1.Cost-effectiveness analysis of cefiderocol for the treatment of confirmed or suspected carbapenem-resistant Gram-negative bacteria serious infections
Yuan GONG ; Shuo KANG ; Yibing HOU ; Xiaohui WANG ; Ying NIE ; Jing WANG ; Zhenhua PAN
China Pharmacy 2026;37(2):192-197
OBJECTIVE To evaluate the cost-effectiveness of cefiderocol versus best available therapy (BAT) or standard-of- care (SOC) for the treatment of confirmed or suspected carbapenem-resistant Gram-negative bacterial (CRGNB) serious infections from the perspective of the Chinese healthcare system, and to explore its reasonable pricing. METHODS A decision tree model was constructed based on data from two phase Ⅲ clinical trials (CREDIBLE-CR and GAME CHANGER) to simulate the cost- effectiveness of cefiderocol in two scenarios: salvage therapy for confirmed CRGNB infection (scenario 1) and empirical therapy for suspected CRGNB infection (scenario 2). The primary outcome measure was the incremental cost-effectiveness ratio (ICER). The willingness-to-pay (WTP) was set at 1 to 3 times China’s per capita GDP in 2024. To verify the robustness of the results, one- way and probabilistic sensitivity analyses were conducted, and based on these, a reasonable price range for cefiderocol in the Chinese market was explored. RESULTS The results for scenario 1 showed that the clinical cure rate in the cefiderocol group was higher than that in the BAT group (47.50% vs. 34.21%), but its ICER was 415 065.03 yuan per cured case, exceeding three times China’s GDP per capita. Scenario 2 revealed that the ICER for cefiderocol relative to SOC was as high as 1 362 446.16 yuan per cured case, far exceeding the WTP. Sensitivity analysis indicated that the treatment duration and price of cefiderocol were key factors affecting its cost-effectiveness. In the two scenarios described above, the unit price of cefiderocol must fall below 683.47 and 242.00 yuan/g, respectively, to be considered cost-effective. CONCLUSIONS Based on the current market price, cefiderocol lacks sufficient cost-effectiveness for treating confirmed or suspected CRGNB serious infections within China’s healthcare system. To improve its accessibility, price negotiations or a tiered medical insurance payment strategy are required.
2.Rapid health technology assessment of serplulimab in the first-line treatment of small-cell lung cancer
Yibing HOU ; Shuo KANG ; Yuan GONG ; Xiaohui WANG ; Ying NIE ; Huanlong LIU
China Pharmacy 2025;36(11):1405-1410
OBJECTIVE To evaluate the efficacy, safety and cost-effectiveness of serplulimab as a first-line treatment of small- cell lung cancer (SCLC), and provide an evidence-based basis for drug selection in hospitals. METHODS Rapid health technology assessment was adopted; PubMed, Cochrane Library, Embase, CNKI, Wanfang, VIP and official websites of domestic and international health technology assessment agencies were systematically searched from the inception to Oct. 2024. Two reviewers independently screened the literature, assessed the quality of included studies and carried out the qualitative analysis according to the inclusion and exclusion criteria. RESULTS A total of 13 systematic reviews/meta-analyses and 9 economic studies were included, and the literature quality was generally good. In terms of effectiveness, compared with chemotherapy alone, serplulimab combined with chemotherapy significantly improved progression-free survival, overall survival, and objective response rate in patients with SCLC. In terms of safety, serplulimab combined with chemotherapy showed no significant difference in the incidence of ≥3 grade adverse events compared with chemotherapy alone in the treatment of SCLC, indicating a good safety profile; compared with combination therapies involving other immunosuppressive agents, the incidence rate of adverse events was also lower. In terms of cost-effectiveness, compared with chemotherapy alone, serplulimab combined with chemotherapy is not cost- effective, which may be related to the high price of serplulimab. CONCLUSIONS Serplulimab is effective and safe in the treatment of SCLC, but has no obvious advantage in terms of cost-effectiveness.
