1.Vonoprazan-based quadruple therapy is non-inferior to esomeprazole-based quadruple therapy for Helicobacter pylori eradication: A multicenter, double-blind, randomized, phase 3 study.
Zhiqiang SONG ; Qin DU ; Guoxin ZHANG ; Zhenyu ZHANG ; Fei LIU ; Nonghua LU ; Liqun GU ; Shingo KURODA ; Liya ZHOU
Chinese Medical Journal 2025;138(22):2938-2946
BACKGROUND:
Owing to the high prevalence of antibiotic resistance in Helicobacter pylori ( H. pylori ) in China, bismuth-containing quadruple therapies have been recommended for H. pylori eradication. This study compared the efficacy and safety of quadruple regimens containing vonoprazan vs . esomeprazole for H. pylori eradication in a patient population in China.
METHODS:
This was a phase 3, multicenter, randomized, double-blind study. Patients with confirmed H. pylori infection were randomized 1:1 to receive quadruple therapy for 14 days: amoxicillin 1000 mg and clarithromycin 500 mg after meals, bismuth potassium citrate 600 mg before meals, plus either vonoprazan 20 mg or esomeprazole 20 mg before meals, all twice daily. The primary outcome was the eradication rate of H. pylori , evaluated using a 13 C urea breath test at 4 weeks after treatment. The non-inferiority margin was at 10%.
RESULTS:
The study included 510 patients, 506 of whom completed the follow-up assessment. The primary analysis revealed eradication rates of 86.8% (210/242) and 86.7% (208/240) for vonoprazan and esomeprazole therapy, respectively (treatment difference: 0.1%; 95% confidence interval [CI]: -5.95, 6.17; non-inferiority P = 0.0009). Per-protocol analysis showed eradication rates of 87.4% for vonoprazan and 86.3% for esomeprazole (treatment difference: 1.2%; 95% CI: -5.03, 7.36; non-inferiority P = 0.0004). Vonoprazan and esomeprazole were well tolerated, with similar safety profiles.
CONCLUSION:
Vonoprazan was found to be well-tolerated and non-inferior to esomeprazole for eradicating H. pylori in patients from China.
TRIAL REGISTRATION
ClinicalTrials.gov , NCT04198363.
Humans
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Esomeprazole/therapeutic use*
;
Double-Blind Method
;
Helicobacter Infections/drug therapy*
;
Male
;
Female
;
Middle Aged
;
Helicobacter pylori/pathogenicity*
;
Pyrroles/therapeutic use*
;
Sulfonamides/therapeutic use*
;
Adult
;
Clarithromycin/therapeutic use*
;
Amoxicillin/therapeutic use*
;
Aged
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Anti-Bacterial Agents/therapeutic use*
;
Pyrrolidines/therapeutic use*
;
Drug Therapy, Combination
;
Proton Pump Inhibitors/therapeutic use*
2.Aorto-Left Atrial Fistula after Aortic Valve Replacement : a Rare Complication
Tomonori OCHIAI ; Tetsuro UCHIDA ; Yoshinori KURODA ; Atsushi YAMASHITA ; Eiichi OHBA ; Shingo NAKAI ; Kimihiro KOBAYASHI ; Mitsuaki SADAHIRO
Japanese Journal of Cardiovascular Surgery 2021;50(1):31-33
A 60-year-old man underwent aortic valve replacement for aortic valve regurgitation, tricuspid valve annuloplasty, and coronary artery bypass grafting. Postoperative echocardiography revealed shunted flow from the noncoronary sinus of Valsalva into the left atrium. The pathogenesis of this complication is considered to be uncertain ; however, it might be due to some kind of intraoperative injury. Three weeks after the initial surgery, we reoperated to repair the aorto-left atrial fistula. According to the intraoperative findings, small slits were found on the left atrial surface close to the posteromedial side of the mitral valve and the noncoronary sinus of Valsalva. The fistula was closed with transmural mattress sutures. Post-operative echocardiography showed no shunt flow. Although an aorto-left atrial fistula is a rare complication after aortic valve replacement, reoperation might be mandatory if the shunt flow is considerable. Surgeons should keep in mind the possibility of intraoperative injury to surrounding structures when performing aortic valve replacement.
