1.A study on the legitimacy and reality of reproduce rights for single women
Chinese Medical Ethics 2025;38(5):634-641
With the social transformation, single women’s reproductive rights have appeared more and more frequently in the public sphere. However, the relevant legal norms have not yet clarified reproductive rights. This paper demonstrated the nature and subjects of reproductive rights, as well as clarified that reproductive rights are human rights owned equally by all natural persons. Judicially, it also analyzed the phenomenon of differential treatment of single women and single widowed women in the realization of their reproductive rights from the judicial practice, explored the main factors for widowed single women to realize their reproductive rights, and compared the possibilities of realizing single reproduction. Conceptually, the main ethical objections against single women’s realization of their reproductive rights were discussed to eliminate the obstacles to single women’s reproductive rights. From the perspective of social reality, the transformation of social factors such as fertility concepts and child-rearing structures were analyzed, to demonstrate the legitimacy and reality of the realization of single women’s reproductive rights.
2.Prevalence and associated factors of diabetic retinopathy among diabetic residents in Longyan of Fujian Province
Shaoqing MA ; Jianning WU ; Dehua CAO ; Yan CHEN ; Pinsheng QIU
Chinese Journal of Ocular Fundus Diseases 2024;40(8):598-607
Objective:To investigate the prevalence and associated factors of diabetic retinopathy (DR) among diabetic residents in Longyan of Fujian Province.Methods:A investigative research. From January 2022 to December 2023, a total of 10 061 diabetic patients enrolled in the chronic disease follow-up management system from 112 towns and sub-districts in 7 counties and districts of Longyan of Fujian Province were selected as the target population. A questionnaire survey, routine physical examination, vision test, and non-mydriatic fundus photography were conducted. A total of 762 cases with missing height, weight, blood pressure, fasting plasma glucose (FPG), and diabetes duration, and 507 cases with unclear fundus photography were excluded, resulting in 8 792 cases included in the final statistical analysis. DR diagnosis and classification were based on the 2019 International Clinical Classification of DR. The prevalence of DR was calculated for single-eye or double-eye DR cases as 1 case; the more severe eye was used for DR grading in double-eye DR cases. Statistical analysis was performed by grouping based on the presence or absence of DR and dividing into age groups ≤67 years and >67 years. χ2 test was used to analyze factors associated with prevalence; binary multivariate logistic regression analysis was employed to identify influencing factors of DR. Results:Among the 8 792 cases, 888 (10.1%, 888/8 792) were diagnosed with DR (DR group), and 7 904 (89.9%, 7 904/8 792) had no DR (non-DR group). Compared to the non-DR group, the DR group showed significant increases in FPG ( Z=-12.448), diabetes duration ( Z=-18.936), systolic blood pressure ( Z=-4.237), diastolic blood pressure ( Z=-2.881), and body mass index (BMI) ≥24 kg/m 2 ( P<0.001). Significant differences were also found between the two groups in hypertension ( χ2=11.450), hyperlipidemia ( χ2=5.100), kidney disease ( χ2=7.039), family history of diabetes ( χ2=5.025), and regular medication use ( χ2=66.034) ( P<0.05). There were 4 688 cases in the ≤67 years group and 4 104 in the >67 years group. In the ≤67 years group, significant differences in DR prevalence were found for FPG levels ( χ2=111.754), diabetes duration ( χ2=231.658), BMI ( χ2=12.404), systolic blood pressure ( χ2=17.912), regular medication use ( χ2=40.727), hyperlipidemia ( χ2=6.816), and hypertension history ( χ2=6.775) ( P<0.05). In the >67 years group, significant differences in DR prevalence were found for FPG levels ( χ2=59.916), diabetes duration ( χ2=128.362), systolic blood pressure ( χ2=5.183), regular medication use ( χ2=22.097), kidney disease ( χ2=6.251), and family history of diabetes duration ( χ2=4.967) ( P<0.05). No significant differences in DR prevalence were found based on sex, education level, smoking history, alcohol consumption, exercise habits, heart disease history, or other family disease history ( P>0.05). Logistics regression analysis results show that patients aged >67 years, FPG [odds ratio (OR)=1.074, 95%confidence interval ( CI) 1.046-1.102], diabetes