Clinical trials are an important method for evaluating the safety and efficacy of in vitro diagnostic reagents, and are a key basis for product registration review and approval. In order to strengthen the management of clinical trials of in vitro diagnostic reagents, the National Medical Products Administration and relevant departments have formulated a series of regulations at the regulatory level, and require applicants and clinical trial institutions to establish a quality management system for clinical trials of in vitro diagnostic reagents. Medical laboratory is the main department and implementer of in vitro diagnostic reagent clinical trials in medical institutions. In recent years, with the rapid development of the in vitro diagnostic industry, the clinical trial projects of in vitro diagnostic reagents conducted by medical laboratory have been increasing day by day. However, there are currently few discussions on the clinical trial of in vitro diagnostic reagents from the perspective of researchers. Therefore, this article summarizes the characteristics of clinical trials of in vitro diagnostic reagents, analyzes the problems and difficulties in conducting clinical trials of in vitro diagnostic reagents in current medical laboratories, and introduces the laboratory′s experience in management; to provide reference for medical testing laboratories that have not yet conducted or have already conducted clinical trials of in vitro diagnostic reagents, in order to improve the quality and efficiency of clinical trials.

Objective To build an intelligent interactive discharge follow-up platform,and to explore its applica-tion effect in the management of discharge follow-up.Methods A research team was established to construct the intelligent interactive discharge follow-up platform,which includes 3 modules,namely follow-up plan customization module,follow-up execution module,and information backup and statistical analysis module.The discharge follow-up data of branch A and B of a tertiary hospital in Beijing from January to December 2022 were selected.Patients in branch A were given manual telephone follow-up by nurses,and patients in branch B were applied by the intelli-gent interactive discharge follow-up platform,and the follow-up efficiency of the 2 branches was compared.100 cas-es of discharged patients in each of 2 hospital branches were randomly selected as research subjects,and the fol-low-up time and nursing manpower of 2 groups were compared.Results The follow-up rate and effective follow-up rate of branch A were 99.96％and 95.10％,while those of branch B were 99.84％and 99.66％,respectively,and the difference was statistically significant(x2=19.028,2 081.008,P＜0.001).The opinion collection rate of branch A was 0.47％,which was higher than that of the branch B(0.01％)(x2=249.365,P＜0.001).The time and nursing man-power spent on follow-up was even less.Conclusion The intelligent interaction discharge follow-up platform real-izes human-robot multi-party intelligent interaction,which can release nursing manpower and time,improve the fol-low-up rate of discharged patients.

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).

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).

Clinical trials are an important method for evaluating the safety and efficacy of in vitro diagnostic reagents, and are a key basis for product registration review and approval. In order to strengthen the management of clinical trials of in vitro diagnostic reagents, the National Medical Products Administration and relevant departments have formulated a series of regulations at the regulatory level, and require applicants and clinical trial institutions to establish a quality management system for clinical trials of in vitro diagnostic reagents. Medical laboratory is the main department and implementer of in vitro diagnostic reagent clinical trials in medical institutions. In recent years, with the rapid development of the in vitro diagnostic industry, the clinical trial projects of in vitro diagnostic reagents conducted by medical laboratory have been increasing day by day. However, there are currently few discussions on the clinical trial of in vitro diagnostic reagents from the perspective of researchers. Therefore, this article summarizes the characteristics of clinical trials of in vitro diagnostic reagents, analyzes the problems and difficulties in conducting clinical trials of in vitro diagnostic reagents in current medical laboratories, and introduces the laboratory′s experience in management; to provide reference for medical testing laboratories that have not yet conducted or have already conducted clinical trials of in vitro diagnostic reagents, in order to improve the quality and efficiency of clinical trials.

