Objectives:The ORION-18 study has demonstrated that inclisiran can significantly reduce low-density lipoprotein cholesterol(LDL-C)and has good safety in Asian atherosclerotic cardiovascular disease(ASCVD)patients or ASCVD high-risk population.This subgroup analysis aims to further evaluate the efficacy and safety of inclisiran in Chinese mainland population.Methods:ORION-18 study is a multi-center,randomized,double-blind,placebo-controlled,phase Ⅲ clinical trial among Asian subjects,Chinese mainland subgroup included 232 ASCVD patients or ASCVD high-risk subjects who had already been treated with diet control and maximum tolerated doses of statins treatment(with or without other lipid-lowering treatments)but still had elevated LDL-C levels.Subjects were randomized in a 1:1 ratio to the inclisiran group and the placebo group(n=116 each),and received 300 mg of inclisiran or placebo respectively on day 0,90 and 270.The primary endpoint was the percentage change in LDL-C from baseline to day 330.The secondary endpoints included the time-adjusted percentage change and absolute change in LDL-C from baseline after day 90 and up to day 360,the absolute change in LDL-C from baseline to day 330,and the percentage changes from baseline to day 330 in proprotein convertase subtilisin/kexin type 9(PCSK9),total cholesterol,apolipoprotein B(ApoB),non-high-density lipoprotein cholesterol(non-HDL-C).Other secondary endpoints included the proportion of participants reaching LDL-C levels of<1.8 mmol/L at day 330,the proportion of participants with≥50%LDL-C reduction from baseline to day 330 and the proportion of participants who attained global lipid targets(the LDL-C target was<1.4 mmol/L for ASCVD patients and<1.8 mmol/L for ASCVD high-risk subjects)at day 330.Safety endpoints included adverse events during treatment,aboratory test abnormalities during treatment,serious adverse events,and assessed their severity and relation to treatment.Results:The inclisiran group showed a placebo-corrected percentage change in LDL-C from baseline to day 330 of-61.16%,and an absolute change of-1.73 mmol/L(both P<0.0001).Compared to the placebo group,the inclisiran group's time-adjusted percentage change in LDL-C from baseline between day 90 and day 360 was-58.51%,and an absolute change of was-1.64 mmol/L(both P<0.0001).At day 330,reductions from baseline were observed in the inclisiran group for PCSK9,total cholesterol,ApoB,non-HDL-C,with placebo-corrected percentage changes of-77.44%,-35.65%,-43.43%,-50.90%(all P<0.0001),respectively.At day 330,79.6%(74/93)of patients in the inclisiran group and 7.8%(6/77)in the placebo group achieved LDL-C levels<1.8 mmol/L,69.9%(65/93)of patients in the inclisiran group and 0%(0/77)in the placebo group achieved≥50%LDL-C reduction from baseline,66.7%(62/93)of patients in the inclisiran group and 2.6%(2/77)in the placebo group achieved their global LDL-C targets.The safety profile of inclisiran treatment over 12 months was comparable to that of the placebo,with no occurrence of treatment-related serious adverse events.Conclusions:In ASCVD patients or ASCVD high-risk subjects in Chinese mainland who have received diet control and maximum tolerable dose statins treatment(with or without other lipid-lowering treatments)and still have elevated LDL-C,inclisiran has a definite efficacy and good safety in reducing LDL-C.The efficacy and safety results of inclisiran assessed in Chinese mainland population are consistent with those of the general Asia population.

