1.Outcome indicators in randomized controlled trials of traditional Chinese medicine treatment of post-stroke depression.
Jin HAN ; Yue YUAN ; Fang-Biao XU ; Yan-Bo SONG ; Yong-Kang SUN ; Xin-Zhi WANG
China Journal of Chinese Materia Medica 2025;50(2):542-559
This study systematically reviewed the randomized controlled trial(RCT) of traditional Chinese medicine(TCM) treatment of post-stroke depression(PSD) and analyzed the clinical study characteristics and outcome indicators, aiming to optimize the design and establish the core outcome set in the future clinical trials of the TCM treatment of PSD. PubMed, Web of Science, Cochrane Library, EMbase, CNKI, VIP, Wanfang, and SinoMed were searched for the relevant RCT published in recent 3 years. The basic characteristics, intervention measures, and outcome indicators of the included RCT were extracted, and the descriptive analysis was carried out. A total of 76 RCTs were eventually included, with the sample size concentrated in 80-100 cases. The most frequent TCM syndromes were liver depression and Qi stagnation(15 times, 31.91%) and phlegm combined with stasis(5 times, 10.63%). The frequency of intervention methods followed a descending trend of TCM decoction(35 times, 46.05%) and TCM decoction + acupuncture(4 times, 5.26%), Chinese patent medicine(3 times, 3.94%), and the intervention mainly lasted for 1 to 3 months(43 times, 60.56%). The adverse reactions of patients were mainly digestive system reaction(150 patients, 39.37%) and nervous system reaction(112 patients, 29.39%). Most of the included studies had unclear risk of bias, involving 84 outcome indicators, which belonged to 8 indicator domains. The RCTs of TCM treatment of PSD showed a variety of problems, such as non-standard TCM syndrome differentiation, inconsistent names of TCM syndrome scores and measurement tools, low quality, unclear risk of bias, neglect of endpoint indicators, unreasonable selection of substitute indicators, lack of differentiation between primary and secondary outcome indicators, non-standard reporting of safety indicators, insufficient attention to economic indicators, and lack of long-term prognosis evaluation. It is suggested that the future research should improve the quality of methodology and build a standardized core outcome set to promote the development of high-quality clinical research in this field.
Humans
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Randomized Controlled Trials as Topic
;
Drugs, Chinese Herbal/administration & dosage*
;
Stroke/psychology*
;
Depression/etiology*
;
Treatment Outcome
;
Medicine, Chinese Traditional
2.Network Meta-analysis of efficacy of different Chinese medicine injections in treating transient ischemic attack.
Jin HAN ; Yong-Kang SUN ; Yue YUAN ; Fang-Biao XU ; Yan-Bo SONG ; Wei-Jie WANG ; Xin-Zhi WANG
China Journal of Chinese Materia Medica 2025;50(8):2282-2297
This study aims to evaluate the efficacy of Chinese medicine injections in treating transient ischemic attack(TIA) based on network Meta-analysis. Randomized controlled trial(RCT) about Chinese medicine injections in treating TIA were retrieved from PubMed, Web of Science, Cochrane Library, EMbase, CNKI, VIP, Wanfang, and SinoMed with the time interval from inception to March 1, 2024. The methodological quality of the included articles was assessed by ROB 2.0, and the GRADE system was employed to evaluate the quality of evidence. The gemtc package of R 4.1.2 was used to perform the network Meta-analysis. Finally, 63 RCTs with a total sample size of 5 750 cases were included, involving 11 Chinese medicine injections(Shuxuetong Injection, Danhong Injection, Shuxuening Injection, Ginkgo Damo Injection, Shenxiong Glucose Injection, Ligustrazine Injection, Salviae Miltiorrhizae and Ligustrazine Hydrochloride Injection, Salvianolic Acids for Injection, Dengzhan Xixin Injection, Guhong Injection, and Xueshuantong Injection). All patients received conventional western medicine treatment, and the experimental group was additionally treated with Chinese medicine injection. Network Meta-analysis yielded the following results.(1) In terms of improving the clinical total response rate, 11 Chinese medicine injections combined with conventional western medicine outperformed conventional western medicine alone, and Dengzhan Xixin Injection + conventional western medicine had the best effect.(2) In terms of reducing plasma viscosity, 7 Chinese medicine injections combined with conventional western medicine outperformed conventional western medicine alone, and Shenxiong Glucose Injection + conventional western medicine had the best effect.(3) In terms of reducing whole blood high shear viscosity, 6 Chinese medicine injections combined with conventional western medicine outperformed conventional western medicine alone, and Guhong Injection + conventional western medicine had the best effect.(4) In terms of reducing whole blood low shear viscosity, 6 Chinese medicine injections combined with conventional western medicine outperformed conventional western medicine alone, and Shuxuening Injection + conventional western medicine had the best effect.(5) In terms of reducing fibrinogen, 9 Chinese medicine injections combined with conventional western medicine outperformed conventional western medicine alone, and Ginkgo Damo Injection + conventional western medicine had the best effect.(6) In terms of increasing the average blood flow velocity, 3 Chinese medicine injections combined with conventional western medicine outperformed conventional western medicine alone, and Shuxuening Injection + conventional western medicine had the best effect. In summary, compared with conventional western medicine alone, Chinese medicine injections combined with conventional western medicine were effective in improving the clinical total response rate and the average blood flow velocity, as well as reducing plasma viscosity, whole blood high shear viscosity, whole blood low shear viscosity, and fibrinogen. However, due to the limited quality and quantity of the included articles, the above conclusions need to be verified by more high-quality, multi-center, and large-sample RCT.
