Summary Background Helicobacter pylori is one of the most common gastric pathogens, affecting at least half the world's population, and is strongly associated with gastritis, peptic ulcer, gastric ...adenocarcinoma, and lymphoma. We aimed to assess the efficacy, safety, and immunogenicity of a three-dose oral recombinant H pylori vaccine in children in China. Methods We did this randomised, double-blind, placebo-controlled, phase 3 trial at one centre in Ganyu County, Jiangsu Province, China. Healthy children aged 6–15 years without past or present H pylori infection were randomly assigned (1:1), via computer-generated randomisation codes in blocks of ten, to receive the H pylori vaccine or placebo. Participants, their guardians, and study investigators were masked to treatment allocation. The primary efficacy endpoint was the occurrence of H pylori infection within 1 year after vaccination. We did analysis in the per-protocol population. This trial is registered with ClinicalTrials.gov , number NCT02302170. Findings Between Dec 2, 2004, and March 19, 2005, we randomly assigned 4464 participants to either the vaccine group (n=2232) or the placebo group (n=2232), of whom 4403 (99%) participants completed the three-dose vaccination schedule and were included in the per-protocol efficacy analysis. We extended follow-up to 3 years. We recorded 64 events of H pylori infection within the first year (14 events in 2074·3 person-years at risk in the vaccine group vs 50 events in 2089·6 person-years at risk in the placebo group), resulting in a vaccine efficacy of 71·8% (95% CI 48·2–85·6). 157 (7%) participants in the vaccine group and 161 (7%) participants in the placebo group reported at least one adverse reaction. Serious adverse events were reported in five (<1%) participants in the vaccine group and seven (<1%) participants in the placebo group, but none was considered to be vaccination related. Interpretation The oral recombinant H pylori vaccine was effective, safe, and immunogenic in H pylori -naive children. This vaccine could substantially reduce the incidence of H pylori infection; however, follow up over a longer period is needed to confirm the protection of the vaccine against H pylori -associated diseases. Funding Chongqing Kangwei Biological Technology.
Bosentan has an established role in the management of pulmonary arterial hypertension (PAH). This clinical trial assessed the benefits of bosentan in the Chinese population.
We investigated the ...efficacy and safety of bosentan in 92 Chinese citizens (mean +/- standard deviation age, 29.0 +/- 3.8 years) with PAH for a minimum of 12 weeks. All received bosentan (62.5 mg twice daily) for 4 weeks; then, patients who weighed <40 kg received 62.5 mg bosentan twice daily and patients who weighed >40 kg received 125 mg twice daily. All patients were eligible to continue bosentan beyond 12 weeks. The primary end point was a change in exercise capacity from baseline to 12 and 24 weeks. Secondary end points included a change in World Health Organization (WHO) functional class and changes in cardiopulmonary hemodynamics.
At baseline, 66 patients (72%) were in WHO functional class III; presentation was 37 (40%) with idiopathic PAH (iPAH), 34 (37%) with PAH related to congenital heart disease (CHD), and 21 (23%) with PAH related to connective tissue disease (CTD). Exercise capacity increased to 67.8 m after 12 weeks and 92.6 m after 24 weeks (p < 0.001). After 24 weeks, WHO functional class decreased (-0.8 +/- 0.6; p < 0.001), mean pulmonary artery pressure and pulmonary vascular resistance decreased (p < 0.01), and cardiac output increased (p < 0.001). Twelve patients (13%) experienced at least 1 adverse event.
Bosentan improved exercise capacity, functional class, and cardiopulmonary hemodynamics in this patient cohort and was well tolerated.
Objectives: To investigate the dosimetric advantages of the voluntary deep inspiration breath-hold technique assisted by optical surface monitoring system for whole breast irradiation in left breast ...cancer after breast-conserving surgery and verify the reproducibility and acceptability of this technique. Methods: Twenty patients with left breast cancer receiving whole breast irradiation after breast-conserving surgery were enrolled in this prospective phase II study. Computed tomography simulation was performed during both free breathing and voluntary deep inspiration breath-hold for all patients. Whole breast irradiation plans were designed, and the volumes and doses of the heart, left anterior descending coronary artery, and lung were compared between free breathing and voluntary deep inspiration breath-hold. Cone beam computed tomography was performed for the first 3 treatments, then weekly during voluntary deep inspiration breath-hold treatment to evaluate the accuracy of the optical surface monitoring system technique. The acceptance of this technique was evaluated with in-house questionnaires completed by patients and radiotherapists. Results: The median age was 45 (27-63) years. All patients received hypofractionated whole breast irradiation using intensity-modulated radiation therapy up to a total dose of 43.5 Gy/2.9 Gy/15f. Seventeen of the 20 patients received concomitant tumor bed boost to a total dose of 49.5 Gy/3.3 Gy/15f. Voluntary deep inspiration breath-hold showed a significant decrease in the heart mean dose (262 ± 163 cGy vs 515 ± 216 cGy, P < .001) and left anterior descending coronary artery (1191 ± 827 cGy vs 1794 ± 833 cGy, P < .001). The median delivery time of radiotherapy was 4 (1.5-11) min. The median deep breathing cycles were 4 (2-9) times. The average score for acceptance of voluntary deep inspiration breath-hold by patients and radiotherapists was 8.7 ± 0.9 (out of 12) and 10.6 ± 3.2 (out of 15), respectively, indicating good acceptance by both. Conclusions: The voluntary deep inspiration breath-hold technique for whole breast irradiation after breast-conserving surgery in patients with left breast cancer significantly reduces the cardiopulmonary dose. Optical surface monitoring system–assisted voluntary deep inspiration breath-hold is reproducible and feasible and showed good acceptance by both patients and radiotherapists.
