[VAGINAL HYSTERECTOMY (CLINICO-STATISTICAL AND TECHNICAL REPORT)].
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Industrial perspective on validation of tangential flow filtration in biopharmaceutical applications. Technical Report No. 15. Parenteral Drug Association. Biotechnology Task Force on Purification and Scale-up.
Validation of tangential flow filtration is required to ensure the process delivers a product of consistent quality, safety, and efficacy. A thorough and sound validation program not only satisfies regulatory requirements, but also provides a valuable source of information which facilitates development of future processes, training of production personnel, and trouble shooting for the validated process. Validation of TFF shares many common elements with validation of other traditional operations and equipment. Existing personnel and procedures should be readily adapted to execute the TFF validation protocols. IQ's and OQ's will most likely follow familiar formats. In performance qualification, key areas needing attention include: assessment of compatibles, testing of parameters affecting membrane retention and selectivity, cleaning, sanitization, and membrane lifetime. Finally, the hallmark of a sound validation program is the quality of its scientific approach and its congruence with the definition of validation contained in the 1987 guidelines (6).
Filtration↗
NTP technical report on the toxicity studies of 2- and 4-Methylimidazole (CAS No. 693-98-1 and 822-36-6) administered in feed to F344/N rats and B6C3F1 mice.
[Structure-see text] 2-Methylimidazole and 4-methylimidazole are intermediate/starting materials or components in the manufacture of pharmaceuticals, photographic and photothermographic chemicals, dyes and pigments, agricultural chemicals, and rubber; these chemicals have been identified as undesirable by-products in several foods and have been detected in mainstream and sidestream tobacco smoke. The National Cancer Institute nominated 2- and 4-methylimidazole as candidates for toxicity and carcinogenicity studies. Toxicity studies were carried out in male and female F344/N rats and B6C3F1 mice. Animals were exposed to 2- or 4-methylimidazole in feed for 15 days or 14 weeks; clinical pathology studies were conducted in the 14-week studies on days 8, 29, and 86 and at week 14. Genetic toxicity studies were conducted in Salmonella typhimurium, rat and mouse bone marrow, and mouse peripheral blood. Groups of five male and five female rats and mice were fed diets containing 0, 1,200, 3,300, or 10,000 ppm 2-methylimidazole (equivalent to average daily doses of approximately 115, 290, or 770 mg 2-methylimidazole/ kg body weight to rats; 220, 640, or 2,100 mg/kg to male mice; 300, 800, or 2,400 to female mice) for 15 days. Groups of five male and five female rats and mice were fed diets containing 0, 300, 800, or 2,500 ppm 4-methylimidazole (equivalent to average daily doses of approximately 30, 80, or 220 mg/kg for rats and 65, 170, or 500 mg/kg for mice) for 15 days. In the 15-day 2-methylimidazole studies, all animals survived to the end of the studies. The mean body weights of 10,000 ppm male rats and female mice were significantly less than those of the controls. Feed consumption by 10,000 ppm male and female rats was reduced. Enlarged thyroid glands were observed in 3,300 and 10,000 ppm male and female rats. The incidences of diffuse hyperplasia of follicular cells of the thyroid gland in 3,300 and 10,000 ppm male and female rats and pars distalis hypertrophy of the pituitary gland in 3,300 and 10,000 ppm males and 10,000 ppm females were increased compared to the controls. In all exposed groups of male and female mice, the incidences and severities of follicular cell hypertrophy of the thyroid gland and the severities of hematopoietic cell proliferation of the spleen generally increased with increasing exposure concentration. In the 4-methylimidazole studies, all animals survived to the end of the studies, and there were no significant differences in mean body weights, clinical findings, organ weights, or gross or microscopic lesions between exposed and control groups. Groups of 10 male and 10 female rats and mice were fed diets containing 0, 625, 1,250, 2,500, 5,000, or 10,000 ppm 2- or 4-methylimidazole (equivalent to average daily doses of approximately 40, 80, 160, 300, or 560 mg/kg 2- or 4-methylimidazole to rats; and 100, 165, 360, 780, or 1,740 mg/kg 2-methylimidazole or 100, 240, 440, 915, or 1,840 mg/kg 4-methylimidazole to male mice; and 90, 190, 400, 800, or 1,860 mg/kg 2-methylimidazole or 110, 240, 540, 1,130, or 3,180 mg/kg 4-methylimidazole to females) for 14 weeks. All animals survived to the end of the 14-week 2-methylimidazole studies. Compared to the controls, the mean body weights were significantly decreased in groups of male rats and mice exposed to 2,500 ppm or greater and in 5,000 and 10,000 ppm female rats and mice. In rats, 2-methylimidazole induced a transient erythrocytosis in females and a minimal, exposure concentration-related, microcytic, normochromic, nonresponsive anemia. 2-Methylimidazole increased thyroid-stimulating hormone concentrations and decreased thyroxine and triiodothyronine concentrations of male and female rats in an exposure concentration-related manner. 