ObjectiveTo systematically organize the relevant research on the treatment of uterine fibroids with Xiaojie'an capsules through clinical evidence evaluation and comprehensive value analysis in the "6+1" dimension，highlighting the efficacy and characteristics of Xiaojie'an capsules. MethodsBased on evidence-based medicine，epidemiology，pharmacoeconomics，health technology assessment （HTA）， and other methodologies，this study adopted qualitative and quantitative evaluation methods. Through a questionnaire survey，official website data information，published literature， and secondary evaluation of real world data，a total of "6+1" dimensions were used to build an evaluation system for the safety，effectiveness，economy，innovation，suitability，accessibility of Chinese patent medicines， and characteristics of traditional Chinese medicines. Results① Safety：From January 2009 to March 2023，the National Adverse Drug Reaction Monitoring Center reported 159 cases （248 cases） of general adverse reactions and four cases of serious adverse reactions to Xiaojie'an capsules，all of which were classified as general adverse reactions after expert judgment. Through literature search，a total of 6 865 patients were treated with Xiaojie'an capsules，of which 26 articles reported adverse reactions to Xiaojie'an capsules，resulting in a total of 244 adverse reactions. The clinical manifestations of adverse reactions to Xiaojie'an capsules include nausea，vomiting，stomach discomfort，diarrhea，rash，itching，dizziness，headache，insomnia，etc. The prognosis was good， and the drug surveillance system was sound. Based on the evaluation of known risks and sufficient evidence，in terms of known risk assessment， according to the monitoring results of the spontaneous reporting system （SRS）， there were four cases of serious adverse reactions to Xiaojie'an capsules. After expert discussion， the four cases of serious adverse reactions were finally judged as general adverse reactions， and the known risks were considered to be small in combination with the known risk evaluation criteria. According to the types of studies carried out on Xiaojie'an capsules （randomized controlled trial and its systematic review， SRS data analysis， real world human experience studies， and non-clinical safety studies） and the evaluation criteria of sufficient evidence， it was considered that Xiaojie'an capsules had sufficient evidence. The safety evidence of this variety was sufficient， and the result was confirmed. ② Effectiveness： Meta-analysis results showed that the combination of Xiaojie'an capsules and Mifepristone tablets had better clinical efficacy compared to Mifepristone tablets alone and had a better effect in reducing the maximum uterine fibroid volume. Due to limitations and imprecision caused by downgrading factors，the quality of evidence was evaluated as Grade C. Based on comprehensive effectiveness evidence and value evaluation，the effectiveness evidence of this variety was relatively sufficient， and the results were clear ③ Economy：The economic evaluation results showed that treating one more patient with uterine fibroid required an additional cost of 5 438.57 yuan by using the combination of Xiaojie'an capsules and Mifepristone tablets，which was lower than the patient's willingness to pay （36 883 yuan according to 2022 National Bureau of Statistics data）. This suggested that compared with using Mifepristone tablets alone，the combination of Xiaojie'an capsules and Mifepristone tablets had a certain economy. The sensitivity analysis results were relatively robust，indicating that this variety had good economy ④ Innovation：Currently，most traditional Chinese medicine treatments for uterine fibroids advocate the method of attacking evil，which can easily harm the body. However，Xiaojie'an capsules not only soften and disperse nodules but also balance supporting the body and supplementing deficiency. The comprehensive evaluation showed sufficient evidence of the innovation of this variety，and the results were confirmed. ⑤ Suitability： The service information of Chinese patent medicines derived from the drug was complete，and the questionnaire survey results showed that the drug was suitable for clinicians，nurses，pharmacists， and patients in multiple dimensions such as individual compliance，system， and management. The comprehensive evaluation of the suitability of the product had sufficient evidence and clear results. ⑥ Accessibility：The daily cost of Xiaojie'an capsules was 16.97 yuan，and the treatment cost was 407.16 yuan. It was affordable for urban residents and rural residents and was available for sale in 23 provinces， cities，municipalities，and autonomous regions across the country. The medicinal resources were abundant