Initial Clinical Testing Research Articles

Initial clinical experience with the MammoSite breast brachytherapy applicator in women with early-stage breast cancer treated with breast-conserving therapy

Purpose: We present the results of the initial clinical testing of the MammoSite balloon breast brachytherapy applicator in women with early-stage breast cancer treated with breast-conserving therapy. Methods and Materials: Seventy patients were enrolled in a multicenter prospective trial testing the applicator for safety and performance. Fifty-four patients were implanted, and 43 patients were ultimately eligible for and received brachytherapy as the sole radiation modality after lumpectomy. Patients were staged T1N0M0 with negative pathologic margins and age >45 years. A dose of 34 Gy was delivered in 10 fractions over 5 days prescribed to 1 cm from the applicator surface using 192Ir high-dose-rate brachytherapy. A minimum skin-to-balloon surface distance of 5 mm was required for treatment. Device performance, complications, and cosmesis were assessed. Results: Computed tomography imaging post-balloon inflation showed 8, 14, and 21 patients with 5–6 mm, 7–9 mm, and >10 mm of skin spacing, respectively. Two patients were explanted because of inadequate skin spacing and 7 because of suboptimal conformance of the surgical cavity to the applicator balloon. One patient was explanted because of positive nodal status and another because of age. The most common side effects related to device placement included mild erythema, drainage, pain, and echymosis. No severe side effects related to implantation, brachytherapy, or explantation occurred. Side effects related to radiation therapy were generally mild with erythema, pain, and dry desquamation being the most common. At 1 month, 88% of patients were evaluated as having good-to-excellent cosmetic results. Conclusions: The MammoSite balloon breast brachytherapy applicator performed well clinically. All eligible patients completed treatment. Side effects were mild to moderate and self-limiting. Skin-balloon surface distance and balloon-cavity conformance were the main factors limiting the initial use of the device.

Cyclin-dependent kinase modulators studied at the NCI: pre-clinical and clinical studies.

The cyclin dependent kinases (CDKs) are key regulators of cell cycle progression. Lead compounds (from empirical anti-proliferative screening approaches) have been defined which modulate CDK function and have evidence of anti-proliferative activity in tissue culture systems and in some cases anti-tumor activity in vivo in conventional xenogaft models. Two of these, flavopiridol and UCN-01, have entered initial clinical testing. Flavopiridol is a "pan-CDK" inhibitor, with essentially equal potency in inhibiting all CDKs tested. The recent elucidation that in addition to cell cycle regulatory functions, CDK family members have been defined which regulate transcription, neuronal, and secretory function has increased the need for definition of CDK antagonists with greater selectivity. Novel purine, pyrimidine, and benzazepinone derivatives have been characterized in part through the National Cancer Institute's drug screening systems. UCN-01, in contrast to flavopiridol, modulates CDK activity participating in the DNA damage response, possibly through potent inhibition of the chk1 checkpoint kinase, as well as affecting CDK function indirectly through activity on other kinase targets. An unexpected feature in its development has been avid binding to alpha(1) acid glycoprotein. Further progress in CDK modulator development will require the definition of additional lead structures that address issues raised by these early molecules entering into clinical development.

Reproducibility of volume-adjusted bone mineral density of spine and hip from dual X-ray absorptiometry.

Skeletal size has a confounding effect on areal bone mineral density (aBMD) related to differences in skeletal volume. Several methods have been proposed for calculating volumetric BMD (vBMD), but in vivo precision data are limited for the spine and have not been published for the hip. We prospectively performed duplicate dual X-ray absorptiometry measurements of the anteroposterior spine and hip (n = 121) in a diverse female population referred for initial clinical BMD testing. Each scan pair was performed and analyzed by two different technologists (mean interval of 4 d) to obtain standard aBMD. Scan data were reprocessed at a later date to calculate vBMD for the lumbar spine (L2-L4), femoral neck, and total hip in the 87 spines and 82 hips for which we had complete analyzable scan data. We found much worse precision in femoral neck volume (5.2% coefficient of variation [CV]) than in spine volume (2.6% CV; p < 0.003). This contributed to greater error in femoral neck vBMD (3.9% CV) than aBMD (2.3= CV; p < 10(-6)). Total hip aBMD had better precision than vBMD (1.0 and 1.3-2.5% CV; p < 10(-5)). The reverse pattern was seen in the spine with slightly better precision for vBMD than aBMD (1.1 and 1.5% CV; p < 0.002). Volumetric measures of lumbar spine density can be obtained with high precision. Because of poor reproducibility in the femoral neck, the total hip region may be preferable for measuring volumetric bone density in the proximal femur.

