In recent years, the reform of the registration, evaluation, and approval system for traditional Chinese medicine(TCM) has been promoted at the national level, with establishment of an evaluation evidence system for TCM registration that combines TCM theory, human use experience, and clinical trials(known as the "three-combined" evaluation evidence system). This system, which aligns with the characteristics of TCM clinical practice and the laws of TCM research and development, recognizes the unique value of human use experience in medicine and returns to the essence of medicine as an applied science, thus receiving widespread recognition from both academia and industry. However, it meanwhile poses new and higher challenges. This article delves into the value and challenges faced by the "three-combined" evaluation evidence system from three perspectives: registration management, medical institutions, and the TCM industry. Furthermore, it discusses how the China Association of Chinese Medicine, leveraging its academic platform advantages and leading roles, has made exploratory and practical efforts to facilitate the research and development of new TCM drugs and the implementation of the "three-combined" evaluation evidence system.
Drugs, Chinese Herbal/standards* ; Humans ; Medicine, Chinese Traditional/standards* ; China ; Drug Development

Objective:Quantified MRCP imaging data was used as a reference for design and preparation of a modified percutaneous transhepatic cholangio drainage (PTCD) tube.Methods:3.0 T upper abdominal MR and MRCP imaging data of 2 300 patients treated from July 2015 to July 2020 at the Department of Radiology of the Affiliated Cancer Hospital of Zhengzhou University were screened and a total of 381 patients diagnosed with biliary duct structures were identified. Causative etiologies among these patients included pancreatic adenocarcinoma (pancreatic head), cholangiocarcinoma, ampullary carcinoma, as well as intrahepatic and/or extrahepatic bile duct dilation. An improved PTCD tube was designed based on MRCP quantification of left and right hepatic and common hepatic duct length.Results:In the setting of biliary obstruction caused by malignancy, the distance of the left hepatic duct from its origin to the point of left and right hepatic duct confluence was 15.9±3.8 mm, while the distance of the right hepatic duct from its origin to the point of left and right hepatic duct confluence was 12.4±3.2 mm; the length of the bile duct from its origin to the point of left and right hepatic duct confluence was 34.0±8.1 mm. The improved PTCD tube design incorporated an altered length of the drainage orifice.Conclusion:MRCP imaging of the biliary tract is effective for measuring biliary tract length in the setting of pathological dilation. Based on our biliary tract measurements, a modified PTCD tube was designed to more effectively meet drainage requirements and manage biliary obstruction caused by Bismuth-Corlette type Ⅱ and Ⅲ malignancies.

Patients with severe trauma require an extremely timely treatment and transfusion plays an irreplaceable role in the emergency treatment of such patients. An increasing number of evidence-based medicinal evidences and clinical practices suggest that patients with severe traumatic bleeding benefit from early transfusion of low-titer group O whole blood or hemostatic resuscitation with red blood cells, plasma and platelet of a balanced ratio. However, the current domestic mode of blood supply cannot fully meet the requirements of timely and effective blood transfusion for emergency treatment of patients with severe trauma in clinical practice. In order to solve the key problems in blood supply and blood transfusion strategies for emergency treatment of severe trauma, Branch of Clinical Transfusion Medicine of Chinese Medical Association, Group for Trauma Emergency Care and Multiple Injuries of Trauma Branch of Chinese Medical Association, Young Scholar Group of Disaster Medicine Branch of Chinese Medical Association organized domestic experts of blood transfusion medicine and trauma treatment to jointly formulate Chinese expert consensus on blood support mode and blood transfusion strategies for emergency treatment of severe trauma patients ( version 2024). Based on the evidence-based medical evidence and Delphi method of expert consultation and voting, 10 recommendations were put forward from two aspects of blood support mode and transfusion strategies, aiming to provide a reference for transfusion resuscitation in the emergency treatment of severe trauma and further improve the success rate of treatment of patients with severe trauma.

