腰椎間盤突出症纖維環修復方法：臨床結果之統合分析與臨床試驗計畫書

Abstract

腰椎間盤突出是背痛和神經壓迫的常見原因，通常需要手術介入。然而，術後復發率和再次手術對病患預後的影響引起了關於纖維環修補技術的研究和討論。 本研究的第一部分透過系統性回顧和統合分析評估了目前的臨床數據，並比較了腰椎間盤切除術結合纖維環修補方法與單純椎間盤切除術之間的復發率、再次手術率和整體患者預後。旨在了解纖維環修補在降低復發率和改善患者預後方面的有效性。研究共納入了9個隨機對照試驗和9個觀察性研究，其中包含了三種不同的纖維環修補技術。結果顯示纖維環修補方法在減少復發和提高接受腰椎間盤切除術患者的生活品質方面具有潛在的優勢。我們還發現了不同的研究類型和修補方法之間效應量的差異，從而根據研究類型和修補方法的不同進行了次族群分析。 基於第一階段的研究結果，在第二部分擬定一項第二期臨床試驗的策略，以評估一種新的纖維環修補技術的安全性和有效性。這項第二期臨床試驗是一項非盲性的隨機對照試驗。納入試驗的受試者將隨機分配到接受椎間盤切除術合併纖維環修補術的實驗組，或僅椎間盤切除術的對照組。 在術後定期追蹤中將以量表和醫學影像進行評估，內容包括：復發、再次手術、疼痛評分、功能狀態和生活品質。試驗將遵守倫理監管標準，制定全面的患者篩選、手術程序、後續評估和數據分析計劃。根據既定指南，嚴密監測和報告不良事件及併發症。通過進行這項第二期臨床試驗，目的在提供有關纖維環修補方法的有效性和安全性的報告，從而有助於改善腰椎間盤突出患者的手術策略。

Lumbar disc herniation is a common cause of back pain and nerve compression, and often requires surgical intervention. Nevertheless, the postoperative recurrence rate and the impact of reoperation on patient prognosis have prompted research and discussion on annular fibrosis repair techniques. The first part of this paper presents a systematic review and meta-analysis of current clinical data. Recurrence rates, reoperation rates, and overall patient prognosis will be compared between standard discectomy combined with annular repair and standard discectomy alone. The aim of this study is to understand the effectiveness of annular repair in reducing recurrence rates and improving patient prognosis. A total of 9 randomized controlled trials and 9 observational studies have been included, from which three types of repair techniques have been also identified. The results highlight the potential benefits of annular repair methods in terms of reducing recurrence and enhancing quality of life for patients undergoing lumbar discectomy. We also found differences in effect sizes between different study types and repair methods, prompting subgroup analysis based on variations in study types and repair methods. Building upon the findings of the first part of the essay, the second part of the essay involves the development of a protocol for a phase II, open-label, randomized controlled clinical trial to assess the safety and effectiveness of a new annular fibrosis repair technique. Enrolled patients will be randomly assigned to either the experimental group, which will undergo standard discectomy combined with annular fibrosis repair, or the control group, which will undergo standard discectomy alone. Scales and medical imaging will be used to assess primary outcomes at regular postoperative visits, including reherniation, reoperation, pain scores, functional status, and quality of life. The trial will adhere to ethical regulatory standards, and comprehensive plans for patient selection, surgical procedures, follow-up evaluations, and data analysis will be established. Adverse events and complications will be closely monitored and reported according to established guidelines. By conducting this phase II clinical trial, we aim to provide valuable insights into the efficacy and safety of an annular repair method, to therefore aid the optimization of surgical strategies for treating lumbar disc herniation.