[Human papillomavirus vaccination for men who have sex with men in China: demand and suggestions].

MSM are a high-risk population for HPV infection and related diseases. MSM can be effectively protected by quadrivalent and nine-valent HPV vaccines. This paper outlines the significance of providing HPV vaccination to MSM, summarizes the basis of HPV vaccination in MSM, and puts forward the following recommendations. First, China should expedite the development and approval of the HPV vaccine for male use. Second, HIV-positive MSM should vaccinate against HPV as soon as possible. Third, prioritize HPV vaccination for MSM individuals aged 26 or less. Fourth, for MSM aged over 26, catch-up vaccination or opportunistic vaccination should be provided when HPV vaccine resources are sufficient. Implementing this vaccination strategy can provide protection for the MSM and control the spread of sexually transmitted diseases.

[Sarcoma arising in fibrous dysplasia: a clinicopathological analysis].

Objective: To study the clinicopathologic characteristics and risk factors of sarcoma arising in fibrous dysplasia. Methods: A total of 18 cases were collected from January 2008 to July 2018 in Shanghai Jiaotong University Affiliated Sixth People's Hospital. The characteristics and the histologic type were retrospectively reviewed. IBM SPSS 19 was used for statistical analysis. Results: The male to female ratio of patients with fibrodysplastic sarcomatosis was 1.57∶1.00. The age of onset ranged from 24 to 87 years (mean 49 years). The long bones, especially the femur, were most frequently involved. Nine cases were osteosarcomas, three cases were high grade sarcoma and six cases were low grade sarcoma. Logistic regression analysis showed that age was an independent risk factor for sarcomatous change, compared with polyostotic or recurrent cases. Value of Wals was 13.61 (P<0.05), and odds ratio was 12.82,95% confidence interval was 3.31-49.70. Conclusions: Fibrodysplasia sarcomatosis is clinically nonspecific and the risk of sarcomatous changes increases approximately 12-fold when age of onset of fibrous dysplasia is over 40 years.

[Influencing factors of suicidal ideation among men who have sex with men].

Objective: To investigate the prevalence of suicidal ideation among MSM, and to explore the influence of perceived social support and depression on suicidal ideation and the possible pathway. Methods: MSM who are ≥18 years, HIV-negative, and ever had sex with men (oral sex/anal sex) in the last year participated in is study. Cross-sectional survey and convenient sampling method were used to recruit MSM through a male social interaction platform Blued 7.5 software from December 2020 to March 2021, with a questionnaire survey. Demographic questionnaire, Perceived Social Support Questionnaire and Center for Epidemiologic Studies Depression Scale were employed to collect data. Mplus 8.3 was used for data analysis. Results: Among 1 394 eligible MSM participants, 25.7% (358/1 394) had suicidal ideation. Perceived social support could have a direct effect on suicidal ideation (ß=-0.11, P=0.009), and an indirect effect on suicidal ideation through depression (ß=-0.18, P<0.001). Conclusions: Suicidal ideation was found to be lower in MSM with a higher level of perceived social support and a lower level of depression. Using social media to improve MSM's perceived social support and reduce depressive symptoms might be an effective means to prevent suicidal ideation.

[Twelve-week of sofosbuvir/velpatasvir therapeutic regimen for chronic hepatitis C patients in northwest region of China: a real-world multicenter clinical study].

Objective: To study the real-world outcome of China FDA-approved Sofosbuvir (SOF)/Velpatasvir (VEL) in Northwest China. Methods: In this multicenter, prospective, real-world cohort study, we recruited patients from 10 sites from Northwest China, who were chronically infected with HCV GTs 1-6 from 06/2018 to 09/2019. Patients received SOF (400mg)/VEL (100mg) for 12 weeks, and with ribavirin 900-1200 mg for GT3 cirrhosis and for any genotype decompensated cirrhosis. The primary endpoint was sustained virological response at 12-weeks post-treatment (SVR12) and safety. The secondary endpoint was the change of liver function after the achievement of SVR12. Results: Totally, 143 patients were enrolled in the study, four patients were lost to follow-up and one died during the follow-up, 138 patients were included in per-protocol analysis. Of the 138 patients, the mean age 53 years, 53.6% male, 94.2% Han nationality, 53.6% liver cirrhosis, 10.1% HBsAg(+), 6.5% renal dysfunction, 5.1% treatment-experienced, and 16.7% patients received ribavirin treatment. The genotype distribution was as follows: 35.5% GT1, 42.8% GT2, 15.9% GT3, and 5.8% un-typed. The SVR12 rate was 96.5% (138/143, 95%CI: 93.5%-99.6%) for intention-to-treat analysis, and in per-protocol analysis, all 138 patients obtained SVR12 (100%). Compared with baseline, the serum total bilirubin, ALT and AFP levels decreased (all P < 0.05), as well as increased ALB and platelet count (all P < 0.001) at post-treatment 12-weeks. Overall adverse events (AEs) rate is 29.0%, and the most common AEs were anemia (14.5%) and fatigue (8.0%). Severe side effects (edema and fatigue) occurred in 2 patients, one of whom needed a short-term interruption of treatment due to fatigue. Conclusion: In this real-world cohort study, 12-week SOF/VEL regimen with or without ribavirin achieved high SVR12 rates (96.5%-100% overall) with excellent safety profile among patients with HCV GT1/2/3 infection including patients with GT3 and cirrhosis, and led to improvement of liver function.