duration ( OR=1.088, 95% CI 1.071-1.106), systolic blood pressure ( OR=1.007, 95% CI 1.001-1.013), and kidney disease ( OR=3.617, 95% CI 1.268-10.320) were identified as risk factors for DR ( P<0.05). In patients aged ≤67 years, FPG ( OR=1.088, 95% CI 1.067-1.110), diabetes duration ( OR=1.108, 95% CI 1.091-1.125), and systolic blood pressure ( OR=1.008, 95% CI 1.003-1.013) were identified as independent risk factors for DR ( P<0.05), while BMI ≥24 kg/m 2 ( OR=0.934, 95% CI 0.908-0.965) was a protective factor for DR ( P<0.05). Age, regular medication use, hypertension, and hyperlipidemia were identified as potential confounding factors for DR occurrence. Conclusions:The prevalence of DR among diabetes patients in Longyan of Fujian Province, is 10.1%. FPG, diabete duration, and systolic blood pressure are independent risk factors for DR, while age, regular medication use, hypertension, and hyperlipidemia are potential confounding factors for DR occurrence.
3.Status quo and improvement countermeasures of the priority review system for encouraged generic drug in China
China Pharmacy 2023;34(2):129-132
OBJECTIVE To provide reference for better implementation of the priority review system for generic drugs of encouraged generic drug catalogues. METHODS Based on literature research, practical status of the priority review system for generic drugs in two batches of encouraged generic drug catalogues in China was analyzed, and the problems existing in the application of the system were compared to propose corresponding solutions. RESULTS & CONCLUSIONS China has issued two batches of encouraged generic drug catalogues, and there were 49 varieties of generic drugs included in the catalogues. In the implementation of the priority review system for generic drugs of encouraged generic drug catalogues, there were some problems in legislation, incentive system for the first generic drug, post-marketing re-evaluation system, and cross-departmental coordination and linkage mechanism. It is suggested to strengthen legislation, improve the “first generic market exclusivity period” system, perfect the post-marketing re-evaluation system and form a normalized cross-departmental coordination mechanism so as to ensure the safety, effectiveness and accessibility of generic drugs in China.
4.Review of the competitive generic drug incentive system in the United States and its enlightenment to China
China Pharmacy 2023;34(13):1562-1566
OBJECTIVE To provide ideas and inspiration for promoting the development of the generic drug industry and legal system of China. METHODS With text analysis, empirical research and other methods, the competitive generic drug incentive system in the United States was combed, its implementation effect and successful experience were analyzed, and the reference was provided for the implementation of relevant systems in China. RESULTS The competitive generic drug incentive system in the United States had achieved a satisfactory effect in three aspects: encouraging generic drug applications, accelerating the listing of generic drugs, and promoting drug price reduction, which was ultimately conducive to improving drug accessibility by publishing List of Off-Patent,Off-Exclusivity Drugs without an Approved Generic, while accelerating the development and review of generic drugs with insufficient competition and giving market exclusivity periods. CONCLUSIONS China’s reference to the competitive generic drug incentive system in the United States meets the needs of the current situation of domestic drug supply and also has the basis for industry practice. Therefore, we can refer to it, improve the system of releasing the catalog of encouraged generic drugs to be imitated, optimize the approval process for them, and authorize the exclusive period incentive to them.
5.Protection of Informed Consent Rights for Subjects in Drug Clinical Trials
Chinese Medical Ethics 2023;36(8):840-846
The right to informed consent is the basic right of subjects in drug clinical trials. International treaties and domestic laws have successively formed a basic right protection framework, while there are still some problems such as imperfect legal norms and incomplete practical operations. To meet future challenges, it is necessary to further improve legislation, standardize notification procedures, improve notification content, expand dynamic notification methods, and strengthen ethical review, so as to build a standardized and modern system for protecting the right to informed consent of subjects.
