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randomized, controlled, open label non-inferiority trial of intravenous ferric carboxymaltose versus iron sucrose

《医学前沿（英文）》 doi: 10.1007/s11684-023-1001-2

摘要： Iron deficiency (ID) and ID anemia (IDA) pose significant public health concerns in China. Although iron sucrose (IS) treatment is well-established in the country, ferric carboxymaltose (FCM) offers the advantage of higher doses and fewer infusions. This open label, randomized, controlled, non-inferiority trial was conducted at multiple sites in China to compare the outcomes of FCM (maximum of 2 doses, 500 or 1000 mg iron) and IS (up to 11 infusions, 200 mg iron) treatments in subjects with IDA. The primary endpoint was the achievement of hemoglobin (Hb) response (an increase of ≥2 g/dL from baseline) within 8 weeks, whereas secondary endpoints included changes in Hb, transferrin saturation, and serum ferritin levels. Among the 371 randomized subjects, a similar percentage of subjects treated with FCM and IS achieved Hb-response (FCM 99.4%, IS 98.3%), thereby confirming the non-inferiority of FCM compared with IS (difference 1.12 (−2.15, 4.71; 95% confidence interval (CI))). Furthermore, a significantly higher proportion of FCM-treated subjects achieved early Hb-response at Week 2 (FCM 85.2%, IS 73.2%; difference 12.1 (3.31, 20.65; 95% CI)). Additionally, the increase in TSAT and serum ferritin levels from baseline was significantly greater at all time points for FCM-treated subjects. The safety profiles of FCM and IS were comparable, with the exception of transient hypophosphatemia and pyrexia, which are consistent with FCM’s known safety profile. In conclusion, FCM proves to be an efficacious treatment for IDA, providing faster Hb-response and correction of ID with fewer administrations than IS.

关键词： iron deficiency     anemia     intravenous iron     ferric carboxymaltose     iron sucrose     Hb response     early response    

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c-Fos expression in rat brainstem following intake of sucrose or saccharin

Ke Chen, Jianqun Yan, Jinrong Li, Bo Lv, Xiaolin Zhao

《医学前沿（英文）》 2011年 第5卷 第3期   页码 294-301 doi: 10.1007/s11684-011-0144-8

摘要： To examine whether the activation of brainstem neurons during intake of a sweet tastant is due to orosensory signals or post-ingestive factors, we compared the distribution of c-Fos-like immunoreactivity (c-FLI) in the nucleus of the solitary tract (NST) and parabrachial nucleus (PBN) of brainstem following ingestion of 0.25 M sucrose or 0.005 M saccharin solutions. Immunopositive neurons were localized mainly in the middle zone of the PBN and four rostral-caudal subregions of the NST. Intake of sucrose increased the number of FLI neurons in almost every subnucleus of the PBN (F = 7.610, = 0.023), in addition to the caudal NST at the level of the area postrema (F = 10.777, = 0.003) and the NST intermediate zone (F = 7.193, = 0.014). No significant increase in the number of c-Fos positive neurons was detected in response to saccharin ingestion, although there was a trend towards a modest increase in a few select NST and PBN nuclei. These results suggest that the PBN and NST may be involved in sweet taste perception and modulation of sweet tastant intake, but the significantly enhanced intensity of Fos expression induced by sucrose indicates that PBN/NST neuronal activity is driven by the integrated effects of sweet taste sensation and post-ingestive signals.

关键词： c-Fos     parabrachial     the nucleus of the solitary tract     sweet tastant     rat    

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Effects of sucrose crystallization and moisture migration on the structural changes of a coated intermediate

Tiancheng LI, Peng ZHOU, Theodore P. LABUZA

《化学科学与工程前沿（英文）》 2009年 第3卷 第4期   页码 346-350 doi: 10.1007/s11705-009-0256-8

摘要： The purpose of this study was to investigate whether moisture migration and sugar crystallization play an important role in the changes of IMF matrix structure. The migration of water was monitored with changes of water activity in different physical domains of samples during storage, while the crystallization of sucrose was determined with X-ray powder diffraction (XRD). The formation of both a hard inner-layer and agglomerated particles in the inner matrix was observed during storage. Our results suggested that both moisture loss and sucrose crystallization were mainly responsible for the formation of the crusty intermediate inner layer, and the agglomerated matrix particles were the result of sucrose crystallization.

关键词： inner-layer     agglomerated     IMF     moisture migration     crystallization    

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One-pot three-component Mannich reaction catalyzed by sucrose char sulfonic acid

Qiong XU, Zhigao YANG, Dulin YIN, Jihui WANG

《化学科学与工程前沿（英文）》 2009年 第3卷 第2期   页码 201-205 doi: 10.1007/s11705-009-0052-5

摘要： Sucrose char sulfonic acid efficiently catalyzed the one-pot three-component Mannich reaction of ketones, aromatic aldehydes and amines in ethanol to afford the corresponding -amino carbonyl compounds in good to excellent yields. A series of heteroaromatic -amino carbonyl compounds can be obtained when using 2-acetylpyrazine as substrate. This reaction can be performed under mild reaction conditions with clean reaction profiles and a simple workup procedure.

关键词： One–pot synthesis     b-amino ketone     char sulfonic acid     2-acetylpyrazine     catalysis    

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The feasibility of coating by cooling crystallization on ibuprofen naked tablets

Fatima Mameri, Ouahiba Koutchoukali, Mohamed Bouhelassa, Anne Hartwig, Leila Nemdili, Joachim Ulrich

《化学科学与工程前沿（英文）》 2017年 第11卷 第2期   页码 211-219 doi: 10.1007/s11705-017-1619-1

摘要： Sugar spray coating is a frequently used process in the pharmaceutical industry. However, this process presents the disadvantage to form an amorphous coating around the active ingredient. A crystalline coating formed on the surface of a tablet is highly desirable. Recently, a new process of coating by cooling crystallization has been developed and applied on bisacodyl pastilles obtained by melt crystallization. In this work, we investigated the feasibility of coating by cooling crystallization on ibuprofen “naked tablets” manufactured by compression. In the first part of this work, the solubility and the metastable zone width have been determined experimentally for the coating solution because they are essential factors for any crystallization process. In the second part, the coating process is investigated on the operating conditions that affect the surface morphology and the crystal growth rate. These experimental conditions include concentration of the coating solution, degree of sub-cooling, agitation speed, retention time, and surface properties of the naked ibuprofen tablets. The results show that naked tablet coating by cooling crystallization is feasible and can be applied in the pharmaceutical industry.

关键词： coating     solution crystallization     ibuprofen tablets     sucrose    

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标题 作者 时间 类型 操作

randomized, controlled, open label non-inferiority trial of intravenous ferric carboxymaltose versus iron sucrose

期刊论文

c-Fos expression in rat brainstem following intake of sucrose or saccharin

Ke Chen, Jianqun Yan, Jinrong Li, Bo Lv, Xiaolin Zhao

期刊论文

Effects of sucrose crystallization and moisture migration on the structural changes of a coated intermediate

Tiancheng LI, Peng ZHOU, Theodore P. LABUZA

期刊论文

One-pot three-component Mannich reaction catalyzed by sucrose char sulfonic acid

Qiong XU, Zhigao YANG, Dulin YIN, Jihui WANG

期刊论文

The feasibility of coating by cooling crystallization on ibuprofen naked tablets

Fatima Mameri, Ouahiba Koutchoukali, Mohamed Bouhelassa, Anne Hartwig, Leila Nemdili, Joachim Ulrich

期刊论文