目的:探讨术后镇痛安全有效的用药最佳途径。方法:将我科住院需手术治疗的90例肝胆疾病患者随机分成3组,在术后采用不同的镇痛给药途径,Ⅰ组为肌肉注射、Ⅱ组为自控硬膜外镇痛(PCEA)、Ⅲ组为微量输液泵。分别于术后6 h、24 h、48 h采用视觉模拟评分法(VAS)观察镇痛效果和不良反应等指标。 结果:Ⅱ组自控硬膜外镇痛(PCEA)和Ⅲ组微量输液泵镇痛效果明显优于Ⅰ组肌肉注射(Plt;001),Ⅱ组自控硬膜外镇痛(PCEA)组并发症多于Ⅰ组肌肉注射和Ⅲ组微量输液泵(Plt;001)。结论:3种不同镇痛给药途径用于术后患者,经临床实践研究,其最佳给药途径为微量输液泵,因易操作、安全、不良反应少、可根据疼痛的程度及时调节有效剂量,患者易接受,是一种经济实用科学的镇痛方法。
摘要:眼部的局部给药方式影响着药物作用的强度,速率及持续时间和不良反应。视网膜,脉络膜,玻璃体及视神经的疾病则对眼后节的局部给药治疗提出了挑战,以局部给药的方式通过解剖学的膜屏障及泪液排泄,并达到在特定部位起治疗作用的药物浓度是其中的重要课题。全身给药则难以在眼组织积蓄足够的药物浓度,且易引起全身性的不良反应。眼表局部应用滴眼剂在泪液循环及角膜,结膜的屏障作用下易发生流失,而有创的给药方式包括玻璃体内注射,结膜下注射等变得越来越普遍的同时,除对病人造成疼痛不适外,甚至也可导致多种严重于疾病本身的并发症。本文综述了近几年来随着各种眼科疾病分子机制的研究和解明,眼部局部给药方式及新剂型的药代动力学及安全性的研究进展。Abstract: The ocular drug delivery system affects the drug’s efficacy,rate of speed,velocity and adverse reaction.How to deliver the drug with therapeutic local concentrations to the posterior segment remains a challenge. Many invasive methods such as intravitreal injection,subconjunctival injection are generally used,noninvasive method like eye drop can not pass through the barrier of the eye although it is convenient.The recent progress in safty and pharmacokinetic of ocular drug delivery system is reviewed in this article.
Objective Dexamethasone (DXM) can regulate the balance of neutrophil and cytokine and enhance the ischemia-reperfusion tolerance of the skin flap; amlodipine besylate (AB) can selectively expand the peripheral blood vesselsand rel ieve the vascular smooth muscle spasm. To investigate the percutaneous penetration abil ity of DXM/AB compound gel and evaluate its effect on survival of ischemic skin flap. Methods Sodium carboxymethylcellulose was used to make blank gel, which was mixed in DXM, AB, azone (AZ), and progylene glycol (PG) respectively to make the compound gel containing 0.3%DXM/0.5%AB only (group D), the compound gel containing 3%AZ/2%PG, 3%AZ, and 2%PG (groups A, B, and C), the 0.3%DXM gel containing 3%AZ/2%PG (group E), the 0.5%AB gel containing 3%AZ/2%PG (group F). The accumulative penetration of DXM and AB in compound gel, 0.3%DXM gel, 0.5%AB gel through excised rat skin and its penetration within flap tissue were investigated by ultraviolet spectrophotometry. Fifty SD rats were selected to make 100 mm × 10 mm random flap at the back, and were randomly divided into 5 groups according to different gels which were used to treat flaps (n=10): compound gel group (group A1), 0.3%DXM gel group (group B1), 0.5%AB gel group (group C1), blank gel group (group D1), and peritoneal injection of DXM (5 mg/kg) and AB (2 mg/kg) (group E1). The survival area of ischemic random skin flap was measured on the 7th day by planimetry. Twenty-four SD rats were selected to make 100 mm × 10 mm random flap at the back, and were randomly divided into 2 groups (n=12). The accumulative penetration of DXM and AB within skin flap were also detected at 2 and 6 hours after appl ication of 2 g of compound gel containing 3%AZ/2%PG (group A2) and peritoneal injection AB (2 mg/kg) / DXM (5 mg/kg) (group B2). Results The accumulative penetration of DXM and AB in compound gel were increased in time-dependent manner (P lt; 0.05), and it was the highest in group A, and was significantly higher than that in group B and group C (P lt; 0.01), but there was no significant difference when compared with group E or group F (P gt; 0.05). The accumulative penetration of DXM and AB in groups A, B, and C were significant higher than that in group D (P lt; 0.05). After 7 days, the survival area of flaps in groups A1, B1, C1, D1, and E1 were (695.0 ± 4.6), (439.3 ± 7.1), (477.5 ± 14.5), (215.2 ± 3.8), and (569.4 ± 9.7) mm2, respectively; group A1 was significantly higher than other groups (P lt; 0.05). After 2 and 6 hours, the quantities of DXM and AB in skin flap of group A2 were significantly higher than that of group B2 (P lt; 0.05). Conclusion In 0.3%DXM/0.5%AB compound gel, DXM and AB might penetrate into skin tissue, which could significantly increase the survivalarea of ischemic skin flap.
Objective To assess the tolerability and safety of Yinhuang injection in Chinese healthy volunteers. Methods Thirty-two healthy subjects were enrolled in the single-dose study. Each subject was administered one of the seven doses of 40, 120, 240, 320, 400, 480, and 560 mg, respectively, by intravenous injection. The sample sizes were 2, 4, 6, 6, 6, 4 and 4, respectively, for each dose group. Twelve healthy subjects were enrolled in the multi-dose study. The subjects in the lower dose group were administered 240 mg and the subjects in the higher dose group were administered 400 mg Yinhuang by intravenous injection once a day for consecutive 7 days. The sample sizes for both groups were 6. The safety was evaluated based on clinical symptoms, vital signs, physical examinations, electrocardiogram (ECG), laboratory tests and adverse events. All analyses were performed by using the software package SAS version 9.1. T-test and analysis of variance were used for continuous variables. Chi-square test and Fisher’s exact test were used for categorical variables.Results A total of 44 healthy volunteers completed the tolerance test. No serious adverse event and clinically significant changes in vital signs, ECG and laboratory tests were found in both single-dose groups and multi-dose groups. Among two mild adverse events, dizziness occurred in one subject in 480 mg dose group in the single-dose trial, which was probably related to the experimental drug. Conclusion Yinhuang injection is safe and well-tolerated in Chinese healthy subjects after administration of single-doses (40-560 mg) and multi-doses (240-400 mg once a day for consecutive 7 days). The maximum-tolerated dose of Yinhuang injection is at 560 mg in the single-dose trial. The dose regimen of 240-400 mg a day is recommended for phase II study.
目的 探讨术中应用缓释5-氟尿嘧啶在结直肠癌治疗中的价值及安全性。方法 回顾性分析173例结直肠癌患者术中应用缓释5-氟尿嘧啶后的疗效和不良反应。结果 171例患者顺利出院，1例患者死于严重骨髓抑制，1例死于真菌败血症； 无出血、吻合口漏、肠穿孔、肠梗阻等严重并发症发生。155例患者获6个月至3年的随访，随访期间死亡23例，发生局部复发5例，肝脏等远处转移3例。结论 结直肠癌术中使用缓释5-氟尿嘧啶是安全、有效的。