Pain and Therapy最新文献

Introduction: Neuropathic pain (NP), including diabetic peripheral neuropathic pain (DPNP) and chemotherapy-induced peripheral neuropathy (CIPN) as common subtypes, imposes a significant clinical burden on patients, severely affecting their quality of life. The real-world evidence on demographic characteristics, treatment patterns, and adherence data of DPNP and CIPN is still limited.

Methods: A multicenter, retrospective, observational study using electronic medical record (EMR) systems involving approximately 600 patients with DPNP and 400 with CIPN from nine hospitals was planned. The study period extended from January 1, 2017 to December 31, 2022, which includes the enrollment period, pre-enrollment period, and observation period. Included patients will be adult (aged ≥ 18 years) diagnosed with DPNP or CIPN and receiving at least one index regimen, with index date defined as the initiation date of index regimen. At least one medical record within 12 months after index date will also be required for inclusion. The observation period is defined as the period from the index date to the end of the study data collection for at least 12 months.

Planned outcomes: The primary objective is to describe the demographics, clinical characteristics, and treatment patterns, including types and proportion of treatment regimens, treatment discontinuation/switching/add-on, restarting after discontinuation, duration of index regimen, and time to treatment add-on. The secondary and exploratory measures include the dosing pattern and real-world adherence of regimens.

Trial registration: NCT06546202 (ClinicalTrials.gov).

Introduction: Peripheral neuropathic pain (PNP) is a chronic condition often inadequately controlled by oral pharmacologic treatments. High-concentration capsaicin patch (HCCP) is a topical neurolytic treatment for PNP. This study assessed the cost-effectiveness of HCCP as an add-on to standard of care (SoC) in patients with PNP in Scotland.

Methods: A cost-utility analysis was conducted using a Markov model with 3-month cycles and a lifetime horizon to determine the cost-effectiveness of HCCP added-on to SoC compared to SoC alone, in adult patients with PNP. The model included five health states (no pain, mild, moderate, severe pain, and death) and was developed according to Scottish Medicines Consortium (SMC) guidance from a National Health Service (NHS) Scotland perspective. Clinical inputs were derived from HCCP trials (e.g., PACE), and health-related quality of life was based on EQ-5D values from HCCP trials. Analyses were conducted for an adult PNP population, and diabetic and non-diabetic etiologies. Costs included drug acquisition, administration, drug and disease monitoring, adverse events, and-in a scenario analysis-societal costs.

Results: For the adult PNP population, HCCP + SoC resulted in an incremental gain of 1.00 quality-adjusted life-years (QALYs) at an additional cost of £13,479, yielding an incremental cost-effectiveness ratio (ICER) of £13,516 per QALY. ICERs for specific etiologies were £11,383 for non-diabetic and £16,442 for diabetic PNP populations. Deterministic and probabilistic sensitivity analyses (PSA) confirmed robustness of the model, with 89% of PSA iterations falling below a £20,000/QALY threshold. Scenario analysis using a societal perspective further improved cost-effectiveness (ICER: £7475).

Conclusions: HCCP is a cost-effective add-on therapy for the treatment of adults with PNP in Scotland, with consistent findings across diabetic and non-diabetic populations. These results support the benefits of integrating HCCP in healthcare systems and clinical practice, both in terms of patient outcomes and economic benefits for the system.

Introduction: Rebox therapy is a form of noninvasive transcutaneous electrotherapy, which delivers microcurrent kilohertz-frequency pulses in multiple points over the target area. Despite decades of use in pain management, clinical evidence supporting Rebox remains inconclusive, with a lack of rigorous sham-controlled trials. This study aimed to evaluate its analgesic effect in a single-center, randomized, double-blind, sham-controlled crossover trial.

Methods: The study included consecutive patients with non-cancer nociceptive pain with average pain intensity ≥ 4 on a numerical rating scale (NRS), and pain duration of 2-12 weeks (de novo or acutely exacerbated chronic pain). Patients were randomized (1:1) into two arms based on the sequence of stimulation periods. Each period consisted of eight sessions of either Rebox or sham treatment, administered every other working day, with a 1-week washout period. The primary outcome was the difference in the reduction of pain intensity (average and worst pain in the last 24 h) following active versus sham stimulation.

Results: Seventy-one patients completed the study, with musculoskeletal back pain being the most common indication (n = 60). Compared to the sham, Rebox significantly reduced both average pain (NRS difference: 2.2, 95% CI 0.8-3.6, Cohen's d = 0.75, p = 0.002) and worst pain (NRS difference: 2.3, 95% CI 1.2-3.5, Cohen's d = 0.91, p < 0.001). A significant placebo analgesic effect was observed only in the sham-first arm. The treatment was well tolerated, with only minor and transient side effects.

Conclusion: Rebox demonstrated a significant analgesic effect compared to the sham. The treatment was safe and well tolerated. These findings support integrating Rebox into clinical pain management, warranting further investigation in larger trials.

