Osteoarthritis treatment using autologous conditioned serum after placebo.

Osteoarthritis treatment using autologous conditioned serum after placebo.
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DOI:
10.3109/17453674.2014.950467
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发表时间:
2015-02
期刊:
影响因子:
3.7
通讯作者:
Saris DB
Saris DB
中科院分区:
医学2区
文献类型:
--
作者:
Rutgers M;Creemers LB;Auw Yang KG;Raijmakers NJ;Dhert WJ;Saris DB

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自体免疫调节血清(ACS)是一种治疗膝关节骨关节炎的疾病缓解药物,在早期的随机对照试验(RCT)中报告了其相对于安慰剂的适度优效性。我们假设,当有机会时,来自该RCT的安慰剂治疗患者现在会选择ACS治疗,这将导致比安慰剂更大的临床改善。在先前试验中接受安慰剂治疗的74名患者中,20名选择了ACS治疗。没有选择进一步治疗的患者接受了采访,了解他们的原因。使用膝关节特异性临床评分测量20例ACS治疗患者的临床改善,以及3个月和12个月时的"反应变化"。在选择ACS的20例患者中,疼痛的视觉模拟量表(VAS)评分有所改善;但12个月后,临床结果与安慰剂治疗后相似。反应位移测量表明,20例患者在治疗期间适应了他们的残疾。早期试验中接受安慰剂治疗的患者不愿意接受ACS治疗,部分原因是治疗的费力性。在一个选择治疗的患者亚组中,安慰剂治疗后的ACS治疗并没有比安慰剂治疗更大的临床改善。然而,由于目前研究的能力有限和可能的选择偏倚,无法给出使用或避免ACS的明确建议。
Autologous conditioned serum (ACS) is a disease-modifying drug for treatment of knee osteoarthritis, and modest superiority over placebo was reported in an earlier randomized controlled trial (RCT). We hypothesized that when given the opportunity, placebo-treated patients from that RCT would now opt for ACS treatment, which would result in a greater clinical improvement than placebo. Of 74 patients treated with placebo in the previous trial, 20 opted for ACS treatment. Patients who did not choose further treatment were interviewed about their reasons. Clinical improvement of the 20 ACS-treated patients was measured using knee-specific clinical scores, as was “response shift” at 3 and 12 months. In the 20 patients who did opt for ACS, the visual analog scale (VAS) score for pain improved; but after 12 months, clinical results were similar to those after placebo treatment. Response shift measurement demonstrated that the 20 patients had adapted to their disabilities during treatment. Placebo-treated patients from an earlier trial were reluctant to undergo ACS treatment, in part due to the laborious nature of the therapy. In a subset of patients who opted for treatment, ACS treatment after placebo did not result in greater clinical improvement than placebo treatment only. However, due to the limited power of the current study and possible selection bias, definite advice on using or refraining from ACS cannot be given.
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