[HIV infection and related factors among men who have sex with men aged 50 and above].

Objectives: To explore the HIV prevalence and related factors among MSM aged 50 and above and provide evidence on the prevention and control of HIV/AIDS. Methods: Based on an MSM social application software Blued 7.1.6, we recruited participants through online convenience sampling to collect demographic variables, behavioral and self-reported HIV infection status, etc. Univariate χ2 test and multivariate logistic regression were used to analyze the related factors of self-reported HIV infection. Results: Self-reported HIV infection rate was 17.6%(126/714) among the participants. In multivariable analysis, participants who got divorced or widowed had a 2.07(95%CI: 1.34-3.21) times greater risk of self-reported HIV-positive than those who were married. Participants unaware of HIV-related knowledge showed a 1.92(95%CI:1.21-3.04) times greater risk of self-reported HIV-positive than those with better HIV-related knowledge. Participants who have ever been diagnosed with sexually transmitted disease (STD) showed a 3.17(95%CI:2.09-4.83) times greater risk of self-reported HIV-positive than those without STD infection history. Conclusion: Our findings indicated that the self-reported HIV infection rate was high among MSM aged 50 and above. Being divorced or widowed, being unaware of HIV-related knowledge and STD infection history was proved related with self-reported HIV infection.

[GAA gene variants and genotype-phenotype correlations in patients with glycogen storage disease type â ¡].

Objectives: To explore the GAA varient spectrum and the genotype-phenotype correlations in patients with glycogen storage disease type Ⅱ (Pompe disease, PD), as well as to estimate the disease incidence based on carrier rate of GAA varients in Guangzhou population. Methods: A total of 57 PD cases were retrospectively enrolled at Guangzhou Women and Children's Medical Center from January 1, 2010 to May 31, 2020. All patients presented symptoms before the age of 18 years. Each diagnosis was further confirmed by GAA enzyme activity and GAA variants. The carrier rate of GAA varients was calculated based on variants detected by whole exon sequencing among 2 395 healthy children in Guangzhou. Results: Among the 57 PD patients (including male 26, female 31),twenty-eight patients with infantile onset PD (IOPD) presented with progressive general muscle weakness and cardiomyopathy. The mean ages of symptom onset and diagnosis were (2.5±1.4) and (5.0±3.0) months, respectively. Twenty-six cases died in the first year after birth.Twenty-three patients with late onset PD (LOPD) presented with progressive muscle weakness. Seven of them had respiratory failure at diagnosis. The mean ages of symptom onset and diagnosis were (12.0±5.0) and (17.0±7.5) years, respectively. Six children with atypical IOPD showed motor delay, muscle weakness and cardiomyopathy. Their diagnosis was confirmed at 2.5-7.0 years of age. Among the 57 patients, 47 different variants were identified in the GAA gene. Three variants: c.797C>T, c.1109G>A and c.1757C>T were novel. c.1935C>A (25/114, 21.9%) and c.2238G>C (15/114, 13.2%) were the most common variants, detected in 57.1% of IOPD and 65.2% (15/23) of LOPD patients, respectively. Among the 28 IOPD patients, 26 cases (92.9%) carried at least one missense variant which indicated positive cross-reactive immunologic material (CRIM). The carrier rate of pathogenic variants in GAA gene among healthy children was 24/2 395. The estimated incidence of PD in this population is about 1/40 000. The frequencies of pseudodeficiency variants c.1726G>A and c.2065G>A homozygotes were 26.3% (15/57) and 35.1% (20/57) in PD patients, which were significantly higher than those (1.7% (40/2 395) and 3.9% (94/2 395)) in healthy children (χ²=151.2, 121.9; both P<0.01). Conclusions: PD presents as a spectrum, some as atypical IOPD. The c.1935C>A and c.2238G>C are common variants, correlated with IOPD and LOPD respectively. The c.796C>T and c.1082C>T are usually found in atypical IOPD. The majority of IOPD patients is predicted to be CRIM positive. The estimated incidence of PD is about 1/40 000.