2-Methylimidazole induced a mild to moderate, exposure concentration-related, macrocytic, hyperchromic, responsive anemia in mice. Triiodothyronine concentrations were increased in exposed male and female mice, and thyroxine concentrations were decreased in exposed females. Relative to the control groups, clinical chemistry evaluations on day 29 and at week 14 identified decreases in alanine aminotransferase concentrations and total protein and albumin concentrations of rats. In the 2-methylimidazole studies, absolute spleen weights were significantly increased in all exposed groups of male rats. The heart and liver weights were increased in all exposed groups of male mice, as were the spleen weights of female mice exposed to 2,500 ppm or greater. Spermatid heads per testis and mean spermatid count were significantly decreased in 10,000 ppm male rats. The estrous cycle of 10,000 ppm female rats was significantly increased. Gross pathology observations included enlarged thyroid glands, small uteri, and mottled spleen in 5,000 and 10,000 ppm mice. The incidences of diffuse follicular cell hyperplasia of the thyroid gland were significantly increased in male rats exposed to 1,250 ppm or greater and female rats exposed to 2,500 ppm or greater. The incidence of testicular degeneration was significantly increased in 10,000 ppm male rats, and two males in the 10,000 ppm group had follicular cell adenoma of the thyroid gland. In mice, there were generally significant increases in the incidences of follicular cell hypertrophy of the thyroid gland, hematopoietic cell proliferation of the spleen, and hemosiderin pigmentation of the renal tubule in males exposed to 1,250 ppm or greater and females exposed to 2,500 ppm or greater. In the 14-week 4-methylimidazole studies, one 10,000 ppm male mouse was found dead during week 4, and seven 10,000 ppm female mice were found dead during weeks 1 and 2. Mean body weights were significantly less than those of the controls for male rats exposed to 2,500 ppm or greater, 5,000 and 10,000 ppm female rats, male mice exposed to 1,250 ppm or greater, and all exposed groups of female mice. Reduced feed consumption was observed in 5,000 and 10,000 ppm male and female rats. Clinical findings included nasal/eye discharge, ruffled fur, thinness, ataxia, and abnormal breathing in rats, and ruffled fur and dull coats in female mice. On days 29 and 82, functional observations in 5,000 and 10,000 ppm rats included labored or increased respiration, mild tremors, walking on tiptoes, hunched posture, piloerection, crouching over, impaired coordination of movement, ataxia, and pupillary constriction. 4-Methylimidazole induced a transient erythrocytosis and a minimal, exposure concentration-related, microcytic, normochromic, nonresponsive anemia in male and female rats. Clinical chemistry evaluations generally showed a cholestatic effect in exposed male and female rats. At week 14, there was a significant decrease in total protein and albumin concentrations of female rats exposed to 5,000 or 10,000 ppm. In mice, 4-methylimidazole induced a macrocytic, hyperchromic, responsive anemia and, particularly in males, increases in triiododthyronine concentrations and transient decreases in thyroxine concentrations. In the 4-methylimidazole studies, the liver weights of male rats exposed to 2,500 ppm or greater were significantly increased; spleen weights of female rats exposed to 2,500 ppm or greater were decreased. The absolute liver weight was decreased in 10,000 ppm male mice, and relative weights were significantly increased in all exposed groups of mice. In female mice, there was a significant decrease in the absolute weights and increase in the relative weights of the heart, right kidney, and liver in groups exposed to 2,500 ppm or greater. The epididymal spermatozoal concentration was significantly increased in 5,000 ppm male rats. Gross pathology observations included pale livers in male rats exposed to 2,500 ppm or greater and small testes and uteri in 10,000 ppm male and female rats. Microscopic analysis identified significantly increased incidences of cytoplasmic hepatocyte vacuolization of the liver of male rats exposed to 2,500 ppm or greater and 10,000 ppm female rats, hypospermia of the epididymis in 10,000 ppm male rats, atrophy and inflammation of the prostate gland in 10,000 ppm male rats, and degeneration of the testes in 5,000 and 10,000 ppm male rats. 2-Methylimidazole and 4-methylimidazole were negative in the S. typhimurium mutation assay when tested in strains TA97, TA98, TA100, and TA1535, with and without S9 activation enzymes. Testing of 2-methylimidazole in vivo for induction of chromosomal damage, as measured by micronucleated erythrocyte frequency, produced mixed results. When administered by intraperitoneal injection three times at 24-hour intervals, 2-methylimidazole produced negative results in bone marrow micronucleus tests in rats and mice. However, in the 14-week study of 2-methylimidazole, a significant exposure-related increase in the frequency of micronucleated normochromatic erythrocytes was noted in peripheral blood of male and female mice. In vivo, 4-methylimidazole produced uniformly negative results in three-injection bone marrow micronucleus tests in rats and mice and in 14-week peripheral blood micronucleus tests in male and female mice.