Acute cardiac ischemia in patients with cocaine-associated complaints: Results of a multicenter trial*1

<h2>Abstract</h2> <b>Study Objective:</b> To describe the characteristics of a large group of patients who presented to emergency departments with cocaine-associated symptoms consistent with acute cardiac ischemia (ACI) and to determine the incidence of confirmed ACI including acute myocardial infarction (AMI) in this population. <b>Methods:</b> We performed a substudy on all patients in a multicenter prospective clinical trial (the Acute Cardiac Ischemia–Time Insensitive Predictive Instrument [ACI-TIPI] Clinical Trial) that enrolled ED patients with chest pain or other symptoms consistent with ACI including subjects with identified cocaine use. Demographic and clinical features, including initial and follow-up clinical data, ECGs, and tests to determine serum creatine kinase isoenzyme MB subunit concentrations, were analyzed. Diagnoses of AMI followed the World Health Organization criteria for AMI and of angina pectoris, the Canadian Cardiovascular Society Classification. <b>Results:</b> Of the 10,689 patients enrolled in the trial, 293 (2.7%) had cocaine-associated complaints. Among the 10 participating hospitals, the incidence of patients with cocaine-associated symptoms varied from 0.3% to 8.4%. Only 6 patients (2.0%, 95% confidence interval [CI] 0.76% to 4.4%) had a diagnosis of ACI; 4 (1.4%, 95% CI 0.37% to 3.5%) had unstable angina, and 2 (0.7%, 95% CI 0.08% to 2.4%) had AMI. Although patients with cocaine-induced complaints were as likely to be admitted to the coronary care unit compared with all study patients without cocaine use (14% versus 18%, <i>P</i> =.14, difference not significant), these patients were much less likely to have confirmed unstable angina (1.4% versus 9.3%, <i>P</i> <.001) or AMI (0.7% versus 8.6%, <i>P</i> <.001). Compared with patients younger than 45 years, patients with cocaine usage were more likely to be admitted to the ICU (14% versus 8.0%, <i>P</i> =.0018) but less likely to have confirmed AMI (0.7% versus 2.8%, <i>P</i> =.033). <b>Conclusion:</b> Patients presenting to EDs with cocaine-associated chest pain or related symptoms infrequently had ACI, and even less so, AMI. This suggests the need for selectivity in the hospitalization of patients with such cocaine-associated symptoms. [Feldman JA, Fish SS, Beshansky JR, Griffith JL, Woolard RH, Selker HP. Acute cardiac ischemia in patients with cocaine-associated complaints: results of a multicenter trial. <i>Ann Emerg Med.</i> November 2000;36:469-476.]

Acute cardiac ischemia in patients with cocaine-associated complaints: Results of a multicenter trial

