1.Establishment and application of evaluation criteria for rational use of pyrotinib
Yiyi LIAO ; Xin LI ; Yaowen XIA ; Hongmei ZHAO ; Qingqing CHEN
China Pharmacy 2025;36(6):742-747
OBJECTIVE To establish drug utilization evaluation (DUE) criteria for pyrotinib to promote its appropriate application in clinical practice. METHODS Based on the label of Pyrotinib maleate tablets, with relevant guiding principles and diagnostic and treatment guidelines as the evaluation basis, DUE criteria for pyrotinib were determined through the Delphi method. Attribute hierarchical model (AHM) and entropy weight method (EWM) were used to combine and assign weights to each indicator within the DUE criteria. Additionally, the weighted technique for order preference by similarity to an ideal solution (TOPSIS) method was applied to perform rationality evaluation of medication in archived medical records from Hainan Provincial Tumor Hospital and Hainan Western Central Hospital regarding the use of pyrotinib from November 2019 to November 2023. RESULTS The established DUE criteria for pyrotinib included 4 primary indicators (prescription authority, indications for use, medication process, and medication outcomes) and 11 secondary indicators. The secondary indicators with higher weights were the route of administration and dosage (0.257) and indications in the label (0.241). Among the 88 archived cases included, there were 28 cases of inappropriate medication (31.82%), 43 cases of generally appropriate medication (48.86%), and 17 cases of appropriate medication (19.32%). The main issues related to inappropriate medication involved off-label use (42.05%) and inappropriate routes of administration and dosage (43.18%). CONCLUSIONS DUE criteria for pyrotinib established using the AHM-EWM-weighted TOPSIS method is highly operational and results in quantifiable evaluation outcomes. The overall rationality of the use of pyrotinib in the above hospitals remains to be improved, and there are some issues, like the off-label use,and inappropriate routes of administration and dosage being liaoyylyy@163.com unreasonable.
2.Optimization of temperature parameters for screening unexpected antibodies in Rh system by manual polybrene test
Xin ZOU ; Minjie CHEN ; Sifei MA ; Hongmei YANG
Chinese Journal of Blood Transfusion 2025;38(1):97-100
[Objective] To explore the temperature parameters affecting the polybrene test and determine the optimal temperature conditions for detecting unexpected antibodies of the Rh system. [Methods] The reaction of IgG human anti-D antibody with different dilutions (undiluted, 1∶2, 1∶4, 1∶8, 1∶16, 1∶32,1∶64) with D antigen-positive red blood cells was detected by manual polybrene test (MPT). Different temperatures (25℃ and 37℃) were set, and the reaction time with low ionic medium was 4 minutes. The agglutination integral value of anti-D and red cell depolymerization time were compared to observe the effect of enhanced agglutination reaction, thereby establishing the test temperature reaction conditions for enhancing the MPT. The same reaction condition was applied to 36 blood samples containing unexpected antibodies of the Rh system, and the effect of enhanced MPT was observed in comparison with the polybrene method and the antiglobulin test (column agglutination). [Results] With all other conditions held constant, when low ionic medium was added, the incubation temperature of 25℃ and 37℃ resulted in different total agglutination integral values for anti-D (20.9±2.025 vs 25.5±2.635), and the comparison showed a significant difference (P<0.05). When the antibody dilution was 1∶16, the incubation temperature of 25℃ and 37℃ resulted in different agglutination integral values (3.9±0.738 vs 5.8±0.632), and the comparison showed a significant difference (P<0.05). Erythrocyte depolymerization time (62.8±8.149 vs 90.1±10.713) was significantly different (P<0.05). At a dilution of 1∶32, the incubation temperatures of 25℃ and 37℃ resulted in different agglutination integral values (2.5±0.527 vs 4.3±0.675), as well as different red blood cell dissociation times (35.4±7.792 vs 57.4±10.885)(P<0.05), and the comparison showed a significant difference (P<0.05), with no differences observed in the other groups. In the detection of 36 Rh system unexpected antibody samples, when the antibody titer was ≤2, the enhanced polybrene method had a higher positive rate, and when the antibody titer was ≥4, the detection rates of the three methods were consistent. [Conclusion] The reference temperature condition for the modified MPT is incubation at 37℃ for 4 min after the addition of low ionic medium. The application of this temperature condition to unexpected antibody samples of Rh system could achieve a significant enhancement effect, thereby increasing transfusion safety for the treatment of emergency patients, and is worth popularizing.
