Medical institutions, with their clinical practice foundation and abundant human use experience data, have become important carriers for the inheritance and innovation of traditional Chinese medicine(TCM) and the "cradles" of the preparation of new TCM. To effectively promote the transformation of new TCM originating from the TCM clinical practice in medical institutions and establish an effective evaluation index system for the transformation of new TCM conforming to the characteristics of TCM, consensus experts adopted the literature research, questionnaire survey, Delphi method, etc. By focusing on the policy and technical evaluation of new TCM originating from the TCM clinical practice in medical institutions, a comprehensive evaluation from the dimensions of drug safety, efficacy, feasibility, and characteristic advantages was conducted, thus forming a comprehensive evaluation system with four primary indicators and 37 secondary indicators. The expert consensus reached aims to encourage medical institutions at all levels to continuously improve the high-quality research and development and transformation of new TCM originating from the TCM clinical practice in medical institutions and targeted at clinical needs, so as to provide a decision-making basis for the preparation, selection, cultivation, and transformation of new TCM for medical institutions, improve the development efficiency of new TCM, and precisely respond to the public medication needs.
Medicine, Chinese Traditional/standards* ; Humans ; Consensus ; Drugs, Chinese Herbal/therapeutic use* ; Surveys and Questionnaires

Objective:To evaluate the incidence, clinical features, factors affecting initial diagnosis, efficacy, and safety of therapy and prognosis of small intestinal Dieulafoy lesions (DL).Methods:Clinical data including clinical background, diagnosis, and treatment details of patients who were admitted to the Department of Gastroenterology, Air Force Medical Center, for suspected small bowel bleeding, diagnosed as having small bowel DL and treated with balloon-assisted enteroscopy (BAE) were retrospectively analyzed from November 2017 to March 2024.Results:Among 800 patients, 30 cases (3.75%, 30/800, 17 males and 13 females) were diagnosed as having small intestine DL with the mean age of 60.90 years. Clinical symptoms included melena (56.67%, 17/30), hematochezia (43.33%, 13/30), and hemodynamic instability (30.00%, 9/30). Active bleeding occurred in 23 (76.67%) patients. Comorbidities existed in 70.00% (21/30) and 33.33% (10/30) used long-term antithrombotic agents. Diagnosis was confirmed after a single BAE in 63.33% (19/30) and after multiple BAEs (mean 1.6 procedures) in 36.67% (11/30). Lesions were predominantly located at jejunal. All patients achieved successful treatment with a single BAE procedure. The median follow-up period was 12.25 months (range: 5.25-23.00 months). Five cases (16.67%) experienced recurrent bleeding, with one case transfered to surgical intervention. Two cases (6.67%) reported post-operative symptoms of dizziness and fatigue, which resolved after symptomatic management. Multivariate analysis showed that long-term oral anticoagulant therapy ( OR=0.06, 95% CI: 0.01-0.73) was an independent predictor of single-session diagnosis. Conclusion:Small intestinal DL is rare and challenging to diagnose. Antithrombotic therapy may facilitate the diagnosis of DL at the first BAE. Jejunal localization is common, and combined endoscopic therapy (including clipping) is effective and safe.

