1.Effect of Modified Xiangsha Liujunzi Decoction (香砂六君子汤) on Clinical Symptoms and Immune Function in Advanced HR+/HER2- Breast Cancer Patients with Abemaciclib-Related Diarrhea of Spleen-Stomach Deficiency Type
Zhanfei GUO ; Luxia QI ; Xiao WEI ; Xuemei ZHANG ; Xuekai WANG ; Jingyu CUI
Journal of Traditional Chinese Medicine 2026;67(21):2311-2318
ObjectiveTo observe the clinical efficacy of modified Xiangsha Liujunzi Decoction (香砂六君子汤, XLD) in the treatment of abemaciclib-related diarrhea of spleen-stomach deficiency type, and its regulatory effect on immune function in patients with advanced hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer. MethodsA prospective, randomized, open-label, blinded-endpoint (PROBE) study was conducted. A total of 70 patients with advanced HR+/HER2- breast cancer and abemaciclib-related diarrhea were randomly divided into two groups, with 35 cases in each group. In addition to abemaciclib, the control group was treated with oral loperamide, while the trial group was treated with oral modified XLD. Both groups received treatment for 7 days as one course. The efficacy for diarrhea after treatment was compared between groups. Traditional Chinese medicine (TCM) syndrome score, Karnofsky performance status (KPS) score, inflammatory markers including interleukin-6 (IL-6) and C-reactive protein (CRP), and immune function indicators including CD4+, CD8+, and CD4+/CD8+ ratio were compared between groups before and after treatment. Adverse events during the study were recorded, and safety was assessed. ResultsDuring the study, 1 case in the trial group and 2 cases in the control group, were lost to follow-up leaving 34 cases in the trial group and 33 cases in the control group for final analysis. The total effective rate of diarrhea in the trial group was 94.12% (32/34), higher than 72.73% (24/33) in the control group (P<0.05). After treatment, both groups showed decreased TCM syndrome scores, increased KPS scores, increased CD4⁺, CD8⁺, and CD4⁺/CD8⁺ ratio, and decreased IL-6 and CRP levels (all P<0.05). Compared to the control group, the trial group had higher KPS scores, CD4⁺ levels, and CD4⁺/CD8⁺ ratios, and lower TCM syndrome scores and IL-6, CRP, and CD8⁺ levels (P<0.05). The incidence of adverse events in the trial group was 20.59% (7/34), with an incidence of adverse drug reactions of 14.71% (5/34) after causality assessment; in the control group, the corresponding rates were 45.45% (15/33) and 39.39% (13/33), respectively. The incidence of adverse events in the trial group was significantly lower than that in the control group (P<0.05). ConclusionModified XLD can effectively alleviate abemaciclib-related diarrhea in patients with advanced HR+/HER2- breast cancer of the spleen-stomach deficiency type, reduce levels of inflammatory cytokines, and regulate immune function, with a favorable safety profile.
2.Enhanced radiotheranostic targeting of integrin α5β1 with PEGylation-enabled peptide multidisplay platform (PEGibody): A strategy for prolonged tumor retention with fast blood clearance.
Siqi ZHANG ; Xiaohui MA ; Jiang WU ; Jieting SHEN ; Yuntao SHI ; Xingkai WANG ; Lin XIE ; Xiaona SUN ; Yuxuan WU ; Hao TIAN ; Xin GAO ; Xueyao CHEN ; Hongyi HUANG ; Lu CHEN ; Xuekai SONG ; Qichen HU ; Hailong ZHANG ; Feng WANG ; Zhao-Hui JIN ; Ming-Rong ZHANG ; Rui WANG ; Kuan HU
Acta Pharmaceutica Sinica B 2025;15(2):692-706
Peptide-based radiopharmaceuticals targeting integrin α5β1 show promise for precise tumor diagnosis and treatment. However, current peptide-based radioligands that target α5β1 demonstrate inadequate in vivo performance owing to limited tumor retention. The use of PEGylation to enhance the tumor retention of radiopharmaceuticals by prolonging blood circulation time poses a risk of increased blood toxicity. Therefore, a PEGylation strategy that boosts tumor retention while minimizing blood circulation time is urgently needed. Here, we developed a PEGylation-enabled peptide multidisplay platform (PEGibody) for PR_b, an α5β1 targeting peptide. PEGibody generation involved PEGylation and self-assembly. [64Cu]QM-2303 PEGibodies displayed spherical nanoparticles ranging from 100 to 200 nm in diameter. Compared with non-PEGylated radioligands, [64Cu]QM-2303 demonstrated enhanced tumor retention time due to increased binding affinity and stability. Importantly, the biodistribution analysis confirmed rapid clearance of [64Cu]QM-2303 from the bloodstream. Administration of a single dose of [177Lu]QM-2303 led to robust antitumor efficacy. Furthermore, [64Cu]/[177Lu]QM-2303 exhibited low hematological and organ toxicity in both healthy and tumor-bearing mice. Therefore, this study presents a PEGibody-based radiotheranostic approach that enhances tumor retention time and provides long-lasting antitumor effects without prolonging blood circulation lifetime. The PEGibody-based radiopharmaceutical [64Cu]/[177Lu]QM-2303 shows great potential for positron emission tomography imaging-guided targeted radionuclide therapy for α5β1-overexpressing tumors.
