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对接受药物排石治疗(MET)的输尿管结石患者随访期间患者报告结局的前瞻性评估。

A prospective evaluation of patient-reported outcomes during follow-up of ureteral stones managed with medical expulsive treatment (MET).

作者信息

Pandey Abhishek, Mandal Swarnendu, Kumaraswamy Santosh, Gaur Abhay Singh, Das Manoj K, Nayak Prasant

机构信息

Department of Urology, All India Institute of Medical Sciences, Bhubaneswar, India.

出版信息

Urolithiasis. 2023 Mar 21;51(1):56. doi: 10.1007/s00240-023-01428-4.

Abstract

Patient-reported outcomes (PROs) for ureteral stones predominantly assess the pain. Despite the lack of evidence, multiple trials studying the efficacy of medical expulsive therapy (MET) have used PROs to define spontaneous stone passage (SSP). We aim to objectively evaluate the accuracy of PROs to predict successful SSP and the probability of patient's symptom resolution after stone passage. A single-center, prospective observational study recruiting adults with isolated, uncomplicated, ≤ 10 mm ureteral calculus was conducted. All patients received 4 weeks of MET, and SSP was confirmed by low-dose non-contrast-enhanced computed tomography (NCCT). The accuracy of PROs: "pain cessation," "decreased pain," "stone seen," and "stone capture" to predict successful SSP were evaluated in 1 month. The patient's symptom resolution rate was assessed at 1 and 4-month follow-ups. A total of 171 patients were included, and the overall SSP rate was 66.4% (n = 99). Patient-reported pain cessation, stone visualization, and stone capture were associated with successful SSP, but their accuracy was 59, 53, and 43%, respectively. Moreover, 25% of patients reporting complete pain cessation still harbored ureteral calculus. Pain resolved in 91% of patients after SSP at a 4-month follow-up. While hematuria and nausea resolved in all patients, lower urinary tract symptoms (LUTS) were not resolved in 17% of patients. We concluded that patient-reported pain cessation, stone visualization, and stone capture predict successful SSP, but confirmatory imaging is required due to the poor accuracy of these measures. The significant rates of non-pain-related symptoms indicate their significant contribution to patient morbidity. Clinical Trial Registration: Registered in Clinical Trial Registry of India (CTRI), Registration number: CTRI/2020/10/028777 (29th October 2020).

摘要

输尿管结石患者报告的结局(PROs)主要评估疼痛情况。尽管缺乏证据,但多项研究药物排石疗法(MET)疗效的试验已使用PROs来定义结石自然排出(SSP)。我们旨在客观评估PROs预测SSP成功的准确性以及结石排出后患者症状缓解的概率。开展了一项单中心、前瞻性观察性研究,纳入患有孤立性、非复杂性、直径≤10mm输尿管结石的成年人。所有患者接受4周的MET治疗,通过低剂量非增强计算机断层扫描(NCCT)确认SSP。在1个月时评估PROs“疼痛停止”“疼痛减轻”“看到结石”和“结石捕获”预测SSP成功的准确性。在1个月和4个月随访时评估患者的症状缓解率。共纳入171例患者,总体SSP率为66.4%(n = 99)。患者报告的疼痛停止、结石显影和结石捕获与SSP成功相关,但其准确性分别为59%、53%和43%。此外,25%报告疼痛完全停止的患者输尿管仍有结石。在4个月随访时,91%的患者在SSP后疼痛得到缓解。虽然所有患者的血尿和恶心症状均得到缓解,但17%的患者下尿路症状(LUTS)未得到缓解。我们得出结论,患者报告的疼痛停止、结石显影和结石捕获可预测SSP成功,但由于这些指标准确性较差,仍需要进行确认性影像学检查。非疼痛相关症状的显著发生率表明它们对患者发病率有重大影响。临床试验注册:在印度临床试验注册中心(CTRI)注册,注册号:CTRI/2020/10/028777(2020年10月29日)。

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