Objective: Compare and analyze the results of the domestic Lanyi AH600 glycated hemoglobin analyzer and other different detection systems to understand the comparability of the detection results of different detectors, and establish the best cut point of Lanyi AH600 determination of haemoglobin A1c (HbA1c) in the diagnosis of diabetes. Methods: Multi center cohort study was adopted. The clinical laboratory departments of 18 medical institutions independently collected test samples from their respective hospitals from March to April 2022, and independently completed comparative analysis of the evaluated instrument (Lanyi AH600) and the reference instrument HbA1c. The reference instruments include four different brands of glycosylated hemoglobin meters, including Arkray, Bio-Rad, DOSOH, and Huizhong. Scatter plot was used to calculate the correlation between the results of different detection systems, and the regression equation was calculated. The consistency analysis between the results of different detection systems was evaluated by Bland Altman method. Consistency judgment principles: (1) When the 95% limits of agreement (95% LoA) of the measurement difference was within 0.4% HbA1c and the measurement score was≥80 points, the comparison consistency was good; (2) When the measurement difference of 95% LoA exceeded 0.4% HbA1c, and the measurement score was≥80 points, the comparison consistency was relatively good; (3) The measurement score was less than 80 points, the comparison consistency was poor. The difference between the results of different detection systems was tested by paired sample T test or Wilcoxon paired sign rank sum test; The best cut-off point of diabetes was analyzed by receiver operating characteristic curve (ROC). Results: The correlation coefficient R² of results between Lanyi AH600 and the reference instrument in 16 hospitals is≥0.99; The Bland Altman consistency analysis showed that the difference of 95% LoA in Nanjing Maternity and Child Health Care Hospital in Jiangsu Province (reference instrument: Arkray HA8180) was -0.486%-0.325%, and the measurement score was 94.6 points (473/500); The difference of 95% LoA in the Tibetan Traditional Medical Hospital of TAR (reference instrument: Bio-Rad Variant II) was -0.727%-0.612%, and the measurement score was 89.8 points; The difference of 95% LoA in the People's Hospital of Chongqing Liang Jiang New Area (reference instrument: Huizhong MQ-2000PT) was -0.231%-0.461%, and the measurement score was 96.6 points; The difference of 95% LoA in the Taihe Hospital of traditional Chinese Medicine in Anhui Province (reference instrument: Huizhong MQ-2000PT) was -0.469%-0.479%, and the measurement score was 91.9 points. The other 14 hospitals, Lanyi AH600, were compared with 4 reference instrument brands, the difference of 95% LoA was less than 0.4% HbA1c, and the scores were all greater than 95 points. The results of paired sample T test or Wilcoxon paired sign rank sum test showed that there was no statistically significant difference between Lanyi AH600 and the reference instrument Arkray HA8180 (Z=1.665,P=0.096), with no statistical difference. The mean difference between the measured values of the two instruments was 0.004%. The comparison data of Lanyi AH600 and the reference instrument of all other institutions had significant differences (all P<0.001), however, it was necessary to consider whether it was within the clinical acceptable range in combination with the results of the Bland-Altman consistency analysis. The ROC curve of HbA1c detected by Lanyi AH600 in 985 patients with diabetes and 3 423 patients with non-diabetes was analyzed, the area under curve (AUC) was 0.877, the standard error was 0.007, and the 95% confidence interval 95%CI was (0.864, 0.891), which was statistically significant (P<0.001). The maximum value of Youden index was 0.634, and the corresponding HbA1c cut point was 6.235%. The sensitivity and specificity of diabetes diagnosis were 76.2% and 87.2%, respectively. Conclusion: Among the hospitals and instruments currently included in this study, among these four hospitals included Nanjing Maternity and Child Health Care Hospital in Jiangsu Province (reference instrument: Arkray HA8180), Tibetan Traditional Medical Hospital of TAR (reference instrument: Bio-Rad Variant Ⅱ), the People's Hospital of Chongqing Liang Jiang New Area (reference instrument: Huizhong MQ-2000PT), and the Taihe Hospital of traditional Chinese Medicine in Anhui Province (reference instrument: Huizhong MQ-2000PT), the comparison between Lanyi AH600 and the reference instruments showed relatively good consistency, while the other 14 hospitals involved four different brands of reference instruments: Arkray, Bio-Rad, DOSOH, and Huizhong, Lanyi AH600 had good consistency with its comparison. The best cut point of the domestic Lanyi AH600 for detecting HbA1c in the diagnosis of diabetes is 6.235%.
Pregnancy ; Child ; Humans ; Female ; Glycated Hemoglobin ; Cohort Studies ; Diabetes Mellitus/diagnosis* ; Sensitivity and Specificity ; ROC Curve