Introduction: Effective and sustained postoperative analgesia is essential to enhance recovery after video-assisted thoracoscopic surgery (VATS). Liposomal bupivacaine, a multivesicular formulation enabling extended local anesthetic release, offers a mechanistic advantage over conventional agents. However, prior comparisons with adjuvant-enhanced regimens such as plain bupivacaine plus dexamethasone were confounded by pharmacological and dose inequivalence. This equivalence-dose randomized controlled trial evaluated whether liposomal bupivacaine provides non-inferior analgesia to the standard combination when administered via rhomboid intercostal block (RIB).

Methods: In this double-blind randomized controlled trial, 90 VATS patients were randomly assigned to receive either: a 20-ml premixed solution containing 93 mg of liposomal bupivacaine combined with 25 mg of plain bupivacaine (liposomal bupivacaine group), or a 20-ml admixture of 105 mg of plain bupivacaine and 5 mg of dexamethasone (plain bupivacaine with dexamethasone group). The primary outcome assessed was the area under the curve (AUC) of the 48-h resting pain numeric rating scale (NRS). Secondary outcomes consisted of opioid consumption, dermatomal spread, and Quality of Recovery-15 scores (QoR-15).

Results: Liposomal bupivacaine was shown to be non-inferior to plain bupivacaine with dexamethasone, with a 48-h NRS AUC of 105.5 ± 13.6 vs. 113.1 ± 16.3 (mean difference - 7.6; 95% CI - 13.9 to - 1.2, upper limit < non-inferiority margin 3.7). Opioid use and dermatomal spread were comparable within the first 24 h (P > 0.05). There was a notable contrast in sustained dermatome blockade at 48 and 72 h between the two groups (P < 0.001). The liposomal bupivacaine group demonstrated a significantly reduced opioid requirement (P = 0.016) within 24-48 h and superior QoR-15 scores on postoperative day 2 (POD2) (P < 0.001). Safety profiles were comparable, with no between-group differences in postoperative nausea and vomiting or other severe complications (P > 0.05).

Conclusions: Rhomboid intercostal block with liposomal bupivacaine provided similar analgesia to plain bupivacaine with dexamethasone for postoperative pain after VATS.

Trial registration: The trial was registered on ClinicalTrials.gov (NCT06392191). Graphical Abstract available in the Supplementary Materials for this article.

Buprenorphine has gained significant attention for its unique pharmacological properties, making it a valuable tool in chronic pain management. Unlike traditional opioids, buprenorphine's partial and biased agonist actions at the μ-opioid receptor provide potent analgesia while minimizing risks such as respiratory depression, tolerance, and dependence. Its favorable pharmacokinetic profile provides the potential for expanding its clinical use in different patient populations. A literature search was conducted in PubMed, Web of Science, and Google Scholar to identify peer-reviewed studies on recent developments in the pharmacological features and new clinical applications of buprenorphine, including original research, reviews, and consensus statements. This comprehensive review explores the expanding clinical applications of buprenorphine, emphasizing its role in managing chronic pain in elderly patients, individuals with cardiac conditions, and those with renal impairments. Emerging evidence highlights its utility in addressing chronic pain in younger adults and its potential in mitigating side effects associated with aromatase inhibitor therapy in patients with breast cancer. Additionally, buprenorphine's lower endocrine side-effect profile and antidepressant properties open new therapeutic avenues for pain-associated depression. With its unique pharmacodynamics, transdermal formulations for sustained drug release, and reduced adverse effects, buprenorphine represents a promising option for tailored, multimodal pain management strategies, especially in populations with complex medical needs. Further studies are warranted to confirm its broad therapeutic potential.

Gabapentinoids, notably gabapentin and pregabalin, are crucial for managing neuropathic pain in conditions like diabetic neuropathy and specific types of cancer-related pain where opioids are ineffective or undesirable. However, the misuse potential of pregabalin has led to stricter regulatory controls in many regions, including Saudi Arabia. This expert opinion presents insights from multidisciplinary experts about the impact of these regulations on clinical practice, patient care, and misuse patterns in Saudi Arabia. Pregabalin's rapid onset of action and probable euphoric effects make it more prone to misuse, especially among younger individuals and those with a history of substance abuse. Gabapentin, in contrast, has a lower abuse potential. Experts discussed the implementation of the National Platform for Narcotic Drugs and Psychotropic Substances (Raqeeb) in Saudi Arabia, a system designed to monitor prescriptions of controlled substances. While effective in curbing over-prescription, it has also introduced unintended challenges. Physicians, fearing scrutiny, often hesitate to prescribe gabapentinoids, leading to delays in treatment and greater reliance on less appropriate alternatives. Moreover, stigma associated with controlled substances has further discouraged patients from seeking treatment, resulting in undertreated pain and a diminished quality of life. This expert opinion highlights the need for a more balanced approach to gabapentinoid regulation. It advocates for improved physician education on the management of neuropathic pain, and public awareness initiatives to curb misuse, reduce stigma, and promote the safe use of medications. Refining the Raqeeb platform could alleviate administrative burdens while ensuring robust oversight. Finally, adopting a risk-stratified approach to prescription would allow close monitoring of high-risk patients for substance abuse while ensuring that low-risk patients maintain access to essential treatments. Addressing these challenges would enable healthcare authorities to prevent abuse while ensuring effective pain relief for patients with legitimate medical needs.