中药新药研究的思路方法和实践

中药新药研究涉及学科理论体系、研究对象、服务对象等多个主、客体系，是一个多因素的复杂的系统工程。对传统中医药学的朴素系统论、西医药学的近代还原论以及现代中医药学的现代系统论特征、优势和不足进行了归纳和辨析。从新药研究的系统思维的角度，将中药药物形成过程划分为药物原料形成、药物制备和药物体内过程3个基本环节，详细分析了各环节中诸影响因素。基于以上认识，提出了中药新药研究应遵循的思维模式和研究方法，并根据自己的科研实践，探讨了目前新药研究的热点及在研制过程中应注意的问题。最后提出：中药新药研究是一个系统工程，在思维模式上要从整体的视角、普遍联系和多变性的观点出发，以证实的实验手段和系统学的分析方法，从生命运动的不同层面，探索疾病的药物干预规律。秉承继承与刨新相结合的原则，不断实现对传统中药的“扬弃”，从中“蜕变”出全新意义的现代中药。     

补肾药物穴位给药治疗骨质疏松症的机理探讨

骨质疏松症是临床常见病多发病。随着人口老龄化的进展,骨质疏松的患病率逐年增加。目前国内外主要应用药物(包括西药和中药)疗法,其研究开展的较早也较系统,已取得了较大的进展,药理学研究多局限于口服药物和注射药物的研究。近年来,伴随着透皮剂和离子导入等理化技术的发展,中药经皮给药治疗骨质疏松症已取得一定进展。就此方面对补肾药物经皮穴位给药治疗骨质疏松症的机理作一探讨。     

不同频率电针对实验性肥胖大鼠脂代谢的影响

目的:通过观察不同频率的电针对实验性肥胖大鼠脂代谢的影响,探讨频率调节脂代谢异常的作用机制。方法:采用谷氨酸钠和高脂饮食诱导的下丘脑性肥胖大鼠模型,选取大鼠曲池、丰隆、三阴交、后三里、中脘和关元穴,采用2Hz、50Hz、100Hz频率针刺。测定大鼠体质量指数(Lee,s指数)、左肾周脂肪和大网膜脂肪湿重;用酶学终点法测血清三酰甘油(TG)、胆固醇(TC)的含量;用磷钨酸-镁沉淀法测血清高密度脂蛋白胆固醇(HDL-C)含量;用聚乙烯硫酸沉淀法测血清低密度脂蛋白胆固醇(LDL-C)含量。结果:与模型组比较,电针3组大鼠Lee,s指数、左肾周脂肪和大网膜脂肪湿重、血清TG、TC和LDL-C含量均显著降低(P<0.05或P<0.01),血清HDL-C含量显著升高(P<0.05)。结论:2Hz、50Hz、100Hz电针频率降低大鼠Lee,s指数、调整脂代谢的作用有依次递减的趋势,50Hz电针频率似在降低脂肪重量上较2Hz和100Hz有优势。     

清脑熄风汤治疗肝火上炎型高血压随机平行对照研究

[目的]观察清脑熄风汤治疗肝火上炎型高血压疗效。[方法]使用随机平行对照方法,将60例门诊患者按抽签法简单随机分为两组。对照组30例牛黄降压丸,3.2g/次,2~3次/d。治疗组30例清脑熄风汤(白蒺藜、磁石各10g,石昌蒲9g,珍珠母30g,菊花、桑叶各9g;四肢麻木加僵蚕、鸡血藤、桑枝;肝肾阴虚加桑椹子、杞果、生地;痰浊盛加志远炒、半夏制、竹茹;肝阳亢甚加生牡蛎、钩藤、生龙骨),1剂/d,水煎200mL,早晚温服。连续治疗42d为1疗程。观测临床症状、相关指标(胆固醇、血糖)、不良反应。治疗1疗程,判定疗效。[结果]降压疗效:治疗组显效15例,有效12例,无效3例,总有效率90.00%。对照组显效6例,有效15例,无效9例,总有效率70.00%。治疗组疗效优于对照组(P0.05)。症状疗效:治疗组显效14例,有效13例,无效3例,总有效率90.00%。对照组显效5例,有效15例,无效9例,总有效率70.00%。治疗组疗效优于对照组(P0.05)。[结论]清脑熄风汤治疗肝火上炎型高血压效果显著,值得推广。     

易黄汤临床新用的文献研究

笔者通过对近年有关易黄汤临床应用文献的研究发现,易黄汤不止限于治疗带下病,也被灵活运用于临床其他各种疾病的治疗中。文章对临床应用易黄汤治疗各种疾病进行概括总结,对其病机和作用机理进行了分析,并报道了易黄汤治疗的相关病例。     

艾灸和针刺治疗对膝骨性关节炎患者临床症状影响与疗法特点调查的对比研究

目的:评价艾灸和针刺治疗膝关节骨关节炎的临床症状疗效、疗效差异和疗法特点,为临床选择艾灸或针刺治疗提供依据。方法:将50例膝骨性关节炎患者按组间均衡原则随机分为艾灸治疗组(25例38只膝关节)和针刺治疗组(25例34只膝关节),两组患者均选取患病膝关节周围腧穴(阳陵泉、阴陵泉、梁丘、血海、内外膝眼、足三里、阿是穴)分别进行温和灸和毫针针刺治疗,通过JOA表观察治疗前后两组患者临床症状的变化及变化差异,并进行疗法特点的问卷调查。结果:艾灸组和针刺组治疗前后临床症状均减轻,JOA表康复评定差值都有统计学意义(P<0.05;P<0.05);艾灸组和针刺组比较,针刺组的总体疗效好于艾灸组,差值有统计学意义(P<0.05)。艾灸组和针刺组治疗结束后,疗法特点的问卷调查结果显示艾灸组掌握率为96%,针刺组掌握率为0%,艾灸组患者对治疗方法的掌握明显高于针刺组。结论:艾灸和针刺对膝关节骨性关节炎均有有效治疗作用,但针刺治疗疗效优于艾灸治疗,而艾灸组患者大多学会艾灸治疗方法,所以,在针灸防治KOA临床运用中,医务工作者可根据患者情况的不同,在确保安全的前提下选择推荐并教授患者自行艾灸(温和灸)的方法进行治疗,也可选择针刺(或包含针刺在内的综合手段)治疗以取得更好的临床疗效,从而满足广大人民群众不同层次和不同方面的医疗保障需求。     

