1.Ten-year real-world data analysis of clinical characteristics in treatment-naive patients with highly suspected prostate cancer and PSA level ≥20 ng/mL
Baolong PENG ; Mingzhe CHEN ; Junxin WANG ; Ranlu LIU ; Baojie MA ; Shanqi GUO ; Xingkang JIANG
Journal of Modern Urology 2025;30(1):13-21
[Objective] To analyze the clinicopathological characteristics of treatment-naive patients with highly suspected prostate cancer (PCa) with prostate-specific antigen (PSA) level ≥20 ng/mL, to provide reference for promoting early screening of PCa. [Methods] A retrospective analysis was conducted on the clinical data of treatment-naive patients with PSA level ≥20 ng/mL, undergoing prostate biopsy for highly suspected PCa at the Department of Urology, Tianjin Medical University Second Hospital during Jan.2013 and Jun.2023. The correlation between patients' age, body mass index (BMI), PSA, prostate volume (PV), prostate cancer-specific antigen density (PSAD), prostate imaging reporting and data system (PI-RADS) score, and International Society of Urological Pathology (ISUP) grade with highly suspected PCa metastasis and PSA stratification were analyzed. [Results] A total of 1778 suspected patients were enrolled. Pathological findings confirmed PCa in 1465 cases (82.4%), with 487(33.2%) diagnosed as metastatic PCa. Over the past decade, the number of patients undergoing prostate biopsy for highly suspected PCa and being confirmed has been increasing annually, with the proportion of metastatic cases remaining at around 30%. Compared with those with PSA level being 20-50 ng/mL, patients with PSA level >50 ng/mL had older age, lower BMI, higher PSAD, higher PI-RADS, higher ISUP, more diverse pathological types, and a higher incidence of metastasis (P<0.05) with lower proportion of urban residents. Additionally, analysis of metastatic PCa cases showed that 46.8%(228/487) had oligometastasis (≤5 metastatic lesions), including 99.0% bone metastasis, 4.1% extraregional lymph node metastasis, and 4.3% other organ metastasis. [Conclusion] Over the past 10 years, there has been a continuous increase in the number of treatment-naive biopsied cases and newly diagnosed cases of highly suspicious PCa with PSA level ≥20 ng/mL, while the proportion of metastatic cases remains high. Therefore, proactive efforts should be made to promote early screening of high-risk suspected cases.
2.Preliminary application of sacral neuromodulation in patients with benign prostatic hyperplasia complicated with underactive bladder after transurethral resection of the prostate
Ning LIU ; Yan ZHANG ; Tao LI ; Qiang HU ; Kai LU ; Lei ZHANG ; Jianping WU ; Shuqiu CHEN ; Bin XU ; Ming CHEN
Journal of Modern Urology 2025;30(1):39-42
[Objective] To evaluate the efficacy and safety of sacral neuromodulation (SNM) in the treatment of patients with benign prostatic hyperplasia (BPH) complicated with underactive bladder (UAB) who respond poorly to transurethral resection of the prostate (TURP). [Methods] A retrospective analysis was performed on 10 patients with BPH and UAB treated with TURP by the same surgeon in Zhongda Hospital Southeast University during Jan.2018 and Jan.2023.The residual urine volume was not significantly relieved after operation, and the maximum urine flow rate and urine volume per discharge were not significantly improved.All patients underwent phase I SNM, and urinary diaries were recorded before and after surgery to observe the average daily frequency of urination, volume per urination, maximum urine flow rate, and residual urine volume. [Results] The operation time was (97.6±11.2) min.During the postoperative test of 2-4 weeks, if the residual urine volume reduction by more than 50% was deemed as effective, SNM was effective in 6 patients (60.0%). Compared with preoperative results, the daily frequency of urination [(20.2±3.8) times vs. (13.2±3.2) times], volume per urination [(119.2±56.7) mL vs. (246.5±59.2) mL], maximum urine flow rate [(8.7±1.5) mL/s vs. (16.5±2.6) mL/s], and residual urine volume [(222.5±55.0) mL vs. (80.8±16.0) mL] were significantly improved, with statistical significance (P<0.05). There were no complications such as bleeding, infection, fever or pain.The 6 patients who had effective outcomes successfully completed phase II surgery, and the fistula was removed.During the follow-up of 1 year, the curative effect was stable, and there were no complications such as electrode displacement, incision infection, or pain in the irritation sites.The residual urine volume of the other 4 unsuccessful patients did not improve significantly, and the electrodes were removed and the vesicostomy tube was retained. [Conclusion] SNM is safe and effective in the treatment of BPH with UAB patients with poor curative effects after TURP.
