健康人 单次和多次口服 普卢利沙星片的药动学研究

  目的 研究健康受试者单次和多次口服普卢利沙星片后的药动学过程。方法 采用多周期试验设计,10名健康受试者单次po（200,400,600 mg）和多次po（400 mg）普卢利沙星片;采用HPLC测定普卢利沙星活性代谢物噻丁啶-喹啉羧酸衍生物（NM394）的血药浓度。用DAS2.0程序计算主要药动学参数,并进行统计分析。结果 健康志愿者单次及多次口服普卢利沙星片后,其活性代谢物NM394符合一级吸收一级消除的二室模型。主要药动学参数：单次给药低、中、高3种剂量普卢利沙星血浆活性代谢物NM394的消除半衰期及体内平均驻留时间相近,ρmax、AUC0-t和AUC0-∞均值与剂量呈良好的线性;多次给药ρ 为（1.02±0.18）mg·L-1,DF为（2.17±0.48）,AUC 为（15.69±3.20）mg·h·L-1,AUC 为（16.38±3.34）mg·h·L-1,t1/2α为（1.23±0.58）h,t1/2β为（7.95±3.28）h。结论 普卢利沙星片单次（低、中、高3种剂量）与多次（中剂量）po给药的主要药动学参数（t1/2、V/F、CL/F）无显著性差异（P>0.05）,体内药物无蓄积现象。 style="width:400px" rows="8" cols="> 摘要：目的 研究健康受试者单次和多次口服普卢利沙星片后的药动学过程。 方法 采用多周期试验设计, 10 名健康受试者单次 <> po （ 200 , 400 , 600 mg ）和多次 <> po （ 400 mg ）普卢利沙星片;采用 HPLC 测定普卢利沙星活性代谢物噻丁啶 - 喹啉羧酸衍生物（ NM394 ）的血药浓度。用 DAS2.0 程序计算主要药动学参数,并进行统计分析。 结果 健康志愿者单次及多次口服普卢利沙星片后,其活性代谢物 NM394 符合一级吸收一级消除的二室模型。主要药动学参数： 单 次给药 低、中、高 3 种剂量普卢利沙星血浆活性代谢物 NM394 的消除半衰期及体内平均驻留时间相近, <> ρ _max 、 AUC_0-<>t 和 AUC_0-∞ 均值与剂量呈良好的线性;多次给药 <> ρ 为（ 1.02±0.18 ） mg·L^-1 , DF 为（ 2.17±0.48 ）, AUC 为（ 15.69±3.20 ） mg·h·L^-1 , AUC 为（ 16.38±3.34 ） mg·h·L^-1 , <> t _1/2α 为（ 1.23±0.58 ） h , <> t _1/2β 为（ 7.95±3.28 ） h 。 结论 普卢利沙星片单次（低、中、高 3 种剂量）与多次（中剂量） <> po 给药的主要药动学参数（ <> t _1/2 、 <> V /<>F 、 <> CL /<>F ） 无显著性差异（ <> P >0.05 ）, 体内药物无蓄积现象 。     

三种剂量国产盐酸塞利洛尔片健康人体内药物动力学及参数相关性研究

目的：测定盐酸塞利洛尔在人体内药代动力学特性及其３种不同剂量的药代动力学参数变化规律。方法：健康志愿者９名,３×３拉丁方设计,单剂量ｐｏ１００,２００,４００ｍｇ盐酸塞利洛尔片,采用反相高效液相色谱法测定不同时间的血药浓度,在计算机上以ＭＣＰＫＰ程序拟合,求算药代动力学参数。结果：１００,２００,４００ｍｇ国产盐酸塞利洛尔片的ｔ１／２Ｋ,Ｋ,ｔｍａｘ,ｃｍａｘ,ＡＵＣ０～∞分别为３．３７,３．４５和３．５６ｈ,０．２４,０．２１和０．２０ｈ－１,３．６４,３．３８和３．８７ｈ,１７７．５５,５０１．４和１１８８．５８ｎｇ·ｍｌ－１,１６１５．４１,４５０８．３８和１０８２８．５５μｇ·ｈ－１。结论：经方差分析,三剂量组的ｔ１／２ｋ,Ｋ,ｔｍａｘ等参数无显著差异（Ｐ＞０．０５）,ｃｍａｘ,ＡＵＣ０～∞均不呈倍数变化。     