6.Significance of serum circRNA hsa_circ_0000437 in the auxiliary diagnosis and prognosis of gastric cancer
Xianjuan SHEN ; Lei SHEN ; Shuo MA ; Jing QI ; Shaoqing JU
Chinese Journal of Laboratory Medicine 2022;45(5):509-515
Objective:To investigate the expression of hsa_circ_0000437 in the serum of patients with gastric cancer and its clinical value.Methods:The serum samples from 80 patients (57 males and 23 females) with pathologically confirmed gastric cancer (GC), 50 gastric benign disease (28 males and 22 females) and 80 healthy controls (46 males and 34 females) were collected from October 2018 to December 2020 in Affiliated Hospital of Nantong University.Serum samples from 35 of 80 gastric cancer patients after operation were collected. The expression of serum hsa_circ_0000437 was determined by real-time fluorescent quantitative PCR (RT-qPCR). Serum carcinoembryonic antigen (CEA), carbohydrate antigen 199 (CA 199) and carbohydrate antigen 724 (CA724) were determined by chemiluminescence method.Comparisons of serum hsa_circ_0000437 between groups were performed by Mann-Whitney U test.The correlation between serum expression of hsa_circ_0000437 in gastric cancer patients and its clinical pathological characteristics was performed by χ 2 test.Receiver operating characteristic (ROC) curve and the area under the curve of ROC (AUC) were used to evaluate their diagnosis efficiency. Kaplan-Meier survival curve analysis was used to analyze the relationship between the expression level of serum hsa_circ_0000437 and the prognosis of patients. Results:The relative expression of hsa_circ_0000437 in GC, gastric benign disease, healthy controls were 2.252 (1.235, 4.765), 1.598(1.139, 1.982) and 1.000 (0.818, 1.385) respectively.The relative expression of hsa_circ_0000437 in GC was significantly higher than that in gastric benign disease ( P<0.001) and healthy controls ( P<0.001). The difference between gastric benign disease and healthy controls was also statistically significant ( P<0.001).The differences of serum hsa_circ_0000437 expression in GC patients between T stage, N stage, and tumor differentiation were statistically significant. The AUC of hsa_circ_0000437, CEA, CA199 and CA724 in GC patients were 0.863, 0.619, 657 and 0.608 respectively compared with healthy controls. The AUC of above four-parameter panel was 0.892 and the sensitivity was up to 97.5% (78/80). Kaplan-Meier survival curve showed that the overall survival rate of patients with high serum hsa_circ_0000437 expression was significantly lower than that of patients with low expression ( P=0.008). Conclusion:Serum hsa_circ_0000437 could be a biomarker for the auxiliary diagnosis and prognosis of GC.
7.Construction of legal clinic education system in health law specialty
Silun GUO ; Shaoqing MA ; Ye RAN
Chinese Journal of Medical Education Research 2021;20(1):39-42
Legal clinic education originating in the United States, aims at educating students on legal practical skills, and plays an positive role in cultivating students' ability of integrating theory with practice and training their various practical vocational skills. The present Chinese training mode of health law specialty does not perform very well in training students' practical ability, while legal clinic education can better make up for some deficiencies. Therefore, this paper learns from the experience of American universities in their legal clinic education, such as the particular division of specialties, the development of outside-school clinics, taking pre-training seriously, and the unique evaluation mechanism. Correspondingly, we explore to construct a set of reasonable legal clinic education system in health law specialty, including the orientation of legal clinics, the double training system inside and outside school, the construction of teaching staff and the establishment of evaluation mechanism.
