ObjectiveTo evaluate the methodological quality and reporting quality of published guidelines/consensuses on traditional Chinese medicine （TCM）/integrated traditional Chinese and Western medicine diagnosis and treatment of nonalcoholic fatty liver disease （NAFLD）， and to provide a basis for formulating guidelines/consensuses on TCM/integrated traditional Chinese and Western medicine diagnosis and treatment of NAFLD in the future. MethodsDatabases including PubMed， Embase， Web of Science， CNKI， Wanfang Data， and CBM and the websites of China Association of Chinese Medicine and China Association of Integrative Medicine were searched for related articles published up to September 1， 2024. Two clinical researchers independently assessed the methodological quality and reporting quality of the guidelines/consensuses on TCM/integrated traditional Chinese and Western medicine diagnosis and treatment of NAFLD by using Appraisal of Guidelines for Research and Evaluation Ⅱ （AGREE Ⅱ） and Reporting Items for Practice Guidelines in Healthcare （RIGHT）. ResultsA total of nine guidelines/consensuses were included after literature screening， with four guidelines and five expert consensuses. The scores of different domains assessed by AGREE Ⅱ for the nine guidelines/consensuses were as follows： scope and purpose （47.1%）， stakeholder involvement （41.0%）， rigor of development （21.6%）， clarity of presentation （40.2%）， applicability （19.0%）， and editorial independence （19.6%）. The recommendation level of the articles was B level （recommended after revision） for four articles and C level （not recommended） for five articles. The RIGHT assessment showed high reporting rates for “Basic Information” and “Background”， while other areas needed to be improved. Currently， there was no international standard for the guidelines/consensuses on TCM/integrated traditional Chinese and Western medicine diagnosis and treatment of NAFLD， and the quality of these guidelines/consensuses needed to be enhanced to ensure comprehensiveness and credibility. ConclusionThere is still potential for improving the quality of guidelines/consensuses on TCM/integrated traditional Chinese and Western medicine diagnosis and treatment of NAFLD， and AGREE Ⅱ and RIGHT checklists should be strictly followed to ensure the fairness， scientific rigor， and transparency of these guidelines/consensuses.

ObjectiveTo assess the quality of randomized controlled trials （RCTs） of compound traditional Chinese medicine （TCM） prescriptions in the treatment of nonalcoholic steatohepatitis （NASH）， and to provide recommendations for standardizing the design and reporting of RCTs in this field. MethodsDatabases such as PubMed， Web of Science， Embase， the Cochrane Library， CNKI， VIP， and Wanfang Data were searched for RCTs of compound TCM prescriptions in the treatment of NASH published from January 1， 2018 to December 31， 2023， and the articles were screened and assessed based on the Cochrane risk-of-bias assessment tool （RoB 2）， the unified standard for clinical trial reporting （CONSORT 2010）， and CONSORT-CHM Formulas 2017 for compound TCM prescriptions. ResultsA total of 45 articles were finally included， and most of these studies were rated as high-risk bias by RoB 2.0. The analysis based on the CONSORT control checklist showed a relatively low reporting rate for most of the key items regarding the quality of RCT studies. ConclusionA relatively large risk of bias is observed in the clinical studies on compound TCM prescriptions in the treatment of NASH published in the past six years， which may lead to the poor quality of reporting and evidence. It is suggested that the top-level design of clinical studies should be taken seriously in addition to investigating the advantages of TCM， so as to improve the quality of clinical studies.