The effect of hydroalcoholic Saffron (Crocus sativus L.) extract on fasting plasma glucose,HbA1c,lipid profile,liver, and renal function tests in patients with type 2 diabetes mellitus: A randomized double‐blind clinical trial

Diabetes mellitus is a metabolic disease that manifested as hyperglycemia due to the defect in secretion or function of insulin. Studies have shown that saffron and its derivatives cause a significant reduction in plasma glucose levels in experimental models. The purpose of this study was to investigate the effect of the saffron extract on fasting plasma glucose (FPG), glycated hemoglobin level (HbA1c), lipid profile, liver enzymes, and renal function tests in type 2 diabetic patients. In this double‐blind randomized clinical trial, 64 type 2 diabetic patients who were on oral anti‐diabetic drugs were examined. Participants received either 15 mg of saffron or placebo capsules (two pills per day) for 3 months. Anthropometric indices, dietary intake, FPG, HbA1c, lipid profiles, liver enzymes (ALT, AST, ALP), and renal function (BUN, Cr.) tests were measured pre and post intervention after 3 months. Independent t test and paired t test were used for data analysis. After 3‐months intervention, mean difference of FPG, Cholesterol, LDL‐c, and LDL/HDL ratio between two groups showed significant reduction(p < 0.0001), but HbA1c, HDL‐C, API, TG showed no significant differences (p > 0.05). In saffron group, FPG, HbA1c, cholesterol, LDL‐c, and LDL/HDL ratio decreased significantly after 3‐months intervention compare with baseline (p < 0.0001).     

Hypotensive effect of aqueous saffron extract (Crocus sativus L.) and its constituents,safranal and crocin,in normotensive and hypertensive rats

In this study, the effects of saffron (Crocus sativus) stigma aqueous extract and two active constituents, crocin and safranal, were investigated on blood pressure of normotensive and desoxycorticosterone acetate‐induced hypertensive rats. Three doses of crocin (50, 100 and 200 mg/kg), safranal (0.25, 0.5 and 1 mg/kg) and the aqueous extract (2.5, 5 and 10 mg/kg) were administered intravenously in different groups of normotensive and hypertensive animals and their effects on mean arterial blood pressure (MABP) and heart rate (HR) were evaluated. The aqueous extract of saffron stigma, safranal and crocin reduced the MABP in normotensive and hypertensive anaesthetized rats in a dose‐dependent manner. For example, administrations of 10 mg/kg of aqueous extract, 1 mg/kg of safranal and 200 mg/kg of crocin caused 60 ± 8.7, 50 ± 5.2 and 51 ± 3.8 mmHg reductions in MABP, respectively. It can be concluded that the aqueous extract of saffron stigma has hypotensive properties which appear to be attributable, in part, to the actions of two major constitutes of this plant, crocin and safranal. It seems that safranal is more important than crocin for lowering down blood pressure of rats. Copyright © 2009 John Wiley & Sons, Ltd.     

罗红霉素与氨溴索药动学相互作用研究

 目的 研究复方罗红霉素氨溴索片中两药在体内是否存在药动学上相互作用。 方法 24 名健康男性志愿者,采用 4 × 4 交叉试验设计,每组 1 人,交叉服用复方罗红霉素氨溴索片、罗红霉素片加氨溴索片、罗红霉素片、氨溴索片,服药后不同时间点取肘静脉血 4~5 mL ,血药浓度采用 HPLC/MS 测定。计算药动学参数,并进行方差分析,以 90% 的可信区间进行药物发生相互作用是否具临床意义的判定。 结果 复方制剂、合用药物以及单用药物药动学参数均无显著性差异。无论是复方或是合用 2 种药物,均未产生有临床意义的药动学相互作用。 结论 罗红霉素氨溴索片中 2 种成分在体内不产生统计学上和临床意义的药动学相互作用。     

Immunomodulatory effects of saffron: a randomized double-blind placebo-controlled clinical trial

