Objective To investigate the occurrence of adverse events of lurasidone in the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)database by using Open Vigil FDA2.1,to enrich the experience and provide the basis for the clinical use of the drug in China.Methods Using Open Vigil FDA2.1,adverse event data were extracted from the FAERS database for a total of 51 quarters from the 4th quarter of 2010 to the 3rd quarter of 2023,and the ratio of reporting ratio(ROR)method and the proportional reporting ratio(PRR)method were used for data mining and analysis.Results A total of 32 728 adverse event reports with lurasidone as the first suspected drug was obtained,with a larger proportion of females(54.26％)and occurring mostly in adults(18 to 59 years).After the screening,326 preferred term(PT)signals were obtained,involving 20 system-organ classifications(injury,poisoning and procedural complications,general disorders and administration site conditions,psychiatric disorders,etc.).Among them,PTs with the higher frequency of occurrence included off label use,feeling abnormal,crying,anxiety,depression,insomnia,etc.PTs with stronger signal strength included activation syndrome,mania,tongue movement disturbance,hypoprolactinaemia,akathisia,etc.Multiple new suspected adverse drug reactions were unearthed,including hypoprolactinaemia,emotional poverty,stiff tongue,etc.Conclusion Lurasidone has a favorable safety profile,and women need to closely monitor prolactin levels when taking this medication.The drug is relatively safe for use in pregnant,puerperal and perinatal women and patients with poor metabolic function.Hypoprolactinaemia and restless leg syndrome are new rare suspected adverse events with lurasidone.

Objective With the widespread of transcatheter aortic valve replacement(TAVR)in patients with severe symptomatic aortic stenosis(AS),the life-cycle management has become a major determinant of prognosis.Methods A total of 408 AS patients who underwent successfully TAVR from June 2021 to August 2023 were consecutively enrolled in Hospital Valve Intervention Center.Patients were assigned to the Usual Care(UC)group between June 2021 and October 2022,while patients were assigned to the Heart Multi-parameter Monitoring(HMM)group between November 2022 and August 2023.The primary endpoint was defined as composite endpoint within 6 months post-TAVR,including all-cause death,cardiovascular death,stroke/transient ischemic attack,conduction block,myocardial infarction,heart failure rehospitalization,and major bleeding events.Secondary endpoints were the time interval(in hours)from event occurrence to medical consultation or advice and patient satisfaction.Statistical analysis was performed using Kaplan-Meier and multivariable Cox proportional hazards models.Results The incidence of primary endpoint in HMM group was significantly lower than that in UC group(8.9％vs.17.7％,P=0.016),the driving event was the rate of diagnosis and recognition of conduction block.The average time intervals from event occurrence to receiving medical advice were 3.02 h in HHM group vs.97.09 h in UC group(P＜0.001).Using cardiac monitoring devices and smart healthcare platforms provided significant improving in patients long-term management(HR 0.439,95％CI 0.244-0.790,P=0.006).Conclusions The utilization of cardiac monitoring devices and smart healthcare platforms effectively alerted clinical events and improved postoperative quality of life during long-term management post TAVR.

Currently,the research or publications related to the clinical comprehensive evaluation of Chinese patent medicine are increasing,which attracts the broad attention of all circles. According to the completed clinical evaluation report on Chinese patent medicine,there are still practical problems and technical difficulties such as unclear responsibility of the evaluation organization,unclear evaluation subject,miscellaneous evaluation objects,and incomplete and nonstandard evaluation process. In terms of evaluation standards and specifications,there are different types of specifications or guidelines with different emphases issued by different academic groups or relevant institutions. The professional guideline is required to guide the standardized and efficient clinical comprehensive evaluation of Chinese patent medicine and further improve the authority and quality of evaluation. In combination with the characteristics of Chinese patent medicine and the latest research achievement at home and abroad,the detailed specifications were formulated from six aspects including design,theme selection,content and index,outcome,application and appraisal,and quality control. The guideline was developed based on the guideline development requirements of China Assoication of Chinese medicine. After several rounds of expert consensus and public consultation,the current version of the guideline has been developed.
Medicine, Chinese Traditional ; Nonprescription Drugs ; Consensus ; China ; Reference Standards ; Drugs, Chinese Herbal