and sustainably supplied，and there was sufficient evidence of accessibility with clear results. ⑦ Characteristics of traditional Chinese medicine：Xiaojie'an capsules were derived from the classic Dai medicine formula of Dr. CHEN Benshan，a renowned Dai doctor，and they have been clinically used for over 20 years. Dai medicine originated from Xishuangbanna，Yunnan province，with the core theory of "four pagodas and five elements". The comprehensive evaluation showed that this variety exhibited significant characteristics of traditional Chinese medicine. ⑧ Comprehensive evaluation of clinical value：Based on the "6+1" dimensions mentioned above，combined with the multi-criteria decision analysis （MCDA） model and calculations using CSC v2.0 software，the results showed that there was sufficient evidence for the clinical value of Xiaojie'an capsules，and the results were clear. ConclusionThe comprehensive evaluation of Xiaojie'an capsules has sufficient evidence of safety and innovation，and the results are confirmed. The evidence of effectiveness，suitability，and accessibility is relatively sufficient，with clear results. The economy is good，and the characteristics of traditional Chinese medicine are prominent. The comprehensive evaluation of clinical value believes that there is sufficient evidence of the clinical value of Xiaojie'an capsules，and the results are clear. In the future，it is recommended to focus on clinical value， conduct high-quality and effective research that is in line with the characteristics of traditional Chinese medicine， and improve acute toxicity testing to provide a scientific and objective basis for clinical efficacy and safety research.

Purpose To explore the clinicopathological features and endoscopic manifestations of cap polyposis(CP).Methods Clinical,endoscopic,pathological,and follow-up data of 17 cases of CP were collected and ana-lyzed.Results There were 14 males and 3 females,aged 15-67 years,with a mean age of 36.5 years.The disease duration ranged from 2 weeks to 5 years,and most patients(64.7％,11/17)had symptoms for more than l year.The most common clinical manifestation was hematochezia(82.4％,14/17),while constipation was generally absent.En-doscopically,all lesions(100％,17/17)were located in the anal canal and lower rectum.The surface was invariably covered with a thick whitish exudate(100％,17/17),and annular growth was the most frequent pattern(76.5％,13/17).Pathologically,the mucosal layer was almost entirely replaced by granulation tissue,and the surface showed extensive inflammatory necrosis forming a cap-like structure.Conclusion CP predominantly occurrs in the anal canal and lower rectum of young men.The presence of abundant whitish exudate under endoscopy is differential diagnostic value.Complete endoscopic resection followed by pathological examination is required for definitive diagnosis.

Objective:To explore the clinicopathological features of rectal neuroendocrine tumor (R-NET) G2, identify prognostic factors, and summarize treatment experience.Methods:The clinical data of patients diagnosed with R-NET G2 by pathological diagnosis admitted to Cancer Hospital of the Chinese Academy of Medical Sciences from January 2003 to September 2023 were retrospectively analyzed. The Fisher's exact test and Kaplan-Meier curves were performed to analyze the association between pathological features and prognosis.Results:A total of 22 patients were enrolled in this study and 21 patients were followed up for a period of 6-98 months with a median follow-up time of 42 months. 5 patients died due to tumor progression during the follow-up period. The 1-, 3-, and 5-year cancer-specific survival (CSS) of the whole group were 100.0%, 92.9%, and 69.6%, respectively. Of the 22 patients, 20 underwent surgical treatment, of which 15 underwent postoperative adjuvant therapy; 2 underwent medical treatment for liver and bone multiple metastases. The 5-year survival rates of patients with tumours ≥2 cm in length, T2-3 stage, lymph node metastasis, and distant metastasis (57.1%, 68.8%, 66.7%, and 63.6%, respectively) were shorter than those of patients with tumours <2 cm in length, T1 stage, no lymph node metastasis, and no distant metastasis (all 100.0%, P＜0.001). In addition, patients with liver metastases had larger primary tumor diameters and higher T-stages compared with those without distant metastasis ( P＜0.05). Conclusions:R-NET G2 has a high degree of malignancy compared with G1 and a high propensity for metastasis. Clinicians should formulate appropriate diagnostic and treatment strategies based on factors such as tumor size, depth of invasion, lymph node status, presence of distant metastasis, and the location and extent of distant metastasis.

