1.Effects of aerobic exercise on cognitive function in elderly patients with bipolar disorder
Xiangjun ZHAO ; Yongli ZHANG ; Xiaoning HUO ; Xiping SHEN ; Xiaoli YANG ; Xirong QIAO ; Xingtong SHU
Sichuan Mental Health 2026;39(3):206-211
BackgroundBipolar disorder is a severe mental disorder characterized by alternating episodes of mania and depression. It has a high recurrence rate and a high rate of disability. Elderly patients often suffer from more severe cognitive impairment due to neurodegenerative changes. The clinical intervention for bipolar disorder mainly relies on drug treatment, but drugs have limited effects on improving cognitive function, and some drugs may even aggravate cognitive impairment. Aerobic exercise, as a non-drug intervention method, has shown positive effects in improving cognitive function in patients with mental disorders. However, there are still insufficient studies on elderly patients with bipolar disorder. ObjectiveTo explore the impact of aerobic exercise on the cognitive function of elderly patients with bipolar disorder, so as to provide references for the formulation of strategies to improve the cognitive function of this population. MethodsA randomized controlled trial was conducted. A total of 60 elderly patients who were hospitalized at the Third People's Hospital of Lanzhou from January 2024 to March 2025 and met the diagnostic criteria for bipolar disorder as defined in the International Classification of Diseases,tenth edition (ICD-10) were selected. They were divided into the study group and the control group, with 30 cases in each group, based on the random number table method. Both groups were given quetiapine fumarate tablets and magnesium valproate sustained-release tablets. The study group additionally received aerobic exercise (including slow walking, doing exercises, and running), three times a week, for 30 minutes each time. At the baseline and at the end of the 3rd, 6th, 9th, and 12th week of the intervention, the Hamilton Depression Scale -24 item (HAMD-24), the Young Manic Rating Scale (YMRS), the Montreal Cognitive Assessment (MoCA), and Wechsler Adult Intelligence Scale Revised in China (WMS-RC) were used for assessment. ResultsThe time effect of the HAMD-24 score was statistically significant (Wald χ2=124.564, P<0.01). The time effect of the YMRS score was also statistically significant (Wald χ2=145.608, P<0.01), and the interaction effect between time and group was statistically significant (Wald χ2=14.968, P<0.05). At the 3rd, 9th, and 12th week of the intervention, the YMRS score of the study group was lower than that of the control group in the same period, and the differences were statistically significant (P<0.05). The time effect and group effect of the MoCA score were both statistically significant (F=99.347, 16.623, P<0.01). The time effect, group effect, and interaction effect between time and group of the WMS-RC memory quotient were all statistically significant (F=64.678, 10.197, 12.472, P<0.01). At the 6th, 9th, and 12th weeks of the intervention, the MoCA score and WMS-RC memory quotient of the study group were higher than those of the control group, and the differences were statistically significant (P<0.05). ConclusionAerobic exercise may help improve the manic symptoms and cognitive functions (especially memory ability) of elderly patients with bipolar disorder. [Funded by Science and Technology Project of Gansu Province (number, 24JRRA775); Science and Technology Project of Lanzhou City(number, 2022-5-155)]
2.Safety and effectiveness of lecanemab in Chinese patients with early Alzheimer's disease: Evidence from a multidimensional real-world study.
Wenyan KANG ; Chao GAO ; Xiaoyan LI ; Xiaoxue WANG ; Huizhu ZHONG ; Qiao WEI ; Yonghua TANG ; Peijian HUANG ; Ruinan SHEN ; Lingyun CHEN ; Jing ZHANG ; Rong FANG ; Wei WEI ; Fengjuan ZHANG ; Gaiyan ZHOU ; Weihong YUAN ; Xi CHEN ; Zhao YANG ; Ying WU ; Wenli XU ; Shuo ZHU ; Liwen ZHANG ; Naying HE ; Weihuan FANG ; Miao ZHANG ; Yu ZHANG ; Huijun JU ; Yaya BAI ; Jun LIU
Chinese Medical Journal 2025;138(22):2907-2916
INTRODUCTION:
Lecanemab has shown promise in treating early Alzheimer's disease (AD), but its safety and efficacy in Chinese populations remain unexplored. This study aimed to evaluate the safety and 6-month clinical outcomes of lecanemab in Chinese patients with mild cognitive impairment (MCI) or mild AD.
