Clinical trials represent a pivotal stage in the development of pharmaceutical drugs. Nevertheless， given the unique characteristics of traditional Chinese medicine （TCM） and the diagnostic and treatment principle of syndrome differentiation and treatment in TCM， the clinical evaluation techniques and methods that can comprehensively reflect the characteristics of TCM and are tailored to its specificities are still in need of refinement and innovation. This paper systematically summarizes the key techniques and methods for designing and evaluating the clinical research on the treatment of the spleen and stomach diseases with TCM from three aspects including clinical research design， evaluation， and platform construction， compares domestic and international research landscapes， and proposes for future directions. It is suggested that a multidimensional evaluation system integrating modern medicine and TCM theory should be established， and further innovation is needed in TCM research design and methodologies， leveraging intelligent devices and technologies powered by next-generation information technology to transform clinical data into high-quality TCM evidence. Moreover， standardized and shared platforms for TCM clinical data should be accelerated， so as to provide references for the design， implementation， and evaluation of future clinical research on the treatment of the spleen and stomach diseases with TCM.

Objective To investigate the incidence and economic burden of healthcare-associated infection(HAI)in patients after liver transplant.Methods Basic clinical information,infection status,and related medical expenses of liver transplant patients in the department of hepatobiliary surgery in a tertiary first-class hospital from November 2012 to December 2023 were investigated retrospectively.A case-control study design was employed,with post-li-ver transplant patients who developed HAI as the infection group and those without HAI during the same period as the control group.The 1∶1 propensity score matching(PSM)method was adopted(caliper value was set at 0.05,employing sampling without replacement).Length of hospital stay and hospitalization expenses between patients in the infection group and the control group were compared using Wilcoxon rank-sum test,and the economic burden due to HAI was calculated.Results A total of 336 liver transplant patients were included in study,out of which 48 had HAI,with an incidence of 14.29％.44 pairs were successfully matched by PSM.After matching,the median hospitalization expense for patients in the infection group was 334 473.73 Yuan,while that of the control group was 285 824.82 Yuan,with a statistically significant difference(Z=-3.430,P＜0.05).The direct economic burden of HAI in liver transplant patients was 48 648.91 Yuan.After matching,the median length of hospital stay in the in-fection group(37.0 days)was 12.5 days longer than that in the control group(24.5 days),with statistically sig-nificnat difference(Z=-3.630,P＜0.001).Conclusion HAI after liver transplant increases patients' hospitaliza-tion expense and prolongs their hospital stay,thus brings huge economic burdens to the patients.

Objective To identify risk factors for pathological upgrading after radical prostatectomy in patients with biopsy-confirmed International Society of Urological Pathology(ISUP)grade 1 prostate cancer and to develop a predictive nomogram.Methods A total of 256 patients with ISUP grade 1 prostate cancer diagnosed by biopsy and undergoing radical prostatectomy in The First Affiliated Hospital of Naval Medical University between Jan.2017 and May 2024 were retrospectively enrolled.Clinical,imaging,and biopsy data were collected.Independent predictors were identified using univariate and multivariate binary logistic regression,and a nomogram model was constructed.Model performance was evaluated using receiver operating characteristic curve,clinical impact curve,and decision curve analysis.The stability of the model was evaluated by Hosmer-Lemeshow test.Results Multivariate binary logistic regression analysis revealed that the number of positive puncture cores(odds ratio[OR]=1.80),prostate imaging and reporting data system(PI-RADS)score(OR=1.88),and prostate specific antigen density(PSAD)stage(OR=1.43)were independent predictors of pathological upgrading(all P＜0.01).The area under curve(AUC)value of the nomogram model based on the above 3 predictors was 0.82(95％confidence interval 0.77-0.87).Decision curve analysis demonstrated favourable clinical utility within a threshold probability range of 0.01-0.99.Clinical impact curve analysis showed that at a threshold probability of 0.40,the model could avoid 45 unnecessary interventions(12％reduction in false-positive rate)with a net clinical benefit of 0.46.The Hosmer-Lemeshow test indicated good model fit(P=0.45).Conclusion The constructed nomogram model can accurately predict the risk of pathological upgrading after radical prostatectomy in patients with ISUP grade 1 prostate cancer,providing a quantitative tool to support individualized decision-making for active surveillance.

