1.Mechanisms of Gegen Qinlian Tang-containing Serum in Improving 5-FU Sensitivity by Inhibiting Glycolysis in Colorectal Cancer Cells Based on CDK16/MYC Pathway
Rong CAI ; Shang WANG ; Fuqing CHENG ; Yanping ZHOU ; Zuowei HU ; Yunhai LI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):1-9
ObjectiveTo explore the molecular mechanisms by which serum containing Gegen Qinlian Tang (GQT) inhibits glycolysis and enhances chemotherapy sensitivity in 5-fluorouracil (5-FU)-resistant colorectal cancer (CRC) cells based on the cyclin-dependent kinase 16 (CDK16)/MYC proto-oncogene (MYC) pathway. MethodsHCT-116/5-FU cells were treated with different concentrations (5%, 10%, 20%, 30%) of GQT-containing serum. Cell viability and 5-FU sensitivity were assessed using the cell counting kit-8 (CCK-8) assay, and the experimental concentrations of 5-FU and GQT for subsequent experiments were determined. Cell proliferation and apoptosis under individual 5-FU, GQT, and combined 5-FU + GQT treatments were evaluated using 5-ethynyl-2′-deoxyuridine (EDU) staining and annexin V-FITC/PI double staining, respectively. Glucose consumption, adenosine triphosphate (ATP) production, and lactate levels were measured by colorimetric assays. Expression levels of glycolysis-related proteins, CDK16, MYC, and phosphorylated MYC were detected by Western blot. Co-immunoprecipitation (CoIP) was used to examine the protein interaction between CDK16 and MYC, and cycloheximide (CHX) treatment was applied to assess the effect of CDK16 overexpression on MYC protein stability. ResultsCCK-8 assays showed that 2.5 mg·L-1 5-FU significantly inhibited HCT-116 cell viability in a dose-dependent manner. In HCT-116/5-FU cells, significant inhibition was observed only at 5 mg·L-1 5-FU (P<0.05), which was used for model establishment. Compared with 5-FU alone, addition of 5% GQT-containing serum significantly suppressed HCT-116/5-FU cell viability (P<0.05), with stronger inhibition at higher serum concentrations. Thus, 5% GQT-containing serum was used in subsequent experiments. Compared with the control group, 5-FU, GQT, and 5-FU + GQT treatments all significantly reduced cell proliferation (P<0.05) and increased apoptosis (P<0.01). The 5-FU + GQT combination showed superior inhibition of proliferation compared with 5-FU or GQT alone (P<0.01), accompanied by more pronounced reductions in glucose consumption, ATP production, and lactate generation (P<0.01). Additionally, compared with control, 5-FU, and GQT groups, the 5-FU + GQT group exhibited stronger suppression of MYC and its phosphorylated forms (P<0.01) and greater inhibition of glycolytic enzymes, including hexokinase 2 (HK2), 3-phosphoinositide-dependent protein kinase 1 (PDK1), lactate dehydrogenase A (LDHA), and pyruvate kinase M2 (PKM2) (P<0.01). CDK16, MYC, and MYC phosphorylation expression levels were significantly downregulated in the 5-FU + GQT group compared with the 5-FU group (all P<0.01). MYC protein stability decreased in a time-dependent manner in the 5-FU + GQT group (P<0.05), which was rescued by CDK16 overexpression (P<0.05). ConclusionGQT significantly enhances the sensitivity of HCT-116/5-FU cells to 5-FU, potentially by inhibiting CDK16 and thereby reducing MYC-mediated glycolysis.
