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.Study on the bacterial biofilm of Streptococcus pneumoniae by clove oil
Yan ZHANG ; Haishi SUN ; Junxing LIU ; Lin WANG ; Jirong SONG ; Gongzhao WANG ; Xinting CHAI ; Zhenyu WANG ; Sheng LI
International Journal of Traditional Chinese Medicine 2018;40(6):547-550
Objective To study the effect of clove oil on bacterial biofilm of Streptococcus pneumoniae. Methods The components of clove oil were determined by GC-MS mass spectrometry. The suspension of streptococcus mutans was prepared to carry out the germicidal test, and to determine the minimum inhibitory concentration (MIC) and the minimum bactericidal concentration (MBC) of clove oil. The effects of different concentrations of clove oil on the formation of biofilm were observed by laser confocal microscopy, and the average fluorescence intensity of live bacteria and dead bacteria in biofilm was recorded. Results Determination of clove oil 8 components were analyzed by GC-MS mass spectrometry method, most of the Eugenol content was 48.93%, followed by the Caryophyllene 20.78%, Methylis salicylas 14.96%. Through MIC, MBC and the experimental results showed that clove oil had antibacterial activity of Proteus, and with the increase of clove oil concentration, the inhibitory effect was better. When it reached a certain concentration, it can showed bactericidal effect that the MIC and MBC were 0.3125%, 0.6250%. The clove oil also had inhibitory effect on Streptococcus mutans biofilm with the concentration depedence. When the concentration of clove oil was 2.5000%, the average fluorescence intensity (live/dead bacteria) was 0.082 ± 0.007, the proportion of living bacteria decreased obviously, and biofilm disappeared. Conclusions The clove oil not only has inhibitory effect on Streptococcus mutants, but also can inhibit and clear the biofilm formation of Streptococcus.
3.Isolation and activity of an α-amylase inhibitor from white kidney beans
Xiaoqi ZHANG ; Mingyan YANG ; Yu MA ; Jia TIAN ; Jirong SONG
Acta Pharmaceutica Sinica 2007;42(12):1282-1287
An α-amylase inhibitor (α-AI) was isolated from white kidney beans (Phaseolus vulgaris. L) by ethanol fractional precipitation, ion exchange chromatography and gel filtration column chromatography. It was a homogeneity glycoprotein demonstrated by SDS-PAGE and gel filtration on CL-6B. The glycoprotein contained 88.2% protein and was rich in aspartic acid, glutamic acid, leucine, threonine and serine. The carbohydrate moiety was consisted of Man, Glc, Gal and Xyl in a mole ratio of 2.42∶1.50∶1.52∶1.00. The glycan and the core protein backbone was connected by O-linkage as determined by β-elimination reaction. The continuous oral administration of the α-AI (150 mg·kg-1·d-1 ) for 7 days can lower fasting blood glucose and 300 mg·kg-1 ·d-1 α-AI for 7 days can improve the sugar tolerance on alloxan-dependent diabetic model rats. The result showed the α-AI obtained from white kidney beans had good hypoglycemic effect on alloxan induced diabetic rats and may have high potential pharmaceutical value as a regulative digestive-starch degradation in patients suffering from diabetes.
4.STUDIES ON THE OPTIMAL MIXED PROPORTION OF INOCULATION IN PRODUCING SINGLE SELL PROTEIN
Kangzhen XU ; Jirong SONG ; Jie HUANG ; Tao YIN ;
Microbiology 1992;0(04):-
Using apple pomace to produce single cell protein (SPC) with three and four strains respectively, the optimal mixed proportion of inoculation, one of the main factors of multiple strains' fermentation to produce SPC, was studied The experiment and analysis indicated that a practicable method to get the optim al mixed proportion of inoculation was obtained, which will perfect correlative researches of this field

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