3.Cost-utility analysis of capivasertib combined with fulvestrant in the second-line treatment of HR+/HER2- advanced breast cancer
Yang ZHANG ; Shuo KANG ; Xiaohui WANG ; Yibing HOU ; Xiangxia FU ; Huanlong LIU
China Pharmacy 2025;36(24):3073-3078
OBJECTIVE To evaluate the cost-utiliby of capivasertib combined with fulvestrant for the second-line treatment of hormone receptor-positive/human epidermal growth factor receptor-2-negative (HR+/HER2-) advanced breast cancer from the perspective of the Chinese healthcare system. METHODS A partitioned survival model was constructed using clinical data from the CAPItello-291 trial. Costs and quality-adjusted life years (QALYs) were used as the output indicators of the model, and the incremental cost-effectiveness ratio (ICER) was used as the evaluation indicator of the model. Using three times the per capita gross domestic product (GDP) of China in 2024 as the willingness-to-pay threshold (WTP), this study analyzed the cost-utility of capivasertib combined with fulvestrant versus fulvestrant monotherapy in the treatment of HR+/HER2- advanced breast cancer, and conducted sensitivity analysis and scenario analysis under conditions where the price of capivasertib was reduced by 50%, 60%, 70% and 95%, respectively. RESULTS The results of the basic analysis showed that compared with the fulvestrant monotherapy regimen, the ICER of capivasertib combined with fulvestrant was 843 038.46 yuan/QALY, which was higher than the WTP(287 247 yuan/QALY). The one-way sensitivity analysis revealed that the top three factors with the most substantial influence on ICER were the utility value in the progression disease state, the price of capivasertib, and the utility value inthe progression free survival state. Probabilistic sensitivity analysis demonstrated the robustness of the basic analysis results. Scenario analysis revealed that even if the price of capivasertib were reduced by 95%, capivasertib combined with fulvestrant did not exhibit cost-effectiveness at the current WTP. CONCLUSION At a WTP of three times China’s GDP per capita in 2024, compared to fulvestrant monotherapy, capivasertib combined with fulvestrant as the second-line treatment for HR+/ HER2- advanced breast cancer is not cost-effective.
4.Effectiveness of staged therapy using external fixation frame for infectious nonunion near knee joint.
Zhiguo WANG ; Xiaoguang GUO ; Zheng KANG ; Xinwei WANG ; Guoqiang JIN ; Honglue TAN ; Xiaohui DENG ; Weihua FENG
Chinese Journal of Reparative and Reconstructive Surgery 2025;39(11):1428-1434
OBJECTIVE:
To explore the methods, fixation points, and effectiveness of staged therapy using external fixation frame in treatment of infectious nonunion near knee joint.
METHODS:
A retrospective analysis was conducted on the clinical data of 60 patients with infectious nonunion near knee joint, who underwent staged therapy using external fixation frame between June 2021 and June 2024 and were followed up. There were 48 males and 12 females with an average age of 47.9 years (range, 16-70 years). The disease duration ranged from 9 months to 20 years, with a median of 14 months. Among them, 21 cases of infectious nonunion located in the distal femur, 36 cases in the proximal tibia, and 3 cases in the patella; 12 cases exhibited segmental bone defects (≥4 cm), while 48 cases presented with localized bone defects (<4 cm). Osteomyelitis was classified using the Cierny-Mader system, with 3 cases classified as type Ⅰ, 6 cases as type Ⅱ, 35 cases as type Ⅲ, and 16 cases as type Ⅳ. Preoperative C-reactive protein levels ranged from 15.1 to 55.8 mg/L (mean, 36.4 mg/L). The erythrocyte sedimentation rate was 35-80 mm/1 h (mean, 56.9 mm/1 h). The Hospital for Special Surgery (HSS) score for knee joint was 69.3±17.7 and the range of motion was (70.61±40.60)°. After debridement and placement of antibiotic carriers at the first-stage operation, unilateral orbital frames ( n=14), combined frames ( n=27), or Ilizarov frames ( n=19) were used for cross joint fixation ( n=9) or joint preservation fixation ( n=51). After 6-8 weeks of infection control, the bone grafting or bone transport was performed at the second-stage operation based on the type of bone defect, with internal fixation employed as an adjunct if necessary. After operation, the infection control and fracture healing were observed and the bone healing time was recorded. The knee joint function was assessed using the HSS score, and the knee joint range of motion was measured as well as the angle of motion loss. Patients were grouped according to the site of nonunion, type of external fixation frame, and fixation method. The bone healing time, change value of HSS score, and knee joint range of motion loss (difference between pre- and post-operation) were compared between groups.