3.Application of Thermal Tomography in Breast Cancer Screening
Kankan ZHAO ; Bo CHEN ; Wenliang LU ; Yao CHENG ; Hongmei ZHENG ; Xinhong WU ; Shengrong SUN ; Ziming HUANG
Cancer Research on Prevention and Treatment 2025;52(5):388-392
Objective To evaluate the effectiveness of thermal tomography in breast cancer (BC) screening. Methods We conducted a general population-based BC screening in three regions of Hubei Province (Xiantao, Hongan, and Yangxin Districts). Participants underwent a questionnaire-based interview for baseline data collection. They then received a physical examination, thermal tomography, and ultrasound from doctors and technicians. We compared the efficacies, including sensitivity, specificity, and false-positive rates, of ultrasound and thermal tomography in BC screening. Results A total of 59 712 eligible women were included in this screening program. The BI-RADS 1, 2, 3, 4, and 5 accordance rates between the two screening methods were
4.Interpretation of Chinese expert consensus on flow cytometric detection of hematological malignant cells in tissue samples
Liangmei LI ; Shuang CHEN ; Lian LI ; Zailin YANG ; Xia MAO ; Mingxia ZHU ; Hongmei JING ; Min XIAO ; Yao LIU ; Yanrong LIU
International Journal of Laboratory Medicine 2025;46(11):1281-1289
Hematologic malignancies,such as lymphoma,myeloma,and myeloid neoplasms,can occur in extramedullary tissues.Traditional histopathological morphology and immunohistochemical staining have lim-itations,including time-consuming specimen processing,prolonged reporting cycles,and relatively low sensi-tivity in cases of limited cell numbers.Flow cytometry offers significant advantages in detecting tissue sam-ples,such as rapid processing,shorter reporting cycles,and high accuracy and sensitivity,making it an effective complement to histopathological and immunohistochemical methods.However,the application of flow cytome-try in tissue sample detection currently lacks standardized protocols for sample collection and preservation,single-cell suspension preparation,antibody panel design for limited samples,data analysis,and result repor-ting.To promote the standardized application of flow cytometry in detecting hematologic tumor cells in tissue samples,the Cell Analysis Professional Committee of the Chinese Society of Biotechnology organized experts to develop the Chinese Expert Consensus on Flow Cytometry for Detecting Hematologic Tumor Cells in Tis-sue Samples(hereinafter referred to as the Consensus).This Consensus elaborates on the technical aspects of flow cytometry for tissue sample detection,covering sample processing,antibody panel design,data analysis,reporting content,and quality management.It particularly emphasizes recommended antibody panels and data analysis methods for flow cytometry when tissue sample cell counts are low.This article aims to interpret the key points of the Consensus to facilitate its better application in clinical practice.
5.The characteristics of intestinal flora and its correlation with peripheral blood microinflammatory factors in patients with pulmonary tuberculosis complicated with diabetes mellitus
Manjiao FU ; Jia LIU ; Huimin LIU ; Yi KANG ; An ZHAI ; Hongmei CHEN ; Liang CHEN ; Yuexi YUAN
International Journal of Laboratory Medicine 2025;46(14):1736-1741
Objective To investigate the characteristics of intestinal flora and its correlation with peripheral blood microinflammatory factors in patients with pulmonary tuberculosis complicated with diabetes mellitus(PTB-DM).Methods A total of 162 patients with PTB-DM admitted to the hospital from September 2022 to September 2024 were selected as the PTB-DM group,and another 150 healthy subjects who underwent physi-cal examinations during the same period in the hospital were selected as the control group.The clinical data of all research subjects was collected.The composition of intestinal flora of the research subjects was analyzed by using 16S rRNA gene sequencing technology.The levels of peripheral blood microinflammatory factors[inter-feron-γ(IFN-γ),interleukin-6(IL-6),and tumor necrosis factor-α(TNF-α)]in all research subjects were detected.The clinical data,composition of intestinal flora and levels of microinflammatory factors of the PTB-DM group were compared with those of the control group.Spearman correlation analysis was used to analyze the correlation between the relative abundance of intestinal flora and the levels of peripheral blood microin-flammatory factors in patients with PTB-DM.Results The relative abundances of Bacteroidales and Clostridi-ales in the PTB-DM group were significantly lower than those in the control group,while the relative abun-dances of Enterobacterales and Actinobacteriales were significantly higher than those in the control group,and the differences were statistically significant(P<0.05).The levels of IFN-γ,IL-6 and TNF-α in the PTB-DM group were significantly higher than those in the control group,and the differences were statistically signifi-cant(P<0.05).The relative abundances of Bacteroidales and Clostridiales in the PTB-DM group were nega-tively correlated with the levels of IFN-γ,IL-6 and TNF-α.The relative abundances of Enterobacterales and Actinobacteriales were positively correlated with the levels of IFN-γ,IL-6 and TNF-α(all P<0.05).Conclu-sion There is a significant imbalance of intestinal flora in patients with PTB-DM,and the levels of microin-flammatory factors IFN-γ,IL-6 and TNF-α in peripheral blood are significantly increased,and are closely re-lated to the relative abundance of specific flora.
