Quality control of hospital preparations: Establishment of a simple and rapid method for quantifying ulinastatin in vaginal suppositories.

Ulinastatin vaginal suppositories, used to prevent threatened premature delivery, are frequently used in hospitals. However, there is no established method for quantifying ulinastatin contained in suppositories. Therefore, we investigated a simple and efficient method for quantifying ulinastatin contained in suppositories. Our analytical method involved removal of the base; optimising the enzyme inhibition reaction time and enzyme reaction time; and measuring the absorbance. The modified method was reproducible, operation time was significantly shortened, and cost was reduced to approximately 1/17 of that of the previously reported method. This simple and rapid quantitative method could contribute to the improvement of quality control of ulinastatin vaginal suppositories as an extemporaneous hospital preparation.

Results of the Health Assessment Questionnaire for Japanese patients with systemic sclerosis--measuring functional impairment in systemic sclerosis versus other connective tissue diseases.

OBJECTIVE: To evaluate the physical functional impairment in patients with systemic sclerosis (SSc) using the Health Assessment Questionnaire (HAQ) and to estimate the correlation of HAQ scores with the severity of SSc. METHODS: One hundred and twenty-four outpatients with connective tissue disease, including 50 patients with SSc, were evaluated using the HAQ. Twelve patients were classified as having diffuse cutaneous SSc (dSSc) and 38 limited cutaneous SSc (lSSc). The severity classification and the guidelines for treatment (2004) were applied to Japanese SSc patients in order to evaluate the relationship between HAQ scores and disease activity in patients with multiple organ involvement. RESULTS: In dSSc the HAQ category scores for eating, walking, grip, activity and the HAQ-disability index (HAQ-DI) showed the greatest deficits in all disease groups. The severity of disease activity correlated significantly with the scores for walking, reach, and the HAQ-DI. The severity of joint, heart, and pulmonary hypertension were correlated independently with the HAQ-DI score by multiple linear regression analysis. CONCLUSION: Patients with dSSc suffer greater functional impairment than patients with other connective tissue diseases, and improvements in hand use and walking represent very important targets for both drug development and rehabilitation. As improvement in organ involvement (joints, heart as well as pulmonary hypertension) can lead to reduced functional impairment, they constitute an important target for therapy in SSc.

A prospective randomized trial of either famotidine or omeprazole for the prevention of bleeding after endoscopic mucosal resection and the healing of endoscopic mucosal resection-induced ulceration.

BACKGROUND: It has been reported that inhibitors of gastric acid secretion prevent bleeding after endoscopic mucosal resection for mucosal gastric neoplasm. However, uncertain whether an histamine2-receptor antagonist or proton-pump inhibitor is more effective. AIM: To evaluate prospectively the effectiveness of famotidine or omeprazole for ulcer management after endoscopic mucosal resection. METHODS: From July 2003 to October 2004, 57 patients were randomly assigned to famotidine or omeprazole for the management of endoscopic mucosal resection. Both drugs were given intravenously for the first 2 days, thereafter by mouth. The bleeding rates after endoscopic mucosal resection, the effects on the healing of endoscopic mucosal resection-induced ulceration, and cost-benefits were compared. RESULTS: Twenty-eight patients received famotidine and 29 received omeprazole. No significant difference was observed between the two groups in patient characteristics. The bleeding rates after endoscopic mucosal resection were not significantly different (18% vs. 14%) between the groups. Similarly, no differences were seen in the size of the endoscopic mucosal resection-induced ulceration at 1, 30 and 60 days after resection between groups. The total costs of anti-secretory agents demonstrated a significant cost-benefit to those treated with famotidine (10,420 yen vs. 17,782 yen). CONCLUSIONS: Famotidine is suggested as a better alternative to omeprazole for the management of endoscopic mucosal resection, as it showed a clear cost-benefit, and the healing results after endoscopic mucosal resection were similar for the two treatment strategies.

LC-MS determination of urinary toluenediamine in workers exposed to toluenediisocyanate.

