1.Semaglutide in the treatment of type 2 diabetes mellitus:rapid health technology assessment
Sihua WANG ; Sheng WANG ; Yan WANG ; Jiajie LUAN
China Pharmacy 2023;34(12):1503-1508
		                        		
		                        			
		                        			OBJECTIVE To evaluate the efficacy, safety and cost-effectiveness of semaglutide in the treatment of type 2 diabetes mellitus (T2DM), and to provide reference for clinical drug use. METHODS Rapid health technology assessment was adopted. Retrieved from PubMed, Embase, Cochrane Library, Web of Science, CNKI, Wanfang database, CBM, domestic and foreign HTA official websites, HTA reports, systematic evaluation/meta-analysis and pharmacoeconomic studies about semaglutide in the treatment of T2DM were collected during the inception to May 1st, 2022. After data extraction and quality evaluation, descriptive analysis was performed on the results of included studies. RESULTS A total of 22 pieces of literature were included, involving 7 meta-analyses and 15 pharmacoeconomic studies. In terms of efficacy and safety, semaglutide showed significant advantages in controlling glycated hemoglobin (HbA1c), fasting blood glucose, postprandial mean glucose, body mass index and achieving a target of glycosylated hemoglobin level <7%; also, there was no increased risk of hypoglycaemia or the incidence of serious adverse effects, but the risk of gastrointestinal adverse effects was significantly higher than other interventions. In terms of cost-effectiveness, results of foreign studies showed that semaglutide was more cost-effective, compared with other glucagon-like peptide-1 receptor agonists, sodium-glucose transporter protein 2 inhibitors, dipeptidyl peptidase-4 inhibitors. Research based on the perspective of China’s health system showed that semaglutide had a clear cost-effectiveness advantage over dulaglutide when using GDP per capita in 2020 (72477 yuan) as the payment threshold. CONCLUSIONS The semaglutide has excellent efficacy and good safety for the treatment of T2DM, with cost-effectiveness advantages over a number of drugs, but attention should be paid to the occurrence of gastrointestinal adverse effects.
		                        		
		                        		
		                        		
		                        	
2.Dermatomyositis with kidney neoplasm: two cases report and literature review
Sheng MA ; Yue GE ; Zezhong XIONG ; Yanan WANG ; Le LI ; Zheng CHAO ; Beining LI ; Junbiao ZHANG ; Yang LUAN ; Bolin WU ; Gan YU ; Cong LI ; Xing ZENG ; Chunguang YANG ; Zhihua WANG
Chinese Journal of Urology 2023;44(3):200-203
		                        		
		                        			
		                        			Objective:To investigate the clinical characteristics, diagnosis and treatment of dermatomyositis with kidney neoplasm.Methods:The data of two patients with dermatomyositis complicated with kidney neoplasm in Tongji Hospital from January to February 2022 were retrospectively analyzed. The first case was a 55-year-old female, who was admitted with the chief complaints of recurrent erythema of upper extremities for 2 months and facial erythema for 1 month. Physical examination: erythema can be seen on upper limbs and face, no tenderness or percussion pain in kidney area. Myositis enzyme profile test showed that anti-Mi-2 antibody and anti-SSA /Ro-52 antibody were positive. Contrast CT showed nodular uneven enhancement in the right kidney with a size of 50 mm×41 mm. The second case was a 58-year-old female, who was admitted with the chief complaints of kidney occupying for a month. Physical examination: flaky erythema on face, no tenderness or percussion pain in kidney area. Myositis enzyme profile test showed that anti-Ro-52 antibody and anti-MDA5 antibody were positive. Contrast CT showed a significantly uneven enhanced mass with a size of about 50 mm×41 mm on left kidney. Both patients were diagnosed with kidney neoplasm before surgery and underwent laparoscopic partial nephrectomy in Tongji Hospital.Results:Both patients received regular oral prednisone after surgery. The pathological presentation of case 1 was papillary renal cell carcinoma, the facial erythema subsided 1 month after surgery, and there was no tumor recurrence for 13 months. The pathological presentation of case 2 was clear cell renal cell carcinoma, facial erythema subsided 2 weeks after surgery, and there was no tumor recurrence for 12 months.Conclusions:The diagnosis of dermatomyositis should be combined with clinical manifestations and laboratory examination, and the possibility of malignant tumor should be excluded due to the high likelihood of concomitant malignancy. For patients with dermatomyositis with kidney neoplasm, the main treatment is still surgery, and supplemented with glucocorticoid therapy.
		                        		
