OBJECTIVE To systematically review the pharmacoeconomic evaluation literature about proprotein convertase subtilisin/kexin type 9 （PCSK9） inhibitors for the prevention of cardiovascular disease in patients with hypercholesterolemia， and to provide a reference for clinical treatment， health decision-making and future follow-up research. METHODS Retrieved from English and Chinese databases such as PubMed and CNKI， the pharmacoeconomic literature about PCSK9 inhibitors （evolocumab and alirocumab） for the prevention of cardiovascular disease in patients with hypercholesterolemia was collected from the establishment of the database to October 8， 2023. The quality of the included literature was assessed with Consolidated Health Economic Evaluation Reporting Standards 2022 （CHEERS 2022） scale. The descriptive analysis was performed for basic information， model structure， related parameters， sensitivity analysis and the results of included studies. RESULTS & CONCLUSIONS A total of 29 literature were included， with overall good quality. The evaluation mainly adopted the Markov model from the healthcare system， payer and societal perspective. The effectiveness and utility data mainly came from the previous studies； the direct cost was mainly considered with a discount rate of 1.5%-5.0% per year， while the willingness-to-pay threshold was often set at 1-3 times the gross domestic product per capita. Most health output indicators were measured in life years and quality-adjusted life years. The sensitivity analysis of most studies demonstrated the robustness and the main influential factor was the drug cost. Most Chinese studies showed that PCSK9 inhibitor was not cost-effective for the prevention of cardiovascular disease in patients with acute coronary syndrome， myocardial infarction and atherosclerotic cardiovascular disease. It was cost-effective to use PCSK9 inhibitors for the prevention of cardiovascular disease only in specific groups， such as patients with triple vessel disease， patients with newly diagnosed acute coronary syndrome and low-density lipoprotein cholesterol≥100 mg/dL. Future research should refer to the CHEERS 2022 scale to improve the design， and strive to select large-scale， high-quality data to enhance the quality of reports and the transparency of health decisions， so as to more accurately assess the cost-effectiveness of PCSK9 inhibitors.

Infectious bone defect is bone defect with infection or as a result of treatment of bone infection. It requires surgical intervention, and the treatment processes are complex and long, which include bone infection control,bone defect repair and even complex soft tissue reconstructions in some cases. Failure to achieve the goals in any step may lead to the failure of the overall treatment. Therefore, infectious bone defect has been a worldwide challenge in the field of orthopedics. Conventionally, sequestrectomy, bone grafting, bone transport, and systemic/local antibiotic treatment are standard therapies. Radical debridement remains one of the cornerstones for the management of bone infection. However, the scale of debridement and the timing and method of bone defect reconstruction remain controversial. With the clinical application of induced membrane technique, effective infection control and rapid bone reconstruction have been achieved in the management of infectious bone defect. The induced membrane technique has attracted more interests and attention, but the lack of understanding the basic principles of infection control and technical details may hamper the clinical outcomes of induced membrane technique and complications can possibly occur. Therefore, the Chinese Orthopedic Association organized domestic orthopedic experts to formulate An evidence-based clinical guideline for the treatment of infectious bone defect with induced membrane technique ( version 2023) according to the evidence-based method and put forward recommendations on infectious bone defect from the aspects of precise diagnosis, preoperative evaluation, operation procedure, postoperative management and rehabilitation, so as to provide useful references for the treatment of infectious bone defect with induced membrane technique.

Objective:To evaluate the feasibility of indocyanine green fluorescence imaging technology applied in thyroid surgery to identify parathyroid gland.Methods:From Oct 2021 to May 2022, data of 42 patients undergoing thyroidectomy via gasless unilateral axillary approach in Zhejiang Provincial Hospital of Traditional Chinese Medicine were retrospectively analyzed. Cases using intraoperative fluorescence imaging technology(42 cases) were compared with conventional laparocopic approach.Results:The number of parathyroid glands dissected in the study group 1.57±0.61 was higher than that in the control group 0.56± 0.59 ( t=-5.472, P<0.05). The PTH value of the study group was (2.88±1.23)pmol/L on the first day after operation, which was higher than that of the control group (2.16±0.10)pmol/L ( t=-1.844, P<0.05). The blood parathyroid hormone value on the third day(3.22±1.31)pmol/L was higher than that of the control group (2.55±0.81) pmol/L ( t=-2.041, P<0.05). There were 2 cases of hypoparathyroidism in the study group, less than 5 cases in the control group, but there was no significant difference between the two groups( χ2=0.942, P>0.05). There was 1 case of hypocalcemia in the study group and 3 cases in the control group ( χ2=0.731, P>0.05). Conclusion:Using indocyanine green fluorescence imaging technology to identify parathyroid gland is feasible, simple, fast, safe and effective.

