1.Manufacturing classification system for oral solid dosage forms of traditional Chinese medicines (Ⅱ): classification of tablets disintegration behavior.
Xiao-Qing ZHAO ; Dong-Ling LIAO ; Fei-Yu QI ; Zi-Chen LIANG ; Xue-Fang TANG ; Sheng-Yun DAI ; Yan-Jiang QIAO ; Bing XU
China Journal of Chinese Materia Medica 2023;48(12):3180-3189
In this paper, 50 batches of representative traditional Chinese medicine tablets were selected and the disintegration time was examined with the method in Chinese Pharmacopoeia. The disintegration time and disintegration phenomenon were recorded, and the dissolution behaviors of water-soluble and ultraviolet-absorbent components during the disintegration process of tablets were characterized by self-control method. The results revealed that coating type and raw material type influenced the disintegration time of tablets. It was found that only 4% of traditional Chinese medicine tablets had obvious fragmentation during the disintegration process, while 96% of traditional Chinese medicine tablets showed gradual dissolution or dispersion. Furthermore, according to the disintegration speed, disintegration phenomenon, and whether the cumulative dissolution of measured components was > 90% at complete disintegration, a disintegration behavior classification system(DBCS) was created for the regular-release traditional Chinese medicine tablets. As a result, the disintegration behaviors of 50 batches of traditional Chinese medicine tablets were classified into four categories, i.e. ⅠA_2, ⅠB_1, ⅡB_1, and ⅡB_2. traditional Chinese medicine tablets(Class I) with disintegration time ≤ 30 min were defined to be rapid in disintegration, which can be the objective of optimization or improvement of Chinese herbal extract(semi extract) tablets. Different drug release models were used to fit the dissolution curve of traditional Chinese medicine tablets with gradual dissolution or dispersion phenomenon(i.e. Type B tablets). The results showed that the dissolution curves of water-soluble components in the disintegration process conformed to the zero order kinetics and the Ritger-Peppas model. It could be inferred that the disintegration mechanisms of type B tablets were a combination of dissolution controlled and swelling controlled mechanisms. This study contributes to understanding the disintegration behavior of traditional Chinese medicine tablets, and provides a reference for the design and improvement of disintegration performance of traditional Chinese medicine tablets.
Commerce
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Medicine, Chinese Traditional
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Tablets
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Water
;
Drug Compounding
2.A descriptive analysis on hypertension in adult twins in China.
Yu Tong WANG ; Wei Hua CAO ; Jun LYU ; Can Qing YU ; Sheng Feng WANG ; Tao HUANG ; Dian Jian Yi SUN ; Chun Xiao LIAO ; Yuan Jie PANG ; Zeng Chang PANG ; Min YU ; Hua WANG ; Xian Ping WU ; Zhong DONG ; Fan WU ; Guo Hong JIANG ; Xiao Jie WANG ; Yu LIU ; Jian DENG ; Lin LU ; Wen Jing GAO ; Li Ming LI
Chinese Journal of Epidemiology 2023;44(4):536-543
Objective: To describe the distribution characteristics of hypertension among adult twins in the Chinese National Twin Registry (CNTR) and to provide clues for exploring the role of genetic and environmental factors on hypertension. Methods: A total of 69 220 (34 610 pairs) of twins aged 18 and above with hypertension information were selected from CNTR registered from 2010 to 2018. Random effect models were used to describe the population and regional distribution of hypertension in twins. To estimate the heritability, the concordance rates of hypertension were calculated and compared between monozygotic twins (MZ) and dizygotic twins (DZ). Results: The age of all participants was (34.1±12.4) years. The overall self-reported prevalence of hypertension was 3.8%(2 610/69 220). Twin pairs who were older, living in urban areas, married, overweight or obese, current smokers or ex-smokers, and current drinkers or abstainers had a higher self-reported prevalence of hypertension (P<0.05). Analysis within the same-sex twin pairs found that the concordance rate of hypertension was 43.2% in MZ and 27.0% in DZ, and the difference was statistically significant (P<0.001). The heritability of hypertension was 22.1% (95%CI: 16.3%- 28.0%). Stratified by gender, age, and region, the concordance rate of hypertension in MZ was still higher than that in DZ. The heritability of hypertension was higher in female participants. Conclusions: There were differences in the distribution of hypertension among twins with different demographic and regional characteristics. It is indicated that genetic factors play a crucial role in hypertension in different genders, ages, and regions, while the magnitude of genetic effects may vary.
