A phase 3 randomized controlled trial of a COVID-19 recombinant vaccine S-268019-b versus ChAdOx1 nCoV-19 in Japanese adults

We assessed S-268019-b, a recombinant spike protein vaccine with a squalene-based adjuvant, for superiority in its immunogenicity over ChAdOx1 nCoV-19 vaccine among adults in Japan. In this multicenter, randomized, observer-blinded, phase 3 study, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)–naïve participants (aged ≥ 18 years, without prior infection or vaccination against SARS-CoV-2) were randomized (1:1) to receive either S-268019-b or ChAdOx1 nCoV-19 as two intramuscular injections given 28 days apart. Participants who provided consent for a booster administration received S-268019-b at Day 211. The primary endpoint was SARS-CoV-2 neutralizing antibody (NAb) titer on Day 57; the key secondary endpoint was the seroconversion rate for SARS-CoV-2 NAb titer on Day 57. Other endpoints included anti–SARS-CoV-2 S-protein immunoglobulin (Ig)G antibody titer and safety. The demographic and baseline characteristics were generally comparable between S-268019-b (n = 611) and ChAdOx1 nCoV-19 (n = 610) groups. S-268019-b showed superior immunogenicity over ChAdOx1 nCoV-19, based on their geometric mean titers (GMTs) and GMT ratios of SARS-CoV-2 NAb on Day 57 by cytopathic effect assay (GMT [95% confidence interval {CI}] 19.92 [18.68, 21.23] versus 3.63 [3.41, 3.87]; GMT ratio [95% CI] 5.48 [5.01, 6.00], respectively; two-sided p-values < 0.0001). Additionally, NAb measured using a cell viability assay also showed similar results (GMT [95% CI] 183.25 [168.04, 199.84] versus 24.79 [22.77, 27.00]; GMT ratio [95% CI] 7.39 [6.55, 8.35] for S-268019-b versus ChAdOx1 nCoV-19, respectively; p < 0.0001). The GMT of anti–SARS-CoV-2 S-protein IgG antibody was 370.05 for S-268019-b versus 77.92 for ChAdOx1 nCoV-19 on Day 57 (GMT ratio [95% CI] 4.75 [4.34, 5.20]). Notably, immune responses were durable through the end of the study. S-268019-b elicited T-helper 1 skewed T-cell response, comparable to that of ChAdOx1 nCoV-19. After the first dose, the incidence of solicited systemic treatment-related adverse events (TRAEs) was higher in the ChAdOx1 nCoV-19 group, but after the second dose, the incidence was higher in the S-268019-b group. Headache, fatigue, and myalgia were the most commonly reported solicited systemic TRAEs, while pain at the injection site was the most frequently reported solicited local TRAE following both doses in both groups. No serious treatment-related adverse serious TRAEs events were reported in the two groups. S-268019-b was more immunogenic than ChAdOx1 nCoV-19 vaccine and was well tolerated (jRCT2051210151)

Efficacy and Safety of Switching Prostaglandin Analog Monotherapy to Tafluprost/Timolol Fixed-Combination Therapy

Purpose. To assess the efficacy and safety of switching from prostaglandin analog (PGA) monotherapy to tafluprost/timolol fixed-combination (Taf/Tim) therapy. Subjects and Methods. Patients with primary open-angle glaucoma, normal-tension glaucoma, or ocular hypertension who had received PGA monotherapy for at least 3 months were enrolled. Patients were examined at 1, 2, and 3 months after changing therapies. Subsequently, the patients were returned to PGA monotherapy. The examined parameters included intraocular pressure (IOP) and adverse events. A questionnaire survey was conducted after the switch to Taf/Tim therapy. Results. Forty patients with a mean age of 66.5 ± 10.3 years were enrolled; 39 of these patients completed the study protocol. Switching to Taf/Tim significantly reduced the IOP from 18.2 ± 2.6 mmHg at baseline to 14.8 ± 2.5 mmHg at 1 month, 15.2 ± 2.8 mmHg at 2 months, and 14.9 ± 2.5 mmHg at 3 months (P<0.001). Switching back to the original PGA monotherapy returned the IOP values to baseline levels. Taf/Tim reduced the pulse rate insignificantly. No significant differences were observed in blood pressure, conjunctival hyperemia, or corneal adverse events. A questionnaire showed that the introduction of Taf/Tim did not significantly influence symptoms. Conclusions. Compared with PGA monotherapy, Taf/Tim fixed-combination therapy significantly reduced IOP without severe adverse events