Humans
;
Drugs, Chinese Herbal/administration & dosage*
;
Injections
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Ischemic Attack, Transient/drug therapy*
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Randomized Controlled Trials as Topic
;
Treatment Outcome
3.Forty years of construction and innovative development of scientific regulation system of traditional Chinese medicine in China.
Jun-Ning ZHAO ; Zhi-Shu TANG ; Hua HUA ; Rong SHAO ; Jiang-Yong YU ; Chang-Ming YANG ; Shuang-Fei CAI ; Quan-Mei SUN ; Dong-Ying LI
China Journal of Chinese Materia Medica 2025;50(13):3489-3505
Since the promulgation of the first Drug Administration Law of the People's Republic of China 40 years ago in 1984, China has undergone four main stages in the traditional Chinese medicine(TCM) regulation: the initial establishment of TCM regulation rules(1984-1997), the formation of a modern TCM regulatory system(1998-2014), the reform of the review and approval system for new TCM drugs(2015-2018), and the construction of a scientific regulation system for TCM(2019-2024). Over the past five years, a series of milestone achievements of TCM regulation in China have been achieved in the six aspects, including its strategic objectives and the establishment of a science-based regulatory system, the reform of the review and approval system for new TCM drugs, the optimization and improvement of the TCM standard system and its formation mechanism, comprehensive enhancement of regulatory capabilities for TCM safety, international harmonization of TCM regulation and its role in promoting innovation. Looking ahead, centered on advancing TCMRS to establish a sound regulatory framework tailored to the unique characteristics of TCM, TCM regulation will evolve into new reform patterns, advancing and extending across eight critical fronts, including the legal framework and policy architecture, the review and approval system for new TCM drugs, the quality standard and management system of TCM, the comprehensive quality & safety regulation and traceability system, the research and transformation system for TCMRS, AI-driven innovations in TCM regulation, the coordination between high-quality industrial development and high-level regulation, and the leadership in international cooperation and regulatory harmonization. In this way, a unique path for the development of modern TCM regulation with Chinese characteristics will be pioneered.
Humans
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China
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Drugs, Chinese Herbal/standards*
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History, 20th Century
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History, 21st Century
;
Medicine, Chinese Traditional/trends*
4.Research and application implementation of the Internet of Things scheme for intensive care unit medical equipment.
Hong LIANG ; Jipeng SUN ; Yong FAN ; Desen CAO ; Kunlun HE ; Zhengbo ZHANG ; Zhi MAO
Journal of Biomedical Engineering 2025;42(1):65-72
The intensive care unit (ICU) is a highly equipment-intensive area with a wide variety of medical devices, and the accuracy and timeliness of medical equipment data collection are highly demanded. The integration of the Internet of Things (IoT) into ICU medical devices is of great significance for enhancing the quality of medical care and nursing, as well as for the advancement of digital and intelligent ICUs. This study focuses on the construction of the IOT for ICU medical devices and proposes innovative solutions, including the overall architecture design, devices connection, data collection, data standardization, platform construction and application implementation. The overall architecture was designed according to the perception layer, network layer, platform layer and application layer; three modes of device connection and data acquisition were proposed; data standardization based on Integrating the Healthcare Enterprise-Patient Care Device (IHE-PCD) was proposed. This study was practically verified in the Chinese People's Liberation Army General Hospital, a total of 122 devices in four ICU wards were connected to the IoT, storing 21.76 billion data items, with a data volume of 12.5 TB, which solved the problem of difficult systematic medical equipment data collection and data integration in ICUs. The remarkable results achieved proved the feasibility and reliability of this study. The research results of this paper provide a solution reference for the construction of hospital ICU IoT, offer more abundant data for medical big data analysis research, which can support the improvement of ICU medical services and promote the development of ICU to digitalization and intelligence.