Objective This study aimed to explore the effect of the combined Danzhi Jiangtang Capsule with dapagliflozin on the blood lipid profile and related inflammatory markers in patients with type 2 diabetes mellitus with peripheral vascular disease. Methods 72 patients with type 2 diabetes mellitus with peripheral vascular disease who met the inclusion criteria were admitted to the Department of Endocrinology,The First Affiliated Hospital of Anhui University of Chinese Medicine,from April 2021 to April 2023. The patients were assigned to the experimental group and the control group using the random number table method (36 cases in each group). The control group was treated with dapagliflozin in addition to standard treatment,while the experimental group received the Danzhi Jiangtang Capsule for 12 weeks. Clinical efficacy,glucose and lipid metabolism indicators,hypersensitive C-reactive protein (hs-CRP),body mass index (BMI) levels,and traditional Chinese medicine (TCM) syndrome scores were observed pre-and post-treatment.Results In post-treatment,the clinical efficacy was higher in the experimental group than in the control group. Significant reductions in fasting blood glucose (FPG),2 h postprandial glucose (2 hPG),triglycerides (TG),total cholesterol (TC),low-density lipoprotein cholesterol (LDL-C),hs-CRP,BMI,and increased high-density lipoprotein cholesterol (HDL-C) were observed. Scores for TCM syndrome and individual items also decreased (P<0.05). Comparisons within the groups for pre-and post-treatment showed reductions in FPG,2 hPG,TG,TC,LDL-C,hs-CRP,and an increase in HDL-C,along with a decrease in total scores of TCM syndrome (P<0.05). Conclusion The Danzhi Jiangtang Capsule combined with dapagliflozin in the treatment of type 2 diabetes mellitus with peripheral vascular disease can regulate the blood lipid profile,reduce inflammatory factors,and improve patient's symptoms. Integrated traditional Chinese and Western medicine treatment are more conducive to controlling the disease,and TCM can be used in clinical practice as a combination treatment.

OBJECTIVE To evaluate the short-term efficacy of single-session microwave ablation for benign thyroid nodule.METHODS Patients with benign thyroid nodules treated by microwave ablation between June 2019 and December 2022 at the Department of Otolaryngology Head and Neck Surgery,the First Affiliated Hospital of Xi'an Jiaotong University,were included for analysis.Thyroid function was tested 1 month after treatment,and ultrasound and thyroid function were performed 3 months,6 months and 1 year after treatment.Volume reduction rates(VRR)of nodules were calculated.Data of the last follow-up within 1 year were included for analysis.Variables including gender,age,whether Hashimoto's thyroiditis was present,longitudinal diameter of nodules,solid volume of nodules were included for univariate and multivariate analysis.RESULTS A total of 151 patients with 163 nodules were included.The perioperative complication rate was 1.99%(3/151).The VRR at half year after treatment was(79.58±17.70)%,and the success rate at half year after treatment was 93.43%(128/137).The VRR of at 1year after treatment was(81.24±24.29)%.The 1-year treatment success rate was 92.77%(77/83).Univariate and multivariate analysis showed that nodular solid volume and age were independent factors affecting VRR after ablation.Regression coefficient of age and solid volume was 0.34(P<0.05)and-0.47(P<0.05),respectively.For every 1 cm3 increase in solid volume,1-year VRR(%)decreased by 0.47.Regression equation:1-year VRR=68.92+0.34×age-0.47×solid volume.Serum FT4 gradually decreased and the thyroid stimulating hormone(TSH)gradually increased within 6 months after ablation,and the differences were statistically significant(P<0.05).After 6 months,serum FT4 gradually recovered to the normal level and TSH gradually recovered.However,TSH still did not reach the preoperative level one year after ablation.FT3 decreased gradually after treatment,but there was no significant difference between the values at each time point(P=0.40).After the ablation of thyroid nodule,the mean value of thyroid function index fluctuated,but all of them were within the normal reference range.CONCLUSION Microwave ablation is a safe and effective treatment method for benign thyroid nodules,with an overall success rate of over 90%.Solid nodule volume and age are independent factors affecting the microwave ablation effect of benign thyroid nodules.

68Ga-DOTATATE/18F-FDG two-day low-dose total-body PET/CT imaging is increasingly employed to facilitate the diagnosis,prognosis,and heterogeneity assessment of neuroendocrine neoplasms.We present a consensus on operational guideline for a two-day combined imaging from experts in low-dose/ultra-low-dose total-body PET/CT from several domestic medical institutions.

