1.Cost-utility analysis of sacituzumab govitecan versus single-agent chemotherapy in the treatment of HR+/HER2- advanced metastatic breast cancer
Yinmei HE ; Xiao LI ; Xiaoli LIU ; Longzhou LI ; Yan GAO ; Jianguo YU ; Jiajie LUAN ; Yilai WU
China Pharmacy 2024;35(20):2493-2498
OBJECTIVE To estimate the cost-utility of sacituzumab govitecan (SG) versus single-agent chemotherapy in the treatment of hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) advanced metastatic breast cancer. METHODS From the perspective of the Chinese medical system, a three-state partitioned survival model was constructed to examine the cost-utility of SG versus single-agent chemotherapy based on TROPiCS-02 trial. The cycle length was set to 1 month, and the time horizon was 10 years. The annual discount was 5%. The model output included total costs and quality adjusted life month (QALM), and incremental cost-effectiveness ratio (ICER) was calculated for cost-utility analysis, by setting willingness-to-pay (WTP) threshold at 3 times gross domestic product (GDP) per capita of China in 2023 (22 340 yuan/QALM). Univariate sensitivity analyses, probability sensitivity analyses, and scenario analyses were performed to evaluate the robustness of the results and calculate the price threshold when SG had economic advantages. RESULTS SG group gained incremental 4.25 QALM and 561 570 yuan compared with single-agent chemotherapy, which resulted in an ICER of 132 102/QALM that was higher than WTP. The results of the univariate sensitivity analysis showed that the monthly average cost of SG had the greatest impact on the results; the results of probability sensitivity analysis showed that the probability of SG scheme being cost-effective at the WTP threshold was 0. The results of scenario analysis showed that the conclusions of this study were robust under different time horizons (5, 10, 15 years). The price threshold for SG being cost-effective was 1 344 yuan per 180 mg. CONCLUSIONS Based on the perspective of Chinese medical system, SG appears to be not cost-effective compared with single-agent chemotherapy for HR+/ HER2- advanced metastatic breast cancer at the price of 8 400 yuan per 180 mg. A substantial price cut should be taken to be cost- effective.
2.Clinical guidelines for the treatment of ankylosing spondylitis combined with lower cervical fracture in adults (version 2024)
Qingde WANG ; Yuan HE ; Bohua CHEN ; Tongwei CHU ; Jinpeng DU ; Jian DONG ; Haoyu FENG ; Shunwu FAN ; Shiqing FENG ; Yanzheng GAO ; Zhong GUAN ; Hua GUO ; Yong HAI ; Lijun HE ; Dianming JIANG ; Jianyuan JIANG ; Bin LIN ; Bin LIU ; Baoge LIU ; Chunde LI ; Fang LI ; Feng LI ; Guohua LYU ; Li LI ; Qi LIAO ; Weishi LI ; Xiaoguang LIU ; Hongjian LIU ; Yong LIU ; Zhongjun LIU ; Shibao LU ; Yong QIU ; Limin RONG ; Yong SHEN ; Huiyong SHEN ; Jun SHU ; Yueming SONG ; Tiansheng SUN ; Yan WANG ; Zhe WANG ; Zheng WANG ; Hong XIA ; Guoyong YIN ; Jinglong YAN ; Wen YUAN ; Zhaoming YE ; Jie ZHAO ; Jianguo ZHANG ; Yue ZHU ; Yingjie ZHOU ; Zhongmin ZHANG ; Wei MEI ; Dingjun HAO ; Baorong HE
Chinese Journal of Trauma 2024;40(2):97-106
Ankylosing spondylitis (AS) combined with lower cervical fracture is often categorized into unstable fracture, with a high incidence of neurological injury and a high rate of disability and morbidity. As factors such as shoulder occlusion may affect the accuracy of X-ray imaging diagnosis, it is often easily misdiagnosed at the primary diagnosis. Non-operative treatment has complications such as bone nonunion and the possibility of secondary neurological damage, while the timing, access and choice of surgical treatment are still controversial. Currently, there are no clinical practice guidelines for the treatment of AS combined with lower cervical fracture with or without dislocation. To this end, the Spinal Trauma Group of Orthopedics Branch of Chinese Medical Doctor Association organized experts to formulate Clinical guidelines for the treatment of ankylosing spondylitis combined with lower cervical fracture in adults ( version 2024) in accordance with the principles of evidence-based medicine, scientificity and practicality, in which 11 recommendations were put forward in terms of the diagnosis, imaging evaluation, typing and treatment, etc, to provide guidance for the diagnosis and treatment of AS combined with lower cervical fracture.
