奥马珠单抗治疗慢性自发性荨麻疹的疗效及安全性分析

【摘要】 目的 回顾分析奥马珠单抗治疗慢性自发性荨麻疹（CSU）的疗效、安全性及停药复发情况。方法 回顾北京大学第一医院皮肤科门诊2018年2月至2021年1月使用奥马珠单抗治疗的CSU病例，分析其临床特征，采用门诊随访形式，通过荨麻疹控制评分（UCT）、皮肤病生活质量指数（DLQI）评估疾病严重程度，监测不良事件及停药后复发情况。正态分布的计量资料组间比较采用独立样本t检验或方差分析，非正态分布的计量资料组间比较采用Mann-Whitney U检验、Wilcoxon符号秩和检验或Kruskal-Wallis H检验，计数资料组间比较采用卡方检验或Fisher 精确检验。结果 纳入59例CSU患者，奥马珠单抗治疗至少3个月，其中45例治疗达6个月，15例达12个月。经奥马珠单抗治疗，UCT从基线期3.0（1.0，6.0）分上升至第1个月11.0 （3.0，14.0）分和第3个月15.0 （12.0，16.0）分（均P < 0.05）。DLQI从基线期16.0（12.0，20.0）分下降至第1个月7.0 （1.0，13.0）分和第3个月1.0 （0.0，4.0）分（均P < 0.05）。疾病部分或完全控制的比例在基线期为0，第1个月上升至44.1%，第3个月达78.0%，第6个月达88.9%。疾病对生活质量存在重度或极重度影响的比例在基线期为84.7%，第1个月降至30.5%，第3个月降至15.3%，第6个月降至4.4%。对奥马珠单抗治疗完全反应组和部分反应组比无反应组病程更短（t = -2.894，P = 0.011；t = -2.511，P = 0.036）；完全反应组比部分反应组和无反应组治疗时间更长（t = 2.479，P = 0.039；t = 2.677，P = 0.022）。慢反应组与快反应组相比，基线DLQI更高（Z = -2.622，P = 0.009），基线UCT更低（Z = -2.746，P = 0.006）。19例患者病情完全控制后停药，其中13例（68.4%）在停药7（5，8）周后复发，复发后UCT评分高于治疗前（Z = 3.172，P = 0.001），复发组比未复发组病程更长（Z = -2.635，P = 0.007）。复发后5例重新开始奥马珠单抗治疗，均再次得到部分或完全控制。治疗期间报告不良反应事件均为轻中度。结论 奥马珠单抗能够有效控制CSU症状，提高患者生活质量，且安全性较好，但停药后复发率高，复发后重新开始奥马珠单抗治疗仍有效。     

Stapled transperineal repair for low- and mid-level rectovaginal fistulas: A 5-year experience and comparison with sutured repair

BACKGROUNDCurrently, rectovaginal fistula (RVF) continues to be a surgical challenge worldwide, with a relatively low healing rate. Unclosed intermittent suture and poor suture materials may be the main reasons for this.AIMTo evaluate the efficacy and safety of stapled transperineal repair in treating RVF.METHODSThis was a retrospective cohort study conducted in the Coloproctology Department of The Sixth Affiliated Hospital of Sun Yat-sen University (Guangzhou, China). Adult patients presenting with RVF who were surgically managed by perineal repair between May 2015 and May 2020 were included. Among the 82 total patients, 37 underwent repair with direct suturing and 45 underwent repair with stapling. Patient demographic data, Wexner faecal incontinence score, and operative data were analyzed. Recurrence rate and associated risk factors were assessed.RESULTSThe direct suture and stapled repair groups showed similar clinical characteristics for aetiology, surgical history, fistula features, and perioperative Wexner score. The stapled repair group did not show superior results over the suture repair group in regard to operative time, blood loss, and hospital stay. However, the stapled repair group showed better postoperative Wexner score (1.04 ± 1.89 vs 2.73 ± 3.75, P = 0.021), less intercourse pain (1/45 vs 17/37, P = 0.045), and lower recurrence rate (6/45 vs 17/37, P = 0.001). There was no protective effect from previous repair history, smaller diameter of fistula (< 0.5 cm), better control of defecation (Wexner < 10), or stapled repair. Direct suture repair and preoperative high Wexner score (> 10) were risk factors for fistula recurrence. Furthermore, stapled repair gave better efficacy in treating complex RVFs (i.e., multiple transperineal repair history, mid-level fistula position, and poor control of defecation).CONCLUSIONStapled transperineal repair is advantageous for management of RVF, providing a high primary healing rate and low recurrence rate.     

