Ertapenem versus piperacillin/tazobactam for diabetic foot infections in China: a Phase 3, multicentre, randomized, double-blind, active-controlled, non-inferiority trial.

OBJECTIVES: Few randomized controlled studies have compared antibiotic regimens against diabetic foot infections (DFIs) in Chinese patients. We evaluated the efficacy and safety of ertapenem versus piperacillin/tazobactam for the treatment of DFIs in Chinese patients. METHODS: Patients with moderate to severe DFIs requiring parenteral antibiotics were randomized in a 1 : 1 ratio to receive ertapenem (1.0 g once daily) or piperacillin/tazobactam (4.5 g every 8 h) by 30 min intravenous (iv) infusions for ≥5 days. The primary outcome was favourable clinical response at discontinuation of iv therapy (DCIV). An evaluable-patient population was identified for primary analysis of non-inferiority at -15%. Safety was assessed. ClinicalTrials.gov: NCT01370616. RESULTS: Of 565 patients randomized, 443 patients (ertapenem = 219 and piperacillin/tazobactam = 224) were clinically evaluable for primary analysis. In the clinically evaluable population, the proportions of patients with favourable clinical response at DCIV were 93.6% (205/219) and 97.3% (218/224) in the ertapenem and piperacillin/tazobactam groups, respectively (difference: -3.8%, 95% CI: -8.3%, 0.0%). Ertapenem had a significantly lower favourable clinical response rate (91.5% versus 97.2%, 95% CI for difference: -12.1%, -0.3%) at DCIV in severe DFI patients. In the modified ITT population, 88.8% (237/267) and 90.6% (241/266) of patients in the ertapenem and piperacillin/tazobactam groups, respectively, had favourable clinical responses at DCIV (difference: -1.9%, 95% CI: -7.3%, 3.3%). Microbiological eradications of causative pathogens and adverse events were similar between treatment groups. CONCLUSIONS: Treatment with ertapenem was non-inferior to piperacillin/tazobactam in Chinese patients with DFIs. Ertapenem treatment resulted in a markedly lower rate of clinical resolution in severe DFIs.

Single-crystal structures of cucurbituril-based supramolecular host-guest complexes for bioimaging.

Two single-crystal structures of cucurbit[n]uril mediated supramolecular complexes were obtained in which [1+3] and [2+3] self-assembly modes are adopted due to the different sizes of cucurbit[7]uril and cucurbit[8]uril. An obvious red-shift in absorption and emission was observed compared to the guest molecule itself which makes them good biolabels.

The impact of trauma-focused group therapy upon HIV sexual risk behaviors in the NIDA Clinical Trials Network "Women and trauma" multi-site study.

Women in drug treatment struggle with co-occurring problems, including trauma and post-traumatic stress disorder (PTSD), which can heighten HIV risk. This study examines the impact of two group therapy interventions on reduction of unprotected sexual occasions (USO) among women with substance use disorders (SUD) and PTSD. Participants were 346 women recruited from and receiving treatment at six community-based drug treatment programs participating in NIDA's Clinical Trials Network. Participants were randomized to receive 12-sessions of either seeking safety (SS), a cognitive behavioral intervention for women with PTSD and SUD, or women's health education (WHE), an attention control psychoeducational group. Participants receiving SS who were at higher sexual risk (i.e., at least 12 USO per month) significantly reduced the number of USO over 12-month follow up compared to WHE. High risk women with co-occurring PTSD and addiction may benefit from treatment addressing coping skills and trauma to reduce HIV risk.

Appropriate timing of G-CSF use after mobilization chemotherapy significantly increases the yield of CD34+ cells in autoPBSCT.

