Immunogenicity and safety of a fully liquid aluminum phosphate adjuvanted Haemophilus influenzae type b PRP-CRM197-conjugate vaccine in healthy Japanese children: A phase III,randomized, observer-blind,multicenter, parallel-group study

BackgroundBroad use of monovalent Haemophilus influenzae type b (Hib) conjugate vaccines based on the capsular polysaccharide polyribosyl-ribitol phosphate (PRP), has significantly reduced invasive Hib disease burden in children worldwide, particularly in children aged <1 year. In Japan, PRP conjugated to tetanus toxoid (PRP-T) vaccine has been widely used since the initiation of public funding programs followed by a routine vaccination designation in 2013.MethodsWe compared the immunogenicity and safety of PRP conjugated to a non-toxic diphtheria toxin mutant (PRP-CRM₁₉₇) vaccine with the PRP-T vaccine when administered subcutaneously to healthy Japanese children in a phase III study. Additionally, we evaluated the immunogenicity and safety profiles of a diphtheria–tetanus acellular pertussis (DTaP) combination vaccine when concomitantly administered with either PRP-CRM₁₉₇ or PRP-T vaccines. The primary endpoint was the “long-term seroprotection rate”, defined as the group proportion with anti-PRP antibody titers ⩾1.0 μg/mL, after the primary series.ResultsLong-term seroprotection rates were 99.3% in the PRP-CRM₁₉₇ group and 95.6% in the PRP-T group. The intergroup difference (PRP-CRM₁₉₇ group – PRP-T group) was 3.7% (95% confidence interval: 0.099–7.336), demonstrating that PRP-CRM₁₉₇ vaccine was non-inferior to PRP-T vaccine (p < 0.0001). Furthermore, the “short-term seroprotection rate” (anti-PRP antibody titer ⩾0.15 μg/mL) before booster vaccination was higher in the PRP-CRM₁₉₇ group than in PRP-T. Concomitant administration of PRP-CRM₁₉₇ vaccine with DTaP vaccine showed no differences in terms of immunogenicity compared with concomitant vaccination with PRP-T vaccine and DTaP vaccine. Although CRM₁₉₇ vaccine had higher local reactogenicity, overall, both Hib vaccines had acceptable safety and tolerability profiles.ConclusionThe immunogenicity of PRP-CRM₁₉₇ vaccine administered subcutaneously as a three-dose primary series in children followed by a booster vaccination 1 year after the primary series induced protective levels of Hib antibodies with no safety or tolerability concerns.Clinical trial registry: Registered on ClinicalTrials.gov: NCT01379846     

Quality of life after single-incision laparoscopic cholecystectomy: A randomized,clinical trial

Background

Controversy continues as to whether single-incision laparoscopic cholecystectomy, with the somewhat larger incision at the umbilicus, may lead to a worse postoperative quality of life and more pain compared with the more classic 4-port laparoscopic cholecystectomy. The aim of this study was to compare single-incision and 4-port laparoscopic cholecystectomy from the perspective of quality of life.

Biochemical activities of lysosomal acid hydrolases in leukemic cells

The biochemical activities of 8 lysosomal acid hydrolases in leukemic cells from 48 patients were examined. Characteristic alterations were found in α-mannosidase, β-galactosidase and N-acetyl-β-glucosaminidase activities of leukemic cells. The level of α-mannosidase activity was much higher in myelo(mono)genous leukemias (AML, AMoL, AMMoL, CML and CMMoL) than in lymphogenous ones (ALL, T-cell leukemia, hairy cell leukemia and CLL) without exception. The β-galactosidase activity also differed as a result of α-mannosidase, except in T-cell leukemia. In T-cell leukemia it was within the range of normal lymphocytes, but in the other lymphogenous leukemias it was significantly below normal. N-acetyl-β-glucosaminidase activity in myelo(mono)genous leukemic cells was above the range of normal granulocytes. The changes in these enzyme levels were consistent. The lymphocytic or myelocytic nature of three cases of acute undifferentiated leukemia could be determined by enzyme studies. In two cases it was lymphocytic and in one it was myelocytic. The enzymatic abnormalities were also found in morphologically mature neutrophils from patients with not only chronic types (CML, CMMoL) but also acute types (AMoL, AMMoL) of leukemias, and were similar to those of their respective leukemic cells. Analysis of lysosomal enzymes (at least three of those mentioned above), can elucidate one of the biochemical properties of leukemic cells and may be valuable in the differentiation of leukemias.     

施延庆治疗震颤麻痹经验

施延庆主任中医师是全国首批500名学术经验继承的名老中医之一。施老擅长温针疗法,在治疗疑难杂病中独树一帜。历年来施老以温针治疗震颤麻痹症数十例,取得很好的疗效,今介绍于下,供同道参考。1 病因病机震颤麻痹又称帕金森病,是以进行性运动徐缓,肌肉强直及震颤为特征的病症,多发于中老年人,60岁以上的人口中可达1％,是一种较常见的神经系统变性疾病,属中医“颤振”、“痉病”等范畴。施老以中医针     

聂小圃治疗不寐经验

聂小圃(1943～),男,1968年7月毕业于江西中医学院,毕业后在江西省万年县人民医院中医科从事中医临床工作,1985年调入万年县中医院,任门诊部主任.1998年晋升为主任中医师,2002年被遴选为第三批全国中医药专家学术经验继承工作指导老师.从医近40载,临证擅长内、妇科常见病及疑难杂症的诊治,如脾胃肝胆疾病、痿证、痹证、不寐、月经不调等.     

中国汉译西医学著作在日本的流传和影响

调查了十九世纪汉译西洋医学著作在日本的出版和流传情况，有９种汉译西洋医学著作曾在日本出版，其中６种曾多次再版，７种有和训或和译本，这些著作曾在日本医生中广泛流传，促进了西洋医学在日本的传播和普及，对日本医学从传统医学向现代医学的转变起过一定的作用。本文还分析了汉译西洋医学著作能够在日本广泛流传的原因     

盘龙七片治疗不稳定性冠心病心绞痛临床观察

对５８例不稳定性冠心病心绞痛患者，用盘龙七片（３８例）及复方丹参片（２０例）治疗，观察治疗前后心电图ＳＴ段，血液流变学及临床症状的变化，结果：盘龙七片组心电图ＳＴ段的缺血变化明业优于复方丹参片组（Ｐ〈０．０１），血浆粘度及纤维蛋白原下降亦明显（Ｐ〈０．０５或Ｐ〈０．０１），结论：盘龙七片虽是一种抗风湿，骨伤的中成药，但同样对治疗不稳定性冠心病心绞痛有一定的疗效。     

张琪治疗劳淋经验

张琪(1922～),男,中医世家.现任黑龙江省中医研究院研究员、主任医师,兼任黑龙江中医药大学教授、博士生导师,黑龙江省中医药学会名誉会长,中华中医药学会顾问.享受政府特殊津贴.精于仲景学说,兼通金元四大家及温病学家的学术理论,对中西汇通亦多有涉猎,尤对王清任、张锡纯的学术思想研究较为深入.善治多种疑难病症,对慢性肾脏疾病的治疗有较深造诣,为黑龙江省中医肾病重点学科带头人.主持完成了"补脾肾泻湿浊解毒活血法治疗慢性肾功能衰竭的临床与实验研究"等多项科研项目,并获省级、部级奖励.代表著作有<脉学刍议>、<临床经验集>、<张琪临证经验荟要>等,发表学术论文50余篇.