1.Preventive Effect and Safety Evaluation of Xiaozhen Formula (消疹方) on Skin Toxicity Induced by Epidermal Growth Factor Receptor Inhibitors in the Treatment of Non-small Cell Lung Cancer:A Multicenter,Randomized,Double-Blind,Placebo-Controlled Trial
Ling LUO ; Xintian WANG ; Cheng CHENG ; Zitong HAN ; Chunru WANG ; Guoli WEI ; Jianyue LI ; Li WANG ; Jirong WANG ; Peng SHU ; Liang LI ; Fenglin LIU ; Ran SONG ; Jing BAI ; Haiyan XING
Journal of Traditional Chinese Medicine 2026;67(18):1987-1994
ObjectiveTo evaluate the clinical efficacy and safety of Xiaozhen Formula (消疹方) in preventing skin toxicity induced by epidermal growth factor receptor inhibitors (EGFRIs) in patients with EGFR-mutant non-small cell lung cancer (NSCLC). MethodsA randomized, double-blind, placebo-controlled, multicenter clinical study was conducted. A total of 120 patients with EGFR-mutant NSCLC from seven centers were enrolled and randomly assigned to a treatment group (60 cases) or a control group (60 cases). On the basis of EGFRI-targeted therapy, patients in the treatment group received Xiaozhen Formula granules, whereas those in the control group received Xiaozhen Formula placebo granules, both at 10 g twice daily for 4 consecutive weeks. The primary outcomes were the grading of skin toxicity evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 and the incidence of rash. Secondary outcomes included the time to onset and time to resolution of the highest-grade rash, the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) scores, the Hospital Anxiety and Depression Scale (HADS) scores, and disease control rate, together with safety assessments. ResultsBased on the full analysis set (FAS), the incidence of skin toxicity in the treatment group was 18.33% (11/60), significantly lower than 45.00% (27/60) in the control group (P<0.01), with the highest severity of skin toxicity in both groups was grade 2. Among patients who developed rash, the resolution rate in the treatment group was 90.91% (10/11), higher than that 33.33% (9/27) in the control group. The median time to resolution was 15 days (95%CI: 8-17 days) in the treatment group and it was not reached in the control group; the distribution of time to resolution differed significantly between groups (P<0.001). After treatment, the treatment group had higher EORTC QLQ-C30 functional scale and global health status/quality-of-life scores, and lower symptom scale, single-item scores, as well as HADS-A, and HADS-D scores than the control group (P<0.05). In the FAS analysis, the disease control rate (DCR) was 85.0% (51/60) in the treatment group, lower than 100.0% (60/60) in the control group (P=0.003), whereas no significant between-group difference was observed in the per-protocol set (PPS) analysis (P=0.464). The incidence of adverse events did not differ significantly between the two groups (P>0.05), and no definite safety signals related to the investigational drug were observed. ConclusionXiaozhen Formula can reduce the incidence of EGFRI-induced skin toxicity, and improve the outcome of rash regression, the patients' quality of life and psychological status in EGFR-mutant NSCLC patients.
2.The correlation between peri-coronary fat attenuation index and different grades of hypertension based on coronary CT angiography
Xia LI ; Dan HAN ; Xiaoying LIU ; Jie JIANG ; Zitong WANG ; Xiaojie XIE ; Hui DUAN
Journal of Practical Radiology 2024;40(1):41-45
Objective lo analyze the difference of peri-coronary tat attenuation index(pr Al)on different grades of hypertension(HT),and to explore the value of pFAI in evaluating the risk of HT patients.Methods Retrospective data on hospitalized patients who underwent coronary computed tomography angiography(CCTA)examination for chest pain were collected.A total of 415 clini-cally confirmed HT patients were selected as observation group(including 132 patients in grade 1 HT group,137 patients in grade 2 HT group,146 patients in grade 3 HT group),and 187 non-hypertension patients during the same period as control group.The differ-ence of fat attenuation index(FAI)in three main coronary arteries[left anterior descending artery(LAD),left circumflex artery(LCX),right coronary artery(RCA)]was compared,and the correlation between pF AI and HT patients was analyzed.Results RCA-FAI(-78.86 HU±7.66 HU)and LAD-FAI(-80.62 HU±7.50 HU)were higher in HT group than those in control group(-84.46 HU± 8.00 HU,-83.43 HU±7.51 HU,P<0.05).pFAI value was higher in grade 3 HT group than that in grade 1 HT group and grade 2 HT group(P<0.05),while there were no differences between grade 1 HT group and grade 2 HT group(P>0.05).After adjusting the influence of traditional risk factors and coronaryartery disease,RCA-FAI had relatively closer relationship with HT grades(r=0.47,P<0.001).Conclusion LAD-FAI,RCA-FAI in the HT group are higher than those in control group and RCA-FAI has relatively closer relationship with HT grades,suggesting that RCA-FAI may be an imaging indicator to evaluate the pro-gression of HT and predict the risk of HT.