Adult
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Female
;
Humans
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Male
;
Alcohol Drinking
;
Diseases in Twins/genetics*
;
Hypertension/genetics*
;
Twins, Dizygotic/genetics*
;
Twins, Monozygotic/genetics*
3.A descriptive analysis of hyperlipidemia in adult twins in China.
Ke MIAO ; Wei Hua CAO ; Jun LYU ; Can Qing YU ; Sheng Feng WANG ; Tao HUANG ; Dian Jian Yi SUN ; Chun Xiao LIAO ; Yuan Jie PANG ; Zeng Chang PANG ; Min YU ; Hua WANG ; Xian Ping WU ; Zhong DONG ; Fan WU ; Guo Hong JIANG ; Xiao Jie WANG ; Yu LIU ; Jian DENG ; Lin LU ; Wen Jing GAO ; Li Ming LI
Chinese Journal of Epidemiology 2023;44(4):544-551
Objective: To describe the distribution characteristics of hyperlipidemia in adult twins in the Chinese National Twin Registry (CNTR) and explore the effect of genetic and environmental factors on hyperlipidemia. Methods: Twins recruited from the CNTR in 11 project areas across China were included in the study. A total of 69 130 (34 565 pairs) of adult twins with complete information on hyperlipidemia were selected for analysis. The random effect model was used to characterize the population and regional distribution of hyperlipidemia among twins. The concordance rates of hyperlipidemia were calculated in monozygotic twins (MZ) and dizygotic twins (DZ), respectively, to estimate the heritability. Results: The age of all participants was (34.2±12.4) years. This study's prevalence of hyperlipidemia was 1.3% (895/69 130). Twin pairs who were men, older, living in urban areas, married,had junior college degree or above, overweight, obese, insufficient physical activity, current smokers, ex-smokers, current drinkers, and ex-drinkers had a higher prevalence of hyperlipidemia (P<0.05). In within-pair analysis, the concordance rate of hyperlipidemia was 29.1% (118/405) in MZ and 18.1% (57/315) in DZ, and the difference was statistically significant (P<0.05). Stratified by gender, age, and region, the concordance rate of hyperlipidemia in MZ was still higher than that in DZ. Further, in within-same-sex twin pair analyses, the heritability of hyperlipidemia was 13.04% (95%CI: 2.61%-23.47%) in the northern group and 18.59% (95%CI: 4.43%-32.74%) in the female group, respectively. Conclusions: Adult twins were included in this study and were found to have a lower prevalence of hyperlipidemia than in the general population study, with population and regional differences. Genetic factors influence hyperlipidemia, but the genetic effect may vary with gender and area.
