Objective To explore the value of 11C-methionine(MET)PET/CT radiomics model for evaluating isocitrate dehydrogenase1(IDH1)status of glioblastoma.Methods Data of 157 patients with glioblastoma who underwent 11C-MET PET/CT examination,including 68 cases of IDH1 mutation and 89 cases of IDH1 wild-type were retrospectively analyzed.The patients were divided into training set(n=125)and validation set(n=32)at the ratio of 8:2.Based on PET/CT images,lesions ROI were delineated and radiomics features were extracted and screened to establish radiomics models with logistic regression(LR),support vector machine(SVM)and decision trees(DT),respectively.Meanwhile,the nomogram based on patients'age and radiomics features was drawn.The efficacy of radiomics models and clinical-radiomics nomogram for evaluating IDH1 status were comparatively observed.Results The area under the curve(AUC)of DT radiomics model for evaluating IDH1 status of glioblastoma in training set was 0.910,higher than that of LR(0.697)and SVM(0.698)models(both P＜0.05).In validation set,the AUC of DT model for evaluating IDH1 status of glioblastoma was 0.805,which was higher than that of LR model(0.740)and clinical-radiomics nomogram(0.704)(both P＜0.05).Conclusion 11C-MET PET/CT radiomics model based on DT was helpful for evaluating IDH1 status of glioblastoma.

Objective To explore the efficacy and safety of ultrasound-guided radiofrequency ablation combined with foam sclerotherapy in the treatment of primary small saphenous vein varicosities.Methods A total of 46 patients with primary small saphenous vein varicosities in our department from November 2021 to November 2022 were retrospectively analyzed.Depending on the patient's choice of surgical method,they underwent radiofrequency ablation combined with sclerotherapy(observation group,n=23)or high ligation and stripping of the saphenous vein(control group,n=23).The surgical time,intraoperative blood loss,length of hospital stay,postoperative Venous Clinical Severity Score(VCSS),incidence of postoperative complications,treatment satisfaction,and recurrence were compared between the two groups.Results Compared with the control group,the observation group had shorter surgical time[(56.1±6.0)min vs.(81.7±10.6)min,t=-10.128,P=0.000],less intraoperative blood loss[(27.0±4.1)ml vs.(41.4±4.8)ml,t=-11.016,P=0.000],shorter hospitalization time[(2.0±0.7)dvs.(5.6±0.9)d,t=-14.319,P=0.000],lower VCSS scores at 3,6,and 12 months after surgery[(7.4±2.0)points vs.(8.9±2.5)points,t=-2.165,P=0.036;(5.3±1.8)points vs.(6.5±2.2)points,t=-2.149,P=0.037;(2.6±1.3)points vs.(4.0±1.8)points,t=-2.912,P=0.006],higher satisfaction[satisfied,somewhat satisfied,dissatisfied in 18,4,and 1 cases in the observation group and 8,10,and 5 cases in the control group,respectively,Z=-2.967,P=0.003].There were no statistically significant differences in the complication incidence and recurrence rate between the two groups(P＞0.05).Conclusion Ultrasound-guided radiofrequency ablation combined with foam sclerotherapy in the treatment of primary small saphenous vein varicosities is safe and effective.

With the boom of China's innovative pharmaceutical industry, licensing-in model has gradually become an important research and development model for innovative pharmaceutical companies. The in-licensed drugs at different stages need different research and development (R&D) strategy in China. The pharmaceutical companies take the responsibility to comprehensively collate the oversea clinical data and conduct a detailed analysis of clinical pharmacology, safety, efficacy and ethnic sensitivity. Clinical R&D strategy should be made based on the results of the above data and analysis. We encourage high-quality drugs which fill unmet clinical needs licensed in, and as early as possible, so as to conduct multi-regional clinical trials (MRCTs). The clinical R&D strategy in China is particularly important for the drug's approval. Guidelines published by the National Medical Products Administration (NMPA) and clinical associations should be followed. Communications about clinical R&D strategy with Center of Drug Evaluation (CDE) are encouraged.
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Antineoplastic Agents/therapeutic use* ; China ; Drug Industry ; Humans ; Lung Neoplasms/drug therapy* ; Pharmaceutical Preparations