3.Effects of the Combination of Herba Epimedii Combined with Fructus Ligustri Lucidi on Autophagy Activation State of ASMCs
Han WANG ; Zitong MA ; Yuting LONG
Journal of Medical Research 2023;52(12):36-40,70
Objective To study the regulatory effect of herba epimedii(HE)combined with fructus ligustri lucidi(FLL)on auto-phagy,apoptosis and proliferation activity of airway smooth muscle cells(ASMCs)induced by rapamycin(RAP).Methods Primary ASMCs of rats were cultured and randomly divided into five groups:normal group,RAP group,HE group,FLL group and compatible group.Normal rat serum or medicated rat serum was added separately according to the group.Except for normal group,all other groups were simultaneously added with RAP-induced ASMCs,which were examined after 48h.Transmission electron microscope was used to observe cell microstructure;MTT assay was used to detect cell viability;immunocytochemistry was used to detect protein expression of proliferation protein ki-67 to evaluate the proliferation activity of cells;Annexin V-FITC/P1 assay was used to detect the apoptosis ac-tivity of cells;Western blot and cell immunofluorescence were used to detect the protein expressions of LC3,Beclin-1,mTOR,p-mTOR,Bax,Bcl-2,caspase-3 and p53.Results The compatibility of HE and FLL significantly inhibited RAP-induced autophagy in ASMCs,and down-regulated LC3-Ⅱ/Ⅰ protein ratio(P<0.05)and Beclin-1 protein expression(P<0.01),alleviated the re-duction of cell viability and proliferation activity(all P<0.01),and depressed apoptosis activity(P<0.01).The above effects of com-patibility of HE and FLL were better than those of HE and FLL alone(P<0.05,P<0.01).In addition,the compatible group could up-regulate the expression of caspase-3 protein(P<0.05)and down-regulate the expression of p53 protein(P<0.01);However,there was no significant effect on the mTOR,p-mTOR,Bax and Bcl-2 protein.Conclusion The compatibility of HE and FLL could suppress the excessive autophagy/apoptosis level of RAP-induced ASMCs,restore the cell viability and proliferation activity of ASMCs,and avoid excessive damage of ASMCs.
4. Mechanism of hydroxysafflower yellow A in the regulation of vascular smooth muscle cell calcification
Yiran HAN ; Tianhua XU ; Xiaobo QIU ; Zitong SHENG ; Pengzhi WAN ; Yue LI ; Li YAO
Chinese Journal of Nephrology 2019;35(11):848-855
Objective:
To investigate the role and mechanism of Hydroxysafflor yellow A (HSYA) in the calcification of vascular smooth muscle cells (VSMC) induced by β-glycerol phosphate (β-GP).
Methods:
VSMC were cultured with 10% fetal bovine serum+1% double anti-high glucose DMEM medium at 37℃ and 5%CO2 incubator, and were subcultured according to cell growth density at 1∶4 ratio. The cells were divided into three groups: control group (NC), high-phosphate-induced calcification (HP) group, and HSYA intervention (HSYA) group. The Calcium deposition amount was measured by alizarin red staining and calcium determination kit. The expressions of ALP, RUNX2, RANKL, α-SMA and inflammation indicators TLR4, TNF-α, IL-8 were detected by Western blotting method; Western blotting was also used to detect calcification index alkaline phosphatase (ALP) and Runt-related transcription factor 2 (RUNX2). Nuclear factor kappa B receptor activating factor ligand(RANKL), α-smooth muscle actin (α-SMA), and the expressions of TLR4/NF-κB pathway and inflammatory response-related indicators Toll-like receptor 4 (TLR4), interleukin-8 (IL-8) and tumor necrosis factor alpha (TNF-α). The nuclear protein and cytoplasmic proteins were respectively extracted. The expressions of p65 in nucleus and cytoplasm, as well as the expressions of p65 and phosphorylated p65 in total proteins were detected by Western blotting method. Superoxide dismutase (SOD) and malondialdehyde (MDA) kit were used to detect the content of antioxidant enzymes and oxidation end products in cells.