3.Clinical application of modified infrared thermal imaging assisted design of peroneal artery perforator propeller flap
Xianting ZHOU ; Jiadong PAN ; Guoqing SHAO ; Dongchao XIAO ; Yaopeng HUANG ; Shanqing YIN ; Xuekai FAN ; Xin WANG
Chinese Journal of Microsurgery 2022;45(3):260-265
Objective:To explore the clinical value of modified infrared thermal imaging assisted design of peroneal artery perforator propeller flap.Methods:From March 2019 to May 2021, tourniquet-reperfusion augmented thermal imaging method (TRATIM) was used to locate the perforating vessels in 14 patients for surgery or peroneal artery perforator propeller flap. The sensitivity, positive predictive value and detection time were calculated and compared with the perforating vessels located by color Doppler ultrasound(CDU), P<0.05 is statistially significant. Results:After operation, 13 flaps survived completely, but 1 flap with distal surface necrosis and healed after dressing change. Only one linear scar was left in 12 cases, and 2 cases healed well by skin grafts. Followed-up for 6-13 months, and showed that the colour and texture of the flaps were similar to the surrounding skin, without obvious swelling. The sensitivity of TRATIM and CDU in location of peral perforator vessels were 88.0% and 92.0%, respectively, and the positive predictive value was 93.6% and 95.8%, with no statistical difference between TRATIM and CDU( P>0.05). The time of positioning perforator was (3.71±0.80) min for TRATIM and(16.21±4.97) min for CDU, There was significant difference between TRATIM and CDU( P<0.01). Conclusion:With TRATIM, a surgeon can locate the peroneal perforator vessels simply, quickly and accurately, and help in design more accurate peroneal artery perforator propeller flap.
4.Effects of Budesonide on pulmonary vascular development and the expressions of vascular endothelial growth factor, nucleotide binding oligomerization domain-like receptor protein 3 in newborn rats with bronchopulmonary dysplasia caused by intrauterine infection
Guofeng LAN ; Yijin WANG ; Yunfang LI ; Qinghua WEI ; Fenglang SHI ; Qiliang CUI ; Hussnain MIRZA ; Xuekai SHI
Chinese Journal of Applied Clinical Pediatrics 2021;36(2):128-133
Objective:To investigate the effect of Budesonide (BUD) on pulmonary vascular development and the expression of vascular endothelial growth factor (VEGF) and nucleotide binding oligomerization domain-like receptor protein 3 (NLRP3) in newborn rats with bronchopulmonary dysplasia (BPD) caused by intrauterine infection.Methods:The 15-day-pregnant SD rats were divided into control group and infection group [intraperitoneal injection of 0.35 mg/(kg·d) lipopolysaccharide], and the newborn rats born by the above groups were divided into 3 groups: BUD group (0.5 mg of BUD suspension), normal control group (NC group, equal amount of 9 g/L saline), BPD group (equal amount of 9 g/L saline), with 40 rats in each group, all of them were inhaled twice a day for 14 days.Ten newborn rats were selected at birth, on the 3 rd, 7 th and 14 th day after administration.Pulmonary histopathological changes and radial alveolar counts (RAC) were observed after HE staining, and the thickness of alveolar respiratory membrane was measured; the platelet-endothelial cell adhesion molecule (PECAM-1/CD 31) in lung tissue was detected by immunohistochemistry, and the density of pulmonary microvessels was calculated; the expressions of VEGF, NLRP3 and Caspase-1 were detected by Western blot; and the levels of serum interleukin( IL)-1β and IL-18 were measured by enzyme-linked immunosorbent assay. Results:With the increase of day-old, the lung tissue of newborn rats in NC group was gradually developed and matured, the structure of alveoli was clear, the size was uniform, the count was significantly increased, and no obvious pathological