3.Mechanism of Modified Danggui Shaoyaosan in Improving Inflammation and Apoptosis in Acne via Regulating JNK/p38 MAPK Pathway
Gongzhen CHEN ; Yuqi YANG ; Xin LIU ; Ting TANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(5):31-40
ObjectiveTo explore the therapeutic effects and mechanisms of modified Danggui Shaoyaosan on acne based on the c-Jun N-terminal kinase (JNK)/p38 mitogen-activated protein kinase (p38 MAPK) pathway. MethodsA rat ear acne model was established in SD rats, and the rats were divided into a blank group, a model group, and low-, medium-, and high-dose groups of modified Danggui Shaoyaosan (7.15, 14.30, 28.60 g·kg·d-1), with six rats in each group. After the administration for 14 consecutive days, morphological changes in the rats' auricles were observed, and hematoxylin-eosin (HE) staining was used to examine the pathological changes in the acne-affected ear tissue. Enzyme-linked immunosorbent assay (ELISA) was employed to measure the levels of interleukin-1β (IL-1β) and tumor necrosis factor-α (TNF-α) in the ear tissue. Quantitative reverse transcription polymerase chain reaction (Real-time PCR) was performed to detect the mRNA expression levels of Caspase-3, B cell lymphoma-2 (Bcl-2), Bcl-2-associated X protein (Bax), JNK, and p38 MAPK in the ear tissue. Additionally, Western blot analysis was conducted to assess the protein levels of Caspase-3, Bcl-2, Bax, JNK, and p38 MAPK in the ear tissue. The active components and key targets of modified Danggui Shaoyaosan in the treatment of acne were identified through network pharmacology analysis. Molecular docking was then employed to evaluate the interactions between the main active components and the key targets. ResultsThe results of the animal experiment demonstrated that compared with those in the blank group, rats in the model group exhibited redness, swelling, thickening, hardening, dryness, and roughness of the auricle. The surface showed sebaceous scales and desquamation, accompanied by acne-like lesions such as papule-like elevations or cysts. Histopathological changes included keratinization, epidermal thickening, dermal collagen fiber degeneration and necrosis, subcutaneous muscle degeneration and necrosis, inflammatory cell infiltration, and fibrous tissue proliferation. The mRNA and protein expression levels of IL-1β, TNF-α, Caspase-3, Bax, JNK, and p38 MAPK were significantly increased (P<0.01), while those of Bcl-2 were significantly decreased (P<0.01). In comparison to the model group, the modified Danggui Shaoyaosan groups showed marked improvement in acne-like lesions of the auricle, with varying degrees of histopathological damage reduction. Additionally, the mRNA and protein expression levels of IL-1β, TNF-α, Caspase-3, Bax, JNK, and p38 MAPK in the tissue were significantly decreased (P<0.05, P<0.01), while those of Bcl-2 were significantly increased (P<0.05, P<0.01). Network pharmacology analysis indicated that the key compounds in modified Danggui Shaoyaosan responsible for its effects in treating acne may include acacetin, kaempferol, luteolin, quercetin, wogonin, and baicalein. These compounds exerted their effects by modulating core targets such as TNF, IL-1β, Caspase-3, and Bcl-2, thereby alleviating inflammation and apoptosis and ultimately improving acne symptoms. ConclusionModified Danggui Shaoyaosan may exert its therapeutic effects on acne by inhibiting the activation of the JNK/p38 MAPK pathway, thereby alleviating inflammation and apoptosis.