[The healthy living master plan (HLMP): Singapore's experience and enlightenment].

The unbalanced economic development, the lifestyle changes of the residents, the aging before getting rich and the burden of non-communicable chronic diseases in China have brought great pressure on China's health system. However, the prevention and control mechanism of chronic diseases in China is far from mature, which restricts the development of the prevention and control of chronic diseases in China. Singapore's new concept on chronic disease management and the the 3-level theoretical framework are good experience in the world and deserve to be learned by China. This article introduced the Healthy Living Master Plan in health promotion practice in Singapore, and made suggestions on construction of health management system to cope with the disease burden in China.

LncRNA MAFG-AS1 promotes the aggressiveness of breast carcinoma through regulating miR-339-5p/MMP15.

OBJECTIVE: The main purposes of this study are to investigate the possible effects of long noncoding RNAs (lncRNAs) MAFG-AS1 on the growth and metastasis of breast carcinoma. PATIENTS AND METHODS: The quantitative Real Time-Polymerase Chain Reaction (qRT-PCR) assay was used to assess the MAFG-AS1 level in breast cancer tissues and cells. The wound healing and transwell invasion analysis were applied to explore the invasion and migration of breast cancer cell in vitro. The expressions of epithelial-mesenchymal transition (EMT) related markers were determined by Western blotting. Xenograft model and lung metastasis model were used to assess the progression of breast carcinoma cell in vivo. RESULTS: The level of lncRNA MAFG-AS1 is higher in breast carcinoma, and the aggressive phenotypes of breast carcinoma cell are enhanced by MAFG-AS1 transfection. Moreover, we identify that MAFG-AS1 overexpression reduces the expression of miR-339-5p and miR-339-5p is the target of MAFG-AS1 in breast carcinoma. In addition, matrix metalloproteinase 15 (MMP15) is the functional regulated gene of miR-339-5p in breast carcinoma. The aggressiveness of breast carcinoma induced by lncRNA MAFG-AS1 is weakened by the miR-339-5p. Finally, we demonstrated that the development of breast carcinoma cell is enhanced by MAFG-AS1 in vivo. CONCLUSIONS: MAFG-AS1 appears to play an oncogene role in breast carcinoma by regulating the miR-339-5p/MMP15.

[Research on the effects of CPAP for OSA combined CHD long-term prognosis].

Objective:To investigate the effects of CPAP for obstructive sleep apnea（OSA） combined CHD（coronary heart disease） long-term prognosis. Method:One hundred and twenty cases of OSA combind CHD in gansu province people's hospital sleep center were randomly divided into two groups according to apnea hypopnea index（AHI）, group A（light, medium OSA and CHD） 60 cases, group B（severe OSA and CHD） 60 cases. Contrast analysis and comparison between two groups PSG（Polysomnography） parameters, and the differences between the degree of coronary artery lesions and CPAP therapy effect on coronary long-term prognosis. Result:Compared group B with A, AHI, BMI, LSaO2, Epworth sleepiness scale（ESS） score, the amino acid homocysteine, the prevalence of hypertension, type 2 diabetes, the prevalence of acute myocardial infarction（ami） and vascular lesions and SYNTAX score increased significantly（P<0.05）. The ejection fraction decreased significantly（P<0.05）. The BNP（Brain natriuretic peptide） and cTNT（cardiac troponin, cTn） concentration there was no significant difference between the two groups（P>0.05）. CPAP treatment（30.0±4.2） months later, Group B: CAPA + conventional treatment group, compared with the simple routine LSaO2, ejection fraction increased significantly（P<0.05）, AHI, cardiovascular adverse events, vascular lesions, SYNTAX score, the BNP and TNT concentration significantly reduced（P<0.05）; Group A: AHI, decreased significantly（P<0.05）, LSaO2increased significantly（P<0.05）, ejection fraction, cardiovascular adverse events, vascular lesions, SYNTAX score, there was no significant difference between the BNP and TNT concentration; Survival analysis showed that: Group A CPAP+conventional treatment group cumulative survival rate higher than the conventional treatment group, but there was no statistically significant difference（P=0.260）. Group B: CPAP+conventional treatment group total survival rate was significantly higher than that of the conventional treatment group（P<0.001）; Conclusion:With the increase of the severity of OSA, OSA merge CHD coronary artery pathological changes degree aggravating, CPAP therapeutic benefit the long-term prognosis of CHD.