Objectives:The ORION-18 study has demonstrated that inclisiran can significantly reduce low-density lipoprotein cholesterol(LDL-C)and has good safety in Asian atherosclerotic cardiovascular disease(ASCVD)patients or ASCVD high-risk population.This subgroup analysis aims to further evaluate the efficacy and safety of inclisiran in Chinese mainland population.Methods:ORION-18 study is a multi-center,randomized,double-blind,placebo-controlled,phase Ⅲ clinical trial among Asian subjects,Chinese mainland subgroup included 232 ASCVD patients or ASCVD high-risk subjects who had already been treated with diet control and maximum tolerated doses of statins treatment(with or without other lipid-lowering treatments)but still had elevated LDL-C levels.Subjects were randomized in a 1:1 ratio to the inclisiran group and the placebo group(n=116 each),and received 300 mg of inclisiran or placebo respectively on day 0,90 and 270.The primary endpoint was the percentage change in LDL-C from baseline to day 330.The secondary endpoints included the time-adjusted percentage change and absolute change in LDL-C from baseline after day 90 and up to day 360,the absolute change in LDL-C from baseline to day 330,and the percentage changes from baseline to day 330 in proprotein convertase subtilisin/kexin type 9(PCSK9),total cholesterol,apolipoprotein B(ApoB),non-high-density lipoprotein cholesterol(non-HDL-C).Other secondary endpoints included the proportion of participants reaching LDL-C levels of<1.8 mmol/L at day 330,the proportion of participants with≥50%LDL-C reduction from baseline to day 330 and the proportion of participants who attained global lipid targets(the LDL-C target was<1.4 mmol/L for ASCVD patients and<1.8 mmol/L for ASCVD high-risk subjects)at day 330.Safety endpoints included adverse events during treatment,aboratory test abnormalities during treatment,serious adverse events,and assessed their severity and relation to treatment.Results:The inclisiran group showed a placebo-corrected percentage change in LDL-C from baseline to day 330 of-61.16%,and an absolute change of-1.73 mmol/L(both P<0.0001).Compared to the placebo group,the inclisiran group's time-adjusted percentage change in LDL-C from baseline between day 90 and day 360 was-58.51%,and an absolute change of was-1.64 mmol/L(both P<0.0001).At day 330,reductions from baseline were observed in the inclisiran group for PCSK9,total cholesterol,ApoB,non-HDL-C,with placebo-corrected percentage changes of-77.44%,-35.65%,-43.43%,-50.90%(all P<0.0001),respectively.At day 330,79.6%(74/93)of patients in the inclisiran group and 7.8%(6/77)in the placebo group achieved LDL-C levels<1.8 mmol/L,69.9%(65/93)of patients in the inclisiran group and 0%(0/77)in the placebo group achieved≥50%LDL-C reduction from baseline,66.7%(62/93)of patients in the inclisiran group and 2.6%(2/77)in the placebo group achieved their global LDL-C targets.The safety profile of inclisiran treatment over 12 months was comparable to that of the placebo,with no occurrence of treatment-related serious adverse events.Conclusions:In ASCVD patients or ASCVD high-risk subjects in Chinese mainland who have received diet control and maximum tolerable dose statins treatment(with or without other lipid-lowering treatments)and still have elevated LDL-C,inclisiran has a definite efficacy and good safety in reducing LDL-C.The efficacy and safety results of inclisiran assessed in Chinese mainland population are consistent with those of the general Asia population.

Following the principles of evidence-based medicine,in accordance with the structure and drafting rules of standardized documents,based on literature research,according to the characteristics of chronic cough in children and issues that need to form a consensus,the TCM Guidelines for Diagnosis and Treatment of Chronic Cough in Children was formulated based on the Delphi method,expert discussion meetings,and public solicitation of opinions.The guideline includes scope of application,terms and definitions,eti-ology and diagnosis,auxiliary examination,treatment,prevention and care.The aim is to clarify the optimal treatment plan of Chinese medicine in the diagnosis and treatment of this disease,and to provide guidance for improving the clinical diagnosis and treatment of chronic cough in children with Chinese medicine.

Objective:To analyze the 6-year operation faults of PHILIPS Brilliance big bore CT, identify the common problems, make corresponding maintenance plans, reduce the incidence of failures, and carry out simulation prediction of the occurrence rate of failures in the next few years.Methods:The failure data of Brilliance big bore CT from June 2012 to June 2018 were collected, and the curve estimation function in SPASS 19.0 software and the pareto diagram were used to analyze the relationship between the number of failures, time and failure types, and the prediction was made.Results:A total of 28 faults occurred during the 6-year opeation of Brilliance big bore CT. During the first half year, five times of faults occurred with the highest fault rate and then tended to stabilize. The linear function model was obtained using the curve estimation: y=-0.033 x+ 2.099( y for the number of fault, unit for times, x for the unit of time for half a year), the model of R2=0.003. In the next three years, approximately twice faults occurred within half year. The pareto chart showed that 16 faults occurred during data collection, including 3 faults in the treatment bed and 3 faults in the power supply system, respectively. The accumulative ratio of the above three faults was 71.4%, which were the main fault sources. Conclusion:The fault statistical analysis of Brilliance big bore CT is helpful for department maintenance personnel to better understand CT, develop effective maintenance programs, reduce the occurrence of faults, and predict the incidence of faults in the future.

OBJECTIVETo detect potential mutation of TCOF1 gene in a Chinese family affected with Treacher-Collins syndrome.

METHODSClinical data of the patient was collected. The analysis included history taking, clinical examination and genetic testing. All coding regions of the TCOF1 gene were subjected to PCR amplification and Sanger sequencing.