3.The application of full-length urethral preservation without anastomosis in single-port laparoscopic radical prostate cancer
Qingyi ZHU ; Jianzhong LIN ; Baixin SHEN ; Yong WEI ; Luming SHEN ; Jianguo ZHU ; Xue HE ; Haibin HU ; Min GU
Chinese Journal of Surgery 2024;62(2):162-166
Objective:To preliminarily examine the feasibility and outcome of single-port laparoscopic radical prostatectomy with full-length urethral preservation (FLUP-SPRP).Method:This study was a prospective case series study. A total of 25 patients with prostate cancer who met the enrollment criteria and agreed to this surgical procedure from March 2022 to December 2022 were collected at the Department of Urology, the Second Affiliated Hospital of Nanjing Medical University. The age of the patients was (67.2±7.6) years (range: 61 to 76 years). This novel procedure was performed by an experienced surgeon who performed single hole radical prostatectomy skillfully. Patient urinary control, tumor control, and related surgical complications after surgery were regularly monitored. Postoperative urinary control was evaluated using the daily amount of urine pad, 0 to 1 piece of urine pad was to restore urinary control, and 0 to 1 piece of pad within 24 hours after catheter removal was immediate urinary control.Result:All prodecures were successfully completed without transit to open surgery. The surgical time was (128.4±22.4) minutes (range: 100 to 145 minutes), the intraoperative blood loss was (68.2±13.7) ml (range: 50 to 120 ml). The urethral injury occurred in 4 cases during surgery and was repaired by sutures. The urinary control recovery rates within 24 hours, 1 week, 4 weeks, and 7 weeks after surgery were 80.0%, 84.0%, 92.0% and 100%, respectively. Postoperative large section pathology revealed 1 case with a positive basal margin of the prostate and negative margins of all prostate glands around the urethra. Postoperative complications included urinary tract infection in 3 cases, urodynia in 2 cases, and acute urinary retention in 1 case. MRI follow-up 3 months after surgery showed normal anatomy of the bladder and urethra. The follow-up values of prostate specific antigen at 3 and 6 months after surgery were less than 0.1 μg/L.Conclusions:The preliminary results of this study indicate that the FLUP-SPRP procedure is safe and feasible. The early results of postoperative urinary control and oncology are as expected.
4.Simultaneous Determination of 10 Effective Components in the Active Parts of Uygur Medicine Dracocephalum Moldavica L.by HPLC
Mei'e TAN ; Chenghui HE ; Hermity PAYMAN ; Ruifang ZHENG ; Ning YU ; Jianguo XING
Herald of Medicine 2024;43(4):567-571
Objective To establish an HPLC method for the simultaneous determination of 10 components in the active parts of Uygur medicine Dracocephalum Moldavica L.Methods The determination was performed on a Shim-pack ODS(4.6 mm×250 mm,5 um)column with the mobile phase consisting of acetonitrile(A)-0.5%formic acid(B)in aqueous solution in a gradient elution mode(0-30 min,17%A;30-60 min,17%→ 28%A;60-78 min,28%A)at a flow rate of 1.0 mL·min-1.The temperature of the chromatographic column was 35℃and the detection was monitored by a UV detector at 330 nm.Results Cof-feic acid,p-coumalic acid,cynaroside,luteolin-7-O-β-D-glucuronide,apigenin 7-O-glucuronide,rosmarinic acid,diosmetin7-O-β-D-glucuronide,salvianolic acid A,tilianin,apigenin were well separated under this chromatographic condition,and the linear relation-ship were good in the concentration range examined(r>0.999 2).The overall recoveries ranged from 91.83%to 106.43%with the RSD ranging from 0.38%to 2.22%.Conclusion The established content determination method is highly accurate and reproduci-ble,and suitable for the analysis and quality control of the active parts of Dracocephalum Moldavica L.
5.Antitumor mechanism of Ardisia Crenata Radix
Qunli REN ; Qian LUO ; Huaqian LIU ; Faming WU ; Yuqi HE ; Jianguo LIU ; Qian WANG
Chinese Journal of Comparative Medicine 2024;34(1):165-170
Ardisia Crenata Radix is a traditional Chinese medicinal plant that belongs to the Myrsinaceae family,and its main active components are coumarins,saponins,flavonoids,and volatile oil.Bergenin,ardisicrenoside A,ardisicrenoside B,ardisiacripin A,ardisiacripin B,and embelin were identified as active anticancer compounds in in-depth studies into the anti-tumor effects of Ardisia Crenata Radix.They show high therapeutic potential in oral cancer,nasopharyngeal carcinoma,liver cancer,colon cancer,bladder cancer,cervical cancer,and leukemia,mainly by inducing tumor cell apoptosis,increasing tumor cytotoxicity,inhibiting cell proliferation,inhibiting tumor cell metastasis and migration,and inducing cell regulatory enzyme cascade reactions.However,most preclinical experimental data on cinnabar root's anti-tumor mechanism have not been verified in high-quality,multi-sample,and repeated randomized controlled trials,and there are a lack of clinical research data on tumor prognosis,pharmacodynamics,and pharmacokinetics.Accurate research experiments and clinical trials should be designed to further explore the pharmacological effects of Ardisia Crenata Radix.