[Radiographic analysis of treatment of inter-trochanteric fractures using proximal femoral nails].

OBJECTIVE: To establish a reliable approach for measuring proximal femoral 3 dimensional anatomy, and to compare post-operative differences of proximal femoralanatomy in the inter-trochanter fractures with two kinds of antegrade nailings. METHODS: Some computer assisted design (CAD) softwares, e.g. Mimics, were used to establish a reliable approach for measuring proximal femoral 3 dimensional (3D) anatomy. Intra-class correlation coefficient (ICC) was used to test the reliability of intra- and inter-observers. The post-operative pelvic CT data of 19 cases of inter-trochanter fracture patients treated with InterTAN nailing and 21 cases of inter-trochanter fracture patients treated with proximal femoral nail anti-rotation (PFNA) were retrospectively analysed and used to measure bilateral proximal femoral anatomical parameters, including 2D and 3D femoral neck-shaft (NS) angle and femoral neck anteversion (NA) angle, and 2D and 3D anteversion angles of the intramedullary (IM) nailings. ICC was used to test the consistency of the NA angles in the different groups, and the paired student T-test was used to test the differences of the paired quantitative data. RESULTS: The established measurement method hasdexcellent consistency within the intra- and inter-observers, with all the ICCs higher than 0.9. The paired student T-test showed no significant difference between the post-operative bilateral 2D or 3D NA angles. The ICCs results showed that there were no consistency between the post-operative bilateral 2D or 3D NA angles (P values were 0.099 and 0.055, respectively), but the excellent consistency between the 2D injured side NA angle and 2D IM nailing's NA angle, or between the 3D injured side NA angle and 3D IM nailing's NA angle (the ICCs were 0.81 and 0.8, respectively, P values < 0.001). In PFNA group, 57% of the differences between the 2D post-operative injured side's and intact side's NA angles were higher than 15°, which was more than 15.78% in InterTAN group. The paired student T-test showed no significant difference between the post-operative injured side's 2D or 3D NS angles and the intact side's respective 2D or 3D angles in PFNA group (P values were 0.925 and 0.367, respectively), but in InterTAN group, the post-operative injured side's 2D or 3D NS angles were significantly smaller than the intact side's respective angles (P values were 0.033 and 0.009, respectively). CONCLUSION: By analyzing and comparing bilateral proximal femoral anatomical parameters after two kinds of IM nailings procedures, the differences between the bilateral post-operative NA angles in PFNA group were significantly larger than those in InterTAN group. There was significant correlation between the NA angles of the injured sides and NA angles of IM nailings in both the groups.

Condoms used but sex not well protected.

Condom use is often equated to safer sex. The prevalence of condom use during sex work among female sex workers (FSW) in China is high. Condom use, however, co-exists with condom failure and improper use and hence risk of HIV transmission. In a cross-sectional study, we interviewed 195 FSW in Shenzhen, China. The prevalence of condom use in the last episode of sex work was 97.4 %, However, respectively 53.8 and 86.2 % had experienced at least one condition of condom failure that may lead to genital contact (wearing condoms after penetration, condom breakage/slippage, condoms removed by clients) and at least one condition of improper condom use (not removing air from the tip of the condom, not pulling it down to the root of penis and not choosing good quality condoms). Factors of individual level (e.g. never choosing high quality condoms for sex work), inter-personal level (e.g. agreement to have unprotected sex if fond of clients or paid more) and environmental/structural level (e.g. non-availability of condoms) were associated with various types of condom failure and improper use. Although HIV prevention interventions have increased prevalence of condom use among FSW, the risk of HIV transmission may still be high as "unsafe" sex due to condom failure and improper use is prevalent. Interventions promoting safer sex need to address such issues and take socio-ecological factors into account. Condom use during sex work is not equivalent to well protected sex as the protective effects could be compromised by frequent condom failure and improper use.