		                        		
		                        		
		                        	
3.Stapled anoplin peptide combined with photothermal therapy enhances oncolytic immunotherapy of triple-negative breast cancer.
Wei-Dong GAO ; Xiao-Xia LIU ; Ting YANG ; Jia-Yi LIN ; Yu-Xuan SONG ; Sheng-Xin LU ; Xiao-Kun ZHANG ; Ye WU ; Xin LUAN ; Wei-Dong ZHANG
China Journal of Chinese Materia Medica 2023;48(18):4981-4992
		                        		
		                        			
		                        			This study constructed a nano-drug delivery system, A3@GMH, by co-delivering the stapled anoplin peptide(Ano-3, A3) with the light-harvesting material graphene oxide(GO), and evaluated its oncolytic immunotherapy effect on triple-negative breast cancer(TNBC). A3@GMH was prepared using an emulsion template method and its physicochemical properties were characterized. The in vivo and in vitro photothermal conversion abilities of A3@GMH were investigated using an infrared thermal imager. The oncoly-tic activity of A3@GMH against TNBC 4T1 cells was evaluated through cell counting kit-8(CCK-8), lactate dehydrogenase(LDH) release, live/dead cell staining, and super-resolution microscopy. The targeting properties of A3@GMH on 4T1 cells were assessed using a high-content imaging system and flow cytometry. In vitro and in vivo studies were conducted to investigate the antitumor mechanism of A3@GMH in combination with photothermal therapy(PTT) through inducing immunogenic cell death(ICD) in 4T1 cells. The results showed that the prepared A3@GMH exhibited distinct mesoporous and coated structures with an average particle size of(308.9±7.5) nm and a surface potential of(-6.79±0.58) mV. The encapsulation efficiency and drug loading of A3 were 23.9%±0.6% and 20.5%±0.5%, respectively. A3@GMH demonstrated excellent photothermal conversion ability and biological safety. A3@GMH actively mediated oncolytic features such as 4T1 cell lysis and LDH release, as well as ICD effects, and showed enhanced in vitro antitumor activity when combined with PTT. In vivo, A3@GMH efficiently induced ICD effects with two rounds of PTT, activated the host's antitumor immune response, and effectively suppressed tumor growth in 4T1 tumor-bearing mice, achieving an 88.9% tumor inhibition rate with no apparent toxic side effects. This study suggests that the combination of stapled anoplin peptide and PTT significantly enhances the oncolytic immunotherapy for TNBC and provides a basis for the innovative application of anti-tumor peptides derived from TCM in TNBC treatment.
		                        		
		                        		
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Animals
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		                        			Mice
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		                        			Photothermal Therapy
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		                        			Triple Negative Breast Neoplasms/pathology*
		                        			;
		                        		
		                        			Antimicrobial Cationic Peptides
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		                        			Immunotherapy/methods*
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		                        			Cell Line, Tumor
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		                        			Phototherapy/methods*
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		                        			Nanoparticles/chemistry*
		                        			
		                        		
		                        	
4.Detecting of obstructive sleep apnea hypopnea syndrome using a multi-parameter pressure sensitive sleep monitor.
Shao Xing ZHANG ; Zi Ming YAO ; Sheng LUAN ; Li WANG ; Ying XU
Journal of Peking University(Health Sciences) 2021;53(3):608-612
		                        		
		                        			OBJECTIVE:
		                        			To evaluate the efficacy of an electro-mechanical film-based(EMFi) multi-parameter pressure sensitive sleep monitor(MPSSM)on clinical diagnosis and research significance of obstructive sleep apnea hypopnea syndrome(OSAHS).
		                        		
		                        			METHODS:
		                        			Retrospective analysis was made of 58 test subjects at Peking University Third Hospital with suspected OSAHS who were simultaneously monitored by MPSSM and polysomnography(PSG). The PSG test results were used as the gold standard in evaluating the sensitivity and specificity of OSAHS diagnosis of MPSSM. The test result consistency of sleep apnea and hypopnea index(AHI)and total apnea time of the two methods was evaluated. Real-time waveform comparison of sleep respiratory events of a randomly selected patient diagnosed with OSAHS was performed.
		                        		