The yield of CD34+ cells collected by apheresis for autologous peripheral blood stem cell (PBSC) transplantation was greatly increased when the appropriate timing was determined to begin using G-CSF after COAEP (Cytoxan, Vinblastine, Arabinosylcytosin, Etoposide and Prednisone) mobilization. Twenty-nine patients with lymphoma or multiple myeloma (MM) received the same mobilization chemotherapy, including cytoxan (CTX) 400 mg/m(2) d1; vinblastine (VLB) 2 mg/m(2) d1; Ara-C 60 mg/m(2) x 5d; vp-16 60 mg/m(2) x 5d; and prednisone 40 mg/m(2) x 5d. The historical control group (12 cases) received subcutaneous G-CSF (filgrastim) at the first restoration after the initial nadir of the peripheral WBC count. The experimental group (17 cases) received G-CSF during the steady rise of the WBC count (end of fluctuating after initial nadir). G-CSF was given in a single daily subcutaneous dose of 5 microg/kg until the final PBSC apheresis. When the peripheral WBC and mononuclear cell (MNC) counts reached 10 x 10(9)/L and 1 x 10(9)/L, respectively, leukapheresis was carried out using the COBE Spectrablood cell separator. Despite comparable treatment with alkylating agents, a significantly increased yield of CD34-positive cells was observed in the experimental group (32 x 10(6)/kg) compared with the historical control group (3.1 x 10(6)/kg) (P = 0.0182). This result indicates the importance of appropriate timing for the use G-CSF after mobilization chemotherapy to increase the CD34+ cell yield.

A multisite study of the clinical diagnosis of different autism spectrum disorders.

CONTEXT: Best-estimate clinical diagnoses of specific autism spectrum disorders (autistic disorder, pervasive developmental disorder-not otherwise specified, and Asperger syndrome) have been used as the diagnostic gold standard, even when information from standardized instruments is available. OBJECTIVE: To determine whether the relationships between behavioral phenotypes and clinical diagnoses of different autism spectrum disorders vary across 12 university-based sites. DESIGN: Multisite observational study collecting clinical phenotype data (diagnostic, developmental, and demographic) for genetic research. Classification trees were used to identify characteristics that predicted diagnosis across and within sites. SETTING: Participants were recruited through 12 university-based autism service providers into a genetic study of autism. PARTICIPANTS: A total of 2102 probands (1814 male probands) between 4 and 18 years of age (mean [SD] age, 8.93 [3.5] years) who met autism spectrum criteria on the Autism Diagnostic Interview-Revised and the Autism Diagnostic Observation Schedule and who had a clinical diagnosis of an autism spectrum disorder. MAIN OUTCOME MEASURE: Best-estimate clinical diagnoses predicted by standardized scores from diagnostic, cognitive, and behavioral measures. RESULTS: Although distributions of scores on standardized measures were similar across sites, significant site differences emerged in best-estimate clinical diagnoses of specific autism spectrum disorders. Relationships between clinical diagnoses and standardized scores, particularly verbal IQ, language level, and core diagnostic features, varied across sites in weighting of information and cutoffs. CONCLUSIONS: Clinical distinctions among categorical diagnostic subtypes of autism spectrum disorders were not reliable even across sites with well-documented fidelity using standardized diagnostic instruments. Results support the move from existing subgroupings of autism spectrum disorders to dimensional descriptions of core features of social affect and fixated, repetitive behaviors, together with characteristics such as language level and cognitive function.

[Yield of CD34(+) cells in graft can be increased significantly by G-CSF used at appropriate time after chemotherapy for AutoPBSCT].

This study was aimed to investigate the influence of timing using G-CSF after chemotherapy on graft yield of mobilized peripheral blood stem cells for autoPBSCT. 39 patients with lymphoma or multiple myeloma (MM) received the same chemotherapy mobilization regimen, including CTX 400 mg/m² d1; VLB 2 mg/m(2) d1; Ara-C 60 mg/m ²× d1-5; VP-16 60 mg/m² × d1-5; and prednisone 40 mg/m² × d1-5. The historical control group (12 cases) received G-CSF subcutaneously (filgrastim) at the first restoration after the initial nadir of the peripheral WBC count. The experimental group (27 cases) received G-CSF during the steady rise of the WBC count (end of fluctuating after initial nadir). G-CSF was given in a single daily subcutaneous dose of 5 µg/kg until the final PBSC apheresis. When the peripheral WBC and mononuclear cell (MNC) counts reached 10 × 109/L and 1.0 × 109/L respectively, leukapheresis was carried out using the COBE Spectra blood cell separator. The results indicated that despite there was comparable treatment with alkylating agents between 2 groups, a significantly increased yield of CD34 positive cells was observed in the experimental group (26.4 × 106/kg), as compared to the historical control group (3.1 × 106/kg) (p = 0.0031). It is concluded that the appropriate timing for the use G-CSF mobilization after chemotherapy is important to increase the CD34(+) cell yield in auto-graft.