RESULTSA novel mutation c.2261ins G (p.E95X) of the TCOF1 gene was discovered in the patient. The same mutation was not found in his parents and 100 healthy controls.

CONCLUSIONThe c.2261insG (p.E95X) mutation of the TCOF1 gene probably underlies the disease in the patient. Genetic testing can facilitate diagnosis and genetic counseling for families affected with TCS.

Objective To study and compare the clinical efficacy between intravitreal conbercept injection and (or) macular grid pattern photocoagulation in treating macular edema secondary to non-ischemic branch retinal vein occlusion (BRVO).Methods Ninety eyes of 90 patients diagnosed as macular edema secondary to non-ischemic BRVO were enrolled in this study.Forty-eight patients (48 eyes) were male and 42 patients (42 eyes) were female.The average age was (51.25 ± 12.24) years and the course was 5-17 days.All patients were given best corrected visual acuity (BCVA),intraocular pressure,slit lamp with preset lens,fluorescence fundus angiography (FFA) and optic coherent tomography (OCT) examination.The patients were divided into conbercept and laser group (group Ⅰ),laser group (group Ⅱ) and conbercept group (group Ⅲ),with 30 eyes in each group.The BCVA and central macular thickness (CMT) in the three groups at baseline were statistically no difference (F=0.072,0.286;P=0.930,0.752).Patients in group Ⅰ received intravitreal injection of 0.05 ml of 10.00 mg/ml conbercept solution (conbercept 0.5 mg),and macular grid pattern photocoagulation 3 days later.Group Ⅱ patients were given macular grid pattern photocoagulation.Times of injection between group Ⅰ and Ⅲ,laser energy between group Ⅰ and Ⅱ,changes of BCVA and CMT among 3 groups at 1 week,1 month,3 months and 6 months after treatment were compared.Results Patients in group Ⅰ and Ⅲ had received conbercept injections (1.20 ± 0.41) and (2.23 ± 1.04) times respectively,and 6 eyes (group Ⅰ) and 22 eyes (group Ⅲ) received 2-4 times re-injections.The difference of injection times between two groups was significant (P＜0.001).Patients in group Ⅱ had received photocoagulation (1.43 ±0.63) times,9 eyes had received twice photocoagulation and 2 eyes had received 3 times of photocoagulation.The average laser energy was (96.05 ±2.34) μV in group Ⅰ and (117.41 ±6.85) μV in group Ⅱ,the difference was statistical significant (P=0.003).BCVA improved in all three groups at last follow-up.However,the final visual acuity in group Ⅰ and group Ⅲ were better than in group Ⅱ (t=4.607,-4.603;P＜0.001) and there is no statistical significant difference between group Ⅲ and group Ⅰ (t=-0.802,P=0.429).The mean CMT reduced in all three groups after treating for 1 week and 1 month,comparing that before treatment (t=-11.855,-10.620,-10.254;P＜0.001).There was no statistical difference of CMT between group Ⅰ and Ⅲ at each follow up (t=0.404,1.723,-1.819,-1.755;P=0.689,0.096,0.079,0.900).CMT reduction in group Ⅰ was more than that in group Ⅱ at 1 week and 1 month after treatments (t=-4.621,-3.230;P＜0.001,0.003).The CMT in group Ⅲ at 3 month after treatment had increased slightly comparing that at 1 month,but the difference was not statistically significant (t=1.995,P=0.056).All patients had no treatment-related complications,such as endophthalmitis,rubeosis iridis and retinal detachment.Conclusions Intravitreal conbercept injection combined with macular grid pattern photocoagulation is better than macular grid pattern photocoagulation alone in treating macular edema secondary to non-ischemic BRVO.Combined therapy also reduced injection times comparing to treatment using conbercept injection without laser photocoagulation.

AIM:To investigate the therapeutic protective effects and function regulations of conventional antidiabetic treatment plus piperazine ferulate tablet on traumatic vascular endothelial cells in type 2 diabetes mellitus.METHODS:80 patients were randomly divided into the treating group(n=37)and the control group(n=43).Conventional antidiabetic treatment plus piperazine ferulate was given to the treating group,and the control group was treated with conventional antidiabetic treatment plus vitamin C every day,and all the patients were treated with 4 weeks.The levels of fasting blood glucose(FBG),glycosylated hemoglobin A1C(Hb A1C),circulating endothelial cell(CEC),serum lipid peroxide(LPO),endothelin(ET)、nitric oxide(NO),tissue-plasminogen activator(t-PA)were determined during the therapeutic period.RESULTS:After 4 weeks of treatment,the levels of serum CEC,LPO and ET were lower in the treating group than those in the control group(P