changes were observed.In BPD group, the lung tissue structure was disordered, the alveoli were different in size and few in count, and inflammatory cells were exuded from the alveoli or the alveoli space.Compared with BPD group, the pathological changes of lung tissue in BUD group were significantly reduced.On the 3 rd, 7 th and 14 th day after administration, compared with NC group, the RAC, average integral optical density of CD 31 positive cells, density of pulmonary microvessel and level of VEGF protein in lung tissue of BPD group and BUD group were lower, and the differences were statistically significant (all P<0.05); while the thickness of respiratory membrane, level of NLRP3, Caspase-1 proteins in lung tissue and serum levels of IL-1β, IL-18 were significantly higher, and the differences were statistically significant(all P<0.05). Compared with BPD group, the RAC, average integral optical density of CD 31 positive cells, density of pulmonary microvessel and level of VEGF protein in lung tissue of BPD group and BUD group were significantly higher, and the differences were statistically significant (all P<0.05); while the thickness of respiratory membrane, level of NLRP3, Caspase-1 proteins in lung tissue and serum levels of IL-1β, IL-18 were significantly lower, and the differences were statistically significant (all P<0.05). Conclusions:The occurrence and development of pathological changes of BPD newborn rats caused by intrauterine infection can affect the development of pulmonary vessels through the inflammatory response of lung tissue.BUD can alleviate pathological changes in lung tissues of BPD newborn rats by reducing inflammatory reaction and up-regulating VEGF expression, promoting pulmonary vascular remodeling, and increasing pulmonary microvascular density.
5.Reconstruction of the skin and soft defects of hand and foot by free medial sural artery perforator flap
Jiadong PAN ; Xin WANG ; Jing MEI ; Hong CHEN ; Xuekai FAN ; Shengwei WANG ; Haoliang HU ; Weiwen ZHANG
Chinese Journal of Microsurgery 2012;35(2):93-96,后插1
ObjectiveTo evaluate the curative effect of reconstruction of the hand and foot defects with bones and tendons exposure using free medial sural artery perforator flap(MSAP). MethodsRadiographs of 2 cadavers injected with a modified lead oxide-gelatin mixture were digitally analyzed. Between April 2007 and December 2010, thirty-four patients with soft tissue defects in the distal limb were treated with the free MSAP flap transplantation. The sizes of the defect ranged 6 cm × 4 cm-13 cm × 8 cm, and the flaps ranged 7 cm× 5 cm-14 cm × 9 cm. These clinical cases included 25 hands and 9 feet, all of them with bones and tendons exposure.In these defects,twenty-two were clean,twelve got infections.In our cases, twenty-three flaps were nourished with single perforator vessel and else 11 with two;perforator vessel fifteen flaps were dissected one superficial vein to anastomose with that of the recipient sites in addition to accompanying vein anastomosis;The sensation of 9 flaps recovered the hands were reconstructed with cutaneous nerve anastomosis. ResultsA partition of the calf skin blood vessels,and three-dimensional reconstruction image of the sural artery were obtained.All flaps survived,five of them appeared partially violet and bubbles. Followed up 6-21 months, the cosmetic results were satisfactory and without apparent bulkiness.The flap colors were similar to recipient sites. The flap senses reconstructed with neural anastomosis recover to S2-S3. ConclusionThe new flap is very suitable to repair the soft tissue defect in the distal limbs,because the fairly constant perforator vessel,the reliable blood supply and the cosmetic shape of the MSAP flap are all advantages of it in addition to no damage to low leg chief artery and gastrocnemius.