2.Mechanisms of Gegen Qinlian Tang-containing Serum in Improving 5-FU Sensitivity by Inhibiting Glycolysis in Colorectal Cancer Cells Based on CDK16/MYC Pathway
Rong CAI ; Shang WANG ; Fuqing CHENG ; Yanping ZHOU ; Zuowei HU ; Yunhai LI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):1-9
ObjectiveTo explore the molecular mechanisms by which serum containing Gegen Qinlian Tang (GQT) inhibits glycolysis and enhances chemotherapy sensitivity in 5-fluorouracil (5-FU)-resistant colorectal cancer (CRC) cells based on the cyclin-dependent kinase 16 (CDK16)/MYC proto-oncogene (MYC) pathway. MethodsHCT-116/5-FU cells were treated with different concentrations (5%, 10%, 20%, 30%) of GQT-containing serum. Cell viability and 5-FU sensitivity were assessed using the cell counting kit-8 (CCK-8) assay, and the experimental concentrations of 5-FU and GQT for subsequent experiments were determined. Cell proliferation and apoptosis under individual 5-FU, GQT, and combined 5-FU + GQT treatments were evaluated using 5-ethynyl-2′-deoxyuridine (EDU) staining and annexin V-FITC/PI double staining, respectively. Glucose consumption, adenosine triphosphate (ATP) production, and lactate levels were measured by colorimetric assays. Expression levels of glycolysis-related proteins, CDK16, MYC, and phosphorylated MYC were detected by Western blot. Co-immunoprecipitation (CoIP) was used to examine the protein interaction between CDK16 and MYC, and cycloheximide (CHX) treatment was applied to assess the effect of CDK16 overexpression on MYC protein stability. ResultsCCK-8 assays showed that 2.5 mg·L-1 5-FU significantly inhibited HCT-116 cell viability in a dose-dependent manner. In HCT-116/5-FU cells, significant inhibition was observed only at 5 mg·L-1 5-FU (P<0.05), which was used for model establishment. Compared with 5-FU alone, addition of 5% GQT-containing serum significantly suppressed HCT-116/5-FU cell viability (P<0.05), with stronger inhibition at higher serum concentrations. Thus, 5% GQT-containing serum was used in subsequent experiments. Compared with the control group, 5-FU, GQT, and 5-FU + GQT treatments all significantly reduced cell proliferation (P<0.05) and increased apoptosis (P<0.01). The 5-FU + GQT combination showed superior inhibition of proliferation compared with 5-FU or GQT alone (P<0.01), accompanied by more pronounced reductions in glucose consumption, ATP production, and lactate generation (P<0.01). Additionally, compared with control, 5-FU, and GQT groups, the 5-FU + GQT group exhibited stronger suppression of MYC and its phosphorylated forms (P<0.01) and greater inhibition of glycolytic enzymes, including hexokinase 2 (HK2), 3-phosphoinositide-dependent protein kinase 1 (PDK1), lactate dehydrogenase A (LDHA), and pyruvate kinase M2 (PKM2) (P<0.01). CDK16, MYC, and MYC phosphorylation expression levels were significantly downregulated in the 5-FU + GQT group compared with the 5-FU group (all P<0.01). MYC protein stability decreased in a time-dependent manner in the 5-FU + GQT group (P<0.05), which was rescued by CDK16 overexpression (P<0.05). ConclusionGQT significantly enhances the sensitivity of HCT-116/5-FU cells to 5-FU, potentially by inhibiting CDK16 and thereby reducing MYC-mediated glycolysis.
3.Cardiomyocyte pyroptosis inhibited by dental pulp-derived mesenchymal stem cells via the miR-19a-3p/IRF-8/MAPK pathway in ischemia-reperfusion.
Yi LI ; Xiang WANG ; Sixian WENG ; Chenxi XIA ; Xuyang MENG ; Chenguang YANG ; Ying GUO ; Zuowei PEI ; Haiyang GAO ; Fang WANG
Chinese Medical Journal 2025;138(18):2336-2346
BACKGROUND:
The protective effect of mesenchymal stem cells (MSCs) on cardiac ischemia-reperfusion (I/R) injury has been widely reported. Dental pulp-derived mesenchymal stem cells (DP-MSCs) have therapeutic effects on various diseases, including diabetes and cirrhosis. This study aimed to determine the therapeutic effects of DP-MSCs on I/R injury and elucidate the underlying mechanism.
METHODS:
Myocardial I/R injury model mice were treated with DP-MSCs or a miR-19a-3p mimic. The infarct volume, fibrotic area, pyroptosis, inflammation level, and cardiac function were measured. Cardiomyocytes exposed to hypoxia-reoxygenation were transfected with the miR-19a-3p mimic, miR-19a-3p inhibitor, or negative control. Pyroptosis and protein expression in the interferon regulatory factor 8/mitogen-activated protein kinase (IRF-8/MAPK) pathway were measured.
RESULTS:
DP-MSCs protected cardiac function in cardiac I/R-injured mice and inhibited cardiomyocyte pyroptosis. The upregulation of miR-19a-3p protected cardiac function, inhibited cardiomyocyte pyroptosis, and inhibited IRF-8/MAPK signaling in cardiac I/R-injured mice. DP-MSCs inhibited cardiomyocyte pyroptosis and the IRF-8/MAPK signaling by upregulating the miR-19a-3p levels in cardiomyocytes injured by I/R.
CONCLUSION
DP-MSCs protected cardiac function by inhibiting cardiomyocyte pyroptosis through miR-19a-3p under I/R conditions.
