选择两种药剂疗法的序列设计比较研究

如果两种治疗方法的疗效差别是大的,那么,通过使用舍位的序列程序来比较两种疗法的优越性,就可早期中止一个临床试验。这种舍位的序列程序是由阿尔米塔吉引进的,用以测试两个二项分布的平均值之间的差。根据瓦尔德的序列概率比例测验的修改而导出的这种序列程序是为了确定样品规模的上限,以便减少平均的样品数目。丹布罗西亚研究了几种程序的可行性。

芪莪合剂与化疗同用治疗消化道肿瘤临床观察

芪莪合剂与化疗同用治疗消化道肿瘤临床观察赵建宏山东济宁医学院（济宁２７２１１３）赵忆宁济宁医学院附属医院笔者临床观察发现，恶性肿瘤病人化疗期间多具气虚血瘀证候，据此病机特点，笔者以益气化瘀复方芪莪合剂，与常规化疗同时应用，治疗２１例中晚期消化道肿瘤，...

金匮肾气丸血塞通治疗糖尿病末梢神经病变26例

观察：益气补阳、活血通络治疗糖尿病末梢神经病变的疗效。方法：采用金匮肾气丸（泽泻、肉桂、附片、水蛭、党参、黄芪、花粉、山药、山萸肉、生地、归尾、丹皮等）和血塞通静滴配合西药治疗本病26例。结果：总有效率92．3％。提示：本方法对本病有益气补阳，活血通络的功效。

Effect of Hewei-Decoction on chronic atrophic gastritis and eradication of Helicobacter pylori

AIM: To demonstrate the effect of Hewei-Decoction (Decoction for regulating the stomach) on chronic atrophic gastritis (CAG) and eradication of Helicobacter pylori. METHODS: Ninety patients with CAG entering the investigation were divided into six differentiation syndromes, based on their major symptoms and signs. Hewei-Decoction was taken by all the patients orally for 4 or 8 wk. The efficacy was assessed by both the composite accumulation of reduced scores of major symptoms and the eradication of H pylori.X2 test was used to compare the efficacy between H pylori-positive and negative cases, and to disclose the relationship between efficacy and eradication of H pylori. RESULTS: In patients with six different syndrome types, the efficacy of Hewei-Decoction was 91.67% (11/12), 92.86% (13/14), 97.22% (35/36), 87.50% (14/16), 75.00% (6/8), 75.00% (3/4) respectively. The rate of highly efficacious was 58.33% (7/12), 50.00% (7/14), 77.78% (28/36), 62.50% (10/16), 12.50% (1/8) and 25.00% (1/4), respectively. The total efficacy was 91.11% (82/90), and the rate of highly efficacious was 60.00% (54/90). The eradication rate of H pylori was 67.86% (38/56). The therapeutic effect of Hewei-Decoction was better in H pylori positive cases than that in H pylori-negative cases with the total effect of 96.43% vs 82.35% (P<0.05). In 56 H pylori positive cases, the therapeutic effect was better in H pylori eradicated cases than that in H pylori-existent cases with the total effect of 97.37% vs 72.22% (P<0.01). CONCLUSION: Hewei-Decoction is effective in most cases of all the syndrome types. The results indicate that eradication of H pylori is one of the important mechanisms for alleviation of symptoms and signs. Also, the decoction is efficacious in H pylori-negative cases.

TCM Treatment of Thromboangiitis Obliterans—A Report of 64 Cases

Thromboangiitis Obliterans (TAO), a common peripheral vascular disease with a long illness course and grave sufferings, can cause acromelic gangrene, ulcer and even amputation at the late stage. We have for many years used TCM syndrome differentiation to diagnose and treat the disease with good therapeutic results. The treatment of 64 TAO cases from 2001 to 2002 is reported as follows.

