Clinical reasoning for manual therapy management of tension type and cervicogenic headache

In recent years, there has been an increasing knowledge in the pathogenesis and better management of chronic headaches. Current scientific evidence supports the role of manual therapies in the management of tension type and cervicogenic headache, but the results are still conflicting. These inconsistent results can be related to the fact that maybe not all manual therapies are appropriate for all types of headaches; or maybe not all patients with headache will benefit from manual therapies. There are preliminary data suggesting that patients with a lower degree of sensitization will benefit to a greater extent from manual therapies, although more studies are needed. In fact, there is evidence demonstrating the presence of peripheral and central sensitization in chronic headaches, particularly in tension type. Clinical management of patients with headache needs to extend beyond local tissue-based pathology, to incorporate strategies directed at normalizing central nervous system sensitivity. In such a scenario, this paper exposes some examples of manual therapies for tension type and cervicogenic headache, based on a nociceptive pain rationale, for modulating central nervous system hypersensitivity: trigger point therapy, joint mobilization, joint manipulation, exercise, and cognitive pain approaches.     

Surrogate end points for overall survival in breast cancer trials: A review

Our aim was to review the studies which assessed potential surrogate endpoints for overall survival (OS) in breast cancer trials. A Literature search in PubMed database of studies which assessed potential surrogate endpoints for OS in breast cancer trials was conducted. The surrogacy was assessed with the German institute of Quality and efficiency in Health Care’s (IWQiG) framework and the Fleming hierarchy. Thirteen studies were identified. At the neoadjuvant setting, two individual patient data (IPD) meta-analyses and one aggregate data meta-analysis assessing surrogacy of pathological complete response (PCR) were identified. Trial-level association was calculated in one study and the squared correlation was 0.24. Therefore PCR was not judged to be valid surrogate for OS at the neoadjuvant setting according to the IWQiG framework and Fleming hierarchy. At the adjuvant setting, one meta-analysis on aggregate data was identified. 2-year DFS was not judged to be valid surrogate for OS at the neoadjuvant setting according to the IWQiG framework and Fleming hierarchy. At the metastatic setting, six meta-analyses based on aggregate data, three IPD meta-analyses and one retrospective study were identified. Within the IPD meta-analyses, at the trial-level association the squared correlation between the potential surrogates and OS ranged from 0.10 to 0.57 and no endpoint was judged to be valid surrogate for OS at the metastatic setting. The level of evidence available supporting a relationship between OS and potential surrogate endpoints in breast cancer trials is low.     

协定肢伤Ⅰ方口服、热敷治疗四肢闭合损伤大样本随机平行对照研究

[目的]观察协定肢伤I方口服热敷治疗四肢闭合损伤疗效。[方法]使用大样本随机平行对照方法,将2468例门诊及住院患者按掷骰子法随机分为两组。对照组1212例协定肢伤I方(红花、延胡索各15g,桃仁、川芎、赤芍、生三七粉另包冲服、当归、泽泻、桂枝、牛膝、山楂各10g),1剂/d,水煎300mL,早晚温服;蜡疗机熬化粗石蜡装塑料袋敷于患处,12h/次。治疗组1256例协定肢伤I方药渣加水送入湿热敷机内与敷布同煮30min,于伤后或术后24h将敷布外套棉布贴敷于伤处,30min/次,2次/d;协定肢伤I方口服同对照组。连续治疗7d为1疗程。观测临床症状、疼痛积分、肿胀指数、不良反应。治疗1疗程,判定疗效。[结果]治疗组痊愈922例,显效248例,有效63例,无效23例,总有效率98.16%。对照组痊愈705例,显效278例,有效105例,无效124例,总有效率89.76%。治疗组疗效优于对照组(P0.05)。相关指标两组均有改善(P0.05),治疗组改善优于对照组(P0.05)。[结论]协定肢伤I方口服热敷治疗四肢闭合损伤效果显著,值得推广。     

自拟舒郁汤联合镇静六穴治疗产后抑郁症的临床研究

目的:探讨自拟舒郁汤联合镇静六穴治疗产后抑郁症的临床效果。方法:选择2019年5月—2020年3月产后抑郁症患者60例,按照投掷硬币法分为对照组和观察组,每组30例。对照组给予盐酸帕罗西汀片治疗,观察组给予自拟舒郁汤联合“镇静六穴”治疗。比较两组患者近期疗效以及治疗前后抑郁症状、产后生活自理能力、照料婴儿能力与生活质量变化情况。结果:观察组治疗总有效率高于对照组,差异有统计学意义(P<0.05);观察组治疗2,4,6,8周末汉密尔顿抑郁量表(HAMD-24)评分均低于对照组,差异有统计学意义(P<0.05);观察组治疗8周末产后生活自理能力评分、照料婴儿能力评分及36条简明健康状况调查表(SF-36)评分均高于对照组,差异有统计学意义(P<0.05)。结论:自拟舒郁汤联合镇静六穴治疗产后抑郁症疗效显著,可有效改善患者抑郁症状,提升产后生活自理能力、照料婴儿能力和生活质量。     

经典名方药物考证关键问题分析与要点建议

笔者对已报道的经典名方药物考证相关研究进行系统梳理与分析，总结当前研究存在的问题与不足，提出经典名方药物考证要点建议，为经典名方药物考证相关研究提供借鉴。该文分别从注意古今药物考证内涵的异同、注重多维信息的综合利用、注重药物不同关键环节历史流变的梳理与考证、注重近代学名考订沿革梳理、注重尊古不泥古的考证原则、注重文献学基础知识等角度进行探讨，提出经典名方药物考证应对本草考证的现状、问题、成果进行深入的总结分析，吸收前人的优点，补充以往考证的不足，并在此基础上根据经典名方药物考证自身特点，形成特有的研究体系，注重历史变迁的脉络梳理，注重横断面分析，在全面分析基原、道地产区、药用部位与炮制等不同关键环节历史变迁基础上，充分吸收近现代研究成果，并结合当前生产力和认知水平，给出不同时期经典名方药物的合理关键信息，为经典名方的开发奠定坚实基础。     

基于河南省药品生产技术转让情况探讨药品生产技术转让项目实施的关注要点

目的:为药品上市许可持有人实施药品生产技术转让提供参考。方法:分析归纳2015年-2019年河南省药品生产技术转让申报资料中存在的主要问题,依据分析结果探讨药品生产技术转让项目实施的关注要点。结果与结论:对河南省161个药品生产技术转让品种申报资料中存在的问题进行分析归纳,存在问题主要集中在转出方产品资料、生产工艺及工艺验证、质量研究及质量标准、稳定性研究、原辅料及药包材等方面,结合发现的问题并综合实践经验及文献资料探讨药品生产技术转让项目实施的关注要点。