Animals↗
NTP technical report on the toxicology and carcinogenesis studies of propylene glycol mono-t-butyl ether (CAS No. 57018-52-7) in F344/N rats and B6C3F1 mice and a toxicology study of propylene glycol mono-t-butyl ether in male NBR rats (inhalation studies).
BACKGROUND: Propylene glycol mono-t-butyl ether is used as a solvent in all-purpose cleaners, inks, and nail polish lacquers. We studied the effects of propylene glycol mono-t-butyl ether on male and female rats to identify potential toxic or cancer-related hazards to humans. METHODS: We exposed groups of male and female rats and mice to air containing vapors of propylene glycol mono-t-butyl ether at concentrations of 75, 300, or 1,200 parts per million (ppm) for 6 hours per day, 5 days a week for 2 years. Untreated control animals were housed in similar exposure chambers but without chemical exposure for comparison. Tissues from more than 40 sites were examined for every animal. RESULTS: Rats receiving 1,200 ppm propylene glycol mono-t-butyl ether weighed less on average than the control animals. Tumors were seen in the liver and kidney of a few male rats exposed to propylene glycol mono-t-butyl ether. No increases in the numbers of tumors were seen in female rats. In male and female mice there were large increases in the numbers of liver tumors compared with the control animals. CONCLUSIONS: We conclude that propylene glycol mono-t-butyl ether caused cancer in the liver of male and female mice. Propylene glycol mono-t-butyl ether did not cause cancer in female rats, and its effect on the liver and kidney of male rats was considered uncertain.
Administration, Inhalation↗
NTP technical report on the toxicity studies of 1,1,2,2-tetrachloroethane (CAS No. 79-34-5) administered in microcapsules in feed to F344/N rats and B6C3F1 mice.
BACKGROUND: 1,1 ,2,2-Tetrachloroethane was widely used in the production of solvents and pesticides. Its production ended in the 1990s, but it is a major component of waste sites. We studied the effects of 1,1 ,2,2-tetrachloroethane on male and female rats and mice to identify potential toxic hazards to humans. METHODS: Because 1,1,2,2-tetrachloroethane can evaporate easily, we enclosed it in starch microcapsules and placed them in the feed of rats and mice for 14 weeks. Male and female rats received up to 4,600 parts per million (ppm) 1,1 ,2,2-tetrachloroethane (equivalent to 0.46%) and mice received up to 9,100 ppm (0.91%). Control animals received empty starch microcapsules in their feed. Tissues from more than 40 sites were examined in all control and high-dose animals; tissues with lesions were examined in the lower exposure groups until no lesions were observed. RESULTS: Rats receiving 1,180 ppm or more 1,1,2,2-tetrachloroethane and mice receiving 2,300 ppm or more weighed less than the control animals. Male and female rats given 1,1 ,2,2-tetrachloroethane had pale and diseased livers and also had atrophy of the bone marrow and of the genital systems. Male and female mice given 1,1,2,2-tetrachloroethane had lesions of the liver and the bile duct. CONCLUSION: We conclude that 1,1,2,2-tetrachloroethane at doses greater than 590 ppm in the feed was toxic to the liver of male and female rats. In mice, 1,1 ,2,2-tetrachloroethane was already known to cause cancer after long-term exposure. In these 14-week studies, 1,1 ,2,2-tetrachloroethane was toxic to the livers of male and female mice.
Administration, Oral↗
NTP technical report on the toxicology and carcinogenesis studies of Elmiron (Cas No. 37319-17-8) in F344/N rats and B6C3F1 mice (Gavage Studies).