METHODS:
In this single-arm, real-world study, participants with MCI due to AD or mild AD received biweekly intravenous lecanemab (10 mg/kg). The study was conducted at Hainan Branch, Ruijin Hospital Shanghai Jiao Tong University School of Medicine. Patient enrollment and baseline assessments commenced in November 2023. Safety assessments included monitoring for amyloid-related imaging abnormalities (ARIA) and other adverse events. Clinical and biomarker changes from baseline to 6 months were evaluated using cognitive scales (mini-mental state examination [MMSE], montreal cognitive assessment [MoCA], clinical dementia rating-sum of boxes [CDR-SB]), plasma biomarker analysis, and advanced neuroimaging.
RESULTS:
A total of 64 patients were enrolled in this ongoing real-world study. Safety analysis revealed predominantly mild adverse events, with infusion-related reactions (20.3%, 13/64) being the most common. Of these, 69.2% (9/13) occurred during the initial infusion and 84.6% (11/13) did not recur. ARIA-H (microhemorrhages/superficial siderosis) and ARIA-E (edema/effusion) were observed in 9.4% (6/64) and 3.1% (2/64) of participants, respectively, with only two symptomatic cases (one ARIA-E presenting with headache and one ARIA-H with visual disturbances). After 6 months of treatment, cognitive scores remained stable compared to baseline (MMSE: 22.33 ± 5.58 vs . 21.27 ± 4.30, P = 0.733; MoCA: 16.38 ± 6.67 vs . 15.90 ± 4.78, P = 0.785; CDR-SB: 2.30 ± 1.65 vs . 3.16 ± 1.72, P = 0.357), while significantly increasing plasma amyloid-β 42 (Aβ42) (+21.42%) and Aβ40 (+23.53%) levels compared to baseline.
CONCLUSIONS:
Lecanemab demonstrated a favorable safety profile in Chinese patients with early AD. Cognitive stability and biomarker changes over 6 months suggest potential efficacy, though high dropout rates and absence of a control group warrant cautious interpretation. These findings provide preliminary real-world evidence for lecanemab's use in China, supporting further investigation in larger controlled studies.
REGISTRATION
ClinicalTrials.gov , NCT07034222.
Humans
;
Alzheimer Disease/drug therapy*
;
Male
;
Female
;
Aged
;
Middle Aged
;
Cognitive Dysfunction/drug therapy*
;
Aged, 80 and over
;
Amyloid beta-Peptides/metabolism*
;
Biomarkers
;
East Asian People
3.Analysis of correlation between Barthel index score and preoperative occurrence of deep vein thrombosis in patients undergoing total hip arthroplasty revision surgery.
Ying SHEN ; Yao YAO ; Liang QIAO ; Dengxian WU ; Xinhua LI ; Qing JIANG
Chinese Journal of Reparative and Reconstructive Surgery 2025;39(2):158-162
OBJECTIVE:
To explore the correlation between the Barthel index score and other factors with the preoperative occurrence of deep vein thrombosis (DVT) in patients undergoing total hip arthroplasty (THA) revision surgery.
METHODS:
A retrospective analysis was conducted on clinical data from 122 patients who met the inclusion criteria and underwent THA revision surgery between April 2017 and November 2020. Among them, 61 were male and 61 were female, with an age range of 32-85 years (mean, 65.3 years). The reasons for revision included prosthetic joint infection in 7 cases, periprosthetic fracture in 4 cases, prosthetic dislocation in 6 cases, and aseptic loosening in 105 cases. The Barthel index score was 76.4±17.7, with 10 cases classified as level 1, 57 as level 2, 37 as level 3, and 18 as level 4. Univariate analysis was performed on variables such as age, gender, body mass index, Barthel index score, preoperative D-dimer positivity, history of diabetes, hypertension, cancer, cerebral infarction, smoking, and thrombosis in patients with and without preoperative DVT. Furthermore, logistic regression was used to identify risk factors for preoperative DVT in THA revision surgery. The incidence of preoperative DVT was compared among different Barthel index score groups.