Saffron is the dried stigmata of the flowers of saffron (Crocus sativus L.). Saffron is rich in carotenoids and carotenoids affect immunity. Thus, in this randomized double‐blind placebo‐controlled clinical trial with healthy men aged 21.4 ± 0.8 years (mean ± SE), the effects of taking one 100 mg saffron tablet daily for 6 weeks on the blood serum levels of IgG, IgM, IgA, C₃ and C₄ complements, counts and percentages of white blood cells, platelets, neutrophils, eosinophils, basophils, lymphocytes and monocytes, levels of some hematological parameters and levels of creatinine, SGOT and SGPT were evaluated in 45 subjects and compared with the placebo group (n = 44). After 3 weeks, saffron increased the IgG level and decreased the IgM level compared with the baseline and placebo (p < 0.01), decreased the percentage of basophils and the count of platelets compared with baseline, but increased the percentage of monocytes compared with placebo (p < 0.05). However, these parameters returned to the baseline levels after 6 weeks. Saffron did not have any significant effects on the other parameters. No adverse effects were reported. The results suggest that the sub‐chronic daily use of 100 mg saffron has temporary immunomodulatory activities without any adverse effects. Copyright © 2011 John Wiley & Sons, Ltd.     

The effect of saffron on weight and lipid profile: A systematic review,meta‐analysis,and dose–response of randomized clinical trials

Plant derivatives such as carotenoids and phytosterols enrich foods have been shown to reduce plasma triglyceride (TG), low‐density lipoprotein (LDL) cholesterol, and cholesterol concentrations. The aim of this systematic review and meta‐analyses study was to investigate the effects of saffron on lipid profiles, reported in randomized controlled trials (RCTs). We performed a systematic electronic search in PubMed/MEDLINE, Cochrane, and SCOPUS to identify RCTs and screening of relevant articles references up to October 12, 2018. There were no language restrictions. We performed this systematic review and meta‐analysis according to the Preferred Items for Reporting of Systematic Reviews and Meta‐Analyses guidelines. We identified and analyzed 14 eligible studies in this meta‐analysis. Our study found a significant reduction in cholesterol and TG following saffron intervention (weighted mean difference [WMD]: ?6.36 mg/dl, 95% confidence interval, CI, [?10.58, ?2.18] and WMD: ?5.37 mg/dl, 95% CI [?10.25, ?0.48], respectively). There was no significant effect on weight and LDL concentration. A meta‐regression analysis showed that long‐term saffron intervention can increase the high‐density lipoprotein (HDL) levels. In conclusions, our study findings indicate some benefits of saffron on cholesterol, HDL, and TG compared with placebo. However, we recommend the conduct of adequately powered, high‐quality RCTs with short‐ and long‐term follow‐up, evaluating relevant clinical outcomes to allow for making definitive recommendations.     

The effect of Momordica charantia and Mucuna pruriens in experimental diabetes and their effect on key metabolic enzymes involved in carbohydrate metabolism

The Indian traditional system of medicine prescribed traditional plant therapies. Two such plants, i.e. Momordica charantia (MC) and Mucuna pruriens (MP), earlier shown to reduce hyperglycaemia, were assessed for their anti hyperglycaemic effect on varying degrees of hyperglycaemia and diabetic complications. Alcohol and aqueous extracts of MC (50, 100 and 200 mg/kg/day) and only an alcohol extract of MP (100, 200 and 400 mg/kg/day) were evaluated in a pilot study (plasma glucose >180 mg/dL, 21 days), a chronic study in alloxanized rats (plasma glucose >280mg/dL, 120 days) and streptozotocin (STZ) mice (plasma glucose >400 mg/dL, 60 days). In the pilot study, the maximum antihyperglycaemic effect occurred with an aqueous extract of MC at week 3 and an alcohol extract of MP at week 6 at a dose of 200 mg/kg/day. In chronic alloxanized rats, the selected dose of MC led to a significant fall of 64.33%, 66.96%, 69.7% and 70.53% in plasma glucose levels at 1, 2, 3 and 4 months, respectively. MP showed a decrease of 40.71%, 45.63%, 50.33% and 51.01% at the same time period. In chronic STZ diabetic mice, MC led to a mean reduction of 15.37%, 18.68% and 22.86% in plasma glucose levels on days 40, 50 and 60 of sampling while MP had no significant effect. The alteration in hepatic and skeletal muscle glycogen content and hepatic glucokinase, hexokinase, glucose-6-phosphate and phosphofructokinase levels in diabetic mice were partially restored by MC but not by MP. The mechanism of action of MC and MP is discussed.     

