Astaxanthin (AX) is a red carotenoid widely distributed in nature and possesses excellent antioxidant activity by quenching singlet oxygen and inhibiting lipid peroxidation. Recently, numerous biological activities of AX are reported. AX has been used for health supplements and cosmetics and is receiving increasing attention for complementary and alternative medicine. In this paper, we would like to clarify aspects of AX by presenting the origin, chemical properties, comparison with other carotenoids. Furthermore, we report the results of in vitro, in vivo analysis and clinical studies related to anti-lipid peroxidation, anti-inflammatory effects, blood flow improvement, effects on metabolic syndrome, anti-eye fatigue, effects on Helicobacter pylori, improved lipid metabolism, muscle endurance, effects on skin health, male infertility, pharmacokinetics, and safety.

A long-term safety study was conducted with astaxanthin derived from Haematococcus pluvialis algae extract. Fifteen healthy volunteers took 9 mg of astaxanthin daily for 12 weeks. Physiological (including doctor’s consultation), haematological, biochemical, and urinary markers were examined at weeks 0, 4, 8 and 12. No adverse effects or clinical changes were observed throughout the test period. It was concluded that a healthy adult can consume 9 mg of astaxanthin derived from Haematococcus pluvialis algae extract for 12 weeks without any safety concern.

Astaxanthin, a red carotenoid, has been known to possess excellent antioxidant activity and various biological activities, thereby attracting attention as a functional food material.The safety of astaxanthin administered orally has been demonstrated in human clinical studies for about ten years.In this review, we summarized the clinical studies related to safety, as well as studies on genotoxicity, and acute and subchronic toxicity, with a focus on AstaREAL, an astaxanthin product derived from Haematococcus pluvialis which has been reported in numerous human clinical studies to be safe and to have multiple health benefits.Furthermore, based on the latest research, we reviewed the effect of astaxanthin on drug-metabolizing enzymes involved in drug interactions, and concluded that the safety of H. pluvialis-derived astaxanthin, AstaREAL has been widely confirmed.

A lower abdominal tumor with thrill and bruit was pointed out in a 59-year-old female. Angiography showed a pelvic arteriovenous malformation (AVM) with remarkably dilated vessels resembling an aneurysm. Feeding arteries for this AVM originated from the right internal iliac artery, right lumbar artery and right renal artery, and drainage blood flowed into the inferior vena cava from the dilated vessel via a large vein. At operation the right internal iliac artery and right lumbar artery were ligated and the dilated vessel with AVM, which connected with the right renal artery, was resected. An angiography 16 days after the operation revealed the normal arteries without AVM and the right internaal iliac artery filled through collateral arteries. Recently catheter embolization in frequently the first choice for treatment of AVM. However, in the case of AVM with aneurysmal dilated vessels, surgical resection should be selected.

We treated 162 patients by isolated CABG with a left internal thoracic artery (LITA) anastomosed to the left anterior descending artery and a radial artery anastomosed to the circumflex artery between August 1996 and December 2002. Late angiograms were performed 6 to 65 months (21.7±15.8) after the operation. The purpose of this study was to compare midterm results of radial arteries anastomosed to the side wall of LITA (group Y) with those anastomosed to the aorta (group AC). There were no operative deaths in either group and no difference in the postoperative complication rate including cerebral infarction. The early patency of group Y was lower than that of group AC (group AC: 97.8%, group Y: 87.1%, p=0.017), and also the late patency of group Y was significantly lower than that of group AC (group AC: 90.9%, group Y: 36.4%, p=0.0008). All of the early patent radial artery grafts in group AC were patent on late angiograms, but 3 of the 25 anastomoses in group Y which were clearly patent on early angiograms later showed a string sign later. When using a radial artery graft in circumflex artery territory, we recommend an aorto-coronary bypass graft rather than Y-graft.