Adult
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Female
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Humans
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Male
;
Middle Aged
;
Young Adult
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China/epidemiology*
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Diseases in Twins/genetics*
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Hyperlipidemias/genetics*
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Metabolic Diseases
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Twins, Dizygotic
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Twins, Monozygotic/genetics*
4.An investigation of hepatitis D virus infection among patients with chronic hepatitis B virus infection in some regions of China
Yumei LIU ; Xiaoping GUO ; Huimin ZHANG ; Hongxia BAI ; Chunmei WANG ; Shan REN ; Yongfang JIANG ; Sheng YANG ; Feng PENG ; Xiaozhong WANG ; Lei YU ; Boming LIAO ; Ling NING ; Yingli HE ; Xia YANG ; Liang HUANG ; Xueen LIU ; Hui ZHUANG
Journal of Clinical Hepatology 2023;39(4):795-803
Objective To investigate the prevalence of hepatitis D virus (HDV) infection among patients with chronic hepatitis B virus (HBV) infection in some regions of China. Methods Serum samples were collected from 3 131 patients with chronic HBV infection in 10 provinces, cities, and autonomous regions of China from March 2021 to June 2022, and anti-HDV IgG ELISA was used for the detection of all serum samples. Nested reverse transcription-polymerase chain reaction (nRT-PCR) was used to detect HDV RNA in anti-HDV IgG-positive samples, and the nRT-PCR amplification products of HDV RNA-positive samples were sequenced and analyzed to determine HDV genotype. The clinical features of anti-HDV IgG-positive patients were analyzed. The Mann-Whitney U rank sum test was used for comparison of continuous data between two groups, and the chi-square test or the Fisher's exact test was used for comparison of categorical data between two groups. Results The positive rate of anti-HDV IgG in the 3 131 patients with chronic HBV infection was 0.70% (22/3 131), and that in the patients with chronic HBV infection in Inner Mongolia Autonomous Region, Xinjiang Uygur Autonomous Region, Beijing, and Hunan Province was 1.81% (16/886), 0.88% (2/226), 0.28% (2/708), and 1.00% (2/200), respectively; the patients with chronic HBV infection in Inner Mongolia Autonomous Region had a significantly higher positive rate of anti-HDV IgG than those in Beijing ( P =0.004), and there was no significant difference between the other regions ( P > 0.05). Clinical features of the patients with chronic HBV infection in Inner Mongolia Autonomous Region showed that compared with the anti-HDV IgG-negative group, the anti-HDV IgG-positive group had a significantly higher proportion of patients with Mongol nationality ( P =0.001), abnormal alanine aminotransferase ( P =0.007), or antiviral treatment ( P =0.029), as well as a significantly lower median HBV DNA level ( P =0.030). A total of 19 HDV RNA-positive samples were identified, all of which had HDV genotype 1. Conclusion The prevalence rate of HDV varies greatly across different regions of China, with a higher prevalence rate of HDV in patients with chronic HBV infection from Inner Mongolia Autonomous Region. HDV genotype 1 is the predominant genotype in some provinces and cities of northern China.
5.Clinical characteristics and prognosis of patients with therapy-related myelodysplastic syndrome and acute myeloid leukemia arising from malignant tumors.
Xu Sheng XU ; Hong DING ; Xin ZHANG ; Yi LIAO ; He LI ; Qin Yu LIU ; Jia Zhuo LIU ; Li ZHANG ; Jie HUANG ; Yu Ping GONG ; Hong Bing MA ; Bing XIANG ; Yang DAI ; Li HOU ; Xiao SHUAI ; Ting NIU ; Yu WU
Chinese Journal of Hematology 2023;44(9):742-748
Objective: To investigate the clinical characteristics, cytogenetics, molecular biology, treatment, and prognosis of patients with therapy-related myelodysplastic syndrome and acute myeloid leukemia (t-MDS/AML) secondary to malignancies. Methods: The clinical data of 86 patients with t-MDS/AML in West China Hospital of Sichuan University between January 2010 and April 2023 were retrospectively analyzed. The clinical characteristics, primary tumor types, and tumor-related therapies were analyzed. Results: The study enrolled a total of 86 patients with t-MDS/AML, including 67 patients with t-AML, including 1 patient with M(0), 6 with M(1), 27 with M(2), 9 with M(3), 12 with M(4), 10 with M(5), 1 with M(6), and 1 with M(7). Sixty-two patients could be genetically stratified, with a median overall survival (OS) of 36 (95% CI 22-52) months for 20 (29.9%) patients