Results:
Western blotting showed that the expressions of ALP, RUNX2 and RANKL in HSYA group were significantly lower than that in HP group. The expression of α-SMA was increased than that of HP group (all
5.Cordyceps sinensis alleviates β-glycerophosphate-induced vascular smooth muscle call calcification through promoting autophagy
Xiaobo QIU ; Zitong SHENG ; Yiran HAN ; Tianhua XU ; Binyao TIAN ; Fei ZHAO ; Yanqiu YU ; Li YAO
Chinese Journal of Nephrology 2019;35(2):119-126
Objective To investigate the influence mechanism of Cordyceps sinensis (CS) on β-glycerophosphate-induced vascular smooth muscle cell (VSMC) calcification.Methods The effect of CS on VSMC cell viability was detected by CCK-8.The cellular models of rat VSMC calcification were established by treating with β-glycerophosphate (β-GP,10 mmol/L);then CS (10 mg/L),autophagy inhibitor 3-methyladenine (3-MA,5 mmol/L),and AMPK inhibitor compound C (CC,10 μmol/L) were added to the cell cultures.There were a total of 5 experiment groups:VSMC cultured in normal medium (Control),VSMC treated with β-GP,VSMC treated with β-GP and CS,VSMC treated with 3-MA,β-GP and CS,and VSMC treated with CC,β-GP and CS.The calcium nodules and calcium content were examined with alizarin red S staining and the O-cresolphthaleincomplexone method,respectively.The autophagosomes within the VSMC were observed using transmission electron microscope (TEM).Immunofluorescence showed the accumulation of microtubule-associated protein 1 light chain 3 (LC3) puncta.In addition,levels of osteogenic related proteins,autophagy related proteins,and AMPK/mTOR pathway related proteins were evaluated by Western blotting.Results CS increased the number of autophagosomes and the accumulation of LC3 puncta within VSMC.It also upregulated the protein levels of LC3 Ⅱ/LC3 Ⅰ,beclin1,α-SMA,and p-AMPK;whereas,the protein levels of Runx2 and p-mTOR,as well as calcium nodules and calcium content were reduced (all P < 0.01).When the cells were pretreated with 3-MA before treating with β-GP and CS,the autophagosomes,accumulation of LC3 puncta,and protein levels of LC3 Ⅱ/LC3 Ⅰ,beclinl,and α-SMA were decreased (all P < 0.01);however,the protein level of Runx2,and the calcium nodules and calcium content were increased (all P < 0.01).Nevertheless,when the cells were pretreated with CC before giving β-GP and CS,the autophagosomes,the accumulation of LC3 puncta,and the expression levels of p-AMPK,LC3 Ⅱ/LC3 Ⅰ,beclin1,and α-SMA were significantly down-regulated (all P < 0.01);whereas,the expression levels of Runx2 and p-mTOR,as well as calcium nodules and calcium content were increased (all P < 0.01).Conclusions CS can effectively alleviate β-GP-induced VSMC calcification,which may be due to the activation of autophagy by AMPK/mTOR signaling pathway.
6.Surgical Treatment of Bronchial Stricture due to Endobronchial Tuberculosis: Results in 36 Consecutive Cases.
Junzhong RUAN ; Tianhui ZHANG ; Fugen LI ; Yong DUAN ; Ming HAN ; Zitong WANG
Chinese Journal of Lung Cancer 2018;21(4):320-322
BACKGROUND:
Bronchial tuberculosis is a common complication of pulmonary tuberculosis. The present report is to investigate and analyze the indication and efficacy of surgical treatment of bronchial stricture due to severe endobronchial tuberculosis, when the drug and endoscopic treatment were no effect.