Effect of Chinese medicine Qinggan Huoxuefang on inducing HSC apoptosis in alcoholic liver fibrosis rats

AIM： To investigate the effect of Qinggan Huoxuefang （QGHXF） on improvement of liver function and pathology in rats, and to analyze the mechanism. METHODS： Wistar rats were divided into three groups at random： normal control group （12）, micro-amount carbon tetrachlodde group （CCh）（12） and model group A （60）. The model group A was ingested with the mixture （500 mL/L alcohol, 8 mL/kg per day; corn oil, 2 mL/kg per day; pyrazole, 24 mg/kg per day） once a day and intraperitoneal injections of 0.25 mL/kg of a 250 mL/L solution of CCh in olive oil twice a week for 12 wk. The CCh group received intraperitoneal injections only. At the end of 8 wk the model group A （60） was divided into 5 subgroups： model group, Xiaochaihu Chongji （XCH） group, QGHXF high dose group, moderate dose group and low dose group, and were given the drugs respectively. At the end of 12 wk, all the rats were killed and blood samples collected, as well as liver tissue. Blood samples were used for evaluation of alanine transaminase （ALT）, aspartate aminotransferase （AST）, alkaline phosphatase （ALP）, gamma-glutamyltransferase （y-GT）. Liver specimens were obtained for routine HE, apoptosis gene array and flow cytometry analysis. RESULTS： A liver fibrosis animal model was successfully established. Fibrosis was obviously reduced in QGHXF high dose group, and no fibrosis formed in CCh group. Compared with model group the QGHXF group and XCH group could obviously decrease the level of ALT, AST, ALP, and GGT （P〈0.05）. QGHXF high dose group was better than XCH group in ALT （615± 190 vs 867± 115）,and AST（1972 ± 366 vs 2777 ± 608）. Moreover, QGHXF could reduce liver inflammation, fibrosis-induced hepatic stellate cell （HSC） apoptosis and regulate apoptosis gene expression. The HSC apoptosis rates of QGHXF groups were 22.4±3.13, 13.79±2.26 and 10.07± 1.14, higher than model group, 6.58±1.04 （P〈 0.05）. Compared to model group, 39 genes were up-regulated, 11 solely expressed and 17 down-regulated in high dose group. CONCLUSION： QGHXF can improve liver fibrosis and induce HSC apoptosis.

Kang Wei Granules in Treatment of Gastropathy Related to Helicobacter Pylori Infection

Kang Wei Granules,a granular preparation for strengthening the spleen and replenishing Qi and for clearing away heat and resolving dampness,was used in the treatment of 288 cases of gastropathy related to Helicobacter pylori infection.The effects were compared with De Nol^(?) triple therapy in the control group of 74 cases.The therapeutic results showed that Kang Wei Granules was superior to the western drugs in improving the principal symptoms of deficiency of the spleen and stomach,and retention of damp-heat in the interior (P<0.05).

Protective effect of Weikang decoction and partial ingredients on model rat with gastric mucosa ulcer