Study Objective: To describe the characteristics of a large group of patients who presented to emergency departments with cocaine-associated symptoms consistent with acute cardiac ischemia (ACI) and to determine the incidence of confirmed ACI including acute myocardial infarction (AMI) in this population. Methods: We performed a substudy on all patients in a multicenter prospective clinical trial (the Acute Cardiac Ischemia–Time Insensitive Predictive Instrument [ACI-TIPI] Clinical Trial) that enrolled ED patients with chest pain or other symptoms consistent with ACI including subjects with identified cocaine use. Demographic and clinical features, including initial and follow-up clinical data, ECGs, and tests to determine serum creatine kinase isoenzyme MB subunit concentrations, were analyzed. Diagnoses of AMI followed the World Health Organization criteria for AMI and of angina pectoris, the Canadian Cardiovascular Society Classification. Results: Of the 10,689 patients enrolled in the trial, 293 (2.7%) had cocaine-associated complaints. Among the 10 participating hospitals, the incidence of patients with cocaine-associated symptoms varied from 0.3% to 8.4%. Only 6 patients (2.0%, 95% confidence interval [CI] 0.76% to 4.4%) had a diagnosis of ACI; 4 (1.4%, 95% CI 0.37% to 3.5%) had unstable angina, and 2 (0.7%, 95% CI 0.08% to 2.4%) had AMI. Although patients with cocaine-induced complaints were as likely to be admitted to the coronary care unit compared with all study patients without cocaine use (14% versus 18%, P =.14, difference not significant), these patients were much less likely to have confirmed unstable angina (1.4% versus 9.3%, P <.001) or AMI (0.7% versus 8.6%, P <.001). Compared with patients younger than 45 years, patients with cocaine usage were more likely to be admitted to the ICU (14% versus 8.0%, P =.0018) but less likely to have confirmed AMI (0.7% versus 2.8%, P =.033). Conclusion: Patients presenting to EDs with cocaine-associated chest pain or related symptoms infrequently had ACI, and even less so, AMI. This suggests the need for selectivity in the hospitalization of patients with such cocaine-associated symptoms. [Feldman JA, Fish SS, Beshansky JR, Griffith JL, Woolard RH, Selker HP. Acute cardiac ischemia in patients with cocaine-associated complaints: results of a multicenter trial. Ann Emerg Med. November 2000;36:469-476.]

Sniffing out the truth: clinical diagnosis using the electronic nose.

Recently the use of smell in clinical diagnosis has been rediscovered due to major advances in odour sensing technology and artificial intelligence (AI). It was well known in the past that a number of infectious or metabolic diseases could liberate specific odours characteristic of the disease stage. Later chromatographic techniques identified an enormous number of volatiles in human clinical specimens that might serve as potential disease markers. "Artificial nose" technology has been employed in several areas of medical diagnosis, including rapid detection of tuberculosis (TB), Helicobacter pylori (HP) and urinary tract infections (UTI). Preliminary results have demonstrated the possibility of identifying and characterising microbial pathogens in clinical specimens. A hybrid intelligent model of four interdependent "tools", odour generation "kits", rapid volatile delivery and recovery systems, consistent low drift sensor performance and a hybrid intelligent system of parallel neural networks (NN) and expert systems, have been applied in gastric, pulmonary and urine diagnosis. Initial clinical tests have shown that it may be possible in the near future to use electronic nose technology not only for the rapid detection of diseases such as peptic ulceration, UTI, and TB but also for the continuous dynamic monitoring of disease stages. Major advances in information and gas sensor technology could enhance the diagnostic power of future bio-electronic noses and facilitate global surveillance models of disease control and management.

Ergonomic Surgeon's Chair for Use During Minimally Invasive Surgery

The characteristic working situation in laparoscopic surgery involves elongated instruments and limited mobility of the surgeon during the operation. These circumstances require new technical solutions to enhance the surgeon's comfort. In other surgical fields with special ergonomic situations, such as microsurgery, some surgeons prefer to operate from a seated position at the operating room table. We developed a new surgeon's chair dedicated to the ergonomic and functional requirements of laparoscopic surgery. The chair allows the surgeon to maintain a semi-standing position during the operation. Foot pedals for high frequency and suction/irrigation are integrated into the base of the chair. The pedals are purposely aligned to be comparable to foot pedals in a car. The chair is driven by electromotors, controlled with a special foot switch that operates independent of assisting personnel during surgery. Initial clinical testing of the chair could prove the theory that supporting the surgeon with a cockpit type of operating room chair helps to avoid fatigue during long endoscopic procedures. Such assistance is especially important in combination with robotic devices for use during solo surgery.

