Directed shift of vaginal flora after topical application of sucrose gel in a phase Ⅲ clinical trial: a novel treatment for bacterial vaginosis

Background Bacterial vaginosis （BV） is one of the most common infectious diseases among sexually active women and is associated with the increased acquisition of a variety of sexually transmitted diseases.This study aimed to compare the efficacy of a non-antibiotic sucrose gel against an antibiotic metronidazole gel for the treatment of BV.Methods A randomized, double-blinded, multi-center, parallel-group, placebo-controlled phase Ⅲ clinical trial was conducted at eight hospitals in China.A total of 560 subjects with clinically diagnosed BV were randomly assigned into three groups for vaginally receiving sucrose, metronidazole, and placebo gels, respectively, twice daily for five consecutive days.The efficacy of therapeutic cure, defined as an achievement of both microbiologic cure （a Nugent score of 3 or less） and clinical cure （a resolution of the clinical findings from the baseline visit）, was evaluated at the 1st and 2nd test-of-cure （TOC） visits at 7-10 and 21-35 days after the start of treatment, respectively.Results Therapeutic cure rates for sucrose, metronidazole, and placebo gel groups were 83.13%, 71.30% and 0.92%,at the 1st TOC, and 61.04%, 66.67% and 7.34%, at the 2nd TOC, respectively.While there was no significant difference between the sucrose and metronidazole gel groups at the 2nd TOC （P=0.305）, and sucrose gel was more effective than metronidazole gel at the 1st TOC （P=0.009）.Conclusion These findings suggest that sucrose gel restores normal vaginal flora more rapidly than metronidazole gel and can be used as a novel treatment for BV.     

Electroacupuncture for the prevention of postoperative gastrointestinal dysfunction in patients undergoing vascular surgery under general anesthesia： study protocol for a prospective practical randomized controlled trial

BACKGROUND： Postoperative gastrointestinal dysfunction（PGD） is one of the most common complications following major surgeries under general anesthesia（GA）. Despite ongoing research and new drug treatments, abdominal distension within 24 h postoperatively occurs in 8%–28% of all surgeries. We aim to analyze the effectiveness of preventing PGD by preoperatively stimulating Neiguan（PC6）, Zusanli（ST36） and Shangjuxu（ST37） bilaterally twice a day compared with sham-acupuncture treatment and standard treatment.METHODS AND DESIGN： This is a single-center, prospective practical randomized controlled trial. All groups will be given standard treatments. Patients undergoing vascular surgery under GA will be included from the Vascular Surgery Unit in West China Hospital of Sichuan University, China, and divided into three groups. The experimental group will receive routine treatments and acupuncture at PC6, ST36 and ST37 bilaterally with electrical stimulation twice a day for 20 min preoperatively. The sham-acupuncture group will receive pseudo-electroacupuncture at sham acupoints of PC6, ST36 and ST37, which are 1 cun away from the real acupoints. The routine-treatment group will not receive electroacupuncture. The outcomes include the incidence of abdominal distention, abdominal circumference, the degree of abdominal distension, the fi rst time of fl atus and defecation, and hospitalization duration. DISCUSSION： The results from this study will demonstrate whether preoperative electroacupuncture is an effective method for the prevention of PGD in patients undergoing vascular surgery under GA. This study may also provide a standardized acupuncture treatment for reduction of PGD. TRIAL REGISTRATION： This study is registered with the Chinese Clinical Trial Registry： Chi CTR-TRC-13003649.     

The study of early application with Dixiong Decoction (地芎汤) for non-small cell lung cancer to decrease the incidence and severity of radiation pneumonitis: A prospective, randomized clinical trial

Objective： To evaluate the efficacy of compound Dixiong Decoction （地芎汤, a Chinese herbal decoction） on early prevention of radiation pneumonitis. Methods： Forty-six patients with non-small cell lung cancer who were planning to receive radiotherapy were randomly assigned to the treatment group treated with the compound Dixiong Decoction and the control group treated with a commonly used herbal decoction which has the effects of supplementing qi and nourishing yin, clearing heat and detoxifying at the time of radiotherapy. Primary measure was the incidence of radiation pneumonitis after radiotherapy. Secondary outcomes included Watters clinical radiographic physiologic （CRP） dyspnea score, the Radiation Therapy Oncology Group （RTOG） grading score, Karnofsky Performance Status （KPS） score, and the application of corticosteroids. Results： The incidence of radiation pneumonitis in the treatment group was 10.0%, while that in the control group was 26.3% （P=0.0032）. The Watters CRP dyspnea score and RTOG grading score in the treatment group were significantly lower than those in the control group （P0.05）. The KPS score in the treatment group was significantly higher than that in the control group （P0.01）. The dosage of corticosteroids was smaller with a shorter duration of therapy in the treatment group than that in the control group. Conclusion： The early application of the Chinese herbal decoction compound Dixiong Decoction can decrease the incidence of radiation pneumonitis, reduce the injury of the lung, and improve the life quality of the patients.     