UNLABELLED: [structure--see text] Elmiron, a white powder, is the sodium salt of pentosan polysulfate, a semisynthetic sulfated polyanion composed of beta-D-xylopyranose residues with biological properties similar to heparin. Elmiron is used in the United States for the relief of urinary bladder pain associated with interstitial cystitis. Because of its stimulating effect on fibrinolysis, Elmiron has been used clinically in the treatment and prevention of thrombotic disorders. The United States Food and Drug Administration nominated Elmiron for toxicology and carcinogenicity testing by the National Toxicology Program because of its orphan drug status. Male and female F344/N rats and B6C3F1 mice received Elmiron, which met product specifications provided by the manufacturer, in deionized water by gavage for 2 weeks, 3 months, or 2 years. Genetic toxicology studies were conducted in Salmonella typhimurium, rat and mouse bone marrow cells, and mouse peripheral blood erythrocytes. 2-WEEK STUDY IN RATS: Groups of five male and five female rats were administered 0, 33, 111, 333, 1,000, or 3,000 mg Elmiron/kg body weight in deionized water by gavage, 5 days per week, for 16 days. Elmiron administration had no effect on survival or body weight gain. Activated partial thromboplastin time was significantly increased in 3,000 mg/kg rats. Liver weights of 3,000 mg/kg rats were significantly greater than those of the vehicle controls. Hepatocellular cytoplasmic vacuolization occurred in all 3,000 mg/kg females. 2-WEEK STUDY IN MICE: Groups of five male and five female mice were administered Elmiron in deionized water by gavage at doses of 0, 33, 111, 333, 1,000, or 3,000 mg/kg, 5 days per week, for 16 days. All mice survived to the end of the study. Mean body weight gains of male mice administered 333 mg/kg or greater were significantly greater than that of the vehicle control group. Liver weights of 1,000 and 3,000 mg/kg males were significantly increased. 3-MONTH STUDY IN RATS: Groups of 10 male and 10 female rats were administered Elmiron in deionized water by gavage at doses of 0, 63, 125, 250, 500, or 1,000 mg/kg, 5 days per week, for 14 weeks. No deaths were attributed to administration of Elmiron. Mean body weights of 125 mg/kg males were less than those of vehicle controls and the mean body weights of all dosed groups of females were greater. Hematology results indicated that Elmiron, at the doses selected, induced a minimal erythron decrease and leukocyte and platelet count increases that may have been secondarily related to the inflammatory lesions observed in various tissues of rats. Liver and spleen weights of males administered 250 mg/kg or greater were significantly increased. Liver weights of all dosed groups of females, and kidney, lung, and spleen weights of 1,000 mg/kg females were significantly increased. Histiocytic cellular infiltration, chronic active inflammation, and ulcers of the rectum occurred in most 500 and 1,000 mg/kg rats. Administration of Elmiron was associated with the presence of vacuolated histiocytes in the mandibular and mesenteric lymph nodes, lung, kidney, and liver of male and female rats. Histochemical investigations of the vacuolated histiocytes indicated the presence of neutral and acidic mucins and lipid material within the vacuoles. Transmission electron microscopy identified these vacuoles as lysosomal structures that exhibited a variety of contents. 3-MONTH STUDY IN MICE: Groups of 10 male and 10 female mice were administered Elmiron in deionized water by gavage at doses of 0, 63, 125, 250, 500, or 1,000 mg/kg, 5 days per week, for 14 weeks. One 250 mg/kg female mouse was sacrificed moribund on day 84; all other mice survived to the end of the study. Mean body weights of dosed groups were similar to those of the vehicle control groups. Hematology results indicated that Elmiron, at the doses selected, induced a minimal erythron decrease and leukocyte and platelet count increases that may have been secondarily related to the inflammatory lesions observed in various tissues of mice. in various tissues of mice. Liver weights of 500 mg/kg males and 1,000 mg/kg males and females, and spleen weights of 1,000 mg/kg males were significantly increased. Histiocytic cellular infiltration and chronic active inflammation of the rectum occurred in most 1,000 mg/kg mice. Administration of Elmiron was associated with the presence of vacuolated histiocytes in the mandibular and mesenteric lymph nodes, liver, and spleen of males and females. Histochemical investigations of the vacuolated histiocytes indicated the presence of neutral and acidic mucins within the vacuoles. Transmission electron microscopy identified these vacuoles as lysosomal structures that exhibited a variety of contents. 2-YEAR STUDY IN RATS: Groups of 50 males and 50 females were administered Elmiron in deionized water by gavage at doses of 0, 14, 42, or 126 mg/kg to males and 0, 28, 84, or 252 mg/kg to females, 5 days per week, for 104 or 105 weeks. Survival of all dosed groups of rats was similar to that of the vehicle control groups. Mean body weights of all dosed groups were similar to those of the vehicle controls throughout the 2-year study. Microscopically, myxomatous changes were present in the rectum of 56% of 126 mg/kg males and 83% of 252 mg/kg females. The incidences of chronic active focal alveolar inflammation of the lung were increased in all dosed groups. The incidences of histiocytic cellular infiltration of the mesenteric lymph nodes were increased in 42 and 126 mg/kg males and in 84 and 252 mg/kg females, and lymphohistiocytic hyperplasia was present in the spleen of 126 mg/kg males and 252 mg/kg females. 