1.Application of Raman spectroscopy in the quality control and in vitro permeation studies of topical drug formulations
Yingxin CUI ; Jingjing WEI ; Xiaoxia YE ; Jian LE
Journal of Pharmaceutical Practice and Service 2026;44(3):113-119
Transdermal drug delivery offers advantages such as safety, convenience, and high patient compliance. However, the complex structure of the skin and significant individual variability, particularly the barrier function of the stratum corneum, result in generally low bioavailability for topical formulations. The formulation of topical drug products is complex, with numerous factors influencing quality, which requires strict control of product quality. Raman spectroscopy, as a non-destructive vibrational technique, combined with chemometric methods, imaging technology, and other spectroscopic techniques, can be applied to study the key quality attributes of topical drug formulations. The applications of Raman spectroscopy in studies of the crystal form, particle size distribution, excipient research, and in vitro transdermal experiments of topical drug formulations were summarized. In particular, it focused on the use of Raman spectroscopy in the selection of skin samples for in vitro permeation tests, the study of drug spatial distribution in the skin, and the interactions between drugs and the skin.
2.The efficacy and safety of nebulized inhalation of recombinant human interferon α1b in the treatment of pediatric respiratory syncytial viral associated lower respiratory tract infections: a multicenter, randomized, double-blind, placebo-controlled phase Ⅲ clinical study
Xiaohui LIU ; Baoping XU ; Yunxiao SHANG ; Han ZHANG ; Zhenkun ZHANG ; Guangyu LIN ; Ju YIN ; Aihua CUI ; Guocheng ZHANG ; Zhaoling SHI ; Liwei GAO ; Chunming JIANG ; Junmei BIAN ; Yongjian HUANG ; Rongfang ZHANG ; Xiaomei LIU ; Xiaoqing YANG ; Yu TANG ; Lili ZHONG ; Hongmei QIAO ; Chuangli HAO ; Yuqing WANG ; Qubei LI ; Ling CAO ; Yungang YANG ; Ling LU ; Rongjun LIN ; Xingzhen SUN ; Wei ZHOU ; Qiang CHEN ; Jikui DENG ; Yuejie ZHENG ; Lin ZHAO ; Tao AI ; Xiaohong LIU ; Xiaoxia LU ; Ning JIANG ; Ming LI
Chinese Journal of Applied Clinical Pediatrics 2025;40(3):180-186
Objective:To evaluate the efficacy and safety of nebulized inhalation of recombinant human interferon (IFN) α1b injection in the treatment of respiratory syncytial virus (RSV) associated lower respiratory tract infections (pneumonia and bronchiolitis) in children.Methods:A randomized, double-blind, parallel, placebo-controlled add-on design was used.Children with pneumonia or bronchiolitis aged 2 months to 5 years who tested positive for RSV antigen within 72 hours of onset from 30 clinical trial sites including Beijing Children′s Hospital, Capital Medical University between February 2021 and December 2022 were included in this study and randomly divided into 2 groups at a ratio of 1∶1 based on a stratified-block method.Both groups received basic treatments such as cough control, asthma relieving, expectorant treatment, fever reduction, oxygen therapy, etc.The experimental group received additional nebulized inhalation of IFN α1b injection at a dose of 2.0 μg/(kg·time), twice a day.The control group received nebulized inhalation of placebo twice a day.Clinical efficacy was evaluated based on indicators such as the duration of clinical symptoms and signs, and the Kaplan-Meier method was used to calculate the median and 95% CI of the duration of clinical symptoms and signs.The Log-rank test was used to compared data between groups.Safety was assessed through the incidence of adverse reactions and laboratory tests, and the Chi-square test was used to analyze the difference between groups. Results:There were 123 children in the experimental group and 122 children in the control group.The median durations of all the 5 clinical symptoms and signs [including shortness of breath, wheezing, dyspnea (visible retractions), decreased transcutaneous oxygen saturation, and abnormal mental state] in the experimental group after treatment were slightly shortened than those in the control group [2.7 d(95% CI: 1.9-3.0 d)] vs.[2.9 d(95% CI: 2.6-3.6 d), P=0.027].The improvement in dyspnea (retractions) was especially pronounced in the experimental group, with a relief rate of 50.0% (0, 100%) on the first day of administration[compared with 0 (0, 50.0%) in the control group ( Z=2.002, P=0.025)].The median duration of dyspnea in the experimental group was nearly 1 day shorter than that in the control group [1.0 d(95% CI: 0.7-1.7 d) vs.1.8 d(95% CI: 1.0-2.5 d), P=0.046].There were no significant difference in hospital stay [6.0(5.0, 8.0) d vs.6.5(5.0, 8.0) d, Z=0.675, P=0.500], oxygen therapy duration [32.0(14.0, 96.3) h vs.39.0 (24.0, 83.2) h, Z=0.094, P=0.925], the recovery rate from clinical symptoms during treatment [(105/106, 99.1%) vs.