Objective To investigate the application value of pre-implantation genetic testing(PGT)in patients with Turner syndrome.Methods The clinical data,embryonic development,PGT results and pregnancy outcome of 18 patients with Turner syndrome who underwent PGT in the reproductive center of 900th Hospital from January 2016 to June 2023 were retrospectively analyzed.Results All 18 patients had spontaneous puberty development,of which 4 patients had primary ovarian insufficiency(POI).A total of 24 oocyte retrieval cycles were performed in 18 patients,of which 6 patients had no biopsied embryos for 10 cycles.Sixty-one embryos were biopsied and 60 embryos were clearly diagnosed,including 25 with chromosomal abnormalities.Seven patients with mosaic Turner syndrome obtained clinical pregnancies after transplantation,including 4 healthy boys had already been delivered and 3 are in pregnancy.Conclusion There are numerous types of karyotype in Turner syndrome.The clinical phenotypes vary greatly in individuals with Turner syndrome,and prognosis of PGT is significant different.Patients with Turner syndrome who had biopsied embryos can obtain available embryo using PGT,and achieve ideal clinical outcomes.

Abstract: Objective To summarize the clinical characteristics of 35 patients with human monkeypox in Chengdu City, in order to provide theoretical basis for prevention and control of monkeypox epidemic in China. Methods A total of 35 patients diagnosed with monkeypox infection by Chengdu CDC from July 1 to July 23, 2023 were included in our study. The results of general clinical data, blood laboratory tests, lymph node ultrasound and chest CT results were collected in order to analyze the clinical features of human monkeypox patients in Chengdu City. Results All 35 monkeypox patients were young adult males, and there were no serious or fatal cases. Among them, 32 cases (91.4%) were men who have sex with men (MSM), and 30 cases had engaged in male-to-male sexual behavior within 21 days prior to the onset of the disease, of which 13 cases had taken protective measures. Fever symptoms were observed in 26 cases (74.3%) of the patients, with 19 cases experiencing fever within 1-6 days after the appearance of rash. The initial rash commonly occurred in the male external genitalia. Color ultrasound examinations indicated that all patients had swollen inguinal lymph nodes. C-reactive protein was elevated in 26 cases (74.3%) of patients, and 19 cases showed CD3+CD4+T/CD3+CD8+T< 1.0. 15 cases (42.8%) of the patients were infected with both monkeypox virus and HIV, 28.5% (10/35) of patients had concomitant skin infections and anorectal proctitis,respectively. The mean time from rash onset to the shedding of rash scabs was 14.8 days. Conclusions The MSM population in sexually active age group is the main infection object of human monkeypox virus. In monkeypox patients in Chengdu City, the rash starting at genital areas and rash occurring before systemic symptoms were common. Swollen inguinal lymph nodes are especially common in monkeypox patients. Skin infection and anorectal proctitis are the most common complications in monkeypox patients in Chengdu City. The abnormal cellular immune function in monkeypox patients is mainly reflected in the inverted ratio of CD3+CD4+T/CD3+CD8+T. Currently, there is no evidence to suggest that protective measures during male-to-male sexual behavior can reduce the risk of human monkeypox infection.

The clinical data of a case with late-onset isolated sulfite oxidase deficiency(ISOD)admitted in the Department of Neurology, Children′s Hospital, Zhejiang University School of Medicine in July 2021 were retrospectively analyzed.Fifteen previously published cases of late-onset ISOD were also reviewed.The patient was a girl, who was hospitalized because of " motor regression with mental retardation for 5 days" at 1 year old.The manifestations of the patient were extrapyramidal symptoms, regression of motor development and seizures.The level of urinary sulfites in the patient was increased.Magnetic resonance imaging (MRI) features were bilateral pallidus and substantia nigra.Gene sequencing suggested a pure missense mutation of the sulfite oxidase( SUOX) gene c. 650(exon5)G>A(p.Arg217Gln). In 16 cases of late-onset ISOD, the median age at onset and diagnosis was 10.5 months and 34.0 months, respectively.The common clinical manifestations were hypotonia (13 cases), seizures (10 cases), movement disorders (9 cases), and ectopia lentis (6 cases). The most common brain MRI feature was pallidus changes (11 cases), followed by lesions of substantia nigra (5 cases), and cerebral atrophy (4 cases). Fourteen cases of late-onset ISOD showed a positive urinary sulfite test.The missense mutation of the SUOX gene was found in 9 cases.It suggested that brain MRI involvement of bilateral pallidus, high excretion of urine sulfites and the missense mutation of the SUOX gene were important diagnostic clues for late-onset ISOD.

