1.Expert consensus on the positioning of the "Three-in-One" Registration and Evaluation Evidence System and the value of orientation of the "personal experience"
Qi WANG ; Yongyan WANG ; Wei XIAO ; Jinzhou TIAN ; Shilin CHEN ; Liguo ZHU ; Guangrong SUN ; Daning ZHANG ; Daihan ZHOU ; Guoqiang MEI ; Baofan SHEN ; Qingguo WANG ; Xixing WANG ; Zheng NAN ; Mingxiang HAN ; Yue GAO ; Xiaohe XIAO ; Xiaobo SUN ; Kaiwen HU ; Liqun JIA ; Li FENG ; Chengyu WU ; Xia DING
Journal of Beijing University of Traditional Chinese Medicine 2025;48(4):445-450
Traditional Chinese Medicine (TCM), as a treasure of the Chinese nation, plays a significant role in maintaining public health. In 2019, the Central Committee of the Communist Party of China and the State Council proposed for the first time the establishment of a TCM registration and evaluation evidence system that integrates TCM theory, "personal experience" and clinical trials (referred to as the "Three-in-One" System) to promote the inheritance and innovation of TCM. Subsequently, the National Medical Products Administration issued several guiding principles to advance the improvement and implementation of this system. Owing to the complexity of its implementation, there are still differing understandings within the TCM industry regarding the positioning of the "Three-in-One" Registration and Evaluation Evidence System, as well as the connotation and value orientation of the "personal experience." To address this, Academician WANG Qi, President of the TCM Association, China International Exchange and Promotion Association for Medical and Healthcare and TCM master, led a group of academicians, TCM masters, TCM pharmacology experts and clinical TCM experts to convene a "Seminar on Promoting the Implementation of the ′Three-in-One′ Registration and Evaluation Evidence System for Chinese Medicinals." Through extensive discussions, an expert consensus was formed, clarifying the different roles of the TCM theory, "personal experience" and clinical trials within the system. It was further emphasized that the "personal experience" is the core of this system, and its data should be derived from clinical practice scenarios. In the future, the improvement of this system will require collaborative efforts across multiple fields to promote the high-quality development of the Chinese medicinal industry.
2.Prevalence and consultation behavior of childhood respiratory diseases in a hospital in Zhejiang Province in 2019-2021
Kaiyi YANG ; Guoqiang QI ; Zhiwen ZHU ; Jian HUANG ; Shasha HU ; Gang YU
Journal of Public Health and Preventive Medicine 2024;35(2):12-16
Objective To analyze the causes of changes in the prevalence of respiratory diseases and the reason for changes in medical visit behavior of children in Zhejiang Province during the winter and spring seasons of 2019-2021, and to provide important reference for the allocation of hospital resources, implementation of hierarchical diagnosis and treatment, and epidemic prevention and control. Methods A retrospective study was conducted on 256 937 outpatient medical records from January 23rd to April 23rd of each year from 2019 to 2021 at the Children's Hospital Affiliated to Zhejiang University School of Medicine. Statistical methods were used for data analysis. Results A total of 256 937 cases were selected in the present study, including 157 000 cases in 2019, 22 192 cases in 2020, and 77 745 cases in 2021. The number of patients to the Children's Hospital of Zhejiang University School of Medicine from outside Hangzhou accounted for 41.74%, 14.36% , and 18.53% in 2019-2021, respectively. For 0~2 years old , 3~6 years old , and 7~14 years old groups , the percentages of patients with upper respiratory tract infections were 49.54%, 45.95%, and 46.74%, respectively ; with lower respiratory tract infections were 42.90% , 31.76% , and 22.95% ; with influenza were 2.23% , 3.15% and 4.09%; and with asthma were 1.37%, 5.08%, and 8.15%, respectively. Conclusion From 2019 to 2021, there have been significant changes in the total number of respiratory diseases in children, the proportion of disease types, and the proportion of children's geographical composition. It is necessary to continue to monitor children's respiratory diseases, grasp the dynamic changes in their medical visits in real time, adjust the hospital admission model , implement the graded treatment policy, and promote the prevention and control of respiratory diseases in children.