3.Treatment Strategy for Leriche Syndrome Complicated with Ischemic Heart Disease
Jun HAYASHI ; Tetsuro UCHIDA ; Yoshinori KURODA ; Eiichi OHBA ; Masahiro MIZUMOTO ; Atsushi YAMASHITA ; Shingo NAKAI ; Kimihiro KOBAYASHI ; Tomonori OCHIAI
Japanese Journal of Cardiovascular Surgery 2021;50(4):283-286
Leriche syndrome is often complicated with ischemic heart disease (IHD). In such cases, as the internal mammary artery (IMA) supplies blood to the lower-limbs through a collateral network, coronary artery bypass grafting (CABG) using IMA is considered to worsen the lower-limb ischemia and use of intra-aortic balloon pumping prior to lower limb revascularization is not possible. Recent advances in endovascular technology enable us to perform endovascular treatment (EVT) even in Leriche syndrome. In 3 patients diagnosed with Leriche syndrome associated with IHD, tailor-made treatments were performed as one-stage or two-stage surgeries. Various techniques such as percutaneous coronary intervention (PCI), CABG, and open surgical revascularization or EVT of lower limbs were employed. EVT is a less invasive and more attractive alternative to open surgical revascularization, it led to new treatment options in patients with this particular circumstance. Considering the severity of pathophysiology, treatment strategy should be determined on a case-by-case basis.
4.Preventive Innominate Artery Transection for a High-Risk Case of Tracheo-Innominate Artery Fistula
Masahiro MIZUMOTO ; Tetsuro UCHIDA ; Yoshinori KURODA ; Atsushi YAMASHITA ; Eiichi OBA ; Jun HAYASHI ; Shingo NAKAI ; Kimihiro KOBAYASHI ; Tomonori OCHIAI
Japanese Journal of Cardiovascular Surgery 2021;50(5):337-341
An 18-year-old man with hypoxic encephalopathy was admitted because of recurrent minor bleeding a tracheal stoma, which was suspected as a tracheo-innominate artery fistula (TIF). He had undergone tracheostomy and gastrostomy 2 years prior and had mild opisthotonos and scoliosis. Although tracheal endoscopy showed no tracheal mucosal erosion, necrosis, or granulation tissue formation, contrast-enhanced computed tomography (CT) revealed a close contact between the innominate artery and the anterior wall of the trachea, and an equal height between the innominate artery and the tip of the tracheal cannula. Magnetic resonance angiography of the head showed dominant intracranial blood flow from the left internal carotid and vertebral arteries. Preventive innominate artery transection through the supra-sternal approach without sternotomy or reconstruction of the innominate artery was performed for this high-risk case of TIF. The patient's postoperative course was uneventful. Postoperative CT revealed that the innominate artery was transected and isolated from the site of tracheostomy. The preserved connection between the right common carotid and subclavian artery at the distal sutured stump helped maintain blood flow in the right internal and middle cerebral arteries. The patient was discharged on postoperative day 9 without any new neurological complications or bleeding from a tracheal stoma. TIF is a rare but fatal complication after laryngotracheal separation or tracheostomy. It is important to prevent the onset of TIF, however, there are no criteria for preventive innominate artery transection. Our preventive innominate artery transection through the supra-sternal approach is considered as one of the useful surgical treatment for high-risk cases of TIF accompanied by severe neuromuscular disorders.
5.A Case of Ruptured Abdominal Aortic Aneurysm Induced by a Hard Blow to the Abdomen
Kimihiro KOBAYASHI ; Tetsuro UCHIDA ; Azumi HAMASAKI ; Yoshinori KURODA ; Atsushi YAMASHITA ; Syuto HIROOKA ; Shingo NAKAI ; Mitsuaki SADAHIRO
Japanese Journal of Cardiovascular Surgery 2020;49(1):35-37
A 77-year-old man was transferred to our hospital with a complaint of a sudden abdominal pain after receiving a hard blow to the abdomen. Contrast-enhanced CT revealed rupture of the abdominal aortic aneurysm with a massive retroperitoneal hematoma. Because of severe hemorrhagic shock, he underwent graft replacement with a woven bifurcated graft through a median laparotomy on an emergent basis. His postoperative course was uneventful and now he is doing well 3 years after surgery. Most blunt abdominal aortic injuries are caused by high-energy trauma, such as motor vehicle collisions and fall injuries. Although body blow is considered as a low-energy trauma, abdominal aortic injury could be caused in patients with an abdominal aortic aneurysm.