Purpose To explore the clinicopathological features and endoscopic manifestations of cap polyposis(CP).Methods Clinical,endoscopic,pathological,and follow-up data of 17 cases of CP were collected and ana-lyzed.Results There were 14 males and 3 females,aged 15-67 years,with a mean age of 36.5 years.The disease duration ranged from 2 weeks to 5 years,and most patients(64.7％,11/17)had symptoms for more than l year.The most common clinical manifestation was hematochezia(82.4％,14/17),while constipation was generally absent.En-doscopically,all lesions(100％,17/17)were located in the anal canal and lower rectum.The surface was invariably covered with a thick whitish exudate(100％,17/17),and annular growth was the most frequent pattern(76.5％,13/17).Pathologically,the mucosal layer was almost entirely replaced by granulation tissue,and the surface showed extensive inflammatory necrosis forming a cap-like structure.Conclusion CP predominantly occurrs in the anal canal and lower rectum of young men.The presence of abundant whitish exudate under endoscopy is differential diagnostic value.Complete endoscopic resection followed by pathological examination is required for definitive diagnosis.

Objective:To explore the clinicopathological features of rectal neuroendocrine tumor (R-NET) G2, identify prognostic factors, and summarize treatment experience.Methods:The clinical data of patients diagnosed with R-NET G2 by pathological diagnosis admitted to Cancer Hospital of the Chinese Academy of Medical Sciences from January 2003 to September 2023 were retrospectively analyzed. The Fisher's exact test and Kaplan-Meier curves were performed to analyze the association between pathological features and prognosis.Results:A total of 22 patients were enrolled in this study and 21 patients were followed up for a period of 6-98 months with a median follow-up time of 42 months. 5 patients died due to tumor progression during the follow-up period. The 1-, 3-, and 5-year cancer-specific survival (CSS) of the whole group were 100.0%, 92.9%, and 69.6%, respectively. Of the 22 patients, 20 underwent surgical treatment, of which 15 underwent postoperative adjuvant therapy; 2 underwent medical treatment for liver and bone multiple metastases. The 5-year survival rates of patients with tumours ≥2 cm in length, T2-3 stage, lymph node metastasis, and distant metastasis (57.1%, 68.8%, 66.7%, and 63.6%, respectively) were shorter than those of patients with tumours <2 cm in length, T1 stage, no lymph node metastasis, and no distant metastasis (all 100.0%, P＜0.001). In addition, patients with liver metastases had larger primary tumor diameters and higher T-stages compared with those without distant metastasis ( P＜0.05). Conclusions:R-NET G2 has a high degree of malignancy compared with G1 and a high propensity for metastasis. Clinicians should formulate appropriate diagnostic and treatment strategies based on factors such as tumor size, depth of invasion, lymph node status, presence of distant metastasis, and the location and extent of distant metastasis.

