中医药临床疗效评价因果关联推断的探讨(续)

3 随机对照试验在干预措施和临床结局之间因果关联推断的价值随机对照试验(randomized controlled trial, RCT)是随机对照临床试验的简称.它是指按照严格的随机方法分配合格的受试者至试验组和对照组,同期观察试验性干预措施和对照措施分别作用在不同组别受试者身上所产生的效应(临床结局),进而比较组间效应的异同,并对试验性干预措施与临床结局之间进行因果关联推断的前瞻性、试验性研究.

加强中医药治疗脂肪性肝病的深入研究

脂肪肝是指各种原因引起的肝脏脂肪代谢功能发生障碍,致使肝脏甘油三酯蓄积过多的一种病理状态,在20世纪50年代从病理学角度提出.1980年Ludwig提出了非酒精性脂肪性肝炎(nonalcoholic steatosis hepatitis, NASH)概念,即指以肥胖或急剧减肥、2型糖尿病、空回肠短路手术、药物损伤等为背景而发生的有别于酒精性肝损伤的脂肪性肝炎.NASH概念目前已被普遍接受.据近年报道,在欧美,10年中约有20%的NASH向肝硬化发展.

Fengchi (GB 20) is a point of the Gallbladder Meridian of Foot-Shaoyang. It is commonly used in clinical practice. According to the literature of traditional Chinese medicine, Fengchi (GB 20) can be used to treat many diseases, especially for the disorders caused by pathogenic wind. The indications include common cold, headache, cervical spondylosis, trigeminal neuralgia, hypertension, apoplexy, neurasthenia, epilepsy, optic atrophy, tinnitus, myopia, and painful heel etc. The viewpoints of different schools varies on the needling angle and depth at Fengchi (GB 20). Perpendicularly puncturing 0.3-0.7cun deep is recorded in most of the ancient books. Puncturing to a depth of 1.2 cun is mentioned in Fundamentals of Acupuncture and Moxibustion (针灸资生经) and Compendium of Acupuncture and Moxibustion (针灸大成). Jiang Yijun, a modern famous acupuncturist, holds that the depth of needle insertion at Fengchi (GB 20) should be varied in different individuals and different diseases. In general, deep puncture should be adopted for the disease in deep location, shallow puncture for the disease in shallow area, and tapping with plum-blossom needle for the disease on the skin. These will be introduced below.

Repeated respiratory tract infection is a frequently-occurring disease during childhood. At present, western medicine doctors generally adopt anti-infectives and immunomodulators to treat the disease, while traditional Chinese medicine doctors mainly administer decoction of Chinese herbs. The authors treated 46 cases of repeated respiratory tract infection from March 1990 to April 1996 by applying mild-moxibustion over points on the back with satisfactory therapeutic results. A report follows.Clinical Data All the 86 cases were outpatients in our hospital with duration of common cold for over 10 days and characterized by relapse of respiratory tract infection. There were over 7-time relapse of respiratory tract infection on each case within a year. Eighty-six cases were randomly divided into treatment group (46 cases) and control group (40 cases). Of the 46 cases in the treatment group, 22 were boys and 24 girls. 17 cases (36.9%) were 6 months to 4 years old, 18 (39.1%) 4 to 6 years, and 11 (23.9%) 6 to 12 years. Among the 40 cases in the control group, 19 cases were boys and 21 girls.

Peripheral vascular disease embraces a variety of conditions such as thromboangiitis obliterans, Raynaud's disease, thrombophlebitis, aorto-arteritis, obliterate atherosclerosis, varix or phlebothrombosis of the lower limb. Although the affected blood vessel may be arterial or venous one and caused either by inflammation or degenerate changes, they share common symptoms and signs, such as blood stasis, ischemia, thrombosis, ecchymosis, swelling, constriction or obliteration of blood vessels due to circulatory impairment. Since they share common characteristics, the treating principles and methods will be discussed as follows.