6.Surgical Experience of Radiation-Induced Coronary Artery Ostial Stenosis
Kimihiro KOBAYASHI ; Tetsuro UCHIDA ; Azumi HAMASAKI ; Yoshinori KURODA ; Atsushi YAMASHITA ; Syuto HIROOKA ; Shingo NAKAI ; Mitsuaki SADAHIRO
Japanese Journal of Cardiovascular Surgery 2019;48(6):396-400
Radiation-induced heart disease includes various types of cardiac disorders that occur after thoracic irradiation therapy. The coronary artery has been known to be affected in this kind of pathological condition. A 37-year-old man diagnosed with acute coronary syndrome was referred to our institution. He had received irradiation therapy for mediastinal malignant lymphoma at the age of 10 and 11 years. An extended thymectomy for a thymoma via median sternotomy was performed at 18 years old. He also underwent thoracoscopic pericardial fenestration for a pericardial effusion at 26 years old. Coronary angiography revealed severe stenosis of the left and right coronary ostia. Considering the patient's characteristics, including a history of thoracic irradiation therapy, radiation induced heart disease was suspected as a pathogenesis for severe ostial stenosis of the coronary arteries. He underwent conventional on-pump beating coronary artery bypass grafting (CABG) on an urgent basis. Neither internal thoracic artery was suitable for bypass conduit because of dense adhesion. Therefore, the radial artery and great saphenous vein were used as free grafts for coronary revascularization. Furthermore, partial clamping of the ascending aorta seemed to be difficult and inappropriate owing to severe adhesion, so proximal anastomosis devices were used without a side biting clamp. The postoperative course was uneventful and both bypass grafts were patent. Now, he is doing well 10 years after the CABG without any other cardiac event.
7.Abdominal Vacuum-Assisted Closure for Secondary Abdominal Fascial Closure into Open Abdomen after Surgical Repair for Ruptured Abdominal Aortic Aneurysm
Daisuke WATANABE ; Tetsuro UCHIDA ; Azumi HAMASAKI ; Yoshinori KURODA ; Eiichi OBA ; Atsushi YAMASHITA ; Jun HAYASHI ; Ai TAKAHASHI ; Shingo NAKAI ; Mitsuaki SADAHIRO
Japanese Journal of Cardiovascular Surgery 2018;47(1):36-39
Secondary abdominal fascial closure by abdominal vacuum-assisted closure (VAC) therapy is required for abdominal organ protection and prevention of infection due to abdominal compartment syndrome (ACS) developing after the surgery. In this paper, we present our experience with abdominal VAC therapy for two cases that required open abdominal management after surgical repair for ruptured abdominal aortic aneurysm, with favorable outcomes. Case 1 involved a 72-year-old man who underwent endovascular aortic repair for ruptured abdominal aortic aneurysm. Abdominal VAC therapy was started after decompression laparotomy because he developed ACS immediately after surgery. Secondary abdominal fascial closure was performed on day 4 postoperatively, and he had no complications. Case 2 involved a 71-year-old man who underwent emergency Y-graft replacement for ruptured abdominal aortic aneurysm. We considered secondary abdominal fascial closure necessary because of prominent intestinal edema and massive retroperitoneal hematoma, and performed abdominal VAC therapy. We changed the VAC system on day 4, postoperatively and performed secondary abdominal fascial closure on day 7, postoperatively. Abdominal VAC therapy is considered effective and safe for patients requiring secondary abdominal fascial closure after abdominal surgery.
8.Aortic Arch Aneurysm 7 Years after Aortic Root Replacement in a Patient of Loeys-Dietz Syndrome
Jun Hayashi ; Seigo Gomi ; Tetsuro Uchida ; Azumi Hamasaki ; Yoshinori Kuroda ; Atsushi Yamashita ; Ken Nakamura ; Daisuke Watanabe ; Shingo Nakai ; Akihiro Kobayashi ; Mitsuaki Sadahiro
Japanese Journal of Cardiovascular Surgery 2017;46(4):157-160
A 14-year-old women who had a history of aortic root replacement at 7 years old admitted our hospital due to dilatation of aortic arch aneurysm. Loeys-Dietz syndrome was diagnosed when she was 10 years old. Computed tomography showed 70 mm proximal arch aneurysm. Operative findings revealed brachiocephalic artery and left common carotid artery branched from aneurysm. Partial arch replacement was performed and distal anastomosis was made between left common carotid artery and left subclavian artery. Close observation by CT regularly is necessary and undergo aortic repair not to miss the timing of surgery.