BACKGROUND: LY01005 (Goserelin acetate sustained-release microsphere injection) is a modified gonadotropin-releasing hormone (GnRH) agonist injected monthly. This phase III trial study aimed to evaluated the efficacy and safety of LY01005 in Chinese patients with prostate cancer. METHODS: We conducted a randomized controlled, open-label, non-inferiority trial across 49 sites in China. This study included 290 patients with prostate cancer who received either LY01005 or goserelin implants every 28 days for three injections. The primary efficacy endpoints were the percentage of patients with testosterone suppression ≤50 ng/dL at day 29 and the cumulative probability of testosterone ≤50 ng/dL from day 29 to 85. Non-inferiority was prespecified at a margin of -10%. Secondary endpoints included significant castration (≤20 ng/dL), testosterone surge within 72 h following repeated dosing, and changes in luteinizing hormone, follicle-stimulating hormone, and prostate specific antigen levels. RESULTS: On day 29, in the LY01005 and goserelin implant groups, testosterone concentrations fell below medical-castration levels in 99.3% (142/143) and 100% (140/140) of patients, respectively, with a difference of -0.7% (95% confidence interval [CI], -3.9% to 2.0%) between the two groups. The cumulative probabilities of maintaining castration from days 29 to 85 were 99.3% and 97.8%, respectively, with a between-group difference of 1.5% (95% CI, -1.3% to 4.4%). Both results met the criterion for non-inferiority. Secondary endpoints were similar between groups. Both treatments were well-tolerated. LY01005 was associated with fewer injection-site reactions than the goserelin implant (0% vs . 1.4% [2/145]). CONCLUSION: LY01005 is as effective as goserelin implants in reducing testosterone to castration levels, with a similar safety profile. TRIAL REGISTRATION ClinicalTrials.gov, NCT04563936.
Humans ; Male ; Antineoplastic Agents, Hormonal/therapeutic use* ; East Asian People ; Gonadotropin-Releasing Hormone/agonists* ; Goserelin/therapeutic use* ; Prostate-Specific Antigen ; Prostatic Neoplasms/drug therapy* ; Testosterone

Endometriosis(EMs) is a stubborn gynecological disease caused by persistent immune-inflammatory effects, and is known as "benign tumor" because of its similar characteristics to malignant tumors. National physician master Professor BAN Xiu-wen believes that the spread of damp-evil is the pathologic foundation for inflammatory response of ectopic endometrium; accumulation of blood stasis is the pathological product of continuous inflammatory attacks, and the combination of dampness and stasis is the main pathogenesis for refractory EMs. Modern researches have shown that immune-inflammatory effect is the key mechanism for development of EMs, and is closely related to cell autophagy, all of which have made it become the hot spots in research of the pathogenesis, diagnosis and treatment of EMs. Therefore, with immune-inflammatory effect as the breakthrough point in this research, and with reference to the related research of autophagy, the correlation between "combination of dampness and stasis" and abnormal autophagy-induced immune inflammatory response in ectopic endometrium was discussed, to provide guidance for the clinical application of traditional Chinese medicine and modern research.
Autophagy ; Endometriosis ; Endometrium ; Female ; Humans ; Medicine, Chinese Traditional

BACKGROUND: It has been a global trend that increasing complications related to pelvic floor surgeries have been reported over time. The current study aimed to outline the development of Chinese pelvic floor surgeries related to pelvic organ prolapse (POP) over the past 14 years and investigate the potential influence of enhanced monitoring conducted by the Chinese Association of Urogynecology since 2011. METHODS: A total of 44,594 women with POP who underwent pelvic floor surgeries between October 1, 2004 and September 30, 2018 were included from 22 tertiary academic medical centers. The data were reported voluntarily and obtained from a database. We compared the proportion of each procedure in the 7 years before and 7 years after September 30, 2011. The data were analyzed by performing Z test (one-sided). RESULTS: The number of different procedures during October 1, 2011-September 30, 2018 was more than twice that during October 1, 2004-September 30, 2011. Regarding pelvic floor surgeries related to POP, the rate of synthetic mesh procedures increased from 38.1% (5298/13,906) during October 1, 2004-September 30, 2011 to 46.0% (14,107/30,688) during October 1, 2011-September 30, 2018, whereas the rate of non-mesh procedures decreased from 61.9% (8608/13,906) to 54.0% (16,581/30,688) (Z = 15.53, P < 0.001). Regarding synthetic mesh surgeries related to POP, the rates of transvaginal placement of surgical mesh (TVM) procedures decreased from 94.1% (4983/5298) to 82.2% (11,603/14,107) (Z = 20.79, P < 0.001), but the rate of laparoscopic sacrocolpopexy (LSC) procedures increased from 5.9% (315/5298) to 17.8% (2504/14,107). CONCLUSIONS: The rate of synthetic mesh procedures increased while that of non-mesh procedures decreased significantly. The rate of TVM procedures decreased while the rate of LSC procedures increased significantly. TRIAL REGISTRATION NUMBER NCT03620565, https://register.clinicaltrials.gov.
China ; Female ; Gynecologic Surgical Procedures/adverse effects* ; Humans ; Pelvic Floor/surgery* ; Pelvic Organ Prolapse/surgery* ; Surgical Mesh/adverse effects* ; Treatment Outcome ; Vagina