Intensive Care Units
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Internet of Things
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Humans
;
Internet
;
Data Collection
5.Prediction of testicular histology in azoospermia patients through deep learning-enabled two-dimensional grayscale ultrasound.
Jia-Ying HU ; Zhen-Zhe LIN ; Li DING ; Zhi-Xing ZHANG ; Wan-Ling HUANG ; Sha-Sha HUANG ; Bin LI ; Xiao-Yan XIE ; Ming-De LU ; Chun-Hua DENG ; Hao-Tian LIN ; Yong GAO ; Zhu WANG
Asian Journal of Andrology 2025;27(2):254-260
Testicular histology based on testicular biopsy is an important factor for determining appropriate testicular sperm extraction surgery and predicting sperm retrieval outcomes in patients with azoospermia. Therefore, we developed a deep learning (DL) model to establish the associations between testicular grayscale ultrasound images and testicular histology. We retrospectively included two-dimensional testicular grayscale ultrasound from patients with azoospermia (353 men with 4357 images between July 2017 and December 2021 in The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China) to develop a DL model. We obtained testicular histology during conventional testicular sperm extraction. Our DL model was trained based on ultrasound images or fusion data (ultrasound images fused with the corresponding testicular volume) to distinguish spermatozoa presence in pathology (SPP) and spermatozoa absence in pathology (SAP) and to classify maturation arrest (MA) and Sertoli cell-only syndrome (SCOS) in patients with SAP. Areas under the receiver operating characteristic curve (AUCs), accuracy, sensitivity, and specificity were used to analyze model performance. DL based on images achieved an AUC of 0.922 (95% confidence interval [CI]: 0.908-0.935), a sensitivity of 80.9%, a specificity of 84.6%, and an accuracy of 83.5% in predicting SPP (including normal spermatogenesis and hypospermatogenesis) and SAP (including MA and SCOS). In the identification of SCOS and MA, DL on fusion data yielded better diagnostic performance with an AUC of 0.979 (95% CI: 0.969-0.989), a sensitivity of 89.7%, a specificity of 97.1%, and an accuracy of 92.1%. Our study provides a noninvasive method to predict testicular histology for patients with azoospermia, which would avoid unnecessary testicular biopsy.
Humans
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Male
;
Azoospermia/diagnostic imaging*
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Deep Learning
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Testis/pathology*
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Retrospective Studies
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Adult
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Ultrasonography/methods*
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Sperm Retrieval
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Sertoli Cell-Only Syndrome/diagnostic imaging*
6.Clinical characteristics and survival analysis of pediatric Hodgkin lymphoma: a multicenter study.
Ying LIN ; Li-Li PAN ; Shao-Hua LE ; Jian LI ; Bi-Yun GUO ; Yu ZHU ; Kai-Zhi WENG ; Jin-Hong LUO ; Gao-Yuan SUN ; Yong-Zhi ZHENG
Chinese Journal of Contemporary Pediatrics 2025;27(6):668-674
OBJECTIVES:
To investigate the clinicopathological characteristics and prognostic factors of pediatric Hodgkin lymphoma (HL).
METHODS:
A retrospective analysis was conducted on the clinical data of children with newly diagnosed HL from January 2011 to December 2023 at four hospitals: Fujian Medical University Union Hospital, Fujian Medical University Zhangzhou Hospital, First Affiliated Hospital of Xiamen University, and Fujian Children's Hospital. Patients were categorized into low-risk (R1), intermediate-risk (R2), and high-risk (R3) groups based on HL staging and pre-treatment risk factors. The patients received ABVD regimen or Chinese Pediatric HL-2013 regimen chemotherapy. Early treatment response and long-term efficacy were assessed, and prognostic factors were analyzed using the Cox proportional hazards regression model.
RESULTS:
The overall complete response (CR) rates after 2 and 4 cycles of chemotherapy were 42% and 68%, respectively. Compared with the ABVD regimen group, patients treated with the HL-2013 regimen in the R1 group showed significantly higher CR rates after both 2 and 4 cycles (P<0.05). However, no statistically significant differences in CR rates were observed between the two regimens in the R2 and R3 groups (P>0.05). The 5-year event-free survival (EFS) rate, overall survival rate, and freedom from treatment failure rate were 83%±4%, 97%±2%, and 88%±4%, respectively. Cox analysis indicated that the presence of a large tumor mass at diagnosis and failure to achieve CR after 4 cycles of chemotherapy were independent risk factors for lower EFS rates (P<0.05).