3.The Chinese guideline for management of snakebites
Lai RONGDE ; Yan SHIJIAO ; Wang SHIJUN ; Yang SHUQING ; Yan ZHANGREN ; Lan PIN ; Wang YONGGAO ; Li QI ; Wang JINLONG ; Wang WEI ; Ma YUEFENG ; Liang ZIJING ; Zhang JIANFENG ; Zhou NING ; Han XIAOTONG ; Zhang XINCHAO ; Zhang MAO ; Zhao XIAODONG ; Zhang GUOQIANG ; Zhu HUADONG ; Yu XUEZHONG ; Lyu CHUANZHU
World Journal of Emergency Medicine 2024;15(5):333-355
In 2009,the World Health Organization included snakebite on the list of neglected tropical diseases,acknowledging it as a common occupational hazard for farmers,plantation workers,and others,causing tens of thousands of deaths and chronic physical disabilities every year.This guideline aims to provide practical information to help clinical professionals evaluate and treat snakebite victims.These recommendations are based on clinical experience and clinical research evidence.This guideline focuses on the following topics:snake venom,clinical manifestations,auxiliary examination,diagnosis,treatments,and prevention.
4.Analysis of the impact of periampullary diverticula on the incidence of post-endoscopic retrograde cholangiopancreatography pancreatitis
Tianyu DE ; Xusheng AN ; Guoqiang WANG ; Qi WANG
Chinese Journal of Digestive Endoscopy 2024;41(8):640-646
Objective:To analyze the association between periampullary diverticula (PAD) and the incidence of post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP), and to further classify diverticula types, and explore the impact of different types of diverticula on PEP.Methods:Data of 505 patients who underwent endoscopic retrograde cholangiopancreatography (ERCP) for various reasons in General Hospital of Ningxia Medical University from May 2021 to May 2022 were retrospectively analyzed. Patients were classified into the diverticula group ( n=133) and the non-diverticula group ( n=372) based on the presence of PAD. The diverticula group was subdivided into types Ⅰ ( n=29), Ⅱ ( n=57), Ⅲ ( n=34), Ⅳ ( n=13) according to the Li-Tanaka classification. The incidences of PEP were compared between the diverticula group and the non-diverticula group, as well as among the four subgroups within the diverticula group. Multivariate logistic regression analysis was used to identify the independent risk factors for PEP. Results:There were significant differences in median age (72 years VS 66 years, Z=-4.626, P<0.001), common bile duct stones [80.45% (107/133) VS 59.94% (223/372), χ2=18.191, P<0.001], acute cholangitis [81.20% (108/133) VS 67.10% (231/372), χ2=16.208, P<0.001], malignant biliary stricture [8.27% (11/133) VS 23.39% (87/372), χ2=14.314, P<0.001] and pancreatic malignant diseases [7.52% (10/133) VS 18.55% (69/372), χ2=9.032, P=0.003] between the diverticula group and the non-diverticula group. The incidence of PEP in the diverticula group was significantly higher than that in the non-diverticula group [24.81% (33/133) VS 7.26% (27/372), χ2=28.835, P<0.001]. The incidence of PEP (36.84%,21/57) in type Ⅱ PAD patients was the highest, showing a significant difference compared with that of type Ⅲ [11.76% (4/34), χ2=6.984, P=0.008]. PAD ( OR=5.045, 95% CI: 2.898-11.194, P<0.001) and difficult cannulation ( OR=4.123, 95% CI: 1.968-8.490, P<0.001) were independent risk factors for PEP. In the Li-Tanaka classification, type Ⅰ ( OR=3.055, 95% CI: 1.131-8.251, P=0.028) PAD and type Ⅱ PAD ( OR=6.082, 95% CI: 3.468-13.344, P<0.001) had a higher risk of PEP compared with non-PAD patients. Conclusion:PAD is one of the independent risk factors for PEP. Types Ⅰ and Ⅱ PAD, according to the Li-Tanaka classification, are associated with an elevated risk of PEP when compared with non-PAD patients.
5.Problems and suggestions in the implementation of drug centralized volume-based procurement policies in the hospitals
Weihua KONG ; Qi QIAO ; Guoqiang LIU ; Nan CHEN ; Chengwu SHEN ; Qi CHEN ; Feng QIU ; Jianhua WANG ; Ling JIANG ; Qinghong LU ; Junyan WU ; Yafeng WANG ; Likai LIN ; Jiajia FENG ; Hong CHENG
Chinese Journal of Hospital Administration 2024;40(7):535-540
Objective:To explore the challenges in the implementation of drug centralized volume-based procurement policies in hospitals and propose corresponding optimization suggestions.Methods:From August to December 2023, a purposive sampling was conducted to select 11 pharmaceutical experts from tertiary hospitals in China for Delphi method. The survey content included " policy recommendations for promoting the acceleration and expansion of national drug centralized procurement and retaining surplus medical insurance funds for centralized procurement" .Results:Survey participants gave feedback on a set of existing problems found in the implementation of drug centralized procurement policies and proposed corresponding optimization methods. Kendall′s W coefficient of the specialist consultation was 0.332( P<0.05), demonstrating good consistency and concentration of the expert opinions. Among the problems, the score of drug supply guarantee was the highest(mean value of importance was 4.45). At the same time, the recommendation of strengthening monitoring and early warning, coordination and dispatch, and effectively ensuring the supply of centralized drug procurement had the highest score and concentration(mean value of importance was 4.91, coefficient of variation was 0.06). Conclusions:Through Delphi method, this study revealed issues and optimization methods in the implementation of drug centralized procurement policies in hospitals. The findings could provide valuable insights for improvements in the pharmaceutical sector and future policy adjustments.