Animals
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MicroRNAs/metabolism*
;
Pyroptosis/genetics*
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Mesenchymal Stem Cells/metabolism*
;
Myocytes, Cardiac/cytology*
;
Mice
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Male
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Mice, Inbred C57BL
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Dental Pulp/cytology*
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Myocardial Reperfusion Injury/therapy*
;
MAP Kinase Signaling System/physiology*
4.Construction of nursing quality evaluation index system of psychiatric closed wards in Sichuan Province
Chunlan BAI ; Zuowei LI ; Qiaoling LIAO ; Huan WANG ; Yali WANG
Sichuan Mental Health 2025;38(2):138-144
BackgroundIn Sichuan Province, most healthcare institutions providing mental health services have adopted self-developed evaluation indicators for the quality of nursing care in psychiatric closed wards, lacking unified standards. This results in insufficient authority and homogeneity, which is unfavorable for the standardized assessment and continuous improvement of nursing quality. ObjectiveTo construct a standardized evaluation indicator system for nursing quality of psychiatric closed wards in Sichuan Province, so as to provide references for nursing quality management and assessment. MethodsBased on bio-psycho-social medical model and guided by "Structure-Process-Outcome" quality evaluation framework, preliminary evaluation indicators for nursing quality in psychiatric closed wards were developed through literature analysis, research team discussions and clinical experience. Through two rounds of Delphi expert consultation, the indicators were revised and finalized. ResultsThe response rates for two rounds of Delphi expert consultation questionnaire were 100%. The expert authority coefficients were 0.845 and 0.864, respectively, and the Kendall's coordination coefficients ranged from 0.119 to 0.210 (P<0.01). Ultimately, a nursing quality evaluation index system for psychiatric closed wards was established, comprising 3 first-level indicators, 9 second-level indicators and 46 third-level indicators. ConclusionThe nursing quality evaluation indicators for psychiatric closed wards constructed based on the Delphi method can provide references for nursing quality management and evaluation in such wards. [Funded by Research Project Fund of Sichuan Nursing Society (number, H20004); Sichuan Hospital Association Hospital Management Research Special Fund (number, YG2323)]
5.Clinical effect of non-transecting anastomotic lingual mucosal augmentation urethroplasty in the treatment of traumatic urethral stricture
Wenxiong SONG ; Jiemin SI ; Xuxiao YE ; Zuowei LI ; Jianwen HUANG ; Yinglong SA ; Yuemin XU
Chinese Journal of Urology 2025;46(2):119-124
Objective:To investigate the clinical effect of lingual mucosal augmentation urethroplasty with non-transecting urethral cavernous anastomosis in the treatment of traumatic urethral stricture.Methods:The clinical data of 39 patients with traumatic urethral stricture admitted to our clinical center from March 2023 to December 2023 were retrospectively analyzed. Their mean age was (49.7±2.0)years. The cause of urethral injury was pelvic fracture in 32 cases, riding injury in 5 cases, and iatrogenic injury in 2 cases. Suprapubic vesicostomy tube was indwelled before operation in 39 cases. There was 1 case with hypospadias and 1 case with urethral false passage. 9 patients had urethral dilatation before surgery, 5 had internal urethrotomy operation, 5 had urethroplasty, and 22 had no history of urethral surgery. The International Erectile Function Index (IIEF-5)score of 39 cases last 1 month before surgery was collected and classified.In which, the IIEF-5 score of 19 cases with no or mild erectile dysfunction was median 20 (18, 23)points, the MSHQ-Ejd score was median 16 (11, 19)points, and the number of effective erections was median 4(3, 5)times on the NPT. And in which, the IIEF-5 score of 20 cases with moderate to severe erectile dysfunction was median 10 (3, 14)points, the MSHQ-Ejd score was median 3(1, 7)points, and the number of effective erections was median 1(0, 2)times on the NPT. All 39 cases underwent non-transecting anastomotic lingual mucosal augmentation urethroplasty. The central tendon of the perineum and the ventral side of the bulbar urethra were preserved through perineal approach. The dorsal side of the urethra was mobilized and through the dorsal side of the urethra, the scar of the urethra was enucleated along the mucosa of the urethra. Then the ventral mucosa of the urethra was anastomosed end to end and the dorsal urethra was repaired by lingual mucosa transplantation. The Clavien-Dindo complication grading system was performed. The catheter was removed 4 weeks after operation, and urine flow rate was recorded 1 month after extubation. IIEF-5 score, MSHQ-Ejd score and NPT were recorded 6 months after operation.Results:The mean operation time of 39 cases was (118.0±18.3)min. 39 cases were followed up for median 8.0(6.0, 10.0)months. The Q max ≥15 ml/s in 24 cases. The Q max <15ml/s in 13 cases, of which, the Q max ≥15 ml/s after 1 internal urethrotomy operation in 10 cases and Q max≥15 ml/s after 2 internal urethrotomy operations in 3 cases. 2 cases were still failed to urinate and Q max≥15 ml/s after end-to-end urethral anastomosis. All 39 cases’ Clavien-Dindo complications were graded Ⅰ.Of the 19 cases with no or mild erectile dysfunction, the IIEF-5 score was median 20(17, 23)points, the MSHQ-Ejd score was median 16(11, 19)points, and the number of effective erections was median 4(3, 4)times on the NPT postoperatively, all were not significantly different from those before operation ( P> 0.05). Of the 20 cases with moderate and severe erectile dysfunction, the IIEF-5 score was median 9(4, 13)points, the MSHQ-Ejd score was median 4(2, 7)points, and the number of effective erections was median 1(0, 2)times on the NPT postoperatively, and all were not significantly different from those before operation ( P>0.05). Conclusions:Non-transecting anastomotic lingual mucosal augmentation urethroplasty is a reliable surgical method with few complications for traumatic urethral stricture. Moreover, the operation has little effect on the sexual function of patients.
