トクシマ ダイガク ニオケル コウド イリョウ ノ シエン キバン セイビ

Establishment of new modality of treatment, diagnosis and prevention of various diseases is an important role of university hospital. In this article, restrictions and guidelines for clinical investigations in Japan are reviewed and supporting system for promotion of clinical trials, now being organized at Tokushima University Hospital, is introduced. The main division in the supporting system of clinical trials is the Clinical Trial Center for Developmental Therapeutics. It was first organized as the Clinical Trial Center for New Drugs and Therapeutic in 1999 under the leadership of Prof. Saburo Sone. Five nurses work as clinical research coordinator (CRC) and coordinates close communication among participants, sponsor and investigators, and plays a crucial role in the efficient progress of clinical trials. Pharmacists and officers also contribute for promotion of clinical trials in the center. The supporting field is now being expanded from the support for clinical trial for drug approval to clinical trials conducted by investigators. For example, one pharmacist supports technically the project of dendritic cell-based vaccination against various malignancies in newly-constructed room. Based on the experience, our task is to grow the center to academic research organization. We are now dealing the following issues ; 1) promotion of clinical trials conducted by investigators, 2) scientific clinical trials of food, 3) setup of network of clinical trials in Tokushima prefecture with general physicians and other institutions

View of physicians on and barriers to patient enrollment in a multicenter clinical trial: experience in a Japanese rural area

<p>Abstract</p> <p>Background</p> <p>Clinical trials in the general practice setting are important for providing evidence on the effectiveness and safety of different agents under various conditions. In conducting these trials, the participation of physicians and patient recruitment are important issues. Various investigations in the literature have reported views and attitudes of physicians on various types of clinical trials. Nevertheless, there is still little information concerning physicians participating in a clinical trial and among them, those who could not recruit any patients (unsuccessful physician recruiters).</p> <p>Methods</p> <p>In 2003, we collaborated in a large-scale multicenter study of Japanese hypertensive patients (COPE Trial). In Tokushima University Hospital and 18 other medical institutions, we investigated the views and attitudes of unsuccessful physician recruiters in comparison with successful physician recruiters, using a questionnaire.</p> <p>Results</p> <p>The questionnaire was provided by mail to 47 physicians and 27 (57%) responded. The response rate was 79% for successful physician recruiters compared to 43% (P = 0.014) for unsuccessful physician recruiters. More successful physician recruiters (73%) than unsuccessful physician recruiters (42%) stated they had participated and enrolled patients in previous multicenter clinical trials. A significantly higher number of successful physician recruiters than unsuccessful physician recruiters (42%; P = 0.040) considered the presence of a support system with clinical research coordinators (CRC) as the reason for participation (80%). A large number of unsuccessful physician recruiters experienced difficulty in obtaining informed consent (67%), whereas a significantly smaller number of successful physician recruiters experienced such difficulty (20%; P = 0.014). The difficulties experienced by unsuccessful physician recruiters in the trial were as follows: inability to find possible participants (100%), difficulty in obtaining informed consent (58%), cumbersome procedures (58%), difficulty in long-term follow up (33%), and insufficient tools for explanation and obtaining informed consent (8%).</p> <p>Conclusion</p> <p>This survey showed that successful physician recruiters consider a support system with CRC of value, and that they are skillful in obtaining informed consent. These views and attitudes may have originated from past experience involving clinical trials. In this regard, we need to develop an infrastructure to enlighten physicians on this support system for the promotion of clinical trials.</p

Trend in maternal-child health services

In Japan, outcome measures for maternal and child health measures such as maternal, perinatal, and infant mortality have consistently shown a trend toward improvement. On the other hand, the problems of the declining birth rate, child abuse, and domestic violence have become evident since the 1990s. In terms of Japan’s maternal and child health, it is necessary to take measures to preserve mental health of mothers and children, and also to respond to family issues such as abuse and violence. The services needed such as comprehensive support centers for families with children and new postpartum care programs have been established. It is necessary to further improve the competence of doctors, public health nurses, and midwives working in the maternal and child health field and to promptly construct a cooperation system in the community

"See and treat" LEEP biopsy for cervical intraepithelial neoplasia grade 2/3

Purpose of investigation: To evaluate the safety and efficacy of loop electrosurgical excision procedure (LEEP) biopsy using a "see-and-treat" strategy, and compare outcomes after "LEEP biopsy, inpatient LEEP and ablation, and inpatient conization with cervical intraepithelial neoplasia (CIN) grade 2/3. Materials and Methods: The authors performed a retrospective study including 300 women with CIN2/3 who were followed up ≥ 6 months following outpatient LEEP/inpatient LEEP and ablation/inpatient conization. Recurrence, additional treatment for recurrence, pregnancy, and term delivery following treatment were evaluated. Results: During the median follow-up duration of 22 months, recurrences were significantly more common following LEEP biopsy (39%) compared to LEEP and ablation (13%) and conization (16%) and were managed by repeat LEEP. Pregnancy and full-term delivery rates following LEEP biopsy were significantly higher. Conclusion: "See-and-treat" LEEP biopsy was safely performed in the outpatient department. Pregnancy rates and full-term deliveries following LEEP biopsy appear favorable