Ecological traits and their diversities of five Zostera marina populations in and around Hiroshima Bay, the Seto Inland Sea, Japan

広島湾および周辺海域の5カ所の生育地のアマモZostera marinaの生態的特性を2004年の繁茂期に調査した。調査場所は広島湾奥部の阿品（St.1），同湾央部の大黒神島（St.2），同湾口部の屋代島（St.3），柳井湾奥部の伊保庄（St.4），および同湾外部に位置する平郡島（St.5）である。アマモの分布水深は生育地により異なり，St.1，St.2では海底でのアオサ類等の堆積により，分布下限水深は1-2m（C.D.L. 基準）までである一方，他の生育地では4-6mまで分布した。アマモの平均現存量は120-180g DWm-2の範囲にあったが，アマモの株のサイズと密度は生育地により異なっていた。平均株密度は生育地により88-278 shoots m-2の範囲であり，St.3およびSt.5では特に浅所で小型の株が密生した。これらの群落では，総現存量に占める地下部現存量の割合が相対的に大きかった。一方，湾奥部に位置するSt.1とSt.4では，アマモの株は大型である一方生育密度は低かった。群落内の底質の粒度組成の相違から，波浪流動等の物理的環境が生育地間で異なることが示唆され，それぞれの場所のアマモの生態的特性はその影響を受けていると考えられた。Ecological traits of five Zostera marina populations in and around Hiroshima Bay were investigated in a luxuriant season of 2004. Study sites were located at the most inner (Ajina; St.1), center (O-kurokami-jima; St. 2) and near the mouth area (northern coast of Yahiro-jima; St. 3) of Hiroshima Bay, and at the inner area (Ihono-sho; St. 4) and the outside (Heigun-jima; St.5) of Yanai Bay which is the strait adjacent to Hiroshima Bay. The distribution depth (C.D.L.) was different among the populations. The lower depth of Zostera distribution was limited to 1-2 m at St.1 and 2 by algal-mat of Ulva spp. and other macroalgae, though it was 4-6 m at St. 3-5. Mean biomass was ranged in 120-180g DWm-2, but shoot size and density was different among the populations. Mean density ranged between 88-278 shoots m-2, and the populations at St.3 and 5 exhibited higher densities with smaller shoots especially in shallow stands of the two population. These stands also exhibited higher proportion of below-ground biomass to total biomass. On the contrary, populations in inner areas (St. 1 and 4) exhibited lower density with larger shoots. Physical conditions such as water motion induced by waves were different among the habitats which were shown in grain size compositions of the sediments, and this could affect the ecological traits of each Z. marina population.本調査は，水産庁委託「生物多様性に配慮したアマモ場造成技術開発調査事業」（平成16～18年度）の一環として実施されたものである

超音波ガイド下肝嚢胞内エタノール注入療法の2例

肝嚢胞2例に対して純無水エタノール(99.5%以上)注入療法を行った.方法は以下のごとくである.超音波ガイド下に嚢胞を穿刺し,J型ガイドワイヤーを用いてカテーテルを留置する.そして嚢胞内容を吸引した後,造影剤を注入して嚢胞造影を行う.その造影剤を排液し,純エタノールを注入して10～15分後にエタノールも完全に排液する.本法で重篤な合併症は発生しなかった.われわれは現在のところ,肝嚢胞の治療として純エタノール注入は有効かつ副作用の少ない優れた方法と考えている.Two cases of liver cyst were treated with absolute (99.5%) ethanol instillation. Under ultrasound guidance, a catheter was advanced over a J-guidewire into the cyst. The contents of the cyst were aspirated and contrast medium was injected. After the contrast medium was removed, absolute ethanol was injected and left for 10-15 minutes. Then it was evacuated completely. There were no major complications. It is considered that instillation of absolute ethanol is effective and harmless in the treatment of liver cyst