OBJECTIVE: To assess the association of CYP2C19 and CYP3A5 gene polymorphisms with the risk of myocardial infarction. METHODS: Five hundred patients with myocardial infarction and 500 healthy controls were randomly selected. Fluorescent PCR and Sanger sequencing were used to detect the CYP2C19 and CYP3A5 gene polymorphisms. Logistic regression was used to analyze the correlation between the polymorphisms and myocardial infarction. Quanto software was used to evaluate the statistical power. RESULTS: The two groups had significant difference in the frequency of AG, GG genotypes and A allele of the CYP2C19 gene rs4986893 locus and the AA, AG, GG genotypes and G allele of the CYP3A5 gene rs776746 locus ( P<0.05), but not in the frequency of genotypes and alleles of CYP2C19 gene rs4244285 and rs12248560 loci, and the AA genotype of the rs4986893 locus. After correction for age, gender, and body mass index, Logistic regression indicated that the AG genotype and A allele of the CYP2C19 gene rs4986893 locus, and the GG genotype and G allele of CYP3A5 gene rs776746 locus are associated with susceptibility of myocardial infarction, while rs4986893 GG genotype and AA and AG genotypes of rs776746 may confer a protective effect. Based on the sample size and allele frequency, analysis with Quanto software suggested that the result of this study has a statistical power of 99%. CONCLUSION CYP2C19 and CYP3A5 gene polymorphisms may increase the risk for myocardial infarction.
Cytochrome P-450 CYP2C19/genetics* ; Cytochrome P-450 CYP3A/genetics* ; Gene Frequency ; Genotype ; Humans ; Myocardial Infarction/genetics* ; Polymorphism, Genetic ; Polymorphism, Single Nucleotide

Objective:To investigate the diagnostic value and cutoff value of the basal luteinizing hormone (LH) level for central precocious puberty (CPP) in girls with different body mass index (BMI) values.Methods:A total of 1 087 girls aged 6 to 8 years old with breast development and visiting the Department of Endocrine Genetics and Metabolism, Fuzhou Children′s Hospital of Fujian Medical University from January 2014 to December 2018 were enrolled.The girls had the breast development of Tanner stage B2 or B3.They were divided into groups of normal weight (840 cases), overweight (133 cases) and obesity (114 cases) according to BMI percentiles corresponding to their age and sex.All individuals underwent gonadotropin-releasing hormone (GnRH) agonist test.Statistical analysis was performed using SPSS 18.0 software, and the receiver operating characteristic (ROC) curve was drawn.Results:In the normal weight group, 393 girls were positive and 447 girls were negative for GnRH test.In the overweight group, 72 girls were positive and 61 girls were negative for GnRH test.In the obesity group, 40 girls were positive and 74 girls were negative for GnRH test.The areas under the ROC curve (AUC) of the basal LH level for the diagnosis of CPP in the normal weight, overweight, and obese girls were 0.826, 0.774, and 0.801, respectively.When the Youden index was maximum, the cutoff values of the basal LH level were 0.245 IU/L, 0.225 IU/L and 0.145 IU/L, respectively; the sensitivities were 63.9%, 65.3%, and 80.0%, respectively; the specificities were 87.9%, 82.0%, and 71.6%, respectively.When the cutoff value of the basal LH level was 0.455 IU/L in the normal weight group, 0.480 IU/L in the overweight group, and 0.335 IU/L in the obesity group, the specificities of the 3 groups were all above 96.6%.Conclusions:It is reliable to use the basal LH level for CPP diagnosis for girls with different BMI values.The cutoff value of the basal LH level for CPP diagnosis in obese girls is the lowest.

