替硝唑、果胶铋与阿司匹林三联治疗幽门螺杆菌阳性萎缩性胃炎临床观察

目的探讨替硝唑、果胶铋与阿司匹林三联治疗幽门螺杆菌（HP）阳性萎缩性胃炎临床观察。方法90例经胃镜证实的萎缩性胃炎伴HP阳性感染患者随机分成2组，治疗组替硝唑片首次2g顿服，以后0．5g／次，2冼／d，餐后服，果胶铋片150mg／次、餐前半小时服，3次／d，阿司匹林片100mg／次、2冼／d饭后服用，对照组多酶片3片／次，每日3次，阿莫西林胶囊0．5g／次、3次／d饭前半小时口服，枸橼酸铋钾胶囊150—400mg／次、3次／d饭前半小时服用，疗程为四周，疗程结束后3天内复查纤维胃镜及检查HP并结合临床症状。结果治疗组治愈率64．40％、好转率31．10％、总有效率95．50％；对照组治愈率44．40％、好转率40．00％、有效率84．00％，治疗组HP根除率91．00％，对照组68．80％。结论三联治疗HP阳性萎缩性胃炎疗效显著，阿司匹林具有预防消化系统肿瘤、降低其发病率的作用，果胶铋保护受损黏膜，替硝唑对胃黏膜炎症有显著减轻作用，此方案是一种短程、安全、高效、依从性好的治疗方案。     

治疗类风湿性关节炎的药物与临床

类风湿性关节炎（rheumatoidarthritis，RA）是一种以滑膜炎为特征、严重影响人体健康的慢性自身免疫性疾病，近年其治疗药物临床报道颇多，现简述如下。1蝮蛇抗栓酶取本品1．0u加入0．9％氯化钠注射液250ml中静滴，qd，3Wb为1疗程。153例RA病人治疗2个疗程后，近期控制37例，显效43例，有效66例，无效7例，总有效率95．4％。2雷公藤缓释片114例RA患者每次服本品2片／每片含雷公藤甲素50ug），bid，连服4周后显效46例，有效59例，总有效率为92．11％，与对照组（107例，服雷公藤片，总有效率90．65％）无显著差异（P＞O．05）。3阿西美…     

香砂养胃胶囊治疗海员非幽门螺杆菌相关性溃疡36例观察

目的观察香砂养胃胶囊治疗海员非幽门螺杆菌相关性溃疡的临床疗效及不良反应。方法非幽门螺杆菌相关性溃疡68例，随机分为治疗组、对照组。治疗组：给予香砂养胃胶囊，3粒／次（1．35g），3次／d，饭前半小时或饭后2h用温开水送服，共服药4周。对照组：服用法莫替丁片，20rag／次，早晚各1片，共服药4周。4周为1个疗程，疗程结束后复查胃镜、尿常规、血常规、肾功能及肝功能。结果治疗组、对照组总有效率分别为88．9％和87．5％；疼痛缓解率治疗组为94．4％，对照组为93．8％，两组差异无统计学意义（P〉0．05）。治疗组的腹痛消失时间、症状消失率亦较对照组快，但差异无统计学意义（P〉005）。治疗组血常规及肝肾功能均正常，对照组有2例白细胞下降，1例肝功能轻度异常。结论香砂养胃胶囊治疗海员非幽门螺杆菌相关性溃疡有较高的治愈率和症状缓解率，服用方便，不良反应少。     

培氟沙星治疗慢性细菌性前列腺炎58例临床疗效观察

目的：评价培氟沙星治疗慢性细菌性前列腺炎的临床疗效。方法：将112例慢性细菌性前列腺炎病人随机分成两组,治疗组58例,用培氟沙星每次0．4g,每日2次;对照组54例,用复方磺胶甲基异恶唑每次2片,每日2次,两组均以20天为一疗程,治疗2个疗程后评定疗效。结果：治疗组治愈率67．24％,有效率91％,用药期间无不良反应;对照组治愈率31％,有效率70％,用药期间个别病人有轻度消化道症状或皮疹。两组疗效对比差异有显著性（χ^2=15．68,P〈0．01）。结论：培氟沙星是一种治疗慢性细菌性前列腺炎的有效药物,疗效比复方磺胺甲基异恶唑好。     

