Department Otorhinolaryngology, Faculty of Health Sciences, University of the Free State, Box 339G42, Bloemfontein 9300, South Africa.
Lipids Health Dis. 2012 Oct 12;11:136. doi: 10.1186/1476-511X-11-136.
Surgery is the mainstay therapy for HPV-induced laryngeal papillomatosis (LP) and adjuvant therapies are palliative at best. Research revealed that conjugated-linoleic acid (CLA) may improve the outcome of virally-induced diseases. The effects of Clarinol™ G-80 (CLA) and high oleic safflower oil (HOSF) on children with LP (concomitant with surgery) were evaluated.
A randomized, double-blinded, crossover and reference-oil controlled trial was conducted at a South African medical university. Study components included clinical, HPV type/load and lymphocyte/cytokine analyses, according to routine laboratory methods.
Overall: ten children enrolled; eight completed the trial; five remained randomized; seven received CLA first; all treatments remained double-blinded.
Children (4 to 12 years) received 2.5 ml p/d CLA (8 weeks) and 2.5 ml p/d HOSF (8 weeks) with a washout period (6 weeks) in-between. The one-year trial included a post-treatment period (30 weeks) and afterwards was a one-year follow-up period.
Changes in numbers of surgical procedures for improved disease outcome, total/anatomical scores (staging system) for papillomatosis prevention/viral inhibition, and lymphocyte/cytokine counts for immune responses between baselines and each treatment/end of trial were measured.
After each treatment all the children were in remission (no surgical procedures); after the trial two had recurrence (surgical procedures in post-treatment period); after the follow-up period three had recurrence (several surgical procedures) and five recovered (four had no surgical procedures). Effects of CLA (and HOSF to a lesser extent) were restricted to mildly/moderately aggressive papillomatosis. Children with low total scores (seven/less) and reduced infections (three/less laryngeal sub-sites) recovered after the trial. No harmful effects were observed. The number of surgical procedures during the trial (n6/available records) was significantly lower [(p 0.03) (95% CI 1.1; 0)]. Changes in scores between baselines and CLA treatments (n8) were significantly lower: total scores [(p 0.02) (95% CI -30.00; 0.00)]; anatomical scores [(p 0.008) (95% CI -33.00: -2.00)]. Immune enhancement could not be demonstrated.
These preliminary case and group findings pave the way for further research on the therapeutic potential of adjuvant CLA in the treatment of HPV-induced LP.
手术是 HPV 诱导的喉乳头状瘤病（LP）的主要治疗方法，辅助治疗最多只能起到姑息作用。研究表明，共轭亚油酸（CLA）可能改善病毒诱导疾病的预后。本研究评估了 Clarinol™ G-80（CLA）和高油酸红花油（HOSF）对 LP（伴有手术）患儿的影响。
在南非一所医科大学进行了一项随机、双盲、交叉和对照油的临床试验。根据常规实验室方法，研究内容包括临床、HPV 类型/负荷和淋巴细胞/细胞因子分析。
共纳入 10 名患儿；8 名完成试验；5 名仍处于随机分组状态；7 名患儿先接受 CLA 治疗；所有治疗均保持双盲。
4 至 12 岁患儿每日接受 2.5 ml CLA（8 周）和 2.5 ml HOSF（8 周）治疗，期间洗脱期为 6 周。为期一年的试验包括治疗后期（30 周）和随后为期一年的随访期。
为改善疾病结局而进行的手术次数变化、乳头状瘤病预防/病毒抑制的总/解剖评分（分期系统）、以及淋巴细胞/细胞因子计数的变化，均在基线和每次治疗/试验结束时进行测量。
每次治疗后所有患儿均处于缓解状态（无需手术）；试验结束后 2 例患儿复发（治疗后期间需手术）；随访后 3 例患儿复发（多次手术），5 例患儿恢复（4 例患儿无需手术）。CLA（以及 HOSF 的作用较小）的效果仅限于轻度/中度侵袭性乳头状瘤病。总评分（七项/更少）较低和感染部位（三个/更少喉部亚部位）较少的患儿在试验后恢复。未观察到有害作用。试验期间手术次数（n6/可用记录）显著减少（p0.03）（95%CI 1.1；0）。与基线和 CLA 治疗相比，评分变化显著降低：总评分（p0.02）（95%CI -30.00；0.00）；解剖评分（p0.008）（95%CI -33.00：-2.00）。免疫增强作用无法得到证实。
这些初步的病例和群组研究结果为进一步研究辅助 CLA 在 HPV 诱导的 LP 治疗中的治疗潜力铺平了道路。