AIM: To investigate the protective mechanisms of Weikang (WK) decoction on gastric mucosae. METHODS: Ninety rats were randomly divided into nine groups of 10 each, namely group, model group, group with large WK dosage, group with medium WK dosage, group with small WK dosage, group with herbs of jianpiyiqi (strengthening the spleen and replenishing qi), group with herbs of yangxuehuoxue (invigorating the circulation of and nourishing the blood), group with herbs of qingrejiedu (clearing away the heat-evils and toxic materials), group with colloidal bismuth pectin (CBP) capsules. According to the method adopted by Yang Xuesong, except normal control group, chronic gastric ulcer was induced with 100% acetic acid. On the sixth day after moldmaking, WK decoction was administered, respectively at doses of 20, 10 and 5 g/kg to rats of the WK groups, or the groups with herbs of jianpiyiqi, yangxuehuoxue and qingrejiedu, 10 ml/kg was separately administered to each group every day. For the group with CBP capsules, medicine was dissolved with water and doses 15 times of human therapeutic dose were administered (10 mL/kg solution containing 0.35% CBP). Rats of other groups were fed with physiological saline (10 ml/kg every day). Administration lasted for 16 d. Rats were killed on d 22 after mold making to observe changes of gastric mucosa. The mucus thickness of gastric mucosa surface was measured. Levels of epidermal growth factor (EGF) in gastric juice, nitric oxide (NO) in gastric tissue, endothelin (ET) in plasma, superoxide dismutase (SOD) in plasma, malondialdehyde (MDA) in plasma and prostaglandin I2 (PGI2) were examined. RESULTS: Compared with control group, ulceration was found in gastric mucosa of model group rats. The mucus thickness of gastric mucosa surface, the levels of EGF, NO, 6-K-PGF1α and SOD decreased significantly in the model group (EGF: 0.818±0.18 vs 2.168±0.375, NO: 0.213±0.049 vs 0.601±0.081, 6-K-PGF1α 59.7±6.3 vs 96.6±8.30, SOD: 128.6±15.0 vs 196.6±35.3, P<0.01),the levels of ET (179.96±37.40 vs 46.64±21.20, P<0.01) and MDA (48.2±4.5 vs 15.7±4.8, P<0.01) increased. Compared with model group, the thickness of regenerative mucosa increased, glandular arrangement was in order, and cystic dilative glands decreased, while the mucus thickness of gastric mucosa surface increased (20 g/kg WK: 51.3±2.9 vs 23.2±8.4,10 g/kg WK: 43.3±2.9 vs23.2±8.4,, 5 g/kg WK: 36.1±7.2 vs 23.2±8.4, jianpiyiqi: 35.4±5.6 vs 23.2±8.4, yangxuehuoxue: 33.1±8.9 vs 23.2±8.4, qingrejiedu: 31.0±8.0 vs 23.2±8.4 and CBP: 38.2±3.5 vs23.2±8.4, P<0.05-0.01). The levels of EGF (20 g/kg WK: 1.364±0.12 vs 0.818±0.18, 10 g/kg WK: 1.359±0.24 vs 0.818±0.18, 5 g/kg WK: 1.245±0.31 vs 0.818±0.18, jianpiyiqi: 1.025± 0.45 vs 0.818±0.18, yangxuehuoxue: 1.03±0.29 vs 0.818±0.18, qingrejiedu: 1.02±0.47 vs 0.818±0.18 and CBP: 1.237±0.20 VS 