RESULTS:
All infection markers returned to the normal range within 6 weeks after the first-stage operation. All patients were followed up 12-48 months (mean, 22.0 months) after the second-stage operation. There were 5 cases of needle tract infection during the external fixation period, and 3 cases of infection recurrence after the second-stage operation, all of which were cured after symptomatic treatment. The bone healing time was 6-18 months (mean, 11.0 months). At last follow-up, the HSS score was 88.5±7.9 and the range of motion was (61.84±40.59)°, with significant differences compared to preoperative values ( P<0.05); the knee joint range of motion loss was (8.77±11.07)°. The bone healing time was significantly longer in the distal femur group than in the proximal tibia group ( P<0.05), and in the unilateral orbital frames group than in the Ilizarov frames group and the combined frames group ( P<0.05). The angle of motion loss was significantly larger in the Ilizarov frames group than in the unilateral orbital frames group and the combined frames group ( P<0.05). The change value of HSS score was significantly higher in the cross joint fixation group than in the joint preservation fixation group ( P<0.05).
CONCLUSION
During the first-stage operation, debridement is performed and antibiotic carriers are placed to control infection. External fixation frames are then precisely positioned based on the distance between the lesion and the joint surface, avoiding the infected wound while ensuring mechanical balance. During the second-stage operation, bone grafting options are selected according to the extent of bone defects to enhance the bone union. Postoperative early functional exercises of the knee joint are permitted to improve joint function.
Humans
;
Male
;
Female
;
Middle Aged
;
Adult
;
Fractures, Ununited/surgery*
;
Retrospective Studies
;
External Fixators
;
Aged
;
Knee Joint/surgery*
;
Adolescent
;
Young Adult
;
Treatment Outcome
;
Osteomyelitis/surgery*
;
Fracture Fixation/instrumentation*
;
Bone Transplantation
;
Tibial Fractures/surgery*
5.Progress of research on drug targets for treatment of leishmaniasis
Zhiqiang KANG ; Xiaohui WO ; Wei WEI
Chinese Journal of Nosocomiology 2025;35(16):2551-2555
Leishmania is a protozoan parasite that causes leishmaniasis,a disease prevalent in tropical regions.Vis-ceral leishmaniasis,also known as kala-azar in Asian countries,and cutaneous leishmaniasis are distributed world-wide.Chemotherapy with sodium stibogluconate and amphotericin B has shown significant effects.However,cur-rent treatment methods for leishmaniasis have various defects,including multiple side effects,prolonged treat-ment duration,varying efficacy across different regions,and the emergence of drug resistance.To address this ur-gent need,it is imperative to identify safer and more effective alternative treatment methods and seek for appropri-ate pharmacological targets.This review discusses key metabolic pathways that represent potential pharmacologi-cal targets,as well as emerging therapeutic strategies for leishmaniasis.
6.Toripalimab for the treatment of advanced esophageal cancer:a rapid health technology assessment
Shou YANG ; Ying NIE ; Yuan GONG ; Shuo KANG ; Yibing HOU ; Xiaohui WANG ; Zhenhua PAN
Chinese Journal of Pharmacoepidemiology 2025;34(11):1302-1310
Objective To evaluate the efficacy,safety,and economic efficiency of toripalimab therapy for advanced esophageal cancer by rapid health technology assessment(rHTA),so as to provide clinical reference for drug use.Methods PubMed,Embase,Cochrane Library,CNKI,WanFang Data,VIP databases and official websites of health technology assessment institutions were electronically searched to collect high-quality clinical evidence and economic evaluation literature of toripalimab therapy for advanced esophageal cancer from inception to September 30,2025.Two reviewers independently identified studies,extracted data,assessed the quality of included studies,then the results were summarised and analysed using qualitative descriptive methods.Results A total of 18 articles were included,including 9 systematic reviews/Meta-analysis and 9 economic studies.In terms of efficacy,compared with the simple chemotherapy regimen,the combination chemotherapy regimen of toripalimab could significantly prolong the overall survival(OS)and progression free survival(PFS)of patients with advanced esophageal cancer,while improving the objective response rate(ORR)of patients.In terms of safety,there was no significant difference in the incidence of serious adverse events and overall adverse events between combination chemotherapy with toripalimab and chemotherapy alone.Moreover,compared with other immunotherapy combination therapies,the incidence of adverse events in combination chemotherapy with toripalimab was lower.In terms of economy,the combination of toripalimab and chemotherapy not only improves the clinical symptoms of advanced esophageal cancer patients,but also offers economic advantages.Conclusion Toripalimab is effective,safe and economical in the treatment of advanced esophageal cancer.