OBJECTIVE To accurately analyze the components of glandular hairs in Lonicera japonica Thunb. buds, and provide reference for quality evaluation and control of Lonicera japonica Thunb.. METHODS Laser microdissection technology was used to obtain glandular hairs of Lonicera japonica Thunb. buds, low-temperature freezing vortex method was used to removal flower buds surface hairs(glandular hairs and non glandular hairs), and the components of flower buds, flower buds removed surface hairs and glandular hairs were detected by HPLC-TOF/MS. Through comparison with standards, database retrieval and mass spectrometry fragmentation, the components were analyzed and identified. RESULTS Thirty-seven components were identified in the flower buds, 31 components were identified in the flower buds removed surface hairs, and 35 components were identified in the glandular hairs. Compared with flower buds, glandular hairs lack 2 phenolic acids, and flower buds removed surface hairs lack 6 flavonoids. CONCLUSION The glandular hair, which contains many secondary substances, is an important place for the synthesis and accumulation of secondary substances in Lonicera japonica Thunb. buds, and is closely related to the quality of Lonicera japonica Thunb..

Objective:To investigate the clinical value of digital technology in repair of soft tissue defect in hand by anterior tibial artery perforator flap.Methods:From January 2015 to February 2021, 9 patients with soft tissue defects in hand were repaired with anterior tibial artery perforator flap assisted by digital technology in flap design, including 6 males and 3 females aged from 19 to 63 years with a mean age of 33 years. The size of defects varied from 2.0 cm×1.5 cm to 4.0 cm×3.0 cm, with exposed bones or tendons. Preoperative CTA scan of lower limb was performed and three-dimensional image was reconstructed with Mimics 20.0. The anterior tibial artery perforator flap was designed according to the shape and size of the defect, then the resection of flap was digitally simulated. The flap based on the digital design was harvested and the defect was repaired in the operation. The size of flap was 2.5 cm×2.0 cm~4.5 cm×3.5 cm. Outpatient clinic follow-up was performed to evaluate the survival of flaps. Disability of Arm, Shoulder and Hand(DASH) was used for function evaluation.Results:All flaps were harvested successfully and all donor sites were closed directly. After surgery, 8 flaps survived completely. One flap developed venous occlusion that showed partial necrosis of the flap, and it was rescued after exploration and re-anastomosis. The follow-up period ranged from 6 to 21 months, with an average of 13 months. The DASH scores of the affected limb were 2 to 15 points at the last follow-up, with an average of 6.4 points. Mild scar hyperplasia occurred at donor site in 1 case without sensory abnormality.Conclusion:The digital technology is able to accurately locate the perforators by allowing an individualised design of the anterior tibial artery perforator flap. The flap is suitable for repair of small and medium-sized soft tissue defect in hand, and the digital technology has certain value in clinical application.

Objective:To explore the characters of CDU imaging anatomy and results of clinical application of perforating branch of median cubital vein, and to find the evidence of utilizing perforating vein to establish high level hemodialysis access.Methods:From November, 2016 to October, 2019, 150 median cubital veins in 75 persons were observed by CDU. And the inner diameter and length of the perforating branch were measured Perforating branches of median cubital vein were categorized with ultrasonic imaging anatomy. Thirty-eight chronic kidney failure patients who can not build forearm fistulas were operated by end-to-side anastomosis between perforating branch vein and brachial artery to build hemodialysis access. The blood flow of fisultas was measured,the mature period of fisultas was recorded. The length of available vessels of fisultas was measured and the long-term utilization rate of fisultas was counted.Results:Perforating branch of median cubital vein was always located in a little below elbow near brachial artery, the rate of occurrence was 94.0%. It was sent out at intersection of veins. There were 4 types of perforating vein in image-anatomy. There was no significant difference in vessel length and vessel inner diameter between different types ( P>0.05) ; All the 38 patients with mature fistulas could meet the needs of hemodialysis. The available vascular length of fistulas in type I and type II patients was better than that in type III ( P<0.01), and the long-term utilization rates of fistulas in type I, type II and type III were 84.6%, 85.7% and 72.7%, respectively. There was no significant difference in blood flow and mature period between different types ( P>0.05) . Conclusion:It is most safe and reliable to use the type I and type II of perforating branch of median cubital vein to make the high level fistulas , which can provide a safe and efficient hemodialysis access for the patients with forearm vascular drain, elderly diabetes patients and difficult fistulas with repeatedly thrombosis.

The number of combination products is increasing, and the cutting-edge and innovative technologies are constantly being used. How to evaluate combination products become difficult points. This study team summarizes the supervision conditions of the combination products and analyzes the common problems of these products application from the perspective of technical review, in order to provide reference for Chinese manufacturers and investigators in these products registration.
Biomedical Technology

This article summarizes the attribute conditions to the combination products designation from 2009 to 2018 in China,analyzes the common problems of combination products attribution definition.It is hoped to be helpful for researchers and manufacturers of combination products.
China ; Equipment and Supplies ; Terminology as Topic

