补充与替代疗法治疗肠易激综合征的研究进展

肠易激综合征是临床常见的功能性胃肠病之一。由于多数患者的症状经过一线药物治疗后仍不能得到较好改善，许多患者为获得更好的治疗效果，转向选择补充与替代疗法进行治疗。然而，由于研究质量和数量的限制，大部分治疗肠易激综合征的补充与替代疗法并未被相关共识和指南所推荐。本文从补充与替代疗法的分类入手，从天然产品、身心治疗、传统医药3个方面就目前国内外常用的补充与替代疗法治疗肠易激综合征的研究进行概述，以期为临床工作者和患者更好地了解和应用提供帮助。     

寰枢椎后路柔性固定的生物力学研究

目的分析细棒、PEEK棒固定对寰枢关节稳定性的影响。方法采用6具新鲜成人枕骨(occipital bone,Oc)~颈椎C4节段进行测试,模拟以下手术及固定状态:①完整状态;②损伤状态:枢椎齿状突II型骨折;③坚强固定:寰枢椎均采用普通椎弓根螺钉固定,直径3.5 mm钛棒连接;④PEEK棒:直径3.5 mm的PEEK棒连接;⑤细棒:直径2.0 mm钛棒连接。采用重复测量实验设计,在完整、损伤和不同的固定状态下,通过脊柱试验机对标本分别施加1.5 N·m的前屈/后伸、左/右侧弯和左/右轴向旋转的纯力偶矩。采用Optotrak三维运动测量系统连续采集标本运动,分析寰枢椎之间角度运动范围和中性区。结果采用直径3.5 mm的钛棒,2.0 mm的细棒以及3.5 mm的PEEK棒固定后,在前屈、后伸、侧弯和旋转方向上均显著减小了固定节段的运动范围(P<0.05)。直径3.5 mm和2.0 mm的棒固定后的运动范围,在各个方向上无显著性差异。PEEK棒固定的运动范围仅在侧弯方向上大于坚强固定(P=0.005),其他方向无显著性差异。3种固定方式在屈伸、侧弯和旋转方向上均显著减小了固定节段的中性区(P<0.05)。各种固定方式之间相比较,无显著性差异(P>0.05)。结论在寰枢关节采用直径2.0 mm的细棒固定,与坚强固定的稳定性相当。采用直径3.5 mm的PEEK棒固定,在前屈、后伸、旋转方向上与坚强固定的稳定性相当,在侧弯方向上弱于坚强固定。     

A Phase I Dose Escalation Study of the Safety,Tolerability, and Pharmacokinetics of Ipilimumab in Chinese Patients with Select Advanced Solid Tumors

Lessons Learned

• The overall safety profiles of ipilimumab 3 mg/kg and 10 mg/kg administered every 3 weeks, were consistent between Chinese patients with solid tumors in the current study and patients from previous U.S. ipilimumab monotherapy studies. No new safety signals were identified.
• The mean systemic exposures to ipilimumab (assessed by first dose area under the curve during the dosing interval and maximum serum concentration) were numerically lower in the Chinese patient population than in U.S. patients for both 3 mg/kg and 10 mg/kg doses; however, the range of serum concentrations in the Chinese and U.S. populations overlapped (3 mg/kg and 10 mg/kg), suggesting that ipilimumab pharmacokinetics was ethnically insensitive in this study.

BackgroundThis phase I, open‐label study assessed ipilimumab safety, tolerability, pharmacokinetics (PK), immunogenicity, and antitumor activity in Chinese patients with unresectable, metastatic, recurrent malignant melanoma (MM) or nasopharyngeal carcinoma (NPC).MethodsOf 39 patients enrolled, 25 received ipilimumab (11 patients received 3 mg/kg, and 14 patients received 10 mg/kg). Reasons for not receiving treatment were withdrawal of consent (3 patients), no longer meeting the criteria (10 patients), and one recorded as “other.” During the induction phase, patients received ipilimumab (3 mg/kg, i.v.), on day 1 of a 3‐week cycle, to a maximum of four doses or progressive disease (PD). During the maintenance phase at week 24, patients received ipilimumab (3 mg/kg, i.v.) on day 1 of a 12‐week cycle, to a maximum of 3 years or PD. Considering the co‐primary safety and PK endpoints, the successive dosing required nine patients with two or fewer dose‐limiting toxicities during the 42‐day observation period to proceed with a new cohort of nine patients at 10 mg/kg.ResultsIpilimumab safety and PK profiles were similar in Chinese and predominantly White populations. Ipilimumab was well tolerated. Most adverse events (AEs) were grades 1–2 and experienced by 11 patients treated with 3 mg/kg and 14 patients treated with 10 mg/kg. There were no new safety concerns. Incidence of anti‐ipilimumab antibodies was low (1 of 10 in the 3 mg/kg patients and 2 of 13 in the 10 mg/kg patients) and without safety implications. In the 3 mg/kg group, 8 of 11 patients had PD. In the 10 mg/kg group (all NPC, 0 MM patients), 11 of 14 patients had PD. Three patients had stable disease (one at 3 mg/kg and two at 10 mg/kg).ConclusionIpilimumab was well tolerated in Chinese patients, showing similar safety and PK to previous studies in predominantly White populations.     

