Suicide risk and symptom reduction in patients assigned to placebo in duloxetine and escitalopram clinical trials: analysis of the FDA summary basis of approval reports.

BACKGROUND: We assessed suicide and suicide attempt risk as well as symptom reduction among 3,282 depressed patients participating in duloxetine and escitalopram clinical trials assigned to either an antidepressant or placebo. METHODS: We reviewed the FDA Summary Basis of Approval reports for data regarding safety and efficacy for duloxetine and escitalopram. Furthermore, we compared suicide risk among antidepressant clinical trials in this study with our two previous analyses on seven antidepressant clinical trials. RESULTS: Suicide and suicide attempt risk varied considerably among the three analyses, showing up to ten fold differences. Interestingly, the variability exists across the three reports, rather than between treatments (antidepressants versus placebo). CONCLUSIONS: These findings suggest caution in generalizing suicide risk even from a relatively large number of participants and thus, firm conclusions can only be drawn if the number of participants is overwhelmingly large (approximately two million patients). We also noted similar magnitude of response to placebo and antidepressants among the three studies.     

Spilled Gallstones: the Source of an Enigma

Spillage of gallstones may occur in the course of laparoscopic cholecystectomy. The incidence of this mishap and its consequences are variable. Ignored by many surgeons, stone spillage may be the source of significant morbidity many years after surgery. In this report, we describe the clinical course of a patient who presented with upper abdominal pain and swelling. The past history was positive for laparoscopic cholecystectomy 15 years earlier. After excision, the swelling was found to be a pseudocyst formed around spilled gallstones during a previous cholecystectomy. Apart from postoperative wound infection, the patient recovered well and remains so. Here, we discuss the problem and provide suggestions for spillage prevention and stone retrieval once spillage occurs.     

The impact of serum sodium concentration on mortality after liver transplantation: a cohort multicenter study.

Modification of the current allocation system for donor livers in the United States to incorporate recipient serum sodium concentration ([Na]) has recently been proposed. However, the impact of this parameter on posttransplantation mortality has not been previously examined in a large risk-adjusted analysis. We assessed the effect of recipient [Na] on the survival of all adults with chronic liver disease who received a first single organ liver transplant in the UK and Ireland during the period March 1, 1994 to March 31, 2005 (n=5,152) at 3 years, during the first 90 days, and beyond the first 90 days, adjusting for a wide range of recipient, donor, and graft characteristics. Compared to those with normal [Na] (135-145 meq/L; n=3,066), severely hyponatremic recipients ([Na]<130 meq/L, n=541), had a higher risk-adjusted mortality at 3 years (hazard ratio [HR] 1.28; 95% confidence interval [CI], 1.04-1.59; P<0.02). The excess mortality was, however, confined to the first 90 days (HR 1.55; 95% CI, 1.18-2.04; P<0.002) with no significant difference thereafter. This was also true for hypernatremic recipients ([Na]>45 meq/L, n=81), who had an even greater risk-adjusted mortality compared to normonatremic recipients (overall: HR 1.85; 95% CI, 1.25-2.73; P<0.002; 90 days: HR 1.12; 95% CI, 0.55-2.29; P=0.8), whereas mildly hyponatremic recipients ([Na] 130-134 meq/L, n=1,127) had similar risk-adjusted mortality to those with normal [Na] at the same time points. In conclusion, recipient [Na] is an independent predictor of death following liver transplantation. Attempts to correct the [Na] toward the normal reference range are an important aspect of pretransplantation management.     

Where's the Beef? The Promise and the Reality of Clinical Documentation

Physician-generated emergency department clinical documentation (information obtained from clinician observations and summarized decision processes inclusive of all manner of electronic systems capturing, storing, and presenting clinical documentation) serves four purposes: recording of medical care and communication among providers; payment for hospital and physician; legal defense from medical negligence allegations; and symptom/disease surveillance, public health, and research functions. In the consensus development process described by Handler, these objectives were balanced with the consideration of efficiency, often evaluated as physician time and clinical documentation system costs, in recording the information necessary for their accomplishment. The consensus panel session participants and authors recommend that 1) clinical documentation be electronically retrievable; 2) selection and implementation be evidence-based and grounded on valid metrics (research is needed to identify these metrics); 3) the user interface be crafted to promote clinical excellence through high-quality information collection and efficient charting techniques; 4) the priorities for integration of clinical information be standardized and implemented within enterprises and across health and information systems; 5) systems use accepted standards for bidirectional, real-time clinical data exchange, without limiting the location or number of simultaneous users; 6) systems fully utilize existing electronic sources of specific patient information and general medical knowledge; 7) systems automatically and reliably capture appropriate data that support electronic billing for emergency department services; and 8) systems promote bedside documentation and mobile access.     

Brucellosis of the spine

Eight cases of spinal brucellosis are included in this study. Diagnosis was established by positive serology. Back pain was the most common complaint. Functional disturbance in walking was observed in three cases; in two others this was because of impairment of cord function. Clinical hepatosplenomegaly was found in one case. Subclinical organomegaly was diagnosed in two other patients. Psoas abscess was identified by computed tomographic scan in two separate cases. Response to drug therapy and surgical decompression, when indicated, resulted in complete recovery in all patients.     

Sustained Release Coprecipitates and Matrix Tablets of Ibuprofen with Polyacrylic Resin Ⅱ:Formulation and in vitro Evaluation

将药物及高分子材料溶于乙醇后边搅拌边加入非溶剂制成布洛芬－聚丙烯酸树脂Ⅱ共沉淀物。通过Ａ、Ｂ两种方法并以不同的药物－聚丙烯酸树脂Ⅱ比例制成了共沉淀物，再以这些共沉淀物直接压片制成骨架片。通过差热分析（ＤＳＣ）、扫描电镜（ＤＳＣ）及红外光谱（ＩＲ）研究了共沉淀物的性质。研究主要集中在处方中高分子材料所占的比例，溶出介质的ｐＨ及制备共沉淀物的方法对布洛芬从骨架中释放的影响。体外溶出实验分别在不同的ｐＨ条件下进行。处方研究表明随着聚丙烯酸树脂Ⅱ用量的增加，药物的释放过程显著延长。另外，增加溶出介质的ｐＨ会显著增加药物的累积释放百分数。此外实验还表明以方法Ｂ制成的共沉淀物的骨架片中药物的累积释放百分数要高于Ａ法制成的骨架片，然而方法Ａ中制得的骨架片中药物的释放却更接近于线性释放。