基于3种数据挖掘模型分析16 618例含附子中成药的处方用药规律

目的:通过数据挖掘分析某院含附子的中成药处方,从中医辨证论治的角度分析该类中成药的临床用药特征规律,探究数据挖掘在中医药处方分析中的应用前景。方法:抽取2017年11月至2018年10月某院门诊含附子成分的中成药处方,从患者基本情况、中医疾病、中医证候等方面回顾分析该类中成药的临床使用情况,采用Microsoft Office Excel 2016进行基本统计,并结合Microsoft SQL Server Analysis Services 2012的3种数据挖掘算法解析处方用药特征。结果:某院使用含附子中成药共8种,14岁以下患者用该类药最多,其中小儿肺咳颗粒用量最大,中医疾病多为咳嗽、感冒、咳喘,中医证型多为寒热错杂证、风痰证、外感风邪。温补肾阳的中成药处方包含金匱肾气丸、龙鹿胶囊、尪痹胶囊、桂附地黄丸,中医疾病多为痹症、眩晕、虚劳等,证型主要为肝肾不足、肾虚血瘀、脾肾不足。决策树分析显示使用含附子的中成药处方具有年龄分布特点,其中中医疾病及证型为主要决策点;聚类分析根据该类处方患者年龄、性别、中西医诊断、中医证型将中成药处方分为10类;关联性分析显示小儿肺咳颗粒联用情况最多,但关联度不高,金匱肾气丸、芪苈强心胶囊、龙鹿胶囊和尪痹胶囊有各自的强关联用药。结论:数据挖掘算法纳入多因素分析临床处方的应用更接近中医临床辩证论治思维,结合基础统计可知某院含附子的处方整体用药符合中医辨证论治的特点。     

基于国家专利的中药复方治疗化学性肝损伤用药规律研究

目的分析国家专利治疗化学性肝损伤的组方用药规律,为新药研发及相关专利的申请提供参考。方法以国家知识产权局中国专利公布公告网站收录的授权专利为资料来源,使用Microsoft Excel 2018建立数据库,对中药频次与分类进行统计分析;采用SPSS Statistic 21.0和SPSS Modeler 15.0对高频中药(频次≥10)进行性味归经分析、系统聚类分析、关联度与网络分析。结果纳入专利100项,涉及中药186味,以葛根最为常见;高频中药15味,药味以甘为主,药性以温、平为主,多归脾、肝经;聚类分析得到7组中药组合;二项、三项和四项关联规则分别为6、24、2项,各项组合分别为6、16、2项;核心药物为葛根、五味子、丹参、甘草、山楂、枸杞子、黄芪、柴胡、姜黄和枳椇子。结论中药复方治疗化学性肝损伤常用补虚、解表、化瘀、活血、渗湿及利水药;临证多采用疏肝理气之剂,适当伍以柔润之品。     

帕累托图及鱼骨图分析法在管理中成药合理用药中的应用

目的分析帕累托图及鱼骨图分析法在管理中成药合理用药中的作用。方法搜集2018年1-12月本院中成药专项点评不合理处方743份,采用帕累托图及鱼骨图进行分析,确定不合理用药的主要类型,找出根本原因,制定整改措施。结果整改前(2018年1-6月)中成药不合理用药处方为537张,整改后(2018年7-12月)为206张。帕累托图分析显示,不合理用药主要类型为:用法用量不适宜(25.33%)、适应证不适宜(15.26%)、禁忌证用药(14.71%)、联合用药不适宜(13.78%)、重复用药(10.43%)。整改后,处方不合格率由2.29%降至0.84%,差异有统计学意义(P<0.01)。结论利用帕累托图及鱼骨图分析法准确分析中成药不合理用药情况,有针对性地采取整改措施,可有效促进中成药合理用药。     