BACKGROUND:One-hole split endoscope as a new type of endoscopic technique is suitable for the treatment of far lateral lumbar disc disease.However,there are few research data on L5/S1,which has a very low incidence of far lateral lumbar disc herniation at home and abroad,and there is no detailed image anatomical data describing the one-hole split endoscope treatment of L5/S1 far lateral lumbar disc herniation. OBJECTIVE:Through the three-dimensional image reconstruction,the bony landmarks were determined to accurately locate the positional relationship between the L5 outlet nerve root,the L5/S1 intervertebral space and other structures.One-hole split endoscope via posterolateral approach was used to accurately,safely and effectively decompress the L5 outlet nerve root and treat the L5/S1 far lateral lumbar disc herniation. METHODS:Twenty-nine patients with L5/S1 unilateral far lateral lumbar disc herniation who met the inclusion and exclusion criteria were selected,including 12 males and 17 females at the age of 48-74 years.The lumbar CT data of the patients were imported into Mimics 21.0 software to reconstruct the three-dimensional lumbar model.Measurement of L5/S1 related parameters:(1)Measurement on the sagittal plane at the intersection(H)of the lower edge of the transverse process and the lateral edge of the isthmus:The vertical distance between H and the upper and lower edges of L5 outlet nerve root(a1,a2);the vertical distance between H and the lower endplate of L5 and the upper endplate of S1(b1,b2);vertical distance from the lower edge of the pedicle from H to L5(c).(2)Horizontal distance between the left and right sides of the sagittal surface where the medial wall of the pedicle was located from H to L5(d).(3)The horizontal distance from H to the left and right side of the sagittal plane where the lateral margin of the dura was located(e).(4)Horizontal distance(f)between the left and right sides of the sagittal plane at the outermost edge of the lower endplate from H to L5.(5)Measurements were made on the sagittal plane where the outermost edge of the lower endplate of L5:The vertical distance between the cross section of H and the upper and lower edges of L5 outlet nerve root(g1,g2);vertical distance(h1,h2)between the transverse section of H and the lower endplate of L5 and the upper endplate of S1,respectively;(6)anteroposterior horizontal distance from H to L5 in the coronal plane where the last edge of the nerve root exits(i);(7)anteroposterior horizontal distance from the highest point of the posterior margin of the sacral wing to the last margin of the inferior endplate of L5 in the coronal plane(j). RESULTS AND CONCLUSION:(1)There was no significant difference in the relevant measurement parameters between men and women(P>0.05).(2)a1,a2,b1,b2,c,d,e,f,h1,h2,g1,g2,i,and j on the affected side were not significantly different from the healthy side(P>0.05).(3)There was no significant difference between a1 and c(P>0.05),indicating that the lower edge of the pedicle was the upper edge of the L5 outlet nerve root;the L5 outlet nerve root was close to the lower edge of the pedicle and ran anterolateral behind the L5 vertebral body,and H was located above the L5 outlet nerve root.(4)With H as the bony marker point,it was not necessary to probe upward or to remove the isthmus,but only to grind part of the bone downward and laterally to reveal the L5 outlet nerve root and vertebral space,and to have enough safe distance to avoid damage to the dural membrane to complete exploration and decompression of the lateral recess and foraminal region.(5)The surgeon could operate in the sagittal plane where the most lateral edge of the L5 inferior endplate was located,and in the"rectangular area"formed by the L5 transverse process and the sacral wing.The closer to the medial and inferior area(Kambin triangle),the safer the operation was.(6)It is suggested that using H as the bony landmark point to locate the L5 outlet nerve root and intervertebral space through one-hole split endoscope via posterolateral approach can achieve accurate,safe and effective decompression of L5/S1 far lateral lumbar disc herniation.

Objective To conduct a bibliometric analysis of domestic and international literature on the research of Sijunzi Decoction over the past 20 years,and to explore the research status,hotspots,and development trends of Sijunzi Decoction.Methods This article retrieved journal articles related to the research of Sijunzi Decoction from 2004 to 2024 in the CNKI,Wanfang,VIP,and Web of Science databases.Microsoft Excel was used for publication volume analysis,while CiteSpace software was employed for keyword co-occurrence,clustering,and burst analysis,and then the analysis results were visualized.Results After literature retrieval and screening,3 573 Chinese articles and 113 English articles were included.Over the past two decades,the publication volume showed a trend of steadily increasing.The most frequent keywords in Chinese and English literature on the research of Sijunzi Decoction were spleen deficiency syndrome and gene expression,while the keywords with strongest burst were experimental research and data mining.Conclusion The research of Sijunzi Decoction in the last 20 years was mainly through animal experiments and clinical applications,and the research hotspots focus on the treatment of diseases of spleen deficiency syndrome and on the improvement of immune function of cancer patients.The extraction and identification of active components in Sijunzi Decoction and the study on the therapeutic mechanism in diseases of spleen deficiency syndrome are probably the future research trends.

