升髓合剂防治化疗后骨髓抑制的临床研究

目的:观察患者临床症状、客观检测指标及用药期间是否出现不良反应等,评价升髓合剂对多西他赛联合顺铂方案(Docetaxel Combined with Cis-platinum,DP)化疗所致骨髓抑制的有效性及安全性。方法:将50例符合标准的恶性肿瘤患者随机分为两组,治疗组和对照组各25例。对照组:DP方案化疗同时加服地榆升白片,治疗组:在DP方案化疗基础上加用升髓合剂。2个周期后观察患者化疗后第3、7、14 d外周血细胞变化及骨髓抑制情况,化疗后中医临床症状评分及疗效以及体力状况评分(Karnofsky,KPS)、体质量变化及其不良反应。结果:①两组化疗完成率观察组明显高于对照组(P<0.05);②观察组血常规中白细胞、中性粒细胞、血小板计数治疗后1周与治疗前比较无统计学意义,(P>0.05),而对照组白细胞、中性粒细胞、血小板计数下降显著,与治疗前差异有统计学意义,(P<0.05);两组相比,化疗后1周观察组血常规白细胞、中性粒细胞、血小板水平明显高于对照组,差距有统计学意义(P<0.05);③化疗后2周观察组白细胞计数升高明显高于对照组,两组差异有显著性(P<0.05);④化疗后中医证候改善方面,观察组症状改善显著(P<0.05)。对照组症状上改善不明显(P>0.05),两组在总体症状改善率方面相比较有显著性差异,治疗组明显优于对照组(P<0.05);⑤治疗组KPS评分明显优于对照组(P<0.05);⑥治疗组不良反应的发生率明显低于对照组(P<0.05)。结论:升髓合剂对于多西他赛联合顺铂化疗方案引起的骨髓抑制等不良反应具有防治作用。     

丹芩消郁合剂治疗乳腺增生病疗效观察

目的:观察丹芩消郁合剂治疗乳腺增生病的临床疗效。方法:将80例乳腺增生病患者随机分为治疗组和对照组各40例,治疗组给予丹芩消郁合剂治疗,对照组给予消癥丸治疗,2个月为1个疗程,疗程结束后评价疗效。结果:两组患者治疗的总有效率均为92.5%,比较其差异无统计学意义(P0.05);两组愈显率分别为:治疗组52.5%,对照组30.0%,两组比较,差异有统计学意义(P0.05)。结论:丹芩消郁合剂治疗乳腺增生病疗效优于消癥丸。     

HPLC法测定蛇伤Ⅱ号合剂中大黄酚的含量

目的建立HPLC检测法测定蛇伤Ⅱ号合剂中大黄酚的含量。方法采用C18柱(4.6mm×250mm,5μm);流动相为甲醇-0.1%磷酸溶液(72:28),流速为1.0m L·min-1;检测波长254nm。结果大黄酚在8.580~171.600ng的范围内呈良好的线性关系(r=1.0000),平均回收率为96.71±0.96(RSD为0.99%)。结论该法具有良好的精密度和重现性,结果准确可靠,可用于蛇伤Ⅱ号合剂中大黄酚的含量测定。     

New legal requirements for submission of product information to poisons centres in EU member states

Introduction: In the past eight years, the European Association of Poisons Centres and Clinical Toxicologists (EAPCCT) has been intensively involved in a European Commission led process to develop EU legislation on the information of hazardous products that companies have to notify to EU Poisons Centres (or equivalent “appointed bodies”). As a result of this process, the Commission adopted Regulation (EU) No 2017/542, amending the CLP Regulation by adding an Annex on harmonised product submission requirements.

Harmonised mixture information requirements: Detailed and consistent information on the composition of the hazardous product will become available to EU Poisons Centres (PC). The information will be submitted by companies to PCs (or equivalent “appointed bodies”) using a web-based software application or in-house software. Two new important features are introduced. Firstly, to be able to rapidly identify the product formula, a Unique Formula Identifier (UFI) on the product label links to the submitted information. Secondly, for better comparability of reports on poisonings between EU member states, a harmonised Product Categorisation System will specify the intended use of a product. Rapid product identification and availability of detailed composition information will lead to timely and adequate medical intervention. This may lead to considerable reduction in healthcare costs.

Additionally, for companies trading across the EU, costs of submission of this information will be reduced significantly.

Next steps: From 2017, an implementation period has started, consisting of a three-year period for stakeholders to implement the new requirements, followed by a gradual applicability for consumer products (2020), professional products (2021) and industrial use-only products (2024). Technical tools to generate the electronic format and the UFI together with guidance documents are expected to be made available by the end of 2017 by the European Chemicals Agency (ECHA). Guidance on interpretation of legal text and ECHA helpdesk support are planned to be ready at the end of 2018.     

Power calculations for delta‐adjusted pattern‐mixture models

Pattern‐mixture models provide a general and flexible framework for sensitivity analyses of nonignorable missing data in longitudinal studies. The delta‐adjusted pattern‐mixture models handle missing data in a clinically interpretable manner and have been used as sensitivity analyses addressing the effectiveness hypothesis, while a likelihood‐based approach that assumes data are missing at random is often used as the primary analysis addressing the efficacy hypothesis. We describe a method for power calculations for delta‐adjusted pattern‐mixture model sensitivity analyses in confirmatory clinical trials. To apply the method, we only need to specify the pattern probabilities at postbaseline time points, the expected treatment differences at postbaseline time points, the conditional covariance matrix of postbaseline measurements given the baseline measurement, and the delta‐adjustment method for the pattern‐mixture model. We use an example to illustrate and compare various delta‐adjusted pattern‐mixture models and use simulations to confirm the analytic results. Copyright © 2014 John Wiley & Sons, Ltd.     