in the low-risk group and 6 (95% CI 3-9) months for 10 (14.9%) in the intermediate-risk group. The median OS time was 8 (95% CI 1-15) months in 32 (47.8%) patients in the high-risk group. For patients with non-acute promyelocytic leukemia (APL) and AML, the median OS of the low-risk group was 27 (95% CI 18-36) months, which was significantly longer than that of the non-low-risk group (χ(2)=5.534, P=0.019). All 9 APL cases were treated according to the initial treatment, and the median OS was not reached, and the 1-, 2-, and 3-year OS rates were 100.0%, (75.0±6.2) %, and (75.0±6.2) % respectively. Of the 58 patients with non-APL t-AML (89.7%), 52 received chemotherapy, and 16 achieved complete remission (30.8%) after the first induction chemotherapy. The 1-, 2-, and 3-year OS rates of the non-APL t-AML group were (42.0 ± 6.6) %, (22.9±5.7) %, and (13.4±4.7) %, respectively. The median OS of patients who achieved remission was 24 (95% CI 18-30) months, and the median OS of those who did not achieve remission was 6 (95% CI 3-9) months (χ(2)=10.170, P=0.001). Bone marrow CR was achieved in 7 (53.8%) of 13 patients treated with vineclar-containing chemotherapy, with a median OS of 12 (95% CI 9-15) months, which was not significantly different from that of vineclar-containing chemotherapy (χ(2)=0.600, P=0.437). In 19 patients with t-MDS, the 1-, 2-, and 3-year OS rates were (46.8±11.6) %, (17.5±9.1) %, and (11.7±9.1) % with a median OS of 12 (95% CI 7-17) months, which was not significantly different from that in t-AML (χ(2)=0.232, P=0.630) . Conclusions: Breast cancer, bowel cancer, and other primary tumors are common in patients with t-MDS/AML, which have a higher risk of adverse genetics. Patients with APL had a high induction remission rate and a good long-term prognosis, whereas patients without APL had a low remission rate and a poor long-term prognosis.
Humans
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Retrospective Studies
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Leukemia, Myeloid, Acute/drug therapy*
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Leukemia, Promyelocytic, Acute/therapy*
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Prognosis
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Myelodysplastic Syndromes/drug therapy*
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Neoplasms, Second Primary/drug therapy*
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Remission Induction
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Antineoplastic Combined Chemotherapy Protocols/therapeutic use*
6.Expression and Significance of Lactate Dehydrogenase A in Renal Cell Carcinoma
Wen-han QIU ; Ding-zhun LIAO ; Yi-yu SHENG ; Hai-yun XIONG ; Jun LI
Journal of Sun Yat-sen University(Medical Sciences) 2023;44(5):816-822
ObjectiveTo analyze the expression of Lactate dehydrogenase A(LDHA) in both renal cell carcinoma (RCC) tissue and RCC cell lines, and to investigate the impact of LDHA expression on the progression of RCC. MethodsFrom June 2018 to June 2022, totally 52 cases of RCC tissue samples and 49 cases of para-cancerous tissue samples were collected through surgical procedures from our hospital. LDHA expression was detected using immunohistochemistry (IHC). The expression levels of LDHA in vitro were also detected in the normal human proximal tubule epithelial cell line HK-2 and renal cell carcinoma cell lines A498, Caki-2, ACHN, and 786-O by using qRT-PCR and Western blot. A recombinant plasmid carrying LDHA-shRNA was constructed and then transfected into 786-O cells to down-regulate the expression of LDHA. Tumor proliferative capacity was monitored using CCK-8 assay, clonal formation assay and EdU assessments. Additionally, cell glycolytic activity was assessed through glucose uptake assay, lactate secretion assay, and ECAR analysis. ResultsIHC analysis revealed significantly higher expression of LDHA in RCC tissue compared to adjacent tissues(P<0.05). Furthermore, RCC tissues with higher TNM stage exhibited greater expression of LDHA than those with lower TNM stage (P<0.05). The results of qRT-PCR and Western blot demonstrated that the expression of LDHA in each RCC cell line was significantly higher than that in HK-2(P<0.05). After blocking the expression of LDHA in 786-O, there was a significant down-regulation of cell proliferation and glycolysis capacity (P<0.05). ConclusionsThe expression of LDHA in RCC tissue and RCC cell lines is significantly overexpressed compared with normal one, particularly in those with higher TNM stage. Knockdown of the expression of LDHA significantly suppresses cell proliferation and aerobic glycolysis capacity in 786-O.