0.818±0.18, p<0.05-0.01), NO (20 g/kg WK: 0.480±0.026 vs 0.213±0.049, 10 g/kg WK: 0.390±0.055 vs 0.213±0.049, 5 g/kg WK: 0.394±0.026 vs 0.213±0.049, jianpiyiqi: 0.393±0.123 vs 0.213±0.049, yangxuehuoxue: 0.463±0.077 vs 0.213±0.049, qingrejiedu: 0.382±0.082 vs 50.213±0.049 and CBP: 0.395±0.053 vs 0.213±0.049, P<0.05-0.01), 6-K-PGF1α (20 g/kg WK: 86.8±7.6 vs 59.7±6.3,10 g/kg WK: 77.9±7.0 vs 59.7±6.3, 5 g/kg WK: 70.0±5.4 vs 59.7±6.3, jianpiyiqi: 73.5±12.2 vs 59.7±6.3, yangxuehuoxue: 65.1±5,3 vs 59.7±6.3, qingrejiedu: 76.9±14.6 vs 59.7±6.3,and CBP: 93.7±10.7 vs 59.7±6.3, P<0.05-0.01) and SOD (20 g/kg WK: 186.4±19.9 vs 128.6±15.0,10 g/kg WK: 168.2±21.7 vs 128.6±15.0, 5 g/kg WK: 155.6±21.6 vs 128.6±15.0, jianpiyiqi: 168.0±85.3 vs 128.6±15.0, yangxuehuoxue: 165.0±34.0 vs 128.6±15.0, qingrejiedu: 168.2±24.9 vs 128.6±15.0, and CBP: 156.3±18.1 vs 128.6±15.0, P<0.05-0.01) significantly increased. The levels of ET (20 g/kg WK: 81.30± 17.20 vs 179.96±37.40, 10 g/kg WK: 83.40±25.90 vs 179.96±37.40, 5 g/kg WK: 93.87±20.70 vs 179.96±37.40, jianpiyiqi: 130.67±43.66 vs 179.96±37.40, yangxuehuoxue: 115.88±34.09 vs 179.96±37.40, qingrejiedu: 108.22±36.97 vs 179.96±37.40, and CBP: 91.96±19.0 vs 179.96±37.40, P<0.01) and MDA (20 g/kg WK: 21.6±7.4 vs 48.2±4.5, 10 g/kg WK: 32.2±7.3 vs 48.2±4.5, 5 g/kg WK: 34.2±6.2 vs 48.2±4.5, jianpiyiqi: 34.9±13.8 vs 48.2±4.5, yangxuehuoxue: 35.5±16.7 vs 48.2±4.5, qingrejiedu: 42.2±17.6 vs 48.2±4.5, and CBP: 30.1±6.1 vs 48.2±4.5, P<0.05-0.01) obviously decreased. The 20 g/kg WK group was better than 10 g/kg (the mucus thickness: 51.3±2.9 vs 43.3±2.9, NO: 0.480±0.026 vs 0.390±0.055, SOD: 186.4±19.9 vs 168,2±21.7, P<0.01) and 5 g/kg (the mucus thickness: 51.3±2.9 vs36.1±7.2, NO: 0.480±0.026 vs0.394±0.026, SOD: 186.4±19.9 vs155.6±21.6, P<0.01) groups and CBP group (the mucus thickness: 51.3±2.9 vs 38.2±3.5, NO: 0.480±0.026 vs 0.395±0.053, SOD: 186.4±19.9 vs 156.3±18.1, P<0.01) in the mucus thickness, NO and SOD levels and better than 10 g/kg (86.8±7.6 vs 77.9±7.0, P<0.05) and 5 g/kg (86.8±7.6 vs 70.0±5.4,P<0.05) groups in 6-K-PGF1α level, 10 g/kg WK group was better than 5 g/kg WK (the mucus thickness: 43.3±2.9 vs 36.1±7.2, P<0.01, SOD: 168.2±21.7 vs 155.6±21.6, P<0.05) and CBP groups (the mucus thickness: 43.3±2.9 vs 38.2±3.5, P<0.01, SOD: 168.2±21.7 vs 156.3±18.1, P<0.05) in the mucus thickness and SOD level. In compound group, jianpiyiqi group, yangxuehuoxue group, qingrejiedu group, the level of ET was decreased, NO contents were increased in gastric tissue of ulcers in rats. CONCLUSION: WK decoction and separated recipes have significantly protective effect on ethanol-induced gastric mucosal injury. They can increase the content of EGF in gastric juice, PGI2 SOD in plasma and NO in gastric tissues, thicken the mucus on the gastric mucosa, and decrease the impairing factor MDA, ET in plasma.