7.Progress of research on drug targets for treatment of leishmaniasis
Zhiqiang KANG ; Xiaohui WO ; Wei WEI
Chinese Journal of Nosocomiology 2025;35(16):2551-2555
Leishmania is a protozoan parasite that causes leishmaniasis,a disease prevalent in tropical regions.Vis-ceral leishmaniasis,also known as kala-azar in Asian countries,and cutaneous leishmaniasis are distributed world-wide.Chemotherapy with sodium stibogluconate and amphotericin B has shown significant effects.However,cur-rent treatment methods for leishmaniasis have various defects,including multiple side effects,prolonged treat-ment duration,varying efficacy across different regions,and the emergence of drug resistance.To address this ur-gent need,it is imperative to identify safer and more effective alternative treatment methods and seek for appropri-ate pharmacological targets.This review discusses key metabolic pathways that represent potential pharmacologi-cal targets,as well as emerging therapeutic strategies for leishmaniasis.
8.Sugemalimab as first-line treatment for non-small cell lung cancer:a rapid health technology assessment
Yibing HOU ; Shuo KANG ; Yuan GONG ; Xiaohui WANG ; Ying NIE ; Huanlong LIU
Chinese Journal of Pharmacoepidemiology 2025;34(7):806-814
Objective To evaluate the efficacy,safety and economy of sugemalimab in the first-line treatment of non-small cell lung cancer(NSCLC)by rapid health technology assessment.Methods PubMed,Cochrane Library,Embase,CNKI,WanFang Data,VIP and official websites of health technology assessment(HTA)institutions were systematically searched to collect HTA reports,systematic reviews/Meta-analysis and pharmacoeconomic studies of sugemalimab in first-line treatment of NSCLC from inception to October 31,2024.Two reviewers independently screened the literature,extracted information and performed quality assessment of the included studies,and then performed descriptive analysis on the results.Results A total of 15 articles were selected,including 4 systematic reviews/Meta-analysis and 11 pharmacoeconomic studies.In terms of effectiveness,compared with chemotherapy alone,sugemalimab combined with chemotherapy significantly improved progression-free survival(PFS),overall survival(OS),and objective response rate(ORR)in patients with NSCLC.In terms of safety,compared with chemotherapy alone,sugemalimab combined chemotherapy had higher incidence of overall adverse events,but it had a better safety profile compared to other immune combination therapies.In terms of economy,most studies suggested that compared with chemotherapy alone,sugemalimab combined with chemotherapy was not cost-effective,which may be related to the high price of sugemalimab.However,a few studies indicated that sugemalimab combined with chemotherapy could be cost-effective in specific scenarios.Conclusion Sugemalimab has good efficacy in the first-line treatment of NSCLC,but its safety and economy need to be further studied.