9.Hemolytic Anemia after Mitral Valve Surgery
Yuki Kuroda ; Kenji Minakata ; Kazuhiro Yamazaki ; Hisashi Sakaguchi ; Shingo Hirao ; Shinya Takimoto ; Kazuhisa Sakamoto ; Tomohiro Nakata ; Tadashi Ikeda ; Ryuzo Sakata
Japanese Journal of Cardiovascular Surgery 2016;45(2):67-72
Objective : The aim of this study is to describe a series of patients undergoing reoperation due to hemolytic anemia after mitral valve surgery and assess the mechanisms and surgical outcomes. Methods : Between 2009 and 2014, we performed redo mitral valve surgery in 11 patients who had refractory hemolytic anemia after mitral valve surgery at Kyoto University Hospital. The mean age of the patients was 72.2±6.8 years old, and there were 5 men. Results : Preoperative echocardiography demonstrated that only 3 patients had ≥ grade 3 mitral regurgitation (MR), the rest of the patients had only mild to moderate MR. The mechanisms of severe hemolysis included paravalvular leakage (PVL) after mitral valve replacement (MVR) in 8 patients, structural valve deterioration (SVD) after MVR using a bioprosthesis in one, and residual/recurrent mitral regurgitation after mitral valve plasty (MVP) in two. All the patients except one (re-MVP) underwent MVR. The mean interval between previous operation and current operation was 14.1±9.4 years in post-MVR cases, and 2.0±1.9 years in post-MVP cases. There were three late deaths, one of which was due to cardiac death (exacerbation of heart failure due to pneumonia). There was one patient who required re-MVR for recurrent hemolysis due to PVL after MVR. Conclusion : Although hemolytic anemia after mitral valve surgery is rare, it often requires reoperation regardless of the degree of MR at late follow-up period. Thus, patients after mitral valve surgery should be carefully followed-up.
10.Accurate and Easy Measurement of Sliding Distance of Intramedullary Nail in Trochanteric Fracture.
Nobuaki CHINZEI ; Takafumi HIRANAKA ; Takahiro NIIKURA ; Takaaki FUJISHIRO ; Shinya HAYASHI ; Noriyuki KANZAKI ; Shingo HASHIMOTO ; Yoshitada SAKAI ; Ryosuke KURODA ; Masahiro KUROSAKA
Clinics in Orthopedic Surgery 2015;7(2):152-157
BACKGROUND: In daily clinical practice, it is essential to properly evaluate the postoperative sliding distance of various femoral head fixation devices (HFD) for trochanteric fractures. Although it is necessary to develop an accurate and reproducible method that is unaffected by inconsistent postoperative limb position on radiography, few studies have examined which method is optimal. Therefore, the purpose of this study is to prospectively compare the accuracy and reproducibility of our four original methods in the measurement of sliding distance of the HFD. METHODS: Radiographs of plastic simulated bone implanted with Japanese proximal femoral nail antirotation were taken in five limb postures: neutral, flexion, minute internal rotation, greater external rotation, and flexion with external rotation. Orthopedic surgeons performed five measurements of the sliding distance of the HFD in each of the flowing four methods: nail axis reference (NAR), modified NAR, inner edge reference, and nail tip reference. We also assessed two clinical cases by using these methods and evaluated the intraclass correlation coefficients. RESULTS: The measured values were consistent in the NAR method regardless of limb posture, with an even smaller error when using the modified NAR method. The standard deviation (SD) was high in the nail tip reference method and extremely low in the modified NAR method. In the two clinical cases, the SD was the lowest in the modified NAR method, similar to the results using plastic simulated bone. The intraclass correlation coefficients showed the highest value in the modified NAR method. CONCLUSIONS: We conclude that the modified NAR method should be the most recommended based on its accuracy, reproducibility, and usefulness.
*Bone Nails
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*Dimensional Measurement Accuracy
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Fracture Fixation, Intramedullary/instrumentation/*methods
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Hip Fractures/*surgery
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Prospective Studies
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Reproducibility of Results


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