卡马西平、氯氮平治疗精神分裂症的双盲对照研究

用卡马西平、氯氮平对63例男性精神分裂症进行了为期八周的双盲对照研究，采用BPRS、SAPS、SANS、TESS进行评定，结果卡马西平有效率为72.41%，对思维障碍，活动过多、迟滞、敌意猜疑均有效，对思维障碍，活动过多的疗效与氯氮平相当。氯氮平对阳性症状均有效，而卡马西平仅对阳性症状有效。副反应卡马西平以头昏多见，氯氮平以窦性动过速，便秘，流涎多见。     

纤维结合蛋白软膏治疗宫颈糜烂双盲对照观察

目的:通过用自制的纤维结合蛋白软膏和太阳石药业生产的复方莪术油栓对150例宫颈糜烂患者进行分组对照治疗,筛选高效、方便、副作用小、患者容易接受的治疗药物。方法:按就诊的顺序将患者依次编号,随机将患者分为两组,分别进行临床观察。结果:纤维结合蛋白软膏组(总有效率90.7%)疗效明显优于复方莪术油栓组(总有效率48.0%)。结论:纤维结合蛋白软膏使宫颈分泌减少,改善阴道内环境,促进鳞状上皮再生,从而加速糜烂面愈合,疗效优于对照组。     

国产万拉法新和阿米替林治疗抑郁症多中心双盲对照研究

为了考察国产万拉法新胶囊治疗抑郁症的疗效，不良反应及其安全性，通过随机双盲模拟和临床多中心试验。结果发现，国产万拉法新胶囊对抑郁症治疗有效，其整体疗效与阿米替林相当。与阿米替林相比，其TESS植物神经，“其它”，心血管系统，神经系统等因子评分均明显降低，有显性差异。万拉法新常见副反应为中干、便秘、出汗、厌食、失眠、恶心、头昏、头痛等，大部分为轻度反应，无需处理，提示万拉法新是一种耐受性较好的新型抗抑郁药。     

加替沙星治疗急性细菌性感染的随机双盲对照临床研究

目的本研究以左氧氟沙星为对照药,对国产新药加替沙星进行临床疗效与安全性评价。方法采用随机双盲对照试验设计,以乳酸左氧氟沙星注射液为对照药,试验组和对照组剂量均为400mg/d,静脉滴注3~5d,改口服胶囊同样剂量,疗程7~14d。结果呼吸系统、泌尿生殖系统细菌性感染368例,其中试验组185例,对照组183例。两组的总体临床有效率与痊愈率、细菌清除率、两组细菌转阴率无显著性差异(P>0.05)。纸片药敏结果表明,临床分离菌对加替沙星敏感率明显高于环丙沙星、司帕沙星与氧氟沙星。MIC结果提示,加替沙星对绝大多数细菌有较强的抗菌活性,尤其是对抗革兰阳性菌的抗菌活性优于其他几种抗生素,对革兰氏阴性菌的抗菌活性与其他几种抗生素相近或略优。两组不良反应发生率比较无显著性差异(P>0.05)。结论国产加替沙星抗菌谱广、抗菌活性强,治疗各种敏感菌所致的急性中、重度感染安全有效。     

尼莫地平可改善老年性痴呆的认知功能

循证医学中心一项荟萃分析研究，纳入14项随机、双盲、安慰剂对照研究，共含2492例认知功能障碍和老年性痴呆的患者，用尼莫地平90～180毫克／日，治疗12～24周。结果显示，尼莫地平每次服30毫克，每日3次，治疗12周，临床检查认知功能（包括智能量表、语言流畅性、词汇量）有显著改善。该药耐受性好，药物不良反应少。     

马来酸氟吡汀治疗慢性腰背痛随机双盲对照研究

慢性腰背痛是临床常见的疾病，治疗方法以口服镇痛药为主。临床常用的镇痛药包括非甾体类消炎镇痛药和阿片类镇痛药，但这两种药物不良反应较多，不宜长时间应用。马来酸氟吡汀是一种新型镇痛药物。本研究采用随机双盲法，以50mg盐酸曲马多胶囊作为对照评价100mg马来酸氟吡汀胶囊治疗慢性腰背痛的疗效，现报道如下。     