AIM To establish the preparation process and quality standard for Zhenggu Pills.METHODS With decoction time,decoction frequency and water addition as influencing factors,comprehensive score for extract yield and transfer rates of epicatechin and naringin as an evaluation index,the decoction process was optimized by orthogonal test.With sugarless paste relative density,medicinal powder fineness,sugarless paste-corn starch ratio,drying temperature and drying time as influencing factors,soft material traits,pill formability,moisture and disintegration time limit as evaluation indices,the formability process was optimized by single factor test.TLC was adopted in the qualitative identification of Dipsaci Radix,salt-processed Psoraleae Fructus,cooked Rhei Radix et Rhizoma and Notoginseng Radix et Rhizoma.HPLC was used for the content determination of paeoniflorin and naringin.RESULTS The optimal decoction process was determined to be 0.5 h for decoction time,two times for decoction frequency,and 10 times for water addition,the comprehensive score was 0.93.The optimal formability process was determined to be 1.21-1.22 for sugarless paste relative density,80 mesh for medicinal powder fineness,1∶0.17-1∶0.18 for sugarless paste-corn starch ratio,70 ℃ for drying temperature,and 24 h for drying time,good soft material traits and pill formability were observable,and moisture and disintegration time limit accored with 2020 edition of Chinese Pharmacopoeia requirements.The TLC spots were clear without negative interference.Two constituents showed good linear relationships within 61.30-490.41 μg/mL(r=0.999 8)and 3.27-26.18 μg/mL(r=0.999 8),whose average recoveries were 100.15％and 98.15％with the RSDs of 0.55％and 2.30％,respectively.CONCLUSION This stable,reliable and specific method can be used for the production and quality evaluation of Zhenggu Pills.

AIM To establish the quantitative models for gallic acid,mononucleoside,loganin,resveratrol,and rhein in Yishen Xiezhuo Mixture.METHODS HPLC was adopted in the content determination of various effective components,after which the near-infrared spectroscopy(NIRS)data were collected in 128 batches of samples and pretreatment was conducted,competitive adaptive reweighting sampling(CARS)algorithm was used for screening wavelength,partial least square method(PLS)regression analysis was performed.RESULTS There were no significant differences between the predicted values obtained by PLS models and measured values obtained by HPLC for various effective components(P＞0.05).CONCLUSION The quantitative models established by NIRS combined with chemometrics display good predictive performance,which can be used for the rapid determination of effective components in Yishen Xiezhuo Mixture,and provide a reference for the rapid monitoring of other traditional Chinese medicine preparations in production processes.

Objective To evaluate the efficacy and safety of enteric-coated metformin hydrochloride capsules(Junlida?)in patients with T2DM and poor glycemic control under lifestyle interventions.Methods In this study,419 patients with T2DM were recruited from 15 research centers from July 2020 to March 2022,and randomly divided into observation(Obs)group(n=209)and control group(Con,n=210)using a multicenter,randomized,double-blind,non-inferiority trial design.Patients in the Obs group were treated with enteric-coated Metformin hydrochloride capsules(Junlida?),and patients in the Con group were treated with Metformin hydrochloride tablets(Glucophage?).The optimal effective dose of 2 g/d was achieved within 4 weeks,and the reasonable dose was maintained until the end of treatment.The treatment period was 24 weeks.HbA1c and its compliance rate,FPG,and body weight were compared between the two groups in full analysis set(FAS)and protocol set(PPS).Safety and adverse events(AE)were evaluated in safety set(SS).Results A total of 414 participants were randomized(207 cases in Obs group and 207 cases in Con group).414 cases in FAS population(207 cases in Obs group and 207 cases in Con group),and 328 cases in PPS population(164 cases in Obs group and 164 cases in Con group),and 414 cases in SS population(207 cases in Obs group and 207 cases in Con group).After treatment,HbA1c,FPG and body weight were lower in both groups(P<0.05)in FAS and PPS.HbA1c compliance rate was not significantly different between the two groups in FAS and PPS(P>0.05).The results of non-inferiority test showed that the lower limit was>-0.4%in both FAS(-0.154,95%CI-0.384～0.069)and PPS(-0.139,95%CI-0.390～0.112),and the Obs group reached non-inferiority end point.The achievement rate,compliance rate,safety index and incidence of AE were not significantly different between the two groups(P>0.05).Conclusions Junlida? demonstrated non-inferiority to Glucophage? in glycemic control and can be safely and effectively used in patients with diabetes.

