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Small-cell lung cancer (SCLC) is a recalcitrant cancer for its dismal prognosis although extensive research had been done. Four to 6 cycles platinum-based chemotherapy is the mainstay treatment for the extensive-stage disease; but the role of maintenance treatment is not fully understood. This is a phase 2, open-label study. Patients with extensive-stage SCLC reaching an objective response or stable disease (SD) after induction chemotherapy were randomly assigned (1:1) with a minimization procedure. One group received oral S-1 and the other group received placebo as maintenance treatment until disease progression or unacceptable toxicities. The primary end point of this study was progression-free survival (PFS), and the secondary end points were overall survival (OS), response rates, and toxicities. This study was based on earlier work, the preliminary results was reported on 2019 ASCO annual meeting. A total of 89 patients were enrolled, of whom 45 received S-1 maintenance therapy and 44 received placebo. The median PFS and OS were 6.35 months and 10.82 months in the S-1 group, as compared to 5.98 months and 10.09 months in the placebo group. The PFS was 7.2 months and 5.3 months, and OS was 12.9 months and 10.9 months in patients with an objective response compared to in patients with SD after induction chemotherapy, respectively. S-1 maintenance therapy did not prolong PFS or OS in patients with extensive-stage SCLC; tumor regression rate was the prognostic factor of PFS or OS. Further research with novel agents in the maintenance setting is warranted.
S-1, maintenance therapy, extensive-stage small-cell lung carcinoma, tumor regression rate
S-1 Maintenance Therapy in Extensive Stage Small-Cell Lung Cancer?A Randomized Clinical Study
Keke Nie, MD,1 Xiuhui Guo, MD,2 Yunhong You, MD,1 Xingjun Zhuang, MD,3 Chunling Zhang, MD,1 and Youxin Ji, MD1
Intravenous zoledronate 5 mg annually reduces fracture risk, and 5 mg every 2 years prevents bone loss, but the optimal dosing regimens for these indications are uncertain.
We conducted a 3-year open-label extension of a 2-year randomized, placebo-controlled, double-blind study. Late postmenopausal women with osteopenia were assigned to receive a single baseline dose of 1 mg, 2.5 mg or 5 mg of zoledronate or placebo. The primary outcome was change in spine bone mineral density (BMD). Secondary outcomes were changes in hip BMD and serum markers of bone turnover.
The study involved 160 women. Zoledronate increased BMD and reduced markers of bone turnover in a dose-dependent manner. After 2 years, the 1-mg, 2.5-mg and 5-mg zoledronate doses increased spine BMD over placebo by 5.0% (95% confidence interval [CI] 3.0% to 7.0%), 5.7% (95% CI 3.7% to 7.7%) and 5.7% (95% CI 3.7% to 7.6%), respectively; after 5 years, the respective increases were 2.0% (95% CI ?1.1% to 5.0%), 2.2% (95% CI ?1.0% to 5.4%) and 5.1% (95% CI 2.2% to 8.1%). After 2 years, the 1-mg, 2.5-mg and 5-mg zoledronate doses increased total hip BMD over placebo by 2.6% (95% CI 1.3% to 3.9%), 4.1% (95% CI 2.9% to 5.4%) and 4.7% (95% CI 3.4% to 5.9%), respectively; after 5 years, the respective increases were 1.8% (95% CI ?0.1% to 3.8%), 2.8% (95% CI 0.8% to 4.8%) and 5.4% (95% CI 3.5% to 7.3%). BMD remained above baseline values for 2-3 years in the 1-mg group, 3-4 years in the 2.5-mg group and at least 5 years in the 5-mg group.
The antiresorptive activity of single zoledronate doses of 1-5 mg persist for at least 3 years in postmenopausal women with osteopenia. Clinical trials would be justified to evaluate the effects on fracture risk of less frequent or lower doses of zoledronate than are currently recommended.
www.anzctr.org.au, no. ACTRN12607000576426
Duration of antiresorptive activity of zoledronate in postmenopausal women with osteopenia: a randomized, controlled multidose trial
Andrew Grey, MD, Mark J. Bolland, PhD, Anne Horne, MBChB, Borislav Mihov, BPhty, Greg Gamble, MSc, and Ian R. Reid, MD
2017 Sep 11
The parietal regions implicated in spatially selective attention differ between patient lesion studies and functional imaging of the intact brain. We aimed to resolve this discordance. In a voxel-based lesion-symptom mapping study in 20 ischemic stroke patients, we applied the same cognitive subtraction approach as in 23 healthy volunteers who underwent functional magnetic resonance imaging (fMRI) using identical tasks and stimuli. An instructive central cue directed attention to one visual quadrant. After a brief delay, a grating appeared in that quadrant together with an irrelevant grating in an uncued quadrant. Subjects had to discriminate the orientation of the grating in the cued quadrant. Patients with a right inferior parietal lesion were significantly more impaired during contralesional versus ipsilesional orienting when stimuli were bilateral and symmetrical than when stimuli occupied diagonally opposite quadrants or two quadrants within the same hemifield. In one area, the lesion-volume map overlapped with the activity map obtained in healthy volunteers: the lower bank of the middle third of the right intraparietal sulcus (IPS). In an additional 37 healthy fMRI subjects, we disentangled the effects of symmetry, bilaterality, and spatial configuration between stimuli on activity in the volume of overlap. Only the axis of configuration between stimuli had a significant effect, with highest activity when the configuration axis was horizontal. This constitutes converging evidence from patients and cognitively intact subjects that the lower bank of the middle third of the right IPS critically contributes to attentive selection between competing stimuli in a spatially anisotropic manner.
attention, neglect, extinction, fMRI, stroke, VLSM
Convergence between Lesion-Symptom Mapping and Functional Magnetic Resonance Imaging of Spatially Selective Attention in the Intact Brain
Pascal Molenberghs,1 Celine R. Gillebert,1 Ronald Peeters,2 and Rik Vandenberghecorresponding author1,3
2008 Mar 26