复方牛黄片治疗舌部疾病的临床疗效观察

目的：观察复方牛黄片治疗舌部疾病的短期临床疗效。方法：舌部疾病129例随机分为两组，观察组68例采用复方牛黄片和艾力可片、龙血竭胶囊治疗，对照组61例采用艾力可片和龙血竭胶囊治疗，观察舌粘膜变化和疼痛指数等指标。结果：通过舌粘膜变化和疼痛指数等指标，观察组显效率和总有效率明显高于对照组，具有统计学意义。观察组的显效率、有效率、总有效率为63．2％，27．9％，91．2％，对照组为42．6％，39．3％，82．0％，差异均有显著性意义；未发现不良反应。结论：复方牛黄片治疗舌部疾病是安全和有效的。     

扶正止咳平喘片的制备及临床应用

目的 研制扶正止咳平喘片，用于治疗慢性肺心病缓解期。方法 制定扶正止咳平喘片制备工艺、质量标准，临床疗效观察。结果 治疗慢性肺心痛68例．显效30例，有效32例，无效6例，总有效率91．18％。结论 扶正止咳平喘片处方合理，质控方法可靠，疗效确切。     

老年消化性溃疡的临床治疗体会

目的探讨老年消化性溃疡的临床特点、治疗及预后。方法回顾分析68例确诊老年消化性溃疡的病例资料。结果68例老年消化性溃疡患者中，临床治愈42例，好转20例，无效6例，总有效率91．2％，有2例发生不良反应，不良反应发生率2．9％。结论奥美拉唑、甲硝唑、果胶铋联合治疗老年消化性溃疡疗效显著，起效快，不良反应少，值得临床推广。     

288例急性中风病人的临床特点与治疗

目的 观察急性中风病人的临床特点及探讨分析其治疗方法。方法 本文通过对我院1998年4月～2004年10月内科收治的288例急性脑卒中病人的资料进行回顾性分析。结果 49例缺血性脑卒中的中医治疗有效率为85．7％，163例缺血性脑卒中的中西医结合治疗有效率为91．4％，59例脑出血的有效率为78％，17例SAH的有效率为76．5％。采用中医或中西医结合治疗缺血性脑卒中死亡率为4．7％，脑出血死亡率为13．5％，SAH的死亡率为23．5％。结论 中医或中西医结合治疗脑卒中疗效肯定。     

中西医结合治疗脑卒中后睡眠障碍临床观察

目的探讨中西医结合治疗脑卒中后睡眠障碍的治疗效果。方法135例脑卒中后睡眠障碍患者随机分为治疗组67例，对照组68例，在常规治疗原发病的基础上，对照组口服阿普唑仑，治疗组在此基础上加服安神养阴中药汤剂，疗程均为1周，1周后至2周评定效果。结果治疗组总有效率98．51％，对照组总有效率82．35％。两组疗效比较差异有统计学意义（P〈0．05）。结论中西医结合治疗脑卒中后睡眠障碍有显著优势。     