ObjectiveTo establish a hospice care training system for nurses in general hospitals and evaluate its implementation effects, and to explore a new path for hospice care education. MethodsThe nurses from 7 clinical departments in the First Affiliated Hospital of He＇nan University of Chinese Medicine from September 2017 to June 2018 were selected by convenience sampling with 24 nurses from each department and randomly divided into the general training group (12 for every department) and in-depth training group (12 for every department). Based on the classic education theory, the nurse hospice care training system for general hospital was established from five aspects including goal, content, method, management and teachers in the in-depth training group and the general training group received the training according to hospice care nursing plan implementation rules of the First Affiliated Hospital of He＇nan University of Chinese Medicine. The two groups were compared in terms of the training effects. ResultsAfter training, in the in-depth training group, the scores of theoretical assessment and skill assessment of hospice care of nurses in the 7 departments were all higher than those in general training group, and the differences were statistically significant (P＜ 0.05). ConclusionsThe general hospital nurse hospice care training system can effectively improve the employees＇knowledge reserve and skills level of hospice care; the strengthening of the construction of hospice care training system is important to guarantee the qualified hospice care nursing team building and to improve the quality of hospice care services.

Single arm trial (SAT) was widely used for new drug application (NDA) of novel anti-cancer drugs in recent years. The listing time was greatly shortened by SAT while comparing with randomized controlled trials (RCT). Thus, the companies intended to get NDA through SAT. To encourage innovation and accelerate the developments of anti-cancer agents, we summarize the background and key issues of SAT, discuss the conditions of accepting SAT for NDA, and systematically elaborate the design and principles of SAT in this review.

Single arm trial ( SAT) was widely used for new drug application ( NDA) of novel anti?cancer drugs in recent years. The listing time was greatly shortened by SAT while comparing with randomized controlled trials ( RCT) . Thus, the companies intended to get NDA through SAT. To encourage innovation and accelerate the developments of anti?cancer agents, we summarize the background and key issues of SAT, discuss the conditions of accepting SAT for NDA, and systematically elaborate the design and principles of SAT in this review.

Single arm trial ( SAT) was widely used for new drug application ( NDA) of novel anti?cancer drugs in recent years. The listing time was greatly shortened by SAT while comparing with randomized controlled trials ( RCT) . Thus, the companies intended to get NDA through SAT. To encourage innovation and accelerate the developments of anti?cancer agents, we summarize the background and key issues of SAT, discuss the conditions of accepting SAT for NDA, and systematically elaborate the design and principles of SAT in this review.

Objective To investigate the characteristics of auditory nerves and brainstem pathways,patho-physiological and nerve damages and the correlation between oxygen indexes,and the values of high stimulation ABR in patients with OSAHS.Methods Auditory brain stem responses (ABR)at rates of 11.1 times/s,31.1 times/s,51.1 times/s were performed in both the moderate-to-severe OSAHS group(5 cases of moderate and 34 cases of severe,in total of 39 cases ,78 ears)and the control group (34 cases,68 ears).According to the character-istics of ABR,the correlation with parameters of blood oxygen was studied.Results At the rate of 11.1 times/s, wave V latencies (5.79±0.22 ms)in OSAHS patients were longer than that in the control group.At the rate of 31.1 times/s,wave V latencies (5.98±0.19 ms)and waveⅠ(1.85±0.18 ms)in OSAHS patients were prolonged more than those in the control group.At the rate of 51.1 times/s,wave V latencies (6.09±0.25 ms)and waveⅠ(1.94±0.26 ms)in OSAHS patients were longer than those in the control group.Increasing stimulation rates from 11.1 times/s to 31.1 times/s showedΔⅠwas longer in OSAHS group(0.12±0.17 ms)than in the control group (0.07±0.11 ms).Increasing stimulation rates from 11.1 times/s to 51.1 times/s showedΔⅠwas longer in OS-AHS group(0.21±0.25 ms)than in the control group(0.15±0.10 ms).All above had correlations with hypoxia. Conclusion High stimulation rates in ABR by amplifying the waveⅠ latency confirm cochlear and auditory nerve damages near the cochlear segment in patients with moderate to severe OSAHS.Therefore the study of nerve injury in OSAHS patients should take blood oxygen saturation and hypoxia percentage rather than AHI.