Evaluation of the long-term safety and effectiveness of tadalafil once daily in Chinese men with erectile dysfunction: interim results of a multicenter, randomized, open-label trial / 亚洲男科学杂志(英文版)

Once-daily tadalafil administration has been well established; however, studies about tadalafil once-daily treatment in the Chinese population are lacking. In this phase 4, postmarketing study, we ascertained the long-term safety and effectiveness of tadalafil 2.5 mg and 5.0 mg once daily in Chinese men with erectile dysfunction (n = 635). The primary endpoint of the study was safety at 12 months as assessed by the proportion of patients experiencing at least one treatment-emergent adverse event (serious or nonserious). The secondary endpoints included safety and effectiveness, measured by the International Index of Erectile Function-Erectile Function (IIEF-EF) domain scores. Similar adverse events to the known safety profile of tadalafil, such as nasopharyngitis, upper respiratory tract infection, headache, and dizziness, were detected. No new cardiovascular safety concerns were observed. After 3 months of treatment, significant increases in IIEF-EF domain scores were detected for both 2.5-mg (least squares [LS] mean change: 6.3; 95% confidence interval [CI]: 5.4-7.1; P < 0.001) and 5.0-mg (LS mean change: 7.4; 95% CI: 6.8-7.9; P < 0.001) tadalafil doses, and significance was maintained up to 12 months. In addition, approximately 40% of patients regained normal erectile function (IIEF-EF ≥26) following 1 year of tadalafil once-daily treatment. The findings in this study provide evidence for the extended effectiveness and tolerability of tadalafil, demonstrating no new safety concerns, in a Chinese population and make once-daily tadalafil administration a viable option for improving sexual performance and satisfaction in Chinese men with erectile dysfunction.

Clinical Values of Combined Diffused Optical Tomography and PET-CT in the Diagnosis of Breast Cancer / 中国医学科学院学报

Objective To investigate the clinical values of combined diffused optical tomography (DOT) combined positron emission tomography-computed tomography (PET-CT) in the diagnosis of breast cancer. Methods We performed DOT and PET-CT examinations in 38 patients with 40 lesions and compared these images with the pathological results to analyze the sensitivity,specificity,accuracy,positive predictive value,and negative predictive value of these two techniques and their combination.Results The sensitivity,specificity,accuracy,positive predictive value,and negative predictive value in diagnosing breast cancer were 78.26%,76.47%,77.50%,72.22%,and 81.81% for DOT,86.96%,82.35%,85.00%,86.96%,and 82.35% for PET-CT,and 86.96%,94.12%,90.00%,95.23%,and 84.21% for the combination of PET-CT and DOT.Conclusions DOT and PET-CT are both effective diagnostic methods for breast cancer.Combined DOT and PET-CT can improve the diagnostic efficacy in terms of specificity,positive predictive value,and accuracy.

Meta-analysis of Influencing Factors ofF-Fluorodeoxyglucose Uptake of Brown Adipose Tissue in PET/CT Imaging / 中国医学科学院学报

Objective To explore the influencing factors ofF-Fluorodeoxyglucose(F-FDG) uptake of brown adipose tissue(BAT) in PET/CT imaging by performing meta-analysis.Methods Relevant articles published between 1980 and 2016 were searched in PubMed,EMBASE,Web of Science,CBM,WanFang Data,CNKI,and VIP.The factors of gender,season and age were extracted according to the inclusive criteria.Meta-analysis was performed to analyze the factors.Results The merger OR value and 95% CI ofF-FDG uptake of BAT with gender,age,season were 2.67 (2.30-3.11),2.17 (1.38-3.39),and 15.35 (4.72-49.95) respectively.TheF-FDG uptake rate of BAT was 2.16 times in females as that in males,8.67 times in the minors as that in the adults,and 1.94 times in winter as that in summer.Conclusion Gender,season,and age are risk factors forF-FDG uptake of BAT.

