吸附型四价联合疫苗(Biken Techno Corp.)(Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio(Sabin strain)Combined Vaccine(Minimum Requirements for Biological Products))

概要

基本信息

药物类型

联合疫苗、预防性疫苗、多价疫苗

别名

4 種混合ワクチン、Combined vaccine(Biken Techno Corp.)、DPT-IPV

+ [9]

靶点-

作用机制

免疫刺激剂

治疗领域

感染神经系统疾病呼吸系统疾病+ [1]

在研适应症

白喉脊髓灰质炎破伤风+ [1]

非在研适应症

细菌性脑膜炎

原研机构-

在研机构

Research Fdn for Microbial Diseases of Osaka University

非在研机构

Mitsubishi Tanabe Pharma Corp.

最高研发阶段批准上市

首次获批日期

日本 (2012-07-27),

白喉脊髓灰质炎破伤风+ [1]

最高研发阶段(中国)-

特殊审评-

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关联

4

项与吸附型四价联合疫苗(Biken Techno Corp.) 相关的临床试验

NCT02140047 / Completed临床2期

Exploratory Clinical Study of MT-2301 in Healthy Infants (Phase 2)

The purpose of this study is to evaluate efficacy and safety of MT-2301 when co-administered with DPT-IPV using ActHIB® as a control in healthy infants.

开始日期2014-04-01

申办/合作机构

Mitsubishi Tanabe Pharma Corp.

JPRN-UMIN000022692 / CompletedN/A

Study to investigate the interchangeability between different polio vaccines (OPV, IPV and DPT-IPV) based on immunogenicity and safety - Study of interchangeability between polio vaccines

开始日期2011-11-15

申办/合作机构

College of Healthcare Management

JPRN-jRCT2080221090 / Unknown status临床3期IIT

Confirmatory study of BK-4SP in healthy infants.

开始日期2010-05-25

申办/合作机构-

100 项与吸附型四价联合疫苗(Biken Techno Corp.) 相关的临床结果

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100 项与吸附型四价联合疫苗(Biken Techno Corp.) 相关的转化医学

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100 项与吸附型四价联合疫苗(Biken Techno Corp.) 相关的专利（医药）

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70

项与吸附型四价联合疫苗(Biken Techno Corp.) 相关的文献（医药）

2024-11-01·American Journal of Ophthalmology

Postoperative Pain in Vitreoretinal Surgery with Combined Regional-General Anesthesia versus General Anesthesia: A Systematic Review and Meta-Analysis

Review

作者: Su, Yu-Chi ; Hsu, Sheng-Min ; Su, Yu-Chen

PURPOSETo investigate postoperative pain variations in vitreoretinal surgeries conducted with combined regional-general anesthesia or general anesthesia.DESIGNSystematic review and meta-analysis.METHODSA systematic search of the PubMed, Embase, and Cochrane Library databases was conducted to identify relevant randomised controlled trials (RCTs) published before December 26, 2023. Studies comparing vitreoretinal surgeries conducted under combined anesthesia to general anesthesia were included, while studies using only regional anesthesia were excluded. The quality of the studies was assessed using the Cochrane Collaboration risk of bias tool, and the results are presented as odds ratios (ORs) or standardised mean differences (SMDs) with 95% confidence intervals (CIs). I2 statistic was calculated to assess heterogeneity. The primary outcomes in our study included the proportions of patients needing as-needed postoperative analgesics, dosage of as-needed postoperative analgesia medications, and time to the first demand for as-needed postoperative analgesia. The secondary outcomes included postoperative pain scores at 0.5, 1, 2, 4, 6, 12, 24 hours (h), duration of surgery and anesthesia, and percentage of patients experiencing postoperative nausea and vomiting (PONV).RESULTSA total of 19 RCTs involving 1314 patients were analysed. Combined anesthesia was associated with lower proportions of patients needing as-needed postoperative analgesics (OR, 0.218 95% CI, 0.114 to 0.418, I2 = 55.2%), reduced dosage of as-needed postoperative analgesia medications (SMD, -1.429, 95% CI, -2.395 to -0.462, I2 = 90.4%), and longer time to the first demand for as-needed postoperative analgesia compared with general anesthesia alone (SMD, 2.650, 95% CI, 1.169 to 4.132, I2 = 96.5%). The effect of additional regional anesthesia lasted for 6 hours (0.5h SMD, -1.471, 95% CI, -2.498 to -0.444, I2 = 90.5%; 1h, -1.507, -2.309 to -0.705, 92.7%; 2h -1.487, -2.300 to -0.674, 93.2%; 4h -1.052, -1.708 to -0.396, 89.5%; 6h -1.053, -1.932 to -0.174, 93.4%; 12h -0.286, -0.648 to 0.076, 57.1%; 24h -0.297, -0.624 to 0.029, 64.0%). Combined anesthesia decreased PONV risk without affecting the surgical or anesthesia duration.CONCLUSIONSCombined anesthesia demonstrated additional postoperative analgesic effects versus general anesthesia only. Further research is needed to validate the results of our study and to identify vision-threatening complications.