Objective To survey the infection status and related factors of Helicobacter pylori(H.pylori) among adult population receiving physical examination in Yunnan plateau area so as to provide a basis for control and treatment of H.pylori infection at the present stage.Methods The epidemiological survey method was applied to collect the intact data on adult health physical examination from Jan.2013 to Feb.2015,including the results of survey by adopting the unified national questionnaire and 13 C-urea breathe test for detecting H.pylori.The guestionniare contents had the basic conditions,socid economy stalus,personal and family health status cinecluding whether sufferring from digestive diseases or symptoms,dietary habit,etc.Results A tatae of 1 680 eligi ble subjects were included in this study.The total infection rate of H.pylori was 33.5％,which of male and female were 33.2％ and 34.5 ％ respectively,the difference was not statistically significant (P＞0.05).The peak of H.pylori infection rate was in the age group 40-49 years(36.7 ％),but the difference among different age groups had no statistical significance(P＞0.05).The univariate analysis indicated that H.pylori infection was not correlated with nationality,permanent residence,occupation,education level,marital status and number of living together members(P＞0.05);H.pylori infection had no correlation with whether the individual or family members having digestive system disease or symptoms(P＞0.05);washing hands before meals and after defecation,stress of work,living and study,mainly used latrine type,daily means of transportation,work and rest time,sharing cutlery,diets habits,brushing teeth frequency per day and source of drinking water had no influence on H.pylori infection(P＞0.05),and smoking,alcohol drinking and frequently contacting with animals also had no influence on H.pylori infection(P＞0.05).H.pylori infection was significanly correlated with the social economical status,daily means of transportation and alcohol drinking(P＜0.05).The multiple unconditional Logistic regression analysis results indicated that there was negative correlation between H.pylori infection and monthly income,the OR (95％CI)value was 0.848(0.759-0.949).Conclusion The H.pylori total infection rate in adult population receiving physical examination in Yunnan plateau area is lower than the national population natural infection rate.It should focus on middle-aged population and low-income people.

Objective To explore the relationship between Helicobacter pylori (HP) infection and dyslipidemia in adult people undergoing the healthy physical examination in Kunming city.Methods The intact population data of adult people undergoing the healthy physical examination and conducting the HP detection by adopting the 13C breath test (13 C-UBT)in the Cadres Physical Examination Center,Yunnan Provincial Second People's Hospital from January 2013 to February 2015 were retrospectively analyzed.The data included the basic information and serum fipids indexes[total cholesterol (TC),triglyceride (TG),high-density lipoprotein cholesterol (HDL-C),low-density lipoprotein cholesterol (LDL-C)].All subjects were divided into the HP positive group and HP negative group according to whether having HP infection.The levels of TC,TG,HDL-C,LDL-C and the incidences of single index of dyslipidemia and total dyslipidemias were compared between 2 groups and Logistic regression analysis was performed for investigating the relationship between HP infection and dyslipidemia.Results A total of 1 354 subjects were included in the study.The HP infection rate was 33.2％.The levels of TC,TG,HDL-C and LDL-C were no statistical significance between positive HP group and negative HP group (P＞0.05).The incidence rate of TC≥6.22 mmol/L of HP positive group was lower than that of HP negative group (P＜0.05).The occurrence rate of TC increase abnormality in the HP positive group was lower than that in the HP negative group (P＜0.05);the occurrence rate of dyslipidemia had no statistical difference between the HP positive group and HP negative group in the stratification according to sex,age and BMI (P＞0.05).The regression analysis showed that the HP infection was an independent influencing factors of TC increase abnormality (OR=0.644,P＜0.05).Conclusion The HP infection affects the incidence of TC increase abnormality,but might not affect the occurrence rate of dyslipidemia.

OBJECTIVETo evaluate the clinicopathological characteristics, treatment and prognosis of the patients with plasmablastic lymphoma(PBL).

METHODSThe clinical and pathological data of 21 patients with PBL diagnosed and treated in our center between January 2009 and September 2017 were retrospectively analyzed. The clinical and pathological features, treatment and therapentic outcome were summarized and the high risk factors affecting the prognosis of patients were investigated.