Features of Acquired Immunodeficiency Syndrome-related Lymphoma on (18)F-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography / 中国医学科学院学报

<p><b>OBJECTIVE</b>To analyze the imaging features of (18)F-fluorodeoxyglucose (¹⁸F-FDG) positron emission tomography(PET)/computed tomography (CT) in acquired immune deficiency syndrome-related lymphoma (ARL) patients correlated with their clinical signs, symptoms, and treatments.</p><p><b>METHODS</b>Five ARL patients underwent ¹⁸F-FDG PET/CT at Peking Union Medical College Hospital from October 2008 to January 2013. Two patients received two additional follow-up studies 6 months later.</p><p><b>RESULTS</b>Among these 5 patients, ¹⁸FDG-PET/CT helped in diagnosis of two patient and changed therapeutic strategy in other two patients. In two patients underwent ¹⁸F-FDG PET/CT brain scans, low-metabolism lesion was newly found in cerebral cortex. Of 4 patients receiving highly active antiretroviral therapy, PET/CT also demonstrated diffusely elevated ¹⁸F-FDG uptake in subcutaneous adipose tissue in two patients.</p><p><b>CONCLUSION</b>¹⁸F-FDG PET/CT is a highly useful tool in the diagnosis and treatment of ARL patients, in particular in the identification of associated encephalopathy and lipodystrophy.</p>

Quantification of GRAF gene expression in patients with acute myeloid leukemia using EvaGreen real time quantitative PCR / 中华医学遗传学杂志

<p><b>OBJECTIVE</b>To quantify the expression level of GRAF gene in acute myeloid leukemia (AML) and analyze its clinical significance.</p><p><b>METHODS</b>The EvaGreen real-time quantitative polymerase chain reaction (RQ-PCR) assay was established and performed to measure the GRAF gene transcripts in 71 cases with AML and 21 with nonmalignant hematological diseases. The clinical correlation of GRAF expression was analyzed.</p><p><b>RESULTS</b>The established EvaGreen RQ-PCR assay had good specificity, reproducibility and sensitivity. The GRAF expression level was significantly lower in AML (0.01%-169.75%, median 3.82%) than that in controls (14.49%-126.85%, median 56.04%) (P<0.05). There was no correlation between the level of GRAF transcript and the sex, age, hematologic parameters, FAB subtypes and karyotypic groups (P>0.05).</p><p><b>CONCLUSION</b>The GRAF gene was down-regulated in AML, which might play a role in the leukemogenesis.</p>

Quantification of the PRAME transcripts in patients with acute myeloid leukemia / 中华医学遗传学杂志

<p><b>OBJECTIVE</b>To analyze the expression level and clinical significance of the preferentially expressed antigen of melanoma (PRAME) transcripts in patients with acute myeloid leukemia (AML).</p><p><b>METHODS</b>Real-time quantitative polymerase chain reaction with EvaGreen dye was established to detect the expression level of PRAME transcripts in the bone marrow mononuclear cells of 56 AML cases and 20 controls. The clinical association of PRAME transcripts was analyzed.</p><p><b>RESULTS</b>The PRAME transcripts were 0-1.46% (median 0.18%) and 0-21 618.09% (median 9.79%) in controls and AML cases, respectively (P< 0.01). Among the FAB subtypes, those with M1, M2, M3 and M4 had significantly higher level of PRAME transcripts than controls. However, those with M5 had similar level of PRAME transcripts as controls. There was a significantly negative correlation between the PRAME transcripts and cytogenetic risk groups (r= -0.438, P= 0.001). Cases in low risk had significantly higher level of PRAME transcripts than those in intermediate and high risk. Among cases with AML-M2, those with t(8;21) had significantly higher level of PRAME transcripts (135.06% -21 618.09%, median 2201.88%) than those without t(8;21)(0.14% -1696.30%, median 17.97%)(P= 0.002). In a patient with sequential samples, PRAME transcripts significantly decreased after induction therapy and significantly increased after relapse.</p><p><b>CONCLUSION</b>The PRAME transcript was highly expressed in AML patients and was a favorable marker of prognosis. Quantification of PRAME transcript can be used in monitoring disease status of AML.</p>