Pharmacokinetics of tramadol in a diverse healthy Chinese population.

WHAT IS KNOWN AND OBJECTIVES: Drug disposition may show ethnicity and gender differences. The objective of this study is to assess whether there are gender and ethnic differences in the pharmacokinetics of tramadol. METHODS: Fifty healthy volunteers from five different ethnic Chinese groups (Han, Mongolian, Korean, Uygur and Hui) were recruited, and blood samples were obtained for up to 36 h after oral administration of a single 100 mg capsule of tramadol. The plasma concentration-time course of tramadol was measured by high-performance liquid chromatography and the pharmacokinetic estimated. RESULTS AND DISCUSSION: The mean maximum plasma concentration (C(max)) of tramadol was different between Chinese males and females. There were also statistically significant differences between Hui and the other ethnic groups in tramadol's clearance (CL/F), volume of distribution (V(d) /F), C(max) and area under the plasma concentration time curve (AUC(0-∞)) (P < 0·05). WHAT IS NEW AND CONCLUSION: The pharmacokinetics of tramadol was different in Hui subjects compared to the other Chinese ethnic groups. Tramadol CL/F may also show gender differences.

Serous effusion cytology of extranodal natural killer/T-cell lymphoma.

OBJECTIVE: Extranodal natural killer/T-cell lymphoma, nasal type (ENKTCL-N), is a rare form of lymphoma that typically occurs at extranodal sites. It is one of the most common extranodal lymphomas in China. Literature on effusions and cytological findings relating to ENKTCL-N is limited. We studied five consecutive cases of ENKTCL-N effusions collected over a 3-year period. The cytomorphological, immunocytochemical and molecular biological features were evaluated with literature review. The purpose of this study is to discuss how to diagnose ENKTCL-N cytologically in effusions. METHODS: Smears and cell block sections were reviewed for each case. Immunocytochemistry was performed on 4-µm paraffin sections. Antibodies used were as follows: cCD3 (intracytoplasmic CD3), CD45RO, surface CD3, CD20, CD79a, CD56, TIA-1, granzyme B, CD30, CD99, TdT and Ki-67. In situ hybridization for EBER1/2 (EBER-ISH) and T-cell receptor γ (TCRγ) gene rearrangement were performed for all cases. RESULTS: Large to medium-sized tumour cells with pleomorphic nuclei and coarse chromatin were found in a necrotic background in all cases. The cytoplasm of the tumour cells was scant to moderately abundant with occasional cytoplasmic projections; in Giemsa-stained smears, fine granules were present in some tumour cells. Mitotic figures were frequent. The tumour cells were all positive for CD56, granzyme B, TIA-1 and cCD3, and were negative for surface CD3, CD20 or CD79a, CD99 and TdT. The MIB index was 50-80%. Epstein-Barr virus-encoded RNA (EBER) hybridizing signals were detected for most neoplastic cells. The T-cell receptor gamma gene rearrangement analysis showed germ-line configuration, except for one case. CONCLUSIONS: Effusion cytology may be appropriate for establishing the diagnosis of ENKTCL-N, particularly for patients in whom tissue biopsy is not possible.

Pharmacokinetics of midazolam tablet in different Chinese ethnic groups.