Objective:To evaluate the safety and efficacy of radiofrequency ablation guided by CT hepatic arteriography (CTHA) in the treatment of multiple nodular liver metastases of colorectal cancer.Methods:Clinical data of 32 patients with liver metastasis of colorectal cancer who underwent femoral arterial catheterization and percutaneous radiofrequency ablation guided by CT hepatic arteriography (CTHA) at the Affiliated Cancer Hospital of Zhengzhou University from March 2020 to September 2021 were retrospectively analyzed, including 21 males and 11 females, aged (53.2±9.9) years old. Before ablation, the angiography catheter were placed in the common or proper hepatic artery under the digital subtraction angiography (DSA). The patients were then transferred to a CT operating room. Under general anesthesia, contrast agent was injected into the indwelling angiography catheter and percutaneous radiofrequency ablation guided by CTHA was performed. The presentation of lesions, the dosage of contrast agent and complications during ablation were analyzed, and the treatment outcome was followed up outpatient or inpatient review.Results:All 32 patients uneventfully underwent DSA-guided angiography catheter placement, and CTHA-guided radiofrequency ablation was successfully performed in 97 lesions, with a technical success rate of 100% (97/97). The difference between CT values at the lesion enhancement site and peri-tumor hepatic parenchyma were greater than 25 HU. The total amount of contrast agent used during the procedure was 63.9±14.7 ml. All ablation-related complications were graded as A or B according to the Society of Interventional Radiology classification system. The complete ablation rate assessed by CTHA after the ablation was 100% (97/97). The rate of lesion necrosis was 100% evaluated by MRI one month after ablation. All patients were followed up and no recurrence was observed in 97 ablated lesions by the end of follow-up period.Conclusion:Radiofrequency ablation guided by CTHA is safe and feasible for the treatment of multiple nodular liver metastases of colorectal cancer, which could reduce the local recurrence of lesions after ablation.

Objective:To investigate the safety and efficacy of C-arm CT laser-guided puncture combined with digital subtraction angiography (DSA)for percutaneous renal pelvic catheter drainage in the treatment of hydronephrosis caused by pelvic malignancy.Methods:A retrospective analysis was performed on the data of 56 patients with ureteral obstruction caused by pelvic malignancy admitted to the Affiliated Cancer Hospital of Zhengzhou University from February 2020 to August 2021, including 10 males and 46 females. The mean age of the patients was (54.0±10.1)years old. The causes were colorectal cancer (7 cases), bladder cancer (3 cases), cervical cancer (36 cases), endometrial cancer (3 cases), ovarian cancer (2 cases), pelvic metastasis of gastric cancer (4 cases) and pelvic sarcoma (1 case). There were 71 sides of renal pelvis dilation in 56 patients, with the degree of dilation ranging from 1.2cm to 5.0cm.The degree of hydronephrosis was mild on 36 sides, moderate on 27 sides, and severe on 8 sides. Preoperative blood urea nitrogen(9.90±6.22)mmol/L and creatinine (155.80±146.83)μmol/L.During the puncture and catheter drainage, the patient was placed in the prone position, the C-arm CT scan was used to plan the puncture path, and the laser positioning of the DSA flat panel detector was used to determine the skin puncture point. With local anesthesia, the puncture direction of the puncture needle was adjusted to make the skin puncture point, the tail of the puncture needle, and the laser fixation point present a state of "three-points in one-line" when the patient stopped breathing temporarily at the end of expiratory breath in a non-fluoroscopic state, so as to achieve the preset puncture angle. Subsequently, pyelocentesis was completed according to the planned puncture depth. After successful pyelocentesis, percutaneous external renal drainage tube insertion or ureteral stents were performed under DSA. The number of renal pelvis puncture, puncture time, radiation dose, deviation of external renal drainage tube insertion angle from puncture angle, as well as postoperative hemoglobin changes, renal function recovery and complications were recorded.Results:In this group, 56 cases of 71 sides of renal pelvis puncture and catheter drainage were successfully completed, and the success rate of the operation was 100.0% (71/71). The success rate of the first needle puncture was 97.2% (69/71). Those who failed the first needle puncture succeeded in the second puncture during the operation. The puncture time of renal pelvis was (1.9±1.8) min.The intraoperative radiation dose was (2.7±1.5) mSV. The external drainage tube of the renal pelvis was placed on 53 sides, and the external drainage tube was placed on 29 sides with the same angle as the preset angle, and 24 sides with a deviation within 3°.On the first day after operation, there was no significant difference in hemoglobin compared with that before operation, urea nitrogen (5.31±1.99) mmol/L and creatinine (62.25±16.72) μmol/L were re-examined after operation, and the differences were statistically significant compared with those before operation ( P=0.008, P=0.002). No serious surgery-related complications occurred in any patient. Conclusion:C-arm CT laser-guided puncture combined with DSA percutaneous renal pelvic catheter drainage could be safe and effective in the treatment of ureteral obstruction caused by pelvic malignancy.

