Journal of The Showa Medical Association
Online ISSN : 2185-0976
Print ISSN : 0037-4342
ISSN-L : 0037-4342
Volume 72, Issue 3
Feature Articles: Special Articles on Human Subjects Protection in Clinical Trials in Japan —From a View Point of Risk Communication by an Expertise— Editors View
Displaying 1-16 of 16 articles from this issue
Feature Articles: Special Articles on Human Subjects Protection in Clinical Trials in Japan
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  • Takehiko NAKASATO, Takashi FUKAGAI, Yu OGAWA, Motoko SUGAHARA, Takayuk ...
    2012 Volume 72 Issue 3 Pages 326-335
    Published: 2012
    Released on J-STAGE: March 14, 2013
    JOURNAL FREE ACCESS
    It is reported that serum testosterone exerts various effects on the human body with prostate cancer. One of the testosterone actions is prostate cancer activity, and another testosterone action affects the physical condition of prostate cancer patients, such as body mass index (BMI) and bone mineral density (BMD). It is reported that free testosterone has more biochemical activity than total testosterone, thus we examined the relationship between the serum testosterone (total T and free T) level and Gleason score (GS), clinical stage and PSA level of the untreated prostate cancer patients. We also examined the relation between serum testosterone and physical condition, such as BMI, BAP, NTX and BMD. No significant relation was seen between T and GS, clinical stage, BAP, NTX and BMD, however PSA values and serum T level showed an inverse association. This result indicates that the prostate cancer that grows under low testosterone level may have higher malignancy. Another interesting result was the patients with high BMI showed a lower testosterone level. This result may indicate that the prostate cancer patients with higher BMI may have a disadvantage of toxicity of hormone treatment that may increase the risk of cardiovascular events. Statistical analysis showed some differing results between T and free T in our study. We suggest both T and free T should be measured in order to investigate the role of testosterone. Upon elucidation of this role, the prospects of further examination will increase in the future.
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  • Masahide SATO, Yuki SHIMIZU, Minoru HAYASHI, Toshiya YOKOYAMA, Shinya ...
    2012 Volume 72 Issue 3 Pages 336-341
    Published: 2012
    Released on J-STAGE: March 14, 2013
    JOURNAL FREE ACCESS
    Botulinum toxin type A (BTX-A) affects the discharge of acetylcholine in a nerve junction, weakens the contractile force of muscles and controls a spasms. BTX-A is used in medical treatment, such as the treatment of a blepharospasm, a hemifacial spasm, spasmodic torticollis, etc... and it also is used in cosmetics medical treatment of expression wrinkles. Moreover, the increased blood flow facilitated by BTX-A has been pointed out, and the possibility of its use in the medical treatment of peripheral vascular disorder has been suggested. We applied BTX-A medication to the femoral artery of the rat, and measured the hemodynamic change using a Laser Doppler blood flow meter. The center of the path of the femoral artery became partially ligated which consequently decreased the blood flow. Xeomin was used as the BTX-A medicine. Xeomin (0.5 U and 1 U, 2 U, 4 U, 8 U) was dissolved in 0.02 ml of physiologic saline, and each reagent, diluted to normal concentration, was injected into the model rat femoral artery where the blood vessel circumference film for ligation was positioned. Moreover, the part was medicated with 0.02 ml of physiological saline as control. The blood flow of the femoral artery was measured before ligation, after ligation and on the 3rd day after injection. In 1 U, 2 U, 4 U, and 8 U group, a marked increase in blood flow was seen by the 3rd day after injection. An apparent change of the blood flow was seen in 0.5 U group or the control group. It was suggested that the effect that BTX-A injection of 1 U or more facilitates blood flow improvement as noted by blood vessel circumference film in the rat. Further research regarding the action time, the grade of diffusion, etc. is necessary in order to use BTX-A as a medicine aimed at a blood flow improvement.