4.Effect of Berberine-Baicalin Combination on Fecal Microbiota Transplantation-induced Type 2 Diabetes Mellitus Due to Internal Accumulation of Dampness-heat in Mice from Perspectives of Gut Microbiota and Metabolomics
Mengjie CHEN ; Yimin LIU ; Yun ZHOU ; Keming YU ; Min XIA ; Hongning LIU ; Yanhua JI ; Zhijun ZENG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(5):52-64
ObjectiveTo investigate the mechanisms by which the combination of berberine (BBR) and baicalin (BAI) ameliorates type 2 diabetes mellitus (T2DM) due to internal accumulation of dampness-heat from the perspectives of gut microbiota and metabolomics. MethodsAntibiotics were used to induce pseudo-sterile mice. Thirty pseudo-sterile mice were randomized into a normal fecal microbiota transplantation group (n=10) and a T2DM (syndrome of internal accumulation of dampness-heat) fecal microbiota transplantation group (n=20). The mice were then administrated with suspensions of fecal microbiota from healthy volunteers and a patient with T2DM due to internal accumulation of dampness-heat by gavage, respectively. Each mouse received 200 µL suspension every other day for a total of 15 times to reshape the gut microbiota. The T2DM model mice were then assigned into a model group (n=8) and a BBR-BAI group (n=11). BBR was administrated at a dose of 200 mg·kg-1, and BAI was administrated in a ratio of BBR-BAI 10∶1 based on preliminary research findings. The administration lasted for 8 consecutive weeks. Fasting blood glucose (FBG), glycated hemoglobin (HbA1c), insulin (INS), triglycerides (TG), total cholesterol (CHOL), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) levels were measured to evaluate the effects of the BBR-BAI combination on glucose and lipid metabolism and liver function in T2DM mice. Hematoxylin-eosin staining was employed to observe pathological changes in the colon tissue. The expression of claudin-1, zonula occludens-1 (ZO-1), and occludin in the colon tissue was determined by Western blot. Real-time quantitative polymerase chain reaction(Real-time PCR) was employed to assess the levels of tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), and interleukin-6 (IL-6) in the colon tissue. The fecal microbiota composition and differential metabolites were analyzed by 16S rRNA sequencing and ultra-high performance liquid chromatography-quadrupole-time of flight tandem mass spectrometry (UPLC-Q-TOF-MS), respectively. ResultsThe BBR-BAI combination lowered the FBG, HbA1c, and INS levels (P<0.05, P<0.01) and alleviated insulin resistance (P<0.01) in T2DM mice. Additionally, BBR-BAI elevated the levels of ZO-1, occludin, and claudin-1 (P<0.05, P<0.01) and down-regulated the expression levels of TNF-α, IL-1β, and IL-6 in the colon (P<0.05, P<0.01). The results of 16S rRNA sequencing showed that BBR-BAI increased the relative abundance of Ligilactobacillus, Phascolarctobacterium, and Akkermansia (P<0.05), while significantly decreasing the relative abundance of Alistipes, Odoribacter, and Colidextribacter (P<0.05). UPLC-Q-TOF-MS identified 28 differential metabolites, which were primarily involved in arachidonic acid metabolism and α-linolenic acid metabolism. ConclusionBBR-BAI can ameliorate T2DM due to internal accumulation of dampness-heat by modulating the relative abundance of various bacterial genera in the gut microbiota and the expression of fecal metabolites.
5.Meta-analysis and Grade Evidence Evaluation of Qi-reinforcing and Blood-activating/ Stasis-expelling Chinese Patent Medicines in Treatment of Coronary Microvascular Disease
Jiaping CHEN ; Juju SHANG ; Hongxu LIU ; Xiang LI ; Xiaolei LAI ; Huiwen ZHOU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(5):157-166
ObjectiveTo systematically evaluate the efficacy and safety of Qi-reinforcing and blood-activating/stasis-expelling Chinese patent medicines in the treatment of coronary microvascular disease (CMD). MethodsPubMed, Cochrane Library, CNKI, Wanfang Data, and VIP were searched for the randomized controlled trials (RCTs) on the treatment of CMD with Chinese patent medicines for reinforcing Qi and activating blood/expelling stasis with the time interval from inception to December 31, 2023. The primary outcome indicators included the index of microcirculatory resistance (IMR), coronary flow reserve (CFR), and corrected TIMI flow frame count (cTFC). The secondary outcome indicators included symptomatic efficacy, left ventricular ejection fraction (LVEF), hypersensitive C-reactive protein (hs-CRP), nitric oxide (NO), and adverse events. Cochrane risk-of-bias assessment tool 2.0 (RoB 2.0) and Stata 17.0 were used for literature quality evaluation and meta-analysis of the included RCTs. The Grading of Recommendations, Assessment, Development and Evaluation (GRADE) was used to evaluate the quality of evidence. ResultsA total of 36 RCTs were included in this study, involving 3 029 patients. Compared with conventional Western medicine alone, the combined use of Chinese patent medicines for reinforcing Qi and activating blood/expelling stasis and Western medicine reduced the IMR [mean difference (MD)=-5.93, 95% confidence interval (95%CI) [-8.73,-3.14], n=382, P<0.01], cTFC (MD=-9.35, 95%CI [-13.94,-4.76], n=618, P<0.01), and hs-CRP [standard mean difference (SMD)=-1.50, 95%CI [-1.90,-1.11], n=1 483, P<0.01], improved the CFR (SMD=1.14, 95%CI [0.08,2.19], n=304, P=0.03), symptomatic efficacy [relative risk (RR)=1.36, 95%CI [1.21,1.53], n=756, P<0.01], LVEF (MD=4.39, 95%CI [2.31,6.47], n=533, P<0.01), and NO (SMD=3.16, 95%CI [2.07,4.25], n=946, P<0.01) of CMD patients. In terms of safety, the combined therapy reduced the occurrence of adverse events in CMD patients (RR=0.49, 95%CI [0.29,0.82], n=591, P=0.01). GRADE showed moderate quality evidence for adverse events, low quality evidence for cTFC, symptomatic efficacy, LVEF, and NO, and very low quality evidence for IMR, CFR, and hs-CRP. ConclusionBased on microcirculatory function indicators, the combined use of Qi-reinforcing and blood-activating/stasis-expelling Chinese patent medicines and Western medicine may further improve the coronary microvascular function in CMD patients with good safety. The above conclusions remain to be verified with high-quality clinical trials.