Treatment for PTSD related to childhood abuse: a randomized controlled trial.

OBJECTIVE: Posttraumatic stress disorder (PTSD) related to childhood abuse is associated with features of affect regulation and interpersonal disturbances that substantially contribute to impairment. Existing treatments do not address these problems or the difficulties they may pose in the exploration of trauma memories, an efficacious and frequently recommended approach to resolving PTSD. The authors evaluated the benefits and risks of a treatment combining an initial preparatory phase of skills training in affect and interpersonal regulation (STAIR) followed by exposure by comparing it against two control conditions: Supportive Counseling followed by Exposure (Support/Exposure) and skills training followed by Supportive Counseling (STAIR/Support). METHOD: Participants were women with PTSD related to childhood abuse (N=104) who were randomly assigned to the STAIR/Exposure condition, Support/Exposure condition (exposure comparator), or STAIR/Support condition (skills comparator) and assessed at posttreatment, 3 months, and 6 months. RESULTS: The STAIR/Exposure group was more likely to achieve sustained and full PTSD remission relative to the exposure comparator, while the skills comparator condition fell in the middle (27% versus 13% versus 0%). STAIR/Exposure produced greater improvements in emotion regulation than the exposure comparator and greater improvements in interpersonal problems than both conditions. The STAIR/Exposure dropout rate was lower than the rate for the exposure comparator and similar to the rate for the skills comparator. There were significantly lower session-to-session PTSD symptoms during the exposure phase in the STAIR/Exposure condition than in the Support/Exposure condition. STAIR/Exposure was associated with fewer cases of PTSD worsening relative to both of the other two conditions. CONCLUSIONS: For a PTSD population with chronic and early-life trauma, a phase-based skills-to-exposure treatment was associated with greater benefits and fewer adverse effects than treatments that excluded either skills training or exposure.

Effectiveness of HIV/STD sexual risk reduction groups for women in substance abuse treatment programs: results of NIDA Clinical Trials Network Trial.

CONTEXT: Because drug-involved women are among the fastest growing groups with AIDS, sexual risk reduction intervention for them is a public health imperative. OBJECTIVE: To test effectiveness of HIV/STD safer sex skills building (SSB) groups for women in community drug treatment. DESIGN: Randomized trial of SSB versus standard HIV/STD Education (HE); assessments at baseline, 3 and 6 months. PARTICIPANTS: Women recruited from 12 methadone or psychosocial treatment programs in Clinical Trials Network of National Institute on Drug Abuse. Five hundred fifteen women with >or=1 unprotected vaginal or anal sex occasion (USO) with a male partner in the past 6 months were randomized. INTERVENTIONS: In SSB, five 90-minute groups used problem solving and skills rehearsal to increase HIV/STD risk awareness, condom use, and partner negotiation skills. In HE, one 60-minute group covered HIV/STD disease, testing, treatment, and prevention information. MAIN OUTCOME: Number of USOs at follow-up. RESULTS: A significant difference in mean USOs was obtained between SSB and HE over time (F = 67.2, P < 0.0001). At 3 months, significant decrements were observed in both conditions. At 6 months, SSB maintained the decrease and HE returned to baseline (P < 0.0377). Women in SSB had 29% fewer USOs than those in HE. CONCLUSIONS: Skills building interventions can produce ongoing sexual risk reduction in women in community drug treatment.