Farrar John, Locke Kenneth, Clemens J, Griffith James, Harte Steven, Kirkali Ziya, Kreder Karl, Krieger John, Lai H Henry, Moldwin Robert, Mullins Chris, Naliboff Bruce, Pontari Michel, Rodríguez Larissa, Schaeffer Anthony, Stephens-Shields Alisa, Sutcliffe Siobhan, Taple Bayley, Williams David, Landis J
University of Pennsylvania Perelman School of Medicine.
University of Pennsylvania, Perelman School of Medicine.
Res Sq. 2023 Feb 23:rs.3.rs-2441086. doi: 10.21203/rs.3.rs-2441086/v1.
Clinical trials of pain are notoriously difficult and inefficient in demonstrating efficacy even for known efficacious treatments. Determining the appropriate pain phenotype to study can be problematic. Recent work has identified the extend of widespread pain as an important factor in the likelihood of response to therapy, but has not been tested in clinical trials. Using data from three previously published negative studies of the treatment of interstitial cystitis/ bladder pain with data on the extent of widespread pain, we examined the response of patients to different therapies base on the amount of pain beyond the pelvis. Participants with predominately local but not widespread pain responded to therapy targeting local symptoms. Participants with widespread and local pain responded to therapy targeting widespread pain. Differentiating patients with and without widespread pain phenotypes may be a key feature of designing future pain clinical trials to demonstrate treatments that are effective versus not.
疼痛的临床试验即便对于已知有效的治疗方法而言，在证明疗效方面也向来困难且效率低下。确定合适的疼痛表型用于研究可能存在问题。近期研究已确定广泛性疼痛的程度是治疗反应可能性的一个重要因素，但尚未在临床试验中得到验证。利用此前发表的三项关于间质性膀胱炎/膀胱疼痛治疗的阴性研究数据以及广泛性疼痛程度的数据，我们根据盆腔以外的疼痛程度来研究患者对不同治疗方法的反应。主要为局部而非广泛性疼痛的参与者对针对局部症状的治疗有反应。既有广泛性疼痛又有局部疼痛的参与者对针对广泛性疼痛的治疗有反应。区分有无广泛性疼痛表型的患者可能是设计未来疼痛临床试验以证明治疗方法是否有效的关键特征。