Double‐blind placebo controlled trial of the anxiolytic effects of a standardized Echinacea extract

Earlier studies suggested that specific Echinacea preparations might decrease anxiety. To further study the issue, we performed a double blind, placebo controlled trial with a standardized Echinacea angustifolia root extract. Participants were volunteers scoring above 45 points on the state or on the trait subscale of the State Trait Anxiety Inventory (STAI). They were treated with 40 mg Echinacea or with placebo tablets twice daily for 7 days followed by a 3 week‐long washout period. Participants were also administered the Beck Depression Inventory (BDI) and the Perceived Stress Scale (PSS). In the Echinacea group, state anxiety scores decreased by approximately 11 points by the end of the treatment period, whereas the decrease was around 3‐points in the placebo group (p< 0.01). The effect maintained over the washout period. The difference from placebo was significant from the 7th day of treatment throughout. Changes were less robust with trait anxiety scores, but the preparation performed better than placebo in patients with high baseline anxiety. Neither BDI nor PSS scores were affected by the treatments. Adverse effects were rare and mild, and all were observed in the placebo group. These findings suggest that particular Echinacea preparations have significant beneficial effects on anxiety in humans.     

The effect of saffron (Crocus sativus L.) on glycemia,lipid profile,and antioxidant status in patients with type-2 diabetes mellitus: A randomized placebo-controlled trial

In the current study, we aimed to investigate the effect of saffron supplementation on glycemic status, lipid profile, atherogenic indices, and oxidative status in patients with type-2 diabetes (T2DM). In a randomized, double-blind controlled trial, 70 patients were randomly allocated into two groups (n = 35, each) and received 100 mg/day of saffron or placebo for eight weeks. Dietary intake, weight, body mass index (BMI), waist and hip circumferences (WC and HC), waist to hip ratio (WHR), fasting blood sugar (FBS), hemoglobin A1c (HbA1c), insulin, and Homeostatic model assessment for insulin resistance (HOMA-IR), lipid profile, atherogenic indices, oxidative status, and liver enzymes were determined before and after the intervention. At the end of the eighth week, saffron intervention could significantly reduce FBS (7.57%), lipid profile (except high-density lipoprotein cholesterol [HDL-C]), atherogenic indices, and liver enzymes (p < .05). Moreover, saffron could improve oxidative status (nitric oxide [NO] and malondialdehyde [MDA] reduced by 26.29% and 16.35%, respectively). Catalase (CAT) concentration remained unchanged. Saffron supplementation may alleviate T2DM by improving glycemic status, lipid profile, liver enzymes, and oxidative status. Further investigation is necessary to assess possible side effects and confirm the positive effect of saffron as a complementary therapy in clinical recommendations for T2DM.     

Effectiveness of Eriomin® in managing hyperglycemia and reversal of prediabetes condition: A double‐blind,randomized, controlled study

This study evaluated the potential effectiveness of different doses of Eriomin® on hyperglycemia and insulin resistance associated with other metabolic biomarkers in prediabetic individuals. Prediabetes patients (n = 103, 49 ± 10 years) were randomly divided into four parallel groups: (a) Placebo; (b) Eriomin 200 mg; (c) Eriomin 400 mg; and (d) Eriomin 800 mg. Assessment of biochemical, metabolic, inflammatory, hepatic, renal, anthropometric markers, blood pressure, and dietary parameters were performed during 12 weeks of intervention. Treatment with all doses of Eriomin (200, 400, and 800 mg) had similar effects and altered significantly the following variables: blood glucose (?5%), insulin resistance (?7%), glucose intolerance (?7%), glycated hemoglobin (?2%), glucagon (?6.5%), C‐peptide (?5%), hsCRP (?12%), interleukin‐6 (?13%), TNFα (?11%), lipid peroxidation (?17%), systolic blood pressure (?8%), GLP‐1 (+15%), adiponectin (+19%), and antioxidant capacity (+6%). Eriomin or placebo did not influence the anthropometric and dietary variables. Short‐term intervention with Eriomin, at doses of 200, 400, or 800 mg/day, benefited glycemic control, reduced systemic inflammation and oxidative stress, and reversed the prediabetic condition in 24% of the evaluated patients.     