The Ji De Sheng She Yao tablet (季德胜蛇药片）is a drug for snake-bites and insect bites. According to recent reports, this drug has been used to treat herpes zoster, hepatitis B, parotitis, nephrotic syndrome, acute conjunctivitis, recurrent aphtha, urticaria, etc.1 with good therapeutic effects. More than half of the AIDS patients suffered from herpes zoster. The area of skin lesion in AIDS patients is larger than that of the patients without AIDS and the pain lasts longer. Many cases have keloids and depigmentation for months, even severe pain till their death. Routine therapeutic methods are not satisfactory in therapeutic effects. The expert group of traditional Chinese medicine for cooperative research on AIDS used Ji De Sheng She Yao tablets (季德胜蛇药片) to treat AIDS complicated by herpes zoster for the first time and the results are reported as follows.

Duodenal bulbar ulcer is a frequently encountered disease. Clinically, it manifests itself by regular epigastric pain accompanied by belching and acid regurgitation, corresponding to epigastralgia and stomach distending pain in traditional Chinese medicine (TCM). Based on the TCM type-differentiation, the author has treated 105 cases of duodenal bulbar ulcer by the combined therapy of catgut embedding at point Zusanli (ST 36) and Chinese drugs with satisfactory results. A summary is as follows. Clinical Data1. Case selection: The cases selected all had the clinical symptoms and signs of duodenal bulbar ulcer, and had been diagnosed by GI examination at this or other hospitals with no obvious therapeutic effects obtained after relevant treatment, and still symptoms and signs and repeated attacks of pain.

Insulin resistance (IR) refers to subnormal response to a certain amount of insulin and is the most characteristic phenomenon in non-insulin dependent diabetes mellitus (NIDDM). It is also an element of the pathogenic mechanism shared with obesity, systemic hypertension, abnormal lipid metabolism and atherosclerosis. In recent years, studies on its treatment with traditional Chinese medicine (TCM) have gradually been carried out and the following is a report of them.Mechanisms of Diabetic IR in TCM TermsAction of insulin antagonizing hormones in peripheral tissues is one of the causes of diabetic IR. Cyclic nucleosides cAMP and cGMP, important intracellular messengers, are considered to be the second messenger of insulin, and cAMP is related to the amount of insulin receptors. Early in 1980s, some authors investigated the relationship among the symptoms of diabetes and such hormones and cAMP/cGMP ratio. Although they did not give due attention to IR, their studies provided evidences for differentiation of symptoms and signs in IR typing.

Psoriasis is a chronic and recurrent dermatosis marked by excessive hyperplasia of epidermal cells. The cause and pathogenesis are unknown. In the last few years, traditional Chinese medicine (TCM) has manifested its strength in treating psoriasis. In order to delve into the mechanism governing the TCM treatment of psoriasis, some clinical and experimental studies were carried out. The following is a review of the advance of the studies since the 1990's.Effects on Proliferation and Differentiation of Keratinocytes (Epithelial Cells)

Liver fibrosis is a gradual process of increased secretion and decreased degradation of extracellular materials (ECM). Most author hold that the process is initiated by the damage of hepatic cells (HCs), which leads to activation and secretion of multiple cellular factors of Kupffer cells. These factors, along with the cellular factors secreted by damaged HCs, thrombocytes and endothelial cells of the hepatic sinusoid, and some chemical mediators are activators of hepatic stellate cells (HSCs). Being activated, HSCs differentiate into myofibroblasts, and, via self-secretion and parasecretion, proliferate and synthesize a massive amount of extracellular materials which gradually accumulate and lead to formation of liver fibrosis.1 Since fibrosis is a common course in a variety of chronic liver diseases, prevention against its formation is of great importance. The following are the recent achievements of traditional Chinese medicine (TCM) in this field.

Even though radiotherapy is a therapy of first choice in the treatment of nasopharyngeal carcinoma, its radiotoxicity is often difficult to bear for patients in addition to the unsatisfactory effect in some patients. Therefore, an important problem in the treatment of nasopharyngeal carcinoma is to abate radiotherapeutic toxicity and improve its effect. Some progresses in promoting the effect of radiotherapy and abating its toxicity have been made through application of traditional Chinese medicine (TCM) which is briefly reviewed as follows.