Real-time endoscopic fluorescence imaging for early cancer detection in the gastrointestinal tract

The utility of autofluorescence imaging for early lung cancer detection has been previously demonstrated. The aim of this work is to extend the use of real-time autofluorescence imaging to the early cancer detection in the esophagus, stomach, and colon. A prototype fluorescence imaging system for the gastrointestinal (GI) tract was developed which produces real-time video images of tissue autofluorescence. It consists of a filtered mercury arc lamp light source, two intensified charge coupled device (ICCD) cameras, a fiber optic endoscope, and a computer-based control console. The system is capable of working with three different imaging modalities: (1) conventional white light imaging mode; (2) light induced fluorescence (LIF) imaging mode based on the fluorescence imaging of two wavelength bands (green and red); and (3) light induced fluorescence and reflectance (LIFR) imaging mode based on the combination of a green band fluorescence image and a red–near-IR reflectance image. The imaging wavelength bands were selected based on in vivo fluorescence spectroscopic studies. The fluorescence images (both LIF image and LIFR image) clearly delineate the abnormal tissue areas for biopsy. Early cancer sites are better visualized under fluorescence imaging than under conventional white light examination. Initial clinical tests demonstrated the usefulness of the imaging prototype system for early cancer detection in the GI tract.

Real‐time endoscopic fluorescence imaging for early cancer detection in the gastrointestinal tract

The utility of autofluorescence imaging for early lung cancer detection has been previously demonstrated. The aim of this work is to extend the use of real-time autofluorescence imaging to the early cancer detection in the esophagus, stomach, and colon. A prototype fluorescence imaging system for the gastrointestinal (GI) tract was developed which produces real-time video images of tissue autofluorescence. It consists of a filtered mercury arc lamp light source, two intensified charge coupled device (ICCD) cameras, a fiber optic endoscope, and a computer-based control console. The system is capable of working with three different imaging modalities: (1) conventional white light imaging mode; (2) light induced fluorescence (LIF) imaging mode based on the fluorescence imaging of two wavelength bands (green and red); and (3) light induced fluorescence and reflectance (LIFR) imaging mode based on the combination of a green band fluorescence image and a red–near-IR reflectance image. The imaging wavelength bands were selected based on in vivo fluorescence spectroscopic studies. The fluorescence images (both LIF image and LIFR image) clearly delineate the abnormal tissue areas for biopsy. Early cancer sites are better visualized under fluorescence imaging than under conventional white light examination. Initial clinical tests demonstrated the usefulness of the imaging prototype system for early cancer detection in the GI tract.

Cancer gene therapy: connecting basic research with clinical inquiry.

Molecular genetics has spawned an impressive outpouring of insights into the biology of neoplastic transformation and the host-tumor relationship. This deeper understanding of cancer pathogenesis presents a rich opportunity to develop novel therapeutic agents with improved selectivity for cancer cells. One promising approach involves gene therapy, which is the introduction of genetic material into a patient's tissues with the intent to achieve therapeutic benefit. A number of gene transfer systems have been designed that enable the genetic modification of relevant target cells, albeit with varying strengths and limitations. Several strategies to exploit gene transfer as a tool to target specific molecular defects intrinsic to cancer cells, enhance tumor chemosensitivity, and augment tumor immunogenicity are under intensive investigation. A number of these approaches have entered initial clinical testing and already provide intriguing new information about the biology of cancer in patients. In this review, I will highlight the critical issues and controversies that underscore preclinical experiments in cancer gene therapy, discuss some of the preliminary findings from the first wave of clinical trials, and speculate about the prospects that cancer gene therapy will change the way that cancer medicine is practiced.