论中成药大品种与中医理论创新

中成药大品种具有临床价值大、科学价值强、市场价值高的基本特征,中成药大品种不仅是中药产业发展的核心引擎,也是中医药学术发展的重要内容,事关中医药事业与产业,意义重大。本文以中医理论创新与中药大品种为切入,在回顾中医理论创新研究方法与模式的基础上,强调有效方药的创制是理论创新研究成果的集中体现,并以风咳理论与苏黄止咳胶囊、络病理论与通心络胶囊为例予以说明。提出以中成药大品种为载体,实现中医理论创新研究的思路与策略,即在梳理和分析中成药大品种组方规律与功能主治的基础上,深度挖掘其蕴含的理论内涵,不仅强调普遍的理论认识,更应关注应用独特的药物及其配伍;不仅仅满足揭示中药作用的现代科学内涵,更应通过中成药大品种作用机制研究,探索未知或可能的新靶点、新通路和新机制,从而促进科学发现,引领医学研究方向。     

Standard-dose gentamicin does not increase risk of patent ductus arteriosus

BackgroundRates of patent ductus arteriosus (PDA) and infection are high in preterm infants. Preterm infants with infection are more likely to develop symptomatic PDA, a potentially fatal disease. Clinically, gentamicin is widely used for early-onset infection in neonates including preterm infants. A recent study demonstrated that standard-dose gentamicin itself, not infection, increased risk of PDA in mice, suggesting that gentamicin should be avoided in neonates with a risk of PDA. This claim has been insufficiently investigated in subsequent in-vivo experiments. We reevaluated the in-vivo effect of standard-dose gentamicin on patency of the rat ductus arteriosus (DA).Methods1) To evaluate the effect of gentamicin on DA patency duration, gentamicin was intraperitoneally injected immediately after birth. 2) To evaluate the effect of gentamicin on DA reopening, gentamicin was intraperitoneally injected 30 min after birth. In both scenarios, 30 min after gentamicin administration, rapid whole-body freezing was performed and the inner diameter of the DA was measured.ResultsStandard-dose gentamicin (5 μg/g) did not prolong patency of the DA or increase the likelihood of DA reopening in rat neonates. High-dose gentamicin (100 μg/g), however, significantly prolonged patency of the DA and was associated with DA reopening in rat neonates, although the dilative effect did not reach statistical significance.ConclusionStandard-dose gentamicin does not increase the risk of PDA in rat neonates. This study suggests that standard-dose gentamicin can be used to treat infection in neonates without increasing PDA morbidity.     

Comparative efficacy of seven Chinese patent medicines for early diabetic kidney disease: A Bayesian network meta-analysis

BackgroundBailing Capsule (BLC), Jinshuibao (JSB), Huangkui Capsule (HKC), Uremic Clearance Granule (UCG), Tripterygium glycosides (TG), Compound Xueshuantong Capsule (CXC), and Shenyan Kangfu Tablet (SYKFT) as classic Chinese patent medicines (CPMs), have been widely used and shown beneficial effects on the treatment of early diabetic kidney disease (DKD). However, the comparative efficacy of seven CPMs in the treatment of early DKD remains unknown.ObjectiveTo evaluate and compare the efficacy of seven CPMs (BLC, JSB, HKC, UCG, TG, CXC, SYKFT) combined with angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) on early DKD by a Bayesian network meta-analysis (NMA) of randomized controlled trials (RCTs).MethodsA comprehensive and systematic literature search was performed in PubMed, Embase, Cochrane Library, Web of Science, Clinical Trials.gov, China Biology Medicine, Chinese National Knowledge Infrastructure, Chinese Scientific Journal, and Wanfang databases from inception to March 14, 2021, for full-text RCTs that evaluated the efficacy of seven CPMs combined with ACEI/ARB on patients with early DKD. Two reviewers independently screened studies for eligibility, extracted data, and assessed the risk of bias. Agreement between reviewers was measured using kappa statistics. Mean difference (MD) and odds ratio (OR) were calculated to evaluate continuous variables and dichotomous, respectively. The random effect modeling NMA was performed and the ranking probability of interventions in various outcomes was also conducted based on the surface under the cumulative ranking curve (SUCRA). Begg’s and Egger’s tests were used to evaluate publication bias. The certainty of the evidence for outcomes was evaluated according to the GRADE system.ResultsA total of 62 RCTs with 5362 patients with early DKD were identified. The value of Kappa calculated for the various parameters extracted by the two investigators was 0.821 (P < 0.001). Among these CPMs, UCG + ACEI/ARB showed the best effectiveness for urinary albumin excretion rate (UAER) (MD 32.25, 95% CrI 19.11–45.67, low certainty) with SUCRA 92%. JSB + ACEI/ARB showed the highest effectiveness for 24-h urinary total protein (24-h UTP) (MD 76.92, 95% CrI 53.54–100.58, low certainty) with SUCRA 97%. CXC + ACEI/ARB showed the highest effectiveness for serum creatinine (SCr) (MD 26.02, 95% CrI 6.10–45.95, low certainty) with SUCRA 96%. HKC + ACEI/ARB showed the highest effectiveness for blood urea nitrogen (BUN) (MD 1.46, 95% CrI 0.42–2.54, very low certainty) with SUCRA 86%. BLC + ACEI/ARB showed significant differences in triglyceride (TRIG) (MD − 1.17, 95% CrI − 1.93 to − 0.43, low certainty) with SUCRA 90%, total cholesterol (TC) (MD − 1.17, 95% CrI − 1.97 to − 0.39, very low certainty) with SUCRA 90%, and C-reaction protein (CRP) (MD − 0.90, 95% CrI − 1.51 to − 0.32, very low certainty) with SUCRA 76%.ConclusionsCPMs + ACEI/ARB might be positive efficacious interventions from which patients with DKD will derive benefit. UCG + ACEI/ARB, JSB + ACEI/ARB, CXC + ACEI/ARB, and HKC + ACEI/ARB might be potentially the preferred intervention for reducing UAER, 24-h UTP, SCr, and BUN levels, respectively. BLC + ACEI/ARB has a better impact on lowing TRIG, TC, and CRP levels in patients with early DKD. However, more high-quality, large-scale, multi-center RCTs and stronger head-to-head trials are required to confirm these findings.     