8.Perfection of Regional Cooperation Supervision Mechanism under Marketing Authorization Holder System
Shaoqing MA ; Yijun SI ; Zenghui HUO
China Pharmacy 2020;31(15):1799-1803
OBJECTIVE:To provide reference for perfecting regional cooperation supervision mechanism under the marketing authorization holder (MAH) system in China. METHODS :Based on the analysis of legal responsibilities of the MAH and entrusted manufacturing enterprise ,the problems were studied and suggestions for improving the regional cooperative supervision mechanism were put forward. RESULTS & CONCLUSIONS :Sub-contract production is the main target of cross-regional collaborative supervision of drug regulatory agencies. The MAH is responsible for the entire life cycle of the drug ,and the entrusted manufacturing enterprise assumes supplementary responsibility. At present , the problems of regional cooperation supervision are lacking of targeted legal enforcement basis ,insufficient supervision power ,difficulty in obtaining evidence , untimely supervision and inadequate department cooperation supervision mechanism. It is necessary to improve the regional cooperative supervision mechanism continuously in perspectives of perfecting legislation ,establishing professional inspector system,improving departmental linkage mechanism ,and strenghtening the database construction.
9. Superficial circumflex iliac artery perforator flap for reconstruction of buccal and plate soft tissue defects
Xiaoguang LI ; Zhonglong LIU ; Chunyue MA ; Shuiting FU ; Junjian JIANG ; Yixin ZHANG ; Shaoqing FENG ; Xiaofeng TAO ; Songtao AI ; Zhiyuan ZHANG ; Weiliu QIU ; Yue HE
Chinese Journal of Plastic Surgery 2018;34(9):693-698
Objective:
To investigate the therapeutic effect of free superficial circumflex iliac artery perforator (SCIP)flap for reconstruction of soft tissue defects secondary to resection of retromolar and lateral buccal squamous cell carcinoma.
Methods:
From January 2014 to January 2017, eight patients with retromolar and lateral buccal squamous cell carcinoma received radical resection and reconstructed with SCIP flap immediately. CTA and color Doppler sonography were routinely performed before the surgery. According to the size of the defect in the recipient area, the flap vascularized by the perforator vessel was carefully prepared and transferred to the buccal-pharynx-palate composite defect. The recipient area and donor area were sutured tightly after arteriovenous anastomosis under microscope. The survival and functional recovery of the flap were observed after operation.
Results:
The flap sizes ranged from 5 cm× 6 cm to 7 cm×9 cm.The mean diameter of the superficial circumflex iliac arteries was 0.65 mm. And the mean diameter of the veins was 1.2 mm. The mean arterial pedicle length was 7.0 cm, and the venous pedicle length was 8.0 cm. Eight flaps were all survived. The shape of the buccal-parapharyngeal-palate was good and the mouth opening was normal after operation.
Conclusions
Superficial circumflex iliac artery perforator flap was a good choice for repairing the defect of parapharyngeal squamous cell carcinoma in the posterior molar region.
10.Change of Whole Brain Degree in Primary Insomnia
Xiaofen MA ; Shaoqing ZENG ; Jin FANG ; Yunfan WU ; Shishun FU ; Kelei HUA ; Yi YIN ; Guihua JIANG
Journal of Sun Yat-sen University(Medical Sciences) 2017;38(3):390-394
[Objective] Based on the resting state functional magnetic resonance imaging to investigate the abnormal features of the functional connectivity of resting brain neural network in the patients with primary insomnia,by using voxel-wise whole-brain finctional networks analysis of degree centrality (DC) for imaging evidence of neural mechanisms underlying primary insomnia.[Methods] The resting state fMRI were performed in 59 PI patients and 47 age,education,and sex-matched normal healthy subjects.Analysis of DC map changes between the two patient groups and the control group were performed by two sample t test.(threshold at P < 0.05).[Results] Compared with the control group,the patients with PI showed significantly reduced DC value in bilateral medial frontal gyrus (MFG),bilateral anterior cingulate gyrus (ACG),and right insula;and increased DC value in right middle temporal gyrus (MTG),and left cuneus,(CUN),P < 0.05.[Conclusion]Changes of DC value occurred in some region of brain in the P[patient groups when compared with the control group.It was indicated that DC,as a novel resting-state fMRI parameter in the voxel-wise whole-brain functional networks,might be an appealing alternative approach for further study on pathologic and neuropsychological states of PI.

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