A random pattern mixture model for ordinal outcomes with informative dropouts

We extend a random pattern mixture joint model for longitudinal ordinal outcomes and informative dropouts. The patients are generalized to ‘pattern’ groups based on known covariates that are potentially surrogated for the severity of the underlying condition. The random pattern effects are defined as the latent effects linking the dropout process and the ordinal longitudinal outcome. Conditional on the random pattern effects, the longitudinal outcome and the dropout times are assumed independent. Estimates are obtained via the Expectation–maximization algorithm. We applied the model to the end‐stage renal disease data. Anemia was found to be significantly affected by the baseline iron treatment when the dropout information was adjusted via the study model; as opposed to an independent or shared parameter model. Simulations were performed to evaluate the performance of the random pattern mixture model under various assumptions. Copyright © 2015 John Wiley & Sons, Ltd.     

养阴活胃合剂对慢性萎缩性胃炎模型大鼠血清炎症因子的影响

目的探讨养阴活胃合剂对慢性萎缩性胃炎(CAG)模型大鼠血清炎症因子含量的影响及其作用机制。方法将实验动物随机分为6组:空白对照组、模型组、阳性药物对照组及中药低剂量组、中剂量组、高剂量组,每组16只。除空白对照组常规饲养、自由进食水之外,其余5组将2 g水杨酸钠加入100 m L的30%乙醇溶液中,给大鼠灌胃,每日1次,每次3 m L,配合隔日喂食不禁水法建立大鼠萎缩性胃炎模型,模型复制成功后中药治疗低、中、高剂量组分别喂饲养阴活胃合剂水煎剂0.74 g·kg-1·d-1、1.48 g·kg-1·d-1和2.22 g·kg-1·d-1。12 w后测定血清中IL-6、TNF-α、IFN-β及NOS2含量。结果养阴活胃合剂能够改善大鼠胃黏膜病理状态,使病变胃黏膜趋于正常。与空白对照组比较,各组IL-6、TNF-α、IFN-β及NOS2均明显升高(P<0.05),证明模型复制成功。与模型组相比,中药高剂量组TNF-α、IL-6、NOS2均明显降低,差异有统计学意义(P<0.05),中药中剂量组IFN-β降低,差异有统计学意义(P<0.05)。结论养阴活胃合剂可降低慢性萎缩性胃炎大鼠血清中炎症因子水平,而抑制炎症反应可能有助于慢性萎缩性胃炎病情的改善。     

克银合剂治疗血热型白疕疗效及对肿瘤坏死因子-α的影响

目的 研究克银合剂治疗血热型白疕(寻常型银屑病)疗效及对肿瘤坏死因子-α(TNF-α)的影响.方法 选取30例寻常型银屑病血热型患者作为研究对象,进行克银合剂治疗,另选取同期接受健康体检的健康人30例作为对照组,研究克银合剂对TNF-α的影响.结果 治疗前TNF-α水平显著高于健康对照组,进行克银合剂治疗后患者症状、体征评分均显著低于治疗前,各项指标水平已经接近对照组.结论 克银合剂能改善寻常型银屑病血热型患者的临床症状,对TNF-α异常也有一定的改善作用.     

银僵合剂治疗坏死性淋巴结炎

目的 观察3型坏死性淋巴结炎患者的临床表现以及银僵合剂对3型坏死性淋巴结炎的疗效.方法 根据病理分型将坏死性淋巴结炎患者分为3组:增生(PT)组29例、坏死(NT)组30例、黄色瘤型(XT)组28例,均给予银僵合剂内服加外熏.观察3组临床表现及治疗前后中医证候积分的变化.结果 PT、NT组中医证候积分明显高于XT组(P＜0.05).3组总有效率及复发率分别为PT组96.55％、3.60％;NT组96.66％、3.44％;XT组89.28％、4.00％,PT组与NT组比较无统计学意义(P＞0.05),与XT组比较有统计学意义(P＜0.01).结论 3组临床表现存在差异;银僵合剂在PT、MT2组中的疗效优于XT组.     

壮精合剂对初老大鼠行为学及脑单胺类神经递质的影响

目的：观察壮精合剂对初老大鼠行为学及脑单胺类神经递质的影响,探讨其抗衰老的作用机制。方法选用12月龄,体质量（300±20）g。雌性初老大鼠50只,建立模型,分为5组：空白对照组、壮精合剂高剂量组、壮精合剂中剂量组、壮精合剂组低剂量组、阳性对照组,每组10只。各组分别灌胃相应药物8周后,采用Morris水迷宫检测各组大鼠的空间学习记忆行为能力及采用高效液相色谱‐荧光检测法检测各组大鼠大脑皮层、海马单胺类神经递质含量。结果与空白对照组比较,壮精合剂高、中剂量组及阳性对照组均能使初老大鼠学习记忆能力有所改善,并能提高其大脑皮层及海马区单胺类经递质含量。壮精合剂高剂量组与阳性对照组比较在改善学习记忆能力方面差异有统计学意义（P＜0．05）,在提高大脑皮层及海马区单胺类经递质含量方面效果最为显著（P＜0．05）。结论壮精合剂能有效改善初老大鼠的学习记忆能力,其作用机制可能与调节大脑内单胺类神经递质有关。