Objective:To develop an EGFR-targeting nanobody engineered exosome drug delivery system and evaluate its antitumor efficacy for colorectal cancer.Methods:The HEK293T cell line stably expressing the pan-cancer inhibitor miR-204-5p, previously established by our group, was selected as a tool cell line to prepare miR-204-5p-enriched exosomes. Using metabolic glycoengineering combined with bioorthogonal reaction strategy, these exosomes were modified with the EGFR-specific nanobody 7D12. Western blot, electron microscopy, and dynamic light scattering were used to characterize the engineered exosomes. The tumor target potential of engineered exosomes was evaluated using immunofluorescence and RT-qPCR. The in vitro anti-tumor activities of engineered exosomes were evaluated using cell growth curves, colony formation, Transwell, and apoptosis analyses. The in vivo anti-tumor activity and safety of engineered exosomes were evaluated using a nude mouse xenograft tumor model. Results:The particle size of 7D12-hExo was (116.8±36.8) nm, with a potential of around -10 mV, and there was no significant change compared with the unmodified hExo. Immunofluorescence assay showed that the fluorescence intensity of the hExo group, 7D12-hExo group, and 7D12+7D12-hExo group were 48.4±3.9, 141.0±6.6, and 38.7±3.2 in EGFR + HCT116 cells, respectively. Compared with the hExo group, the fluorescence intensity of HCT116 cells in the 7D12-hExo group was significantly enhanced ( P＜0.05). Compared with the 7D12-hExo group, the fluorescence intensity in HCT116 cells in the 7D12+7D12-hExo group was significantly decreased ( P＜0.05). However, there was no significant difference in the uptake of hExo and 7D12-hExo in EGFR - SW620 colorectal cancer cells. The number of cell clones, invasion, and migration of HCT116 cells in the hExo (204) group was 215.0±14.0, 862.3±61.4, and 1 197.0 ± 36.7, respectively, with an apoptosis rate of (14.1±1.4)%. The number of cell clones, invasion, and migration of HCT116 cells in the 7D12-hExo (204) group was (65.0±15.1), (232.0±27.9), (725.7±32.7), respectively, with an apoptosis rate of (29.3±1.0)%. The 7D12-hExo (204) significantly inhibited the proliferation, invasion, and migration ability of HCT116 cells ( P＜0.05), resulting in promoting the apoptosis of HCT116 cells ( P＜0.05). Nude mouse experiments showed that 7D12-hExo (204) significantly inhibited the growth of tumors transplanted with HCT116 cells, with the inhibition rate being 82.8%. However, there was no significant change in mouse weight, and H&E staining of major organs such as heart, liver, spleen, lung, and kidney did not show any abnormalities. Conclusion:Naturally miR-204-5p-loaded exosomes were successfully modified with nanobody 7D12, which can efficiently deliver miR-204-5p into EGFR + tumor cells, thereby exerting good anti-tumor therapeutic effects.

Purpose This study aimed to investigate the expression of CTLA-4 and PD-L1 in pulmonary lympho-epithelial carcinoma(PLEC)and to explore their relationships with patient prognosis and with tumor-infiltrating lym-phocytes(TILs).Methods Fifty cases of PLEC were retrospectively collected,together with 23 samples of adjacent normal lung tissue.Immunohistochemistry was performed to detect CTLA-4 and PD-L1 expression in both PLEC and adjacent normal lung tissues,as well as to quantify CD4+and CD8+T-lymphocytes infiltration within the tumor micro-environment.CTLA-4,PD-L1,and the distributions of CD4+T cells and CD8+T cells were then correlated with the clinicopathological features of PLEC.Results The positive rate of CTLA-4 in PLEC was significantly higher than that in adjacent normal lung tissue(P＜0.05).PD-L1 expression differed significantly across TNM stages of PLEC(P＜0.05)and was positively correlated with TNM stages(r=0.31,P=0.03).CD4+and CD8+T-lymphocytes were pre-dominantly localized in the tumor stroma,with CD4+T cells density exceeding that of CD8+(P＜0.05).Within canc-er nests,CD8+T cells density was significantly higher than CD4+(P＜0.05).Conclusion Both PD-L1 and CTLA-4 are frequently expressed in PLEC,suggesting they represent potential immunotherapeutic targets.In the PLEC micro-environment,lymphocytes primarily infiltrated the stromal compartment,and CD4+T cells are more abundant than CD8+T cells in that locale.

