Bocanegra Mildred, Seijas Alberto, Yibirín Maria González
Natera Guarapo Dental Group, Caracas, Venezuela.
Policlinical Institute, Caracas, Venezuela, and.
Curr Ther Res Clin Exp. 2003 May;64(5):279-89. doi: 10.1016/S0011-393X(03)00087-0.
Pain following extraction of an impacted third molar is widely used to assess analgesic efficacy, especially that of a single dose of a drug. The analgesic activity of conventional nimesulide (CN) has been documented in a variety of types of acute and chronic pain. Beta-cyclodextrin nimesulide (BN) is a new formulation in which nimesulide is included in a cyclodextrin molecule, which increases its solubility in water and its dilution rate, allowing extended, rapid absorption of the drug.
The aim of this study was to assess the efficacy and tolerability of a single dose of BN compared with CN in patients with pain following extraction of an impacted third molar.
This was a prospective, randomized, double-blind, double-dummy study conducted at 3 dentistry centers in Venezuela. The patients were randomized to 1 of 2 groups. One group received a single dose of BN (400-mg tablet, equivalent to 100 mg of nimesulide); the other group received a single dose of CN (100-mg tablet). Both groups also received a placebo. The efficacy variables were (1) pain intensity (PI), assessed on a visual analog scale (VAS) at the following times: 0, 5, 10, 15, 30, and 45 minutes and 1, 2, 4, 6, 8, 10, and 12 hours after drug administration; (2) time to first measurable difference in PI from baseline (PID) (PID ≥1 cm on the VAS; ie, the beginning of analgesic action); (3) maximum PID (max PID); (4) sum of PIDs in the 12-hour observation period; (5) pain relief (PR), as rated on a 5-point scale; (6) maximum PR; and (7) sum of the PR scores in the 12-hour observation period (ie, total PR). For the tolerability analysis, all adverse events (AEs) were to be recorded, and the investigators were to assess whether each AE was drug related.
Seventy-two patients were enrolled in the study. Of these, 62 patients (40 women, 22 men; mean [SD] age, 20.1 [5.9] years) were assessed; 35 were treated with BN and 27 with CN. PI reduction was more rapid and greater in the BN group. The first measurable change in PI (PID ≥1 on the VAS) was reached within 5 minutes by 39% and 15% of the patients in the BN and CN groups, respectively, and within 10 minutes by 52% and 30% of the patients in the BN and CN groups, respectively. The max PID was reached <1 hour in 32% and 15% of patients in the BN and CN groups, respectively. No AEs were reported.
In this study population, both BN and CN were similarly effective in relieving pain after extraction of an impacted third molar, and both drugs were well tolerated. PI changes were statistically significantly more rapid and greater with BN than CN.
拔除阻生第三磨牙后的疼痛被广泛用于评估镇痛效果，尤其是单剂量药物的镇痛效果。传统尼美舒利（CN）的镇痛活性已在多种急慢性疼痛中得到证实。β-环糊精尼美舒利（BN）是一种新剂型，其中尼美舒利被包含在环糊精分子中，这增加了其在水中的溶解度和稀释率，使药物能够延长、快速吸收。
本研究旨在评估单剂量BN与CN相比，对拔除阻生第三磨牙后疼痛患者的疗效和耐受性。
这是一项在委内瑞拉3个牙科中心进行的前瞻性、随机、双盲、双模拟研究。患者被随机分为2组中的1组。一组接受单剂量BN（400毫克片剂，相当于100毫克尼美舒利）；另一组接受单剂量CN（100毫克片剂）。两组均接受安慰剂。疗效变量包括：（1）疼痛强度（PI），在给药后0、5、10、15、30和45分钟以及1、2、4、6、8、10和12小时，通过视觉模拟量表（VAS）进行评估；（2）PI从基线开始首次出现可测量差异的时间（PID）（VAS上PID≥1厘米；即镇痛作用开始）；（3）最大PID（max PID）；（4）12小时观察期内PID的总和；（5）疼痛缓解（PR），采用5分制评分；（6）最大PR；（7）12小时观察期内PR评分的总和（即总PR）。对于耐受性分析，记录所有不良事件（AE），研究人员评估每个AE是否与药物相关。
72名患者纳入研究。其中，62名患者（40名女性，22名男性；平均[标准差]年龄，20.1[5.9]岁）接受评估；35名接受BN治疗，27名接受CN治疗。BN组PI降低更快且幅度更大。BN组和CN组分别有39%和15%的患者在5分钟内达到PI的首次可测量变化（VAS上PID≥1），分别有52%和30%的患者在10分钟内达到。BN组和CN组分别有32%和15%的患者在<1小时内达到最大PID。未报告AE。
在本研究人群中，BN和CN在缓解阻生第三磨牙拔除后疼痛方面同样有效，且两种药物耐受性良好。与CN相比，BN引起的PI变化在统计学上更快速、幅度更大。