Advances in Antiplatelet Therapy in Coronary Artery Disease: Importance of the Platelet GPIIb/IIIa Receptor

It is now widely agreed that platelets are intimately involved in and contribute to the pathogenesis of acute coronary thrombosis. Aspirin, a relatively weak inhibitor of platelet activation, saves lives when administered early after acute myocardial infarction and should be routinely used as lifelong therapy in patients with coronary atherosclerosis. Ticlopidine has a mechanism of action distinct from and additive to that of aspirin; it inhibits activation of platelets mediated by the agonist, adenosine diphosphate (ADP). The reduction in subacute coronary thrombosis attained by the use of combination therapy with aspirin and ticlopidine (for 2–4 weeks) after intracoronary stenting is further evidence of the role of platelets in mediating acute arterial thrombosis. Potent platelet agonists (like thrombin) can override the effect of aspirin and ticlopidine; therefore these agents are of limited efficacy. In contrast, inhibitors of the platelet glycoprotein (GP) IIb/IIIa receptor are potentially more potent inhibitors of adhesive platelet interaction and may therefore be effective in blocking adhesive platelet interactions irrespective of the activating agonist. The GPIIb/IIIa receptor mediates the bridging of platelets (platelet aggregation) via fibrinogen, thus allowing platelet to bind other platelets at the injured vessel wall. Antagonists of this receptor are thus capable of blocking the “effector function” by acting at a step that is downstream to platelet activation. By abrogating the final common pathway of platelet aggregation, antagonists of GPIIb/IIIa also affect the most proximal step in thrombin generation (that most efficiently occurs on the membrane surface provided by platelets). Accordingly, these agents can profoundly inhibit arterial thrombosis. The clinical use of the antibody fragment directed against the GPIIb/IIIa receptor (c7E3 Fab) has truly revolutionized the practice of interventional cardiology and has the potential to effectively treat heparin‐resistant intracoronary thrombosis. Synthetic antagonists of fibrinogen binding to the GPIIb/IIIa receptor (the “fibans”) are currently under initial clinical testing.

Insuficiencia mitral que simula una estenosis aórtica

We report a patient with a mitral insufficiency due to myxomatous valve change, with a regurgitation murmur heard principally at aortic area and radiating to the neck base. Even though the topography of the murmur seemed to suggest aortic stenosis, the other auscultation findings and the initial clinical tests clearly supported its source in a mitral insufficiency. The echocardiography allowed us not only to confirm our suspicion, but also to explain this auscultation finding mechanism, to show a severe mitral insufficiency with a anterior and medial jet, which struck the aorta and atrial septum. The surgery found a clear aortic vibration, which disappeared after implanting the mitral protheses. Our case illustrates the value of new diagnostic image techniques to complement the semiologic findings.

Pulsed Delivery of Inhaled Nitric Oxide to Patients With Primary Pulmonary Hypertension: An Ambulatory Delivery System and Initial Clinical Tests

Inhaled nitric oxide (NO) has been shown to be a selective pulmonary vasodilator in certain patients with primary pulmonary hypertension (PPH).The purpose of this study was to design and test a system for delivery of NO to awaken, ambulatory patients with PPH and to evaluate this system in the home setting.The ambulatory delivery system consisted of a tank of 80 ppm of NO (balance N2), a modified gas-pulsing device, and nasal cannulas. The pulsing device was set to deliver NO for 0.1 s at the beginning of each inspiration.Using this system, eight patients with PPH were studied with pulmonary artery catheters in place. Inhalation of NO led to significant reductions in both mean pulmonary arterial pressure (PAPm) (51 +/-12 to 43 +/- 10 mm Hg; p=0.001) and pulmonary vascular resistance (PVR) (790 +/- 285 to 620 +/- 208 dyne x s x cm-5; p=0.01). Three of the eight patients had both greater than 20% and greater than 30% decreases in PAPm and PVR, respectively. No exhaled NO or N02 was detectable in any of the eight patients. One patient was discharged home from the hospital on a regimen of inhaled NO. At 9 months, no adverse effects were noted and the system was working well.Pulsed delivery of inhaled NO to ambulatory patients with PPH, via nasal prongs, is feasible and, in some patients, leads to significant improvement in pulmonary hypertension. Inhaled 09NO, therefore, may have a role in the long-term treatment of patients with PPH.