Imaging of 99Tcm-labeled new cyclic RGDfK Dimer in nude mice bearing U87MG human glioma xenografts / 中华核医学杂志

Objective (1) To evaluate the effect of insertion of two 15-amino-4,7,10,13-tetraoxapentadecanoic (2 PEG4 ) linkers into cyclic Arg-Gly-Asp (RGD) Dimer E [c(RGDfK)]2 on receptor binding in vitro, (2) to assess its biodistribution in vivo and (3) to investigate the value of 99Tcm labeled 2PEG4-Dimer for integrin αvβ3-positive tumors imaging.Methods The expression of U87 human glioma cells and integrin αv β3 was determined by immunofluorescence staining.The half-inhibition concentrations (IC50) for 125 I-cyclo (Arg-Gly-Asp-D-Tyr-Lys) (c(RGDyK) ) of c ( RGDyK ), hydrazinonictinamide ( HYNIC )-Dimer and HYNIC-2PEG4-Dimer binding to integrin αvβ3 were measured.99Tcm-HYNIC-Dimer and 99Tcm-HYNIC-2PEG4-Dimer were synthesized using non-SnCl2 formulation.Biodistribution and imaging studies were performed in nude mice bearing human glioma xenografts.The unpaired t test was used for statistical analysis.Results The labeling yield of the two radiotracers was more than 95%, and the radiochemical purity was more than 99% through Sep-Pek C18 cartridge.HYNIC-2PEG4-Dimer had significantly higher binding affinity of integrin αvβ3 than c(RGDyK) and HYNIC-Dimer (IC50 = 0.8 nmol/L, 27 nmol/L and 2.4 nmol/L, respectively).Biodistribution study showed that 99Tcm-HYNIC-2PEG4-Dimer was mainly excreted via the kidney.The tumor uptake of 99Tcm-HYNIC-2PEG4-Dimer was higher than that of 99Tcm-HYNIC-Dimer at 2h post injection ((5.71 ±0.96) and (2.10 ±0.50) % ID/g, t =4.80, P＜0.05).The xenografted tumors were visible at 0.5 h post injection and the image contrast increased with time due to the tracer clearance of the background tissue.Conclusion 99 Tcm-HYNIC-2PEG4-Dimer is a promising radiotracer for integrin αvβ3-positive tumor imaging.

Quantification of prame gene transcript in chronic myeloid leukemia / 中国实验血液学杂志

This study was purposed to analyze the expression level of preferentially expressed antigen of melanoma (prame) transcript in the patients with chronic myeloid leukemia (CML) and explore its clinical significance. Real-time quantitative PCR (RQ-PCR) assay was used to detect the level of prame gene transcript in the bone marrow samples from 30 patients with CML and 15 patients with iron deficiency anemia (IDA). The results showed that CML patients had significantly higher prame mRNA level (0% - 772.25%, median 8.28%) than IDA cases (0% - 1.46%, median 0.19%) (p < 0.001). The level of prame gene transcript was significantly correlated with that of bcr-abl fusion gene transcript (r = 0.708, p < 0.001) in CML patients. Furthermore, 6 patients in blastic crisis (BC) and accelerated phase (AP) had significantly higher prame gene transcript than that of 24 cases in chronic phase (CP) (p = 0.007). In 2 CML patients with sequential samples, prame gene transcript increased in AP and BC, compared with in CP, and was consistent with the altering tendency of bcr-abl transcript. It is concluded that the level of prame gene transcript increases in CML which associates with the progression of the disease, prame gene transcript level can be used for monitoring the disease state.

