重症胆管炎23例临床治疗分析

目的：探讨急性重症胆管炎患者的手术时机和死亡原因。方法：回顾性分析23例急性重症胆管炎患者的治疗及预后情况。结果：死亡2例（手术死亡及传统治疗死亡各1例）。早期大剂量短期应用糖皮质激素患者休克得到纠正率85％，明显高于未用糖皮质激素患者休克纠正率50％。结论：急性重症胆管炎患者应在出现休克和（或）精神症状之前手术，对已出现休克的患者，应先给予充分的保守治疗，待病情稳定后再手术。贻误手术时机，严重合并症如多器官功能衰竭及高龄是死亡的主要原因。     

Comparison of assays for determination of peptide content for lyophilized thymalfasin*

Abstract: Precise determination of the peptide content in drug substance samples depends highly upon the particular peptide compound and methodology used. Four independent methods were evaluated and compared to determine which would produce the best experimental precision for analysis of thymalfasin (thymosin α‐1). Four different methods were evaluated including elemental analysis (CHN), quantitative amino acid analysis (AAA), high‐performance liquid chromatography (HPLC), and Kjeldahl. This study demonstrates that the AAA method is highly variable in one laboratory while quite precise in another laboratory. Similarly, HPLC results depended on the laboratory conducting the study with more precise values obtained under cGMP. On the contrary, the CHN method yielded highly precise [i.e. <2% coefficient of variation (CV)] values. As precise knowledge of protein content is fundamental for the compounding of final pharmaceutical product of a specific potency, the CHN analysis is recommended for peptide content determination of the drug substance thymalfasin.     

The shape of stress: the use of frequent sampling to measure temporal variation in S‐IgA levels during acute stress

Previous studies have indicated that statistically significant increases in Secretory immunoglobulin A (S‐IgA) can be achieved in as little as 5min as a result of mental stress. However, the temporal resolution of these changes is low and therefore the rate and pattern of changes during the stress task and during subsequent recovery is unclear. A within‐subjects design was used to examine levels of S‐IgA before, during and after a short (8 min) mental stress task. S‐IgA was measured from saliva samples obtained every 2 min during the entire 30‐min session. Significant increases in S‐IgA concentration were observed as early as the task instruction period, with additional increases during the stress task itself. The data also show a rapid recovery of S‐IgA, with a return to baseline levels within 6 min. Results suggest that S‐IgA changes can occur very rapidly and that the observed increases are short‐lived. Copyright © 2007 John Wiley & Sons, Ltd.     

Fat and water separation in balanced steady-state free precession using the Dixon method.

In this work the feasibility of separating fat and water signals using the balanced steady-state free precession (SSFP) technique is demonstrated. The technique is based on the observation (Scheffler and Hennig, Magnetic Resonance in Medicine 2003;49:395-397) that at the nominal values of TE = TR/2 in SSFP imaging, phase coherence can be achieved at essentially only two orientations (0 degrees and 180 degrees ) relative to the RF pulses in the rotating frame, under the assumption of TR < T2, and independently of the SSFP angle. This property allows in-phase and out-of-phase SSFP images to be obtained by proper choices of the center frequency offset, and thus allows the Dixon subtraction method to be utilized for effective fat-water separation. The TR and frequency offset for optimal fat-water separation are derived from theories. Experimental results from healthy subjects, using a 3.0 Tesla system, show that nearly complete fat suppression can be accomplished.     

Granulocytic sarcoma: An atypical presentation in the oral cavity

Acute myelogenous leukemia (AMU is a hematologic disorder that is characterized by an abnormal proliferation of immature myeloid cells. Granulocytic sarcomas are clusters of leukemic myeloid cells that may develop as a result of AML. Oral manifestations of AML are common and often involve enlargements of the gingiva and/or mucosal tissue from direct leukemia cell infiltration. We describe the case history of a 50-year-old man who had an ulcera-tive lesion of the oral mucosa that was determined to be a granulocytic sarcoma of AML-M0 subtype. The combination of both the subtype and clinical presentation of the leukemia makes this presentation unusual, and to the best of our knowledge, of a type that has not been previously reported in the literature.     

One‐ and two‐stage design proposals for a phase II trial comparing three active treatments with control using an ordered categorical endpoint

Phase II clinical trials are performed to investigate whether a novel treatment shows sufficient promise of efficacy to justify its evaluation in a subsequent definitive phase III trial, and they are often also used to select the dose to take forward. In this paper we discuss different design proposals for a phase II trial in which three active treatment doses and a placebo control are to be compared in terms of a single‐ordered categorical endpoint. The sample size requirements for one‐stage and two‐stage designs are derived, based on an approach similar to that of Dunnett. Detailed computations are prepared for an illustrative example concerning a study in stroke. Allowance for early stopping for futility is made. Simulations are used to verify that the specified type I error and power requirements are valid, despite certain approximations used in the derivation of sample size. The advantages and disadvantages of the different designs are discussed, and the scope for extending the approach to different forms of endpoint is considered. Copyright © 2008 John Wiley & Sons, Ltd.