METHODS:
Reviewed the clinical-pathological records documenting the surgical outcomes in 36 bronchial stricture due to severe endobronchial tuberculosis who underwent lobectomy or pneumonectomy enrolled in our hospital between January 2000 and February 2016. Pneumonectomy in 8 cases, lobectomy in 23 cases, sleeve resection in 5 cases.
RESULTS:
No intraoperative or early postoperative death occurred. Six patients developed complications. All 6 cases recovered well after treatment.
CONCLUSIONS
Surgical treatment is still the recommended treatment modatity for bronchial stricture caused by endobronchial tuberculosis due to its good results. It should be performed in time when the drug and intraluninal treatment were no effect for avoiding of being progeressed.
Adolescent
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Adult
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Bronchi
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surgery
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Bronchoscopy
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Female
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Humans
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Male
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Middle Aged
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Pneumonectomy
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Retrospective Studies
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Tuberculosis, Pulmonary
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surgery
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Young Adult
7.Expression of Fascin on human early-stage non-small-cell lung cancer tissue and its clinical characteristics
Tiepeng HAN ; Lei YANG ; Jinjing TAN ; Meng GU ; Yue WANG ; Zitong WANG ; Wentao YUE
Chinese Journal of Thoracic and Cardiovascular Surgery 2017;33(1):36-40
Objective To investigate the expression of Fascin in early-stage NSCLC, evaluate the relevance between Fascin expression level and prognosis.Methods The immunohistochemistry method was used to assess the expression of Fas-cin in 111 lung cancer FFPE tissues with stage Ⅰ and Ⅱ NSCLC.The relationship between Fascin expression and the clinico-pathological characteristics was analyzed.The prognostic significance of Fascin expression was evaluated with Kaplan-Meier sur-vival analysis.Results In the early-stage of NSCLC, the positive rate of Fascin expression was 64.8%, no expression in the paracarcinoma tissue.The positive rate of squamous cell carcinoma was 78.7% and was significantly higher than that in adeno-carcinoma 48.0%(P<0.01).Whether in squamous cell carcinoma or adenocarcinoma group, the expression of Fascin was correlated significantly with lymph node metastasis tumor stages and DFS(P<0.05).And the positive expression of Fascin was an independent risk factor of poor prognosis for patient with NSCLC .Conclusion Fascin is expected to be a biomarker for the prognosis of patients with early-stage NSCLC.
8.Diagnosis and treatment of tracheal or bronchuotracheal adenoid cystic carcinoma.
Ming QIN ; Yu FU ; Daping YU ; Shaofa XU ; Ming HAN ; Zitong WANG
Chinese Journal of Lung Cancer 2010;13(6):628-631
BACKGROUND AND OBJECTIVEAdenoid cystic carcinoma is primary bronchopulmonary carcinoma with low malignancy, and 43 patients treated in the past 50 years in our hospital were retrospectively studied. The aim of this study is to discuss the clinical symptoms, pathologic characteristic and therapeutic method of primary tracheal or bronchuotracheal adenoid cystic carcinoma.
METHODSThis study summarized total 43 patients of primary tracheal or bronchus adenoid cystic carcinoma treated in our hospital from Jan. 1958 to Dec. 2007. Among them, 40 patients were treated by surgical resection, and 3 patients were treated by fiberoptic bronchoscope's interventional treatment.
RESULTSThe 1-yr, 3-yr, 5-yr survival rates of the 43 patients above were 100% (41/41), 89.5% (34/38), 87.1% (27/31), respectively.
CONCLUSIONPrimary tracheal or bronchus adenoid cystic carcinoma are rare and low malignancy carcinoma. The clinical symptoms of them are not typical. The best treatment is early detection and taking measures of operation plus radiotherapy. The other palliative treatment is fiberoptic bronchoscope's interventional treatment.
Adult ; Aged ; Bronchial Neoplasms ; diagnosis ; mortality ; surgery ; Carcinoma, Adenoid Cystic ; diagnosis ; mortality ; surgery ; Female ; Humans ; Male ; Middle Aged ; Prognosis ; Tomography, X-Ray Computed ; Tracheal Neoplasms ; diagnosis ; mortality ; surgery

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