中药外敷联合三阶梯镇痛药物治疗癌性骨痛：一项系统评价和meta分析

External application of traditional Chinese medicine in combination with three-step analgesic ladder therapy for cancer-induced bone pain: a systematic review and meta-analysis

    摘要
  • 摘要:
    目的 对中药外敷联合口服三阶梯镇痛药物对癌性骨痛患者的总体疗效进行系统评价。
    方法 我们在10个数据库和2个注册系统中检索了关于中药外敷联合三阶梯镇痛疗法治疗癌性骨痛的随机对照试验，其中包括4个中文数据库：中国生物医学文献数据库（SinoMed）、中国知网（CNKI）、万方数据库、维普数据库（VIP），6个英文数据库（Scopus、Embase、Web of Science、PubMed、Cochrane Library和OpenGrey）和2个注册系统（中国临床试验注册中心和ClinicalTrials.gov）。文献检索的时间范围从各数据库建立之日至2023年12月31日。使用RevMan（v5.4.1）进行meta分析，并使用GRADEprofiler（v3.6）对结局指标（疼痛缓解率、镇痛持续时间、生活质量、疼痛强度、爆发痛次数及不良反应）进行证据质量分级。
    结果 根据既定的纳入和排除标准，共43项研究符合条件，包括3142名癌性骨痛患者。meta分析结果表明，中药外敷联合三阶梯镇痛药物与单独口服三阶梯镇痛药物相比，疼痛缓解率风险比（RR）= 1.32，95% 置信区间（CI）：1.24～1.41, P < 0.000 01、镇痛持续时间平均差（MD ）= 1.33，95% CI：0.97～1.69, P < 0.000 01和生活质量（MD = 5.66，95% CI：4.88～6.44, P < 0.000 01）均有显著改善。中药外敷联合口服三阶梯镇痛药物还可显著降低癌性骨痛患者的疼痛强度（MD = – 1.00，95% CI：– 1.19～– 0.80, P < 0.000 01）、爆发痛发生频率（MD = – 0.43，95% CI：– 0.51～– 0.36, P < 0.000 01）和不良反应（RR = 0.60，95% CI：0.53～0.68, P < 0.000 01）。根据GRADE评估，证据等级从低到中不等。
    结论 中药外敷联合三阶梯镇痛药物可有效缓解癌性骨痛患者的疼痛症状，提高其生活质量。此外，中药外敷还能有效降低三阶梯镇痛药物的不良反应发生率。

     

    Abstract:
    Objective To systematically evaluate the overall efficacy of external application of traditional Chinese medicine (EA-TCM) in combination with oral three-step analgesic ladder therapy for patients suffering from cancer-induced bone pain (CIBP).
    Methods We conducted a literature search of randomized controlled trials on the combination of EA-TCM and three-step analgesic ladder therapy for CIBP across ten databases and two registration systems. It included four Chinese databases Chinese Biomedical Literature Database (SinoMed), China National Knowledge Infrastructure (CNKI), Wanfang Database, and China Science and Technology Journal Database (VIP) , six English databases (Scopus, Embase, Web of Science, PubMed, Cochrane Library, and OpenGrey), and two registration systems (Chinese Clinical Trial Registry and ClinicalTrials.gov). The timeframe for the literature search extended from the inception of each database to December 31, 2023. Meta-analysis was performed using RevMan (v5.4.1), and the outcome indicators (pain relief rate, analgesic duration, quality of life, pain intensity, breakthrough pain frequency, and adverse reactions) were graded using GRADE profiler (v3.6).
    Results According to the established inclusion and exclusion criteria, a total of 43 studies was deemed eligible, involving 3 142 participants with CIBP. The results of meta-analysis showed that compared with oral three-step analgesic ladder therapy alone, the combined therapy of EA-TCM and three-step analgesic ladder has a significant improvement in pain relief rate risk ratio (RR) = 1.32, 95% confidence interval (CI): 1.24 to 1.41, P < 0.000 01, analgesic duration mean difference (MD) = 1.33, 95% CI: 0.97 to 1.69, P < 0.000 01, and quality of life (MD = 5.66, 95% CI: 4.88 to 6.44, P < 0.000 01). Furthermore, the combined therapy significantly reduced pain intensity (MD = – 1.00, 95% CI: – 1.19 to – 0.80, P < 0.000 01), breakthrough pain frequency (MD = – 0.43, 95% CI: – 0.51 to – 0.36, P < 0.000 01), and adverse reactions (RR = 0.60, 95% CI: 0.53 to 0.68, P < 0.000 01) in CIBP patients. Based on the GRADE assessment, the level of evidence varied from low to moderate.
    Conclusion EA-TCM combined with the three-step analgesic ladder therapy can effectively alleviate pain symptoms in patients with CIBP and improve their quality of life. Additionally, the EA-TCM can effectively reduce the incidence of adverse reactions associated with three-step analgesic therapy.

     

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