CONCLUSIONS
Pediatric HL generally has a favorable prognosis. The presence of a large tumor mass at diagnosis and failure to achieve CR after 4 cycles of chemotherapy indicate poor prognosis.
Humans
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Hodgkin Disease/pathology*
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Male
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Child
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Female
;
Adolescent
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Retrospective Studies
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Child, Preschool
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Antineoplastic Combined Chemotherapy Protocols/therapeutic use*
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Prognosis
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Proportional Hazards Models
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Survival Analysis
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Infant
7.Buccal Acupuncture Alleviates Postoperative Pain in Patients Undergoing Radical Resection of Gastrointestinal Cancers: A Randomized Controlled Pilot Study.
Zhi-Xin ZHU ; Chen CHEN ; Yong-Feng ZHENG ; Wei-Li GONG ; Zheng CHEN ; Shi-Lei FANG ; Dong-Hua SHAO ; Cai-Xia SUN
Chinese journal of integrative medicine 2025;31(6):558-565
OBJECTIVE:
To preliminarily investigate the effect of buccal acupuncture therapy on ameliorating postoperative pain and enhancing recovery quality among patients undergoing radical resection of gastrointestinal cancers.
METHODS:
Fifty-two participants were randomized at a 1:1 ratio to either the buccal acupuncture or the control group. The acupuncture protocol entailed targeting 5 predetermined acupoints [CA-2 (Upper jiao), CA-3 (Middle jiao), CA-4 (Lower jiao), CA-6 (back), and CA-7 (waist) and two adjustable acupoints [CA-1 (head) and CA-8 (sacrum)] on each side of the face. The outcomes included the Numeric Rating Scale (NRS) scores for each day within 7 days postoperatively, 15-Item Quality of Recovery Scale (QoR-15) scores, analgesics consumption during and after surgery, incidences of postoperative nausea and vomiting, and perioperative levels of interleukin-6 and glucose. Adverse events related to acupuncture were recorded.
RESULTS:
Of the initial 52 participants, 46 completed the study and were included in the analysis. Findings indicated that the buccal acupuncture group experienced significantly reduced resting NRS scores in post-anesthesia care unit and throughout the postoperative phase (P=0.001 and P=0.003, respectively), along with enhanced QoR-15 scores on the 3rd postoperative day (P=0.008), compared to the control group. No notable differences were identified in the remaining indicators (P>0.05).
CONCLUSION
Buccal acupuncture therapy demonstrated significant effectiveness in reducing postoperative pain and improving recovery quality for patients undergoing radical resection of gastrointestinal cancers, presenting a viable intervention without associated adverse outcomes. (Trial registration No. ChiCTR2200060441).
Humans
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Male
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Pilot Projects
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Female
;
Acupuncture Therapy/methods*
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Pain, Postoperative/therapy*
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Middle Aged
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Gastrointestinal Neoplasms/surgery*
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Aged
;
Acupuncture Points
;
Adult
8.Icaritin Targets P53 to Regulate DNA Damage Repair and FOXO Signaling Pathways to Inhibit Glioma Cell Growth
Zhi-Qiong LUO ; Zhuo-Yi WANG ; Yong-Ping WANG ; Xiao-Zhong CHEN ; Jia YU ; Sha CHENG ; Ning-Ning ZAN ; Bao-Fei SUN ; Heng LUO
Chinese Journal of Biochemistry and Molecular Biology 2025;41(5):753-763
Icaritin(ICT)is an 8-isopentenylflavonoid,which is the main effective component of the tra-ditional Chinese medicine Epimedium.Previously,we found that Icaritin inhibits the growth of glioblasto-ma(GBM)cells.Herein we aim to study the in vivo anti-GBM effectiveness of Icaritin and explore its mechanism.The results of MTT assay,flow cytometry,comet assay and cellular immunofluorescence as-say in vitro showed that ICT inhibited the proliferation of four kinds of GBM cells,U87,U251,U118 and A172,induced early apoptosis(P<0.001)and late apoptosis(P<0.05)in U87 cells,induced DNA damage in U87 cells,and blocked the growth of U87 cells at the G0/G1 phase(P<0.0001)in a concen-tration-time-dependent manner.In vivo subcutaneous tumor transplantation tumor experiments showed that feeding 200 mg/kg(P<0.01)and 400 mg/kg(P<0.001)ICT had a