1.Analysis of ethical dilemmas and coping strategies for the establishment of human milk banks in hospitals
Yao JIN ; Zhenyan FU ; Huixiang SHANG ; Lijuan WEI ; Chi HUANG ; Juan CHEN ; Mingtao QUAN
Chinese Medical Ethics 2025;38(11):1441-1446
Breast milk is the optimal natural food for newborns. However, some newborns cannot receive maternal breast milk due to reasons such as mother-infant separation or insufficient lactation. The establishment of human milk banks (HMB) can effectively address these issues, thereby increasing the breastfeeding rate among hospitalized newborns and improving their quality of survival. However, HMB in China is still in the development and improvement stage. Its implementation involves a series of ethical issues, such as informed consent, privacy protection, economic incentives, quality and safety, and fair resource distribution, which hinder HMB’s widespread promotion. Therefore, discussing the ethical dilemmas faced by the widespread establishment of HMB in China’s hospitals and analyzing coping strategies are crucial for improving the breastfeeding rate of newborns. This paper deeply analyzed and sorted out the ethical issues and challenges currently faced by HMB in China, and proposed corresponding strategies, including “ensuring informed consent and voluntary participation of both donors and recipients,” “protecting the privacy of donors and recipients,” “establishing an ethics-based moral incentive and social support system,” “strictly controlling quality and safety issues”, and “developing fair and rational policies,” aiming to provide a reference solution for addressing ethical concerns in the establishment and operation of HMB.
2.Application of MSCT Image Post-Processing Techniques in the Identification of Rib Fracture Malunion
Jing-Chen GE ; Min SHANG ; Ming-Yang YAO ; Ming-Fei WEI ; Jun-Zhan SHI ; Ze-Wei YAO ; Jia-Yin SHI ; Fan LI
Journal of Forensic Medicine 2024;40(4):324-329
Objective To compare the application value of three image post-processing techniques volume rendering(VR),multiplanar reformation(MPR)and curved planar reformation(CPR)in the identifi-cation of rib fracture malunion.Methods The types and numbers of rib fracture malunion in 75 pa-tients were recorded,and the sensitivity,specificity,accuracy and Youden index of VR,MPR and CPR in the diagnosis of rib fracture malunion were compared.Receiver operator characteristic(ROC)curve was drawn and area under the curve(AUC)was calculated,and the detection rates of three image post-processing techniques for different types of rib fracture malunion were compared.Results A total of 243 rib fractures were malunion in 75 patients.The diagnostic sensitivity of VR,MPR and CPR for rib fracture malunion was 52.67%,79.84%and 91.36%,the specificity was 99.58%,97.89%and 99.15%,the accuracy was 83.66%,91.76%and 96.51%,the Youden index was 0.52,0.78 and 0.91,the AUC was 0.761,0.889 and 0.953,respectively.Compared with VR,there were statistically signifi-cant differences in the number of broken rib end misalignment over 1/3,broken rib end overlap,bro-ken rib end angulation and intercostal bridge detected in MPR(P<0.05).Compared with VR,there was a statistically significant difference in the number of different types of rib fracture malunion de-tected by CPR(P<0.05).Compared with MPR,there were statistically significant differences in the number of broken rib end misalignment over 1/3,broken rib end separation and intercostal bridge de-tected in CPR(P<0.05).Conclusion The three image post-processing techniques are of great signifi-cance for the identification of rib fracture malunion.Especially CPR is highly effective in the diagno-sis of rib fracture malunion,and can be used as the main post-processing technique for forensic clini-cal identification of rib fracture malunion.