6.The application of full-length urethral preservation without anastomosis in single-port laparoscopic radical prostate cancer
Qingyi ZHU ; Jianzhong LIN ; Baixin SHEN ; Yong WEI ; Luming SHEN ; Jianguo ZHU ; Xue HE ; Haibin HU ; Min GU
Chinese Journal of Surgery 2024;62(2):162-166
Objective:To preliminarily examine the feasibility and outcome of single-port laparoscopic radical prostatectomy with full-length urethral preservation (FLUP-SPRP).Method:This study was a prospective case series study. A total of 25 patients with prostate cancer who met the enrollment criteria and agreed to this surgical procedure from March 2022 to December 2022 were collected at the Department of Urology, the Second Affiliated Hospital of Nanjing Medical University. The age of the patients was (67.2±7.6) years (range: 61 to 76 years). This novel procedure was performed by an experienced surgeon who performed single hole radical prostatectomy skillfully. Patient urinary control, tumor control, and related surgical complications after surgery were regularly monitored. Postoperative urinary control was evaluated using the daily amount of urine pad, 0 to 1 piece of urine pad was to restore urinary control, and 0 to 1 piece of pad within 24 hours after catheter removal was immediate urinary control.Result:All prodecures were successfully completed without transit to open surgery. The surgical time was (128.4±22.4) minutes (range: 100 to 145 minutes), the intraoperative blood loss was (68.2±13.7) ml (range: 50 to 120 ml). The urethral injury occurred in 4 cases during surgery and was repaired by sutures. The urinary control recovery rates within 24 hours, 1 week, 4 weeks, and 7 weeks after surgery were 80.0%, 84.0%, 92.0% and 100%, respectively. Postoperative large section pathology revealed 1 case with a positive basal margin of the prostate and negative margins of all prostate glands around the urethra. Postoperative complications included urinary tract infection in 3 cases, urodynia in 2 cases, and acute urinary retention in 1 case. MRI follow-up 3 months after surgery showed normal anatomy of the bladder and urethra. The follow-up values of prostate specific antigen at 3 and 6 months after surgery were less than 0.1 μg/L.Conclusions:The preliminary results of this study indicate that the FLUP-SPRP procedure is safe and feasible. The early results of postoperative urinary control and oncology are as expected.
7.Clinical research progress of subretinal fibrosis secondary to age-related mac-ular degeneration
Wu SUN ; Jianguo WU ; Dong WEI ; Wanyu ZHOU ; Yan HE ; Wentao FU ; Liqun CHU
Recent Advances in Ophthalmology 2024;44(12):991-994
Subretinal fibrosis(SRF),the end pathological stage of neovascular age-related macular degeneration(nAMD),can cause severe and irreversible vision loss in patients.In recent years,the high clinical incidence of SRF and the severe visual impairment it causes have led to a rapid development of SRF-related research.In order to systematically understand the clinical progress of SRF,recent studies on SRF secondary to nAMD were reviewed in this article.
8.Design of variable stiffness insole based on diabetics plantar pressure during gait period
Fang WANG ; Tao YANG ; Yaoguang HE ; Zijun CAO ; Guoqing LIU ; Jun HU ; Jianguo ZHANG ; Yubo FAN
Chinese Journal of Rehabilitation Theory and Practice 2023;29(4):408-415
ObjectiveTo analyze the characteristics of plantar pressure of diabetic patients during gait cycle, and to design a offloading insole with variable stiffness. MethodsThe plantar pressure experiment was carried out and a database including 157 subjects was established. The differences of plantar pressure distribution were analyzed among diabetic patients with and without peripheral neuropathy, and healthy people. The insole pressure area was divided, and porous units were filled in different insole areas according to the pressure gradient. The fed-calf-insole finite element model of diabetic patients was constructed. The simulation analysis of different insole schemes was carried out under the conditions of push-off, footheel-strike and dynamic neutrality posture, and to explore the most reasonable insole stiffness design. ResultsCompared with the healthy group, the percentage of peak pressure and high pressure in the left and right heel areas of diabetic neuropathy patients showed a decreasing trend, in which the left peak pressure was significantly reduced by 11% (P = 0.026) and the percentage of high pressure was significantly reduced by 9.8% (P = 0.02). When the porous elements of 2.5 MPa and 1.9 MPa were used in the high pressure area of the insole metatarsal and high pressure area of the heel, the peak plantar pressure of footheel-strike, dynamic neutral and push-off was reduced by 42.4%, 27.4% and 26.4%, and the peak stress of the soft tissue was reduced by 49.8%, 43.6% and 25.1%, respectively. ConclusionThere is a higher risk of ulcer in the metatarsal region than in the heel region for diabetic patients. The variable stiffness insoles based on the optimization of plantar pressure and internal stress under multi-posture can effectively reduce the peak pressure of plantar and peak stress of soft tissue during walking, which provides a reference for the design of variable stiffness insoles.
