针刺及针药合用治疗干燥综合征口干和眼干症状的系统评价和Meta分析

Systematic review and Meta-analysis of the efficacy of acupuncture and acupuncture combined with herbal medicine for treating xerostomia and dry eye in patients with Sjögren’s syndrome

关键词:  针刺  口干  眼干  随机对照试验（RCT）  干燥综合征  Meta分析  针药合用

Key words:  acupuncture  xerostomia  dry eye  randomized controlled trial（RCT）  Sjögren’s syndrome  Meta-analysis  combined acupuncture and herbal medicine

摘要:

[目的] 通过系统评价和Meta分析，评估针刺及针药合用在改善干燥综合征患者口干和眼干症状方面的疗效。[方法] 检索中国知网（CNKI）、万方数据库、维普网（VIP）、中国生物医学文献数据库（CBM）、PubMed、Cochrane Library、EMbase和Web of Science等数据库，收集截至2024年10月1日的针刺或针药合用治疗干燥综合征口干眼干症状的随机对照试验（RCT）文献。由两名研究者独立筛选文献、提取数据并评估偏倚风险，使用RevMan 5.4软件进行Meta分析，效应量采用标准化均数差（SMD）和优势比（OR），并评估研究间的异质性。[结果] 本研究共纳入16项随机对照试验（RCT），涉及1 319例干燥综合征患者。Meta分析显示，单纯针刺治疗与对照组相比差异无统计学意义[OR=3.73，95%CI（0.42，33.08），P=0.24]，而针药合用治疗显示出明显的临床疗效优势[OR=3.60，95%CI（2.53，5.11），P＜0.05]。在客观生物学指标方面，针刺治疗能显著提高患者唾液流率[MD=1.98，95%CI（0.20，3.75），P＜0.05]，针药合用治疗同样能显著提高患者唾液流率[MD=0.25，95%CI（0.03，0.47），P＜0.05]。Schirmer测试结果表明，针药合用治疗能有效改善干燥综合征患者的泪液分泌[MD=1.47，95%CI（0.54，2.40），P＜0.05]。但存在异质性，经治疗时长（>4周/≤4周）和干预方案（纯针刺/针药合用）的亚组分析后，异质性仍高于50%，提示潜在异质性来源可能涉及操作者技术差异、穴位配伍特异性及受试人群基线特征等因素。在症状评估维度，治疗组显著降低中医证候积分[SMD=-1.29，95%CI（-1.97，-0.61），Z=-3.74，P＜0.05]和ESSPRI评分[SMD=-1.73，95%CI（-2.51，-0.95），Z=-4.34，P＜0.05]，尽管两者异质性分别达84.90%和90%，但敏感性分析证实结果稳健。所有异质性大的结局指标采用随机效应模型，异质性来源的系统分析表明，操作者资质、干预方案细节（如穴位选择、针刺频数）及疗效评估时点差异可能是影响研究间异质性的关键因素。[结论] 针刺及针药合用治疗显著改善了干燥综合征患者的临床疗效、唾液流率、Schirmer测试、中医证候积分及患者汇报指数（ESSPRI）评分，且安全性良好。未来需要更多大规模、高质量的随机对照试验，以进一步验证针刺的长期疗效并探讨不同针刺方案的具体作用机制。

Abstract:

[Objective] To evaluate the efficacy of acupuncture and acupuncture-medicine combination therapy in improving the symptoms of dry mouth and dry eyes in patients with Sjögren’s syndrome through systematic review and Meta-analysis. [Methods] We searched databases including CNKI，Wanfang Data，VIP，CBM，PubMed，Cochrane Library，Embase，and Web of Science，collecting randomized controlled trials（RCTs） on acupuncture or acupuncture-medicine combination therapy for dry mouth and dry eyes symptoms in Sjögren’s syndrome patients，published up to October 1，2024. Two researchers independently screened the literature，extracted data，and assessed the risk of bias. Meta-analysis was performed using RevMan 5.4 software，with effect sizes calculated using standardized mean difference（SMD） and odds ratio（OR），and heterogeneity between studies was assessed. [Results] This study included 16 randomized controlled trials（RCTs） with 1 319 patients diagnosed with Sjögren’s syndrome. Meta-analysis showed that acupuncture alone compared to control groups demonstrated no statistically significant difference [OR=3.73，95%CI（0.42，33.08），P=0.24]，while combined acupuncture and medication therapy showed significant clinical efficacy advantages [OR=3.60，95%CI（2.53，5.11），P＜0.05]. Regarding objective biological indicators，acupuncture significantly increased salivary flow rate [MD=1.98，95%CI（0.20，3.75），P＜0.05]，and combined acupuncture and medication therapy similarly increased salivary flow rate significantly [MD=0.25，95%CI（0.03，0.47），P＜0.05]. Schirmer test results indicated that combined acupuncture and medication therapy effectively improved tear secretion in Sjögren’s syndrome patients [MD=1.47，95%CI（0.54，2.40），P＜0.05]. However，heterogeneity persisted even after subgroup analyses based on treatment duration（>4 weeks/≤4 weeks） and intervention approach（acupuncture alone/combined acupuncture and medication），with heterogeneity remaining above 50%，suggesting po tential sources of heterogeneity may involve differences in practitioner techniques，acupoint selection specificity，and baseline characteristics of study populations. In symptom assessment dimensions，the treatment groups significantly reduced traditional Chinese medicine syndrome scores [SMD=-1.29，95%CI（-1.97，-0.61），Z=-3.74，P＜0.05] and ESSPRI scores [SMD=-1.73，95%CI（-2.51，-0.95），Z=-4.34，P＜0.05]. Despite heterogeneity reaching 84.9% and 90% respectively，sensitivity analysis confirmed the robustness of results. Random effects models were applied to all outcome measures with high heterogeneity. Systematic analysis of heterogeneity sources indicated that practitioner qualifications，intervention protocol details（such as acupoint selection and treatment frequency），and differences in efficacy evaluation timepoints may be key factors affecting inter-study heterogeneity. [Conclusion] Acupuncture and acupuncture-medicine combination therapy significantly improved clinical efficacy，salivary flow rate，Schirmer test results，traditional Chinese medicine syndrome scores，and ESSPRI scores in patients with Sjögren’s syndrome，with good safety. Future large-scale，high-quality randomized controlled trials are needed to further verify the long-term efficacy of acupuncture and explore the specific mechanisms of different acupuncture schemes.