Scrotal hematocele is defined as retention of blood in the tunica vaginalis. Although it is usually an acute change, it can also have a chronic course. A 55-year-old man was being treated for hypertension and diabetes in the Department of Internal Medicine at our hospital. He visited the hospital’s Department of Urology because 3 months earlier he had noticed enlargement of the right scrotum without trauma to the perineum. The right scrotum was swollen to the size of a small child’s head. Imaging examination showed no testicular tumor. Puncture yielded 550 ml of bloody fluid. Surgery was performed to find and treat the source of bleeding. The tunica vaginalis was highly irregular and thickened. Considering the possibility of mesothelioma or other malignancy, we removed the testis after transection of the spermatic cord as proximally as possible. The histopathological diagnosis was encapsulated hematoma with cholesterin granuloma, which was diagnosed as chronic scrotal hematocele.

STUDY DESIGN: Retrospective case-control study. PURPOSE: To determine whether kissing spine is a risk factor for recurrence of sciatica after lumbar posterior decompression using a spinous process floating approach. OVERVIEW OF LITERATURE: Kissing spine is defined by apposition and sclerotic change of the facing spinous processes as shown in X-ray images, and is often accompanied by marked disc degeneration and decrement of disc height. If kissing spine significantly contributes to weight bearing and the stability of the lumbar spine, trauma to the spinous process might induce a breakdown of lumbar spine stability after posterior decompression surgery in cases of kissing spine. METHODS: The present study included 161 patients who had undergone posterior decompression surgery for lumbar canal stenosis using a spinous process floating approaches. We defined recurrence of sciatica as that resolved after initial surgery and then recurred. Kissing spine was defined as sclerotic change and the apposition of the spinous process in a plain radiogram. Preoperative foraminal stenosis was determined by the decrease of perineural fat intensity detected by parasagittal T1-weighted magnetic resonance imaging. Preoperative percentage slip, segmental range of motion, and segmental scoliosis were analyzed in preoperative radiographs. Univariate analysis followed by stepwise logistic regression analysis determined factors independently associated with recurrence of sciatica. RESULTS: Stepwise logistic regression revealed kissing spine (p=0.024; odds ratio, 3.80) and foraminal stenosis (p<0.01; odds ratio, 17.89) as independent risk factors for the recurrence of sciatica after posterior lumbar spinal decompression with spinous process floating procedures for lumbar spinal canal stenosis. CONCLUSIONS: When a patient shows kissing spine and concomitant subclinical foraminal stenosis at the affected level, we should sufficiently discuss the selection of an appropriate surgical procedure.
Case-Control Studies ; Constriction, Pathologic ; Decompression ; Humans ; Intervertebral Disc Degeneration ; Logistic Models ; Magnetic Resonance Imaging ; Odds Ratio ; Postoperative Complications ; Range of Motion, Articular ; Recurrence ; Retrospective Studies ; Risk Factors ; Sciatica* ; Scoliosis ; Spinal Canal ; Spine ; Weight-Bearing

PURPOSE: The pathological mechanism of lumbar spinal stenosis is reduced blood flow in nerve roots and degeneration of nerve roots. Exercise and prostaglandin E1 is used for patients with peripheral arterial disease to increase capillary flow around the main artery and improve symptoms; however, the ankle-brachial index (ABI), an estimation of blood flow in the main artery in the leg, does not change after treatment. Lumbar spinal nerve roots contain somatosensory, somatomotor, and unmyelinated autonomic nerves. Improved blood flow by medication with prostaglandin E1 and decompression surgery in these spinal nerve roots may improve the function of nerve fibers innervating muscle, capillary, and main vessels in the lower leg, resulting in an increased ABI. The purpose of the study was to examine whether these treatments can improve ABI. MATERIALS AND METHODS: One hundred and seven patients who received conservative treatment such as exercise and medication (n=56) or surgical treatment (n=51) were included. Low back pain and leg pain scores, walking distance, and ABI were measured before treatment and after 3 months of conservative treatment alone or surgical treatment followed by conservative treatment. RESULTS: Low back pain, leg pain, and walking distance significantly improved after both treatments (p<0.05). ABI significantly increased in each group (p<0.05). CONCLUSION: This is the first investigation of changes in ABI after treatment in patients with lumbar spinal stenosis. Improvement of the spinal nerve roots by medication and decompression surgery may improve the supply of blood flow to the lower leg in patients with lumbar spinal stenosis.
Adult ; Aged ; Aged, 80 and over ; Alprostadil/therapeutic use ; *Ankle Brachial Index ; Decompression, Surgical/methods ; Female ; Humans ; Low Back Pain/drug therapy/physiopathology/surgery/*therapy ; Lumbar Vertebrae/physiopathology/*surgery ; Male ; Middle Aged ; Pain/surgery ; Spinal Nerve Roots/physiopathology ; Spinal Stenosis/physiopathology/*surgery/*therapy ; Treatment Outcome