3.Efficacy evaluation of extending or switching to tenofovir amibufenamide in patients with chronic hepatitis B: a phase Ⅲ randomized controlled study
Zhihong LIU ; Qinglong JIN ; Yuexin ZHANG ; Guozhong GONG ; Guicheng WU ; Lvfeng YAO ; Xiaofeng WEN ; Zhiliang GAO ; Yan HUANG ; Daokun YANG ; Enqiang CHEN ; Qing MAO ; Shide LIN ; Jia SHANG ; Huanyu GONG ; Lihua ZHONG ; Huafa YIN ; Fengmei WANG ; Peng HU ; Xiaoqing ZHANG ; Qunjie GAO ; Chaonan JIN ; Chuan LI ; Junqi NIU ; Jinlin HOU
Chinese Journal of Hepatology 2024;32(10):883-892
Objective:In chronic hepatitis B (CHB) patients with previous 96-week treatment with tenofovir amibufenamide (TMF) or tenofovir disoproxil fumarate (TDF), we investigated the efficacy of sequential TMF treatment from 96 to 144 weeks.Methods:Enrolled subjects who were previously assigned (2:1) to receive either 25 mg TMF or 300 mg TDF with matching placebo for 96 weeks received extended or switched TMF treatment for 48 weeks. Efficacy was evaluated based on virological, serological, biological parameters, and fibrosis staging. Statistical analysis was performed using the McNemar test, t-test, or Log-Rank test according to the data. Results:593 subjects from the initial TMF group and 287 subjects from the TDF group were included at week 144, with the proportions of HBV DNA<20 IU/ml at week 144 being 86.2% and 83.3%, respectively, and 78.1% and 73.8% in patients with baseline HBV DNA levels ≥8 log10 IU/ml. Resistance to tenofovir was not detected in both groups. For HBeAg loss and seroconversion rates, both groups showed a further increase from week 96 to 144 and the 3-year cumulative rates of HBeAg loss were about 35% in each group. However, HBsAg levels were less affected during 96 to 144 weeks. For patients switched from TDF to TMF, a substantial further increase in the alanine aminotransferase (ALT) normalization rate was observed (11.4%), along with improved FIB-4 scores.Conclusion:After 144 weeks of TMF treatment, CHB patients achieved high rates of virological, serological, and biochemical responses, as well as improved liver fibrosis outcomes. Also, switching to TMF resulted in significant benefits in ALT normalization rates (NCT03903796).
4.Safety profile of tenofovir amibufenamide therapy extension or switching in patients with chronic hepatitis B: a phase Ⅲ multicenter, randomized controlled trial
Zhihong LIU ; Qinglong JIN ; Yuexin ZHANG ; Guozhong GONG ; Guicheng WU ; Lvfeng YAO ; Xiaofeng WEN ; Zhiliang GAO ; Yan HUANG ; Daokun YANG ; Enqiang CHEN ; Qing MAO ; Shide LIN ; Jia SHANG ; Huanyu GONG ; Lihua ZHONG ; Huafa YIN ; Fengmei WANG ; Peng HU ; Xiaoqing ZHANG ; Qunjie GAO ; Peng XIA ; Chuan LI ; Junqi NIU ; Jinlin HOU
Chinese Journal of Hepatology 2024;32(10):893-903
Objective:In chronic hepatitis B (CHB) patients with previous 96-week treatment with tenofovir amibufenamide (TMF) or tenofovir disoproxil fumarate (TDF), we investigated the safety profile of sequential TMF treatment from 96 to 144 weeks.Methods:Enrolled subjects that previously assigned (2:1) to receive either 25 mg TMF or 300 mg TDF with matching placebo for 96 weeks received extending or switching TMF treatment for 48 weeks. Safety profiles of kidney, bone, metabolism, body weight, and others were evaluated.Results:666 subjects from the initial TMF group and 336 subjects from TDF group with at least one dose of assigned treatment were included at week 144. The overall safety profile was favorable in each group and generally similar between extended or switched TMF treatments from week 96 to 144. In subjects switching from TDF to TMF, the non-indexed estimated glomerular filtration rate (by non-indexed CKD-EPI formula) and creatinine clearance (by Cockcroft-Gault formula) were both increased, which were (2.31±8.33) ml/min and (4.24±13.94) ml/min, respectively. These changes were also higher than those in subjects with extending TMF treatment [(0.91±8.06) ml/min and (1.30±13.94) ml/min]. Meanwhile, switching to TMF also led to an increase of the bone mineral density (BMD) by 0.75% in hip and 1.41% in spine. On the other side, a slight change in TC/HDL ratio by 0.16 (IQR: 0.00, 0.43) and an increase in body mass index (BMI) by (0.54±0.98) kg/m 2 were oberved with patients switched to TMF, which were significantly higher than that in TMF group. Conclusion:CHB patients receiving 144 weeks of TMF treatment showed favorable safety profile. After switching to TMF, the bone and renal safety was significantly improved in TDF group, though experienceing change in metabolic parameters and weight gain (NCT03903796).