三七粉质量标志物研究＊

三七为常用中药材，具有散瘀、止血，消肿定痛的功效。三七粉作为三七市场应用的主要形式之一，市场逐年增大。现行标准难以评价和控制三七粉“多重功效”的质量特点。本课题组在系统辨识三七粉化学物质组及其传递规律的基础上，采用网络药理学和体内、体外模型，研究并阐明了三七粉的活血、心肌与血管保护、止血以及消肿定痛的药效物质基础；进一步结合成分的特有性分析，确定了三七粉的质量标志物；在此基础上，建立了基于质量标志物的三七粉的指纹图谱及“一测多评”的多指标含量测定方法，为建立三七粉整体质量控制方法提供了理论与实验证据。     

First-line nivolumab plus chemotherapy vs chemotherapy in patients with advanced gastric,gastroesophageal junction and esophageal adenocarcinoma: CheckMate 649 Chinese subgroup analysis

First-line chemotherapy for advanced/metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric/gastroesophageal junction cancer (GC/GEJC) has poor median overall survival (OS; <1 year). We report efficacy and safety results from Chinese patients in the phase III global CheckMate 649 study of nivolumab plus chemotherapy vs chemotherapy for the first-line treatment of GC/GEJC/esophageal adenocarcinoma (EAC). Chinese patients with previously untreated advanced or metastatic GC/GEJC/EAC were randomized to receive nivolumab (360 mg Q3W or 240 mg Q2W) plus chemotherapy (XELOX [capecitabine and oxaliplatin] Q3W or FOLFOX [oxaliplatin, leucovorin and 5-fluorouracil] Q2W), nivolumab plus ipilimumab (not reported) or chemotherapy alone. OS, blinded independent central review-assessed progression-free survival (PFS), objective response rate (ORR), duration of response (DOR) and safety are reported. Of 1581 patients enrolled and randomized, 208 were Chinese. In these patients, nivolumab plus chemotherapy resulted in clinically meaningful improvement in median OS (14.3 vs 10.2 months; HR 0.61 [95% CI: 0.44-0.85]), median PFS (8.3 vs 5.6 months; HR 0.57 [95% CI: 0.40-0.80]), ORR (66% vs 45%) and median DOR (12.2 vs 5.6 months) vs chemotherapy, respectively. The safety profile was acceptable, with no new safety signals observed. Consistent with results from the global primary analysis of CheckMate 649, nivolumab plus chemotherapy demonstrated a clinically meaningful improvement in OS and PFS and higher response rate vs chemotherapy and an acceptable safety profile in Chinese patients. Nivolumab plus chemotherapy represents a new standard first-line treatment for Chinese patients with non-HER2-positive advanced GC/GEJC/EAC.     

进食障碍患者家庭顺应量表的汉化及信效度检验

目的 汉化进食障碍患者家庭顺应量表，并检验其信效度。方法 根据Brislin翻译模式将量表翻译成中文，通过专家函询和预调查对量表进行文化调适和修订。将量表应用于300例进食障碍患者照顾者检验信效度。结果 中文版进食障碍患者家庭顺应量表的量表水平内容效度指数为0.918。探索性因子分析结果显示5个因子可解释总变异量的49.862%。量表的各维度得分与量表总分呈中高度相关，各维度得分之间呈中低度相关或不相关。量表总Cronbach′s α为0.877，重测信度为0.883。结论 中文版进食障碍患者家庭顺应量表具有较好的信效度，可用于测量进食障碍患者的家庭顺应情况。