To improve the biological monitoring method for 2,6- and 2,4-toluenediisocyanate (TDI) exposure, we developed a simple and rapid method for analysis of the corresponding urinary metabolites, 2,6- and 2,4-toluenediamine (TDA) using liquid chromatograph-mass spectrometry (LC-MS). One ml of urine was hydrolyzed at 100 degrees C for 1.5 h with H(2)SO(4). Alkalinized hydrolysate was extracted with dichloromethane (DCM) and analyzed by atmospheric pressure chemical ionization (APCI) LC-MS, in positive-ion mode. The mass spectra of TDA isomers showed the protonated molecule [M+H](+), at m/z 123 as the base peak. Calibration curves of 2,6-TDA were linear up to 400 microg/l. TDA isomers in urine of exposed workers as determined by LC-MS correlated well with those obtained by gas chromatography-mass spectrometry. 2,6- and 2,4-TDA were not detected in non-exposed subjects, whereas exposed workers showed urinary levels up to 250 and 63 microg/l, respectively.

A new dynamic myocardial phantom for the assessment of left ventricular function by gated single-photon emission tomography.

Gated myocardial perfusion single-photon emission tomography (SPET) has been used for the measurement of left ventricular (LV) function and validated by means of comparison with other imaging modalities. We have designed a new dynamic myocardial phantom in order to validate the LV function as assessed by the use of gated myocardial perfusion SPET. The phantom consists of two half-ellipsoids (an endocardial surface and an epicardial surface) and a thorax. The myocardial space is filled with a radioactive solution. The endocardial surface moves continuously towards and away from the epicardial surface in the longitudinal axis to vary the LV volume [143 ml at end-diastole (ED), 107 ml at end-systole (ES)] and thickness (apex 8 mm at ED and 26 mm at ES, midplane 8 mm). The mean values of wall motion (WM) for the apical midplane region and the basal midplane region were 5 mm and 2 mm, respectively. Gated myocardial SPET was performed during 8 and 16 intervals. These projection data sets were processed using a Butterworth filter with an order of 5 and a critical frequency of 0.34 cycles/cm. LV function was calculated using the quantitative gated SPET (QGS) algorithm. The LV function values estimated by gated SPET during 16 intervals [22% for ejection fraction (EF), 3.7 mm for WM of the apical midplane, 1.7 mm for WM of the basal midplane] closely resembled actual LV functions [25% for EF, 5 mm for WM of the apical midplane, 2 mm for WM of the basal midplane]. However, the estimated values during 8 intervals were smaller than those during 16 intervals (19% for EF, 3.3 mm for WM of the apical-midplane, 1.1 mm for WM of the basal-midplane). The estimated LV volumes closely correlated with the actual volumes (r=0.99 for 16 intervals, r=0.95 for 8 intervals). Utilizing this phantom, LV function estimated using gated myocardial SPET can be compared with actual values.

[Assessment of allergenic activity of heated and ovomucoid-depleted egg white].

We investigated allergenic activity of heated and ovomucoid (OM)-depleted egg white by RAST inhibition tests, skin tests and and oral challenge tests. Freeze-dried egg white, OM and ovalbumin (OA) were coupled with CNBr-activated paper discs. Freeze-dried, heated, and heated and OM-depleted egg white antigens were used as inhibitors in RAST inhibition tests. Freeze-dried egg white significantly inhibited the IgE-binding to freeze-dried egg-white-, OM- and OA-discs. Heated egg white showed a significant inhibition against only OM-disc, but heated and OM-depleted egg white didn't effectively suppress IgE-binding to all discs. Fifty-six patients were subjected for skin tests and 27 patients for oral challenge tests with freeze-dried egg white, heated egg white and heated and OM-depleted egg white. Eighteen of 25 subjects with positive prick tests results to freeze-dried egg white showed negative results to heated egg white. Four of 7 cases with positive prick test results to heated egg white gave negative results to heated and OM-depleted egg white. 20-minutes patch tests showed almost similar results to prick tests. Four of 8 subjects showing positive oral challenge tests with freeze-dried egg white were negative to heated egg white. All of 4 with positive oral challenge tests by heated egg white were negative results to heated and OM-depleted egg white. These evidence indicated that heated and OM-depleted egg white was more hypoallergenic than heated egg white.

[Two cases of severe acute pancreatitis-CT scan was useful to the assessment].

We report two cases of severe acute pancreatitis; a 53-year-old man (Case 1) and a 60-year-old woman (Case 2). Case 1 was classified as "severe" according to the Ranson's criteria and he died of MOF on the 21st hospital day. Case 2 was classified as "moderate", but a large pancreatic abscess was observed by CT scan. She died of this abscess complicated with duodenal perforation on the 33rd hospital day. CT findings showed that this case was not "moderate" but "severe". Therefore, we believe that the findings of CT scan are an important factor for assessment of the severity of acute pancreatitis.