Enhanced transdermal delivery of testosterone: a new physiological approach for androgen replacement in hypogonadal men

This report describes the rationale, development and initial clinical testing of a new modality for the treatment of hypogonadal men — an enhanced transdermal delivery system (TDS) for administering native testosterone. In contrast to the experimental trans-scrotal testosterone patches, the enhanced testosterone TDS can be applied to non-scrotal skin sites, such as the back, chest, arms, etc. A one-month pilot study in six hypogonadal men shows that the nightly application of two patches (for 24 h) delivers ~ 4 to 7 mg of testosterone per day, and produces testosterone plasma levels that closely mimic the magnitude and time course of the normal circadian rhythm seen in healthy young men. Moreover, the enhanced delivery of testosterone across non-scrotal skin, is not associated with any appreciable degree of transdermal first-pass metabolism, and therefore produces physiological levels and patterns of dihydrotestosterone (DHT) and estradiol (E 2). In all but one subject, skin tolerability has been acceptable. During 7 months of treatment in two patients, hormone levels have remained within the normal range, tolerability has been good, and subjective improvements in sexual function and well being have been reported. In comparison to other available methods of androgen replacement therapy (i.e. testosterone-ester injections, synthetic oral agents and testosterone pellet implants), we believe that the enhanced transdermal delivery of native testosterone promises to be a more physiological and patient-friendly approach for the treatment of hypogonadal men.

A new method of tooth replantation and autotransplantation: Aluminum oxide ceramic for extraoral retrograde root filling

After an initial clinical test phase, the new method of replantation and transplantation with the use of aluminum oxide ceramic for retrograde root filling may be viewed as possible differential indications to other methods, even to apicectomy in the molar region. Twenty-three of the twenty-five replantations and eight of the nine transplantations may be regarded as having been successful. Contraindications are cases of wide apical foramina and oval or octagonal root canal cross sections.

Gamekeepers thumb: A prospective study of functional bracing

Patients with acute thumb metacarpophalangeal joint injuries were assessed by stress radiography, arthrography, and clinical examination. Arthrograms served to assess tissue injury by the extent and location of dye leaks including the differentiation of displaced (Stener lesion) from undisplaced tears of the ulnar collateral ligament. Patients were treated for a minimum of 6 weeks by use of a removable custom-fit splint and daily range of motion exercises, and followed at a minimum of 1 year. In the 32 patients available for follow-up, mean relative instability improved from 17 degrees (after injury) to 2.3 degrees (follow-up) (p = 0.0001). Functional and subjective outcomes were good or satisfactory in more than 90% of patients; outcomes for all patients with Stener lesions were satisfactory, although joint stabilization was less than in the whole group. The three failures involved persistent symptoms, that defied subsequent surgery. These cases could not be predicted from the initial clinical tests. The treatment regimen was an economical, noninvasive, and effective method for a range of acute thumb metacarpophalangeal joint injuries.

Recovery of Vision after Presumed Direct Optic Nerve Injury

Immediate loss of light perception after direct optic nerve injury is usually irreversible. Our patient sustained presumed direct optic nerve injury because of a shotgun injury with loss of light perception, absent pupillary response, and absent visual-evoked potential. A small pupillary response was noted 12 days after injury, light perception returned by 15 days, and visual acuity was 20/100 at 4 months. A variety of pathophysiologic mechanisms may lead to visual loss after direct optic nerve injury. It is important to recognize that blindness is not always permanent in these cases despite the results of initial clinical and electrophysiologic testing.

Efficacy and safety of sustained (48 hour) intravenous infusions of milrinone in patients with severe congestive heart failure: A multicenter study