6.Management strategies for vesicovaginal fistula following cervical cancer radiotherapy in women
Jiemin SI ; Weidong ZHU ; Ranxing YANG ; Lujie SONG ; Chongrui JIN ; Jianwen HUANG ; Xuxiao YE ; Zuowei LI ; Wenxiong SONG ; Qiang FU ; Yinglong SA
Chinese Journal of Urology 2025;46(8):587-592
Objective:To investigate the treatment strategies for vesicovaginal fistula(VVF)in women following cervical cancer radiotherapy.Methods:A retrospective analysis was performed on the clinical data of 33 female patients with post-radiotherapy VVF after cervical cancer treatment at Shanghai Sixth People’s Hospital between January 2020 and June 2024. The patients were categorized into three groups based on surgical approaches:Group A(11 patients):Underwent prone-position VVF repair. Mean age:(50.0±9.6)years;mean radiotherapy sessions:(22.6±2.2). All had simple VVF without concurrent intestinal or surrounding soft-tissue fistulas. Among them,1 patient previously received laparoscopic VVF repair,1 transvaginal VVF repair,and 2 gracilis muscle flap packing for VVF repair. One month prior to surgery,the average daily usage of urine pads was 16.7(12.8,25.7)pieces,and the quality of life(QOL)score stood at 4.0(4.0,5.0)points. Preoperative cystoscopy revealed that 8 cases had fistulas located in the trigonal region of the bladder,while 3 cases had fistulas on the posterior bladder wall. The diameter of the fistula openings,measured under a microscope,was 1.2(0.8,1.6)cm. Based on the Goh classification criteria for vesicovaginal fistulas,this group included 3 cases of type 1,4 cases of type 2,2 cases of type 3,and 2 cases of type 4;7 cases of type A and 4 cases of type B;as well as 3 cases of typeⅠ,7 cases of type Ⅱ,and 1 case of type Ⅲ.Group B(20 patients):Underwent gracilis muscle flap packing for VVF repair. Mean age:(58.6±8.8)years;mean radiotherapy sessions:(29.8±3.9). Three patients had concurrent rectovaginal fistulas and received colostomy for fecal diversion. History of previous interventions:3 had laparoscopic VVF repair,4 transvaginal VVF repair,and 1 both transvaginal and laparoscopic VVF repair. One month prior to surgery,the average daily usage of urine pads was 19.7(15.8,27.7)pieces,and the QOL score stood at 5.0(5.0,6.0)points. Preoperative cystoscopy revealed that 13 cases had fistulas located in the trigonal region of the bladder,while 7 cases had fistulas on the posterior bladder wall. The diameter of the fistula openings,measured under a microscope,was 1.8(1.0,3.2)cm. Based on the Goh classification criteria for vesicovaginal fistulas,this group included 4 cases of type 1,9 cases of type 2,3 cases of type 3,and 4 cases of type 4;6 cases of type A,11 cases of type B and 3 cases of type C;as well as 1 cases of type Ⅱ,and 19 case of type Ⅲ. Group C(2 patients):Underwent ureterocutaneous diversion. Ages:67 and 73 years;radiotherapy sessions:51 and 60,respectively. Both had concurrent rectovaginal fistulas and bladder soft-tissue fistulas. The patient presented with recurrent thigh abscesses accompanied by fever. One month prior to surgery,the daily usage of urine pads was 29 and 23 pieces,respectively,and the QOL score was 6 points. Cystoscopic examination revealed that the vesicovaginal fistulas were located in the trigone of the bladder,with diameters of 3 cm and 4 cm,respectively. Additionally,partial defects were noted in the ventral wall of the urethra,while no bladder soft tissue fistulas were detected. According to the Goh classification for vesicovaginal fistulas,both cases were categorized as type 4,type C,and type Ⅲ. For Groups A and B,urinary catheters were indwelled for 3 weeks postoperatively,then removed to assess spontaneous urination and incontinence. QOL was evaluated,with a minimum 6-month follow-up. For confirmed postoperative VVF recurrence,re-repair was performed 3?6 months later based on patient preference. For Group C,double-J stents were placed in the ureters,and stoma bags were applied 3 days postoperatively. Stents were replaced every 1?2 months,with QOL assessment. Successful fistula repair in Groups A and B was defined as the absence of vaginal leakage confirmed by cystoscopy after six months of the procedure with no vaginal leakage. For Group C,surgical success was determined by the resolution of perineal urinary leakage and improvement in QOL.Results:All 33 patients completed surgery successfully. Group A:Follow-up duration:16.3(9.6,24.6)months. Surgical repair succeeded in 7 patients,with unobstructed spontaneous urination and no vaginal incontinence. Four patients had VVF recurrence:2 refused further treatment,and 2 underwent repeat gracilis muscle flap packing. One was successfully repaired,while one recurrence case refused further treatment. Group B:Follow-up