External humeral epicondylitis or tennis elbow, is a commonly encountered disease in orthopaedics and traumatology. The curative effect is not satisfactory as far as its treatment by western and traditional Chinese medicine is concerned, which has a long course of treatment and a high recurrent rate. 70 cases of external humeral epicondylitis were treated by massotherapy after local blocking from August 1995 to October 1997 at this hospital with satisfactory therapeutic effects.Clinical DataOf the 70 cases in this series treated by massotherapy after local blocking, 30 were males and 40 females, ranging in age from 19 to 65 years. 55 cases were 30 to 50 years old, 20 had the left elbow affected and 50 the right elbow. 7 cases had a history of trauma, 50 a history of chronic strain, and 13 the cause unknown. The shortest duration of disease was 15 days and the longest 24 months.Among 50 cases in the control group treated by massotherapy, 20 cases were males and 30 females, ranging in age from 16 to 58 years. 40 cases were 30 to 50 years old. 15 cases were affected on the left elbow and 35 on the right elbow. 6 cases had a history of trauma, 32 a history of chronic strain, and 12 the cause unknown. The shortest duration of diseases was 7 days and the longest 22 months.

世纪之交:现代中药药理学的回顾与展望

In the 20th Century，modern pharmacology of traditional Chinese drugs（herbal pharmacology）has been developed by Chinese pharmacologists，clinicians and related scientists using modern technology. 200～300 single active ingredients have been isolated and a number of them being used in clinics． Modern pharmacological actions of nearly 400 recipes have been investigated and a number of jounals carrying papers on herbal pharmacology have been published．The development of herbal pharmacology could be roughly divided into two periods in the 20th Century．In the first half of the Century，actions of a number of herbs have been investigated and single compounds have been isolated.The dramatic event was the isolation and action study of ephedrine done by KK Chen．In the second half of the Century，the study of herbal drugs has been carried out not only using modern technology but also under the guidance of the theory of TCM （traditional Chinese medicine）．The emphasis has been put on the sutdy of a group（or category）of herbs and recipes. Based on these studies，theories of mechanism of action of herbs is emerging．It is hoped in the next Century that the new and systematic modern herbal pharmacology will grow mature. And it is anticipated that there will be a great leap forward in the future decades．

中西医结合治疗胆道蛔虫症30例疗效观察

胆道蛔虫症是人类常见的寄生虫病,尤其是卫生意识差的儿童易患此症.蛔虫有钻孔的习性,当受到刺激时蛔虫沿肠道向上逆行,进入胆道,形成胆道蛔虫症,引起胆道阻塞,也是形成胆石症、胆囊炎的一个重要因素.现将30例经B超确诊的胆道蛔虫症患者中西医结合治疗效果报告如下.

纳米中药制剂的研究介绍

Traditional Chinese medicine has been used for thousands of years, and has been contributing to human health. It is considered as a great treasure of mankind. However, nowadays, Traditional Chinese medicine falls behind of modern medicine. It has not been accepted extensively in the worldwide. How can we change this situation? Modernizing traditional Chinese medicine is an effective way. We must improve traditional Chinese medicine with modern science and technology.

病毒性肝炎的现代中医辨病辨证概况

我国自20世纪50年代开展中医药治疗病毒性肝炎的临床研究,至今已经走过了半个世纪的漫长历程,积累了丰富的经验,取得了丰硕的成果.有资料表明,目前我国有80%以上的肝病患者接受过和正在接受中医药治疗,而我国发表的抗肝纤维化的论文有80%以上为中医药研究论文,而80%以上的常用护肝药为中药或中药提取物制剂.

中医及中西医结合干预拉米夫定耐药的研究进展

抗病毒耐药的发生是人们十分关心的问题,在慢性乙型肝炎(chronic hepatitis B,CHB)治疗中被作为一个重要的考虑因素.核苷类药物治疗后耐药乙型肝炎(乙肝)病毒(HBV)的出现将使后续治疗药物的疗效降低,并且抵消了之前获得的临床效果,会出现病毒指标反弹,血清转氨酶升高,HBeAg血清转换率降低,肝脏病理进展,肝硬化患者出现肝功能失代偿和死亡,肝移植后肝炎复发率增高等等.