(96/101, 95.0%)], and recurrence rate [(0/106, 0) vs.(2/101, 2.0%)] between the 2 groups (all P>0.05).However, the above-mentioned four indicators in the experimental group showed a trend of clinical benefits.The quantitative virus detection results showed that the RSV viral load in both groups decreased after treatment compared to before treatment.After 2 days of treatment, the decline rate of RSV viral load from the baseline was 0.90 lg copies/(mL·d) in the experimental group and 0.25 lg copies/(mL·d)in the control group, with a statistically significant difference ( P<0.05).Furthermore, there was no statistically significant difference in the incidence of adverse reactions between the 2 groups ( P>0.05).Importantly, no drug-related serious adverse reactions occurred in both groups. Conclusions:The nebulized inhalation therapy of IFN α1b demonstrates efficacy and safety in treating pediatric RSV associated lower respiratory tract infections.It particularly offers outstanding clinical therapeutic value for severe children.
3.Analysis of the medication patterns of famous traditional Chinese medicine practitioners for the treatment of idiopathic membranous nephropathy based on data mining
Sheng LI ; Xiaoxia FENG ; Lingzhi YU ; Min CUI ; Qin CHEN
China Modern Doctor 2025;63(28):58-63
Objective To explore the medication patterns of famous traditional Chinese medicine practitioners in treating challenging aspects of idiopathic membranous nephropathy(IMN)based on data mining.Methods Medical cases meeting the inclusion and exclusion criteria were collected.Statistical analysis of syndrome patterns,herb frequency,association rules,and cluster analysis were conducted for key challenges,including disease duration ≥ 1 year,renal function impairment,hypoalbuminemia,and hypertriglyceridemia.Results A total of 128 medical cases were included.Spleen-kidney deficiency syndrome was identified as the most common pattern.Based on herb frequency and association rule analysis,Huangqi,Baizhu,Fuling,Danggui,Danshen were the most frequently used in prescription.Cluster analysis revealed core herbal groupings primarily based on classical formulas such as Zhenwu decoction,Shenling Baizhu powder,and Shuilu Erxian dan.Conclusion In the medical cases addressing treatment challenges,the syndrome patterns were predominantly characterized by spleen-kidney deficiency.Core medications included Huangqi,Baizhu,Fuling,Danggui and Danshen.The treatment emphasizes strengthening invigorating spleen and kidney,with variations in medication patterns based on disease duration and complications.
4.Analysis of the medication patterns of famous traditional Chinese medicine practitioners for the treatment of idiopathic membranous nephropathy based on data mining
Sheng LI ; Xiaoxia FENG ; Lingzhi YU ; Min CUI ; Qin CHEN
China Modern Doctor 2025;63(28):58-63
Objective To explore the medication patterns of famous traditional Chinese medicine practitioners in treating challenging aspects of idiopathic membranous nephropathy(IMN)based on data mining.Methods Medical cases meeting the inclusion and exclusion criteria were collected.Statistical analysis of syndrome patterns,herb frequency,association rules,and cluster analysis were conducted for key challenges,including disease duration ≥ 1 year,renal function impairment,hypoalbuminemia,and hypertriglyceridemia.Results A total of 128 medical cases were included.Spleen-kidney deficiency syndrome was identified as the most common pattern.Based on herb frequency and association rule analysis,Huangqi,Baizhu,Fuling,Danggui,Danshen were the most frequently used in prescription.Cluster analysis revealed core herbal groupings primarily based on classical formulas such as Zhenwu decoction,Shenling Baizhu powder,and Shuilu Erxian dan.Conclusion In the medical cases addressing treatment challenges,the syndrome patterns were predominantly characterized by spleen-kidney deficiency.Core medications included Huangqi,Baizhu,Fuling,Danggui and Danshen.The treatment emphasizes strengthening invigorating spleen and kidney,with variations in medication patterns based on disease duration and complications.