Effect of oral administration ofHypericum perforatum extract (St. John's Wort) on skin erythema and pigmentation induced by UVB,UVA, visible light and solar simulated radiation

Hypericin from St John's wort (Hypericum perforatum L.) is a photosensitizing agent that may cause a severe photodermatitis when higher amounts of St John's wort are ingested by animals. Although Hypericum extracts are widely used in the treatment of depressive disorders, only a little information on the photosensitizing capacity of St John's wort in humans is available. In the present prospective randomized study we investigated the effect of the Hypericum extract LI 160 on skin sensitivity to ultraviolet B (UVB), ultraviolet A (UVA), visible light (VIS) and solar simulated radiation (SIM). Seventy two volunteers of skin types II and III were included and were divided into six groups, each consisting of 12 volunteers. In the single-dose study the volunteers (n = 48) received 6 or 12 coated tablets (5400 or 10 800 microgram hypericin). In the steady-state study the volunteers (n = 24) received an initial dose of 6 tablets (5400 microgram hypericin), and subsequently 3 x 1 tablets (2700 microgram hypericin) per day for 7 days. Phototesting was performed on the volar forearms prior to medication and 6 h after the last administration of Hypericum extract. The erythema-index and melanin-index were evaluated photometrically using a mexameter. After both single-dose and steady-state administration, no significant influence on the erythema-index or melanin-index could be detected, with the exception of a marginal influence on UVB induced pigmentation (p = 0.0471) in the single-dose study. The results do not provide evidence for a phototoxic potential of the Hypericum extract LI 160 in humans when administered orally in typical clinical doses up to 1800 mg daily. This is in accordance with previous pharmacokinetic studies that found hypericin serum and skin levels after oral ingestion of Hypericum extract always to be lower than the assumed phototoxic hypericin threshold level of 1000 ng/mL.     

The effect of saffron supplement on clinical outcomes and metabolic profiles in patients with active rheumatoid arthritis: A randomized,double‐blind,placebo‐controlled clinical trial

Rheumatoid arthritis (RA) is a systemic autoimmune and inflammatory disease. Our study aimed to determine the effect of saffron supplement on clinical outcomes and metabolic profiles in patients with active RA. In this randomized, double‐blind, placebo‐controlled trial, 66 women older than 18 years old received 100 mg/day either saffron supplement in the intervention group (n = 33) or matched placebo in the placebo group (n = 33) for a period of 12 weeks. Sixty‐one patients (30 in the control and 31 in the saffron group) remained for the final analysis. No adverse effects were reported by the patients. Saffron supplementation significantly decreased the number of tender (?1.38 ± 1.66 vs. 0.10 ± 0.40, p < .001) and swollen (?2.12 ± 2.34 vs. 0.63 ± 2.79, p < .001) joints, pain intensity based on visual analogue scale (?18.36 ± 15.07 vs. ?2.33 ± 5.04), p < .001), and disease activity score (DAS28) (?0.75 ± 0.67 vs. 0.26 ± 0.77, p < .001) at the end of intervention between the two groups and in saffron group compared with baseline values. Physician Global Assessment (p = .002) and erythrocyte sedimentation rate were significantly improved after intervention (24.06 ± 12.66 vs. 32.00 ± 14.75, p = 0.028). High‐sensitivity C‐reactive protein reduced at the end of the intervention in the saffron group compared with baseline values (12.00 ± 7.40 vs. 8.82 ± 7.930, p = .004). Tumor necrosis factor alpha, interferon gamma, and malondialdehyde were decreased, and total antioxidant capacity were increased, but their differences between the two groups were not significant (p > .05). According to the results, saffron supplements could positively and significantly improve clinical outcomes in RA patients.     