Objective: To investigate the distribution of HIV-1 genetic subtypes and pretreatment drug resistance (PDR) among men who have sex with men (MSM) from 19 cities of 6 provinces in China. Methods: From April to November 2019, 574 plasma samples of ART-naive HIV-1 infected MSM were collected from 19 cities in Hebei, Shandong, Jiangsu, Zhejiang, Fujian, and Guangdong provinces, total ribonucleic acid (RNA) was extracted and amplified the HIV-1 pol gene region by nested polymerase chain reaction (PCR) after reverse transcription. Then sequences were used to construct a phylogenetic tree to determine genetic subtypes and submitted to the Stanford drug resistance database for drug resistance analysis. Results: A total of 479 samples were successfully amplified by PCR. The HIV-1 genetic subtypes included CRF01_AE, CRF07_BC, B, CRF55_01B, CRF59_01B, CRF65_cpx, CRF103_01B, CRF67_01B, CRF68_01B and unrecognized subtype, which accounted for 43.4%, 36.3%, 6.3%, 5.9%, 0.8%, 0.8%, 0.4%, 0.4%, 0.2% and 5.5%, respectively. The distribution of genetic subtypes among provinces is statistically different (χ²=44.141, P<0.001). The overall PDR rate was 4.6% (22/479), the drug resistance rate of non-nucleoside reverse transcriptase inhibitors, nucleoside reverse transcriptase inhibitors, and protease inhibitors were 3.5% (17/479), 0.8% (4/479) and 0.2% (1/479), respectively. The PDR rate of recent infections was significantly higher than that of long-term infections (χ²=4.634, P=0.031). Conclusions: The HIV-1 genetic subtypes among MSM infected with HIV-1 from 19 cities of 6 provinces in China are diverse, and the distribution of subtypes is different among provinces. The overall PDR rate is low, while the PDR rate of recent infections was significantly higher than that of long-term infections, suggesting the surveillance of PDR in recent infections should be strengthened.
China/epidemiology* ; Cities ; Drug Resistance ; Drug Resistance, Viral/genetics* ; Female ; Genotype ; HIV Infections/epidemiology* ; HIV Seropositivity/drug therapy* ; HIV-1/genetics* ; Homosexuality, Male ; Humans ; Male ; Phylogeny ; Reverse Transcriptase Inhibitors/therapeutic use* ; Sexual and Gender Minorities

Anastomosis, Surgical ; Gastrectomy/adverse effects* ; Humans ; Jejunum/surgery* ; Laparoscopy ; Retrospective Studies ; Stomach Neoplasms/surgery*