RESULTS:
Preoperative DVT was detected in 11 patients (9.02%), all of whom had intermuscular venous thrombosis. Among them, 1 had prosthetic joint infection, 1 had periprosthetic fracture, 1 had prosthetic dislocation, and 8 had aseptic loosening. Univariate analysis showed significant differences between the two groups in terms of age, gender, and Barthel index score ( P<0.05). logistic regression further revealed that female, age ≥70 years, and Barthel index score<60 were independent risk factors for preoperative DVT in patients undergoing THA revision surgery ( P<0.05). The incidence of preoperative DVT in patients with Barthel index scores of levels 1, 2, 3, and 4 were 0 case (0%), 2 cases (3.5%), 3 cases (8.1%), and 6 cases (33.3%), respectively. A significant correlation was found between Barthel index score classification and the incidence of preoperative DVT in patients undergoing THA revision surgery ( χ 2=10.843, P=0.001).
CONCLUSION
In patients undergoing THA revision surgery, older age, female, and lower Barthel index scores are associated with higher preoperative DVT incidence. For patients with low preoperative Barthel index scores, preoperative thrombosis screening should be emphasized.
Humans
;
Arthroplasty, Replacement, Hip/adverse effects*
;
Male
;
Female
;
Aged
;
Middle Aged
;
Retrospective Studies
;
Reoperation
;
Aged, 80 and over
;
Venous Thrombosis/epidemiology*
;
Adult
;
Risk Factors
;
Postoperative Complications/etiology*
;
Preoperative Period
4.A case-control study of shoulder arthroscopic double row and single row technique for the treatment of Ideberg type ⅠA scapular glenoid fracture.
Zhe-Yuan SHEN ; Rong WU ; Qiao-Ying PENG ; Heng LI ; Song-Hua GUO ; Zhan-Feng ZHANG
China Journal of Orthopaedics and Traumatology 2025;38(3):223-230
OBJECTIVE:
To compare clinical effect of arthroscopic double row fixation and single row fixation in treating Ideberg typeⅠA scapular glenoid fracture.
METHODS:
From June 2018 to December 2022, 26 patients with Ideberg typeⅠA scapular glenoid fracture treated with shoulder arthroscopy were divided into single-row anchor group and double-row anchor group according to the fixation method of fracture block. There were 12 patients in single-row anchor group, including 7 males and 5 females, aged from 25 to 53 years old with an average of (38.42±9.61) years old;the time from injury to operation ranged from 2 to 7 days with an average of (4.75±1.82) days. There were 14 patients in double-row anchor group, including 10 males and 4 females, aged from 21to 53 years old with an average of (37.36±10.19) years old;the time from injury to operation ranged from 1 to 8 days with an average of (4.21±2.01) days. The changes of shoulder joint flexion, abduction, lateral lateral rotation, Constant-Murley shoulder function score and Rowe scores were compared between two groups before operation and 1 year after operation. The percentage of bone mass in pelvis area before operation and the percentage of bone defect in pelvis area at the latest follow-up were compared between two groups.
RESULTS:
All patients were followed up for 12 to 15 months with an average of (13.08±1.17) months in single-row anchor group and 12 to 15 months with an average of (13.29±1.07) months in double-row anchor group, with no statistical significance between two groups (P>0.05). The results of anterior flexion, abduction and lateral lateral rotation in single-row anchor group were(86.67±6.62) °, (79.50±5.68) °, (38.17±1.70) ° before operation, and (162.50±4.52)°, (169.17±3.35)°, (50.67±10.20)° at 1 year after operation; while in double-row anchor group were (84.14±5.48) °, (81.71±5.20) °, (39.29±3.63) ° before operation and (162.29 ± 5.53) °, (167.14±3.61) °, (56.93±9.56) ° at 1 year after operation;the difference between two groups before operation and 1 year after operation was statistically significant (P<0.05). There were no significant difference between two groups (P>0.05). Constant-Murley scores and Rowe scores in single-row anchor group were (55.42±3.75), (43.75±18.49) before operation and (94.83±2.21), (95.42±4.50) at 1 year after operation, respectively;while in double-row anchor group were (54.50±7.88), (41.79±18.25) before operation and (94.36±4.73), (95.00±4.80) at 1 year after operation;there was no significant difference in Constant-Murley score and Rowe score between two groups before operation and 1 year after operation (P>0.05). There was significant difference in the percentage of bone mass in pelvis area between two groups before operation (P>0.05). There was no significant difference in the percentage of bone defect in the shoulder area between single-row anchor group(4.42±1.51)% and double-row anchor group (2.71±1.44)% at 1 year after operation (P<0.05).