Objective:To explore the medication law and core TCM prescriptions of Jia Yuejin in the treatment of coronary heart disease (CHD) complicated with depressive disorder (DD) by analyzing target-based network and mining clinical data.Methods:The targets of CHD complicated with DD were obtained by GeneCards, OMIM, TTD and other databases, and then the protein-protein interaction network of the two disease targets was constructed and then screened out the core targets. The Metascape platform was used to perform GO and KEGG pathway enrichment analysis on the intersection targets respectively to analyze the mechanism of action of CHD complicated with DD. Then TCMSP was used to query the active components acting on the targets and the Chinese materia medica containing these active components, and the data were imported into Cytoscape 3.9.0 to construct the core target-active component-Chinese materia medica network for network topology analysis. The outpatient clinical data of Jia Yuejin from January 1, 2015 to January 1, 2021 were collected, and data mining was conducted by using the Ancient and Modern Medical Case Cloud Platform (V2.3.5) to obtain his commonly used prescriptions. The results were fitted with the core TCM prescriptions obtained by target network analysis, and the drugs in the core prescriptions were analyzed.Results:Totally 1 501 intersection targets were obtained by protein interaction network analysis of CHD complicated with DD, which could be divided into 4 core target clusters, including inflammation cause, subclass tumor cause, subclass lipid metabolism factor, and fibrosis factor; a total of 480 active components were obtained by TCMSP, which belonged to 181 types of Chinese materia medica, including 8 core components: quercetin, kaempferol, luteolin, carotene, beta-carotene, acacetin, formononetin and ellagic acid. GO enrichment analysis yielded 61 results, mainly including positive regulation of protein phosphorylation, signal receptor agonist activity, side of membrane , etc.; KEGG pathway enrichment analysis yielded a total of 20 results, mainly including cancer pathways, lipid and atherosclerosis, JAK-STAT signaling pathway, etc. Clinical data mining included 120 cases and 148 prescriptions, including 135 types of Chinese materia medica; the properties were mainly mild, warm, slightly cold and cold; the tastes were mainly sweet, bitter and light, and the medicine mainly belongs to the lung, spleen, liver, heart, stomach, kidney and other meridians; drug association analysis, cluster analysis and complex network analysis were used to synthesize common prescriptions. The core TCM prescriptions obtained from common prescription and target network analysis were fitted: Pinelliae Rhizoma, Glycyrrhizae Radixet Rhizoma, Bupleuri Radix, Cyperi Rhizoma, Salviea Miltiorrhizae Radix et Rhizoma, Corydalis Rhizoma, Codonopsis Radix, Astragali Radix, Acori Tatarinowii Rhizoma. Conclusion:The medication law of Jia Yuejin in the treatment of CHD complicated with DD is in accordance with core TCM prescriptions. This study can provide guidance for clinical treatment and further research of CHD complicated with DD.

ObjectiveTo observe the clinical efficacy of Danzhi Jiangtang capsules with the functions of replenishing Qi， nourishing Yin， and dredging collaterals on patients with type 2 diabetes mellitus （T2DM） combined with lower-extremity macroangiopathy and serum levels of homocysteine （Hcy） and cystatin C （Cys C）. MethodA total of 80 eligible patients who were treated in the department of endocrinology of the First Affiliated Hospital of Anhui University of Chinese Medicine from May 2017 to December 2019 were randomized into the treatment group （40 cases） and control group （40 cases）. Both groups received the basic therapies for diabetes and Danzhi Jiangtang capsules （oral） was added to the treatment group. The levels of glycosylated hemoglobin A1c （HbA1c）， fasting plasma glucose （FPG）， 2-hour postprandial glucose （2 hPG）， fasting C-peptide （C-P）， and 2-hour postprandial C-peptide （2 hC-P）， triglycerides （TG）， total cholesterol （TC）， high density lipoprotein cholesterol （HDL-C）， and low density lipoprotein cholesterol （LDL-C） and serum levels of Hcy and Cys C were measured and the traditional Chinese medicine（TCM） syndrome scores were calculated before and after treatment in the two groups. ResultAfter 12 weeks of treatment， levels of HbA1c， FPG， and 2 hPG were lower than those before treatment in the two groups （P<0.05）. Levels of C-P （P<0.05） and 2 hC-P were higher than those before treatment in the two groups. After treatment， levels of HbA1c， FPG， and 2 hPG in the treatment group were lower than those in the control group （P<0.05）， while levels of C-P and 2 hC-P showed no significant difference between two groups. After treatment， the levels of TG， TC， and LDL-C were lower than those before treatment （P<0.05） and HDL-C level was higher than that before treatment （P<0.05） in both groups. After treatment， levels of TG and LDL-C in the treatment group were lower than those in the control group （P<0.05）， and levels of TC and HDL-C demonstrated no significant difference between two groups. After the treatment， the TCM syndrome score was lower than that before the treatment in both groups （P<0.05） and lower in the treatment group than in the control group （P<0.05）. The overall effective rate of the treatment group was higher than that of the control group （χ^２=7.585， P<0.05）. The levels of Cys C and Hcy were lower than those before treatment in the two groups （P<0.05） and lower in the treatment group than in the control group （P<0.05）. Doppler echocardiography of the lower limbs showed no obvious improvement in the control group after treatment. However， for the treatment group， slight decrease in intima-media thickness of the lower limb arteries and a slight reduction in the plaque area were observed， but the difference was not statistically significant. ConclusionDanzhi Jiangtang capsules has definite therapeutic effect on T2DM combined with lower-extremity macroangiopathy， which can improve glucolipid metabolism and reduce serum levels of Hcy and Cys C. This study can serve a reference for the prevention and treatment of T2DM combined with macroangiopathy.