Utility of laparoscopic surgery for pelvic abscesses

骨盤内膿瘍に対する治療は，抗生剤による薬物療法が主体であるが，抗生剤無効例や，消化管から発生した膿瘍との鑑別を要する症例では外科的アプローチが必要となる。骨盤内膿瘍の場合，炎症による癒着が強いことが多く，手術は比較的難易度が高い。しかし，高度の炎症で疲弊した患者の負担を軽減するために，近年では腹腔鏡手術が積極的に導入されており，当院でも可能な限り腹腔鏡手術で対応している。抗生剤による治療が無効であった付属器膿瘍に対して腹腔鏡下手術を施行した4症例について報告する。4例とも輸血を要するような出血はなく，また他臓器損傷もなかった。術後は，速やかに炎症所見が改善し特に問題なく経過した。 骨盤内膿瘍に対する腹腔鏡手術は，ドレナージによりすみやかな炎症軽減が可能であり，かつ低侵襲であることから有用性は高い。一方で，（汎発性腹膜炎などで，）腸管麻痺を伴う症例では，腸管の膨隆のため腹腔鏡下の視野確保が困難であり，腹腔鏡手術の適応は慎重であるべきであると考える。Tubo-ovarian abscesses are classically treated with broad-spectrum antibiotics. Frequently, this approach fails, and surgical intervention becomes necessary. In recent years, laparoscopic surgery was positively introduced, and in our hospital, laparoscopic surgery, which is minimally invasive for patients, is selected as much as possible. We performed laparoscopy for four patients with tubo-ovarian abscess that did not improve with antibiotic treatment. No hemorrhage damage to other internal organs was noted in any of the patients. Inflammation was improved immediately, and postoperative progress was good. Usually, surgery for tubo-ovarian abscess is often technically difficult and associated with complications. For peritonitis accompanied with intestinal tract paralysis, it is difficult to secure the field of vision with the laparoscope, and therefore, the indications for laparoscopic surgery should be carefully considered before conducting the surgery

Effect of hospitalization on fetal growth

Objective : We aimed to demonstrate the effect of prolonged hospitalization on fetal growth in cases of threatened preterm labor (TPL). Methods : In this retrospective cohort study, we included women who received prenatal care for TPL but delivered their child after 36 weeks of gestation. These were compared with a control group of healthy pregnant women and fetuses delivered at term. Fetal growth was compared using biparietal diameter, abdominal circumference (AC), femur length, and estimated fetal weight (EFW) assessed using ultrasonography at 18, 26, 30, and 36 weeks of gestation. Neonatal parameters at birth were also compared. Results : In total, we enrolled 228 control women and 114 women with TPL who were treated with hospitalization, including bed rest. The AC at 30 and 36 weeks of gestation and EFW at 36 weeks of gestation were smaller in women treated with bed rest than for normal pregnant women. The mean duration of pregnancy was shorter in the hospitalization group than in the control group. Neonatal weight, length, head circumference, and chest circumference at birth were smaller after prolonged hospitalization for TPL than after normal pregnancy. Conclusion : Prolonged hospitalization for threatened preterm labor is associated with impaired fetal growth, particularly AC

The effects of ovariectomy and lifelong high-fat diet

In females, ovarian hormones play pivotal roles in metabolic, appetite, and body weight regulation. In addition, it has been reported that ovarian hormones also affect longevity in some species. Recently, it was found that the consumption of a high-fat diet aggravates ovariectomy-associated metabolic dysregulation in female rodents. The aim of this study was to investigate the hypothesis that long-term high-fat diet consumption and ovariectomy interact to worsen body weight regulation and longevity in female rats. At 21 days of age, female rats were weaned and randomly divided into two groups, one of which was given the high-fat diet, and the other was supplied with standard chow. At 23 weeks of age, each group was further divided into ovariectomized and sham-operated groups, and then their body weight changes, food intake, and longevity were measured until 34 months of age. The sham – high-fat diet rats exhibited greater body weight changes and higher feed efficiency than the sham – standard chow rats. On the other hand, the ovariectomized – high-fat diet and ovariectomized - standard chow rats displayed similar body weight changes and feed efficiency. The sham – high-fat diet and ovariectomized – standard chow rats demonstrated similar body weight changes and feed efficiency, indicating that the impact of ovariectomy on the regulation of body weight and energy metabolism might be similar to that of high-fat diet. Contrary to our expectations, ovariectomy and high-fat diet consumption both had small favorable effects on longevity. As the high-fat diet used in the present study not only had a high fat content, but also had a high caloric content and a low carbohydrate content compared with the standard chow, it is possible that the effects of the high-fat diet on body weight and longevity were partially induced by its caloric/carbohydrate contents. These findings indicate that the alterations in body weight and energy metabolism induced by ovariectomy and high-fat diet might not directly affect the lifespan of female rats