咪达唑仑片在中国维吾尔族、蒙古族和汉族受试者体内的药动学比较

 目的 比较研究中国维吾尔族、蒙古族和汉族健康受试者单剂量口服咪达唑仑片的药动学。方法 维吾尔族、蒙古族、汉族受试者各10名,男、女各半,单剂量口服15 mg咪达唑仑片后,用HPLC测定咪达唑仑的血浆浓度,用DAS 2.0药动学软件拟合药动学参数,并采用单因素方差分析和KrusKal-Wallis秩合检验对药动学参数进行比较。结果 咪达唑仑片的药动学参数ρmax、V_z/F、MRT_{0-12 h}、t1/2和tmax等在维吾尔族、蒙古族和汉族间的差异有显著性意义（P＜0.05）,男、女受试者间的药动学差异大多无显著性意义（P＞0.05）。所有药动学参数在同一民族和不同民族的个体间差异都较大。半数的男、女性受试者的药-时曲线都存在双峰现象。结论 咪达唑仑片在维吾尔族、蒙古族和汉族健康受试者间的药动学存在显著的民族差异和个体差异,临床应用时应该注意调整剂量。     

Effect of SKI 306X, a new herbal anti-arthritic agent, in patients with osteoarthritis of the knee: a double-blind placebo controlled study.

SKI 306X is a purified extract from a mixture of three oriental herbal medicines (Clematis mandshurica, Trichosanthes kirilowii and Prunella vulgaris) that have been widely used for the treatment of inflammatory diseases such as lymphadenitis and arthritis in far East Asia. A double-blind, controlled study was performed to evaluate the efficacy and safety of SKI 306X with placebo in 96 patients with classical osteoarthritis of the knee. Patients were randomized to four treatment groups: placebo, 200 mg, 400 mg and 600 mg of SKI 306X t.i.d.. Clinical efficacy and safety were evaluated for 4 weeks continuous treatment. SKI 306X demonstrated its clinical efficacy, as assessed by 100 mm visual analogue scale (VAS), Lequesne index and patients' and investigators opinion of the therapeutic effect compared with placebo (p<0.01). No significant adverse events were observed in patients treated with SKI 306X. This study demonstrated that SKI 306X, a new herbal anti-arthritic agent provided clinical efficacy in patients with osteoarthritis.     

三种剂量国产盐酸塞利洛尔片健康人体内药物动力学及参数相关性研究

 目的:测定盐酸塞利洛尔在人体内药代动力学特性及其3种不同剂量的药代动力学参数变化规律?方法:健康志愿者9名,3×3拉丁方设计,单剂量po 100,200,400mg盐酸塞利洛尔片,采用反相高效液相色谱法测定不同时间的血药浓度,在计算机上以MCPKP程序拟合,求算药代动力学参数?结果:100,200,400mg国产盐酸塞利洛尔片的t_1/2K,K,t_max,c_max,AUC_0～∞分别为3.37,3.45和3.56h,0.24,0.21和0.20h^-1,3.64,3.38和3.87h,177.55,501.4和1188.58ng·ml^-1,1615.41,4508.38和10828.55μg·h^-1。结论:经方差分析,三剂量组的t_1/2k,K,t_max等参数无显著差异(P>0.05),c_max,AUC_0～∞均不呈倍数变化?     

A prospective double‐blind randomized placebo‐controlled study of the effect of saffron (Crocus sativus Linn.) on semen parameters and seminal plasma antioxidant capacity in infertile men with idiopathic oligoasthenoteratozoospermia

Male factor infertility is a multifactorial disorder that affects a significant percentage of infertile couples; however, many of them remained untreated. In recent years, considerable numbers of infertile men have sought ‘herbal remedies’ as an effective treatment. Among ‘herbal remedies’, saffron is recommended for male infertility in our community. The effect of saffron was evaluated compared with placebo for the treatment of idiopathic male factor infertility. The study included 260 infertile men with idiopathic oligoasthenoteratozoospermia (OAT) who were randomized to saffron 60 mg/day (130, group 1) or a similar regimen of placebo (130, group 2) for 26 weeks. The two groups were compared for changes in semen parameters and total seminal plasma antioxidant capacity. Saffron administration did not result in beneficial effects. At the end of the study no statistically significant improvements were observed in either group in any of the studied semen parameters (sperm density, morphology and motility) (all p = 0.1). At the end of the trial, patients in group 1 had a mean motility of 25.7 ± 2.4%, which was not statistically different from the mean of 24.9 ± 2.8% in the placebo group (p = 0.1). Normal sperm morphology was 18.7 ± 4.7% and 18.4 ± 4.3%, in groups 1 and 2, respectively (p = 0.1). Patients treated with saffron and placebo had a mean sperm density of 20.5 ± 4.6% and 21.4 ± 4.6% per mL, respectively (p = 0.1). Saffron administration did not improve total seminal plasma antioxidant capacity, compared with baseline (p = 0.1) and placebo subjects (p = 0.1). Based on Pearson correlations, each semen parameter did not correlate significantly with treatment duration, including sperm density (r = 0.146, p = 0.13), percent of motile sperm (r = 0.145, p = 0.15) and percent of sperm with normal morphology (r = 0.125, p = 0.30). Saffron does not statistically significantly improve semen parameters in infertile men with idiopathic OAT. If medical professionals want to prescribe herbal remedies for male infertility, previous rigorous scientific investigations, documenting their safety and efficacy are required. Copyright © 2010 John Wiley & Sons, Ltd.     