Purpose This study aimed to investigate the expression of CTLA-4 and PD-L1 in pulmonary lympho-epithelial carcinoma(PLEC)and to explore their relationships with patient prognosis and with tumor-infiltrating lym-phocytes(TILs).Methods Fifty cases of PLEC were retrospectively collected,together with 23 samples of adjacent normal lung tissue.Immunohistochemistry was performed to detect CTLA-4 and PD-L1 expression in both PLEC and adjacent normal lung tissues,as well as to quantify CD4+and CD8+T-lymphocytes infiltration within the tumor micro-environment.CTLA-4,PD-L1,and the distributions of CD4+T cells and CD8+T cells were then correlated with the clinicopathological features of PLEC.Results The positive rate of CTLA-4 in PLEC was significantly higher than that in adjacent normal lung tissue(P＜0.05).PD-L1 expression differed significantly across TNM stages of PLEC(P＜0.05)and was positively correlated with TNM stages(r=0.31,P=0.03).CD4+and CD8+T-lymphocytes were pre-dominantly localized in the tumor stroma,with CD4+T cells density exceeding that of CD8+(P＜0.05).Within canc-er nests,CD8+T cells density was significantly higher than CD4+(P＜0.05).Conclusion Both PD-L1 and CTLA-4 are frequently expressed in PLEC,suggesting they represent potential immunotherapeutic targets.In the PLEC micro-environment,lymphocytes primarily infiltrated the stromal compartment,and CD4+T cells are more abundant than CD8+T cells in that locale.

Objective:To evaluate the incidence, clinical features, factors affecting initial diagnosis, efficacy, and safety of therapy and prognosis of small intestinal Dieulafoy lesions (DL).Methods:Clinical data including clinical background, diagnosis, and treatment details of patients who were admitted to the Department of Gastroenterology, Air Force Medical Center, for suspected small bowel bleeding, diagnosed as having small bowel DL and treated with balloon-assisted enteroscopy (BAE) were retrospectively analyzed from November 2017 to March 2024.Results:Among 800 patients, 30 cases (3.75%, 30/800, 17 males and 13 females) were diagnosed as having small intestine DL with the mean age of 60.90 years. Clinical symptoms included melena (56.67%, 17/30), hematochezia (43.33%, 13/30), and hemodynamic instability (30.00%, 9/30). Active bleeding occurred in 23 (76.67%) patients. Comorbidities existed in 70.00% (21/30) and 33.33% (10/30) used long-term antithrombotic agents. Diagnosis was confirmed after a single BAE in 63.33% (19/30) and after multiple BAEs (mean 1.6 procedures) in 36.67% (11/30). Lesions were predominantly located at jejunal. All patients achieved successful treatment with a single BAE procedure. The median follow-up period was 12.25 months (range: 5.25-23.00 months). Five cases (16.67%) experienced recurrent bleeding, with one case transfered to surgical intervention. Two cases (6.67%) reported post-operative symptoms of dizziness and fatigue, which resolved after symptomatic management. Multivariate analysis showed that long-term oral anticoagulant therapy ( OR=0.06, 95% CI: 0.01-0.73) was an independent predictor of single-session diagnosis. Conclusion:Small intestinal DL is rare and challenging to diagnose. Antithrombotic therapy may facilitate the diagnosis of DL at the first BAE. Jejunal localization is common, and combined endoscopic therapy (including clipping) is effective and safe.