		                        			RESULTS:
		                        			For 58 test subjects, 48 were male, 10 were female, with an average age of(40.6±12.2)years. Thirty-nine out of the 58 test subjects were diagnosed with OSHAS by PSG. The sensitivity of MPSSM for OSAHS diagnosis was 92.3%, with 95% confidence interval of 79.1%-98.4%, and the specificity of MPSSM for OSAHS diagnosis was 100%, with 95% confidence interval of 82.3%-100%. Kappa test k=0.887 (P < 0.001) showed OSAHS diagnosis results of the two methods were almost identical. The AHI measured by MPSSM [12.0(2.6-32.2) times/h] and PSG [13.4(3.1-38.8) times/h] were highly correlated (ρ=0.939, P < 0.001). The total apnea time measured by MPSSM [37.9(9.9-80.5) min] and PSG [32.3(8.6-93.0) min] were highly correlated(ρ=0.924, P < 0.001). Bland-Altman plot showed that the consistency between the test results of the two methods was very high.
		                        		
		                        			CONCLUSION
		                        			As a portable, non-contact, fully automatic monitoring device, MPSSM is reliable in the screening of OSAHS compared with PSG. It is suitable to be promoted and applied in primary medical institutions, nursing homes and domestic usage. However, further research is required in improving the analysis of different sleep phase and the differentiation of central sleep apnea syndrome respiratory events in order to effectively assist medical personnel in making an accurate sleep apnea diagnosis.
		                        		
		                        		
		                        		
		                        			Adult
		                        			;
		                        		
		                        			Female
		                        			;
		                        		
		                        			Humans
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		                        			Male
		                        			;
		                        		
		                        			Middle Aged
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		                        			Polysomnography
		                        			;
		                        		
		                        			Retrospective Studies
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		                        			Sensitivity and Specificity
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		                        			Sleep
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		                        			Sleep Apnea, Obstructive/diagnosis*
		                        			
		                        		
		                        	
5. Distribution of gene polymorphism in folate metabolism pathway and its effect on serumhomocysteine concentration
Chunyan YANG ; Wen ZHANG ; Peipei WANG ; Jing PENG ; Jia JIANG ; Jing SONG ; Jun LIU ; Yueran LI ; Kui YANG ; Sheng WANG ; Zhenyu XU ; Jiajie LUAN
Chinese Journal of Clinical Pharmacology and Therapeutics 2021;26(11):1259-1264
		                        		
		                        			
		                        			 AIM: To study the polymorphism distribution of methylenetetrahydrofolate reductase (MTHFR) and methionine synthase reductase (MTRR) genes and their influence on serum homocysteine (Hcy) concentration. METHODS: A total of 148 patients diagnosed with ischemic stroke from November 2020 to February 2021 in Yijishan Hospital of Wanan Medical College were selected for the study, and patients were typed for MTHFR 677C/T and MTRR 66A/G genes using fluorescent staining in situ hybridization technique. Serum Hcy concentrations were measured in 21 patients using a circulating enzyme assay. The distribution of MTHFR 677C/T and MTRR 66A/G gene polymorphisms were analyzed, and the differences in serum Hcy concentrations between patients with different genotypes were compared. RESULTS: The mutation rates of MTHFR 677C/T and MTRR 66A/G genes were 42.57% and 26.01%, respectively, and no significant differences in gene distribution frequencies were observed between men and women (P>0.05). The mean Hcy serum concentration was (16.04±4.34) μmol/L in 21 patients, including 8 patients (38.10%) with <15 μmol/L and 13 patients (61.90%) with ≥15 μmol/L. The Hcy serum concentrations in patients with different genotypes of MTHFR were TT (18.91±5.34) μmol/L, CT (14.38±1.84) μmol/L and CC (13.58±2.86) μmol/L, respectively, and were statistically different (P<0.001). Serum Hcy concentrations in patients with different genotypes of MTRR were not statistically different (P>0.05). CONCLUSION: MTHFR gene polymorphisms can affect serum Hcy concentrations. The MTHFR genotyping can be considered for individualized folic acid supplement. This conclusion should be further verified by expanding the clinical sample size. 
		                        		