Detailed Analysis of Japanese Population Substructure with a Focus on the Southwest Islands of Japan

Uncovering population structure is important for properly conducting association studies and for examining the demographic history of a population. Here, we examined the Japanese population substructure using data from the Japan Multi-Institutional Collaborative Cohort (J-MICC), which covers all but the northern region of Japan. Using 222 autosomal loci from 4502 subjects, we investigated population substructure by estimating FST among populations, testing population differentiation, and performing principal component analysis (PCA) and correspondence analysis (CA). All analyses revealed a low but significant differentiation between the Amami Islanders and the mainland Japanese population. Furthermore, we examined the genetic differentiation between the mainland population, Amami Islanders and Okinawa Islanders using six loci included in both the Pan-Asian SNP (PASNP) consortium data and the J-MICC data. This analysis revealed that the Amami and Okinawa Islanders were differentiated from the mainland population. In conclusion, we revealed a low but significant level of genetic differentiation between the mainland population and populations in or to the south of the Amami Islands, although genetic variation between both populations might be clinal. Therefore, the possibility of population stratification must be considered when enrolling the islander population of this area, such as in the J-MICC study

脾機能亢進症に対するPartial Splenic Embolization(PSE)療法

著明な脾機能亢進症を認めた肝硬変症7例(肝癌合併5例)に対し部分的脾動脈塞栓術(PSE)を施行しPSE前後の末梢血液所見(血小板数,白血球数),肝機能,脾容積について検討した.血小板数は術後全例増加し2週目に最高値(術前値の平均3.8倍)に達した.うち2例において1年以上10×10^4/μl以上を維持できた.脾容積は術後平均約30%の縮小を認めた.PSEによる副作用は一過性の左側腹部痛,発熱,胸腹水がみられたがいずれも対症的治療で軽快した.以上の結果より脾機能亢進症を伴った肝硬変症,肝癌合併肝硬変症に対しPSEは血小板増加作用により出血傾向の改善に有用であると考えられた.Experiences of partial splenic embolization (PSE) in seven cases of liver cirrhosis with marked portalhypertension was reported. Changes in peripheral blood (platelets and white blood cells), liver function tests and splenic volume were examined. The peripheral platelet count at the 14th day was 3.8 times higher than that before PSE. The peripheral platelet count was kept higher than 10×10^4/μl for more than one year in two cases. The splenic volume decreased to about 70% of the original volume. The side effects of PSE included left hypochondrial pain, fever, ascites and pleural effusion, which could be easily controlled by palliative treatment. Thus, PSE was thought to be an effective method for the improvement of the platelet count in liver cirrhosis with portalhypertension

超音波ガイド下経皮的嚢胞ドレナージにより改善した膵尾部仮性嚢胞の1例

症例は飲酒歴の長い49歳男性.昭和60年5月,慢性膵炎に合併した膵尾部仮性嚢胞の摘除術を受けた.しかし,約5カ月後に膵尾部嚢胞が再発した.再手術の同意が得られなかったため,まず,超音波ガイド下経皮的嚢胞穿刺吸引を行ったが無効であった.そこで,超音波ガイド下経皮的ドレナージを施行し,約2カ月後に嚢胞を縮小せしめた.本例は嚢胞と主膵管に交通があり,膵液逆流による嚢胞再発の恐れがあったが,ドレナージチューブの閉鎖と開放をくり返すことで嚢胞を次第に縮小器質化させるよう工夫した結果,今のところ再発はみられていない.A case of pancreas tail cyst with an underlying disease of alcoholic pancreatitis in a 49-year-old man, was successfully treated by ultrasound guided drainage. In May 1985, he had a resection of the pancreas tail pseudocyst, but it recurred after five months. Then, ultrasound guided cyst aspiration was performed, but its effect was unsatisfactory. Therefore, drainage was performed under ultrasound guidance. About two months later the cyst disappeared