三只手臂,随机化,进行了安慰剂对照临床研究,以评估用滴定菠萝蛋白酶(Brome-Inf®)和纯化菠萝蛋白酶的冻干菠萝提取物对疼痛的影响,肿胀,刺耳,下颌第三磨牙手术拔除后的生活质量(QoL)。此外,这项研究通过与安慰剂组比较非甾体类抗炎药(NSAIDs)的效果,来检查非甾体类抗炎药的必要性.这项研究招募了42名需要在局部麻醉下拔除单个下颌第三磨牙的个体。患者被随机分配接受Brome-Inf®,纯化菠萝蛋白酶,或者口服安慰剂,在手术当天开始治疗,并在接下来的7天内继续治疗。测量的主要结果是三组对NSAIDs的需求。疼痛,肿胀,牙关是次要结果变量,术后1、3和7天评估。这项研究还评估了冻干菠萝提取物和单组分菠萝蛋白酶的比较功效。最终,在研究结束时,安慰剂组(第1~7天)对布洛芬的需求在统计学上较高(p<0.0001).此外,菠萝蛋白酶和菠萝组疼痛和肿胀的减轻程度明显更高(几乎所有患者的p<0.0001,在所有时间间隔)比安慰剂组。与安慰剂组相比,活性组还表现出QoL的显著差异(p<0.001)。与安慰剂组相比,在治疗组中出现了不显著的减少。因此,对于接受下颌第三磨牙手术的患者,在菠萝蛋白酶中滴定的菠萝提取物的给药除了改善术后QoL外,还显示出显着的镇痛和抗水肿作用。此外,菠萝蛋白酶和Brome-Inf®补充剂都将布洛芬的需求降低到了相当的程度,证明它们是NSAIDs的良好替代品,可以使这些患者的术后过程更加舒适。除了下颌第三磨牙手术外,有必要对更大样本进行进一步研究,以评估整个菠萝植物复合体在外科手术中的缓解疼痛和抗炎作用。
A three-arm, randomized, placebo-controlled clinical study was conducted to assess the impact of lyophilized pineapple extract with titrated bromelain (Brome-Inf®) and purified bromelain on pain, swelling, trismus, and quality of life (QoL) following the surgical extraction of the mandibular third molars. Furthermore, this study examined the need for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) by comparing their effects with a placebo group. This study enrolled 42 individuals requiring the extraction of a single mandibular third molar under local anesthesia. The patients were randomly assigned to receive Brome-Inf®, purified bromelain, or a placebo orally, initiating treatment on the day of surgery and continuing for the next 7 days. The primary outcome measured was the requirement for NSAIDs in the three groups. Pain, swelling, and trismus were secondary outcome variables, evaluated postoperatively at 1, 3, and 7 days. This study also assessed the comparative efficacy of freeze-dried pineapple extract and single-component bromelain. Ultimately, the placebo group showed a statistically higher need for ibuprofen (from days 1 to 7) at the study\'s conclusion (p < 0.0001). In addition, reductions in pain and swelling were significantly higher in both the bromelain and pineapple groups (p < 0.0001 for almost all patients, at all intervals) than in the placebo group. The active groups also demonstrated a significant difference in QoL compared to the placebo group (p < 0.001). A non-significant reduction in trismus occurred in the treatment groups compared to the placebo group. Therefore, the administration of pineapple extract titrated in bromelain showed significant analgesic and anti-edema effects in addition to improving QoL in the postoperative period for patients who had undergone mandibular third molar surgery. Moreover, both bromelain and Brome-Inf® supplementation reduced the need for ibuprofen to comparable extents, proving that they are good alternatives to NSAIDs in making the postoperative course more comfortable for these patients. A further investigation with larger samples is necessary to assess the pain-relieving and anti-inflammatory impacts of the entire pineapple phytocomplex in surgical procedures aside from mandibular third molar surgery.