Objective:To analyze the application effect of integrated medical and nursing management model based on intelligent medical system in preventing postoperative breast cancer lymphedema.Methods:A total of 180 patients undergoing axillary lymph node dissection for breast cancer were selected in the Affiliated Hospital of Nantong University from July 2018 to August 2019. According to the random number table method, they were divided into treatment group and control group for 90 cases in each group, and finally completed the study: 86 cases in treatment group and 82 cases in control group. The control group was given routine health management, and the treatment group was given an integrated management model based on intelligent medical systems. After 6 months of follow-up, the two groups of patients were compared for their cognition of lymphedema, prevention behavior, incidence of lymphedema, and patient satisfaction.Results:The incidence, clinical manifestations, risk factors, prevention methods, and overall awareness rates of lymphedema in the treatment group were 82.56%(71/ 86), 84.88%(73/86), 83.72%(72/86), 83.72%(72/86), 83.72%(72/86), and the control group were 67.07%(55/82), 70.73%(58/82), 68.29%(56/82), 69.51%(57/82), 70.73%(58/82), the differences were statistically significant ( χ2 values were 4.046-5.508, P<0.05). The total scores of skin care, lifestyle, avoidance of upper limb compression, and prevention of lymphedema in the treatment group were (9.54±1.04), (30.45±2.45), (9.35±1.08), (58.92±8.20) points, and the control group were (8.12±1.32), (8.12±1.32), (8.74±1.14), (53.45±7.64) points, the differences were statistically significant ( t values were 3.561-7.764, P<0.01). The incidence of lymphedema in the treatment group was 9.30%(8/86), and that in the control group was 23.17%(19/82), the difference was statistically significant ( χ2 value was 5.985, P<0.05). Satisfaction was 95.35%(82/86) in the treatment group and 82.93%(68/82) in the control group, the difference was statistically significant ( χ2 value was 6.771, P<0.01). Conclusions:The integrated management of medical care and patients based on intelligent medical system can help improve the level of lymphedema cognition in patients with breast cancer surgery, promote the development of lymphedema prevention behavior, reduce the incidence of postoperative lymphedema, and improve patient satisfaction.

OBJECTIVE: To assess the application value of mapping allele with resolved carrier status (MaReCs) technique for preimplantation genetic testing (PGT). METHODS: The characteristics of MaReCs for PGT and outcome of patients were retrospectively analyzed. RESULTS: Compared with those who could not use the technique, carriers who have used the MaReCs technique were younger, had significantly higher level of anti-Mullerian hormone, more antral follicles, occytes, mature occytes, biopsied embryos and euploid embryos, and lower risks for de novo chromosomal abnormality (P<0.05). It was necessary for couples with fewer oocytes, mature oocytes and balstocyst to preserve discarded embryos to facilitate the test. Carriers who have used the MaReCs technique had higher clinical pregnancy rate and abortion rate compared with those undergoing routine PGT, albeit no significant difference was found between the two groups (P> 0.05). Carriers undergoing MaReCs test could preferentially select embryos with normal chromosome structures for the transfer. CONCLUSION Application of MaReCs has a prerequisite for having a minimum number of occytes and biopsied embryos and using discarded embryos sometimes. MaReCs is efficient for the detection of carrier status of embryos and attaining higher rate of pregnancy and live birth, which can significantly improve the outcome for couples carrying chromosomal translocations.
Alleles ; Aneuploidy ; Blastocyst ; Female ; Fertilization in Vitro ; Genetic Testing ; Humans ; Pregnancy ; Preimplantation Diagnosis ; Retrospective Studies ; Translocation, Genetic