Objective:To study the incidence and risk factors of central vein stenosis (CVS) in chronic kidney disease (CKD) patients who received arteriovenous fistula (AVF) creation for the first time, as well as effects of CVS on patency of ipsilateral AVF.Methods:It was a retrospective study. The CKD patients who received AVF creation for the first time in the First Affiliated Hospital of Zhengzhou University from January 2019 to August 2020, with central vein digital subtraction angiography (DSA) results prior to angioplasty were selected as the study subjects. The differences of incidence of CVS in CKD patients with/without a history of cervical catheterization and primary patency rates of AVF between CVS and non-CVS groups were compared. Logistic regression analysis method was applied to analyze the influencing factors of CVS in CKD patients. Kaplan-Meier method was used to analyze the primary patency rate of AVF. Cox regression analysis method was used to analyze the effect of CVS on the primary patency of ipsilateral AVF.Results:A total of 283 CKD patients aged (50.45±14.76) years were enrolled in the study, including 165 males (58.3%). The dialysis age was 0.5 (0, 7.0) months. There were 55 patients (19.4%) diagnosed with CVS before AVF, including 39 patients with stenosis <50% and 16 patients with stenosis ≥50%. The incidence of CVS in patients with history of right internal jugular vein central venous catheter insertion was significantly higher than that in those without this history [60.5% (26/43) vs. 9.9% (15/151), χ2=51.274, P<0.001]. Multivariate logistic regression analysis results showed that hemodialysis catheters indwelling time ≥3 months elevated the risk of CVS ( OR=4.345, 95% CI 1.540-12.263, P=0.006). A subset of 268 patients who had AVF creation ipsilateral to CVS were analyzed to determine the effects of CVS on patency of AVF. The median follow-up time was 34 months. The primary patency rate of AVF in the moderate to severe CVS group was significantly lower than that in the non-CVS group (5/7 vs. 58/228, χ2=7.720, P=0.005). The primary patency rates of AVF in the subclavian vein stenosis group and superior vena cava stenosis group were significantly lower than those in the brachiocephalic vein stenosis group (4/5 vs. 8/27, χ 2=6.974, P=0.008; 6/8 vs. 8/27, χ 2=6.908, P=0.009, respectively). Moderate to severe CVS and combined diabetes were independent influencing factors of primary patency of AVF ( HR=4.362, 95% CI 1.644-11.574, P=0.003; HR=2.682, 95% CI 1.624-4.431, P<0.001, respectively). Conclusions:The incidence of CVS is higher in CKD patients who establish an arteriovenous fistula for the first time. Hemodialysis catheter indwelling time ≥3 months is an independent risk factor of CVS. The moderate to severe CVS is an independent risk factor of primary patency of AVF.

With the boom of China's innovative pharmaceutical industry, licensing-in model has gradually become an important research and development model for innovative pharmaceutical companies. The in-licensed drugs at different stages need different research and development (R&D) strategy in China. The pharmaceutical companies take the responsibility to comprehensively collate the oversea clinical data and conduct a detailed analysis of clinical pharmacology, safety, efficacy and ethnic sensitivity. Clinical R&D strategy should be made based on the results of the above data and analysis. We encourage high-quality drugs which fill unmet clinical needs licensed in, and as early as possible, so as to conduct multi-regional clinical trials (MRCTs). The clinical R&D strategy in China is particularly important for the drug's approval. Guidelines published by the National Medical Products Administration (NMPA) and clinical associations should be followed. Communications about clinical R&D strategy with Center of Drug Evaluation (CDE) are encouraged.
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Antineoplastic Agents/therapeutic use* ; China ; Drug Industry ; Humans ; Lung Neoplasms/drug therapy* ; Pharmaceutical Preparations