6.Evaluation for clinical application of UniCel DxH 800 hematology analyzer
Chengwei PU ; Ke SHANG ; Jianzhong WANG ; Xuekai LIU ; Ying XING ; Xiaoling TANG ; Hui GAO ; Ning DONG ; Huiqing SU ; Xiufen MING
Chinese Journal of Laboratory Medicine 2012;35(7):643-646
ObjectiveTo evaluate the improvement on test performance of UniCel DxH 800 automated hematology analyzer for complete blood count (CBC) by detecting its performance indicators and comparing the differences of the results with LH 750 hematology analyzer and ADVIA 2120 hematology analyzer.MethodsThe precision,carryover and linearity of UniCel DxH 800 in measurement of CBC were evaluated by using fresh blood samples and instrument quality control of products.To evaluate the accuracy of leukocyte differential count and reticulocyte count with the microscopic method as the “gold standard”.To calculate the bias and correlation between the results measured by LH 750,ADVIA 2120 and UniCel DxH 800 hematology analyzers and compare these three instruments on the validity of the alarm in abnormal cells.ResultsIntra-precision:The coefficient of variation (CV) of the results of RBC,Hb and MCV were less than 0.5%,the CV of WBC and PLT results were less than 1.5%.Inter-precision:the CV of the parameters above were less than 2.5%.The carryover rate of WBC,RBC,Hb,MCV and PLT were less than 0.51%.In the concentration range covered by clinical samples,the correlation coefficients between the measured values and theoretical value in testing WBC,RBC,Hb and PLT were greater than 0.999 ( P <0.01 ).The measurement results of WBC,RBC,Hb,MCV and PLT hy UniCel DxH 800,ADV1A 2120 and LH 750 hematology analyzers have good correlation (r > 0.973,P < 0.01 ).Correlation of reticulocyte count between the UniCel DxH 800 hematology analyzer and microscolpic method was significant (r =0.920,P <0.01 ).Correlation of leukocyte differential count about the grauulocytes, lymphocytes and eosinophils between the UniCel DxH 800 hematology analyzer and microscopic method was good (r =0.914,0.900 and 0.725,P <0.01 ),followed by monocytes ( r =0.612,P <0.01 ),which were better than the LH 750 with similar detection principle.The UniCel DxH 800 hematology analyzer demonstrated higher sensitivity (96.6% ) for the alarm of abnormal cells and achieved a lower false-negative rate (2.5% ).Meanwhile,the sensitivity of the neutrophil nuclei left shift was higher (90.5% ) and the false-negative rate (5.0%) was lower.ConclusionsThe UniCel DxH 800 hematology analyzer for complete blood count shows advantages of high precision,low carryover rate and wide linear range.The results detected by the UniCel DxH 800 hematology analyzer have good correlation with the LH 750 and ADVIA 2120.
7."Leukocyte differential count in peripheral blood ""with"" single tube/ten colors""flow cytometry"
Xuekai LIU ; Jianzhong WANG ; Ying XING ; Chenxue QU ; Chengwei PU ; Ping WU ; Hui WANG ; Kangyuan LIU ; Lan MA ; Na PAN
Chinese Journal of Laboratory Medicine 2011;34(5):395-402
Objective To explore the values of potential clinical application ofsingle tube/ten colorsflow cytometry for leukocyte differential count in peripheral blood.Methods Utilizing multiple monoclonal antibody combinations and the vavious logical gating strategies,the single tube/12 antibodies with no-wash method for the leukocyte differential count in peripheral blood were determined by using 10 colors flow cytometry.Leukocyte differentials of 142 peripheral blood samples were determined by both Beckman-Coulter LH750 hematology analyzer and 10 colors flow cytometry.The results were then compared to standard microscopic examination as a reference method.The clinical diagnostic efficiency ofsingle tube/10 colorsflow cytometry was calculated.The correlations between standard microscopic cytology,single tube/10 colorsflow cytometry and the hematology analyzer were determined.In addition,the clinical diagnosis efficiency for blast counts ofsingle tube/10 colorswere compared to the results determined by BD FACS Calibur flow cytometer.Results The leukocyte differentials were correlated well between the single tube/10 colorsflow cytometry and standard microscopic cytology(r>0.700,P<0.01) except for basophils.The correlations with neutrophilic granulocytes,lymphocytes,immature granulocytes and blasts were superior(r=0.972,0.951,0.801,0.912,respectively,P<0.01).When 1% was selected as the cut-off point for immature granulocytes determined by standard microscopic cytology,the sensitivity and the specificity ofsingle tube/10 colorsflow cytometry were 92%(57/62) and 79% (63/80),respectively.When 0.5% was selected as the cut-off point for blasts detected by standard microscopic cytology,the sensitivity and the specificity were 99% (67/68) and 92% (68/74).Using the immunophenotyping results from BD FACS Calibur as a standard,the sensitivity for detecting blasts bysingle tube/10 colOrsflow cytometry was 100% (40/40),the specificity was 91% (10/11),the positive predictive value was 98% (40/41),the negative predictive value was 100% (10/10) and the accuracy was 98% (50/51).Conclusions Thesingle tube/10 colorsflow cytometry has a excellent correlation with the standard microscopic cytology when applied on leukocyte differential count in peripheral blood.It may potentially use as a subsequent method for verification of abnormal results of complete blood cell count in the future.

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