2-YEAR STUDY IN MICE: Groups of 50 males and 50 females were administered Elmiron in deionized water by gavage at doses of 0, 56, 168, or 504 mg/kg, 5 days per week, for 104 or 105 weeks. Survival of all dosed groups of mice was similar to that of the vehicle control groups. Mean body weights of males were similar to those of vehicle controls. Mean body weights of 504 mg/kg females were progressively less than those of the vehicle controls during the second year of the study. Increased incidences of hemangiosarcomas of the liver and hepatocellular neoplasms were observed in male and female mice. The incidences of hemangiosarcomas in the 504 mg/kg groups exceeded the historical control ranges for males and females; both the trend and the incidence in the 504 mg/kg groups were significant for males. Hemangiosarcomas in males and females were attributed to Elmiron administration. The incidence of hepatocellular adenoma in 504 mg/kg females was significantly increased and exceeded the historical control range; the trends for hepatocellular adenoma and for hepatocellular adenoma or carcinoma (combined) were also significant in females and were attributed to Elmiron administration. There was also a marginal increase in the incidences of hepatocellular neoplasms in male mice, which may have been associated with Elmiron administration. Malignant lymphomas occurred with a positive trend in female mice; the incidence in the 504 mg/kg group was also significantly increased and matched the upper limit of the historical control range. These malignant lymphomas may have been associated with Elmiron administration. Nonneoplastic lesions related to the administration of Elmiron occurred in the liver, rectum, mesenteric lymph node, and spleen of 504 mg/kg mice and to a lesser extent in 168 mg/kg mice. These lesions were similar to those observed in the 3-month study. GENETIC TOXICOLOGY: Elmiron was not mutagenic in S. typhimurium strains TA97, TA98, TA100, or TA1535 with or without induced hamster or rat liver S9 enzymes. No increases in the frequency of micronucleated polychromatic erythrocytes were seen in bone marrow cells of rats or mice administered Elmiron by gavage three times at 24-hour intervals. No significant alterations in the frequency of micronucleated normochromatic erythrocytes were seen in peripheral blood samples from male or female mice administered Elmiron for 3 months by gavage. CONCLUSIONS: Under the conditions of these 2-year gavage studies, there was no evidence of carcinogenic activity of Elmiron in male F344/N rats administered 14, 42, or 126 mg/kg or in female F344/N rats administered 28, 84, or 252 mg/kg. There was some evidence of carcinogenic activity of Elmiron in male B6C3F1 mice based on increased incidences of liver hemangiosarcoma. The increased incidences of hepatocellular neoplasms in male mice may have been related to Elmiron administration. There was some evidence of carcinogenic activity of Elmiron in female B6C3F1 mice based on the increased incidences of liver hemangiosarcoma and hepatocellular neoplasms. The increased incidences of malignant lymphomas in female mice may have been related to Elmiron administration. Elmiron administration caused increased incidences of nonneoplastic lesions (presence of vacuolated histiocytes) of the rectum, lung, mesenteric lymph node, and spleen (males) in rats and of the liver, rectum, mesenteric lymph node, and spleen in mice.
Adenoma, Liver Cell↗
Retainer design for posterior resin-bonded fixed partial dentures: a technical report.
This article describes a new posterior preparation and retainer design for resin-bonded fixed partial dentures to resist eccentric loading, using a noble alloy (a silver-palladium-copper-gold alloy), a recently developed metal adhesive conditioner (Metaltite), and an adhesive resin-luting agent (Super-Bond C&B).
Boron Compounds↗
Engineering and algorithm design for an image processing Api: a technical report on ITK--the Insight Toolkit.
We present the detailed planning and execution of the Insight Toolkit (ITK), an application programmers interface (API) for the segmentation and registration of medical image data. This public resource has been developed through the NLM Visible Human Project, and is in beta test as an open-source software offering under cost-free licensing. The toolkit concentrates on 3D medical data segmentation and registration algorithms, multimodal and multiresolution capabilities, and portable platform independent support for Windows, Linux/Unix systems. This toolkit was built using current practices in software engineering. Specifically, we embraced the concept of generic programming during the development of these tools, working extensively with C++ templates and the freedom and flexibility they allow. Software development tools for distributed consortium-based code development have been created and are also publicly available. We discuss our assumptions, design decisions, and some lessons learned.
Algorithms↗
Comparison of the platelet concentrate collection system with the plasma-rich-in-growth-factors kit to produce platelet-rich plasma: a technical report.