5.Mechanistic Studies on the Improvement of Diabetic Peripheral Neuropathy by Plantamajoside via Promoting the PINK1/Parkin Mitochondrial Autophagy Pathway
Xiaoxia ZHANG ; Haoyuan DANG ; Mingyao FAN ; Huan PEI ; Jie ZHAO ; Huantian CUI ; Qingshan HAI
Journal of Kunming Medical University 2025;46(9):45-53
Objective To investigate the efficacy of plantamajoside(PMS)on diabetic peripheral neuropathy(DPN)and to explore its mechanism of action from mitochondrial autophagy.Methods Mice(C57BL/6J)were randomly divided into 6 groups(n=10):normal group(Control),model group(Model),positive drug group(LA),and low(L-PMS),medium(M-PMS),and high(H-PMS)dosage groups.High-sugar and high-fat diet with intraperitoneal injection of streptozotocin was used to duplicate the DPN model.After successful model duplication,the intervention was administered by gavage for 4 weeks.Sciatic nerve was taken,and pathological changes were observed by HE and Nissl staining;oxidative stress indexes SOD,MDA,GSH-Px and inflammatory factors such as IL-1β,IL-6,TNF-αin sciatic nerve tissues were detected by kits,and the expression of VDAC1,TOM20,COX IV,PINK1,Parkin,and autophagy proteins of Beclin1,LC3,P62 in mouse sciatic nerves was detected by Western blotting.Results PMS dose-dependently improved the behavioral indexes of DPN mice,reduced the pathological damage of sciatic nerve,and resulted in tightly arranged sciatic nerve fibers,clearly visible myelin structure,uniform coloration,and increased number of Schwann cells as well as Nissl bodies.Compared with the model group,both the M-PMS group and the H-PMS group increased the expression levels of SOD and GSH-Px(P<0.05),while decreased the expression of MDA(P<0.05);the M-PMS group and the H-PMS groups reduced the expression of IL-1β,IL-6,and TNF-α(P<0.05);the L-PMS group,M-PMS group,and H-PMS group reduced the expression levels of VDAC1,TOM20,and COX IV proteins(P<0.05);the L-PMS group,M-PMS group,and H-PMS group could differentially increase the expression of PINK1,Beclin1,Parkin,and LC3 proteins(P<0.05),and decrease the expression of P62 proteins(P<0.05).Conclusion PMS can play a role in ameliorating neurological injury in DPN mice by promoting PINK1/Parkin pathway-mediated mitochondrial autophagy and alleviating oxidative stress-related inflammatory injury.