9.HSDL2 overexpression promotes rectal cancer progression by regulating cancer cell cycle and promoting cell proliferation.
Yang CHENG ; Xuxu HE ; Lian WANG ; Yibo XU ; Mengdi SHEN ; Wenjing ZHANG ; Yongsheng XIA ; Jie ZHANG ; Min ZHANG ; Yijun WANG ; Jianguo HU ; Jun HU
Journal of Southern Medical University 2023;43(4):544-551
OBJECTIVE:
To analyze the expression of hydroxysteroid dehydrogenase like 2 (HSDL2) in rectal cancer tissues and the effect of changes in HSDL2 expression level on proliferation of rectal cancer cells.
METHODS:
Clinical data and tissue samples of 90 patients with rectal cancer admitted to our hospital from January 2020 to June 2022 were collected from the prospective clinical database and biological specimen database. The expression level of HSDL2 in rectal cancer and adjacent tissues was detected by immunohistochemistry, and based on the median level of HSDL2 expression, the patients were divided into high expression group (n=45) and low expression group (n=45) for analysis the correlation between HSDL2 expression level and the clinicopathological parameters. GO and KEGG enrichment analyses were performed to explore the role of HSDL2 in rectal cancer progression. The effects of changes in HSDL2 expression levels on rectal cancer cell proliferation, cell cycle and protein expressions were investigated in SW480 cells with lentivirus-mediated HSDL2 silencing or HSDL2 overexpression using CCK-8 assay, flow cytometry and Western blotting.
RESULTS:
The expressions of HSDL2 and Ki67 were significantly higher in rectal cancer tissues than in the adjacent tissues (P < 0.05). Spearman correlation analysis showed that the expression of HSDL2 protein was positively correlated with Ki67, CEA and CA19-9 expressions (P < 0.01). The rectal cancer patients with high HSDL2 expressions had significantly higher likelihood of having CEA ≥5 μg/L, CA19-9 ≥37 kU/L, T3-4 stage, and N2-3 stage than those with a low HSDL2 expression (P < 0.05). GO and KEGG analysis showed that HSDL2 was mainly enriched in DNA replication and cell cycle. In SW480 cells, HSDL2 overexpression significantly promoted cell proliferation, increased cell percentage in S phase, and enhanced the expression levels of CDK6 and cyclinD1 (P < 0.05), and HSDL2 silencing produced the opposite effects (P < 0.05).
CONCLUSION
The high expression of HSDL2 in rectal cancer participates in malignant progression of the tumor by promoting the proliferation and cell cycle progress of the cancer cells.
Humans
;
CA-19-9 Antigen
;
Ki-67 Antigen/metabolism*
;
Prospective Studies
;
Cell Line, Tumor
;
Cell Proliferation/genetics*
;
Rectal Neoplasms/genetics*
;
Cell Cycle
;
Gene Expression Regulation, Neoplastic
;
Hydroxysteroid Dehydrogenases/metabolism*
10.Structural Design and Optimization of Cushioning Insole with Variable Stiffness
Jun HU ; Guoqing LIU ; Fang WANG ; Tao YANG ; Zijun CAO ; Yu ZHANG ; Yaoguang HE ; Jianguo ZHANG
Journal of Medical Biomechanics 2023;38(3):E574-E579
Objective An X-shaped cushioning insole with variable stiffness was designed to explore its effects on plantar pressure and internal stress of diabetic patients with toe amputation. Methods Based on CT images, the feet-calf finite element model of diabetic patients with toe amputation was established, and the insole was divided into different areas according to distribution characteristics of the planter pressure. The three-dimensional (3D) printed cushioning insole with an X-shaped sandwich structure was designed. The modulus of the sandwichstructure was changed by changing thickness of the sandwich structure panel. For simulation analysis, the divided area was filled with the X-shaped sandwich structure with different modulus. Results The peak plantar pressure of diabetic patients with toe amputation was in calcaneal region, and the combined insoles with 1. 2 mpanel thickness in toe area, 1. 4 mm panel thickness in metatarsal area, 2. 0 mm panel thickness in middle area and 1. 6 mm panel thickness in heel area had the best decompression effect. Compared with bare feet, the peak pressure in heel area of the insole, the peak pressure in phalangeal head area and the stress in plantar softissues were reduced by 40. 18% , 31. 7% , and 50. 44% , respectively. Conclusions The 3D printed insoles with variable stiffness can effectively reduce surface pressure and internal stress of the sole and reduce probability of the 2nd toe amputation

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