Background: and Purpose Intravenous tenecteplase (TNK) efficacy has not been well demonstrated in acute ischemic stroke (AIS) beyond 4.5 hours after onset. This study aimed to determine the effect of intravenous TNK for AIS within 4.5 to 24 hours of onset. Methods: In this pilot trial, eligible AIS patients with diffusion-weighted imaging (DWI)-fluid attenuated inversion recovery (FLAIR) mismatch were randomly allocated to intravenous TNK (0.25 mg/kg) or standard care within 4.5–24 hours of onset. The primary endpoint was excellent functional outcome at 90 days (modified Rankin Scale [mRS] score of 0–1). The primary safety endpoint was symptomatic intracranial hemorrhage (sICH). Results: Of the randomly assigned 80 patients, the primary endpoint occurred in 52.5% (21/40) of TNK group and 50.0% (20/40) of control group, with no significant difference (unadjusted odds ratio, 1.11; 95% confidence interval 0.46–2.66; P=0.82). More early neurological improvement occurred in TNK group than in control group (11 vs. 3, P=0.03), but no significant differences were found in other secondary endpoints, such as mRS 0–2 at 90 days, shift analysis of mRS at 90 days, and change in National Institutes of Health Stroke Scale score at 24 hours and 7 days. There were no cases of sICH in this trial; however, asymptomatic intracranial hemorrhage occurred in 3 of the 40 patients (7.5%) in the TNK group. Conclusion This phase 2, randomized, multicenter study suggests that intravenous TNK within 4.5–24 hours of onset may be safe and feasible in AIS patients with a DWI-FLAIR mismatch.

Objective: To compare the application effect of the colonoscopy, fecal immunochemical test (FIT) and novel risk-adapted screening approach in colorectal cancer screening in Xuzhou population. Methods: From May 2018 to April 2019, 4 280 subjects aged 50-74 were recruited from Gulou district, Yunlong district and Quanshan district of Xuzhou. They were randomly assigned to the colonoscopy group (n=863), FIT group (n=1 723) and novel risk-adapted screening approach group (n=1 694) according to the ratio of 1∶2∶2. For the novel risk-adapted screening approach group, after the risk assessment, high-risk subjects were invited to undergo colonoscopy and low-risk subjects were invited to undergo FIT examination. All FIT positive subjects were invited to undergo colonoscopy. Colonoscopy participation rate [(the number of colonoscopies completed/the number of colonoscopies invited to participate)×100%], detection rate of colorectal lesions [(the number of diagnosed patients/the number of colonoscopies completed)×100%], colonoscopy resource load (the number of colonoscopies completed/the number of diagnosed advanced tumors) and FIT resource load in each group were calculated and compared. Results: The age of all subjects was (61±6) years old, including 1 816 males (42.43%). There was no statistically significant difference in the socio-demographic characteristics of the subjects in different screening groups. The colonoscopy participation rate was 22.60% (195/863) in the colonoscopy group, 57.04% (77/135) in the FIT group, and 33.94% (149/439) in the novel risk-adapted screening approach group, respectively. The colonoscopy participation rate was higher in the FIT group than in the colonoscopy group and the novel risk-adapted screening approach group (P<0.001). The colonoscopy participation rate of novel risk-adapted screening group was significantly higher than the colonoscopy group (P<0.001). The detection rates of advanced tumors were 6.67% (13/195), 9.09% (7/77) and 8.72% (13/149), respectively, and the difference was not statistically significant (P>0.05). The colonoscopy resource load (95%CI) was 15 (13-17) in the colonoscopy group, 11 (9-14) in the FIT group and 11 (10-13) in the novel risk-adapted screening approach group, respectively. Among them, the colonoscopy resource load of high-risk individuals in the novel risk-adapted screening approach group was 12 (9-15). FIT resource loads (95%CI) were 207 (196-218) and 88 (83-94) in the FIT group and the novel risk-adapted screening approach group. Conclusion: The combined application of risk-adapted screening approach and FIT may have a good application effect in colorectal cancer screening.
Aged ; Colonoscopy ; Colorectal Neoplasms/pathology* ; Early Detection of Cancer ; Feces ; Female ; Humans ; Male ; Mass Screening ; Middle Aged ; Occult Blood