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  • Satomi AZUMA
    2012 Volume 72 Issue 3 Pages 342-348
    Published: 2012
    Released on J-STAGE: March 14, 2013
    JOURNAL FREE ACCESS
    Decreased functional residual capacity (FRC) reportedly plays a role in postoperative hypoxemia, a common problem following surgery under general anesthesia that can persist for several days after upper abdominal procedures. In recent years, laparoscopy has been preferentially performed over laparotomy in consideration of invasiveness, but laparoscopic upper abdominal surgery entails a risk of decreased FRC due to induced cranial displacement of the diaphragm. We report herein changes in FRC during laparoscopic upper abdominal surgery in adult and elderly patients. FRC was measured immediately post-intubation and pre-extubation in patients 20∼55 years old (adult group; n = 11) and ≥ 70 years old (elderly group; n = 9) using the nitrogen washout method with an Engstrom Carestation(GE Healthcare). Both groups exhibited a significant decrease in FRC between immediately post-intubation (about 2400 ml) and immediately pre-extubation (p < 0.05). A significant difference in the rate of intraoperative FRC decrease was also observed between adult and elderly groups (14.1 ± 7.8% vs. 23.6 ± 9.7%; p < 0.05). Investigation of correlations between the rate of FRC decrease and patient characteristics and preoperative respiratory function test results revealed positive linear correlations between the rate of FRC decrease and age, operative time, anesthesia time and FEV1.0% and negative linear correlations with the remaining four parameters. However, a significant difference was only observed for age (p < 0.05). The study revealed a significant decrease in FRC, during minimally invasive laparoscopic upper abdominal surgery. Furthermore, the rate of intraoperative decrease was greater in the elderly group.
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  • —Based on the Difference in Consciousness for Euthanasia and/or Death with Dignity between Medical Students and Biological Students—
    Chieko KARIBE, Keizo SATO, Luka MARUMO, Akemi MARUMO, Masaya FUJISHIRO ...
    2012 Volume 72 Issue 3 Pages 349-358
    Published: 2012
    Released on J-STAGE: March 14, 2013
    JOURNAL FREE ACCESS
    Recently, the right of self-determining and quality of life (QOL) have been considered to be important in terminal care. We should investigate euthanasia and/or death with dignity in relation to the right of self-determining and QOL in terminal care. To date there are no reports which discuss the difference in consciousness for euthanasia and death with dignity between medical students and biology students to our knowledge. In this paper, we studied the right of self-determinination and QOL in terminal care by examining the difference in consciousness for euthanasia and/or death with dignity between medical students and biology students. The results of an opinion poll for euthanasia and death with dignity were compared between medical students and biology students. The data obtained were statistically analyzed regarding the students' sex and field of specialty. The similarities and differences were examined with the chi-squared test. When considering euthanasia, medical students held the opinion of “disagree” more frequently than biology students. The reason why both students agreed with euthanasia and/or death with dignity for their families was due to the respect for the right of self-determining. When considering death with dignity, female students held the opinion of “agree” more frequently than male students. Both medical and biology students preferred death with dignity to euthanasia. Most medical students desired legislation for euthanasia and/or death with dignity though biology students did not always desire it. Around thirty percent of female students desired legislation for death with dignity only. From the results obtained, the conclusion seems to be that medical students want to perform passive euthanasia or death with dignity according to the law enacted to improve QOL for the patients with their self-determination. A previous study by another group concluded that the aim of medicine should be to save life, rather than to shorten it. The present study seems to indicate that the right of self-determining and QOL have been recently considered to be important even in terminal care.
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  • Tamotsu OKADA
    2012 Volume 72 Issue 3 Pages 359-365
    Published: 2012
    Released on J-STAGE: March 14, 2013
    JOURNAL FREE ACCESS
    Background: Preoperative lung function tests are useful to evaluate the preoperative pulmonary condition and to detect a high risk of postoperative pulmonary complications. However, maximum expiratory effort by patients is necessary to determine lung function using spirometry, flow-volume curve and single breath N2 washout test. When patients are not able to expire completely during the measurement, incorrect data regarding their respiratory system is obtained. On the other hand, it is believed that respiratory system impedance using an impulse oscillatory system (IOS) can quickly evaluate total airway resistance (R5), large airway resistance (R20), small airway resistance (R5-R20) and capacitive reactance (X5) under breathing at rest. There are so few reports which indicate the standard values for IOS that the evaluation of IOS values is not clear. In this study we evaluate the relationship between parameters in ISO and non-ISO such as VC, FEV(1.0), PEFR, MMEF, V25, CV and FRC-CC.
    Subjects and Methods: Six hundred twenty patients ranging from 20 to 89 years of age and scheduled for elective surgery were studied. IOS and non-IOS, such as spirometry [VC, FEV(1.0)], maximum expiratory flow-volume curve (PEFR, MMEF and V25) and single N2 washout curve (CV and FRC-CC) were preoperatively measured to investigate the relationship between parameters in IOS and non-IOS. We examined the relationship between IOS and non-IOS by calculating Pearson's product-moment correlation coefficient.
