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《Vaccine》2016,34(38):4635-4641
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 相似文献
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Eitaro Ito Akihiro Takai Yoshinori Imai Hiromi Otani Yoshihiro Onishi Yosuke Yamamoto Kohei Ogawa Taiji Tohyama Shunichi Fukuhara Yasutsugu Takada 《Surgery》2019,165(2):353-359
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.Methods
This study was a multicenter, parallel-group, open-label, randomized clinical trial. A total of 120 patients who were scheduled to undergo elective cholecystectomy were randomly assigned 1:1 into the single-incision laparoscopic cholecystectomy or the 4-port laparoscopic cholecystectomy group and then assessed continuously for 2 weeks during the postoperative period. The primary outcome was quality of life, defined as the time to resume normal daily activities. Postoperative pain was also assessed. To explore the heterogeneity of treatment effects, we assessed the interactions of sex, age, and working status on recovery time.Results
A total of 58 patients in the single-incision group and 53 in the 4-port group (n?=?111, 47 male, mean age 57 years) were analyzed. The mean time to resume daily activities was 10.2 days and 8.8 days, respectively, for single-incision and 4-port laparoscopic cholecystectomy (95% confidence interval –0.4 to 3.2, P?=?.12). Similarly, the time to relief from postoperative pain did not differ significantly between the groups. Statistically insignificant but qualitative interactions were noted; in the subgroups of women, full-time workers, and patients younger than 60 years, recovery tended to be slower after single-incision laparoscopic cholecystectomy.Conclusion
Postoperative quality of life did not differ substantially between single-incision laparoscopic cholecystectomy and 4-port laparoscopic cholecystectomy. Patients younger than 60 years, women, and full-time workers tended to have a somewhat slower recovery after single-incision laparoscopic cholecystectomy. 相似文献5.
Tanaka Takeo Kobayashi Masao Saito Osamu Kamada Nanao Kuramoto Atsushi Usui Tomofusa 《Clinica chimica acta; international journal of clinical chemistry》1981,117(2):121-131
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. 相似文献
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目的 通过比较中日两围老年人生活满足感,探讨老年人社区护理的发展方向。方法 中国大连市选取60岁以上老年人,进行人户调查,日本滨松市选取俱乐部的65岁以上老年人,填写问卷。结果 除在与亲人、朋友交往及存钱以防万一等方面外,2国老年人在其他生活满足感方面比较,差异均有统计学意义,P〈0.05。结论 中日两国不同的经济基础导致了不同层次需求的差异。在中国发展老年人社区护理,一方面可以借鉴国外经验,从物质基础上改进和完善;另一方面,借助传统文化优势,从社会风气上进行促进。 相似文献
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Jungsun Park MD PhD Naomi Hisanaga MD Yangho Kim MD MPH 《American journal of industrial medicine》2009,52(8):625-632
Many corporations move their manufacturing facilities or technologies from developed to developing countries. Stringent regulations have made it costly for industries to operate in developed, industrialized countries. In addition, labor costs are high in these countries, and there is increasing awareness among the general public of the health risks associated with industry. The relocation of hazardous industries to developing countries is driven by economic considerations: high unemployment, a cheaper labor force, lack of regulation, and poor enforcement of any existing regulations make certain countries attractive to business. The transfer of certain industries from Japan to Korea has also brought both documented occupational diseases and a new occupational disease caused by chemicals without established toxicities. Typical examples of documented occupational diseases are carbon disulfide poisoning in the rayon manufacturing industry, bladder cancer in the benzidine industry, and mesothelioma in the asbestos industry. A new occupational disease due to a chemical without established toxicities is 2‐bromopropane poisoning. These examples suggest that counter‐measures are needed to prevent the transfer of occupational health problems from a developed to a developing country. Corporate social responsibility should be emphasized, close inter‐governmental collaboration is necessary and cooperation among non‐governmental organizations is helpful. Am. J. Ind. Med. 52:625–632, 2009. © 2009 Wiley‐Liss, Inc. 相似文献
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Cytogenetic characterization of ten cases of Ph1-positive acute myelogenous leukemia 总被引:1,自引:0,他引:1
Chromosome banding analyses were made on 10 cases of Ph1-positive AML (7 M1 and 3 M2). The standard type Ph1 translocation, t(9q +;22q -), was identified in all of them. Karyotypically normal cells were observed in 6-65% of bone marrow metaphases at the initial cytogenetic examination of 7 patients, whereas the remaining 3 patients had only Ph1-positive cells at diagnosis. Follow-up studies performed in 5 cases indicated that the frequency of karyotypically normal cells increased up to 81-100% when the patients were in remission, whereas it was much reduced in relapse. In 5 cases, there was observed a clone of cells in which the Ph1 translocation was the sole karyotypic abnormality. Various types of other chromosome abnormalities, in addition to the Ph1, were observed in all cases, among which-7 was the most frequent, being found in three cases as a stem line. Other additional changes encountered were + Ph1, del(5), i(17q), - 10, + 18, + X, and various numerical and structural changes including certain secondary translocations that occurred in the Ph1 (22q -) or its partner (9q +). The types and frequencies of these additional changes appeared to be different from those found in the acute phase of CML or in Ph1-positive ALL. 相似文献
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Masaharu Muranaka Shuji Suzuki Kazuhiro Koizumi Hiroshi Igarashi Hiroshi Okumura Koyo Takeda Kenji Tadokoro Yoshihiko Horiuchi 《The Journal of allergy and clinical immunology》1978,62(5):276-282
All of the five commercially available benzylpenicillin preparations obtained from different sources and a PcG preparation prepared by filtration of a commercial PcG on Sephadex G10 elicited the systemic anaphylactic reactions in guinea pigs which had been immunized with benzylpenicilloyl (BPO)-Ascaris extract conjugate (BPO-As) mixed with aluminum hydroxide gel. These preparations could evoke no such reactions in guinea pigs immunized with BPO-bovine gamma globulin conjugate (BPO-BGG) emulsified with complete Freund's adjuvant. The severity of the systemic anaphylactic reactions correlated significantly with the titers of either 8-day passive cutaneous anaphylactic (8-day PCA) reactions or 4-hr PCA reactions evoked with the same benzylpenicillin preparations. In vitro benzylpenicillin preparation contracted the tracheas of the guinea pigs immunized with BPO-As. These results indicated that the commercially available benzylpenicillin preparations have enough antigenicity to evoke systemic anaphylactic reactions in guinea pigs immunized with BPO-As mixed with aluminum hydroxide gel. Such guinea pigs represent an animal model for investigation of penicillin allergy. 相似文献