Point injection of Injectio Radici Astragali for Treatment of Post-chemotherapy Adverse Reactions

With injection of Injectio Radici Astragli into the point Zusanli (ST 36), we have obtained quite satisfactory therapeutic results for treating leukopenia and the impairment in immune functions occurred in cancer chemotherapy. A report follows.

TCM Treatment for 63 Cases of Senile Dyssomnia

In order to study the therapeutic effects of the TCM drugs on senile dyssomnia, 121 such patients were randomly divided into a treatment group of 63 cases (given the TCM drugs) and a control group of 58 cases (given estazolam). The changes shown in the SDRS and HAMA scores and the other indexes were observed in both of the two groups to evaluate the therapeutic effects. The results showed that the effective rate was 76.3% in the treatment group, and it was 69.1% in the control group; and that the TCM drugs had better effects in improving such symptoms as lethargy, dry mouth, and rebound of insomnia. Therefore, it can be concluded that the effect of the TCM drugs is better for senile dyssomnia than that of the Western drug estazolam.

Dr.Zang Kuntang's Experience in Treating Diabetes

Dr. Zang Kuntang (臧堃堂), professor of the First PLA Military Medical University, has been engaged in the science of traditional Chinese medicine for more than 50 years, with a rich experience accumulated in the treatment of diabetes. It is a great honor for us to have the fortune to follow him in the clinic. The following is a summary of what we have learned from him.

Chemoradiotherapy with twice-weekly administration of low-dose gemcitabine for locally advanced pancreatic cancer

AIM:To evaluate the chemoradiotherapy for locally advanced pancreatic cancer utilizing low dose gemcitabine as a radiation sensitizer administered twice weekly. METHODS: We performed a retrospective analysis of chemoradiotherapy utilizing gemcitabine administered twice weekly at a dose of 40 mg/m2. After that, maintenance systemic chemotherapy with gemcitabine, at a dose of 1000 mg/m2, was administered weekly for 3 wk with 1-wk rest until disease progression or unacceptable toxicity developed. RESULTS: Eighteen patients with locally advanced unresectable pancreatic cancer were enrolled. Three of those patients could not continue with the therapy; one patient had interstitial pneumonia during radiation therapy and two other patients showed liver metastasis or peritoneal metastasis during an early stage of the therapy. The median survival was 15.0 mo and the overall 1-year survival rate was 60%, while the median progression-free survival was 8.0 mo. The subgroup which showed the reduction of tumor development, more than 50% showed a tendency for a better prognosis; however, other parameters including age, gender and performance status did not correlate with survival. The median survival of the groups that died of liver metastasis and peritoneal metastasis were 13.0 mo and 27.7 mo, respectively.CONCLUSION: Chemoradiotherapy with low-dose gemcitabine administered twice weekly could be effective to patients with locally advanced pancreatic cancer; however, patients developing liver metastases had a worse prognosis. Another chemoradiotherapy strategy might be needed for those patients, such as administrating one or two cycles of chemotherapy initially, followed by chemoradiotherapy for the cases with no distant metastases.

TCM Differential Treatment of IgA Nephrosis

IgA nephrosis, with an incidence of 38%-49% in the primary glomerulopathy in China, is one of the main causes for the late renal failure. In view of the fact that there are no specific Western remedies for IgA nephrosis characterized by hematuria, the researches on TCM differential treatment of IgA nephrosis have been listed in the major projects of 'the Scientific Technologies in thel0th 5-year plan of China'.

Novel approaches towards conquering hepatitis B virus infection

Currently approved treatments for hepatitis B virus （HBV） infection include the immunomodulatory agent, IFN-α, and nucleos（t）ide analogues. Their efficacy is limited by their side effects, as well as the induction of viral mutations that render them less potent. It is thus necessary to develop drugs that target additional viral antigens. Chemicals and biomaterials by unique methods of preventing HBV replication are currently being developed, including novel nucleosides and newly synthesized compounds such as capsid assembling and mRNA transcription inhibitors. Molecular therapies that target different stages of the HBV life cycle will aid current methods to manage chronic hepatitis B （CriB） infection. The use of immunomodulators and gene therapy are also under consideration. This report summarizes the most recent treatment possibilities for CHB infection. Emerging therapies and their potential mechanisms, efficacy, and pitfalls are discussed.

