and fifth day (P>0. 05). The levels of TNF-αsignificantly decreased after 3 days of therapy compared with the control group (P<0. 05). The levels of IL-6 significantly decreased and IL-10 significantly increased from the first day of therapy in the ob-servation group compared with the control group (P<0. 05). The survival rate of skin grafts in the observation group was significantly higher than that in the control group, and time of wound healing and hospitalization in the observation group was significantly shorter than that in the control group (P<0. 05). The complication rate of the observation group was 11. 1% which was significantly lower than that in the control group 29. 7% (P<0. 05). Conclusion To treat burn with massive deepⅡdegree burn wounds for elderly patients with tangential excision within 24 hours which can effectively reduce the inflammatory, reduce wound infection and improve the success rate of skin grafting.

Objective:To understand the epidemiological characteristics of COVID-19 cases in different epidemic stages in Gansu province.Methods:Epidemiological investigation was conducted to collect the information of confirmed COVID-19 cases, including demographic, epidemiological and clinical information.Results:As of 25 February 2020, a total of 91 confirmed COVID-19 cases had been reported in Gansu. The epidemic of COVID-19 in Gansu can be divided as three different stages, i.e. imported case stage, imported-case plus indigenous case stage, and indigenous case stage. A total of 63 cases were clustered cases (69.23%), 3 cases were medical staff infected with non-occupational exposure.The initial symptoms included fever (54.95%, 50/91), cough (52.75%, 48/91), or fatigue (28.57%, 26/91), the proportion of each symptom showed a decreasing trend along with the three epidemic stages, but only the differences in proportions of fever (trend χ2=2.20, P<0.05) and fatigue (trend χ2=3.18, P<0.05) among the three epidemic stages were statistically significant. The cases with critical severe symptoms accounted for 42.85% (6/14), 23.73% (14/59) and 16.67% (3/18), respectively, in three epidemic stages, showed a decreasing trend ( H=6.45, P<0.05). Also, the incubation period prolonged along with the epidemic stage ( F=51.65, P<0.01), but the intervals between disease onset and hospital visit ( F=5.32, P<0.01), disease onset and diagnosis ( F=5.25, P<0.01) became shorter along with the epidemic stage. Additionally, the basic reproduction number ( R0) had decreased from 2.61 in imported case stage to 0.66 in indigenous case stage. Conclusions:The COVID-19 epidemic in Gansu was caused by the imported cases, and about 2/3 cases were clustered ones. No medical worker was observed to be infected by occupational exposure. With the progression of COVID-19 epidemic in Gansu, the change in initial symptom and incubation period suggests. the early screening cannot only depend on body temperature monitoring.