Objective To study the three-dimensional changes of soft and hard tissue in male patients with unilateral non-syndromic cleft lip and palate in the mixed dentition period before and after maxillary protraction.Methods Twenty male patients with unilateral non-syndromic cleft lip and palate in the mixed dentition period treated by maxillary anterior traction in the Department of Orthodontics of Affiliated Stomatological Hospital of Nanjing Medical University were selected(average age(10.6±1.23)years old).Cone beam CT was taken before and after treatment.Dolphin 3D 11.95 software was used for three-dimensional measurement and analysis.SPSS 25.0 software package was used for statistical analysis.The self-controlled paired t test was used to compare the changes in soft and hard tis-sues of male patients with unilateral cleft lip and palate before and after treatment.The changes in the anterior displacement of the ANS point,the anterior displacement of point A,and the posterior displacement of point B were tested using the one-sample t test.Results The sagittal skeletal changes were significantly increased in ∠ SNA(P＜0.01),∠ANB(P＜0.01),Y axis(P＜0.05),the forward displacement of ANS point(P＜0.01)and A point(P＜0.01)and the backward displacement of B point(P＜0.01),but ∠SNB(P＜0.05)was decreased significantly.The vertical skeletal changes showed that ∠MP-FH(P＜0.01),∠MP-SN(P＜0.05)and the dis-tance of ANS-Me(P＜0.05)were increased significantly,but ∠SN-PP(P＜0.01)was decreased significantly.The dental changes inclu-ding ∠U1-NA(P＜0.01),the distance of U1-NA(P＜0.01),∠U1-SN(P＜0.01),overjet and the Wits were increased significantly,but ∠ L1-NB(P＜0.01),the distance of L1-NB(P＜0.01)and ∠L1-MP(P＜0.01)were decreased significantly.The changes of soft tis-sue including ∠ S-Ns-Sn(P＜0.01),∠ Sn-Ns-Bs(P＜0.01),the distance of UL-EP(P＜0.01)and LL-UL(P＜0.01)were increased sig-nificantly.Conclusion After the treatment of maxillary protraction,the forward growth of maxilla will be possibly promoted on patients with cleft lip and palate in the peak of growth timing,as well as the intermaxillary relationship and soft tissue profile,but the side effects should be paid attention to.

Objective To construct a quality evaluation index system for non-medical technical services in public hospitals,aiming to provide a more scientific and feasible basis for evaluating patient service quality.Methods Based on literature research,the SERVQUAL theory was used to preliminarily formulate a comprehensive and full-cycle evaluation index for patient service quality.The final evaluation index system was determined through expert consultation,and the Analytic Hierarchy Process was used to determine the weights of the evaluation indices.Results The questionnaire response rates for the two rounds of expert consultation were both 100％.The authority coefficients of the experts were 0.82 and 0.80,respectively,indicating a high level of expert authority.The Kendall's W coefficient increased from 0.088 to 0.107 between the two rounds,and the difference was statistically significant (P<0.001),indicating good consistency of expert opinions.The consistency results of each judgment matrix were less than 0.1,passing the consistency test.The final evaluation index system consisted of six primary indicators (tangibility,reliability,responsiveness,assurance,empathy,and continuity) and 33 secondary indicators.Conclusion The selection of evaluation indicators revolves around the core service processes of outpatient,inpatient,and other hospital services,focusing on key elements at various critical junctures that influence patient experience.The evaluation indicators aim to guide hospitals to improve not only essential needs but also desired improvements in service quality,thus promoting the continuous enhancement of hospital services.

The incidental detection rate of pancreatic cystic neoplasms continues to rise annually. While precise imaging diagnosis is critical for patient treatment and prognosis, significant challenges persist in current practice. Extensive overlaps in imaging features among different tumor types, coupled with phenomena of "different imaging manifestations for the same disease" and "similar imaging presentations across different diseases," create substantial difficulties in achieving accurate diagnosis. By elucidating the advantages and limitations of various clinically employed imaging modalities for diagnosing pancreatic cystic neoplasms, along with practical challenges encountered in clinical settings, this article explores how to achieve precise differential diagnosis of pancreatic cystic neoplasms based on distinct imaging characteristics, aiming to facilitate individualized precision treatment for patients.

Objective To construct a quality evaluation index system for non-medical technical services in public hospitals,aiming to provide a more scientific and feasible basis for evaluating patient service quality.Methods Based on literature research,the SERVQUAL theory was used to preliminarily formulate a comprehensive and full-cycle evaluation index for patient service quality.The final evaluation index system was determined through expert consultation,and the Analytic Hierarchy Process was used to determine the weights of the evaluation indices.Results The questionnaire response rates for the two rounds of expert consultation were both 100％.The authority coefficients of the experts were 0.82 and 0.80,respectively,indicating a high level of expert authority.The Kendall's W coefficient increased from 0.088 to 0.107 between the two rounds,and the difference was statistically significant (P<0.001),indicating good consistency of expert opinions.The consistency results of each judgment matrix were less than 0.1,passing the consistency test.The final evaluation index system consisted of six primary indicators (tangibility,reliability,responsiveness,assurance,empathy,and continuity) and 33 secondary indicators.Conclusion The selection of evaluation indicators revolves around the core service processes of outpatient,inpatient,and other hospital services,focusing on key elements at various critical junctures that influence patient experience.The evaluation indicators aim to guide hospitals to improve not only essential needs but also desired improvements in service quality,thus promoting the continuous enhancement of hospital services.