中药治疗哮喘-慢阻肺重叠的Meta分析＊

目的 系统评价中药治疗哮喘-慢阻肺（ACO）的疗效与安全性。方法 全面检索PubMed、Cochrane Library、Web of Science、中国知网、万方、维普、中国医学文献数据库，纳入有关中医药治疗ACO的随机对照试验（RCT），运用Cochrane手册对纳入研究的方法学质量进行评估，采用Review Manager 5.3进行Meta分析。结果 共纳入32项RCT，包括2688例ACO患者，其中试验组1361例，对照组1327例。Meta分析结果显示，中医药可以显著改善ACO患者的中医证候疗效［RR=1.19，95% CI（1.13，1.25），P<0.00001］、CAT评分［MD=-3.62，95% CI（-4.37，-2.87），P<0.00001］、ACT评分［MD=3.42，95% CI（2.23，4.62），P<0.00001］，、中医证候总积分［MD=-3.61，95% CI（-4.83，-2.39），P<0.00001］、FEV₁［MD=0.59，95% CI（0.08，1.10），P=0.02］、FEV₁%［MD=8.61，95% CI（5.20，12.1），P<0.00001］、FEV₁/FVC［MD=6.52，95% CI（4.24，8.80），P<0.00001］、6 min步行实验［MD=41.18，95% CI（22.15，60.21），P<0.0001］、急性发作次数［MD=-2.46，95% CI（-3.62，-1.13），P<0.0001］。所有研究均未报道严重不良反应。结论 中药治疗ACO，可以显著提高临床疗效，改善患者的肺功能且具有较好安全性，但是需要更高质量、多样本、多中心的随机对照试验进一步确认。     

面肌痉挛微血管减压术中异常肌反应变化特点与术后疗效关系探究

目的探究面肌痉挛患者微血管减压术(MVD)中异常肌反应(AMR)的变化特点与术后疗效的关系。方法回顾性分析73例MVD术中采用AMR全程定量化监测患者的AMR变化特点,减压操作前AMR阈值较基础阈值升高≥1倍为A1组、1倍为A2组,手术结束时AMR完全消失为B1组、未消失为B2组,B2组中AMR阈值较基础阈值升高≥1倍为B2a组、1倍为B2b组,对各组的术后疗效进行对比分析。结果 A1组21例中,19例立即治愈,1例延迟治愈,1例未愈; A2组52例中,35例立即治愈,9例延迟治愈,8例未愈。A1组较A2组疗效好(P=0. 046)。B1组50例中,42例立即治愈,5例延迟治愈,3例未愈; B2组23例中,12例立即治愈,5例延迟治愈,6例未愈。B1组较B2组疗效好(P=0. 003)。B2 a组的治愈比例较B2 b组高(分别为14/16、3/7),差异有统计学意义(P=0. 045)。结论 AMR在术中的变化特点对术者有重要参考意义,AMR在减压前升高、在手术结束时完全消失、未消失但升高较基础阈值≥1倍者术后疗效相对较好。     

国内外安宁疗护准入标准的研究进展

安宁疗护可提高患者在生命终末阶段的生活质量，减轻患者和家属的身心痛苦。科学合理的安宁疗护准入标准可帮助医护人员识别出需要安宁疗护服务的患者，使其及时获得安宁疗护服务，因此明确安宁疗护的准入标准是推进安宁疗护发展的基础。本文就国内外安宁疗护准入标准的制定方法、具体内容及优缺点进行综述，以期为我国安宁疗护准入标准的构建提供参考。