9.Distribution patterns and predictive study of oxford phase 3 unicompartmental knee arthroplasty prosthe-sis sizes:A retrospective analysis based on 270 clinical cases
Kang XU ; Shucai BAI ; Xiaohui LI
The Journal of Practical Medicine 2025;41(14):2243-2249
Objective To investigate the distribution characteristics of model numbers associated with the third-generation Oxford unicompartmental knee arthroplasty(UKA)prostheses,in order to provide evidence-based guidance for the selection of appropriate UKA prostheses in clinical practice.Methods A retrospective analysis was conducted on data from 270 patients who underwent UKA using third-generation Oxford prostheses and fulfilled the inclusion criteria between April 2019 and September 2023.Patient characteristics,including gender,age,height,weight,affected side,and prosthesis model numbers,were collected and recorded.The distribution and matching patterns of femoral and tibial prosthesis model numbers were evaluated.Multiple ordinal logistic regres-sion analyses and receiver operating characteristic(ROC)curves were employed to identify significant predictors influencing the selection of femoral component models.Additionally,a parameter distribution map related to UKA prosthesis model numbers was developed.Results Among the femoral prostheses,the XS size accounted for 21.5%,S for 44.1%,M for 26.3%,and L for 8.1%.Regarding tibial prostheses,AA represented 11.1%,A 23.7%,B 29.3%,C 18.9%,D 10.4%,and E 6.7%.The matching rates between tibial and femoral components were as follows:93.3%for tibial AA corresponding to femoral XS,96.0%for tibial A/B corresponding to femoral S,95.8%for tibial C/D corresponding to femoral M,and 91.7%for tibial E corresponding to femoral L,resulting in an overall matching rate of 95.2%.Height(AUC=90.63%),gender(AUC=81.59%),and weight(AUC=84.47%)showed significant correlations with femoral model selection(P<0.01),whereas age and side did not demonstrate statistical significance.The S femoral model was predominantly used in female patients(59.6%),while the M and L models were more commonly utilized in male patients(65.2%).When female patients' height was ≤160 cm,the combined usage rate of the XS and S models exceeded 90%.For male patients taller than 175 cm,the utilization rate of the L model reached 88.9%.The accuracy rate of preoperative prediction based on height and gender was 70.7%,which improved to 77.0%when incorporating intraoperative tibial model information.Conclusions The distribution of UKA prostheses in the study population differed from that observed in Western populations,as well as from other regions in Asia and China.The distribution map of UKA prostheses and the corresponding matching rules established in this study demonstrate a high level of predictive accuracy,which can effectively support preoperative planning and intraoperative selection of femoral prosthesis model numbers.
10.Chinese experts' consensus on principles of preoperative hair removal
Yiping MAO ; Jun ZHENG ; Lei LI ; Deyan YANG ; Bing ZHANG ; Lei YANG ; Wang JIA ; Peng KANG ; Hui JIAO ; Yun YANG ; Qi QI ; Shiqing FENG ; Xiao LONG ; Yuewei ZHANG ; Xiaohui WANG ; Lize WANG ; Yuan WEI ; Jichao ZHOU ; Minghui MAO ; Pengju XIN ; Hongyu TAN ; Dahong ZHANG ; Lianxin LIU ; Lei TAO ; Xietong WANG ; Xiaoning YUAN ; Mang CAI ; Li MU ; Fang DU ; Rongzhu CHEN ; Fengmao ZHAO ; Jiuzuo HUANG ; Mingzi ZHANG ; Jie ZHANG ; Baoguo WANG ; Kun WANG ; Fang LUO ; Jinhua ZHANG ; Nong HE ; Ling LYU ; Zhiyong ZONG
Chinese Journal of Nosocomiology 2025;35(10):1441-1449
To formulate an expert consensus on the principles of preoperative hair removal and provide scientific guidance for standardized removal of hair before surgical procedures so as to reduce the incidence of surgical site infections.METHODS Led by the Hospital Management Institute of National Health Commission of the People's Republic of China,this consensus was reached with the joint efforts from the expects of relevant fields such as surgeries,interventional therapies,nursing,and infection prevention and control.The consensus facilitates the classification and evaluation of literatures by following the evidence grade formulated by Oxford Evidence-based Medicine Center and focuses on the association of preoperative hair removal with surgical site infection,it reaches the evidence grade of expert consensus and recommendation intensity by integrating with discussions on meetings and clinical experience of the expects from relevant fields.RESULTS A total of 6 items of consensus were reached by summarizing the latest evidence on the aspects including the indications for preoperative hair removal,tools,range,timing and places.CONCLUSION The consensus,to some extent,make supplements to and complete the exiting regulations and standards.It provides guidance for the medical institutions to carry out the preoperative hair removal.

Result Analysis
Print
Save
E-mail