PURPOSE: The aim of this study was to compare a new method for the production of platelet-rich plasma (PRP), the plasma-rich-in-growth-factors kit (PRGF kit; G.A.C. Medicale San Antonio, Vitoria, Spain), with an established method, the Platelet Concentrate Collection System (PCCS; 3i/Implant Innovations, Palm Beach Gardens, FL) with respect to resulting cellular and growth factor contents. MATERIALS AND METHODS: Whole blood was drawn from 51 healthy donors (20 men, 31 women) aged 19 to 59 years (mean +/- SD 35.12 +/- 9.65 years), and PRP was prepared by both methods. RESULTS: Platelet counts differed significantly (signed rank test, P < .001 for all) between the donor blood (274,200 +/- 54,050/microL), the PCCS PRP preparation (1,641,800 +/- 426,820/microL), and the PRGF kit PRP preparation (513,630 +/- 139,470/microL). The PCCS concentrated leukocytes (whole blood, 6,992 +/- 2,011/microL; PCCS PRP, 14,153 +/- 7,577/microL), while the PRGF kit produced a leukocyte-poor PRP (65 +/- 108/microL). Higher concentrations of transforming growth factor beta1 (TGF-beta1) and platelet-derived growth factor AB (PDGF-AB) were found in the PCCS PRP (TGF-/beta1, 290 +/- 95 ng/mL; PDGF-AB, 157 +/- 62 ng/mL) than in the Anitua PRGF kit PRP (TGF-beta1, 73 +/- 26 ng/mL; PDGF-AB, 47 +/- 21 ng/mL). Statistical analysis showed significant differences (P < .001 for TGF-beta1 and P < .01 for PDGF-AB). DISCUSSION: The results of this study and some data in the literature indicate that the content of growth factors in PRP can vary tremendously, depending on the system used for the preparation of PRP. CONCLUSION: PCCS collects more platelets and leukocytes than the PRGF kit. This results in significantly higher growth factor levels. Further in vivo studies are needed to determine whether this results in a clinically different biologic effect.
Adult↗
[Targeted small craniotomy and evacuation for subscute subdural hematomas: technical report of two cases].
The etiology and proper treatment of symptomatic subacute subdural hematomas remains to be elucidated. We describe two cases of this entity successfully treated with small craniotomy and evacuation. Both patients initially treated conservatively for traumatic thin subdural hematomas because of poor medical condition and mild neurological symptoms, but suffered abrupt neurological deterioration between 2 and 3 weeks after the admission. CT scan showed decreased density of hematomas with minimal increase in volume, and significant swelling of ipsilateral cerebral hemisphere. Urgent two-burr-hole small craniotomy was effective for evacuation of partially organized hematoma. During surgery, definite hematoma membrane was not confirmed. Postoperatively, brain swelling rapidly disappeared and both patients discharged ambulatory without neurological deficit. The present cases are a reminder of this peculiar type of hematoma in patients with delayed neurological deterioration after nonsurgical management of acute subdural hematoma. The rationale for use of small craniotomy is discussed in terms of current understanding of pathogenetic mechanism for this unusual condition.
Aged↗
[Linac based radiosurgery; a technical report].
A method for highly dose-localized irradiation using a linear accelerator (linac) for a brain tumor has been developed. The method requires a linac, a computed tomography (CT) system, a CT simulator, and a treatment planning system for radiotherapy, with which most major radiotherapy centers are equipped. To immobilize a patient during irradiation, a custom-made device made of synthetic material which became flexible with heating was used. With the CT system and the CT simulator the target was identified and geometrical data for positioning the tumor at a point to which x-ray beams were directed (an isocenter of the linac) were obtained. By rotating a treatment couch it was made possible for the x-ray source to rotate around the isocenter on multiple planes. Dose distribution obtained with this method was compared to that of the gamma unit and found comparable. Since the method requires no invasive procedure, it appears suitable for treatment, with fractionated irradiation, of malignant tumors.
Brain Neoplasms↗
Operative vein-mapping for vascular bypass procedures: an early technical report.
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Humans↗
NTP Technical Report on the comparative toxicity studies of allyl acetate (CAS No. 591-87-7), allyl alcohol (CAS No. 107-18-6) and acrolein (CAS No. 107-02-8) administered by gavage to F344/N rats and B6C3F1 mice.