聚甲酚磺联合抗宫炎片治疗宫颈糜烂的临床疗效观察

目的：观察聚甲酚磺醛联合抗宫炎片治疗宫颈痰烂的疗效。方法：将397例经宫颈细胞学检查，阴道分泌物检查排除恶变，霉菌及滴虫的宫颈糜烂患者随机分为2组，联合用药组200例，宫颈糜烂局部使用聚甲酚磺醛浓缩液，每周2次，同时加服抗宫炎片4片，tid，单用药组197例，宫颈糜烂局部使用聚甲酚磺醛浓缩液，每周2次，结果：宫颈糜烂Ⅰ，Ⅱ，Ⅲ度分别治疗2，4，6wk后，宫颈糜烂面修复有效率，联合用药分别为98．8％，92．7％，75．0％，单用药组分别为98．8％，92．95，72．7％，2组比较，无显著性差异（P＞0．05），联合用药组和单用药组的腰酸，腹痛改善者分别为97．6％和91．6％（P＜0．05），白带减少分别为97．0％和91．3％（P＜0．05）。结论：聚甲酚磺醛不仅局部疗效明确，而且能缓解临床症状，如加服抗宫炎片，临床症状改善更佳。     

Safety assessment of poloxamers 101, 105, 108, 122, 123, 124, 181, 182, 183, 184, 185, 188, 212, 215, 217, 231, 234, 235, 237, 238, 282, 284, 288, 331, 333, 334, 335, 338, 401, 402, 403, and 407, poloxamer 105 benzoate, and poloxamer 182 dibenzoate as used in cosmetics

Poloxamers are polyoxyethlyene, polyoxypropylene block polymers. The impurities of commercial grade Poloxamer 188, as an example, include low-molecular-weight substances (aldehydes and both formic and acetic acids), as well as 1,4-dioxane and residual ethylene oxide and propylene oxide. Most Poloxamers function in cosmetics as surfactants, emulsifying agents, cleansing agents, and/or solubilizing agents, and are used in 141 cosmetic products at concentrations from 0.005% to 20%. Poloxamers injected intravenously in animals are rapidly excreted in the urine, with some accumulation in lung, liver, brain, and kidney tissue. In humans, the plasma concentration of Poloxamer 188 (given intravenously) reached a maximum at 1 h, then reached a steady state. Poloxamers generally were ineffective in wound healing, but were effective in reducing postsurgical adhesions in several test systems. Poloxamers can cause hypercholesterolemia and hypertriglyceridemia in animals, but overall, they are relatively nontoxic to animals, with LD(50) values reported from 5 to 34.6 g/kg. Short-term intravenous doses up to 4 g/kg of Poloxamer 108 produced no change in body weights, but did result in diffuse hepatocellular vacuolization, renal tubular dilation in kidneys, and dose-dependent vacuolization of epithelial cells in the proximal convoluted tubules. A short-term inhalation toxicity study of Poloxamer 101 at 97 mg/m(3) identified slight alveolitis after 2 weeks of exposure, which subsided in the 2-week postexposure observation period. A short-term dermal toxicity study of Poloxamer 184 in rabbits at doses up to 1000 mg/kg produced slight erythema and slight intradermal inflammatory response on histological examination, but no dose-dependent body weight, hematology, blood chemistry, or organ weight changes. A 6-month feeding study in rats and dogs of Poloxamer 188 at exposures up to 5% in the diet produced no adverse effects. Likewise, Poloxamer 331 (tested up to 0.5 g/kg day(-1)), Poloxamer 235 (tested up to 1.0 g/kg day(-1)), and Poloxamer 338 (at 0.2 or 1.0 g/kg day(-1)) produced no adverse effects in dogs. Poloxamer 338 (at 5.0 g/kg day(-1)) produced slight transient diarrhea in dogs. Poloxamer 188 at levels up to 7.5% in diet given to rats in a 2-year feeding study produced diarrhea at 5% and 7.5% levels, a small decrease in growth at the 7.5% level, but no change in survival. Doses up to 0.5 mg/kg day(-1) for 2 years using rats produced yellow discoloration of the serum, high serum alkaline phosphatase activity, and elevated serum glutamicpyruvic transaminase and glutamic-oxalacetic transaminase activities. Poloxamers are minimal ocular irritants, but are not dermal irritants or sensitizers in animals. Data on reproductive and developmental toxicity of Poloxamers were not found. An Ames test did not identify any mutagenic activity of Poloxamer 407, with or without metabolic activation. Several studies have suggested anticarcinogenic effects of Poloxamers. Poloxamers appear to increase the sensitivity to anticancer drugs of multidrug-resistant cancer cells. In clinical testing, Poloxamer 188 increased the hydration of feces when used in combination with a bulk laxative treatment. Compared to controls, one study of angioplasty patients receiving Poloxamer 188 found a reduced myocardial infarct size and a reduced incidence of reinfarction, with no evidence of toxicity, but two other studies found no effect. Poloxamer 188 given to patients suffering from sickle cell disease had decreased pain and decreased hospitilization, compared to controls. Clinical tests of dermal irritation and sensitization were uniformly negative. The Cosmetic Ingredient Review (CIR) Expert Panel stressed that the cosmetic industry should continue to use the necessary purification procedures to keep the levels below established limits for ethylene oxide, propylene oxide, and 1,4-dioxane. The Panel did note the absence of reproductive and developmental toxicity data, but, based on molecular weight and solubility, there should be little skin penetration and any penetration of the skin should be slow. Also, the available data demonstrate that Poloxamers that are introduced into the body via routes other than dermal exposure have a rapid clearance from the body, suggesting that there would be no risk of reproductive and/or developmental toxicity. Overall, the available data do not suggest any concern about carcinogenesis. Although there are gaps in knowledge about product use, the overall information available on the types of products in which these ingredients are used, and at what concentration, indicates a pattern of use. Based on these safety test data and the information that the manufacturing process can be controlled to limit unwanted impurities, the Panel concluded that these Poloxamers are safe as used.     