duration:17.0(9.5,24.8)months(8?32 months). Thirteen patients restored spontaneous urination without recurrence. Seven had recurrence:5 refused further surgery,and 2 underwent re-repair. One repair succeeded without incontinence,while one recurrence case refused treatment. Group C:Follow-up durations were 6 and 22 months. Perineum remained dry without incontinence(no urine pads needed),and no recurrence of thigh soft-tissue redness/infection occurred. QOL scores were 2 and 3,respectively.Conclusions:Post-radiotherapy VVF in women after cervical cancer presents complex and variable conditions. The primary goal of treatment should be to improve patients’ quality of life. Treatment approaches should be selected based on the complexity of urinary fistulas and local tissue conditions. In general,patients who are younger,have received lower doses of radiation therapy,present with smaller fistula diameters,have well-vascularized and elastic perifistular tissues,and have no concurrent tissue fistulas are candidates for prone-position VVF repair. Patients who do not meet the criteria for transvaginal repair,have a history of at least two previous repair attempts,or have concurrent vaginorectal fistulas require gracilis muscle flap packing for VVF repair. Patients with three or more types of concurrent tissue fistulas,extensive pale and inelastic perifistular tissues,and who are not amenable to repair surgery undergo ureterocutaneous diversion.
7.Correlation between cerebral blood flow measured by 3D pseudo-continuous arterial spin labeling and gait disorder in patients with cerebral small vessel disease
Xiyu PENG ; Haiyan LIU ; Cuicui ZHANG ; Zuowei DUAN ; Shuya LI
International Journal of Cerebrovascular Diseases 2025;33(2):101-107
Objective:To investigate the correlation between cerebral blood flow (CBF) in different brain regions and gait disorder (GD) in patients with cerebral small vessel disease (CSVD).Methods:Patients with CSVD visited the Department of Neurology, the Second Affiliated Hospital of Xuzhou Medical University from November 2023 to October 2024 were included prospectively. They were divided into GD group (<0.8 m/s) and non-GD group (≥0.8 m/s) based on their step speed. CBF was measured using 3D pseudo-continuous arterial spin labeling (3D-pCASL) perfusion imaging. Gait parameters were quantitatively evaluated using a wearable gait analyzer. Multivariate logistic regression analysis was used to determine independent factors associated with GD in patients with CSVD. Partial correlation analysis was used to determine the correlation between gait parameters and CBF in different brain regions. Results:A total of 52 patients with CSVD were enrolled, including 26 males and 26 females, aged 67.00±6.84 years. Thirty-eight cases (73.1%) had mild overall burden of CSVD, and 14 cases (26.9%) had a moderate to severe overall burden of CSVD. There were 17 patients (32.7%) in the GD group and 35 (67.3%) in the non-GD group. Compared with the non-GD group, the body mass index was significantly higher, the CBF of the left occipital lobe and bilateral cerebellum decreased significantly, the step speed, step length, stride length, step frequency, swing phase, peak arm angular velocity, arm swing amplitude, maximum calf anterior/posterior swing angle, peak calf angular velocity, foot swing speed, and peak sagittal plane angular velocity in the torso decreased significantly, while the number of steps, stance phase, step length asymmetry, stride length, and step length variability increased significantly in the GD group (all P<0.05). Multivariate logistic regression analysis showed that left cerebellar CBF was an independent protective factor for GD in patients with CSVD (odds ratio 0.902, 95% confidence interval 0.827-0.982; P=0.019). For every 1 ml/(100 g.min) decreased in left cerebellar CBF, the patients with CSVD had an increased risk of developing GD by approximately 9.8%. Partial correlation analysis showed that left occipital lobe CBF was significantly positively correlated with step speed ( r=0.305, P=0.032), maximum calf back swing angle ( r=0.314, P=0.026), and peak calf angular velocity ( r=0.356, P=0.011). The left cerebellar CBF was significantly positively correlated with step speed ( r=0.295, P=0.037) and significantly negatively correlated with step length variability ( r=-0.335, P=0.017); the right cerebellar CBF was significantly positively correlated with step speed ( r=0.309, P=0.029) and significantly negatively correlated with step length variability ( r=-0.344, P=0.014). Conclusion:GD in patients with CSVD is associated with decreased CBF in the left occipital lobe and bilateral cerebellum, and decreased CBF in the left cerebellum significantly increased the risk of GD in patients with CSVD.