6.Reevaluation of systematic evluation of Xianling gubao capsules for knee osteoarthritis
Dongdong CAO ; Jixin CHEN ; Weijie YU ; Tianci GUO ; Yu ZHANG ; Puyu NIU ; Aifeng LIU
China Pharmacy 2025;36(2):232-238
OBJECTIVE To conduct a reevaluation of the systematic review (SR)/meta-analysis on the use of Xianling gubao capsules (XLGBC) for knee osteoarthritis (KOA), and provide evidence-based support for the clinical use of the drugs. METHODS Computerized searches including CNKI, Wanfang Data, VIP, China Biomedical Literature Database, the Cochrane Library, PubMed, Embase and Web of Science were conducted to collect systematic reviews (SR) or meta-analyses of XLGBC for the treatment of KOA from the inception to May 31st, 2024. The report quality, methodological quality, risk of bias and evidence quality were assessed using the PRISMA 2020 statement, AMSTAR 2 scale, ROBIS tool and GRADE tool, respectively. A comprehensive quality analysis of the quantitative results from the SR/meta-analysis was also performed. RESULTS A total of five SR/meta-analyses were included. The evaluation results based on the PRISMA 2020 statement showed that one study report was relatively complete (21 points), while four studies had deficiencies (18-20 points). The assessment using the AMSTAR 2 scale indicated that the methodological quality of all five studies was rated as very low. According to the ROBIS tool evaluation, the risk of comprehensive bias in all five studies was classified as high. GRADE tool evaluation revealed that among 49 outcome indicators, 5 (10.2%) were rated as moderate-quality evidence (10.2%), 12 as low-quality evidence (24.5%), and 32 as very low-quality evidence (65.3%). The results of comprehensive quality analysis showed that the clinical efficacy, visual analogue scale score, pain relief time, comprehensive indexes of knee joint function, the levels of inflammatory factors and the incidence of adverse events in patients with XLGBC combined with conventional treatment were significantly better than conventional treatment alone (P<0.05). CONCLUSIONS Compared with conventional treatment, XLGBC in combination with conventional treatment for KOA may have some efficacy and safety advantages. However, due to the low quality of evidence for the outcome indicators included in the studies, the conclusions should be interpreted with caution.
7.Study progress of novel biomarkers for early prediction of polymyxin-associated acute kidney injury
Ge YANG ; Jun YANG ; Fang LIU ; Yongchuan CHEN ; Hong ZHANG
China Pharmacy 2025;36(2):251-256
Polymyxin is an essential antibiotic for treating multidrug-resistant Gram-negative bacterial infections; however, its significant nephrotoxicity greatly limits its clinical application. To enhance its safety and improve patient outcomes, the study of novel biomarkers for the early prediction of polymyxin-associated acute kidney injury is critically important. Novel biomarkers, such as cystatin C, kidney injury molecule-1, neutrophil gelatinase-associated lipocalin, N-acetyl-β-glucosaminidase, β2- microglobulin, have shown obvious advantages in the early prediction of polymyxin-associated acute kidney injury. Compared to traditional biomarkers, these biomarkers can provide sensitive and specific diagnostic information in the early stages of kidney injury, helping to optimize individualized treatment plans and reduce clinical risks. However, the high cost of detection and complex operation still limit their clinical promotion. Future research should focus on optimizing the detection technology of new biomarkers, simplifying the operation process and reducing costs, while conducting multi-center, large-scale randomized controlled trials to systematically evaluate the sensitivity and specificity of various novel biomarkers, in order to promote their application in the field of prediction of renal injury in clinical practice.