Milrinone is a new bipyridine inotrope that has shown promise in initial clinical testing when administered intravenously or orally. The present multicenter study was designed to evaluate the clinical effectiveness and safety of sustained (48 hour) intravenous infusions of different doses of milrinone, as would be used clinically, in a controlled fashion using invasive hemodynamic monitoring. Entry was limited to adult patients with chronic heart failure of functional class III or IV, with a cardiac index less than or equal to 2.5 liters/min per m2 or a pulmonary capillary wedge pressure greater than or equal to 15 mm Hg, or both. After stable baseline hemodynamic recordings were obtained, milrinone was given as loading (microgram/kg per 10 min) and maintenance infusions (microgram/kg per min) to 189 patients in one of four loading/maintenance dosage regimens: 37.5/0.375 (low dose, n = 26), 50/0.50 (intermediate dose, n = 95), 75/0.75 (high dose, n = 15) and 50/0.25 (lowest dose, n = 53). The lowest dose was shown to be ineffective for maintenance therapy. Effective individual patient responses were defined as greater than or equal to 20% increase in cardiac index or decrease in pulmonary capillary wedge pressure, or both. During early therapy (less than or equal to 3 hour), 99% of patients showed an effective maximal response, and 90% an effective mean response. An effective mean response was observed during days 1 and 2 in 80% of patients, with a positive dose-response trend (69% response, low dose; 80%, intermediate dose; 93%, high dose; day 1). Each loading regimen was effective, with maximal mean response occurring at 15 minutes. Cardiac index initially increased by an average of 24 to 42% for all patients in the three groups, whereas pulmonary capillary wedge pressure decreased by 24 to 33%. Initial decreases in systemic vascular resistance averaged 15 to 31%. Initial changes in heart rate (+4 to +13%) and mean arterial pressure (-2 to -13%) were modest. Significant mean hemodynamic responses were maintained over the 48 hours. Increases in cardiac index for days 1 and 2 averaged 38 and 39% for those completing constant low dose drug, 34 and 37% for intermediate dose and 73 and 44% for high dose. Decreases in pulmonary capillary wedge pressure for all patients averaged 18 to 32% on days 1 and 2, with little dose response. Heart rate changes were modest and variable, averaging -9 to 9%.(ABSTRACT TRUNCATED AT 400 WORDS)

Long-term effect of iodized oil on serum thyroglobulin levels in endemic goitre patients.

Serum thyroglobulin (Tg) response to bovine TSH (bTSH) was evaluated in 44 goitrous patients (grades III and IV) living in conditions of chronic iodine (I) deficiency (iodine urinary excretion less than 40 micrograms I/g) and in 26 normal subjects. After the initial clinical evaluation and laboratory tests (bTSH test, T4, T3, anti-Tg and anti-microsomal antibodies) all goitrous patients received 1 ml i.m. of iodized oil (I-oil) and were followed up for 30 months. The bTSH test was repeated at 6, 12, 20 and 30 months after I-oil in 21 subjects. A marked reduction in goitre size was observed in 85% of the patients with a concomitant significant increase in the mean serum T4 and T3 concentrations, a significant fall in the mean serum TSH level and a significant decrease in the T3/T4 ratio. Goitrous patients had elevated serum basal Tg levels (55 +/- 8 SEM micrograms/l) and a significantly mean higher peak Tg value after bTSH (200 +/- 65 micrograms/l) as compared with normal subjects (respectively, 11 +/- 1.4 and 32 +/- 3.4 micrograms/l). Larger goitres (grade IV) had a significantly higher mean peak Tg response as compared with grade III goitres. Treatment with I-oil significantly reduced the mean peak Tg response to bTSH after 6 months (59 +/- 10 micrograms/l) but at 12 and 20 months the peak Tg response after the injection rose, respectively, to 110 +/- 19 micrograms/l and 92 +/- 14 micrograms/l (P less than 0.02 as compared with 6 months), returning to the normal range only at 30 months.(ABSTRACT TRUNCATED AT 250 WORDS)

An apparatus making possible restoration of simple functions of the tetraplegic hand

In the Rehabilitation Institute at Konstancin investigations and clinical tests have been carried out over the last ten years with a view to restoring the tetraplegic hand function by means of implanted stimulation of the peripheral nerves of the upper extremity. Lately, an apparatus for a tetraplegic has been constructed, based on patient controlled stimulation of the median and radial nerves. In this report the principle of the apparatus and also the initial clinical tests are discussed. Investigations carried out so far have demonstrated that grasping function of the hand is compatible with the projected programme and that the induced function of the hand is useful for the patient.