6.Pharmacoeconomic evaluation of serplulimab combined with chemotherapy regimens for the first-line treatment of extensive-stage small cell lung cancer
Ran QI ; Xuyang NIE ; Xuting LIU ; Shengnan GAO ; Guoqiang LIU
China Pharmacy 2023;34(11):1368-1373
OBJECTIVE To evaluate the economics of serplulimab combined with chemotherapy regimens for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) from the perspective of health system in China. METHODS A partitioned survival model was constructed based on the ASTRUM-005 clinical trial and related literature data, with a model simulation time frame of 10 years and a 3-week cycle, and both cost and utility values were discounted using a 5% discount rate. The quality-adjusted life year (QALY) was used as a model output indicator and the incremental cost-effectiveness ratio (ICER) was calculated to evaluate the economics of serplulimab combined with chemotherapy regimens (serplulimab group) versus chemotherapy alone regimens (chemotherapy alone group) for the first-line treatment of ES-SCLC. One-way sensitivity analysis and probabilistic sensitivity analysis were used to verify the robustness of the results of the base-case analysis and to conduct a scenario analysis for the serplulimab patient assistance program. RESULTS The results of the base-case analysis showed that compared with chemotherapy alone group, ICER of serplulimab group was 758 690.27 yuan/QALY, which was higher than 3 times China’s per capita gross domestic product (GDP) in 2022 as the willingness-to-pay (WTP) threshold. The results of the scenario analysis showed that compared with chemotherapy alone group, the ICER of serplulimab group was 172 275.74 yuan/QALY, which was below above WTP threshold. The one-way sensitivity analysis showed that the progress-free survival utility value, serplulimab price and so on had a significant impact on the model results. The results of the probabilistic sensitivity analysis showed that the probability of the serplulimab group being economic was 0 when the serplulimab patient assistance program was not considered, but 100% when the patient assistance program was considered. CONCLUSIONS At a WTP threshold of 3 times China’s per capita GDP in 2022, the serplulimab group is no cost-effectiveness compared to the chemotherapy alone group; however, this result is reversed when the patient assistance program is taken into account.
7.Systematic review of the economical efficiency of drugs for anapastic lymphoma kinase-positive non-small cell lung cancer
Ran QI ; Shengnan GAO ; Xuting LIU ; Yang LIU ; Guoqiang LIU
China Pharmacy 2022;33(11):1368-1373
OBJECTIVE To systematically evaluate the economical efficiency of marketed a naplastic lymphoma kinase (ALK)-tyrosine kinase inhibitors (TKI)for the treatment of ALK-positive non-small cell lung cancer (NSCLC)in China ,and to provide a reference for the selection of China ’s medical insurance list and drug pricing. METHODS Computer searches of databases such as CNKI ,Wanfang database ,VIP,PubMed,Embase and the Cochrane Library were conducted to collect pharmacoeconomic evaluation studies of four marketed ALK-TKI (crizotinib,seretinib,aletinib and ensatinib )in the treatment of ALK-positive NSCLC in China during the inception to July 2021. The qualities of the included literature were evaluated using CHEERS checklist ,and analyzed systematically in terms of both methodological and economic outcomes. RESULTS A total of 6 literatures were included ,with a compliance rate of 71% to 83% for the CHEERS list criteria ,and the overall quality of the literature was high. In terms of methodological analysis ,the pharmacoeconomic evaluation methods included in the study were mainly model-based (Markov or partitioned survival models ) and real-world data-based cost-utility analysis. Most research perspectives were health insurance payer and health system perspectives ;all cost types were direct medical costs. In terms of economical efficiency analysis ,compared with chemotherapy plan ,2 studies confirmed that ALK-TKI (crizotinib,seretinib)were not economic ,1 study confirmed ALK-TKI (crizotinib) showed economical efficiency. Seretinib showed relatively higher economical efficiency when compared to other ALK-TKIs. High drug prices were the main factor why ALK-TKI was not economically viable for treating ALK-positive NSCLC. CONCLUSIONS The second-generation ALK-TKI (seretinib, 163.com alectinib) have better economical efficiency than the first-generation ALK-TKI (crizotinib). The economical efficiency of seretinib is the best among the second-generation · ALK-TKI. The economical efficiency of chemotherapy regimen is better than that of the second-generation ALK-TKI (seretinib). Economic comparison between chemotherapy and first-generation ALK-TKI (crizotinib)remains controversial.