CONCLUSION
Both single and double row fixation techniques for the treatment of Ideberg typeⅠA scapular glenoid fracture could receive satisfactory functional recovery. However, double-row fixation has more advantages in reducing bone resorption of fracture mass.
Humans
;
Female
;
Male
;
Middle Aged
;
Arthroscopy/methods*
;
Adult
;
Scapula/surgery*
;
Case-Control Studies
;
Fractures, Bone/physiopathology*
;
Fracture Fixation, Internal/methods*
;
Shoulder Joint/physiopathology*
;
Range of Motion, Articular
5.Exploration and Practice of Performance Evaluation System for Large Medical Equipment Based on Internet of Things Technology.
Chang SU ; Caixian ZHENG ; Linling ZHANG ; Yunming SHEN ; Kai FAN ; Tingting DONG ; Hangyan ZHAO ; Xiaofeng WANG ; Dawei QIAO ; Kun ZHENG
Chinese Journal of Medical Instrumentation 2025;49(2):191-196
Medical equipment, as an important indicator of smart hospital evaluation, plays a vital role in hospital operations. To ensure the safe and efficient operation of medical equipment, a reasonable performance evaluation system is indispensable. This study introduces a platform based on Internet of Things (IoT) technology that connects medical devices and collects data, achieving standardized and structured data processing, and supporting online operational supervision. Through the Delphi method, a performance evaluation system for large medical equipment is constructed, including 4 primary indicators and 22 secondary indicators. DICOM data acquisition devices are used to achieve functions such as efficiency analysis, benefit analysis, usage evaluation, and decision-making support for medical equipment. The study is still in its early stages, and in the future, it is expected to integrate more types of equipment, achieve rational resource allocation, and significantly impact decision-making for the development of public hospitals.
Internet of Things
;
Delphi Technique
6.Effects of acupuncture on SATB1/p21 signaling pathway and SASPs in MPTP-induced Parkinson disease model mice
Guona LI ; Chen ZHAO ; Zhaoqin WANG ; Xuegui HUA ; Luyi WU ; Xiyin ZHANG ; Lin SHEN ; Ziyi CHEN ; Wenqing HU ; Yiyi CHEN ; Ling CHENG ; Yu QIAO
Journal of Acupuncture and Tuina Science 2025;23(1):1-11
Objective:To observe the effects of acupuncture on the motor function of Parkinson disease(PD)model mice and to investigate the neuroprotective effects of acupuncture on PD from the perspective of cellular senescence.Methods:C57BL/6J mice were randomly divided into a normal control(NC)group,a 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine(MPTP)group,an acupuncture(ACU)group,and a rasagiline(RAS)group,with 6 mice in each group.Except for the mice in the NC group,all mice were injected intraperitoneally with MPTP[30 mg/(kg·bw)]to establish a PD mouse model.After the models were successfully established,mice in the ACU group received acupuncture at Baihui(GV20)and bilateral Yanglingquan(GB34)for 15 min,once a day for 14 consecutive days.Mice in the RAS group were treated with gavage of rasagiline mesylate[0.5 mg/(kg·bw)],once daily for 14 d.Mouse balance and motor functions were detected using the mouse fatigue rotating rod apparatus.Immunohistochemistry staining was used to detect the number of tyrosine hydroxylase(TH)-positive neurons and the protein expression levels of special AT-rich sequence-binding protein 1(SATB1),p21,and p53 in the substantia nigra(SN)region of the mouse brain in each group.The glutathione peroxidase(GSH-Px)activity of mouse brain SN tissue was detected by enzyme-linked immunosorbent assay.The protein expression levels of interleukin(IL)-6 and senescence-associated β-galactosidase(SA-β-gal)in the SN tissue of mice in each group were detected by Western blotting.The relative expression of SATB1,p21,and p53 mRNA in the SN of each group was detected by real-time quantitative polymerase chain reaction.Results:Compared to the NC group,the overall rod performance(ORP)score,the number of TH-positive neurons,and GSH-Px activity in the SN region were significantly lower in the mice in the MPTP group(P<0.01);compared to the MPTP group,the ORP score,the number of TH-positive neurons,and GSH-Px activity were significantly increased in the ACU group and the RAS group(P<0.01 or P<0.05).Compared to the NC group,the protein levels of IL-6 and SA-β-gal in the SN tissue,the protein and mRNA expression levels of p21 and p53 were significantly increased(P<0.01);compared to the MPTP group,the protein levels of IL-6 and SA-β-gal in the SN tissue,the protein and mRNA expression levels of p21 and p53 were significantly decreased in the ACU group and the RAS group(P<0.01 or P<0.05).Compared to the NC group,the relative expression of SATB1 protein and mRNA in the SN of mice in the MPTP group was significantly decreased(P<0.01);compared to mice in the MPTP group,mice in the ACU group and the RAS group showed significant increases in the relative expression of SATB1 protein and mRNA(P<0.01 or P<0.05).Conclusion:Acupuncture can improve motor function and increase the number of TH-positive neurons in the SN of PD model mice.Its neuroprotective effect may relate to the regulation of the SATB1/p21 signaling pathway and the inhibition of cellular senescence-related biomarker expression in the SN.