WHAT IS KNOWN AND OBJECTIVES: Subjects of different ethnic groups may respond differently to drugs. The present study was conducted to compare the oral pharmacokinetics of midazolam among healthy volunteers from five different ethnic groups in China: Han, Mongolian, Uygur, Hui and Korean. METHODS: Healthy volunteers (10 Hans, 10 Mongolians, 10 Uygurs, 10 Huis and 9 Koreans) of Chinese nationality received a single oral tablet dose of 15 mg midazolam in an open label, parallel-group study. Blood samples were collected at intervals and analysed for midazolam by high performance liquid chromatography (HPLC). Ethnic differences in pharmacokinetic parameters of midazolam using non-compartmental methods and anova and Kruskal-Wallis rank test. RESULTS AND DISCUSSION: Midazolam maximum concentration (C(max) ) was significantly lower in Mongolians than that in Hans, Uygurs, Huis and Koreans (74·9 ± 33·7, 103·1 ± 26·4, 124·8 ± 50·0, 130·0 ± 38·3 and 189·0 ± 82·1 µg/L, respectively). C(max) for the Koreans were significantly greater, compared with Hans and Mongolians. The time to attain C(max) (t(max) ) for Hans was significantly longer as compared with Koreans and Uygurs (1·5 ± 0·7, 0·8 ± 0·5, 0·6 ± 0·7 h, respectively). Midazolam terminal half-life (t(1/2z)) were 3·0 ± 0·8, 2·2 ± 0·7, 1·9 ± 0·7, 3·5 ± 1·9, 3·8 ± 2·3 h for Hans, Mongolians, Uygurs, Huis and Koreans, respectively. The differences in half-life were significant between Koreans and Mongolians, Koreans and Uygurs, Uygurs and Huis, respectively. There were no differences between young males and females for all pharmacokinetic parameters. Double peaks in the concentration-time profiles were observed in some subjects. WHAT IS NEW AND CONCLUSION: There were some significant differences in midazolam pharmacokinetics between the five Chinese ethnic groups. However, the wide intra-ethnic variability observed in PK parameters makes predictions of midazolam kinetics, using ethnicity as predictor, unreliable.

Concise preparation of N(alpha)-Fmoc-N(epsilon)-(Boc, methyl)-lysine and its application in the synthesis of site-specifically lysine monomethylated peptide.

A concise preparation of N(alpha)-Fmoc-N(epsilon)-(Boc, methyl)-lysine and its application in the synthesis of site-specifically lysine monomethylated peptide is described. N (alpha)-Fmoc-N(epsilon)-(Boc, methyl)-lysine is obtained, via consecutive reductive benzylation and reductive methylation in a one-pot reaction, followed by debenzylation through catalytic hydrogenolysis and Boc protection in another one-pot reaction. A peptide containing monomethylated lysine is successfully synthesized by incorporating N(alpha)-Fmoc-N(epsilon)-(Boc, methyl)-lysine as a building block via solid-phase peptide synthesis.

Molecular cytogenetic characterization and clinical relevance of additional, complex and/or variant chromosome abnormalities in acute promyelocytic leukemia.

Acute promyelocytic leukemia (APL) is characterized by typical morphological manifestation, t(15;17) translocation and active response to all-trans retinoic acid (ATRA) in the great majority of patients. However, a subset of APL cases may present atypical phenotypic, cytogenetic or molecular features at different stages of the disease. The biological and clinical significance of these features sometimes remains obscure. In this study, 284 APL patients were cytogenetically analyzed and precise diagnosis was performed according to the molecular cytogenetic results. Twenty-six APL patients were identified as having additional, complex and/or variant chromosomal abnormalities at diagnosis or at relapse, 16 of them being further analyzed using fluorescence in situ hybridization (FISH) or chromosome painting (CP). Interestingly, some of these chromosomal aberrations were found to be associated with atypical morphology and/or drug response, indicating a genotype-phenotype correlation. Analysis of the complex karyotype may also allow a better understanding of the levels of cellular origin of the leukemogenesis. Examination of the remission induction and survival data showed that the presence of the additional/complex chromosome abnormalities was related to the prognosis in both primarily diagnosed and relapsed patients in this series.

Total parenteral nutrition in the surgical patient: a meta-analysis.

OBJECTIVE: To examine the relationship between total parenteral nutrition(TPN) and complication and death rates in surgical patients. DATA SOURCES: A computer search of published research on MEDLINE, personal files and a review of relevant reference lists. STUDY SELECTION: A review of 237 titles, abstracts or papers. Primary studies were included if they were randomized clinical trials of surgical patients that evaluated the effect of TPN (compared to no TPN or standard care) on complication and death rates. Studies comparing TPN to enteral nutrition (EN) were excluded. DATA EXTRACTION: Relevant data were abstracted on the methodology and outcomes of primary studies. Data were independently abstracted in duplicate. DATA SYNTHESIS: There were 27 randomized trials in surgical patients that compared the use of TPN to standard care (usual oral diet plus intravenous dextrose). When the results of these trials were aggregated, there was no effect on mortality (risk ratio = 0.97, 95% confidence intervals, 0.76 to 1.24). There were fewer major complications in patients who received TPN, although there was significant heterogeneity in the overall estimate (risk ratio = 0.81, 95% CI, 0.65 to 1.01). Because of this significant heterogeneity, several a priori hypotheses were examined. Studies that included only malnourished patients demonstrated a trend to a reduction in complication rates but no difference in death rate when compared with studies of patients who were not malnourished. Studies published in 1988 or earlier and studies with a lower methods score were associated with a significant reduction in complication rates and a trend to a reduction in death rate when compared with studies published after 1988 and studies with a higher methods score. There was no difference in studies that provided lipids as a component of TPN when compared with studies that did not. Studies that initiated TPN preoperatively demonstrated a trend to a reduction in complication rates but no difference in death rate when compared with studies that initiated TPN postoperatively. CONCLUSIONS: TPN does not influence the death rate of surgical patients. It may reduce the complication rate, especially in malnourished patients, but study results are influenced by methodologic quality and year of publication.