Allyl acetate, allyl alcohol, and acrolein are used in the manufacture of detergents, plastics, pharmaceuticals, and chemicals and as agricultural agents and food additives. Male and female F344/N rats and B6C3F(1) mice received allyl acetate, allyl alcohol, or acrolein by gavage for 14 weeks. Genetic toxicology studies were conducted in Salmonella typhimurium, Drosophila melanogaster, cultured Chinese hamster ovary cells, rat bone marrow erythrocytes, and mouse peripheral blood erythrocytes. Groups of 10 male and 10 female rats were administered 0, 6, 12, 25, 50, or 100 mg allyl acetate/kg body weight, 0, 1.5, 3, 6, 12, or 25 mg/kg allyl alcohol, or 0, 0.75, 1.25, 2.5, 5, or 10 mg/kg acrolein in 0.5% methylcellulose by gavage, 5 days per week for 14 weeks. Groups of 10 male and 10 female mice were administered 0, 8, 16, 32, 62.5, or 125 mg/kg allyl acetate, 0, 3, 6, 12, 25, or 50 mg/kg allyl alcohol, or 0, 1.25, 2.5, 5, 10, or 20 mg/kg acrolein in 0.5% methylcellulose by gavage, 5 days per week for 14 weeks. In the allyl acetate rat study, all males and females in the 100 mg/kg groups died or were killed moribund by day 8; there were no other deaths. In the allyl alcohol study, all rats survived to the end of the study except one 6 mg/kg female. In the acrolein rat study, eight males and eight females in the 10 mg/kg groups died by week 9 of the study. Two males in the 2.5 and 5 mg/kg groups and one or two females in the 1.25, 2.5, and 5 mg/kg groups also died early; two of these deaths were gavage accidents. In the allyl acetate mouse study, all males and females in the 125 mg/kg group died during the first week of the study. All other early deaths, except five 62.5 mg/kg males and one 32 mg/kg female, were gavage accidents. In the allyl alcohol mouse study, one 50 mg/kg female died due to a gavage accident; all other animals survived to the end of the study. In the acrolein mouse study, all males and females administered 20 mg/kg died during the first week of the study. All other early deaths, except one male and one female administered 10 mg/kg, were unrelated to chemical administration. The concentration of 3-hydroxypropyl mercapturic acid (3-HPM) in the urine of rats and mice was determined after the first dose of chemical and at the end of the 14-week study. At both time points, the concentrations of 3-HPM in the urine of animals that received allyl acetate or allyl alcohol increased linearly with dose. In animals dosed with acrolein, the concentrations of 3-HPM exhibited a nonlinear increase with dose at the first time point. At the end of the study, the concentration of 3-HPM in the urine of animals dosed with acrolein was linear with dose except at the highest concentration administered. Since urine volumes were not recorded during the urine collection, complete quantitation of these data was not possible. The final mean body weights and mean body weight gains of male rats administered 12 or 50 mg/kg allyl acetate and of male and female rats administered 10 mg/kg acrolein were significantly less than those of the vehicle controls. The mean body weight gain of male mice in the 50 mg/kg group in the allyl alcohol study was also less than that of the vehicle controls. Final mean body weights and mean body weight gains of dosed female rats and male and female mice in the allyl acetate studies, male and female rats and female mice in the allyl alcohol studies, and male and female mice in the acrolein studies were generally similar to those of the respective vehicle controls. Clinical findings related to allyl acetate administration included pallor, eye or nasal discharge, ruffled fur, lethargy, diarrhea, and thinness among rats in the 100 mg/kg groups and lethargy, abnormal breathing, thinness, and ruffled fur among mice that died early. In the acrolein study, clinical findings included abnormal breathing, eye or nasal discharge, ruffled fur, thinness, and lethargy in rats in the 10 mg/kg groups. The liver weights of male rats administered 25 mg/kg allyl alcohol, female rats administered 50 mg/kg allyl acetate or 5 or 10 mg/kg acrolein, and male mice administered 10 mg/kg acrolein were significantly greater than those of the vehicle controls. Female rats administered 10 mg/kg acrolein had significantly lower absolute and relative thymus weights than did the vehicle controls. Female rats administered 25 mg/kg allyl alcohol spent more time in diestrus and less time in metestrus than the vehicle controls. The estrous cycles of female mice dosed with 16 or 32 mg/kg allyl acetate were significantly longer than that of the vehicle controls. Gross lesions related to allyl acetate treatment were observed in the liver, forestomach, and thorax/abdomen of male and female rats in the 100 mg/kg groups. Microscopically, the incidences of forestomach squamous epithelial hyperplasia were significantly increased in male rats administered 12 mg/kg or greater, female rats administered 25 or 50 mg/kg, male mice administered 32 or 62.5 mg/kg, and female mice administered 16, 32, or 62.5 mg/kg. Forestomach necrosis, hemorrhage, and inflammation were present in most rats in the 100 mg/kg groups, and the