8.Cost-utility analysis of pembrolizumab combined with chemotherapy in the first-line treatment of advanced or metastatic esophageal carcinoma
Ran QI ; Guiping DU ; Xuting LIU ; Shengnan GAO ; Guoqiang LIU
China Pharmacy 2022;33(12):1466-1473
OBJECTIVE To evaluate the cost-utility of pembrolizumab combined with chemotherapy versus chemotherapy alone in the first-line treatment of advanced or metastatic esophageal carcinoma. METHODS Cost-utility analysis of pembrolizumab combined with chemotherapy versus chemotherapy alone for advanced or metastatic esophageal carcinoma was conducted by using a three-state partitioned survival model from the perspective of health system in China. The model use d a lifetime simulation time frame with 3 weeks as a cycle. The survival data were extrapolated using KEYNOTE- 590 data;cost data were obtained from the median of 2022 public winning bid on Yaozhi network ,among which the price of pembrolizumab was obtained after discounting by a patient assistance program ;utility data were obtained from the literatures ,and a 5% discount rate was used for both cost and utility. One-way sensitivity analysis and probabilistic sensitivity analysis were also conducted to examine model robustness. RESULTS Analysis of the base case results showed that compared to chemotherapy alone ,the incremental cost-effectiveness ratio (ICER)of pembrolizumab combined with chemotherapy regimens were 950 528.42 yuan/QALY,107 845.39 yuan/QALY and 315 754.56 yuan/QALY for esophageal squamous cell carcinoma (ESCC),programmed deathligand- 1 combined positive score (PD-L1 CPS)≥10 and intention-to-treat population (ITT),respectively. The results of sensitivity analysis verified the robustness of the basic analysis results. CONCLUSIONS Under our healthcare system ,using a threshold of willingness-to-pay of 1-3 times our GDP per capita in 2021,pembrolizumab combined with chemotherapy regimen isn ’t cost-utility compared with chemotherapy alone in the ESCC and ITT subgroups of patients ,while it is cost-utility in the PD-L 1 CPS≥10 subgroup of patients.
9.High-risk phenotypes of genetic disease in a Neonatal Intensive Care Unit population.
Tiantian XIAO ; Qi NI ; Huiyao CHEN ; Huijun WANG ; Lin YANG ; Bingbing WU ; Yun CAO ; Guoqiang CHENG ; Laishuan WANG ; Liyuan HU ; Hongfang MEI ; Yulan LU ; Mengchun GONG ; Xinran DONG ; Wenhao ZHOU
Chinese Medical Journal 2022;135(5):625-627
10.Research progress in retroauricular incision decompressive hemicraniectomy for the treatment of severe traumatic brain injury
Zhou QI ; Guoqiang LI ; Fan TIAN ; Zihao WEI ; Yinian ZHANG
Chinese Journal of Trauma 2022;38(7):661-665
Severe traumatic brain injury (sTBI) as the most common emergency severe syndrome in neurosurgery has a high mortality and poor prognosis. Decompressive craniectomy is the first treatment choice for sTBI. The reverse question mark incision was usually adopted in decompressive craniectomy, but some scholars also suggest using the n-type incision and Kempe incision. Although the curative effect is remarkable when using the above incisions, the incidence of postoperative complications is high, such as cerebrospinal fluid leakage, poor wound healing and flap ischemic necrosis. Moreover, the advantages and disadvantages of different incisions are not clear. Therefore, some scholars proposed retroauricular incision decompressive craniectomy for sTBI patients because this incision that retains blood supply through a new flap can provide better decompression effect and reduce incision-related complications. The authors review the research progress in retroauricular incision in aspects of the methods, indications and its advantages and disadvantages in constrast with other incisions, so as to provide a theoretical basis for the selection of incision for decompressive craniectomy in sTBI patients.


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