		                        		
		                        		
		                        	
6.Analysis on Application of Salviae Miltiorrhizae Radix et Rhizoma Related Health Food
Yan-hong WANG ; Jian FAN ; Hong-jing LI ; Ning LUAN ; Kai SHENG ; Da-zhong CHEN
Chinese Journal of Experimental Traditional Medical Formulae 2020;26(6):168-177
		                        		
		                        			
		                        			With the improvement of living standard and enhancement of health consciousness, Salviae Miltiorrhizae Radix et Rhizoma, as a common medicinal material that can be widely used in health food, is focused an increasing number of scholars′ attention at home and abroad. Based on Salviae Miltiorrhizae Radix et Rhizoma health food published by the food website of National Medical Products Administration (NMPA), this paper combs and analyzes their dosage forms, functional components, health-care functions and prescriptions of traditional Chinese medicine (TCM). Meanwhile, the Apriori algorithm module in SPSS Modeler 15.0 is used to explore the formulation rules of Salviae Miltiorrhizae Radix et Rhizoma health food. The results showed that capsules was the most common (about 55.34%), and the infusions and beverages were rare. In the aspect of health-care function, it is mainly used to auxiliary hypolipidemic, auxiliary protective function to chemical liver injury, enhance immunity and dispel chloasma. Among 92 cases of the health food with auxiliary hypolipidemic, the common combination of TCM was Salviae Miltiorrhizae Radix et Rhizoma-Gynostemmatis Pentaphylli Herba-Puerariae Lobatae Radix. Among 55 cases of the health food with auxiliary protective function to chemical liver injury, the common combination of TCM was Salviae Miltiorrhizae Radix et Rhizoma-Puerariae Lobatae Radix-Schisandrae Chinensis Fructus. Among 54 cases of the health food with immune-enhancing, the common combination of TCM was Salviae Miltiorrhizae Radix et Rhizoma-Astragali Radix-Lycii Fructus. Among 46 cases of the health food with dispelling chloasma, the common combination of TCM was Salviae Miltiorrhizae Radix et Rhizoma-Angelicae Sinensis Radix-grape seeds. The selection of prescription compatibility of Salviae Miltiorrhizae Radix et Rhizoma health food with different health-care functions is basically consistent with the TCM treatment with syndrome differentiation theory and modern medical theory. This article interprets the application of Salviae Miltiorrhizae Radix et Rhizoma health food from the perspective of dosage forms, functional components, health-care functions and compatibility of prescriptions, which can provide a basis and reference for precise and efficient research and development of this kind of health food.
		                        		
		                        		
		                        		
		                        	
7.Prevalence and influencing factors of depression and anxiety among 322 pregnant women in Jianyang City
Xin-ya MA ; Dan-dan YANG ; Yao-ming XU ; Rong-sheng LUAN ; Zhe-fei GAO ; Si-yi LI ; Jian-ping FAN ; Wen-qiang ZHANG ; Zong-lei ZHOU
Chinese Journal of Disease Control & Prevention 2020;24(1):109-113
		                        		
		                        			
		                        			 Objective To analyze the prevalence and influencing factors of anxiety and depression among pregnant women in Jianyang City. Methods Convenience sampling method was used to select 322 pregnant women in Jianyang Maternal and Child Health Hospital of Jianyang City. The depression and anxiety of the participants were measured with self-rating anxiety scale(SAS) and self-rating depression scale(SDS),and the degree of social support was measured with social support rating scale (SSRS). Pearson correlation analysis was used to analyze the relationship between anxiety, depression and social support. The chi square ( 2) test and the non-conditional Logistic regression model were used to analyze the influencing factors of anxiety and depression. Results Anxiety rate and depression rate of pregnant women in Jianyang city were 5.3% and 5.6% respectively. There was a negative correlation between anxiety, depression and social support (P<0.05). Absence of prenatal examination (OR=4.554, 95% CI: 1.063-19.510) was a risk factor for anxiety among pregnant women in Jianyang City. Late pregnancy (OR=5.381, 95% CI: 1.422-20.363) and medium degree of social support (OR=4.150, 95% CI: 1.198-14.375) were risk factors for depression among pregnant women in Jianyang City. Junior high school (OR=0.015, 95% CI: 0.001-0.275), high school or technical secondary school (OR=0.004, 95% CI: 0.001-0.128), junior college or above (OR=0.053, 95% CI: 0.003-0.851) were protective factors for depression. Conclusions The prevelance of anxiety and depression in pregnant women cannot be ignored. It is important to carry out mental health intervention according to the above factors. 
		                        		