Omega-7 Mixed Fatty Acid Supplementation Fails to Reduce Serum Inflammatory Biomarkers: A Placebo-Controlled,Double-Blind Randomized Crossover Trial

We report the effects of mixed omega-7 fatty acid supplementation on changes in serum hsCRP, TNFα, and IL-6 levels and self-reported outcomes in people with non-specific chronic musculoskeletal discomfort. Design: A double-blind, placebo-controlled, 1:1 randomized single crossover trial composed of 688 mg/day palmiteolate for the verum and an equivalent amount of medium-chain triglycerides for the placebo. Method: Data were analyzed in two independent groups and as a crossover group. Results: From 211 screened participants in 2017–2019, 56 were randomized. Six participants dropped out and fifty completers contributed to the statistical analyses. At baseline, none of the investigated biomarkers were significantly correlated to subjectively assessed musculoskeletal discomfort levels. For the two-group analysis (n = 26 and n = 24), none of the serum biomarkers reached statistical significance; however, a statistically significant placebo effect was found in the subjective outcomes. Conclusion: For the crossover analysis (n = 50), three weeks of supplementation with n7FA containing 688 mg per day of palmiteolate did not reduce serum inflammatory biomarkers nor did it improve subjectively measured quality of life (QoL) compared to placebo. Future studies should explore appropriate biomarkers, sufficient power, length of dosing, inclusion criteria for volunteers with higher BMI, and the verification of cis-palmiteolate versus trans-palmiteolate.     

Lactobacillus plantarum HAC01 Supplementation Improves Glycemic Control in Prediabetic Subjects: A Randomized,Double-Blind,Placebo-Controlled Trial

A recent animal study demonstrated that administration of Lactobacillus plantarum HAC01 isolated from Korean kimchi improved glycemic control in type 2 diabetic mice. In the present study, we evaluated Lactobacillus plantarum HAC01’s effects on metabolic parameters of prediabetic human subjects. Forty subjects with isolated impaired glucose tolerance were randomly assigned to receive a daily placebo (n = 20) or a dose of Lactobacillus plantarum HAC01 (n = 20) over eight weeks. The primary endpoint was a change in 2 h postprandial glucose (2h-PPG) levels and the secondary endpoints were assessment of other glucose metabolism parameters, including HbA1c, gut microbiota composition, and fecal short-chain fatty acids (SCFAs). The group with a diet supplemented with Lactobacillus plantarum HAC01 saw a significant reduction in 2h-PPG and HbA1c levels compared to the placebo group. Fasting plasma glucose, insulin, HOMA-IR, QUICKI, microbiota composition, and fecal SCFAs, however, were not significantly altered. No serious adverse effects were reported. This is the first clinical trial to show a beneficial effect of single-strain probiotic supplementation administered over eight weeks on HbA1c levels in prediabetic subjects.     

Plant-Derived Lactobacillus paracasei IJH-SONE68 Improves Chronic Allergy Status: A Randomized,Double-Blind,Placebo-Controlled Clinical Trial

We have recently demonstrated that the exopolysaccharides (EPSs) produced by a plant-derived lactic acid bacterium, Lactobacillus paracasei IJH-SONE68, prevent and ameliorate allergic reaction on contact in dermatitis model mice. In the present study, we conducted a clinical trial using a capsule containing spray-dried powder from pineapple juice broth fermented with the LAB strain as an experimental diet. The clinical trial was conducted as a double-blind and placebo-controlled randomized comparative study from May 2019 to July 2021. Males and females between the ages of 21 and 70 who experience chronic allergies participated in the study. Sixty subjects were instructed to orally take a capsule containing the IJH-SONE68 powder or placebo, every day for 12 weeks. After the clinical trial was over, the scores based on subjects’ self-assessment of allergic status were significantly improved in the intervention group, as compared with the placebo group. Some serum biochemicals associated with inflammation response were also significantly improved by intake of the experimental diet. In conclusion, the IJH-SONE68-derived EPS improves chronic allergy status in humans and is expected to decrease their inconvenience.     