6.The efficacy and safety of nebulized inhalation of recombinant human interferon α1b in the treatment of pediatric respiratory syncytial viral associated lower respiratory tract infections: a multicenter, randomized, double-blind, placebo-controlled phase Ⅲ clinical study
Xiaohui LIU ; Baoping XU ; Yunxiao SHANG ; Han ZHANG ; Zhenkun ZHANG ; Guangyu LIN ; Ju YIN ; Aihua CUI ; Guocheng ZHANG ; Zhaoling SHI ; Liwei GAO ; Chunming JIANG ; Junmei BIAN ; Yongjian HUANG ; Rongfang ZHANG ; Xiaomei LIU ; Xiaoqing YANG ; Yu TANG ; Lili ZHONG ; Hongmei QIAO ; Chuangli HAO ; Yuqing WANG ; Qubei LI ; Ling CAO ; Yungang YANG ; Ling LU ; Rongjun LIN ; Xingzhen SUN ; Wei ZHOU ; Qiang CHEN ; Jikui DENG ; Yuejie ZHENG ; Lin ZHAO ; Tao AI ; Xiaohong LIU ; Xiaoxia LU ; Ning JIANG ; Ming LI
Chinese Journal of Applied Clinical Pediatrics 2025;40(3):180-186
Objective:To evaluate the efficacy and safety of nebulized inhalation of recombinant human interferon (IFN) α1b injection in the treatment of respiratory syncytial virus (RSV) associated lower respiratory tract infections (pneumonia and bronchiolitis) in children.Methods:A randomized, double-blind, parallel, placebo-controlled add-on design was used.Children with pneumonia or bronchiolitis aged 2 months to 5 years who tested positive for RSV antigen within 72 hours of onset from 30 clinical trial sites including Beijing Children′s Hospital, Capital Medical University between February 2021 and December 2022 were included in this study and randomly divided into 2 groups at a ratio of 1∶1 based on a stratified-block method.Both groups received basic treatments such as cough control, asthma relieving, expectorant treatment, fever reduction, oxygen therapy, etc.The experimental group received additional nebulized inhalation of IFN α1b injection at a dose of 2.0 μg/(kg·time), twice a day.The control group received nebulized inhalation of placebo twice a day.Clinical efficacy was evaluated based on indicators such as the duration of clinical symptoms and signs, and the Kaplan-Meier method was used to calculate the median and 95% CI of the duration of clinical symptoms and signs.The Log-rank test was used to compared data between groups.Safety was assessed through the incidence of adverse reactions and laboratory tests, and the Chi-square test was used to analyze the difference between groups. Results:There were 123 children in the experimental group and 122 children in the control group.The median durations of all the 5 clinical symptoms and signs [including shortness of breath, wheezing, dyspnea (visible retractions), decreased transcutaneous oxygen saturation, and abnormal mental state] in the experimental group after treatment were slightly shortened than those in the control group [2.7 d(95% CI: 1.9-3.0 d)] vs.[2.9 d(95% CI: 2.6-3.6 d), P=0.027].The improvement in dyspnea (retractions) was especially pronounced in the experimental group, with a relief rate of 50.0% (0, 100%) on the first day of administration[compared with 0 (0, 50.0%) in the control group ( Z=2.002, P=0.025)].The median duration of dyspnea in the experimental group was nearly 1 day shorter than that in the control group [1.0 d(95% CI: 0.7-1.7 d) vs.1.8 d(95% CI: 1.0-2.5 d), P=0.046].There were no significant difference in hospital stay [6.0(5.0, 8.0) d vs.6.5(5.0, 8.0) d, Z=0.675, P=0.500], oxygen therapy duration [32.0(14.0, 96.3) h vs.39.0 (24.0, 83.2) h, Z=0.094, P=0.925], the recovery rate from clinical symptoms during treatment [(105/106, 99.1%) vs.(96/101, 95.0%)], and recurrence rate [(0/106, 0) vs.(2/101, 2.0%)] between the 2 groups (all P>0.05).However, the above-mentioned four indicators in the experimental group showed a trend of clinical benefits.The quantitative virus detection results showed that the RSV viral load in both groups decreased after treatment compared to before treatment.After 2 days of treatment, the decline rate of RSV viral load from the baseline was 0.90 lg copies/(mL·d) in the experimental group and 0.25 lg copies/(mL·d)in the control group, with a statistically significant difference ( P<0.05).Furthermore, there was no statistically significant difference in the incidence of adverse reactions between the 2 groups ( P>0.05).Importantly, no drug-related serious adverse reactions occurred in both groups. Conclusions:The nebulized inhalation therapy of IFN α1b demonstrates efficacy and safety in treating pediatric RSV associated lower respiratory tract infections.It particularly offers outstanding clinical therapeutic value for severe children.