RESULTSThe 21 PBL patients included 12 males and 9 females, and their median age was 52 years old. The human immunodeficiency virus (HIV) was negative in all patients. The primary involved sites of 16 patients were extranodal, and the patients staged in III-IV accounted for 81%; 18 patients receved first-line chemotherapy with standard CHOP(E) (cyclophosphamide +epirubicin +vincristine +prednisone±etoposide). After treatment, only 1 patient achieved complete response (CR), and 8 patients achieved partial response (PR). The median overall survival time was 6.3 months. Multivariate analysis showed the America Eastern Cooperative Oncology Group (ECOG) physical score and bone marrow infiltration were significant prognostic factors (P<0.01).

CONCLUSIONPlasmablastic lymphoma frequently occurrs in the middle-old aged persons with all HIV negative. Primary extranodal lesions are frequent. Most patients were in advanced stage with poor treatment response. ECOG score≥2 and bone marrow infiltration are independent prognostic factors related with worse prognosis.

Objective To investigate the relationship between methyle-netetrahydrofolate reductase ( MTHFR ) genetic polymorphisms and ad-verse drug reactions of methotrexate ( MTX) chemotherapy for acute lym-phoblastic leukemia ( ALL ) in China.Methods The relevant data bases were searched and reviewed.Meta -analysis was performed by software of RevMan 5.3.Results Ten studies were included , and half of them only involved MTHFR C 677 T, and the others involved both.The meta-analysis showed thatcompared with 677 CT/TT, 677 CC had a low-er risk of erythra ( P<0.05 );there were no significant differences in the total adverse drug reactions and other types of adverse drug reaction;age had no effect on the relationship between MTHFR genetic polymorphisms and adverse reactions of MTX.There were no significant differences in the total adverse reactions and different types of adverse reaction between 1298 AA and 1298 AC/CC; 1298 AA had a lower risk of mucositis than 1298 AC/CC in pediatric ALL ( P<0.05 ).Conclusion MTHFR C677 T and A1298 C polymorphisms do not seem to be good markers of MTX -re-lated total adverse drug reactions , but may affect part types such as eryth-ra and mucositis in Chinese ALL.

BACKGROUND:For the elderly osteoporotic thoracolumbar burst fractures without nerve root symptoms,it is difficult to choose between traditional surgical and conservative treatment,because they have their advantages and disadvantages.How to select their advantages and to discard their disadvantages? Concept of minimal invasion builds a new platform and provides a new way of thinking and therapeutic tool.OBJECTIVE:To design and develop a new thoracolumbar distraction reduction devicein vitro in the repair of elderly osteoporotic burst fractures.METHODS:We designed and developed a new type of thoracic and lumbar spinein vitrodistraction reduction device,including bracket,guide pin and two holow screws.Its characteristic is that it also contained distractor,pressurizer and wrench.In accordance with the theory of muscles as important as bones and actual anatomical condition,bone fragment in the spine canal was restored using percutaneous ligament reconstructive technique.RESULTS AND CONCLUSION:This thoracic and lumbar spinein vitro distraction reduction device combined with ligament reconstructive technique can be used in elderly osteoporotic burst fractures and elderly osteoporotic compression fractures.It is percutaneous minimaly invasive operation,can restore the height of anterior and central cylinders and correct Cobb's angle through multi angle distraction.Simultaneously,percutaneousvertebroplasty can be utilized.Bone cement was infused in the injured vertebra.According to patients' economic situation,percutaneous baloon kyphoplasty can be employed.These can provide an inexpensive,less-pain,less-invasive way to repair.

OBJECTIVE:To investigate the way to provide suitable pharmacecaical care for antineophastic drug-induced ADR by clinical pharmacists. METHODS:For one case of 5-FU chemotherapy-induced neutropenia associated with fever and diarrhea, clinical pharmacists provided advices on antibacterial treatment,including imipenem/cilastatin 0.5 g,q6 h,ivgtt;norvancomycin 0.4 g,q6 h,po;levofloxacin 0.4 g,qd,ivgtt;loperamide with initial dose of 4 mg for anti-diarrheal medication,maintaining at 2 mg,q4 h. RESULTS:After 22 days of appropriate antibacterial and anti-diarrheal treatment,the patient's body temperature and he-mogram returned to normal,diarrhea stopped and β-HCG decreased to 61.58 U/L;then the patient was discharged from hospital. CONCLUSIONS:It is beneficial to optimize chemotherapy plan and ADR disposal,and ensure the safety of the treatment that clini-cal pharmacists assist physicans to optimize therapy plan and provide pharmaceutical care.