The Effects of Spirulina maxima Extract on Memory Improvement in Those with Mild Cognitive Impairment: A Randomized,Double-Blind,Placebo-Controlled Clinical Trial

Spirulina maxima is a marine microalga that has been promoted worldwide as a super food. This study was conducted to evaluate its ability to improve memory in the older adults using Spirulina maxima 70% ethanol extract (SM70EE). This randomized, double-blind, placebo-controlled clinical trial comprised 80 volunteers recruited from Jeonbuk National University Hospital in Jeonju, Republic of Korea, who were randomly assigned to two groups. The participants received either 1 g/day of SM70EE or a placebo without otherwise changing their diet or physical activity. The participants were examined at baseline and after a 12-week interval to determine whether there were changes in their results for visual learning, visual working memory, and verbal learning tests from the Korean version of the Montreal Cognitive Assessment, brain-derived neurotrophic factor and beta-amyloid levels, and total antioxidant capacity. Compared to the placebo group, the treatment group showed a significant improvement in visual learning and visual working memory test results and enhanced vocabulary. SM70EE use was shown to improve memory, with no adverse effects. Its efficacy in alleviating Alzheimer’s disease symptoms was verified for the first time through this clinical trial. SM70EE could play a role in the management of patients with dementia. This trial is registered with registration number of clinical research information service (CRIS: KCT0006161).     

Evidence for the Presence of Non-Celiac Gluten Sensitivity in Patients with Functional Gastrointestinal Symptoms: Results from a Multicenter Randomized Double-Blind Placebo-Controlled Gluten Challenge

Non-celiac gluten sensitivity (NCGS) is characterized by the onset of symptoms after eating gluten-containing food. We aimed to single out NCGS subjects among subjects with functional gastrointestinal symptoms. Patients were enrolled in a multicenter double-blind placebo-controlled trial with crossover. Symptoms and quality of life were evaluated by means of 10-cm VAS and SF36. Iron parameters, transaminases and C reactive protein (CRP) were evaluated. After a three-week-long gluten-free diet (GFD), responsive patients were randomly assigned to gluten intake (5.6 g/day) or placebo for seven days, followed by crossover. The primary endpoint was the worsening of symptoms (VAS increase ≥3 cm) during gluten ingestion compared to placebo. One hundred and forty patients were enrolled and 134 (17 males, mean age 39.1 ± 11.7 years, BMI 22.4 ± 3.8) completed the first period. A total of 101 subjects (10 males, mean age 39.3 ± 11.0 years, BMI 22.3 ± 4.0) reported a symptomatic improvement (VAS score 2.3 ± 1.2 vs. 6.5 ± 2.2 before and after GFD, p = 0.001). 98 patients underwent the gluten challenge and 28 (all females, mean age 38.9 ± 12.7 years, BMI 22.0 ± 2.9) reported a symptomatic relapse and deterioration of quality of life. No parameters were found to be statistically associated with positivity to the challenge. However, 14 patients responded to the placebo ingestion. Taking into account this finding, about 14% of patients responding to gluten withdrawal showed a symptomatic relapse during the gluten challenge. This group is suspected to have NCGS.     

13例脑血管病合并Meige综合征A型肉毒素治疗及综合干预效果分析

目的探讨脑血管病合并Meige综合征患者A型肉毒毒素治疗及综合干预措施效果。方法本组13例脑血管病合并meige综合征患者在常规脑血管治疗的同时,采取面部肌肉局部多点注射A型肉毒毒素治疗,并采取加强病房环境管理、饮食指导、眼部管理、安全防护、功能训练、心理疏导等综合干预。结果脑血管病合并Meige综合征在常规治疗的同时,采取A型肉毒毒素局部注射治疗和综合干预,效果满意。本组患者均于注射后24小时症状开始改善;3～10天后痉挛明显缓解,药效持续12～24周,平均（14±1.5）周。结论 A型肉毒毒素局部肌肉注射是治疗脑血管病合并Meige综合征的一种安全、有效的方法;综合干预可减轻症状,减少发作频率,提高患者生活质量。     