8.A randomized,double-blind,placebo-controlled,multicenter clinical study of Shengxuebao Mixture in treating cancer-related anemia
Zhu LIU ; Xiangrong LI ; Xiaojun DAI ; Yanjun WANG ; Xiao LI ; Keqiong WANG ; Tao WU ; Miaowen ZHONG ; Hongjiang YU ; Ji FENG ; Zuowei HU ; Kainan LI ; Shaowei CHEN ; Chunhua LI ; Zhengchuan FU ; Rui ZHANG ; Yongfa CHEN ; Hongyu XU ; Tao REN ; Yibo YAO ; Jianxu JIN ; Pengyin WANG ; Zhijiang HE ; Jian SHEN ; Lei WANG ; Min LI ; Wenming CHANG ; Xinyi CHEN ; Li HOU
Journal of Beijing University of Traditional Chinese Medicine 2025;48(10):1447-1459
Objective We aimed to evaluate the efficacy and safety of Shengxuebao Mixture in the treatment of cancer-related anemia(CRA)presenting with syndrome of deficiency of liver and kidney combined with syndrome of deficiency of both qi and blood.Methods A randomized,double-blind,placebo-controlled,multicenter clinical trial was conducted.Eligible patients with malignant tumors meeting the inclusion and exclusion criteria were enrolled from 26 hospitals,including Dongzhimen Hospital,Beijing University of Chinese Medicine,Xiaogan Central Hospital,and Yangzhou Hospital of Traditional Chinese Medicine,from June 1,2022,to September 30,2024.Patients were allocated 1:1 to either the experimental group receiving Shengxuebao Mixture or the control group receiving its simulator(placebo)using a block randomization method under double-blind conditions.Both groups received 15 mL orally three times daily for 28 consecutive days.The primary efficacy indicators included the hemoglobin(Hb)improvement rate(RHb)and the traditional Chinese medicine(TCM)syndrome improvement rate(RTCM)at week 4 of treatment.The secondary efficacy indicators encompassed Hb and red blood cell(RBC)count,Karnofsky Performance Status(KPS)score,TCM syndrome score,individual TCM symptom scores,and changes in each of these indicators compared to the baseline period at weeks 2,4,and 6 of treatment.Safety evaluations were conducted at week 4 of treatment.Results A total of 239 patients were enrolled,with 225 cases included in the Full Analysis Set(FAS)(109 in the experimental group vs.116 control group),163 in the Per Protocol Set(PPS)(77 vs.86),and 225 in the Safety Set(SS)(109 vs.116).Baseline characteristics between groups showed no significant differences.Significant differences were observed between the experimental and control groups in RHb at week 4(FAS:49.51%vs.35.24%,P<0.05;PPS:53.25%vs.36.05%,P<0.05)and RTCM at week 4(FAS:61.54%vs.39.62%,P<0.01;PPS:64.94%vs.40.70%,P<0.01).At weeks 2,4,and 6,the experimental group showed greater improvements in Hb and RBC counts than the control group.Additionally,the TCM syndrome scores were lower in the experimental group than in the control group at these time points.Except for week 2 in PPS,the KPS improvement was better in the experimental group than in the control group(P<0.05).The experimental group also demonstrated a greater reduction in scores for individual TCM symptoms such as spiritlessness and weakness,poor appetite and reduced food intake at weeks 4 and 6 compared to the control group(P<0.05,P<0.01).Furthermore,the reduction in vertigo score was more pronounced in the experimental group at week 6(P<0.01).For the score of pale and lusterless complexion,only in the PPS was the reduction from baseline more significant in the experimental group than in the control group at weeks 4 and 6(P<0.05).No significant differences were observed between the experimental and control groups in the incidence of all adverse events or drug-related adverse reactions.Conclusion Shengxuebao Mixture demonstrates significant efficacy in patients with CRA presenting syndrome of deficiency of liver and kidney combined with syndrome of deficiency of both qi and blood,effectively increasing Hb levels,ameliorating TCM syndromes,alleviating clinical symptoms,and enhancing functional status,with no significant difference in adverse drug reactions compared to the placebo.