OBJECTIVE: To investigate the effects of MetS on the prognosis of patients with clear cell renal cell carcinoma (ccRCC). METHODS: Clinical and pathological data and the laboratory test of ccRCC 342 patients with diverticular stones who underwent ccRCC who underwent radical or partial nephrectomy were retrospectively collected and analyzed.The patients were divided into MetS group and non-MetS group, and the subgroups were defined according to the tumor size. The overall survival (OS), cancer-specific survival (CSS), and progression-free survival (PFS) of the two groups were analyzed by univariate Cox analysis, and the subgroup analyses were also performed. Kaplan-Meier survival curve and survival analysis for OS, CSS, and PFS of the two groups and the subgroups were conducted. RESULTS: Univariate Cox analysis showed that MetS was a protective factor of postoperative OS [hazard ratio (HR)=0.551, 95%CI: 0.321-0.949, P=0.031], CSS (HR=0.460, 95%CI: 0.234-0.905, P=0.025), and PFS (HR 0.585, 95%CI: 0.343-0.998, P=0.049) in the patients with ccRCC. In the subgroup with tumor size≤4 cm, MetS was not associated with postoperative OS (HR=0.857, 95%CI: 0.389-1.890, P=0.702), CSS (HR=1.129, 95%CI: 0.364-3.502, P=0.833), and PFS (HR=1.554, 95%CI: 0.625-3.864, P=0.343). In the subgroup with tumor size>4 cm, Mets was a protective factor of postoperative OS (HR=0.377, 95%CI: 0.175-0.812, P=0.013), CSS (HR=0.280, 95%CI: 0.113-0.690, P=0.006), and PFS (HR=0.332, 95%CI: 0.157-0.659, P=0.002); Obesity was a protective factor of postoperative CSS (HR=0.464, 95%CI: 0.219-0.981, P=0.044), and PFS (HR=0.445, 95%CI: 0.238-0.833, P=0.011). Kaplan-Meier survival analysis showed that the long-term survival of patients with MetS was better than those without MetS in OS (P=0.029), CSS (P=0.021), and PFS (P=0.046); for the subgroup with tumor size≤4 cm, there was no significant difference in postoperative OS (P=0.702), CSS (P=0.833), and PFS (P=0.339) between patients with and without MetS; For the subgroup with tumor size>4 cm, the OS (P=0.010), CSS (P=0.003), and PFS (P=0.001) of patients with MetS were better than those without MetS. CONCLUSION MetS was a protective factor of postoperative OS, CSS, and PFS in the patients with ccRCC, which was more obvious in subgroup with tumor size>4 cm. And obesity, the component of MetS, was correlated with postoperative OS and CSS.
Carcinoma ; Carcinoma, Renal Cell/surgery* ; Humans ; Kidney Neoplasms/pathology* ; Metabolic Syndrome/complications* ; Obesity ; Prognosis ; Retrospective Studies

A total of 18 batches of Zhuru Decoction samples were prepared. Chromatographic fingerprints were established for Zhuru Decoction and single decoction pieces, the content of which was then determined. The extraction rate ranges, content, and transfer rate ranges of puerarin, liquiritin, and glycyrrhizic acid, together with the common peaks and the similarity range of the fingerprints, were determined to clarify key quality attributes of Zhuru Decoction. The 18 batches of Zhuru Decoction samples had 25 common peaks and the fingerprint similarity higher than 0.95. Puerariae Lobatae Radix, Glycyrrhizae Radix et Rhizoma, and Zingiberis Rhizoma Recens had 21, 3, and 1 characteristic peaks, respectively. The 18 batches of samples showed the extraction rates within the range of 18.45%-25.29%. Puerarin had the content of 2.20%-3.07% and the transfer rate of 38.5%-45.9%; liquiritin had the content of 0.24%-0.85% and the transfer rate of 15.9%-37.5%; glycyrrhizic acid had the content of 0.39%-1.87% and the transfer rate of 16.2%-32.8%. In this paper, the quality value transmitting of substance benchmarks of Zhuru Decoction was analyzed based on chromatographic fingerprints, extraction rate, and the content of index components. A scientific and stable method was preliminarily established, which provided a scientific basis for the quality control and formulation development of Zhuru Decoction.
Chromatography, High Pressure Liquid ; Drugs, Chinese Herbal/standards* ; Glycyrrhizic Acid/analysis* ; Quality Control ; Rhizome/chemistry*

OBJECTIVE: To analyze the short-term prognosis of elderly patients with hip fracture after operation, and to explore the main factors affecting the recovery of daily life function. METHODS: From November 2015 to November 2016, 130 elderly patients with hip fracture were analyzed, including 43 males and 87 females, aged from 60 to 95 (77.54±8.49) years. The death, fall and complications were recorded 3 months after operation. The daily life function of the patients was followed up 3 months after operation with the functional recovery of daily life scale (FRS). T-test, analysis of variance and single factor linear regression analysis were used to analyze the general clinical data. The factors with RESULTS: Among 130 patients, 7 died (5.4%), 4 fell (3.1%), 103 (79.2%) had postoperative complications, and the FRS score of 123 patients was 65.92±22.79. The results showed that gender, age, fracture site, pre fracture Basel rating, frailty index, postoperative hospital stay and total number of postoperative complications had significant differences in the recovery of daily life function ( CONCLUSION The short term rehabilitation level of elderly patients with hip fracture after operation is poor. Basel rating before fracture, frailty index, postoperative hospital stay and total number of postoperative complications may be related risk factors affecting the recovery of daily life function of patients after operation.
Activities of Daily Living ; Aged ; Female ; Hip Fractures/surgery* ; Humans ; Length of Stay ; Male ; Postoperative Complications ; Postoperative Period ; Risk Factors