Highlights • We investigated the long-term effectiveness of oral hygiene with chlorhexidine gluconate in prevention of nosocomial pneumonia in a medical-surgical intensive care unit. • Chlorhexidine ...gluconate (0.2%) may reduce the incidence of nosocomial pneumonia and ventilator-associated pneumonia in an intensive care unit, but not in microbiologic epidemiology when noted. • Oral hygiene with 0.2% chlorhexidine gluconate showed a benefit in the prevention of nosocomial pneumonia, including ventilator-associated pneumonia in intensive care units, considering the safety and less selective pressure of antibiotic resistance.
Purpose This clinical study assessed a pedicled supraclavicular fasciocutaneous island flap (SFIF) based on the transverse cervical artery that was extended to include shoulder skin for ...reconstructing the head and neck. Patients and Methods Pedicled SFIFs extended to include the shoulder skin based on the cutaneous feeder vessels and perforator vessels in the deep fascia of the transverse cervical artery were designed for 24 patients with defects of the head and neck after cancer ablation. Preoperative 3-dimensional computed tomographic angiography was performed in all patients. The patients consisted of 15 men and 9 women ranging in age from 24 to 73 years. Results The primary lesions included squamous cell carcinoma of the tongue, buccal mucosa, floor of the mouth, oropharynx, palate, and lower gingiva. Three-dimensional computed tomographic angiography showed that the transverse cervical artery arose from the thyrocervical trunk in 13 cases and from the subclavian artery in 11 cases. The diameter of the artery ranged from 0.15 to 0.24 cm. The size of flaps ranged from 4 × 8 cm to 6 × 12 cm, and the mean length of the vascular pedicle was approximately 18.5 cm. Of the flaps, 23 survived completely, for a success rate of 95.8%. Three patients underwent radiotherapy, and the follow-up period ranged from 3 to 12 months. One patient died of local tumor recurrence, and cervical recurrences developed in 3 patients. Conclusion An SFIF extended to include the shoulder skin based on the cutaneous feeder vessels and perforator vessels in the deep fascia of the transverse cervical artery is a useful, viable option for defects of the head and neck after cancer ablation.
Purpose The purpose of this study was to assess the reliability of 2 patterns of submental island flaps—the facial-submental artery island flap and the reverse facial-submental artery island ...flap—used for reconstruction of oral and maxillofacial defects following cancer ablation. Patients and Methods Thirty-eight soft tissue defects were repaired with facial-submental artery island flaps and reverse facial-submental artery island flaps following cancer surgery. The ages of the patients ranged from 28 to 90 years; 24 were male and 14 were female. The primary lesions included squamous cell carcinoma of the tongue (8 cases), buccal mucosa (16), floor of the mouth (4), lower gingiva (3), oropharynx (2); recurrent squamous cell carcinoma of the palate (3); and basal cell carcinoma of the facial skin (2). The clinical stage of the tumors was stage I in 5 cases, stage II in 25, and stage III in 8. Facial-submental artery island flaps were used in 20 cases, reverse facial-submental artery island flaps in 18. The size of the skin paddle varied from a minimum of 4 cm × 8 cm to a maximum of 5 cm × 15 cm. Direct closure was achieved at all donor sites. Results The postoperative outcome for 2 patterns of submental flaps was 36 cases surviving, 2 of complete necrosis, and one other of temporary palsy of the marginal mandibular branch of the facial nerve. The success rate was 95% and 94.4% for the facial-submental artery island flap and the reverse facial-submental artery island flap, respectively. The form and function of recipient sites were well recovered. The donor site leaves a well-hidden scar. The follow-up period was 3 to 24 months, 1 patient died of tumor local recurrences and 2 cases of cervical recurrence were observed. Conclusion Two patterns of submental island flaps are safe, rapid, and simple to elevate. The facial-submental artery island flap can reliably be used for reconstruction of the lower and middle thirds of the medium-sized oral and maxillofacial defects and the reverse pattern for reconstruction of the middle and upper thirds of the medium-sized oral and maxillofacial defects.
Objective We sought to test the feasibility and technical ease of a newly designed nitinol–based modified esophageal stent and its effects on preventing postcaustic stricture in mongrel dogs and to ...try to explain the result at the molecular level. Methods Twenty-four dogs were included in this controlled study. Stenosis index (wall thickness/intraluminal diameter), pathologic features, hydroxyproline quantities, esophageal compliance, and biomechanics were compared between the injured but unstented and stented dogs. Transforming growth factor β1, Sma/Mad (Smad)3, and Smad7 mRNA expression and protein levels in esophageal tissue were detected by means of reverse transcriptase–polymerase chain reaction and Western blotting, respectively. Results The modified esophageal stent was able to be placed and retrieved successfully and conveniently and was not only intact but there was also no macroscopic esophageal mucosal injury after the stent removal 4 months later. In comparison with the injured but unstented group, esophageal compliance, biomechanics, and the stenosis index were significantly better in the stented group. Histopathologic study revealed that collagen bundles were thinner and its orientation tended toward a regular and parallel pattern. Transforming growth factor β1 and Smad3 mRNA expression and protein levels increased and Smad7 mRNA expression and protein levels decreased significantly in esophageal tissue in the stented group. These variables showed no statistically significant difference 2 months after stent removal. Conclusions The modified esophageal stent might be a promising stent in preventing stricture formation after corrosive esophageal burns clinically.
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