胃癌同证型中肿瘤转移相关基因蛋白的表达

目的:从基因蛋白表达层次探索胃癌中医证本质.方法:从第二军医大学长征医院普外科收集术前胃癌患者,并按中医辨证分型标准将其归属;取术后肿瘤标本,用免疫组化方法检测胃癌肿瘤中E-Cadherin、C-erbB-2、P53、nm23、ICAM-1、VEGF、KDR、MMP-2、TIMP-29种基因蛋白表达情况.结果:每个证型中的9个基因蛋白之间均有不同表达,统计学分析表明6证型的9个基因蛋白表达均有显著性差异P=0.0 001,进一步两两比较示同一证型内部多组基因都存在表达差异性;VEGF、E-cad、nm23表达率较高,分别为94%、90%、92%.痰湿凝结型中E-cad的蛋白表达高,以平均秩和表示为:63.09,肝胃不和、瘀毒内阻两型E-cad表达较低.结论:肝胃不和、瘀毒内阻两型胃癌发生转移可能主要与E-cad的缺失有关,但内部既有癌基因的高表达亦有抑癌基因高表达.

胃癌癌前病变的中医研究

目的:对近年来国内中医及中西医结合领域在胃癌癌前病变(PLGC)方面的研究进行简要述评.方法:从概念和诊断标准、科研课题的设计和流行病学方面的研究、实验动物模型、中药抗幽门螺杆菌机制、中药方药的选择、中医药治疗PLGC的机制等方面,对取得的进展进行了简要的回顾,并对存在的问题作简要的分析.结果:PLGC的概念和诊断标准有了较为统一的认识,还应进一步明确;科研课题设计取得可喜的进步,但还存在不足之处,尤其流行病学方面的研究还很缺乏;实验动物模型的研究逐渐增多,但还缺乏理想的模型;PLG,-C的中医病机已渐达成共识,辨证渐趋一致,采用固定方法治疗已成主流,如何选择合理有效的中医方药仍应进一步研究;中药抗幽门螺杆菌及中医药治疗PLGC机制的研究正逐步开展,取得了一些进展,还要大力加强.结论:PLGC的中医研究已取得很大的进展,但还存在一些不足之处,今后仍应进一步加强.

清热活血健脾中药对大鼠肝癌基因转录差异的调整

目的:观察中药抑癌扶正行气活血方(全方)及其不同治法的拆方:清热方、活血方、健脾方对肝癌大鼠的作用和对肝组织基因转录的整体调节作用.方法:采用二乙基亚硝胺(DEN)诱发大鼠肝癌,设正常组、模型组、不同中药组及FT-207组对照,分别观察各组大鼠生存率、肝、体、肝/体及肝组织的病理、甲胎蛋白(AFP)免疫组化变化;以及采用DDPCR技术显示正常肝组织与模型组肝癌组织中呈差异转录的cDNA片段,Northern blot验证这些cDNA片段在各组中转录的差异,并将呈差异转录的cDNA片段进行克隆与测序.结果:全方其及拆方均能不同程度地改善肝癌大鼠的一般情况,提高大鼠的生存率.各拆方中以清热组与活血组为优;全方其及拆方均能不同程度地抑制肿瘤的生长及肝脏AFP的合成,其中以全方组与清热组为优;采用DDPCR结合Northern blot筛选出在各组中呈显著差异转录的9个阳性cDNA片段,经与Genbank比较4个为新的基因,且这9个基因在肝癌发生与转归中的作用至今未见报道;全方及其拆方对这些基因的转录水平有不同程度的调节作用,其中DD29下调57-78%,DD11 、DD25也有下调至60%和78%,使基因转录水平接近正常肝组织.结论:全方及其不同治法的拆方中药对大鼠肝癌具有直接治疗作用,能不同程度地广泛地调控肝组织(含肝癌组织)有关基因的转录水平.