HPLC法测定抗妇炎胶囊中木兰花碱、黄柏碱、药根碱、巴马汀、小檗碱、槐果碱、苦参碱、氧化槐果碱、槐定碱和氧化苦参碱

目的 采用高效液相色谱（HPLC）法同时测定抗妇炎胶囊中木兰花碱、黄柏碱、药根碱、巴马汀、小檗碱、槐果碱、苦参碱、氧化槐果碱、槐定碱和氧化苦参碱10种活性成分。方法 采用InerSustain AQ-C₁₈色谱柱（250 mm×4.6 mm,5 μm）,流动相A：乙腈–无水乙醇（80∶20）,流动相B：0.1%磷酸溶液,梯度洗脱,检测波长220 nm,体积流量1.0 mL/min,柱温30℃,进样量10 μL。结果 木兰花碱、黄柏碱、药根碱、巴马汀、小檗碱、槐果碱、苦参碱、氧化槐果碱、槐定碱和氧化苦参碱分别在2.69～134.50、1.95～97.50、0.63～31.50、0.86～43.00、11.95～597.50、0.59～29.50、6.08～304.00、4.85～242.50、1.66～83.00、19.79～989.50 μg/mL线性关系良好（r≥0.999 3）;平均回收率分别为99.11%、98.23%、96.95%、97.78%、100.02%、97.21%、99.66%、99.52%、98.81%、100.08%,RSD值分别为1.04%、1.23%、1.37%、1.65%、0.70%、1.28%、0.65%、0.81%、1.11%、0.63%。结论 建立的HPLC法可用于抗妇炎胶囊中10种活性成分的测定,作为抗妇炎胶囊质量控制方法。     

Arformoterol: (R,R)-eformoterol, (R,R)-formoterol, arformoterol tartrate, eformoterol-sepracor, formoterol-sepracor, R,R-eformoterol, R,R-formoterol