司帕沙星人体药代动力学与相对生物利用度研究

 目的:研究司帕沙星片在健康人体内的药代动力学与相对生物利用度?方法:采用反相高效液相色谱法测定10名健康志愿者po 200mg国产和进口的司帕沙星片后血药浓度变化情况,计算两者的药代动力学参数及相对生物利用度,并以AUC_0～∞,t_max,c_max为指标,用配对t检验法分析国产片与进口片的生物等效性?结果:国产与进口司帕沙星片的药-时曲线可用二室模型拟合,其AUC_0～∞分别是:(23.73±2.11)μg·h·ml^-1与(23.91±3.18)μg·h·ml^-1;t_max分别是(3.13±0.54)h与(2.84±0.56)h,c_max分别是:(0.70±0.05)μg·ml^-1与(0.73±0.05)μg·ml^-1?配对t检验结果表明:AUC_0～∞,t_max,c_max均无显著性差异(P>0.05)?结论:国产与进口司帕沙星片为生物等效制剂;国产司帕沙星片对进口片的相对生物利用度为(97.81±13.62)%?     

A double-blind study with a new monodrug Kan Jang: Decrease of symptoms and improvement in the recovery from common colds

In a placebo-controlled double-blind study, the therapeutic effect of Kan Jang tablets made from Andrographis paniculata (Barm. F.) (Ness) dried extract was tested in patients with common colds. The patients were divided in two groups, in which group 1 (n = 33) received 1200 mg of Andrographis paniculata and group 2 (n = 28) a placebo (P). On day 3–4 after treatment the possible effect of Kan Jang tablets on selected symptoms and clinical signs of common cold was evaluated. A significant reduction in clinical symptoms at day 4 of administration of the Kan Jang tablets was observed. A better efficacy against the placebo is discussed. The differences in the total ‘sumscores’ of clinical and symptomatic findings indicate that the Kan Jang treated group did far better than the placebo group. We conclude that Kan Jang in a dose of 1200 mg daily has the capacity to significantly shorten the course/duration of the disease and therefore is indicated for an enhanced resistance to common colds.     

肾康注射液联合低分子量肝素钠注射液对原发性肾病综合征高凝状态的影响

目的观察肾康注射液联合低分子量肝素钠注射液对原发性肾病综合征（PNS）高凝状态的影响。方法将88例PNS患者随机分为4组,均予常规降压、调脂治疗,并口服甲基强的松龙。双嘧达莫片组21例,加用双嘧达莫片治疗;肾康注射液组22例,加用肾康注射液治疗;低分子量肝素钠注射液组22例,加用低分子量肝素钠注射液治疗;联合治疗组23例,加用肾康注射液联合低分子量肝素钠注射液治疗。4组疗程均为2周。观察治疗前后24 h尿蛋白定量、血浆白蛋白、凝血酶原时间（PT）、活化部分凝血活酶时间（APTT）、纤维蛋白原（FIB）变化。结果肾康注射液组、低分子量肝素钠注射液组治疗后24 h尿蛋白定量、FIB均较双嘧达莫片组下降（P〈0.05）,血浆白蛋白、PT、APTT均较对照组升高（P〈0.05）。肾康注射液组24 h尿蛋白定量较低分子量肝素钠注射液组下降明显（P〈0.05）,血浆白蛋白升高明显（P〈0.05）。联合治疗组治疗后24 h尿蛋白定量、FIB均较其余3组显著下降（P〈0.05）,血浆白蛋白、PT、APTT均较其余3组显著升高（P〈0.05）。结论肾康注射液联合低分子量肝素钠注射液治疗PNS高凝状态有明显疗效,且未出现明显的不良反应。