5.Differential component analysis between Fructus Tritici Levis and Triticum aestivum based on qualitative and quantitative methods
Xuejiao LI ; Yu HU ; Yun CHEN ; Juan SHANG ; Zhenyang LI ; Yunhua FENG ; Jiandong ZOU ; Weifeng YAO ; Su LU ; Meijuan XU
China Pharmacy 2024;35(11):1296-1302
OBJECTIVE To analyze the compositional differences between Fructus Tritici Levis and Triticum aestivum, and to provide reference for identification and quality control of both. METHODS Twenty batches of Fructus Tritici Levis and three batches of T. aestivum were collected, and their fingerprints were acquired by high-performance liquid chromatography and the similarities were evaluated by the Evaluation System of Similarity of Chromatographic Fingerprints of Traditional Chinese Medicine (2012 version). Cluster analysis (CA), principal component analysis (PCA) and orthogonal partial least squares-discriminant analysis (OPLS-DA) were performed to analyze the difference of Fructus Tritici Levis and T. aestivum from different regions, and the differential components were screened. The contents of the six identified components in Fructus Tritici Levis and T. aestivum were determined. RESULTS The similarities of the fingerprints of Fructus Tritici Levis ranged from 0.928 to 0.996, and the relative similarities of T. aestivum with Fructus Tritici Levis ranged from 0.761 to 0.773. A total of 19 common peaks were calibrated, and six components including linolenic acid, linoleic acid, 5-heptadecylresorcinol, 5-nonadodecylresorcinol, 5- heneicosylresorcinol, and 5-tricosylresorcinol were identified. The results of CA and PCA showed that Fructus Tritici Levis and T. aestivum could be clearly distinguished; the distribution of Fructus Tritici Levis from Anhui province was relatively concentrated. The results of OPLS-DA showed that linolenic acid, linoleic acid, and other six unknown compounds were the differential components between Fructus Tritici Levis and T. aestivum. The average contents of the six identified components in Fructus Tritici Levis were 0.100 9, 1.094 0, 0.005 1, 0.030 9, 0.098 2,and 0.024 8 mg/g, respectively; the contents of linolenic acid and linoleic acid in Fructus Tritici Levis were significantly higher than those in T. aestivum (P<0.05).CONCLUSIONS The established qualitative and quantitative methods are simple and reliable, and can be used for the identification and quality evaluation of Fructus Tritici Levis and T. aestivum. The identified differential components, such as linolenic acid and linoleic acid, can also provide clues for the differentiation and pharmacological study of Fructus Tritici Levis and T. aestivum.
6.Differential component analysis between Fructus Tritici Levis and Triticum aestivum based on qualitative and quantitative methods
Xuejiao LI ; Yu HU ; Yun CHEN ; Juan SHANG ; Zhenyang LI ; Yunhua FENG ; Jiandong ZOU ; Weifeng YAO ; Su LU ; Meijuan XU
China Pharmacy 2024;35(11):1296-1302
OBJECTIVE To analyze the compositional differences between Fructus Tritici Levis and Triticum aestivum, and to provide reference for identification and quality control of both. METHODS Twenty batches of Fructus Tritici Levis and three batches of T. aestivum were collected, and their fingerprints were acquired by high-performance liquid chromatography and the similarities were evaluated by the Evaluation System of Similarity of Chromatographic Fingerprints of Traditional Chinese Medicine (2012 version). Cluster analysis (CA), principal component analysis (PCA) and orthogonal partial least squares-discriminant analysis (OPLS-DA) were performed to analyze the difference of Fructus Tritici Levis and T. aestivum from different regions, and the differential components were screened. The contents of the six identified components in Fructus Tritici Levis and T. aestivum were determined. RESULTS The similarities of the fingerprints of Fructus Tritici Levis ranged from 0.928 to 0.996, and the relative similarities of T. aestivum with Fructus Tritici Levis ranged from 0.761 to 0.773. A total of 19 common peaks were calibrated, and six components including linolenic acid, linoleic acid, 5-heptadecylresorcinol, 5-nonadodecylresorcinol, 5- heneicosylresorcinol, and 5-tricosylresorcinol were identified. The results of CA and PCA showed that Fructus Tritici Levis and T. aestivum could be clearly distinguished; the distribution of Fructus Tritici Levis from Anhui province was relatively concentrated. The results of OPLS-DA showed that linolenic acid, linoleic acid, and other six unknown compounds were the differential components between Fructus Tritici Levis and T. aestivum. The average contents of the six identified components in Fructus Tritici Levis were 0.100 9, 1.094 0, 0.005 1, 0.030 9, 0.098 2,and 0.024 8 mg/g, respectively; the contents of linolenic acid and linoleic acid in Fructus Tritici Levis were significantly higher than those in T. aestivum (P<0.05).CONCLUSIONS The established qualitative and quantitative methods are simple and reliable, and can be used for the identification and quality evaluation of Fructus Tritici Levis and T. aestivum. The identified differential components, such as linolenic acid and linoleic acid, can also provide clues for the differentiation and pharmacological study of Fructus Tritici Levis and T. aestivum.
