Good Post-Marketing Surveillance Practice (GPMSP) defines “post-marketing clinical trials” as industry-initiated studies constituting a part of Post-Marketing Surveillance (PMS). Post-marketing clinical studies play the role of gathering further information on appropriate drug use. This is why the proper conduct of medically required post-marketing clinical trials would facilitate the proposal of new treatments with improved efficacy and/or safety over existing therapies, thereby contributing to the promotion of EBM and to the advance of healthcare. In the case of anticancer drugs, in particular, post-marketing clinical trials are of great importance, because they also serve as Phase III studies. In reality, however, pharmaceutical companies are not very active in conducting these studies because of the many issues involved. To solve or alleviate these problems, the Japan Pharmaceutical Manufacturers Association and COTEC are making aggressive efforts.

As of April 2005, “Shihango-rinsyoushiken” defined in the GPMSP was renamed “Seizouhanbaigo-rinsyoushiken” in the revised regulations (GPSP). The relevant part of the GCP was also modified at the same time. Strictly speaking, therefore, post-approval clinical trials are not the same as postmarketing clinical trials. This report provides an explanation of post-approval clinical trials and the related regulations. It is generally considered that post-approval clinical trials, which help gather more clinical information, should be actively pursued for the further development of approved drugs in the post-marketing setting. However, the results of the questionnaire show that pharmaceutical companies are not willing to conduct them, mainly due to the high cost. To improve the economic efficiency of post-approval clinical trials, it is necessary to streamline monitoring activities that account for 40% of the cost.

In this seminar, the effects of acupuncture and moxibustion on muscle diseases and muscular functions/metabolism were reported, and the status of these techniques were summarized.
In the clinical study section, it was reported that the effects of treatment on muscle diseases and muscular functions were evaluated using objective criteria, such as electromyograms. In the review of the methods for the evaluation of muscular functions using surface electromyograms, the static electromyograms, dynamic electromyograms, and power-spectrum analysis were presented, and the effects of acupuncture and manual treatment on diseases mainly in locomotor organs and their problems were discussed. For example, 72.9% of the 48 patients with cervical dystonia were found to show improvement by 10 courses of acupuncture treatment, and effects were observed in all patients by electromyography. Similar effects were obtained with patients with drug-induced dystonia. In many of the patients with writer's cramp who underwent 10 courses of acupuncture treatment, improvement in writing tests, subjective evaluation, and the strength of pen stokes were observed.
In the review of the basic studies, the effects of acupuncture, electroacupuncture, and transcutaneous electrical nerve stimulation (TENS) on muscular tension, muscular metabolism (energy metabolism, intracellular pH, lactate metabolism), muscular circulation, and noxious and non-noxious motor reflex were surveyed, and their mechanisms and problems were discussed.

Optical coherence tomography (OCT) is an optical analog of intravascular ultrasound (IVUS) that can be used to examine the coronary arteries and has 10-fold higher resolution than IVUS. Based on polarization properties, OCT can differentiate tissue characteristics (fibrous, calcified, or lipid-rich plaque) and identify thin-cap fibroatheroma. Because of the strong attenuation of light by blood, OCT systems required the removal of blood during OCT examinations. A recently developed frequency-domain OCT system has a faster frame rate and pullback speed, making the OCT procedure more user-friendly and not requiring proximal balloon occlusion. During percutaneous coronary intervention (PCI), OCT can provide detailed information (dissection, tissue prolapse, thrombi, and incomplete stent apposition [ISA]). At follow-up examinations after stent implantation, stent strut coverage and ISA can be assessed. Several OCT studies have demonstrated delayed neointimal coverage following drug-eluting stent (DES) implantation vs. bare metal stent (BMS) placement. While newer DESs promote more favorable vascular healing, the clinical implications remain unknown. Recent OCT studies have provided insights into restenotic tissue characteristics; DES restenotic morphologies differ from those with BMSs. OCT is a novel, promising imaging modality; with more in-depth assessments of its use, it may impact clinical outcomes in patients with symptomatic coronary artery disease.
*Angioplasty, Balloon, Coronary/adverse effects/instrumentation ; Coronary Angiography ; Coronary Artery Disease/*pathology/radiography/*therapy/ultrasonography ; Coronary Restenosis/etiology/pathology ; Coronary Vessels/*pathology/ultrasonography ; Humans ; Predictive Value of Tests ; Severity of Illness Index ; Stents ; *Tomography, Optical Coherence ; Treatment Outcome ; Ultrasonography, Interventional

Cystic adventitial disease of the popliteal artery is a rare cause of lower extremity occlusive disease. We report 2 cases of this disease. Two male patients aged 27 and 59 year old complaining of intermittent claudication visited our vascular service. Angiography showed a smooth sharp defect of the popliteal artery. Postcontrast computed tomography (CT) scanning and magnetic resonance image (MRI) showed a cystic lesion around the popliteal artery. One patient underwent resection of the cyst, which in the other patient endscopic surgery was performed with the aid of intravascular ultrasonograpy and intravascular endscope. Fifty three cases of this disease have been reported in Japan so far. These patients included 45 men and 8 women with a mean age of 47.7, ranging from 19 to 76 years old. Chief complaints were commonly intermittent claudication and sensory disturbance. In all cases, angiography revealed a smooth sharp defect. Recently 3D-CT scan, ultrasonography and magnetic resonance angiography (MRA) also are accurate for cystic lesions around the popliteal artery and these new technologies easily distinguish such cases from arteriosclerosis obliterans, Buerger disease and popliteal entrapment syndrome. Treatment consist resection of the cyst, in 27 cases reconstruction of the popliteal artery using a saphenous vein graft or artificial graft in 19 cases, percutaneus aspiration under the guide of CT and endscopy in 2 cases and 1 with spontaneous resolution, was seen in 1 case. In conclusion, we encountered 2 cases of cystic adventitial disease of the popliteal artery. 3D-CT scan, ultrasonography and MRA were useful for preoperative diagnosis and evaluation of postoperative condition.