Effect of Gui Zhi decoction on enteric mucosal immune in mice with collagen-induced arthritis

AIM： To explore the effect of Gui Zhi decoction on enteric mucosal immune in type Ⅱ collagen-induced arthritis （CIA） in DBA mice. METHODS： Eighty DBA/1, weighing 18-22 g, were randomly divided into four groups with 20 in each group： control group, CIA group, treatment groups at high dosage and low dosage （GZH and GZL）. CIA was induced by immunization with type Ⅱ collagen （CII） emulsified with equal complete adjuvant at 0.1 mg CII each mouse. Blood lymphocyte suspension was screened for CD4 and CD8 expression using a flow cytometry, the CD4 and CD8 and secretory IgA （sIgA）-positive cells in enteric lamina propria tested with immunohistochemical staining. Tumor necrosis factor-alpha （TNF-α）, interleukin-1 （IL-1）-β, and IL-6 concentrations in serum were assayed with RIA. RESULTS： Gui Zhi decoction can lower the arthritic scores and decrease the occurrence of arthritis. The CD4, CD8, and sIgA-positive cells in CIA mice are less than in control mice, and in Gui Zhi decoction at high dosage could restore the lowered CD4- and CD8-positive cells in lamina propria, and at both high and low dosages could increase the lowered sIgA-positive cells in lamina propria, even still lower than in normal mice. In periphery, the CD4 cells in periphery are higher in CIA mice than in control mice, and Gui Zhi decoction at high and low dosages could decrease the CD4 and CD8 cells. Also, Gui Zhi decoction at high dosage could decrease the IL-6 and TNF-α concentration in serum. CONCLUSION： Gui Zhi decoction can lower the arthritic scores and decrease the incidence of CIA in mice, and the mechanism is in part regulating enteric mucosal immune.

健脾调肝汤治疗肠易激综合征50例

目的:观察运用健脾调肝法配合微生态制剂治疗肠易激综合征的疗效。方法:治疗组50例采用健脾调肝汤(太子参、黄芪、白术、云苓、佩兰、厚朴、苡仁、木香等)配合贝飞达口服;对照组予以贝飞达口服。结果:治疗组总有效率明显优于对照组,而复发率明显低于对照组(P<0.05)。提示:健脾调肝汤配合贝飞达治疗肠易激综合症疗效确切,复发率低。

Juvenile Myasthenia Laryngis Treated by Acupuncture and TCM Medication

Myasthenia laryngis, or laryngoparalysis, oftenoccurs in juvenile teachers, actors or actresses, andmusical school students.

中西医结合治疗缓解期慢性肺心病28例

目的探讨中西医结合治疗缓解期慢性肺心病的疗效。方法28例慢性肺心病缓解期患者经过家庭氧疗、口服复方丹参滴丸、静脉补充血浆联合治疗。结果(1)慢性肺心病低蛋白血症患者,反复住院率明显降低,观察组10%,对照组75%,两组比较有显著性差异(P<0.01);(2)右下肺动脉横径、红细胞数、全血粘度、血清白蛋白改善情况,观察组与对照组比较有显著性差异(P<0.01)。结论家庭氧疗、丹参、血浆可以降低慢性肺心病反复住院率,延缓慢性肺心病病程进展。

Recent Advances in TCM Treatment of Diabetic Gangrene

Diabetic gangrene (DG) is a severe complication of diabetes.Clinically, it is characterized by pain in the distal end of the extremities, infection, ulceration, gangrene, and even dactylolysis (of the fingers and toes). DG has become the most important reason for amputation for non-traumatic patients.About half of patients receiving amputation are DG patients each year. In recent years TCM doctors have made a great deal of clinical trials on DG and achieved significant curative effects. Following is a brief summary of the literature concerned.

大剂量山莨菪碱治疗感染性休克31例临床分析

大剂量山莨菪碱治疗感染性休克３１例临床分析湖南中医学院第三附属医院（４１２０００）罗秋生我院自１９８８年至１９９７年应用大剂量６５４—２治疗感染中毒性休克３１例，抢救成功２８例，死亡３例，治愈率９０３２％，病死率９６８％，取得良好效果，现报道如下...