6.Progress in the application of coagulation curve waveform analysis in the detection of coagulation function
Hongmei DONG ; Huan WANG ; Huihui DING ; Hong CHEN
International Journal of Laboratory Medicine 2025;46(15):1879-1884
The detection of coagulation function is helpful for the diagnosis of blood diseases,the assess-ment of bleeding and thrombus risks in patients,and the treatment of hemostasis and anticoagulation.It plays an important role in the diagnosis,treatment,and prevention of diseases.Solidification curve waveform analy-sis is a newly developed method for assessing coagulation function.It obtains more sensitive parameters for e-valuating the coagulation function of the body by taking the order derivative of the waveform reflecting the co-agulation process in routine coagulation experiments.Compared with traditional coagulation function tests,co-agulation cuvre waveform analysis curves is more comprehensive and effective in assessing the risk of bleeding and thrombosis.
7.Research progress in the clinical application and mechanisms of Chinese materia medica in treating chronic atrophic gastritis of spleen-stomach damp-heat syndrome
Lining SU ; Junhong LIU ; Dan WANG ; Jinxue ZHANG ; Hongmei LI ; Bingrui XU ; Jiale CHEN ; Yudie HE
International Journal of Traditional Chinese Medicine 2025;47(12):1792-1797
Spleen-stomach damp-heat syndrome is currently the most prevalent TCM pattern in patients with chronic atrophic gastritis (CAG), with internal damp-heat accumulation regarded as a key factor contributing to its prolonged and refractory course. This syndrome represents a critical stage in the progressive pathogenesis of CAG, characterized by a deepening pathological evolution. Modern TCM practitioners generally agree that its core pathogenesis lies in "deficiency in root and excess in superficiality, with internal damp-heat retention", and emphasize a treatment strategy that combines eliminating pathogenic factors and reinforcing the body's healthy qi through dynamic syndrome differentiation. Chinese materia medica used in treating CAG with spleen-stomach damp-heat syndrome can effectively relieve clinical symptoms, improve the internal damp-heat environment, mitigate gastric mucosal atrophy and intestinal metaplasia, and delay the inflammation-to-cancer transformation. Its mechanisms may involve eradication of Helicobacter pylori, repair of gastric mucosal injury, regulation of immune inflammatory response and other aspects, which has the advantages of multi-channel and multi-target.
8.Equivalence of SYN008 versus omalizumab in patients with refractory chronic spontaneous urticaria: A multicenter, randomized, double-blind, parallel-group, active-controlled phase III study.