7.Effects of multidisciplinary management combined with 60-second high-risk diabetic foot screening in patients with diabetic foot
Li LIU ; Xiaoxia FANG ; Kun ZHANG ; Xinli WANG ; Qingling SUN ; Yalin WANG ; Baoping CUI ; Jun CAO
Chinese Journal of Modern Nursing 2024;30(27):3673-3677
Objective:To explore the effect of multidisciplinary management combined with 60-second high-risk diabetic foot screening in diabetic foot.Methods:From January to December 2022, 138 patients with diabetic foot were selected from Xinxiang Central Hospital by convenience sampling. The patients were randomly divided into a control group and an observation group, with 69 cases in each group. Control group implemented routine follow-up management of diabetic foot, and observation group carried out multidisciplinary management combined with 60-second high-risk diabetic foot screening on the basis of control group, and the intervention lasted for six months. The progress of Wagner grading of diabetic foot and foot self-care were compared between the two groups.Results:After intervention, the number of Wagner grading progression patients in observation group and control group was four cases (5.80%) and 10 cases (14.49%), respectively. The number of progression patients in observation group was less than that in control group, and the difference was statistically significant (χ 2=4.161, P=0.041). The total score and dimension scores of diabetic foot self-management in the two groups after the intervention were higher than those before the intervention, but only the scores of observation group before and after the intervention were statistically significant ( P<0.05). After intervention, the total score and dimension scores of diabetic foot self-management in observation group were higher than those in control group, with a statistically significant difference ( P<0.05) . Conclusions:Multidisciplinary management combined with 60-second high-risk diabetic foot screening can effectively delay the progress of diabetic foot and improve patients' foot self-care.
8.Feasibility of wavelet index in monitoring depth of sedation with propofol in pediatric patients
Tingting ZI ; Jianmin ZHANG ; Xiaoxia PENG ; Lijing LI ; Jie YU ; Muyang TIAN ; Xiaohuan CUI ; Fang WANG
Chinese Journal of Anesthesiology 2024;44(8):1000-1005
Objective:To assess the feasibility of wavelet index (WLI) in monitoring the depth of sedation with propofol in pediatric patients.Methods:This was a prospective observational trial. One hundred and sixty-five pediatric patients, aged >1-12 yr, of American Society of Anesthesiologists Physical Status classification Ⅰ or Ⅱ, undergoing elective surgery requiring general anesthesia with endotracheal intubation or laryngeal mask airway from July to December 2016 in our hospital, were divided into 11 age groups ( n=15 each): >1-2 yr group, >2-3 yr group, >3-4 yr group, >4-5 yr group, >5-6 yr group, >6-7 yr group, >7-8 yr group, >8-9 yr group, >9-10 yr group, >10-11 yr group, and >11-12 yr group. General anesthesia was induced by injection of propofol 3 mg/kg for more than 30 s. WLI and BIS values were recorded immediately before administration and at 30, 40, 50, 60, 90, 120, 180 and 240 s after the end of administration. If there were differences among age groups, age groups with no statistically significant differences were combined and re-grouped. Pearson linear correlation analysis and Bland-Altman consistency analysis were performed. Results:A total of 149 pediatric patients were actually included. There were no significant differences in BIS values between 4 groups aged > 1-5 yr and between 7 groups aged > 5-12 yr ( P>0.05). Regrouping was performed based on the aforementioned results, 4 groups of children aged > 1-5 yr were divided into > 1-5 yr group ( n=60), and 7 groups of children aged > 5-12 yr were divided into > 5-12 yr group ( n=89). WLI values and BIS values were significantly decreased at each time point after administration compared with immediately before administration in group aged > 1-5 yr and in group aged >5-12 yr ( P<0.05). The BIS values were the lowest at 60 s after the end of the administration, and the WLI values were the lowest at 120 and 180 s after the end of the administration in two groups ( P<0.05). There were no statistically significant differences between WLI values and BIS values at 90 s and 240 s after the end of the administration ( P>0.05), and there was statistically significant difference at the other time points in group aged > 1-5 yr ( P<0.05). There was no significant difference between WLI values and BIS values at 180 s and 240 s after the end of the administration ( P>0.05), but there were significant differences at the other time points in group aged > 5-12 yr ( P<0.05). The Pearson correlation coefficients between WLI values and BIS values were 0.61 and 0.56 in group aged > 1-5 yr and group aged > 5-12 yr, respectively ( P<0.001). Bland-Altman agreement analysis: In group aged > 1-5 yr and group aged > 5-12 yr, the 95% agreement limits were -0.484-0.621 and -0.551-1.015, respectively, and there were 4.6% (23/504) and 5.1% (40/777) of the points outside the 95% agreement limits, respectively, and both limits exceeded the clinically acceptable range. Conclusions:WLI is feasible for monitoring the depth of sedation with propofol in pediatric patients aged > 1-12 yr, but the accuracy is lower than BIS.