Objective:To analyze the predictors of systemic lupus erythematosus (SLE) with intestinal symptoms as the first manifestation, and to provide evidence for the diagnosis and differential diagnosis of the disease.Methods:From January 2013 to June 2020, the clinical data of 165 patients diagnosed with SLE and treated at the First Affiliated Hospital of Zhengzhou University were retrospectively analyzed. According to whether the intestinal symptoms were the first manifestations, they were divided into intestinal symptoms as the first manifestations group ( n=50) and intestinal symptoms not as the first manifestations group ( n=115). The baseline data, imaging findings, orgen involvement and laboratory indicators of the two groups were compared and analyzed. Independent sample t test, non-parametric test and chi-square test were used for statistical analysis. Logistic regression analysis was used to establish a prediction model of SLE with intestinal symptoms as the first manifestation. Receiver operating characteristic curve (ROC) and Hosmer-Lemeshow test were used to evaluate the predictive value of the model. From July 2020 to May 2021, the data of 72 SLE patients treated at the First Affiliated Hospital of Zhengzhou University were collected (22 patients with intestinal symptoms as the first manifestation and 50 patients with intestinal symptoms not the first manifestation), and the predictive power of the model was validated. Results:Compared with intestinal symptoms not as the first manifestation group, the proportions of patients with fever, muscle involvement and joint involvement in intestinal symptoms as the first manifestation group were lower, while the proportions of patients with polyserositis, ascites, edema and dilatation or thickening of intestines, hydronephrosis or dilatation of the ureter, kidney involvement, blood system involvement were higher, and the level of complement C3, level of complement C4, absolute lymphocyte value and albumin level were lower (67.8%, 78/115 vs. 32.0%, 16/50; 24.3%, 28/115 vs. 4.0%, 2/50; 68.7%, 79/115 vs. 14.0%, 7/50; 27.8%, 32/115 vs. 86.0%, 43/50; 16.5%, 19/115 vs. 78.0%, 39/50; 13.9%, 16/115 vs. 86.0%, 43/50; 4.3%, 5/115 vs. 62.0%, 31/50; 29.6%, 34/115 vs. 48.0%, 24/50; 30.4%, 35/115 vs. 52.0%, 26/50; 0.76 g/L, 0.43 to 0.97 g/L vs. 0.48 g/L, 0.40 to 0.57 g/L; 0.14 g/L, 0.08 to 0.23 g/L vs. 0.09 g/L, 0.06 to 0.15 g/L; 0.90×10 9/L, 0.51×10 9 to 1.28×10 9/L vs. 0.64×10 9/L, 0.44×10 9 to 1.08×10 9/L; (34.07±7.30) g/L vs. (28.77±5.43) g/L), and the differences were statistically significant ( χ2=18.246, 9.699, 41.776, 47.567, 57.781, 78.833, 67.903, 5.195 and 6.955, Z=-4.053, -3.295 and -2.204, t=-4.606; all P<0.05). The results of multivariate logistic regression analysis showed that low level of complement C3 and low albumin level were risk factors of SLE with intestinal symptoms as the first manifestation (odds ratio 0.136, 95% confidence interval 0.031 to 0.590; odds ratio 0.923, 95% confidence interval 0.871 to 0.977; P=0.008 and 0.006). The established prediction model for SLE with intestinal symptoms as the first manifestation was p=1/(1+ e - Y), in which Y=2.906-1.994×complement C3 (g/L) -0.08×albumin (g/L). The area under the ROC was 0.761 (95% confidence interval 0.687 to 0.834, P<0.01). The result of Hosmer-Lemeshow test showed the model had good calibration ability ( χ2=13.024, P=0.111). The result of validation analysis showed that when p≥0.255 to predict SLE with intestinal symptoms as the first symptoms, the sensitivity of the model was 72.7% (16/22), the specificity was 76.0% (38/50), and the accuracy was 75.0% (54/72). Conclusions:The symptoms of SLE with intestinal symptoms as the first manifestations are obscure and easily misdiagnosed. When the imaging examination of patients with intestinal symptoms as the first manifestations shows edema and dilatation or thickening of intestines, hydronephrosis or dilatation of the ureter, or laboratory examination indicates low level of complement C3 and low albumin level, be wary of the possibility of SLE. Early diagnosis and intervention can greatly improve the prognosis of patients.