Jingyi LI ; Yunsheng LIANG ; Wenli FENG ; Liehua DENG ; Hong FANG ; Chao JI ; Youkun LIN ; Furen ZHANG ; Rushan XIA ; Chunlei ZHANG ; Shuping GUO ; Mao LIN ; Yanling LI ; Shoumin ZHANG ; Xiaojing KANG ; Liuqing CHEN ; Zhiqiang SONG ; Xu YAO ; Chengxin LI ; Xiuping HAN ; Guoxiang GUO ; Qing GUO ; Xinsuo DUAN ; Jie LI ; Juan SU ; Shanshan LI ; Qing SUN ; Juan TAO ; Yangfeng DING ; Danqi DENG ; Fuqiu LI ; Haiyun SUO ; Shunquan WU ; Jingbo QIU ; Hongmei LUO ; Linfeng LI ; Ruoyu LI
Chinese Medical Journal 2025;138(16):2040-2042
9.Effects of milk processing method on the content of esculentoside A and hepatotoxicity in Mongolian medicine Phytolacca acinosa
Jinhua CHEN ; Hongmei CHEN ; XINTUYA ; Xing’an ZHOU ; Jiesi WU ; Minglan BAO
China Pharmacy 2025;36(23):2941-2945
OBJECTIVE To study the effects of milk processing method on the content of esculentoside A and hepatotoxicity in Mongolian medicine Phytolacca acinosa. METHODS High performance liquid chromatography-evaporative light-scattering detection was used to determine the content of esculentoside A in raw P. acinosa, milk-soaked P. acinosa and milk-boiled P. acinosa. The rats were randomly divided into normal group, raw P. acinosa group, milk-soaked P. acinosa group and milk-boiled P. acinosa group, with 10 rats in each group. Except for the normal group, the rats in the remaining groups were administered corresponding medicinal solutions at a dose of 0.8 g/kg once daily for 15 consecutive days. After the last administration, the levels of biochemical markers [alanine transaminase (ALT), aspartate transaminase (AST)] and inflammatory factors [interleukin-2 (IL- 2), IL-6, tumor necrosis factor- α (TNF- α)] in plasma of rats, as well as the levels of malondialdehyde (MDA), superoxide dismutase (SOD) and glutathione peroxidase (GSH-Px) in liver tissue, were determined. The pathological changes of liver tissue in rats were observed. RESULTS The contents of esculentoside A in raw P. acinosa, milk-soaked P. acinosa and milk-boiled P. acinosa were 6.46-6.59, 4.79-4.89, 5.04-5.14 mg/g, respectively. Compared with the normal group, the plasma levels of ALT, AST, IL-2 and TNF-α in rats were increased significantly in the raw P. acinosa group (P<0.05), while the level of SOD in liver tissue was decreased significantly (P<0.05); scattered punctate necrotic foci were observed within the hepatic lobules, and hepatocytes exhibited slight vacuolar degeneration. Compared with the raw P. acinosa group, the levels of ALT and AST in plasma of rats and the level of MDA in liver tissue were all decreased significantly in the milk-soaked P. acinosa group and the milk-boiled P. acinosa group (P<0.05), while the level of SOD in liver tissue was increased significantly (P<0.05). The plasma level of TNF-α in the rats of the milk-soaked P. acinosa group and the plasma levels of IL-2 and IL-6 in the rats of the milk-boiled P. acinosa group were all decreased significantly (P<0.05); additionally, the degree of liver injury was markedly alleviated in both groups. CONCLUSIONS The content of esculentoside A and hepatotoxicity both decrease after processing Mongolian medicine P. acinosa using the milk processing method.
10.Influence of occupational hazard factors on incidence of hypertension in calcium carbide plant: Historical cohort study
Meng LIU ; Wei ZHANG ; Qi ZHUANG ; Xingyu PENG ; Jinling LIU ; Tiantian CHEN ; Hongmei GU ; Shu GUO
Journal of Environmental and Occupational Medicine 2025;42(5):565-570
Background The high work intensity and possible subsequently increased susceptibility to occupational hazards of calcium carbide plants may lead to hypertension in workers, but there are few studies on the relationship between occupational hazard exposure and hypertension in workers involving the production process of calcium carbide. Objective To explore the influence of occupational hazards on the incidence of hypertension in calcium carbide plants. Methods Using historical cohort design, the employees of a calcium carbide factory in the western part of Inner Mongolia Autonomous Region were selected as research subjects. According to the pre-determined inclusion and exclusion criteria, the study population comprised an exposure group of 377 employees (including furnace workers, inspection workers, and maintenance workers) exposed to dust, noise & carbon monoxide, and a control group of 388 employees (including central control workers, electricians, and administrative personnel) without above-mentioned exposure. The total sample size was 765 participants. The follow-up period was from April 2011 to October 2022, and the study endpoint was defined as the conclusion of the follow-up period or diagnosed hypertension in annual occupational health examination. Information on general demographic characteristics, living habits, and work status was collected from all study subjects. Cox proportional hazards regression model was used to analyze the association between occupational hazard exposure and the risk of hypertension among the calcium carbide plant employees. Results The average age, mean systolic and diastolic blood pressure, proportion of males, smoking rate, and alcohol consumption rate in the exposure group were higher than those in the control group (P<0.05). Compared to baseline, both systolic and diastolic blood pressure levels increased in the exposure group and the control group at the end of the follow-up (P<0.05). At the end of the follow-up, the average differences between systolic/ diastolic blood pressure and baseline values in the exposure group were higher than those in the control group (P<0.05). During the follow-up period, a total of 223 cases of hypertension occurred, with a total follow-up of

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