ObjectiveTo systematically review the existing evidence of Tongxiening（TXN） Granules in the treatment of diarrhea-predominant irritable bowel syndrome （IBS-D） with liver Qi invading spleen syndrome，and evaluate the clinical comprehensive value from the 6+1 dimension，providing references for national medical decision-making，drug clinical application promotion，pharmaceutical services，etc. MethodFollowing the relevant standards of the "Guidelines for the Management of Clinical Evidence and Value Evaluation of Drugs"， a combination of qualitative and quantitative approaches based on evidence-based medicine，questionnaire surveys，pharmacoeconomic evaluation，etc.，was employed. Multi-criteria decision analysis （MCDA） model was employed to comprehensively evaluate the clinical evidence and value of TXN Granules in the treatment of IBS-D with liver Qi invading spleen syndrome from the "6+1" dimensions of effectiveness，safety，economy，innovation，suitability，accessibility， and traditional Chinese medicine （TCM） characteristics Result① Safety： Based on the evaluation of known risks and adequacy of safety evidence， TXN granules were considered to have controllable risks with sufficient safety evidence. ② Effectiveness： Meta-analysis showed that TXN granules combined with probiotics could reduce the intestinal symptom score level of IBS-D patients ［mean difference （MD）=-2.29， 95% confidence interval （CI） （-3.20， -1.38）， P<0.01］， and TXN granules combined with conventional treatments （such as Bifidobacterium triple viable capsules，pinaverium bromide tablets，or trimebutine maleate tablets）effectively improved the comprehensive improvement rate of IBS-D patients ［relative risk （RR）=1.19， 95%CI （1.14，1.25）， P<0.01］. TXN granules significantly improved abdominal pain ［RR=1.99， 95%CI （1.62，2.44）， P < 0.01］ and diarrhea efficacy rate ［RR = 1.56， 95% CI （1.07，2.25）， P<0.05］ in IBS-D patients. TXN granules were comparable to pinaverium bromide tablets in reducing HAMA score ［MD = 0.29， 95% CI （-0.30， 0.88）， P=0.34］， HAMD score ［MD=0.35， 95%CI （-0.31，1.00），P=0.30］， and improving IBS-QOL score ［MD = 0.28， 95%CI （-1.70，2.26）， P=0.78］. Based on the quality of evidence and evidence value assessment of effectiveness， it was considered that there was sufficient evidence of effectiveness for this product. ③ Economy： TXN granules are a national medical insurance category B product. After 5 years of simulation with three kinds of Markov models， it was considered that TXN granules were the advantageous treatment option with stable results and good economy. ④ Innovation： TXN granules adhered to original innovation， conducting research and development from clinical application， product components， and production processes. They have obtained national TCM new drug certificates， first prizes from the China Association of Chinese Medicine for Science and Technology， and excellent awards for Chinese patents， providing sufficient innovative evidence in clinical， corporate， and industrial aspects. ⑤ Suitability： The information service of this drug is comprehensive. The questionnaire survey results showed that this drug was suitable for clinical doctors， nurses， pharmacists， and patients in terms of individual compliance， system， and management across multiple dimensions. The overall assessment showed sufficient evidence of suitability for this product. ⑥ Accessibility： The daily cost of TXN granules accounts for 2.43% of the median disposable daily income of urban residents and 9.26% of rural residents， which is moderate and reasonable compared to similar drugs. There is sufficient evidence of affordability， and it is sold nationwide covering all 31 provinces， municipalities， and autonomous regions， with full accessibility evidence and clear results. TCM characteristics： TXN granules originate from the prescription for treating diarrhea in Danxi's Experiential Therapy. They are derived from classical formulas and have undergone multiple clinical trials involving 5 000 cases since their launch， accumulating a certain amount of human use experience. Based on the principles of evaluating TCM characteristics， TXN granules highlight TCM characteristics. The comprehensive value measured using CSC V2.0 software is 0.83 points based on the results of “6+1” dimensions. ConclusionBased on the evaluation results of TXN granules in various dimensions and the comprehensive evaluation score， it is considered that there is sufficient clinical value evidence for TXN granules in treating IBS-D with liver Qi invading spleen syndrome， which can provide references for clinical decision-making and pharmaceutical management. It is suggested for future research to conduct network Meta-analysis， conduct horizontal comparisons of similar TCM treatments for IBS-D， improve the quality of evidence-based evidence， and fully leverage the clinical value advantages of TXN granules.