Association Between a Body Shape Index and Subclinical Carotid Atherosclerosis in Population Free of Cardiovascular and Cerebrovascular Diseases

Aim: We used a dataset from a cross-sectional survey conducted in China to determine which of the anthropometric indices of obesity are important in terms of carotid atherosclerosis free of cardiovascular and cerebrovascular diseases. Methods: A total of 5,245 participants who were volunteering for carotid ultrasound unit in this cross-sectional survey were included in the present analysis. All subjects were free of angina, myocardial infarction, heart failure and stroke, and cancer. A low-risk subgroup was defined as people free of hypertension, diabetes, and hyperlipidemia. All analyses based on logistic regression were gender-specific. Results: The present study consisted of 2,501 males and 2,744 females, with 776 (31.03%) diagnosed as carotid artery plaque in males and 550 (20.04%) in females. Univariable analyses in unadjusted logistic model showed significant associations between disease presence and all central obesity indices. After adjusting for more variables, only a body shape index (ABSI) was associated with the presence of disease in both males and females. Moreover, stepwise regression approaches revealed that ABSI was always an independent determinant of the presence of subclinical carotid plaque. Multiple regression shows a linear and significant increase in the prevalence of atherosclerosis in males and females as ABSI decile levels increased. Similar results were obtained when the association between ABSI and carotid plaque was studied in this low-risk subgroup. Conclusions: ABSI, as a novel anthropometric indicator compared with traditional indices, was found to have a closer relationship with subclinical carotid atherosclerosis, even in populations free of hypertension, diabetes, and hyperlipidemia.     

Birth outcomes of patients with isolated anorectal malformations: A population‐based case‐control study

In most patients affected by isolated anorectal malformation (IARM) the etiology is largely unknown. Thus, the aim of our project was to analyze possible risk factors for IARM. In the first step, birth outcomes of cases with IARM were analyzed on the basis of maternal socio‐demographic variables, and these data are presented in this paper. Gestational age at delivery, birthweight, preterm birth, low birthweight and small for gestational age of cases with IARM were evaluated in the function of maternal age, birth/pregnancy order, marital and employment status of mothers in the population‐based large dataset of the Hungarian Case‐Control Surveillance of Congenital Abnormalities, 1980–1996. The study samples included 231 live‐born cases with IARM, 361 matched and 38 151 population controls without any defect. IARMs are more frequent in males, twins and newborn infants with low birthweight and small‐for‐gestational‐age, the latter being the consequence of intrauterine growth restriction. In addition, mothers of cases were younger but with higher birth order, and had lower socio‐economic status. These maternal variables are characteristic for the gypsy population in Hungary. The higher proportion of gypsy women among the mothers of cases with IARM was confirmed during the home visits of the study. Male sex and intrauterine growth restriction of cases, in addition to low socioeconomic status and gypsy origin of mothers may have a role in the risk of IARMs.     

Ovarian hyperstimulation syndrome: a clinical retrospective study on 565 inpatients

Abstract

The aim of this study was to analyze clinical manifestations of 565 ovarian hyperstimulation syndrome (OHSS) inpatients in the largest Obstetrics and Gynecology hospital in China from year 2010 to 2017, to get more understanding of epidemiologic features of this disease, and to provide some insight on the diagnosis, treatment, and preventions of OHSS. It is a clinical retrospective study. In the 565 cases that developed OHSS over an eight-year period between 2010 and 2017 were reviewed, we assessed patients’ general characteristics, clinical manifestations, treatment, prognosis, and the relationship between different indicators and the severity of OHSS. Totally 12 kinds of ovulation induction protocols (Protocol 1: CC; Protocol 2: Gn; Protocol 3: hCG; Protocol 4: GnRh-a; Protocol 5: CC & Gn; Protocol 6: CC & hCG; Protocol 7: Gn & hCG; Protocol 8: GnRh-a & Gn; Protocol 9: CC & Gn & hCG; Protocol 10: GnRh-a & CC & Gn; Protocol 11: Letrozole & Gn & hCG; Protocol 12:GnRh-a & Letrozole & Gn) were analyzed and the Odds Ratio (OR) of each protocol were calculated. Five hundred and sixty-five patients were reviewed in our study. In all these patients, the number of hospitalizations, mean age, primary infertility rate, and pregnancy rate did not differ through the last 8?years. From which we may infer that the incidence rate of OHSS may not change over the last 8?years. Older patients tend to develop into more severe stage easily. The pregnancy rate was much lower in mild stage patients, but no difference was found between patients in moderate, severe and critical stage. Oocytes retrieval is strongly associated with severity. PCOS history, irregular menstrual cycle and infertility type do not seem to affect the severity of OHSS. Twelve kinds of ovulation induction protocols were analyzed, OR of different protocols were calculated, what is noteworthy is that patients who used GnRh easily developed more severe OHSS than the patients who received oocytes retrieval. We suggest that we may choose ovulation induction protocols according to the OR table while treating women with high-risk factors.