OBJECTIVES:Current PsA therapies, from conventional agents (e.g. MTX) to targeted biologics (e.g. TNF and IL-17 inhibitors), demonstrate distinct therapeutic profiles. Vunakizumab (SHR-1314) is a novel humanized mAb targeting IL-17A. The phase 2 trial evaluated the efficacy and safety of vunakizumab in patients with active PsA. METHODS:Patients aged 18-75 years with a confirmed diagnosis of active PsA were randomized (1:1:1) to receive either s.c. vunakizumab 120 mg (n = 38), vunakizumab 240 mg (n = 37) or placebo (n = 37) at weeks 0, 2, 4 and 8. At week 12, patients on placebo were switched to vunakizumab (1:1 re-randomized to 120 mg or 240 mg through week 20), while vunakizumab groups continued treatment. The primary endpoint was ACR 20% improvement (ACR20) response rate at week 12. RESULTS:At week 12, ACR20 response rates were higher in the vunakizumab 120 mg (47.4%) or 240 mg (59.5%) groups vs placebo group (21.6%; P = 0.02 and P = 0.001, respectively). In addition, improvements were sustained through 24 weeks and were noted in patients who switched from placebo after week 12. Treatment-emergent adverse events (TEAEs) incidence exhibited analogous frequencies between vunakizumab [73.7% (120 mg), 64.9% (240 mg)] and placebo (70.3%) during the 12-week core treatment period, and no severe TEAEs occurred. CONCLUSIONS:Vunakizumab demonstrated superior efficacy to placebo and was well tolerated with an acceptable safety profile in patients with active PsA. The findings support proceeding to a phase 3 study. TRIAL REGISTRATION:ClinicalTrials.gov, www. clinicaltrials.gov, NCT05055934.
Background: Polyacrylamide hydrogel, commercially referred to as Amazingel, was prohibited for use in China in 2006 owing to its associated high complication rates. Conventional techniques for its removal are frequently insufficient to achieve complete eradication, often leading to persistent complications and suboptimal aesthetic results. This study aims to evaluate the safety and aesthetic outcomes of a novel transaxillary endoscopic-assisted removal of Amazingel (TERA) with or without immediate prepectoral implant-based breast augmentation (IPBA). Methods: This retrospective study encompassed 42 patients who underwent TERA with or without IPBA between April 2020 and May 2025. Surgical safety was evaluated through the incidence of postoperative complications within the one-month postoperative period. Aesthetic outcomes were assessed three months after surgery using the Harris scale. Results: The 42 patients were divided into two groups: 25 patients who underwent TERA with IPBA (the IPBA group) and 17 patients who underwent TERA alone (the N-IPBA group). A statistically significant improvement in aesthetic outcomes, as measured by the Harris scale, was demonstrated in the IPBA group compared to the N-IPBA group (P=0.01). Regarding safety, only one patient (2.38%) in the IPBA group developed a local infection, which was successfully managed with a course of oral antibiotics. Minimal residual Amazingel was detected on imaging in two patients (4.76%), with no associated discomfort. Conclusions: The findings of this study demonstrate that TERA with or without IPBA is a safe and effective method. The TERA technique facilitates a more thorough hydrogel removal and superior aesthetic results compared to conventional methods. Furthermore, the concomitant performance of IPBA significantly enhances postoperative patient satisfaction without elevating the risk of complications. These promising results warrant further validation through large-scale, multicenter prospective trials to generalize the findings.
Clamping training has a protective effect on bladder function. However, due to the risk of excessive bladder distension, it has not been widely applied in clinical practice over the past century, with continuous drainage remaining the predominant approach. The China National Health Industry Standard WS/T 509-2016 Specifications for Prevention and Control of Healthcare-associated Infections in Intensive Care Units explicitly stipulates that indwelling urinary catheters should be kept continuously clamped and opened at regular intervals. To date, this requirement has not been extensively implemented, primarily due to the persistent risk of excessive bladder distension. In patients with elevated intra-abdominal pressure, traditional clamping training tends to induce increased intravesical pressure without adequate bladder filling, which may further lead to upper urinary tract injury. To address this clinical dilemma, the critical care medical staff at Fourth People's Hospital of Sichuan Province have designed a passive intermittent urination device for clamping training. This device can ensure sufficient bladder filling while eliminating the risk of overdistension. Currently, the device has been granted a national invention patent (patent number: ZL 2017 1 1242878.6). Its core mechanism involves shaping the external urinary catheter into a "Ji"-shaped configuration. It utilizes the hydrostatic pressure generated by the height of urine column in the catheter to prevent urine outflow, thereby ensuring proper bladder distension. When the intravesical pressure exceeds the preset hydrostatic pressure threshold, urine is automatically drained out, which effectively prevents excessive bladder distension. Meanwhile, the device is not affected by high intra-abdominal pressure and can stably maintain the optimal bladder filling state. Innovatively, this device adopts a liquid barrier (urine) to replace the conventional solid barrier. It not only circumvents the risk of excessive bladder distension during clamping training but also avoids insufficient bladder filling caused by the interference of intra-abdominal pressure with intravesical pressure, thus achieving both efficacy and safety of clamping training. With its simple structure, convenient operation and no need for power supply, this device is expected to facilitate the popularization of clamping training, and further promote its replacement of continuous drainage to become the mainstream clinical practice.