7.Investigation on the current status of information systems in CSSD of hospitals in China
Ying ZHANG ; Yuhua GAO ; Sainan QIAO ; Jian SHEN ; Baohua LI
China Medical Equipment 2025;22(5):142-146
Objective:To investigate the status of development and application of information system of central sterile supply department(CSSD)in hospitals of China,so as to provide references for the promotion of CSSD information system in hospital.Methods:Hierarchical sampling method was adopted to combine with CSSD Professional Committee of Chinese Nursing Association to design questionnaire for Questionnaire Star Network Survey about basic information,CSSD information system,whether the CSSD information system connected with equipment,tracing links and tracing levels,identification method of apparatuses,automation of equipment in 3,074 hospitals of 22 provinces,4 municipalities directly under the central government,and 5 autonomous regions.Results:In 3,074 hospitals,1,811 hospitals(accounting for 58.91%)adopted the CSSD information system.The utilization rate of tertiary hospitals was 81.90%for the information system,which was higher than that(34.51%)in secondary hospitals,and the difference was statistically significant(x2=636.65,P<0.05).The proportion of hospitals that included the recycling,cleaning,disinfection,inspection and packaging,sterilization,storage,and distribution links of CSSD internal management into information management was all>88%,while the utilization link only accounted for 15.18%.The proportion that surgical apparatuses and the apparatuses of clinical diagnosis and treatment were included in management was higher in 1811 hospitals that used CSSD information system,which were respectively 88.02%and 84.70%,while the proportion of surgical soft endoscope was lower,which only was 49.20%.A total of 84.37%of hospitals conducted informatization management for using extracorporeal apparatuses and implants.The connection rates of the main CSSD equipment,which included the washing and disinfection machine,the pressure steam sterilizer and the low-temperature sterilizer,were connected with information system were respectively 56.60%,63.06%and 43.95%.The full compatibility between the information system and all monitoring methods did not be realized in these hospitals.Barcode was the main identification form(69.91%)of the CSSD information system,and personnel management was the most common management module(53.62%)of the information system.The utilization rate(2.93%-5.14%)of automated equipment was low,and 35.45%of the CSSD information systems had the function of automatic emergency handling.Conclusion:The CSSD informatization management of China has achieved remarkable results,but there are still problems such as insufficient connection of equipment,inclusion of monitoring data,and insufficient automation and intelligence.It is necessary to increase the promotion efforts to promote the high-quality development of hospitals.
8.Common Problems and Solutions in the Implementation of Clinical Research on Ethnic Medicine for External Use
Zhixiu SHEN ; Yanxue QIAO ; Shuang WANG ; Kailie LIU ; Min ZHAO ; NYANGMOTSE ; Yuwei LIU ; Jianping LIU
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(6):13-17
The ethnic medicine for external use is an important dosage form in the external treatment methods of ethnic medicine.China has made significant progress in related research and applications.However,the regulations and guidelines for clinical research on external medicine are limited,and the related technologies and quality standards are not yet well-established in China.This article summarized the specific issues during the implementation of clinical research on ethnic medicine of external use:the research design failing to reflect the value and unique characteristics of these medicine;the big difficulty in the recruitment of participants,leading to delays in progress;inconsistent implementation of interventions;and the quality of research data needing to be improved,etc.Combining the authors'experience in project implementation management,this article proposed solutions to improve research quality and progress,including incorporating experts from various fields including ethnic medicine and research centers;refining participant recruitment strategies;analyzing factors affecting progress and optimizing the implementation process;and strengthening overall management and establishing a competitive enrollment mechanism.The article also shared a case study of the Tibetan medicine Qingpeng Ointment for the treatment of acute gouty arthritis,aiming to provide a reference for the clinical research on ethnic medicine of external use.