7.Comparison of efficacy of O-arm assisted and free-hand pedicle screw placement in the treatment of AO type C thoracolumbar fracture
Weichao SHENG ; Wensheng LIAO ; Jingyi ZHANG ; Guang YANG ; Dongbo LYU ; Zhenghong YU ; Yanzheng GAO
Chinese Journal of Trauma 2023;39(4):341-348
Objective:To compare the effect of O-arm assisted and free-hand pedicle screw placement in the treatment of AO type C thoracolumbar fracture.Methods:A retrospective cohort study was used to analyze the clinical data of 34 patients with type C thoracolumbar fracture admitted to Henan Provincial People′s Hospital from January 2018 to June 2021, including 23 males and 11 females; aged 42-63 years [(50.4±7.4)years]. The fracture was located at T 11 in 4 patients, T 12 in 10, L 1 in 12, L 2 in 6, T 11~12/L 1 in 1 and T 12/L 1 in 1. Posterior reduction and internal fixation was carried out for all patients, of whom 18 were treated with O-arm assisted pedicle screw placement (navigation group) and 16 with free-hand pedicle screw placement (free-hand group). The operation time, single screw placement time, intraoperative bleeding volume, operation mode and screw placement accuracy were compared between the two groups. The kyphotic Cobb angle, visual analogue score (VAS) and American Spinal Injury Association (ASIA) score were compared between the two groups before operation, at 1 week after operation, at 3 months after operation and at the last follow-up. Postoperative complications were observed. Results:All patients were followed up for 12-29 months [(16.8±6.1)months]. There was no significant difference between the two groups in the operation time, intraoperative bleeding volume and operation mode (all P>0.05). The single screw placement time was (9.4±1.6)minutes in navigation group, but was (10.8±1.5)minutes in free-hand group ( P<0.05). The screw placement accuracy was 97.4% in navigation group, but was 81.5% in free-hand group ( P<0.01). The kyphotic Cobb angle and VAS had no significant differences between the two groups before operation (all P>0.05). The kyphotic Cobb angle in navigation group and free-hand group was (4.3±1.1)° and (5.9±1.1)° at 1 week after operation, (4.4±1.2)° and (5.7±1.3)° at 3 months after operation, and (4.4±1.2)° and (6.8±0.9)° at the last follow-up, decreased significantly from that before operation [(21.8±3.1)°, (22.2±3.2)°] (all P<0.01). The kyphotic Cobb angle in navigation group was significantly lower than that in free-hand group at 1 week, 3 months after operation and at the last follow-up (all P<0.01). The VAS in navigation group and free-hand group was (3.2±0.7)points and (4.1±0.7)points at 1 week after operation, (2.4±0.6)points and (3.0±0.8)points at 3 months after operation, and (1.8±0.9)points and (2.6±0.7)points at the last follow-up, decreased significantly from that before operation [(8.4±0.8)points, (8.3±0.9)points] (all P<0.01). The VAS in navigation group was significantly lower than that in free-hand group at 1 week, 3 months after operation and at the last follow-up (all P<0.01). The ASIA score showed no significant difference within and between the two groups before operation, at 1 week, 3 months after operation and at the last follow-up (all P>0.05). Postoperative incision infection occurred in 1 patient in both groups ( P>0.05). Implant failure such as loosening or displacement was not observed in navigation group, and only occurred in 2 patients in free-hand group ( P>0.05). Conclusion:Compared with free-hand pedicle screw placement, O-arm assisted pedicle screw placement in the treatment of AO type C thoracolumbar fracture has advantages of rapid and accurate screw placement, good reduction and notable pain relief.
9.Revealing characteristics and rules of acupoint sensitization phenomena: based on knee osteoarthritis.
Gui-Xing XU ; Yu-Mei ZHOU ; Ning SUN ; Jin CUI ; Xiao-Rong CHANG ; Lai-Xi JI ; Si-Yu LIU ; Liao-Jun LUO ; Xiao-Jia LIU ; Dan WANG ; Ling ZHAO ; Ding-Jun CAI ; Hui ZHENG ; Ming-Sheng SUN ; Guo-Yan GENG ; Jian CHENG ; Fan-Rong LIANG
Chinese Acupuncture & Moxibustion 2022;42(1):51-57
OBJECTIVE:
To explore the characteristics and rules of acupoint sensitization phenomena based on knee osteoarthritis (KOA), one of the clinical dominant diseases of acupuncture-moxibustion.