8.Reevaluation of systematic evluation of Xianling gubao capsules for knee osteoarthritis
Dongdong CAO ; Jixin CHEN ; Weijie YU ; Tianci GUO ; Yu ZHANG ; Puyu NIU ; Aifeng LIU
China Pharmacy 2025;36(2):232-238
OBJECTIVE To conduct a reevaluation of the systematic review (SR)/meta-analysis on the use of Xianling gubao capsules (XLGBC) for knee osteoarthritis (KOA), and provide evidence-based support for the clinical use of the drugs. METHODS Computerized searches including CNKI, Wanfang Data, VIP, China Biomedical Literature Database, the Cochrane Library, PubMed, Embase and Web of Science were conducted to collect systematic reviews (SR) or meta-analyses of XLGBC for the treatment of KOA from the inception to May 31st, 2024. The report quality, methodological quality, risk of bias and evidence quality were assessed using the PRISMA 2020 statement, AMSTAR 2 scale, ROBIS tool and GRADE tool, respectively. A comprehensive quality analysis of the quantitative results from the SR/meta-analysis was also performed. RESULTS A total of five SR/meta-analyses were included. The evaluation results based on the PRISMA 2020 statement showed that one study report was relatively complete (21 points), while four studies had deficiencies (18-20 points). The assessment using the AMSTAR 2 scale indicated that the methodological quality of all five studies was rated as very low. According to the ROBIS tool evaluation, the risk of comprehensive bias in all five studies was classified as high. GRADE tool evaluation revealed that among 49 outcome indicators, 5 (10.2%) were rated as moderate-quality evidence (10.2%), 12 as low-quality evidence (24.5%), and 32 as very low-quality evidence (65.3%). The results of comprehensive quality analysis showed that the clinical efficacy, visual analogue scale score, pain relief time, comprehensive indexes of knee joint function, the levels of inflammatory factors and the incidence of adverse events in patients with XLGBC combined with conventional treatment were significantly better than conventional treatment alone (P<0.05). CONCLUSIONS Compared with conventional treatment, XLGBC in combination with conventional treatment for KOA may have some efficacy and safety advantages. However, due to the low quality of evidence for the outcome indicators included in the studies, the conclusions should be interpreted with caution.
9.Study progress of novel biomarkers for early prediction of polymyxin-associated acute kidney injury
Ge YANG ; Jun YANG ; Fang LIU ; Yongchuan CHEN ; Hong ZHANG
China Pharmacy 2025;36(2):251-256
Polymyxin is an essential antibiotic for treating multidrug-resistant Gram-negative bacterial infections; however, its significant nephrotoxicity greatly limits its clinical application. To enhance its safety and improve patient outcomes, the study of novel biomarkers for the early prediction of polymyxin-associated acute kidney injury is critically important. Novel biomarkers, such as cystatin C, kidney injury molecule-1, neutrophil gelatinase-associated lipocalin, N-acetyl-β-glucosaminidase, β2- microglobulin, have shown obvious advantages in the early prediction of polymyxin-associated acute kidney injury. Compared to traditional biomarkers, these biomarkers can provide sensitive and specific diagnostic information in the early stages of kidney injury, helping to optimize individualized treatment plans and reduce clinical risks. However, the high cost of detection and complex operation still limit their clinical promotion. Future research should focus on optimizing the detection technology of new biomarkers, simplifying the operation process and reducing costs, while conducting multi-center, large-scale randomized controlled trials to systematically evaluate the sensitivity and specificity of various novel biomarkers, in order to promote their application in the field of prediction of renal injury in clinical practice.
10.STAR Guideline Terminology (I): Planning and Launching
Zhewei LI ; Qianling SHI ; Hui LIU ; Xufei LUO ; Zijun WANG ; Jinhui TIAN ; Long GE ; Yaolong CHEN
Medical Journal of Peking Union Medical College Hospital 2025;16(1):216-223
To develop a guideline terminology system and promote its standardization, thereby enhancing medical staff's accurate understanding and correct application of guidelines. A systematic search was conducted for guideline development manuals and method ological literature (as of October 25, 2024). After screening, relevant terms from the guideline planning and launching stages were extracted and standardized. The term list and definitions were finalized through discussion and evaluation at a consensus conference. A total of 36 guideline manuals and 14 method ological articles were included, and 27 core terms were identified. The standardization of guideline terminology is essential for improving guideline quality, facilitating interdisciplinary communication, and enhancing other related aspects. It is recommended that efforts to advance the standardization and continuous updating of the terminology system should be prioritized in the future to support the high-quality development of guidelines.

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