    Results: Regression equations obtained between IOS and non-IOS parameters were statistically significant (p < 0.05). The highest correlation coefficient (R2) was 0.267 between X5 and FEV(1.0) (Table 2). The second highest R2 was 0.226 between X5 and VC. R2 was 0.189 between R5-R20 and MMEF, which is relatively high considering that those values indicate small airway conditions.
    Conclusions: Although the relationship between IOS and non-IOS was statistically significant in this study, further study is necessary to obtain sufficiently high R2 to apply IOS clinically in place of non-IOS.
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  • Takeshi HAYASHI, Kenichiro IKEDA, Hiroshi GOMIBUCHI, Toshikazu SHIMANE ...
    2012 Volume 72 Issue 3 Pages 366-370
    Published: 2012
    Released on J-STAGE: March 14, 2013
    JOURNAL FREE ACCESS
    We examined 48 patients diagnosed with papillary thyroid cancer who underwent primary treatment in our department. The preoperative diagnosis was based on evaluation of the presence of cervical lymph node metastasis and extracapsular invasion by ultrasonography, CT, and fine-needle aspiration cytology. All patients received surgical treatment. The most common operative procedure was lobectomy (44%) followed by total thyroidectomy (35%), subtotal thyroidectomy (17%), total thyroidectomy combined with resection of the trachea (2%), and total thyroidectomy with total laryngectomy (2%). As for cervical lymph node dissection, D1 dissection was performed in all cases. In cases where preoperative ultrasonography and CT revealed cervical lymph node metastasis, operative procedures were determined according to the extent of metastasis. Cervical lymph node metastasis and extracapsular invasion were examined as prognostic factors. In many cases, lymph node metastasis accompanied extracapsular invasion, suggesting that extracapsular invasion as well as cervical lymph node metastasis were important prognostic factors. In terms of operative procedures, no clear differences were found between patients with extracapsular invasion and those without. All of the patients are alive according to short-term prognosis with a mean observation period of 22.6 months.
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  • Masaya OI
    2012 Volume 72 Issue 3 Pages 371-378
    Published: 2012
    Released on J-STAGE: March 14, 2013
    JOURNAL FREE ACCESS
    Atrial fibrillation (AF) is a common complication after coronary artery bypass grafting (CABG). It is associated with increased risk of morbidity, mortality, length of hospital stay, and hospital costs. We studied the effects of atorvastatin pretreatment on the prevention of AF after off-pump CABG. Twenty-seven patients without a history of AF were scheduled to undergo elective off-pump CABG. Patients with hypercholesterolemia, pretreated with atorvastatin (20mg/day) more than 4 days before the surgery (treatment group; n = 20), were compared with those without (control group; n = 7). Primary outcome was the incidence of postoperative AF. Secondary outcomes were in-hospital death, hospital stay, major adverse cardiac and cerebrovascular events, and perioperative C-reactive protein (CRP) variations. The incidence of AF was significantly lower in the treatment group than in the control group (25.0% vs. 71.4%; p = 0.03). No side effects occurred in the treatment group. There was no statistical difference in in-hospital death, hospital stay, the incidence of major adverse cardiac and/or cerebrovascular events between the two groups. CRP levels at postoperative day 5 were significantly lower in the atorvastatin group (3.4 ± 2.1 vs. 7.2 ± 4.2mg/dl; p = 0.029). Pretreatment with atorvastatin significantly reduced the occurrence of postoperative AF after off-pump CABG.
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Case Report
  • Kei OMORI, Takehiko NAKAZATO, Takashi FUKAGAI, Yoshio OGAWA
    2012 Volume 72 Issue 3 Pages 379-383
    Published: 2012
    Released on J-STAGE: March 14, 2013
    JOURNAL FREE ACCESS
    The patient was a 66-year-old woman who presented to the outpatient gynecology clinic of our hospital with the chief complaint of abnormal vaginal bleeding. Transvaginal sonography revealed a mass lesion at the top of the bladder, and the patient was referred to our department. Transurethral biopsy of the bladder tumor revealed the diagnosis of adenocarcinoma. After various diagnostic examinations, we made the diagnosis of urachal cancer invading the bladder wall, and performed complete resection of the urachus and partial resection of the urinary bladder. We report this case with a brief review of the literature.
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