significant inhibitory effect on the growth of GBM subcutaneous tumors,and had no significant toxic effects on heart,liver,spleen,lung and kidney tissues.The results of network pharmacological analysis,molecular docking and cellular thermodynamic experiments showed that there were 26 possible target proteins between ICT and GBM,a-mong which the expression of p53 in GBM tissues was significantly(P<0.001)higher than in normal tis-sues,and the binding energy of ICT and p53 was lower;cellular thermodynamic experiments verified that ICT significantly enriched the level of p53 in the living cells of GBM,which indicated that ICT could tar-get p53.The expression of key proteins in the DNA damage repair and apoptosis-associated FOXO signa-ling pathway was detected by ICT.The results showed that the expression of ATR(P<0.01),P53(P<0.001),P21(P<0.05)and γ-H2AX(P<0.05)was up-regulated,whereas the expression of Cyc-lin E1(P<0.01),E2F1(P<0.05),CDK2(P<0.01),Rb(P<0.001),p-Rb(P<0.0001)and WRN(P<0.0001)expression were down-regulated.There was no significant change in the expres-sion of FOXO 1 in the FOXO pathway or a significant down-regulation of its phosphorylation level.This study demonstrated that ICT could effectively inhibit the growth of GBM cells in vivo.It targets p53 to regulate the DNA damage repair pathway and FOXO signaling pathway to induce GBM cell cycle arrest and apoptosis.
9.The impact of DIP payment on medical expense and efficiency in public hospitals:An empirical study based on the difference-in-differences method
Meng-ya SUN ; Zhi-yong LIU ; Qian-peng LYU ; Zhi-fan KOU ; Can LU ; Sheng-nan LI
Chinese Journal of Health Policy 2025;18(7):35-43
Objective:To evaluate the impact of Diagnosis-Intervention Packet(DIP)payment reform on medical service costs and efficiency for inpatients in public hospitals,and to compare differences between surgical and medical groups.Methods:A quasi-experimental design was employed,using 605 636 discharged patients from a tertiary hospital in Hebei Province between January 2020 and March 2025 as the sample.The difference-in-differences(DID)model was used to analyze the changes in key indicators between the DIP settlement group(intervention group)and the non-DIP settlement group(control group).Results:Total hospitalization costs,out-of-pocket expenses,and medication costs were significantly reduced in the DIP settlement group(P<0.05),while costs for examinations,nursing,laboratory tests,and treatments increased significantly(P<0.05).Material costs increased by 30.7%in the surgical group(P<0.1)and decreased by 19.8%in the medical group(P<0.01).In terms of efficiency,the average length of stay,time,and cost consumption index all decreased(P<0.01),while the proportion of medical services increased(P<0.01).The case mix index(CMI)showed no significant changes.Conclusion:The DIP reform effectively controlled costs and improved efficiency,but it also resulted in cost shifting and departmental disparities.Therefore,it is necessary to optimize cost control and departmental management policies.
10.The impact of DIP payment on medical expense and efficiency in public hospitals:An empirical study based on the difference-in-differences method
Meng-ya SUN ; Zhi-yong LIU ; Qian-peng LYU ; Zhi-fan KOU ; Can LU ; Sheng-nan LI
Chinese Journal of Health Policy 2025;18(7):35-43
Objective:To evaluate the impact of Diagnosis-Intervention Packet(DIP)payment reform on medical service costs and efficiency for inpatients in public hospitals,and to compare differences between surgical and medical groups.Methods:A quasi-experimental design was employed,using 605 636 discharged patients from a tertiary hospital in Hebei Province between January 2020 and March 2025 as the sample.The difference-in-differences(DID)model was used to analyze the changes in key indicators between the DIP settlement group(intervention group)and the non-DIP settlement group(control group).Results:Total hospitalization costs,out-of-pocket expenses,and medication costs were significantly reduced in the DIP settlement group(P<0.05),while costs for examinations,nursing,laboratory tests,and treatments increased significantly(P<0.05).Material costs increased by 30.7%in the surgical group(P<0.1)and decreased by 19.8%in the medical group(P<0.01).In terms of efficiency,the average length of stay,time,and cost consumption index all decreased(P<0.01),while the proportion of medical services increased(P<0.01).The case mix index(CMI)showed no significant changes.Conclusion:The DIP reform effectively controlled costs and improved efficiency,but it also resulted in cost shifting and departmental disparities.Therefore,it is necessary to optimize cost control and departmental management policies.

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