The preoperative pulmonary arterial pressure of 38 patients aged over 50 undergoing surgical closure of a secundum atrial septal defect was studied. They were divided into three groups according to systolic pulmonary arterial pressure (PAP): Group A (PAP<30mmHg, n=14), Group B (30≤PAP<50mmHg, n=16), and Group C (PAP≥50mmHg, n=8). The mean age of group C patients was older than that of group A patients. With higher PAP, the Pp/Ps, Rp/Rs and cardiothoracic ratios increased, atrial fibrillation and heart failure (NYHA≥2) were more frequent, and PaO₂ levels declined. There were no differences in left to right shunt ratio and Qp/Qs among the three groups. The PAP and Rp/Rs were under 70mmHg and 0.30, respectively in all patients. High pulmonary blood flow seems to be the cause of pulmonary hypertension in most elderly patients because PAP and Rp/Rs decreased after surgery in all groups. Findings of cardiomegaly and heart failure also improved after surgery. Surgical intervention is recommended even in elderly patients with a ASD.

A case of pseudoaneurysm of the external iliac artery after a total hip arthroplasty is reported. A 48-year-old man had undergone a total left hip arthroplasty 5 years previously. Acute arterial occlusion (AAO) of the left lower extremity occurred 3 times. AAO was due to pseudoaneurysm of the external iliac artery, which was detected by rotating digital subtraction angiography (DAS). Aneurysmectomy and reconstruction were carried out. Rotating DSA was useful for the diagnosis of this unusual case of pseudoaneurysm of the external iliac artery after a total hip arthroplasty is unusual.

Objective: While antipsychotics are necessary for relapse prevention in the treatment of schizophrenia in general, some minority of patients may be maintained without continuous antipsychotic treatment. However, the characteristics of such patients are not well known and previous reports have not evaluated key elements such as physical comorbidities and functioning. Methods: Among 635 patients with schizophrenia who participated in a 12-year follow-up, those who were maintained without antipsychotic treatment for at least one year after the study were investigated. The patients underwent comprehensive assessments, including Positive and Negative Syndrome Scale (PANSS) for psychopathology, Cumulative Illness Rating Scale for Geriatrics (CIRS-G) for physical comorbidities, and Functional Assessment for Comprehensive Treatment of Schizophrenia (FACT-Sz), Barthel Index, and EuroQoL five dimensions (EQ5D) for function. Results: Six patients were included (mean ± standard deviation age, 66.8 ± 17.4 years; 4 inpatients). The four inpatients were old (77.8 ± 4.8 years) and chronically ill (duration of illness, 49.3 ± 12.5 years) with a high PANSS score (total score, 118.0 ± 9.8; negative syndrome subscale, 41.3 ± 6.9), low functioning (FACT-Sz, 9.8 ± 3.6; Barthel Index, 8.8 ± 9.6), and serious physical comorbidities (CIRS-G, 15.5 ± 1.1). By contrast, the two outpatients were relatively young (45.0 ± 12.0 years) and clinically in good condition (PANSS total score, 44.5 ± 0.5; Barthel Index, 100 for both; EQ5D, 0.85 ± 0.04). Conclusion Although the number is limited, two types of patients with schizophrenia were identified who were free from ongoing antipsychotic treatment; 1) older chronic inpatients with serious physical comorbidities, and 2) younger outpatients with milder impairments. Future explorations are needed to identify those who will be successfully withdrawn from continuous antipsychotic treatment.

Objective：To investigate the effects of being instructed to use a squat method on posture and the joints involved in the pelvic position.Methods：The subjects were 15 healthy men (mean age, 23.8 ± 1.0 years)．We set free and squat conditions as the measurement tasks and instructed the subjects to lift an object from the floor. Differences in joint angles between the two conditions at the time the object left the floor were examined using a corresponding t test. To assess the joints that affect the pelvic anterior tilt angle, lumbar and limb joint angles and the correlation coefficient between them were calculated.Results：In the squat condition, the extension angles of the thoracic vertebrae, upper and lower thoracolumbar transitional vertebrae, and upper lumbar vertebrae；the pelvic posterior tilt angle；flexion angles of the hip and knee joints；and dorsiflexion angle of the ankle joint increased. The pelvic anterior tilt angle was related to the knee and ankle joint angles in both conditions.Conclusion：Instructions to use a squat method increased the trunk extension and leg flexion angles. In both conditions, the knee and ankle joints affect the pelvic anterior tilt angle.

Objective：To investigate the effects of being instructed to use a squat method on posture and the joints involved in the pelvic position.Methods：The subjects were 15 healthy men (mean age, 23.8 ± 1.0 years)．We set free and squat conditions as the measurement tasks and instructed the subjects to lift an object from the floor. Differences in joint angles between the two conditions at the time the object left the floor were examined using a corresponding t test. To assess the joints that affect the pelvic anterior tilt angle, lumbar and limb joint angles and the correlation coefficient between them were calculated.Results：In the squat condition, the extension angles of the thoracic vertebrae, upper and lower thoracolumbar transitional vertebrae, and upper lumbar vertebrae；the pelvic posterior tilt angle；flexion angles of the hip and knee joints；and dorsiflexion angle of the ankle joint increased. The pelvic anterior tilt angle was related to the knee and ankle joint angles in both conditions.Conclusion：Instructions to use a squat method increased the trunk extension and leg flexion angles. In both conditions, the knee and ankle joints affect the pelvic anterior tilt angle.