ObjectiveTo comprehensively assess the clinical value of Duliang soft capsules in the treatment of migraine with wind-cold blood stasis syndrome， and to provide guidance for national medical decision-making， clinical drug promotion， and pharmaceutical services. MethodThe evaluation of Duliang soft capsules' clinical value was conducted in accordance with the Guidelines for the Management of Comprehensive Clinical Evaluation of Drugs （Trial Version， 2021） using a combination of qualitative and quantitative methods. Utilizing the CSC v2.0 software， this study conducted a comprehensive clinical evaluation of Duliang soft capsules across the "6+1" dimensions， including safety pre- and post-market launch， effectiveness in treating migraine， economy （cost-effectiveness）， and innovation， suitability， accessibility， and traditional Chinese medicine （TCM） characteristics in both its technology and clinical applications. ResultSafety： Duliang soft capsules were found to have good safety based on evidence from known adverse reactions （spontaneous reporting system （SRS） data， literature data， etc.）， pre-marketing toxicological research， and post-marketing drug monitoring. Effectiveness： A meta-analysis indicated that the combination of Duliang soft capsules and western medicine was more effective than Western medicine alone in the treatment of migraine. The product's effectiveness was rated as "Best" based on the quality and value of the evidence. Economy： Duliang soft capsules are moderately priced and categorized as a Type B medical insurance product. Economic research indicated that the combination of Western medicine and Duliang soft capsules was more cost-effective than Western medicine alone. The product's economy was rated as "Better". Innovation： Duliang soft capsules， with Angelicae Dahuricae Radix and Chuanxiong Rhizoma as the main components， hold one invention patent and have been awarded the China Patent Excellence Award. The pharmaceutical company has introduced innovative extraction （CO₂ supercritical extraction technology） and formulation （soft capsule） processes. The product's innovation was rated as "Better". Suitability： A questionnaire survey on Duliang soft capsules showed that it was well-suited for both patients and healthcare professionals. The product received a comprehensive assessment of suitability through the "Evaluation of Chinese Patent Medicine Information Services". The product's suitability was rated as "Best". Accessibility： Duliang soft capsules are moderately priced， making them accessible and affordable. The product's accessibility was rated as "Good" based on evidence from these three aspects. TCM characteristics： The formulation of Duliang soft capsules can be traced back to WANG Qiu's Selected Formulas from the Praiseworthy Studio （Shi Zhai Bai Yi Xuan Fang） from the Song Dynasty， and it was documented in ZHANG Jiebin's The Complete Works of Zhang Jing-yue （Jing Yue Quan Shu） as "Duliangwan". The product has been extensively studied with over 2000 clinical cases since its market launch， and its TCM characteristics were rated as outstanding with sufficient evidence. ConclusionThe comprehensive clinical value evaluation of Duliang soft capsules demonstrated its high effectiveness， suitability， and accessibility， and outstanding TCM characteristics. The product's safety， economy， and innovation received good ratings. In summary， Duliang soft capsules exhibited significant clinical value and outstanding TCM characteristics， the evidence was sufficient， and the result was confirmed， providing crucial references for clinical decision-making and pharmaceutical management.

Objective To introduce the initial application experience of SUTURE (suture-undertent and underside-reposition-enhancement) technique in robotic-assisted radical prostatectomy and discuss its safety and effectiveness.Methods The surgeon has performed 64 cases of Robotic-assisted radical prostatectomy between November 2016 to April 2017.The mean age was (66.6 ± 1.6) years (53-81 years);median PSA was 15.29 ng/ml(1.41-152.53 ng/ml),tumor stage was T1cN0M0-T3bN0M0.The patients were diagnosed by ultrasound-guide prostate biopsy.The number of cores was 6-15,average Gleason score was 7.3 points (6-10 pionts).ECT and MR were used to assess local stage and bone metastasis.The tPSA and urine recovery (urine pad test) was followed-up regularly.SUTURE technique consists of two parts,control the DVC effectively by retain the puboprostatic ligaments and puboprostatic ligaments reconstruction.Result All cases were successfully completed without complication,the average operation time was 95 min (66-150 min);bleeding (106 ± 15) ml(50-300 ml).All the catheters were released 14 days after surgery.Postoperative pathological staging was pT2aN0-pT3bN1,25 cases of capsule invasion,12 cases with seminal vesicle invasion,37 cases with nerve invasion.Average Gleason score was 7.2 points (6-10 points).The median tPSA detected 4 weeks after surgery was 0.047 ng/ml(0.007-12.050 ng/ml).The follow-up time was 1-6 months.The rate of urine control in 1 month and 3 month were 40.8％ (20/49) and 75.8％ (25/33).Conclusions By using SUTURE technique we can control thedorsal vascular complexstrictly,and complete the puboprostatic ligaments reconstruction by stitch it to the anterior vesicourethral.The SUTRUE is a safe and effective systematic DVC controlling technique,and the early urinary control rate is satisfactory.