提高中医药临床研究报道质量的建议

循证医学的兴起引起了国际医学界的极大关注并很快发展成为临床科研的标准.这不仅对临床随机对照试验的设计提出了严格的要求,如应用科学的随机方法和设定合理的对照组,同时也对准确、全面地报道临床科学研究成果提出了新的要求.尽管近年来中国国内中医药的临床研究成绩斐然,但由于报道质量上的缺陷,多数中医药的中文文献难于与国际标准接轨.随着世界上对中医药研究信息需求的日增,提高研究成果的报道质量势在必行.这就要求从报道文章的每一方面,即前言或背景介绍、材料和方法、结果以至讨论及结论各部分提高论文的质量;而各杂志的编辑则是质量把关的关键,应提高审稿标准并鼓励促进更多的高质量的来稿.     

针刺治疗香港地区慢性疲劳综合征的临床研究

目的:评价传统针剌治疗香港地区慢性疲劳综台征(chronic fatigue syndrome,CFS)的临床疗效。方法:采用单盲、随机、对照研究方法,将99例合恪受试者按1:1比例随机分成治疗组50例和对照组49例。治疗组以传统针刺法,选取百会、足三里、三阴交穴治疗;对照组以平针按穴法(针不刺入皮肤),选穴同治疗组。疗程共4周。每周治疗2次。按照英国Trudie Chalder等制定的疲劳量表和美国疾病控制中心1994年制定的CFS诊断标准及SF-12生活质量量表,建立效应评价表,评价疗效及安全性。结果:治疗后两组临床症状得到改善,在身体疲劳、精神疲劳及SF-12生活质量方面,治疗组优于对照组(P<0.01或P<0.05);受试者未发现不良反应。结论:针剌治疗CFS安全有效。     

一种自制速干手消毒剂的临床研究

目的探讨甘油乙醇免洗手消毒剂的临床实验效果,为产品推广提供依据。方法通过临床医务人员采用普通肥皂洗手和3种速干手消毒剂(甘油乙醇免洗手消毒剂、3M公司爱护佳免洗手消毒液、洗得宝牌手消毒凝胶)进行卫生手消毒,并比较4种方法的效果。结果采用普通肥皂洗手法及3种速干手消毒剂处理前、后手部细菌菌落数比较,差异有统计学意义(P<0.01);甘油乙醇免洗手消毒液的消毒效果优于其他3种方法,其余3种方法效果均能达到卫生部相应标准,其合格率差异无统计学意义(P>0.05)。结论甘油乙醇免洗手消毒剂杀菌效果好,价格低廉,有润肤作用,是一种值得推广的速干手消毒剂。     

多囊卵巢综合征临床试验受试者筛查分析

目的 通过对多囊卵巢综合征(PCOS)临床试验受试者的筛查,了解患者对PCOS及其临床试验的认知程度,探究筛查环节在临床试验中的作用及PCOS发病的相关因素和临床特点.方法 研究助手向PCOS患者宣讲PCOS及其临床试验的相关内容,同意接受筛查者,填写纸质版PCOS筛查-纳入情况记录表、门诊病历表及中医证候分级量化表,保留患者的必要检查结果,以作统计分析.结果 1)筛查患者对PCOS及其临床试验的认知程度较低;2)筛查后入组失败的原因主要是:距离远、不感兴趣等;3)受筛查的PCOS患者中医证型分布由高到低依次为:脾虚痰湿证、痰瘀互结证、肾虚肝郁证、肾虚血瘀证;4)基线资料:初潮后月经周期一直不规律者占72.04％;曾有规律的月经周期,后不规律者占27.96％;月经稀发或闭经者占95.70％,子宫异常出血者占4.30％;饮食方式不良者占52.78％,无运动习惯者占81.94％;有家族病史者占57.90％;多毛、痤疮、黑棘皮分别占32.47％、35.07％、41.56％;肥胖者占57.61％,其中向心性肥胖占68.00％;84例受筛查患者中,促黄体生成素(LH)/促卵泡生成素(FSH)比值异常33例,高雄激素血症58例,非酒精性脂肪肝48例,血脂异常24例,胰岛素抵抗(IR)51例,糖耐量异常16例.结论 PCOS患者多无良好的饮食、运动及生活习惯,有明显的家族疾病史,除典型的临床特征外,常表现为向心性肥胖,伴糖脂代谢异常.大多数PCOS患者对该疾病及其临床试验的认知程度低,试验前的筛查环节有助于PCOS知识的普及及早诊早治.     