		                        		
		                        		
		                        	
9.A phase II trial of cytoreductive surgery combined with niraparib maintenance in platinum-sensitive, secondary recurrent ovarian cancer: SGOG SOC-3 study
Tingyan SHI ; Sheng YIN ; Jianqing ZHU ; Ping ZHANG ; Jihong LIU ; Libing XIANG ; Yaping ZHU ; Sufang WU ; Xiaojun CHEN ; Xipeng WANG ; Yincheng TENG ; Tao ZHU ; Aijun YU ; Yingli ZHANG ; Yanling FENG ; He HUANG ; Wei BAO ; Yanli LI ; Wei JIANG ; Ping ZHANG ; Jiarui LI ; Zhihong AI ; Wei ZHANG ; Huixun JIA ; Yuqin ZHANG ; Rong JIANG ; Jiejie ZHANG ; Wen GAO ; Yuting LUAN ; Rongyu ZANG
Journal of Gynecologic Oncology 2020;31(3):e61-
		                        		
		                        			 Background:
		                        			In China, secondary cytoreductive surgery (SCR) has been widely used in ovarian cancer (OC) over the past two decades. Although Gynecologic Oncology Group-0213 trial did not show its overall survival benefit in first relapsed patients, the questions on patient selection and effect of subsequent targeting therapy are still open. The preliminary data from our pre-SOC1 phase II study showed that selected patients with second relapse who never received SCR at recurrence may still benefit from surgery. Moreover, poly(ADP-ribose) polymerase inhibitors (PARPi) maintenance now has been a standard care for platinum sensitive relapsed OC. To our knowledge, no published or ongoing trial is trying to answer the question if patient can benefit from a potentially complete resection combined with PARPi maintenance in OC patients with secondary recurrence. 
		                        		
		                        			Methods
		                        			SOC-3 is a multi-center, open, randomized, controlled, phase II trial of SCR followed by chemotherapy and niraparib maintenance vs chemotherapy and niraparib maintenance in patients with platinum-sensitive second relapsed OC who never received SCR at recurrence. To guarantee surgical quality, if the sites had no experience of participating in any OC-related surgical trials, the number of recurrent lesions evaluated by central-reviewed positron emission tomography–computed tomography image shouldn't be more than 3. Eligible patients are randomly assigned in a 1:1 ratio to receive either SCR followed by 6 cyclesof platinum-based chemotherapy and niraparib maintenance or 6 cycles of platinum-based chemotherapy and niraparib maintenance alone. Patients who undergo at least 4 cycles of chemotherapy and must be, in the opinion of the investigator, without disease progression, will be assigned niraparib maintenance. Major inclusion criteria are secondary relapsed OC with a platinum-free interval of no less than 6 months and a possibly complete resection. Major exclusion criteria are borderline tumors and non-epithelial ovarian malignancies, received debulking surgery at recurrence and impossible to complete resection. The sample size is 96 patients. Primary endpoint is 12-month non-progression rate. 
		                        		
		                        		
		                        		
		                        	
10.Quality of life and its influencing factors of hepatitis B positive in pregnant women in Jianyang
Dan-dan YANG ; Yao-ming XU ; Jian-wei ZHAO ; Wen-qiang ZHANG ; Xin-ya MA ; Jun XIAO ; Rong-sheng LUAN
Chinese Journal of Disease Control & Prevention 2019;23(3):360-364
		                        		
		                        			
		                        			 Objective To evaluate the quality of life in pregnant women with hepatitis B positive and to explore its influencing factors. Methods Eighty pregnant women with positive hepatitis B were randomly selected from Jan. to Apr. 2018 in Jianyang Maternal and Child Health Hospital as the case group, and 323 normal pregnant women were selected as the control group. A face-to-face survey was conducted using the Concise Health Survey Scale SF-36. t test, ANOVA and multiple linear regression were used for statistical analysis. Results The scores of PF and RP in the case group were lower than those in the control group, and the scores of GH in the case group were higher than those in the control group. Analysis of the factors affecting the quality of life of the case group found that the more severe the early pregnancy reaction, the lower the quality of life score. Conclusions The PF and RP of pregnant women with hepatitis B positive in Jianyang City are worse than those of normal pregnant women. Comprehensive measures should be taken to improve their quality of life. 
		                        		
		                        		
		                        		
		                        	
            
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