Endoscopic activity has been used as an endpoint in treatment of Crohn's disease (CD).Simplified Endoscopic Score for Crohn's Disease (SES-CD) is a simple and easy-to-use endoscopic scoring system for CD, however, studies evaluating the correlation between SES-CD and noninvasive inflammatory markers are scarce.Aims: To investigate the correlation between SES-CD and clinical and laboratory inflammatory markers for identifying a noninvasive surrogate marker for endoscopic activity of CD.Methods: Forty-two patients with CD were enrolled for detecting laboratory inflammatory markers including leukocyte and platelet count, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), hemoglobin (Hb), albumin (Alb) and fecal calprotectin (FC);SES-CD and Crohn' disease activity index (CDAI) were assessed.Predictive performance of these markers for endoscopic activity of CD was analyzed by ROC curve, and the correlation of SES-CD with all these markers was evaluated.Results: The platelet count, CRP, ESR, FC and SES-CD were significantly higher in active CD than in inactive CD, while Hb and Alb were significantly lower in active CD (P all <0.05).In all the noninvasive markers, only CDAI and FC had an area under the curve (AUC) greater than 0.9 for predicting CD endoscopic activity.Taken 150 as the cut-off value of CDAI and 50 μg/g (the upper limit of normal, ULN) as the cut-off value of FC, the sensitivity of CDAI and FC were 58.8% and 100%, and the specificity were 100% and 60.0%, respectively.SES-CD had moderate correlation with CDAI, platelet count, CRP, ESR, Alb and FC, respectively (P all <0.05).Conclusions: SES-CD is correlated moderately with the clinical and laboratory inflammatory markers, however, when taken the ULN as cut-off value the conventional inflammatory markers such as CDAI, CRP and ESR are hard to predict sensitively and accurately the endoscopic activity of CD;while FC has fairly high accuracy and sensitivity and can be used as a noninvasive surrogate marker for evaluating endoscopic activity of CD.

Background:Dysregulation of microRNAs is associated with intestinal mucosal barrier injury,intestinal inflammation and intestinal dysfunction. Abnormal expression of microRNAs occurs in patients with inflammatory bowel disease(IBD). Aims:To investigate the expression and significance of microRNA-595( miR-595)in IBD. Methods:A total of 100 patients with IBD at Nanjing General Hospital of Nanjing Military Command of PLA from July 2012 to July 2014 were enrolled,in which 63 cases were ulcerative colitis(UC)and 37 cases were Crohn’s disease(CD). According to disease activity,patients were divided into active UC(aUC)group,remissive UC(rUC)group,active CD(aCD)group and remissive CD(rCD)group. A total of 42 healthy subjects were served as normal control(NC)group. Specimens of serum and intestinal tissue were collected. Expression of miR-595 in serum and intestinal tissue was determined by fluorescence quantitative PCR. Luciferase report gene plasmid containing the 3’UTR of neural cell adhesion molecule 1(NCAM1)or fibroblast growth factor receptor 2(FGFR2)and plasmid containing miR-595 were co-transfected into human colon cancer cell line HCT116 to detect the effect of miR-595 on transcriptional activities of NCAM1 and FGFR2. Results:Expression of miR-595 in serum and intestinal tissue in UC and CD groups was significantly higher than that in NC group(P < 0. 05), and that in aUC and aCD groups was significantly higher than that in rUC and rCD groups,respectively(P < 0. 05). MiR-595 could down-regulate the transcriptional activities of NCAM1 and FGFR2 through directly binding to the 3’UTR of NCAM1 and FGFR2. Conclusions:Expression of miR-595 in serum and intestinal tissue is increased in patients with IBD and correlates with disease activity. MiR-595 inhibits the expressions of tight junction protein NCAM1 and FGFR2,thereby inducing injury of intestinal mucosal barrier and promoting intestinal inflammation. MiR-595 can serve as a serum biomarker for diagnosis of IBD and disease activity evaluation.