7.Application progress of electronic tongue on taste evaluation for drug products
Shu-ye QI ; Li-hua GENG ; Yue ZHAO ; Chen WANG ; Li ZHU ; Shang-chen YAO ; Bao-ming NING
Acta Pharmaceutica Sinica 2023;58(11):3151-3159
The taste of oral dosage forms has become a critical factor affecting the drug compliance and adherence to the treatment, and clinical application of the drug product may seriously restricted due to its bad taste. On the basis of the statement for the basic principle and specific performance of existing instruments, the application progress of electronic tongue on drug taste evaluation is addressed in detail. In view of its objective, fatigue-free, less harmful and accurate advantages, electronic tongue has been widely and meaningfully applied in the aspects of bitterness masking, and quality assessment and assurance of drug products. In addition, the reasons limiting the popularization of electronic tongue are mentioned in the paper, and some suggestions might be useful to enlarge the further application in the future.
8.Technical status and development trends of electronic tongue
Shu-ye QI ; Yue-zhong MAO ; Li-hua GENG ; Dao-xuan YANG ; Hui-dan TU ; Shang-chen YAO ; Shi-yi TIAN ; Bao-ming NING
Acta Pharmaceutica Sinica 2023;58(11):3165-3172
Electronic tongue is one kind of bionic detection technologies, which can objectively reflect the taste of drugs based on electrochemical principle. In this paper, the development histories of electronic tongue both of potential type and voltammetry type were introduced, including their detection principles and key innovation technologies. In order to comprehensively improve the understanding of electronic tongue, its technological progresses, such as the study of dedicated sensors or biosensors for specific tastes, and the development of miniaturized or hybrid devices, were also discussed in detail. And the challenges and countermeasures in the application of electronic tongue were analyzed to provide some suggestions for its further technology promotion.
9.Study on formulation screening of chloral hydrate oral solution
Shu-ye QI ; Wen-hui LIU ; Hui-dan TU ; Shang-chen YAO ; Bao-ming NING
Acta Pharmaceutica Sinica 2023;58(11):3210-3215
Chloral hydrate is a commonly used central sedative drug before pediatric clinical examination, but its clinical safety and medication adherence are needed to focus on normally because of its poor stability and palatability. Under the premise of investigating the stability of different formulations, their palatability were also screened by using both human sensory and electronic tongue evaluation techniques. Human sensory evaluation has been conducted with the informed consent of all participants in accordance with the ethical requirements of the Good Clinical Practice for Drug Trials. The results showed that the addition of sorbitol and sucralose could effectively ensure the stability of the oral solution. Sorbitol is the main taste-masking component, and the ratio of 40% sorbitol and 0.5% sucralose can effectively mask the bitterness, astringency and spicy taste of 10% chloral hydrate oral solution. The results detected by human sensory and electronic tongue have good correlation and complementarity, and the combination of these two methods is more conducive to getting objective and reasonable conclusions.
10.Comparison and improvement of palatability for multisourced oral azithromycin suspension
Shu-ye QI ; Yi ZHENG ; Min HUANG ; Min YANG ; Hui-dan TU ; Shang-chen YAO ; Bao-ming NING
Acta Pharmaceutica Sinica 2023;58(11):3216-3221
Azithromycin dry suspension is one of the most commonly used drugs in pediatric clinic, but its taste masking has been difficult to achieve. 5 representative products of azithromycin dry suspension were chose to compare their tastes both using electronic tongue and human sensory evaluation methods, and there existed the differences of bitterness, later bitterness, graininess, and adhesion among these products. Raman micro-imaging was used to determine the difference in taste mainly due to different prescription ingredients and manufacturing techniques. Through mixing the dry suspensions with alkaline mixing solvent, the bad taste of each product was masked after evenly dispersing in the solvent, and their tastes were all close to the taste of the solvent. In the future, it is planned to investigate the stability and bioavailability of the solvent preparations, and then to give the medication suggestion of solvent preparation after ensuring their efficacy.

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