Objective:To investigate the diversity and structural characteristics of fungal communities on lesions of the face, upper limbs and back in patients with atopic dermatitis (AD) .Methods:Samples were collected from the lesions on the face, upper limbs and back of 10 AD patients, who visited the Department of Dermatology, the First Affiliated Hospital of Chengdu Medical College from September to October in 2015, and collected from the corresponding body sites of 10 healthy controls. DNA was extracted from the samples, and subjected to MiSeq high-throughput sequencing for diversity index analysis, species composition analysis and principal component analysis. Statistical analysis was carried out by using two-independent-sample t test for comparisons between two groups, one-way analysis of variance for comparisons among multiple groups, and least significant difference- t test for multiple comparisons. Results:Diversity index analysis showed that Shannon index was significantly higher in the samples from the lesions on the face, upper limbs and back of the AD patient group than in those from corresponding body sites of the healthy control group ( t = 2.67, 2.37, 3.34 respectively, all P < 0.05) . Species composition analysis showed that Malassezia was predominant in the skin samples from the face, upper limbs and back of the AD patient group and healthy control group, and the total abundance of Malassezia globosa and Malassezia restricta was about 80%. The abundance of Candida and Aspergillus in the total samples was significantly higher in the AD patient group than in the healthy control group ( t = 3.515, 2.137 respectively, both P < 0.05) . There was no significant difference in the abundance of major fungal genera on the face between the AD patient group and healthy control group (all P > 0.05) ; the abundance of Candida in the upper limbs was significantly higher in the AD patient group than in the healthy control group ( t = 3.186, P < 0.05) , and the abundance of Aspergillus in the back was significantly higher in the AD patient group than in the healthy control group ( t = 2.736, P < 0.05) . In either the AD patient group or the healthy control group, there was no significant difference in the abundance of major fungal genera among samples from the face, upper limbs and back (all P > 0.05) . Moreover, no significant difference in the abundance of major fungal genera was observed among the mild, moderate and severe AD patient groups (all P > 0.05) . Principal component analysis showed that fungal communities in the samples from the lesions on the face, upper limbs and back of the AD patient group were not clustered by the disease severity. Conclusions:The diversity of fungal communities is significantly higher in the lesions on the face, upper limbs and back of the AD patients than in the normal skin at the corresponding body sites of the healthy controls. Malassezia is the dominant fungal genus in both lesions of the AD patients and normal skin of the healthy controls at the above body sites. The composition of fungal communities in lesional samples may be uncorrelated with the disease severity in AD patients.

BACKGROUND: Albuvirtide is a once-weekly injectable human immunodeficiency virus (HIV)-1 fusion inhibitor. We present interim data for a phase 3 trial assessing the safety and efficacy of albuvirtide plus lopinavir-ritonavir in HIV-1-infected adults already treated with antiretroviral drugs. METHODS: We carried out a 48-week, randomized, controlled, open-label non-inferiority trial at 12 sites in China. Adults on the World Health Organization (WHO)-recommended first-line treatment for >6 months with a plasma viral load >1000 copies/mL were enrolled and randomly assigned (1:1) to receive albuvirtide (once weekly) plus ritonavir-boosted lopinavir (ABT group) or the WHO-recommended second-line treatment (NRTI group). The primary endpoint was the proportion of patients with a plasma viral load below 50 copies/mL at 48 weeks. Non-inferiority was prespecified with a margin of 12%. RESULTS: At the time of analysis, week 24 data were available for 83 and 92 patients, and week 48 data were available for 46 and 50 patients in the albuvirtide and NRTI groups, respectively. At 48 weeks, 80.4% of patients in the ABT group and 66.0% of those in the NRTI group had HIV-1 RNA levels below 50 copies/mL, meeting the criteria for non-inferiority. For the per-protocol population, the superiority of albuvirtide over NRTI was demonstrated. The frequency of grade 3 to 4 adverse events was similar in the two groups; the most common adverse events were diarrhea, upper respiratory tract infections, and grade 3 to 4 increases in triglyceride concentration. Renal function was significantly more impaired at 12 weeks in the patients of the NRTI group who received tenofovir disoproxil fumarate than in those of the ABT group. CONCLUSIONS: The TALENT study is the first phase 3 trial of an injectable long-acting HIV drug. This interim analysis indicates that once-weekly albuvirtide in combination with ritonavir-boosted lopinavir is well tolerated and non-inferior to the WHO-recommended second-line regimen in patients with first-line treatment failure. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02369965; https://www.clinicaltrials.gov.Chinese Clinical Trial Registry No. ChiCTR-TRC-14004276; http://www.chictr.org.cn/enindex.aspx.
Adult ; Anti-HIV Agents/adverse effects* ; Antiretroviral Therapy, Highly Active ; China ; Drug Therapy, Combination ; HIV Infections/drug therapy* ; HIV-1 ; Humans ; Maleimides ; Peptides ; Ritonavir/therapeutic use* ; Treatment Outcome ; Viral Load