Objective:To investigate the effectiveness of surgical treatment for patients with T 4 stage prostate cancer. Methods:The clinical data and prognosis of 18 patients with T 4 stage prostate cancer treated in Shanghai Tenth People's Hospital from July 2013 to December 2019 were retrospectively analyzed. The average age of these 18 patients was 68.3 (53-81)years. 10 patients were castration resistant prostate cancer (CRPC) and 8 patients were hormone-sensitive prostate cancer (HSPC). 10 CRPC patients were treated with surgical treatment due to bladder clot packing and/or lower urinary tract obstruction. 8 HSPC patients had severe hematuria, severe dysuria and local symptoms. The KPS scores of all patients were ≥80 points with an average score of 84 (80-90). The average QOL score of 18 patients was 28 (21-32). 2 cases in 18 patients underwent total pelvic resection for rectal invasion (one CRPC and one HSPC). 7 cases underwent radical cystoprostatectomy for ureteral invasion (5 cases of CRPC, 2 cases of HSPC), 9 cases underwent bladder preservation surgery for bladder neck invasion (4 cases of CRPC, 5 cases of HSPC), of which 4 cases of enlarged lymph node dissection were all HSPC patients. Results:All cases of T 4 stage prostate cancer patients operation were successfully completed, the average operation time was 256 (219-310)min and the median intraoperative blood loss was about 300 (250-350)ml. Four of them (3 cases of CRPC and 1 case of HSPC) received blood transfusion after operation. The average postoperative hospital stay was 21(11-37) days. All 18 cases were followed up and the median follow-up time was 23.8 months. There was no perioperative death, and no bladder-preserving patients had true urinary incontinence or bladder outlet stenosis.2 CRPC cases died 8 and 15 months after surgery respectively, 7 patients were PSA relapse treated with docetaxel or abiterone therapy, and 1 HSPC patient with rectal invasion was followed up for 58 months after total pelvic resection, the PSA level was still 0.003ng/ml, no distant metastasis was found. 8 cases of hormone-sensitive patients were treated with endocrine therapy, and PSA was less than 0.2 ng/ml. The average QOL of 18 patients 3 months after operation was 37 points (25-45), which was significantly higher than that before operation. The average maximum urine flow rate of patients with bladder preservation was 23(19-25)ml/s. Conclusions:For T 4 stage prostate cancer, surgical treatment is feasible and safe for doctors with extensive surgical experience. For CRPC patients, the surgery can significantly improve short-term symptoms and quality of life, and long-term benefits need to be further evaluated with a large sample. For HSPC patients, it can not only improve clinical symptoms and QOL of patients, but also provide long-term benefits.

Objective:To investigate the role and regulatory mechanism of miR-125b-1-3p in rotavirus replication.Methods:MA104 cells were infected with rotavirus after upregulation and down-regulation of miR-125b-1-3p, respectively. The expression of miR-125b-1-3p and the copy number of rotavirus were analyzed by RT-PCR. The effect of miR-125b-1-3p on the protein expression of rotavirus was analyzed by immunofluorescence. The expression of related proteins involved in the regulation of miR-125b-1-3p was analyzed by Western blot analysis.Results:After rotavirus infection, the expression level of miR-125b-1-3p was significantly up-regulated, the copy number of VP7 and NSP3 gene of rotavirus decreased after up-regulation of miR-125b-1-3p, and the copy number of VP7 and NSP3 gene of rotavirus was significantly increased after down-regulation of miR-125b-1-3p.The fluorescence number of rotavirus protein decreased after upregulation of miR-125b-1-3p expression level, and increased after down-regulation of miR-125b-1-3p expression level. The activity of PI3K/Akt pathway was inhibited 16 h after rotavirus infection, and the up-regulation of miR-125b-1-3p could inhibit the activation of PI3K/Akt pathway.Conclusions:MiR-125b-1-3p inhibits rotavirus replication by regulating the PI3K/Akt pathway. These results provide an experimental basis for exploring the specific regulatory mechanism between miR-125b-1-3p and PI3K/Akt pathway, and provide a target for anti-infection therapy of rotavirus.