Objective:To develop an EGFR-targeting nanobody engineered exosome drug delivery system and evaluate its antitumor efficacy for colorectal cancer.Methods:The HEK293T cell line stably expressing the pan-cancer inhibitor miR-204-5p, previously established by our group, was selected as a tool cell line to prepare miR-204-5p-enriched exosomes. Using metabolic glycoengineering combined with bioorthogonal reaction strategy, these exosomes were modified with the EGFR-specific nanobody 7D12. Western blot, electron microscopy, and dynamic light scattering were used to characterize the engineered exosomes. The tumor target potential of engineered exosomes was evaluated using immunofluorescence and RT-qPCR. The in vitro anti-tumor activities of engineered exosomes were evaluated using cell growth curves, colony formation, Transwell, and apoptosis analyses. The in vivo anti-tumor activity and safety of engineered exosomes were evaluated using a nude mouse xenograft tumor model. Results:The particle size of 7D12-hExo was (116.8±36.8) nm, with a potential of around -10 mV, and there was no significant change compared with the unmodified hExo. Immunofluorescence assay showed that the fluorescence intensity of the hExo group, 7D12-hExo group, and 7D12+7D12-hExo group were 48.4±3.9, 141.0±6.6, and 38.7±3.2 in EGFR + HCT116 cells, respectively. Compared with the hExo group, the fluorescence intensity of HCT116 cells in the 7D12-hExo group was significantly enhanced ( P＜0.05). Compared with the 7D12-hExo group, the fluorescence intensity in HCT116 cells in the 7D12+7D12-hExo group was significantly decreased ( P＜0.05). However, there was no significant difference in the uptake of hExo and 7D12-hExo in EGFR - SW620 colorectal cancer cells. The number of cell clones, invasion, and migration of HCT116 cells in the hExo (204) group was 215.0±14.0, 862.3±61.4, and 1 197.0 ± 36.7, respectively, with an apoptosis rate of (14.1±1.4)%. The number of cell clones, invasion, and migration of HCT116 cells in the 7D12-hExo (204) group was (65.0±15.1), (232.0±27.9), (725.7±32.7), respectively, with an apoptosis rate of (29.3±1.0)%. The 7D12-hExo (204) significantly inhibited the proliferation, invasion, and migration ability of HCT116 cells ( P＜0.05), resulting in promoting the apoptosis of HCT116 cells ( P＜0.05). Nude mouse experiments showed that 7D12-hExo (204) significantly inhibited the growth of tumors transplanted with HCT116 cells, with the inhibition rate being 82.8%. However, there was no significant change in mouse weight, and H&E staining of major organs such as heart, liver, spleen, lung, and kidney did not show any abnormalities. Conclusion:Naturally miR-204-5p-loaded exosomes were successfully modified with nanobody 7D12, which can efficiently deliver miR-204-5p into EGFR + tumor cells, thereby exerting good anti-tumor therapeutic effects.

Objective:To evaluate the bone hook pulling technique in reduction of valgus-impacted femoral neck fractures.Methods:A retrospective study was conducted to analyze the clinical data of 12 patients who had been treated from September 2021 to September 2022 for valgus-impacted femoral neck fractures at Department of Orthopaedics and Traumatology, Honghui Hospital. There were 6 males and 6 females with an age of (43.8±10.1) years. By the Garden classification, the 12 cases were all type Ⅰ; by the Pauwels classification, 10 cases were type Ⅰ and 2 cases type Ⅱ. All patients were definitively diagnosed preoperatively by radiographs and CT images. The bone hook pulling technique was used to extend the bone hook from the lateral side to the medial side of the lesser trochanter, pull the bone hook to the lateral side, and reset the fracture with the help of pulling force and the action of the surrounding soft tissue hinge. The fractures were then fixed with the Femoral Neck System (FNS). Length of surgical incision, number of fluoroscopy for bone hook-related operations, operation time, quality of fracture reduction, fracture healing time, functional recovery of the hip and shortening of the femoral neck at the last follow-up were recorded.Results:The 12 valgus-impacted femoral neck fractures were successfully reset by the hook pulling technique. In this cohort, the length of surgical incision was (4.6±0.7) cm, the number of fluoroscopy for bone hook-related operations (4.3±0.7) times, and the operation time (54.3±4.2) min. The 12 patients were followed up for (11.5±4.2) months postoperatively and the fracture healing time (4.2±0.7) months. According to the Garden score, the quality of postoperative fracture reduction was assessed as grade Ⅰ in 10 cases and as grade Ⅱ in 2 cases. According to the Harris hip score, the hip function was assessed as excellent in 10 cases and as good in 2 cases at the last follow-up. The length of femoral neck shortening was (1.17±0.68) mm at the last follow-up in the 12 patients; no complications related to fracture reduction were observed.Conclusion:In the reduction of valgus-impacted femoral neck fractures, bone hook pulling technique shows advantages of operational simplicity, a high rate of successful reduction, and satisfactory clinical effects.