Objective: To analyse the mental state of patients with allergic rhinitis (AR) in Chengdu. Methods: One thousand five hundred and thirty-six AR patients from Sichuan Provincial Integrated Traditional Chinese and Western Medicine Hospital, West China Hospital of Sichuan University, Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Sichuan People′s Hospital, Sichuan Second Hospital of Traditional Chinese Medicine were selected from July 2013 to January 2018. Eight hundred and twenty-seven patients were screened into study group by inclusion and exclusion standards. The symptom check list 90 (SCL-90) was used to group and score the mental state of these patients according to nine classification criteria: gender, BMI, age, marital status, monthly salary, disease duration, living environment, education level and working environment. Then, the scores were compared within groups. Inter-group comparison was made between the study group and the Chinese norm, and the positive factors for psychological disorders were extracted. Four symptoms in the study group, i.e. nasal itching, sneezing, clear discharge and nasal congestion, were scored on the visual analogue scale (VAS). SPSS 19.0 software was used to carry out statistical analysis. Partial correlation analysis was performed between the positive factors and the symptom scores by multiple regression statistical method. Results: The total score of SCL-90 in the study group was 2.64±0.25, which was accorded with mild to moderate mental health impairment. There were 124 (15.0%) without mental health damage, 176 (21.3%) with mild damage, 474 (57.3%) with mild to moderate damage, 41 (5.0%) with moderate to severe damage and 12 (1.4%) with severe damage. The in-group comparison showed that the top three categories of different items were the living environment, gender and working environment. The scores of somatization, obsessive-compulsive symptoms, interpersonal sensitivity, depression, anxiety, psychosis, other (sleep, diet) and total average score of urban residents were higher than that of country residents (3.29±0.61 vs 2.65±0.50, 2.81±0.77 vs 2.05±0.38, 3.10±0.19 vs 2.49±0.67, 3.40±0.84 vs 2.49±0.70, 3.04±0.64 vs 2.33±0.51, 3.02±0.55 vs 2.40±0.77, 3.40±0.41 vs 2.52±0.77, 2.91±0.11 vs 2.29±0.40, Z value was 4.88, 5.25, 4.57, 5.91, 5.09, 4.63, 5.55, -4.55, respectively, all P<0.05). Women scored higher than man for somatization, interpersonal sensitivity, depression and others (2.66±0.51 vs 2.00±0.45, 3.37±0.47 vs 2.63±0.51, 3.44±0.57 vs 2.85±0.52, 3.47±0.36 vs 2.76±0.45, Z value was -5.10, -5.51, -4.86, -5.28, respectively, all P<0.05). The scores of somatization, interpersonal sensitivity, psychosis and other (sleep, diet) were higher in the indoor group than those in the outdoor group (3.49±0.64 vs 2.78±0.46, 3.33±0.30 vs 2.56±0.68, 3.28±0.60 vs 2.67±0.31, 3.50±0.85 vs 2.85±0.37, Z value was 5.31, 5.79, 4.89, 5.00, respectively, all P<0.05). The outdoor group scored higher on obsessive-compulsive symptoms, anxiety and hostility (3.44±0.40 vs 2.83±0.35, 3.40±0.50 vs 2.57±0.93, 3.34±0.88 vs 2.69±0.56, Z value was 4.96, 6.22, 5.08, respectively, all P<0.05). The inter-group comparison found that depression, anxiety, psychosis and other (sleep, diet) could be partially correlated with VAS scores as 4 positive factors. The results of partial correlation analysis showed that depression was positively correlated with sneezing and nasal runny discharge, anxiety was positively correlated with nasal itching and nasal obstruction, psychosis was positively correlated with nasal itching and sneezing, and other (sleep, diet) was positively correlated with nasal runny discharge and nasal obstruction. Conclusion AR patients have mild to moderate mental health impairments, which are correlated with AR symptoms.

Objective: To evaluate the feasibility and potential value of comprehensive geriatric assessment (CGA) in elderly (≥60 years) patients with newly diagnosed acute myeloid leukemia (AML) in China. Methods: The CGA results of 83 newly diagnosed AML (non-APL) patients from 16 hospitals in Beijing and Tianjin between March 2016 and December 2017 were prospectively collected and analyzed. The clinical data, treatment and follow-up information were also collected. Results: Of 83 newly diagnosed elderly AML patients, 81 patients (97.6%) completed all designated CGA assessment. The median number of impaired scales of the CGA assessment in the studied population was 2(0-6). Sixteen patients (19.3%) showed no impairments according to the geriatric assessment scales implem ented by this study. The distributions of impaired scales were as follows: impairment in ADL, 55.4%; IADL impairment, 42.2%; MNA-SF impairment, 48.2%; cognitive impairment, 15.7%; GDS impairment, 31.7%; HCT-CI impairment, 19.5%, respectively. In patients with "good" ECOG (n=46), the proportion of impairment for each CGA scale ranged from 6.5% to 37.0% and 32 patients (68.9%) had at least one impaired CGA scale. Survival analysis showed that the number of impaired scales of the CGA was significantly correlated with median overall survival (P=0.050). Conclusions CGA was a tool with feasibility for the comprehensive evaluation in elderly AML patients in China. Combined with age and ECOG, CGA may be more comprehensive in assessing patients’ physical condition.