9.Value of unenhanced CT combined with clinical features in predicting adnexal torsion in women
Xiaowen GU ; Lu JIANG ; Lei CUI ; Xiaoxia WU ; Jibin ZHANG ; Ying FEI
Chinese Journal of Clinical Medicine 2024;31(6):951-958
Objective To investigate the value of unenhanced CT combined with clinical features in predicting adnexal torsion in women with abdominal pain and an adnexal mass. Methods A retrospective selection of patients with abdominal pain and an adnexal mass underwent operation in 2 tertiary hospitals from January 2018 to September 2023. The torsion group (n=53) and non-torsion group (n=53) were matched in a 1∶1 ratio. 15 CT signs of adnexal masses were reviewed independently by two radiologists using a double-blind method. The high-risk factors were screened using multivariate logistic regression analysis. The diagnostic values of high-risk factors for adnexal torsion were assessed using receiver operating characteristic (ROC) curves. Results According to the surgical and pathological results, the most common adnexal mass in torsion group was mature cystic teratoma (32.1%), and the most common mass in the non-torsion group was adnexal abscess (20.8%). The age, fever rate, white blood cell count, location of mass, thickened fallopian tube rate, and pelvic effusion rate were not statistically different between the two groups, the nausea and vomiting and remaining CT signs were significant different between the two groups (P<0.05). Multivariate logistic analysis showed that nausea and vomiting (OR=4.886), navel sign (OR=22.733), and whirl sign (OR=43.462) were independently associated with adnexal torsion (P<0.05). The area under the curve (AUC) of nausea and vomiting, navel sign, and whirl sign were 0.717, 0.802, and 0.840, respectively; AUC of the combination of all three was 0.877 with 92.45% of sensitivity, 84.91% of specificity, 85.96% of positive predictive value, 91.84% of negative predictive value, and 88.68% of accuracy. Conclusions For women with abdominal pain and an adnexal mass, nausea and vomiting, navel sign, and whirl sign are help of predicting adnexal torsion, and combination value of all three is best.
10.Risk factors and prediction model of catheter-associated urinary tract multidrug resistant bacterial infection in elderly patients
Juan LIU ; Xiaoxia ZHANG ; Feng ZANG ; Songqin LI ; Zhanjie LI ; Ting CUI ; Ke WANG ; Xiaoying LAI ; Dongfang ZHANG
Chongqing Medicine 2024;53(10):1519-1524
Objective To study the infection of multidrug-resistant organism(MDRO)in elderly pa-tients with catheter-associated urinary tract infection(CAUTI)and analyze the infection factors.Methods The medi-cal records of 175 elderly patients with CAUTI admitted to Jiangsu Province Hospital from January 2021 to July 2022 were selected,the distribution of MDRO infection in elderly patients with CAUTI was analyzed,and the influencing factors of MDRO infection were analyzed.The predictive value of independent risk factors for rele-vant nosocomial infections was analyzed by receiver operating characteristics(ROC)curves.Results Among the 175 elderly patients with CAUTI,87 cases(49.71%)developed MDRO infection and were included in the MDRO infection group),and 88 cases(50.29%)had no MDRO infection and were included in the non-MDRO infection group.A total of 432 MDRO pathogens were detected in the MDRO infection group,inclu-ding 415 strains of Gram-negative bacteria,accounting for 96.06%,186 strains of carbapenem-resistant Acine-tobacter baumannii(43.06%),147 strains of carbapenem-resistant Klebsiella pneumoniae(34.03%),79 strains of carbapenem-resistant Pseudomonas aeruginosa(18.29%)and 3 strains of carbapenem-resistant Escherichia coli(0.69%).There were 17 strains of Gram-positive bacteria(3.94%),all of which were methi-cillin-resistant Staphylococcus aureus.Multivariate analysis showed that the use of carbapenems,tigecycline,polymyxin,and days of central venous intubation were considered as independent risk factors.The area under the curve of MDRO infection was 0.883.Conclusion For elderly patients with CAUTI,it is necessary to take strict antimicrobial management measures,master the indications of antimicrobial application,shorten the hos-pitalization time of patients and reduce the incidence of MDRO infection.

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