PurposeThe reverse-sequence endoscopic-assisted nipple-sparing mastectomy (R-E-NSM), with or without direct-to-implant breast reconstruction (DTI-BR), has become increasingly popular in China. This study aimed to evaluate whether previous breast surgery (PBS) affects surgical complications and aesthetic outcomes after R-E-NSM.MethodsClinical data of patients who underwent R-E-NSM at the Breast Center, West China Hospital, Sichuan University, between April 30, 2020, and April 30, 2025, were prospectively collected and analyzed.ResultsA total of 1081 patients were enrolled in the study. Among them, 89 had intraoperative breast surgery (IBS), 56 had short-term previous breast surgery (SPBS), 75 had long-term previous breast surgery (LPBS), and 861 had no previous breast surgery (NPBS). SPBS and IBS were not significantly associated with increased complication risk after multivariable adjustment (all P > 0.05). LPBS was significantly associated with lower odds of any complications (OR, 0.238; 95% CI, 0.089–0.633; P = 0.040), minor complications (OR, 0.304; 95% CI, 0.122–0.752; P = 0.010), and CDC ≥ 2 complications (OR, 0.333; 95% CI, 0.125–0.885; P = 0.027). BREAST-Q scores did not differ significantly among groups. Compared with the NPBS group, the SPBS group showed a statistically significant difference in Ueda scores at 3 months (P = 0.014). Oncologic outcomes did not differ significantly among the four groups (all P > 0.05).ConclusionFor patients with SPBS, implementing R-E-NSM warrants careful clinical evaluation due to potential safety concerns. Among patients with LPBS, current evidence indicates that incorporating R-E-NSM is not an independent risk factor and may be linked to a significantly lower incidence of complications.
BACKGROUND:We have developed an innovative integrated approach, combining reverse-sequence endoscopic nipple-sparing mastectomy (R-E-NSM) with reverse-sequence endoscopic latissimus dorsi muscle flap (R-E-LDMF) harvest for breast reconstruction (BR), through a discreet axillary incision. While both techniques demonstrate clinical feasibility, a systematic comparison of patient-reported outcomes, complications, and cost-efficacy between endoscopic implant-based BR and R-E-LDMF BR remains unexplored. METHODS:A prospective, two-center cohort study was conducted from July 2021 to March 2024, enrolling breast cancer patients who underwent R-E-NSM followed by either Dual-plane BR or R-E-LDMF BR. The Primary endpoint was patient-reported outcomes assessed using the BREAST-Q reconstruction module (focusing on breast satisfaction and quality of life). Others included clinical outcomes, complications, and oncological outcomes. RESULTS:Among 191 enrolled patients (41 R-E-LDMF vs. 150 Dual-plane), R-E-LDMF BR required longer operative times but incurred substantially lower hospitalization costs. After controlling for baseline patient characteristics, patients who underwent R-E-LDMF BR had greater satisfaction with their breasts (difference, -9.39; -16.97 to -1.80; P =0.016) at 1 year compared with patients who underwent Dual-plane BR. BREAST-Q scores showed no intergroup differences in quality of life. The R-E-LDMF group had higher rates of any and minor complications, while the major complication rates and oncological outcomes were similar between the two groups. CONCLUSIONS:The R-E-LDMF BR technique achieved comparable aesthetic results and major complication rates to the Dual-plane approach, while significantly reducing overall medical costs, despite higher minor complication rates. This approach represents a cost-effective alternative for patients seeking optimal aesthetic results with reduced financial burden.