医院专利管理法律问题探析

在医疗市场竞争日趋激烈的情形下,加强专利的申报、管理、利用,对于提升医院竞争力、增加经济收入、促进医院长远发展意义重大。本文以医院专利为主题,阐明了医院专利管理中的相关法律问题,指出依法加强医院专利管理工作的重大意义。     

大鼠乙酸性胃溃疡复发模型的复制及健胃愈疡颗粒的干预作用

[目的]复制大鼠乙酸性胃溃疡复发模型并观察健胃愈疡颗粒（JWYY）的干预作用。[方法]采用改良Okabe乙酸涂抹法制作大鼠胃溃疡模型，腹腔注射白细胞介素1β（IL-1β）致愈合溃疡复发。44只大鼠随机分为正常对照组、假手术组、模型复发组、模型未复发组、JWYY组、奥美拉唑（OMLZ）组，观察各组胃溃疡复发率、胃蜜大体改变、胃窦组织病理学改变、炎症细胞密度计数。[结果]模型复发组胃溃疡复发率为87．50％，呈溃疡病理结构改变，溃疡边缘见残留之再生黏膜，再生黏膜较薄，有较多炎症细胞浸润。JwYY能改善胃溃疡愈合，减低IL-1β所诱导的瘢痕黏膜炎症细胞浸润的密度，降低溃疡复发率，与OMLZ无显著差别。[结论]IL-1β可能通过炎症细胞浸润诱导愈合的乙酸性胃溃疡复发；抑制炎症反应可能是JWYY抗溃疡复发的疗效机制之一。     

口服消旋布洛芬治疗新生儿动脉导管未闭的疗效

目的：探讨口服布洛芬（INN）治疗新生儿动脉导管未闭（PDA）的疗效及安全性。方法：2011年2月至2013年12月在本院住院并经彩色超声心动图检查确诊有 PDA 的160例新生儿,按随机数字表法均分为高剂量组（第1d 给予布洛芬10mg/kg,第2d 和第3d 给予5mg/kg）,低剂量组（每天给予布洛芬5 mg/kg,连续3d）,每组各80例。观察两组经布洛芬治疗后 PDA 关闭情况并作对照分析。结果：本研究的160例 PDA 患儿,经 INN 治疗后96例（60％）闭合,高剂量组动脉导管关闭57例（71.3％）,显著高于低剂量组动脉导管关闭39例（48.8％）, P ＜0.01;两组患儿不良反应发生率无明显差异（P 均＞0.05）。结论：使用高剂量布洛芬治疗新生儿动脉导管未闭效果较好,不良反应少,可避免部分患儿以后手术的痛苦。