Endourological treatment of aged high-risk patients with benign prostate hyperplasia: a report of 283 cases / 中华男科学杂志

<p><b>OBJECTIVE</b>To evaluate the safety and effectiveness of endourological techniques in the treatment of benign prostate hyperplasia (BPH) in aged high-risk patients.</p><p><b>METHODS</b>We used endourological techniques in the treatment of 283 BPH patients aged over 70 years and complicated with hydronephrosis, renal failure, heart failure, cerebral infarction, respiratory dysfunction, anemia, diabetes, bladder tumor, or prostate weight over 80 g, TURP (transurethral resection of the prostate) for 112 cases and PKRP (transurethral plasmakinetic resection of the prostate) for the other 171. All the patients were followed up for 1-30 months.</p><p><b>RESULTS</b>In the TURP group, the scores on IPSS and QOL were decreased from 27.5 +/- 2.8, 5.5 +/- 1.0 to 5.8 +/- 1.2, 1.0 +/- 0.5, and the residual urine volume (RUV) from (75.0 +/- 20.0) ml to (8.0 +/- 3.0) ml, but the maximal flow rate (Qmax) increased from (6.5 +/- 2.0) ml/s to (18.5 +/- 1.5) ml/s (P < 0.05), while in the PKRP group, the scores on IPSS and QOL were decreased from 28.2 +/- 2.2, 5.5 +/- 1.0 to 5.4 +/- 1.6, 1.0 +/- 0.5, and RUV from (80.0 +/- 20.0) ml to (7.0 +/- 3.0) ml, and Qmax increased from (6.8 +/- 2.1) ml/s to (20.0 +/- 1.5) ml/s (P < 0.05). There were no statistically significant differences in IPSS, QOL, Qmax and RUV after treatment between the two groups (P > 0.05), but significantly less complications were found in the PKRP than in the TURP group (P < 0.05).</p><p><b>CONCLUSION</b>Endourological treatment, especially PKRP, with comprehensive perioperative preparations, unerring operative skills, well-controlled operation time, and intensive postoperative monitoring and nursing, has the advantages of high safety, less bleeding, fewer complications and definite effectiveness for aged high-risk BPH patients.</p>

Combined application of enzyme-linked immunospot assay, positron emission tomography, and gene chip assay in the diagnosis of a case of chronic disseminated tuberculosis / 中国医学科学院学报

<p><b>OBJECTIVE</b>To highlight the clinical features and diagnosis of chronic disseminated tuberculosis, with emphasizing the usefulness of several recently available diagnostic technologies in this setting.</p><p><b>METHOD</b>We presented a case of chronic disseminated tuberculosis diagnosed with the combined application of interferon-gamma release assay T-SPOT. TB, 18F-fluorodeoxyglucose (FDG)-positron emission tomography (PET), and gene chip assay.</p><p><b>RESULTS</b>A 53-year-old gentleman who had chronic cough for 7 years and fever for 2 weeks was referred to our hospital for further evaluation. 18F-FDG-PET/CT scan showed increased FDG uptake in multiple lesions involving bilateral lungs, supraclavicular, mediastinal and intro-abdominal lymph nodes and bones, mimicking metastatic malignancy. T-SPOT. TB assay revealed significant responses [ early secreting antigen target 6 (ESAT-6): 3 908 spot forming cells (SFCs)/10(6) peripheral blood mononuclear cells (PBMCs), culture filtrate protein (CFP-10): 3 400 SFCs/10(6) PBMCs]. Subsequent biopsy of supraclavicular lymph node, lung, and ilium revealed granulomas, while culture of the obtained tissue yeilded mycobacteria. Gene chip testing identified M. tuberculosis sensitive to isoniazid and rifampin. After 10 weeks of treatment for tuberculosis, the patient's condition was improved and a second T-SPOT. TB assay showed significantly reduced responses (ESAT-6: 1528 SFCs/10(6) PBMCs; CFP-10: 1460 SFCs/10(6) PBMCs).</p><p><b>CONCLUSIONS</b>Timely diagnosis of chronic disseminated tuberculosis requires high index of suspicion. T-SPOT. TB assay, PET/CT, and gene chip assay may provide valuable information that facilitates further diagnostic procedures and treatment decision.</p>