incidence of hemorrhage in 125 mg/kg male mice was increased; male mice in the 62.5 and 125 mg/kg groups and 125 mg/kg female mice had significantly increased incidences of glandular stomach hemorrhage. Increased incidences of several liver lesions occurred in male or female rats administered 50 or 100 mg/kg, and to a lesser extent in 25 mg/kg rats, 62.5 mg/kg male mice, and 125 mg/kg male and female mice. Bone marrow hyperplasia, hemorrhage or depletion in the mediastinal, mandibular, and mesenteric lymph nodes, hemorrhage and necrosis of the thymus, and hematopoietic cell proliferation of the red pulp were also observed in 100 mg/kg rats. Increased incidences of necrosis in the mandibular and mesenteric lymph nodes, spleen, and thymus were observed in 62.5 and 125 mg/kg mice. Male and female rats administered 6 mg/kg allyl alcohol or greater and male and female mice administered 12 mg/kg allyl alcohol or greater had significantly increased incidences of squamous hyperplasia of the forestomach epithelium. Female rats in the 25 mg/kg group had significantly increased incidences of bile duct hyperplasia and periportal hepatocyte hypertrophy in the liver. Incidences of portal cytoplasmic vacuolization were significantly increased in 50 mg/kg male mice and female mice in the 25 and 50 mg/kg groups. Gross lesions related to acrolein treatment were observed in the forestomach and glandular stomach of male and female rats in the 10 mg/kg groups and 20 mg/kg female mice. Microscopically, the incidences of squamous hyperplasia of the forestomach epithelium were significantly increased in male rats in the 5 and 10 mg/kg groups, female rats administered 2.5 mg/kg or greater, and male and female mice administered 2.5, 5, or 10 mg/kg. Male and female rats in the 10 mg/kg groups and 20 mg/kg male and female mice had significantly increased incidences of glandular stomach hemorrhage. Female mice in the 20 mg/kg group also had significantly increased incidences of glandular stomach inflammation and epithelial necrosis. Allyl acetate was mutagenic in S. typhimurium strains TA100 and TA1535, in the absence of S9 activation. With S9, no mutagenicity was detected in these two strains; negative results were obtained in strains TA97 and TA98, with and without S9. Allyl alcohol was not mutagenic in four strains of S. typhimurium, with or without S9 metabolic activation. Acrolein, tested in a preincubation protocol, was weakly mutagenic in S. typhimurium strain TA100 in the presence of 10% induced rat liver S9. Equivocal results were obtained in strains TA100 and TA1535 with 10% induced hamster liver S9. Negative results were obtained with TA97, TA98, and TA1538 under all test conditions, and acrolein gave negative results in all four S. typhimurium strains tested for mutation induction under a vapor protocol. No induction of micronuclei was noted in bone marrow erythrocytes of male rats administered allyl acetate by gavage three times at 24-hour intervals. No significant increases in micronucleated erythrocytes were noted in bone marrow samples from male rats administered allyl alcohol by intraperitoneal injection for 3 days. A small, but significant increase in the frequency of micronucleated normochromatic erythrocytes was observed in the peripheral blood of female mice administered allyl acetate by gavage for 14 weeks; no increase was observed in male mice. No increases in the frequencies of micronucleated normochromatic erythrocytes were observed in the peripheral blood of male or female mice administered allyl alcohol or acrolein by gavage for 14 weeks. Acrolein induced sister chromatid exchanges in cultured Chinese hamster ovary cells in the absence, but not the presence, of S9; it did not induce chromosomal aberrations, with or without S9. Results of three independent Drosophila melanogaster sex linked recessive lethal tests in which acrolein was administered to adult flies via feeding or injection and to larvae via feeding were negative.
Acetates↗
Dentine bonding. Fédération Dentaire Internationale Technical Report No. 35.
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Dental Bonding↗
Alternative casting alloys for fixed prosthodontics. Fédération Dentaire Internationale. Technical Report No. 34.
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Chromium Alloys↗
Leder-Giemsa stain for bone marrow trephine--a technical report.
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Bone Marrow Diseases↗
[Technical report of the Study Group on Arterial Hypertension: self-measurement of arterial pressure].
Although experience is still limited and more research is needed, the World Hypertension League recommends self-measurement of blood pressure in selected patients as an additional source of information to practicing physician, and as a way of encouraging patients to participate more actively in the therapeutic regimen. English version statement published in Bulletin of the World Health Organisation 1988;66,2:155-9.
Blood Pressure Determination↗
Premedication in dentistry. Fédération Dentaire Internationale Technical Report No. 32.
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Adolescent↗