Penetrating Missile Injuries During the Iraqi Insurgency

INTRODUCTION

Since the invasion of Iraq in 2003, the conflict has evolved from asymmetric warfare to a counter-insurgency operation. This study investigates the pattern of wounding and types of injuries seen in casualties of hostile action presenting to a British military field hospital during the present conflict.

PATIENTS AND METHODS

Data were prospectively collected on 100 consecutive patients either injured or killed from hostile action from January 2006 who presented to the sole coalition field hospital in southern Iraq.

RESULTS

Eighty-two casualties presented with penetrating missile injuries from hostile action. Three subsequently died of wounds (3.7%). Forty-six (56.1%) casualties had their initial surgery performed by British military surgeons. Twenty casualties (24.4%) sustained gunshot wounds, 62 (75.6%) suffered injuries from fragmentation weapons. These 82 casualties were injured in 55 incidents (mean, 1.49 casualties; range 1–6 casualties) and sustained a total 236 wounds (mean, 2.88 wounds) affecting a mean 2.4 body regions per patient. Improvised explosive devices were responsible for a mean 2.31 casualties (range, 1–4 casualties) per incident.

CONCLUSIONS

The current insurgency in Iraq illustrates the likely evolution of modern, low-intensity, urban conflict. Improvised explosive devices employed against both military and civilian targets have become a major cause of injury. With the current global threat from terrorist bombings, both military and civilian surgeons should be aware of the spectrum and emergent management of the injuries caused by these weapons.     

Advancing pharmacovigilance through academic–legal collaboration: the case of gadolinium-based contrast agents and nephrogenic systemic fibrosis—a research on adverse drug events and reports (RADAR) report

Objective:

To compare and contrast three databases, that is, The International Centre for Nephrogenic Systemic Fibrosis Registry (ICNSFR), the Food and Drug Administration Adverse Event Reporting System (FAERS) and a legal data set, through pharmacovigilance and to evaluate international nephrogenic systemic fibrosis (NSF) safety efforts.

Methods:

The Research on Adverse Drug events And Reports methodology was used for assessment—the FAERS (through June 2009), ICNSFR and the legal data set (January 2002 to December 2010). Safety information was obtained from the European Medicines Agency, the Danish Medicine Agency and the Food and Drug Administration.

Results:

The FAERS encompassed the largest number (n = 1395) of NSF reports. The ICNSFR contained the most complete (n = 335, 100%) histopathological data. A total of 382 individual biopsy-proven, product-specific NSF cases were analysed from the legal data set. 76.2% (291/382) identified exposure to gadodiamide, of which 67.7% (197/291) were unconfounded. Additionally, 40.1% (153/382) of cases involved gadopentetate dimeglumine, of which 48.4% (74/153) were unconfounded, while gadoversetamide was identified in 7.3% (28/382) of which 28.6% (8/28) were unconfounded. Some cases involved gadobenate dimeglumine or gadoteridol, 5.8% (22/382), all of which were confounded. The mean number of exposures to gadolinium-based contrast agents (GBCAs) was gadodiamide (3), gadopentetate dimeglumine (5) and gadoversetamide (2). Of the 279 unconfounded cases, all involved a linear-structured GBCA. 205 (73.5%) were a non-ionic GBCA while 74 (26.5%) were an ionic GBCA.

Conclusion:

Clinical and legal databases exhibit unique characteristics that prove complementary in safety evaluations. Use of the legal data set allowed the identification of the most commonly implicated GBCA.

Advances in knowledge:

This article is the first to demonstrate explicitly the utility of a legal data set to pharmacovigilance research.Nephrogenic systemic fibrosis (NSF) induces cutaneous and subcutaneous “scleroderma-like” changes with acute-onset thickening and hardening of the skin.¹ This condition was first reported in 2000 as a debilitating disorder in persons with chronic kidney disease (CKD) who were on dialysis.^1–11 Although initially named “nephrogenic fibrosing dermopathy”, since the condition seemed to be limited to the skin, it is now well documented that lesions extend beyond the dermis and can involve the joints, skeletal muscles, testes, kidney, myocardium and dura.^12–14 Currently, the diagnosis is made by clinicopathological correlation.¹⁵ Major clinical diagnostic criteria include patterned plaques of bound-down skin, sometimes leading to a “peau d''orange” appearance, overlying hard subcutaneous tissue on the extremities, at times extending to the lower trunk and leading to joint contractures.^15,16 Histologically, dermal changes include increased cellularity with numerous spindle-shaped fibroblasts, CD34⁺ tram tracks, thick collagen bundles with surrounding clefts, mucin deposition and retention of elastic fibres extending into widened subcutaneous septae. Electron microscopy has identified increased elastic fibres apposed to dendritic cell processes.¹⁷ Although information regarding gadolinium exposure is not necessary for the diagnosis of NSF, it is highly recommend that this information be sought to better clarify the role of prior gadolinium exposure in the pathogenesis of NSF.¹⁵ Cardiac, vascular and nervous system complications have been reported as NSF can have systemic fibrotic effects.^18–21Gadolinium-based contrast agents (GBCAs) are gadolinium chelates and may be divided into four classes: linear vs macrocyclic and ionic vs non-ionic. Linear, non-ionic GBCAs have predominantly been implicated in the development of NSF (16 In 2007, the European Medicines Agency (EMA) mandated that only protein-binding linear agents (intermediate risk group) and macrocyclic formulations be used in patients with Stage 4 or 5 CKD. In 2007, the Food and Drug Administration (FDA) required that a “boxed warning” be placed on each of the five FDA-approved GBCAs.²² No differentiation was made between the various agents as to the strength of their associations with NSF. In one reported series of 36 patients, more than half of the patients with NSF died from NSF or underlying comorbidities within 18 months of diagnosis.²³

Table 1.

Identification of the different gadolinium-based contrast agents