9.A randomized,double-blind,placebo-controlled,multicenter clinical study of Shengxuebao Mixture in treating cancer-related anemia
Zhu LIU ; Xiangrong LI ; Xiaojun DAI ; Yanjun WANG ; Xiao LI ; Keqiong WANG ; Tao WU ; Miaowen ZHONG ; Hongjiang YU ; Ji FENG ; Zuowei HU ; Kainan LI ; Shaowei CHEN ; Chunhua LI ; Zhengchuan FU ; Rui ZHANG ; Yongfa CHEN ; Hongyu XU ; Tao REN ; Yibo YAO ; Jianxu JIN ; Pengyin WANG ; Zhijiang HE ; Jian SHEN ; Lei WANG ; Min LI ; Wenming CHANG ; Xinyi CHEN ; Li HOU
Journal of Beijing University of Traditional Chinese Medicine 2025;48(10):1447-1459
Objective We aimed to evaluate the efficacy and safety of Shengxuebao Mixture in the treatment of cancer-related anemia(CRA)presenting with syndrome of deficiency of liver and kidney combined with syndrome of deficiency of both qi and blood.Methods A randomized,double-blind,placebo-controlled,multicenter clinical trial was conducted.Eligible patients with malignant tumors meeting the inclusion and exclusion criteria were enrolled from 26 hospitals,including Dongzhimen Hospital,Beijing University of Chinese Medicine,Xiaogan Central Hospital,and Yangzhou Hospital of Traditional Chinese Medicine,from June 1,2022,to September 30,2024.Patients were allocated 1:1 to either the experimental group receiving Shengxuebao Mixture or the control group receiving its simulator(placebo)using a block randomization method under double-blind conditions.Both groups received 15 mL orally three times daily for 28 consecutive days.The primary efficacy indicators included the hemoglobin(Hb)improvement rate(RHb)and the traditional Chinese medicine(TCM)syndrome improvement rate(RTCM)at week 4 of treatment.The secondary efficacy indicators encompassed Hb and red blood cell(RBC)count,Karnofsky Performance Status(KPS)score,TCM syndrome score,individual TCM symptom scores,and changes in each of these indicators compared to the baseline period at weeks 2,4,and 6 of treatment.Safety evaluations were conducted at week 4 of treatment.Results A total of 239 patients were enrolled,with 225 cases included in the Full Analysis Set(FAS)(109 in the experimental group vs.116 control group),163 in the Per Protocol Set(PPS)(77 vs.86),and 225 in the Safety Set(SS)(109 vs.116).Baseline characteristics between groups showed no significant differences.Significant differences were observed between the experimental and control groups in RHb at week 4(FAS:49.51%vs.35.24%,P<0.05;PPS:53.25%vs.36.05%,P<0.05)and RTCM at week 4(FAS:61.54%vs.39.62%,P<0.01;PPS:64.94%vs.40.70%,P<0.01).At weeks 2,4,and 6,the experimental group showed greater improvements in Hb and RBC counts than the control group.Additionally,the TCM syndrome scores were lower in the experimental group than in the control group at these time points.Except for week 2 in PPS,the KPS improvement was better in the experimental group than in the control group(P<0.05).The experimental group also demonstrated a greater reduction in scores for individual TCM symptoms such as spiritlessness and weakness,poor appetite and reduced food intake at weeks 4 and 6 compared to the control group(P<0.05,P<0.01).Furthermore,the reduction in vertigo score was more pronounced in the experimental group at week 6(P<0.01).For the score of pale and lusterless complexion,only in the PPS was the reduction from baseline more significant in the experimental group than in the control group at weeks 4 and 6(P<0.05).No significant differences were observed between the experimental and control groups in the incidence of all adverse events or drug-related adverse reactions.Conclusion Shengxuebao Mixture demonstrates significant efficacy in patients with CRA presenting syndrome of deficiency of liver and kidney combined with syndrome of deficiency of both qi and blood,effectively increasing Hb levels,ameliorating TCM syndromes,alleviating clinical symptoms,and enhancing functional status,with no significant difference in adverse drug reactions compared to the placebo.