9.The value of IVIM in the differential diagnosis of benign and malignant breast nodules
Xinyu WANG ; Jingjing ZHANG ; Songli ZHANG ; Chaofan WANG ; Weiying SHEN ; Hongmei QIAO ; Yuan CHEN ; Yu ZHANG ; Hu LIU
China Modern Doctor 2025;63(21):5-9
Objective To explore the application value of intravoxel incoherent motion(IVIM)imaging parameters in the differential diagnosis of benign and malignant breast nodules and their correlation with the expression of Ki-67 receptor in breast cancer.Methods The data of 41 female patients who completed 3.0 T breast magnetic resonance imaging(MRI)with complete surgical pathology results in the Second Hospital of Jiaxing City from October 2022 to January 2025 were analysed and evaluated.Conventional images and diffusion-weighted images with 11 b values were collected.The IVIM imaging parameters of real diffusion coefficient(D),perfusion related diffusion coefficient(D*)and perfusion fraction(f)were measured and calculated in the region of interest of each lesion.The receiver operating characteristic curve were plotted to quantify the differential diagnostic efficacy of each parameter of IVIM imaging in benign and malignant breast nodules.The differences of parameters between benign and malignant breast nodules and between the groups with different expression levels of Ki-67 receptor in breast cancer were analysed,and the correlation between each parameter and the expression level of Ki-67 in breast cancer was counted.Results The D value of benign breast nodules group(benign groups)was significantly higher than that of malignant breast nodules group(malignant groups),and the D*value was significantly lower than that of malignant group,and the differences between benign group and malignant group were statistically significant(t=-4.773,t=2.063,P<0.05);Thefvalue of benign group was slightly lower than that of malignant group,and the differences between two groups were not statistically significant(t=0.035,P>0.05).Among the parameters of IVIM imaging,D value had the best differential diagnostic efficacy for benign and malignant breast nodules,with area under the curve(AUC)of 0.870(95%CI:0.755-0.985)and a specificity of 75.0%;D*value had the second best differential diagnostic efficacy after D value,with an AUC of 0.789(95%CI:0.658-0.920),but it had the highest sensitivity of 88.2%;And the differential diagnosis efficiency off value was the worst,much less than D and D*values.The D value in the high Ki-67 expression group of breast cancer was lower than that in the low expression group,while the D* and f values in the high expression group were higher than that in the low expression group,and the differences of each imaging parameter of IVIM were not statistically significant between two groups(t=-2.617,t=2.169,t=0.647,P>0.05).There was a significant negative correlation between the expression of the Ki-67 receptor and the D value(r=-0.615,P<0.05),and no significant correlation was seen with either D *or f value(r=0.223,r-0.031,P>0.05).Conclusion The D and D*values of IVIM imaging parameters have great clinical value in the differential diagnosis of benign and malignant breast nodules.
10.Practice and Reflection on Clinical Positioning Research of Chinese Patent Medicines for External Use
Zhixiu SHEN ; Kailie LIU ; Yanxue QIAO ; NYANGMOTSE ; Min ZHAO ; Shuang WANG ; Jianping LIU
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(12):15-19
Chinese patent medicines for external use represent a distinct category of clinical drugs with unique therapeutic characteristics.At present,the research foundation of some topical Chinese patent medicines for external use is weak,and the accuracy and standardization of clinical application need to be improved.The research on clinical positioning of Chinese patent medicines for external use is of great significance for standardizing clinical medication,exploring the differentiated value of drugs and similar products,enhancing the safety of drug use,improving the efficiency of medical resource use,and promoting the secondary development and cultivation of drugs after listing.On the basis of summarizing the research status of clinical positioning of Chinese patent medicines for external use,this article put forward the significance,necessity and challenges of carrying out this research.Combined with the authors'practical experience,the authors put forward five experiences to carry out the post marketing clinical positioning research of Chinese patent medicines for external use,including distinguishing the theory of external treatment of Chinese materia medica,paying attention to the unmet needs in the modern medical system,not separating from the actual efficacy and dosage form characteristics of Chinese patent medicines for external use,clarifying the mechanism of"same treatment for different diseases",and verifying the clinical positioning hypothesis,which can provide references for relevant research.

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