2024-04-01·Vaccine

Immunogenicity and safety of adsorbed diphtheria-purified pertussis-tetanus-inactivated polio (Sabin strain)-Haemophilus type b conjugate combined vaccine (DPT-IPV-Hib) in healthy Japanese Infants ≥ 2 and < 43 months of Age: A phase III, multicenter, active controlled, assessor-blinded, randomized, parallel-group study

Article

作者: Matsuda, Keiko ; Hasegawa, Masumi ; Tamai, Hoshio ; Nakano, Takashi ; Endo, Mai

OBJECTIVEThis study investigated the immunogenicity and safety of a pentavalent vaccine Gobik (DPT-IPV-Haemophilus influenzae type b [Hib]) in healthy Japanese infants aged ≥ 2 and < 43 months using a concomitant vaccination with ActHIB® (Hib) and Tetrabik (DPT-IPV) as a comparator.METHODSThis study was conducted as a phase 3, multicenter, active controlled, assessor-blinded, randomized, parallel-group study. Participants received a total of 4 subcutaneous doses (3 primary immunization doses and a booster dose) of either the experimental drug (DPT-IPV-Hib) or the active comparator (Hib + DPT-IPV). The primary endpoints were the anti-PRP antibody prevalence rate with ≥ 1 μg/mL, and the antibody prevalence rates against pertussis, diphtheria toxin, tetanus toxin, and attenuated poliovirus after the primary immunization.RESULTSIn 267 randomized participants (133 in the DPT-IPV-Hib group and 134 in the Hib + DPT-IPV group), the antibody prevalence rates after the primary immunization in both groups were 100.0 % and 88.7 % for anti-PRP antibody with ≥ 1 μg/mL, 99.2 % and 98.5 % against diphtheria toxin, and 100.0 % and 99.2 % against tetanus toxin, respectively. The antibody prevalence rates against pertussis and attenuated poliovirus were 100.0 % in both groups. The non-inferiority of the DPT-IPV-Hib group to the Hib + DPT-IPV group was verified for all measured antibodies. In both groups, all the GMTs of antibodies after the primary immunization were higher than those before the first dose, and those after the booster dose were higher than those after the primary immunization. No safety issues were identified.CONCLUSIONA single-agent Gobik, the first DPT-IPV-Hib pentavalent vaccine approved in Japan, was confirmed to simultaneously provide primary and booster immunizations against Hib infection, pertussis, diphtheria, tetanus, and poliomyelitis and to have a preventive effect and safety comparable to concomitant vaccination with Hib (ActHIB®) and DPT-IPV quadrivalent vaccine (Tetrabik).

2023-09-01·Surgical endoscopy

Epinephrine injection monotherapy shows similar hemostatic efficacy to epinephrine injection combined therapy in high-risk patients (Forrest Ib) with bleeding ulcers.