Feasibility and clinical significance of real-time quantitative RT-PCR assay of PML-RARalpha fusion transcript in patients with acute promyelocytic leukemia.

INTRODUCTION: To study the relationship between the expression level of the PML-RARalpha fusion transcripts and the clinical status and efficiency of the therapy in acute promyelocytic leukemia (APL) patients, we applied a very sensitive and specific real-time Reverse Transcription Polymerase Chain Reaction (RT-PCR) system to quantify the dose of PML-RARalpha fusion transcripts in a series of APL patients at distinct disease stages. MATERIALS AND METHODS: A total of 31 APL patients (19 males and 12 females; aged from 8 to 74 years) from eight hospitals in Shanghai were analysed. Real-time Quantitative RT-PCR was used to measure the normalized dose (DoseN) of PML-RARalpha fusion transcripts. RESULTS: A wide range of PML-RARalpha DoseN above 1 x 10(3) was noted in 25 newly diagnosed patients. PML-RARalpha DoseN was significantly decreased after remission induction with ATRA, ATRA/chemotherapy or As2O3 and further reduced after consolidation. The fact that all patients with long disease free survival had a constantly low PML-RARalpha DoseN below 2 x 10(2) and a higher level predicted impending relapse suggests that this value could serve as a 'threshold' for molecular remission. PML-RARalpha DoseN was also of prognostic value in a group of relapsed patients, since good response to As2O3 reinduction was accompanied by a remarkable reduction of fusion transcript level, whereas patients with high PML-RARalpha Dose(N) after the second CR tended to relapse again rapidly. CONCLUSION: These results confirm that real-time RT-PCR assay for PML-RARalpha transcripts in APL patients is useful in reflecting leukemic burden, assessing response to treatment and indicating the ultimate clinical outcome or curability of disease.

Studies on treatment of acute promyelocytic leukemia with arsenic trioxide: remission induction, follow-up, and molecular monitoring in 11 newly diagnosed and 47 relapsed acute promyelocytic leukemia patients.

Fifty-eight acute promyelocytic leukemia (APL) patients (11 newly diagnosed and 47 relapsed) were studied for arsenic trioxide (As2O3) treatment. Clinical complete remission (CR) was obtained in 8 of 11 (72.7%) newly diagnosed cases. However, As2O3 treatment resulted in hepatic toxicity in 7 cases including 2 deaths, in contrast to the mild liver dysfunction in one third of the relapsed patients. Forty of forty-seven (85.1%) relapsed patients achieved CR. Two of three nonresponders showed clonal evolution at relapse, with disappearance of t(15;17) and PML-RARalpha fusion gene in 1 and shift to a dominant AML-1-ETO population in another, suggesting a correlation between PML-RARalpha expression and therapeutic response. In a follow-up of 33 relapsed cases over 7 to 48 months, the estimated disease-free survival (DFS) rates for 1 and 2 years were 63.6% and 41.6%, respectively, and the actual median DFS was 17 months. Patients with white blood cell (WBC) count below 10 x 10(9)/L at relapse had better survival than those with WBC count over 10 x 10(9)/L (P =.038). The duration of As2O3-induced CR was related to postremission therapy, because there was only 2 of 11 relapses in patients treated with As2O3 combined with chemotherapy, compared with 12 of 18 relapses with As2O3 alone (P =.01). Reverse transcription polymerase chain reaction (RT-PCR) analysis in both newly diagnosed and relapsed groups showed long-term use of As2O3 could lead to a molecular remission in some patients. We thus recommend that ATRA be used as first choice for remission induction in newly diagnosed APL cases, whereas As2O3 can be either used as a rescue for relapsed cases or included into multidrug consolidation/maintenance clinical trials.