国家医师资格考试上海考区临床实践技能考试的评价研究

随机抽取上海考区 5 0名考生 ,对他们重复实施两次 2 0 0 2年上海考区的临床实践技能考试及实施以标准化病人为基础的多站客观结构临床能力考试 (OSCE)。信度分析 :r=0 .832 2 4 ,P=0 .0 0 0 1<0 .0 5 ;效度分析 :r=0 .86 4 32 ,P=0 .0 0 0 1<0 .0 5。结果表明上海考区的临床实践技能考试比较可靠、有效 ,为改革、完善国家医师资格考试的方法、措施提供了科学依据。     

随机对照试验及统计学分析在临床医学应用中存在的问题

随机对照试验(RCT)研究被认为是临床治疗试验中论证强度最高的试验方法,可为临床实践提供真实的科学依据,引导临床医师在实践中做出正确的决策.本文介绍了RCT的方法及设计原则,分析了在临床实际应用中存在的问题,并对RCT中统计学方法应用的常见错误进行了分析,阐述了应用RCT及采用正确的统计学分析方法的重要性.     

临床药物治疗性研究论著质量的调查

采取典型整群调查法,对1996－1998年部分中华医学系列杂志刊登的304篇临床药物治疗性研究论著进行了调查和评价。结果显示：1996－1998年临床药物治疗性研究论著在“试验前有明确的排除标准,对照应用、有随访、主要指标统计推断方法正确”4项指标比较时,差别有显著性意义或显著性意义; 同一水平的刊物不同单位级别研究者论著水平无显著性差异。提示：近3年间该类研究质量无实质性差异,中华系列杂志中不同单位的组织研究者论质量处同一水平。     

改进中药临床试验报告的参考条目

为改进中药临床试验报告质量，本文在《草药随机对照临床试验的报告：CONSORT声明细则》的基础上，结合中医药的特点，制定了中药临床试验报告的参考条目。本条目沿用了草药CONSORT声明的22项要求，对其中11项的部分内容根据中医药特点进行了细化和增减，并根据中成药和汤药两大类临床试验的特点，争别对参考条目进行细化；最目突出了受试者（participant）、干预措施（intervention）、对照（control）和结局（outcome）四个方面的内容。制定中药临床武验报告的参考条目旨在提高中药临床试验报告的质量，并为杂志编辑和审稿人员提供参考。     

糖皮质激素治疗海洛因海绵状白质脑病的临床对照研究

目的评价糖皮质激素对海洛因海绵状白质脑病的疗效。方法随机将20名患者分为对照组和治疗组。对照组给予维生素B族药及辅酶Q10治疗,1个月后带药出院;治疗组在上述用药的基础上加用地塞米松20 mg/d,连用10 d后渐减量。对比治疗前、治疗后1个月、半年及1年两组患者的症状改善情况。结果两组患者治疗前、后对比无显著差异(P>0.05)。各组内对比结果显示,治疗后均较治疗前好转(P<0.05)。结论糖皮质激素治疗海洛因海绵状白质脑病无显著疗效,病后1~6个月内恢复较快,而6个月后症状恢复较慢。     

自编简易临床失语量表的信度和效度验证

目的:对自编简易临床失语量表进行信度和效度检验.方法:对符合标准的45例正常受试者和46例卒中后失语患者进行自编简易临床失语量表的2次评估:不同评定者间评估、汉语失语成套测验(Aphasia Battery of Chinese,ABC)量表评估.计算本量表的重测信度、内部一致性、评定者间信度及校标效度、结构效度、区分...