Article

作者: He, Shan ; Shang, Guanqun ; Shu, Xu ; Wang, Jingsong ; Zhu, Zhenhua ; Lv, Nonghua

BACKGROUNDWhether combination therapy has higher hemostatic efficacy than epinephrine injection monotherapy in different Forrest classifications is not clear. This study aimed to compare hemostatic efficacy between epinephrine injection monotherapy (MT) and combination therapy (CT) based on different Forrest classifications.METHODSWe retrospectively analyzed peptic ulcer bleeding (PUB) patients who underwent endoscopic epinephrine injections or epinephrine injections combined with a second therapy between March 2014 and June 2022 in our center, and the patients were divided into MT group or CT group. Subsequently, a propensity score matching analysis (PSM) was performed and rebleeding rates were calculated according to Forrest classifications via a stratified analysis.RESULTSOverall, 605 patients who met the inclusion criteria were included, and after PSM, 173 patients in each of the CT and MT groups were included. For PUB patients with nonbleeding visible vessels (FIIa), the rebleeding rates by Days 3, 7, 14, and 30 after PSM were 8.8%, 17.5%, 19.3%, and 19.3% in the MT group, respectively, and rates were 0%, 4.1%, 5.5%, and 5.5% in the CT group, respectively, with significant differences observed between the two groups by Days 3, 7, 14, and 30 (P = 0.015, P = 0.011, P = 0.014, and P = 0.014, respectively). However, for PUB patients with oozing bleeding (FIb), the rebleeding rates by Days 3, 7, 14, and 30 after PSM were 14.9%, 16.2%, 17.6%, and 17.6% in the MT group, respectively, and rates were 13.2%, 14.7%, 14.7%, and 16.2% in the CT group, respectively, with no significant differences observed between the two groups by Days 3, 7, 14, and 30 (P = 0.78, P = 0.804, P = 0.644 and P = 0.825).CONCLUSIONCombined therapy has higher hemostatic efficacy than epinephrine injection monotherapy for PUB patients with visible blood vessel (FIIa) ulcers. However, epinephrine injection monotherapy is equally as effective as combined therapy for PUB patients with oozing blood (FIb) ulcers.

100 项与吸附型四价联合疫苗(Biken Techno Corp.) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	J07CA02	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
白喉	日本	Research Fdn for Microbial Diseases of Osaka University	2012-07-27
脊髓灰质炎	日本	Research Fdn for Microbial Diseases of Osaka University	2012-07-27
破伤风	日本	Research Fdn for Microbial Diseases of Osaka University	2012-07-27
百日咳	日本	Research Fdn for Microbial Diseases of Osaka University	2012-07-27

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
细菌性脑膜炎	药物发现	日本	Mitsubishi Tanabe Pharma Corp.	2019-04-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02140047 (CTgov)	临床2期	嗜血杆菌感染	154	Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate+DPT-IPV (MT-2301-Low)	鑰壓鬱鹹繭廠廠獵獵鏇(餘顧蓋窪鑰醖鹽醖糧蓋) = 鏇襯鹹襯構淵網襯築網齋淵遞夢淵積鏇鏇壓獵 (淵衊鏇餘襯獵製壓淵壓, 鑰獵齋鬱膚築淵窪鑰願 ~ 廠鑰蓋遞選夢壓淵鏇顧) 更多	-	2024-09-19
				Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate+DPT-IPV (MT-2301-High)	鑰壓鬱鹹繭廠廠獵獵鏇(餘顧蓋窪鑰醖鹽醖糧蓋) = 鏇遞構築餘窪襯獵觸憲齋淵遞夢淵積鏇鏇壓獵 (淵衊鏇餘襯獵製壓淵壓, 壓壓窪構壓獵構鑰鹽淵 ~ 選蓋網鏇製膚願鑰願夢) 更多
WCLC2019	N/A	晚期非小细胞肺癌三线	158	S-1 monotherapy	(廠積廠齋獵壓憲憲選網) = 憲鑰獵範衊繭鏇襯廠憲獵壓範憲憲窪壓簾範餘 (憲膚遞憲選範願襯繭積 ) 更多	积极	2019-09-08
				Combined regimens	(壓壓襯艱憲獵廠蓋範鑰) = 觸顧鹽願遞醖繭壓壓艱遞遞壓鬱鬱範顧鑰蓋淵 (顧鏇艱觸廠積製膚鏇醖 )