PURPOSE: To examine the effects of conservative and surgical treatments for nocturnal leg cramps in patients with lumbar spinal stenosis (LSS). Nocturnal leg cramps is frequently observed in patients with peripheral neuropathy. However, there have been few reports on the relationship between nocturnal leg cramps and LSS, and it remains unknown whether conservative or surgical intervention has an impact on leg cramps in patients with LSS. MATERIALS AND METHODS: The subjects were 130 LSS patients with low back and leg pain. Conservative treatment such as exercise, medication, and epidural block was used in 66 patients and surgical treatment such as decompression or decompression and fusion was performed in 64 patients. Pain scores and frequency of nocturnal leg cramps were evaluated based on self-reported questionnaires completed before and 3 months after treatment. RESULTS: The severity of low back and leg pain was higher and the incidence of nocturnal leg cramps was significantly higher before treatment in the surgically treated group compared with the conservatively treated group. Pain scores improved in both groups after the intervention. The incidence of nocturnal leg cramps was significantly improved by surgical treatment (p=0.027), but not by conservative treatment (p=0.122). CONCLUSION: The findings of this prospective study indicate that the prevalence of nocturnal leg cramps is associated with LSS and severity of symptoms. Pain symptoms were improved by conservative or surgical treatment, but only surgery improved nocturnal leg cramps in patients with LSS. Thus, these results indicate that the prevalence of nocturnal leg cramps is associated with spinal nerve compression by LSS.
Adult ; Aged ; Aged, 80 and over ; Decompression, Surgical ; Female ; Humans ; Leg/*pathology ; Low Back Pain/epidemiology/etiology ; Male ; Middle Aged ; Pain/*epidemiology/*etiology ; Prospective Studies ; Questionnaires ; Spinal Stenosis/*complications/*physiopathology/surgery

In Japan, a re-examination system was introduced in the 1970s, and Post-marketing surveillance (PMS) has been conducted in many cases after the launch of new drugs or the approval of new indications for existing drugs. The revised Good Post-marketing Study Practice (r-GPSP) was enacted in 1 April 2018, and more scientific approach has been required for PMS. The survey aims to identify what kinds of change occurred in the PMS planned after r-GPSP enacted. As for the study method, after confirming the review report of each product, Risk Management Plan (RMP), and the package insert, and extracting necessary items, tabulation and analysis were performed. As a result of analysis, Drug Use Investigations (DUI) still accounted for more than 60％ of the total in PMS. Regarding the target number of DUI, Fifty-eight out of 90 had a sample size of 500 or fewer, only 3 studies exceeded 3,000. Regarding the newly introduced Post-marketing database surveillance (DB study) after r-GPSP enacted, 13 products and 18 surveillances were confirmed, although the number was not as large as the number of DUI. The most used database was Medical Data Vision Co., Ltd. (MDV), which were used in twelve DB studies, and cardiovascular disease and interstitial pneumonia were set as survey targets for safety considerations in multiple studies. There was no Drug Use Comparative Investigation. Furthermore, there were two products which were approved on the condition with re-examination period but did not required additional Pharmacovigilance activities. In terms of sample size calculation, 88 out of 135 studies mentioned rationales for setting the number of samples. Of which, 58 studies had statistical rationales. In many studies, the sample size calculation method that was commonly used in conventional PMSs, called ‘Rule of three’ was described as the statistical rational. After r-GPSP enacted, newly introduced Post-marketing surveillance, including DB surveys, and the scientific approach recommended by PMDA have been adopted in companies gradually. In the future, in order to further promote the scientific approach, it is necessary to further improve the capability of human resources of companies involved in PMS.