载脂蛋白B基因G11039A多态与脑血管病的关系研究

目的探讨载脂蛋白B基因(apolipoproteinB,apoB)G11039A多态与脑血管病的关系。方法采用聚合酶链式反应-限制性片段长度多态性分析法(PCR-RFLP)分析130例脑梗死患者、130例脑出血患者、100例对照组人群apoB基因G11039A多态;并采用氧化酶法测定血清甘油三脂(TG)、总胆固醇(TC)、高密度脂蛋白(HDL)、低密度脂蛋白(LDL),运用酶联免疫吸附法测定LP(a)浓度,免疫比浊法测定apoB100及apoAI浓度。结果脑梗死组apoB基因G11039A多态A等位基因频率(0.065)高于对照组(0.015)(P<0.05);脑出血组apoB基因G11039A多态A等位基因频率(0.023)与对照组无显著差别。脑梗死组及脑出血组中,G/G或G/A基因型亚组的各项血脂水平无显著差别(P>0.05)。结论apoB基因G11039A多态可能与脑梗死有关,而与脑出血无关。     

Blackcurrants Reduce the Risk of Postmenopausal Osteoporosis: A Pilot Double-Blind,Randomized, Placebo-Controlled Clinical Trial

Beneficial effects of blackcurrant supplementation on bone metabolism in mice has recently been demonstrated, but no studies are available in humans. The current study aimed to examine the dose-dependent effects of blackcurrant in preventing bone loss and the underlying mechanisms of action in adult women. Forty peri- and early postmenopausal women were randomly assigned into one of three treatment groups for 6 months: (1) a placebo (control group, n = 13); (2) 392 mg/day of blackcurrant powder (low blackcurrant, BC, group, n = 16); and (3) 784 mg/day of blackcurrant powder (high BC group, n = 11). The significance of differences in outcome variables was tested by repeated-measures ANOVA with treatment and time as between- and within-subject factors, respectively. Overall, blackcurrant supplementation decreased the loss of whole-body bone mineral density (BMD) compared to the control group (p < 0.05), though the improvement of whole-body BMD remained significant only in the high BC group (p < 0.05). Blackcurrant supplementation also led to a significant increase in serum amino-terminal propeptide of type 1 procollagen (P1NP), a marker of bone formation (p < 0.05). These findings suggest that daily consumption of 784 mg of blackcurrant powder for six months mitigates the risk of postmenopausal bone loss, potentially through enhancing bone formation. Further studies of larger samples with various skeletal conditions are warranted to confirm these findings.     

Non-Celiac Gluten Sensitivity Has Narrowed the Spectrum of Irritable Bowel Syndrome: A Double-Blind Randomized Placebo-Controlled Trial

Several studies have shown that a large number of patients who are fulfilling the criteria for irritable bowel syndrome (IBS) are sensitive to gluten. The aim of this study was to evaluate the effect of a gluten-free diet on gastrointestinal symptoms in patients with IBS. In this double-blind randomized, placebo-controlled trial, 148 IBS patients fulfilling the Rome III criteria were enrolled between 2011 and 2013. However, only 72 out of the 148 commenced on a gluten-free diet for up to six weeks and completed the study; clinical symptoms were recorded biweekly using a standard visual analogue scale (VAS). In the second stage after six weeks, patients whose symptoms improved to an acceptable level were randomly divided into two groups; patients either received packages containing powdered gluten (35 cases) or patients received placebo (gluten free powder) (37 cases). Overall, the symptomatic improvement was statistically different in the gluten-containing group compared with placebo group in 9 (25.7%), and 31 (83.8%) patients respectively (p < 0.001). A large number of patients labelled as irritable bowel syndrome are sensitive to gluten. Using the term of IBS can therefore be misleading and may deviate and postpone the application of an effective and well-targeted treatment strategy in gluten sensitive patients.