10.Complication profiles of different surgical repair techniques for donor sites following lingual mucosa graft harvesting: a comparative study
Song LI ; Jiemin SI ; Xuxiao XIE ; Wenxiong SONG ; Zuowei LI ; Fangmin CHEN ; Kai LI ; Yinglong SA
Chinese Journal of Urology 2025;46(8):611-616
Objective:To compare postoperative complications between acellular dermal matrix(ADM)and direct suture for tongue mucosa defect repair during lingual mucosa urethroplasty.Methods:A retrospective analysis was conducted on 106 patients with anterior urethral stricture who underwent lingual mucosal urethroplasty at the Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine from July 2022 to July 2024. According to the needs of urethral reconstruction,lingual mucosa was harvested(graft length 0.5 cm longer than the stricture length). Using an instrumental variable method based on the surgeon’s preference,the tongue wound was repaired either with ADM or direct suture. The ADM group included 56 patients,aged(46.2±18.7)years;diabetes in 8 cases(14.3%),hypertension in 15 cases(26.8%),cardiopulmonary dysfunction in 3 cases(5.3%);stricture location:penile segment in 44 cases(78.6%),penoscrotal junction in 12 cases(21.4%);etiology:lichen sclerosus in 8 cases(14.3%),urethritis in 8 cases(14.3%),trauma in 24 cases(42.9%),and re-stricture after hypospadias surgery in 16 cases(28.6%);maximum urinary flow rate(5.8±2.9)ml/s;graft length(4.02±1.72)cm. The direct suture group included 50 patients,aged(45.8±19.2)years;diabetes in 6 cases(12.0%),hypertension in 12 cases(24.0%),cardiopulmonary dysfunction in 2 cases(4.0%);etiology:lichen sclerosus in 6 cases(12.0%),urethritis in 8 cases(16.0%),trauma in 25 cases(50.0%),and re-stricture after hypospadias surgery in 11 cases(22%);stricture location:penile segment in 36 cases(72.0%),penoscrotal junction in 14 cases(28.0%);maximum urinary flow rate(6.2±3.1)ml/s;graft length(4.18±1.68)cm. There were no statistically significant differences in the above baseline characteristics between the two groups( P>0.05).ADM group after electrocautery hemostasis,an ADM patch tailored to the wound size was used to cover the donor site. The edges of the ADM were overlapped with the wound margin and sutured to the submucosal layer using interrupted 4-0 polyglactin sutures. Direct suture group after electrocautery hemostasis,the wound was stretched into a diamond shape and closed in layers by suturing the mucosal layer down to the muscle layer using interrupted 4-0 polyglactin sutures. The primary outcome measures were postoperative tongue complications including hemorrhage,hematoma,and infection(Clavien-Dindo classification). Secondary outcomes included VAS pain scores,functional recovery(difficulty drinking,difficulty eating,speech impairment,limited mouth opening),and sensory recovery(sensory disturbance,taste disturbance). Results:The follow-up period ranged from 6 to 24 months,with a mean of 9.2 months. The 6-month follow-up rate was 100%. No Clavien-Dindo grade Ⅲ or higher complications(hemorrhage,hematoma,infection)occurred by the end of follow-up. Regarding secondary outcomes,the VAS pain score on postoperative day 1 was significantly better in the ADM group than in the suture group[0(0,3)vs. 2(0,3),P=0.013].Functional impact:The incidence of difficulty drinking[24 cases(42.9%)vs. 36 cases(72.0%),16 cases(28.6%)vs. 36 cases(72.0%),8 cases(14.3%)vs. 21 cases(42.0%)],difficulty eating[20 cases(35.7%)vs. 36 cases(72.0%),16 cases(28.6%)vs. 36 cases(72.0%),8 cases(14.3%)vs. 27 cases(54.0%)],and speech impairment[20 cases(35.7%)vs. 36 cases(72.0%),16 cases(28.6%)vs. 36 cases(72.0%),8 cases(14.3%)vs. 27 cases(54.0%)]on postoperative day 1,day 7,and within the first month,respectively,was significantly lower in the ADM group(all P<0.05). On postoperative day 1 and day 7,the incidence of limited mouth opening was higher in the ADM group[0 cases vs. 6 cases(12.0%),0 cases vs. 6 cases(12.0%)]( P<0.05).Sensory recovery:The incidence of taste disturbance was higher in the ADM group at 7 days[8 cases(14.3%)vs. 0 cases],1 month[8 cases(14.3%)vs. 0 cases],and 3 months[8 cases(14.3%)vs. 0 cases]postoperatively( P<0.05). The incidence of sensory disturbance was higher in the ADM group at 1 day[20 cases(35.7%)vs. 6 cases(12.0%)],7 days[16 cases(28.6%)vs. 6 cases(12.0%)],and 1 month[16 cases(28.6%)vs. 6 cases(12.0%)]postoperatively( P<0.05). Pain scores and complication rates were zero in both groups after 6 months. Conclusions:ADM repair improves early recovery but may increase transient sensory complications. Both methods are safe for clinical application.

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