Sepracor in the US is developing arformoterol [R,R-formoterol], a single isomer form of the beta(2)-adrenoceptor agonist formoterol [eformoterol]. This isomer contains two chiral centres and is being developed as an inhaled preparation for the treatment of respiratory disorders. Sepracor believes that arformoterol has the potential to be a once-daily therapy with a rapid onset of action and a duration of effect exceeding 12 hours. In 1995, Sepracor acquired New England Pharmaceuticals, a manufacturer of metered-dose and dry powder inhalers, for the purpose of preparing formulations of levosalbutamol and arformoterol. Phase II dose-ranging clinical studies of arformoterol as a longer-acting, complementary bronchodilator were completed successfully in the fourth quarter of 2000. Phase III trials of arformoterol began in September 2001. The indications for the drug appeared to be asthma and chronic obstructive pulmonary disease (COPD). However, an update of the pharmaceutical product information on the Sepracor website in September 2003 listed COPD maintenance therapy as the only indication for arformoterol. In October 2002, Sepracor stated that two pivotal phase III studies were ongoing in 1600 patients. Sepracor estimates that its NDA submission for arformoterol, which is projected for the first half of 2004, will include approximately 3000 adult subjects. Sepracor stated in July 2003 that it had completed more than 100 preclinical studies and initiated or completed 15 clinical studies for arformoterol inhalation solution for the treatment of bronchospasm in patients with COPD. In addition, Sepracor stated that the two pivotal phase III studies in 1600 patients were still progressing. In 1995, European patents were granted to Sepracor for the use of arformoterol in the treatment of asthma, and the US patent application was pending.     

欧洲刺柏（Juniper）

活性成分与药理作用欧洲刺柏药用部位是其浆果，具有促水排泄、防腐、抗胃肠胀气和抗风湿作用，还可改善胃功能。用作促水排泄药可增加尿量（水丢失），但不增加钠排泄。成分萜品烯-4-醇可增加肾小球滤过率，但刺激肾。欧洲刺柏浆果对单纯疱疹病毒体外显示抗病毒活性，并具抗真菌活性。动物实验显示，欧洲刺柏浆果提取物具有堕胎、抗生育、抗炎、抗胚胎植入、降血压、升血压和降血糖作用。欧洲刺柏浆果油具有兴奋子宫的活性，以及利尿、胃肠道抗菌和刺激作用，该油对平滑肌有阻止解痉作用。     

Oral Presentations (LDD, LPES, LNM, LPAT, LNT, LPPT, LPM)

Probiotic microorganisms have been shown to provide specific health benefits when consumed as food supplements or as food components. The main problem of such products is the poor survival of the probiotic bacteria in the low pH of gastric fluid. However the use of synthetic excipients for enteric coating to prevent the exposure of microorganisms to gastric fluid is limited in food supplementary industry. Therefore the aim of this study was to develop an enteric coating formulation containing shellac as a natural polymer. Shellac possesses good resistance to gastric juice; the major disadvantage of this polymer is its low solubility in the intestinal fluid [1, 2]. Thus films containing different ratios of shellac and water-soluble polymers (sodium alginate, hydroxypropyl methylcellulose (HPMC) and polyvinylpyrrolidon (PVP)) or plasticizers (glycerol and glyceryl triacetate (GTA)) were prepared in order to analyse the films’ melting temperatures (T_m), the changes in enthalpy (ΔH), their capability of taking up water, and their solubility in different media. The release characteristics of the films were studied by loading pellets with Enterococcus faecium M74 and coating them with formulations containing different amounts of shellac and polymer or plasticized shellac. Using dissolution tests, performed according to USP XXXI paddle method, the resistance of the coatings to simulated gastric fluid (SGF, pH 1.2) and the release of cells in simulated intestinal fluid (SIF, pH 6.8) was investigated.The trials showed that an increasing amount of plasticizer results in a decrease of T_m and ΔH of the films whereat glycerol had a superior plasticization effect to GTA. The compatibility of films made of water-soluble polymers and shellac was also concentration dependent. HPMC and PVP showed superior compatibility with shellac compared to sodium alginate, since films containing shellac and more than 10% [w/w] sodium alginate tended to separate into two phases. In the end five formulations containing shellac and either 5% [w/w] glycerol, 10% [w/w] PVP, 20% [w/w] PVP, 10% [w/w] HPMC, or 5% [w/w] sodium alginate emerged as feasible for enteric coating purposes.