METHODS:
In combination with literature and expert experiences, the acupoints with the highest use frequency in treatment of KOA were screened, e.g. Heding (EX-LE 2), Liangqiu (ST 34), Mingmen (GV 4), Neixiyan (EX-LE 4), Ququan (LR 8) and Dubi (ST 35). In 814 patients with KOA and 217 healthy subjects, the acupoint temperature, mechanic pain threshold and pressure pain threshold were detected separately. Using machine learning method, the sensitization was judged at each acupoint.
RESULTS:
Compared with healthy subjects, the acupoint temperature was increased and the mechanic pain threshold and pressure pain threshold were reduced in KOA patients (P<0.05). Besides, the cut-off value was presented to distinguish whether the acupoint was sensitized or not. The results of machine learning showed that the highest prediction accuracy of acupoint sensitization was 86.7% (Shenshu [BL 23]) and the lowest one was 73.9% (Heding [EX LE 2]). The prediction accuracy at the third clinical stage trial was higher, the highest was 93.3% (Ququan [LR 8]) in KOA patients.
CONCLUSION
It is confirmed that the acupoint sensitization reflects the characteristics of disease and is correlative with the conditions of illness, which may provide the reference for the auxiliary diagnosis and condition assessment of KOA.
Acupuncture Points
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Acupuncture Therapy
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Humans
;
Moxibustion
;
Osteoarthritis, Knee/therapy*
;
Treatment Outcome
10.A descriptive analysis on type 2 diabetes in twins in China.
Ke ZHENG ; Wen Jing GAO ; Jun LYU ; Can Qing YU ; Sheng Feng WANG ; Tao HUANG ; Dian Jian Yi SUN ; Chun Xiao LIAO ; Yuan Jie PANG ; Zeng Chang PANG ; Min YU ; Hua WANG ; Xian Ping WU ; Zhong DONG ; Fan WU ; Guo Hong JIANG ; Xiao Jie WANG ; Yu LIU ; Jian DENG ; Lin LU ; Wei Hua CAO ; Li Ming LI
Chinese Journal of Epidemiology 2022;43(5):634-640
Objective: To describe the distribution characteristics of type 2 diabetes in twins in Chinese National Twin Registry (CNTR), provide clues and evidence for revealing the influence of genetic and environmental factors for type 2 diabetes. Methods: Of all twins registered in the CNTR during 2010-2018, a total 18 855 twin pairs aged ≥30 years with complete registration information were included in the analysis. The random effect model was used to describe the population and area distribution characteristics and concordance of type 2 diabetes in twin pairs. Results: The mean age of the subjects was (42.8±10.2) years, the study subjects included 10 339 monozygotic (MZ) twin pairs and 8 516 dizygotic (DZ) twin pairs. The self-reported prevalence rate of type 2 diabetes was 2.2% in total population and there was no sighificant difference between MZ and DZ. Intra-twin pairs analysis showed that the concordance rate of type 2 diabetes was 38.2% in MZ twin pairs, and 16.0% in DZ twin pairs, the difference was statistically significant (P<0.001). The concordance rate of type 2 diabetes in MZ twin parts was higher than that in DZ twin pairs in both men and women, in different age groups and in different areas (P<0.05). Further stratified analysis showed that in northern China, only MZ twin pairs less than 60 years old were found to have a higher concordance rate of type 2 diabetes compared with DZ twin pairs (P<0.05). In southern China, the co-prevalence rate in male MZ twin pairs aged ≥60 years was still higher than that in DZ twin pairs (P<0.05). Conclusion: The twin pairs in this study had a lower self-reported prevalence of type 2 diabetes than the general population. The study results suggested that genetic factors play a role in type 2 diabetes prevalence in both men and women, in different age groups and in different areas, however, the effect might vary.
Adult
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China/epidemiology*
;
Diabetes Mellitus, Type 2/genetics*
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Diseases in Twins/genetics*
;
Female
;
Humans
;
Male
;
Middle Aged
;
Registries
;
Twins, Dizygotic
;
Twins, Monozygotic/genetics*

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