| 引用本文:江月1,2，余泽宇1,2，郑偌祥1,2，蓝惠娣3，乔舒昱1,2，韩梅2，曹卉娟2，刘建平1.中医药治疗艾滋病带状疱疹及后遗神经痛随机对照试验方法学及报告质量评价[J].世界中医药,2022,(17):. |
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| 中医药治疗艾滋病带状疱疹及后遗神经痛随机对照试验方法学及报告质量评价 |
| Quality Evaluation of Randomized Controlled Trials on Chinese Medicine in the Treatment of HIV/AIDS-associated Herpes Zoster and Postherpetic Neuralgia |
| 投稿时间：2021-07-14 |
| DOI：10.3969/j.issn.1673-7202.2022.17.014 |
| 中文关键词: 艾滋病 带状疱疹 后遗神经痛 中医 针灸 CONSORT声明 STRICTA清单 报告质量 |
| English Keywords:HIV/AIDS Herpes zoster Postherpetic neuralgia Chinese medicine Acupuncture and moxibustion CONSORT 2010 Statement STRICTA checklist Reporting quality |
| 基金项目:国家自然科学基金面上项目（81673828） |
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| 中文摘要: |
| 目的：系统评价中药及针灸治疗艾滋病带状疱疹及后遗神经痛随机对照试验的文献质量。方法：系统检索8个中英文数据库，筛选中医药干预的随机对照试验。基于Cochrane偏倚风险评价工具、CONSORT声明2010版及其草药扩展版、STRICTA清单进行资料提取并评价纳入文献的方法学质量及报告质量。结果：共纳入随机对照试验16篇，包括中药11篇、针刺5篇。25%的文献总体偏倚风险较高，75%整体偏倚评估可能存在风险。随机方法、分配隐匿的报告比例分别为37.5%和18.75%。CONSORT声明平均报告完整度为36.32%，试验注册及方案、盲法及实施等11项条目报告率均为0%；根据CONSORT草药扩展版，中药干预报告完整度平均为56.25%，最高81.25%；仅27.27%的研究报告了药材认证及定性检验。按照STRICTA清单，针灸干预报告完整度平均为67.06%，最高82.35%；无试验报告针刺研究人员资质或经验。结论：中医药治疗艾滋病带状疱疹及后遗神经痛的随机对照试验，整体偏倚风险较高且多数研究整体报告质量较低，但干预措施报告相对较好。建议今后的研究应遵循CONSORT声明、CONSORT草药扩展版和针刺STRICTA清单进行方案设计和研究报告，并提前注册试验方案，报告随机方法和施盲情况，报告实施治疗的中医师或针灸师资质。 |
| English Summary: |
| To assess the quality of randomized controlled trials(RCTs) on Chinese medicine and acupuncture and moxibustion in the treatment of HIV/AIDS-associated herpes zoster(HZ) and postherpetic neuralgia.Methods:Relevant articles were retrieved from eight databases in Chinese and English.The methodology quality and reporting quality of the eligible articles were evaluated based on Cochrane ROB Tool 2.0，CONSORT 2010 Statement，CONSORT Extension for Reporting Chinese Herbal Medicine Formulas，and STRICTA checklist.Results:A total of 16 eligible RCTs were included，with 12 on Chinese medicine and 4 on acupuncture and moxibustion.A total of 25% of RCTs showed high overall risk of bias，and 75% had possible overall risk of bias.A total of 37.5% and 18.75% of the articles reported the random sequence generation and allocation concealment，respectively.The average compliance to the CONSORT 2010 Statement was 36.32%，and no trail depicted 11 items in the statement such as the registration，trail design，blinding，and implementation.The average compliance of articles on the Chinese medicine to CONSORT Extension for Reporting Chinese Herbal Medicine Formulas was up to 56.76%(maximum:81.25%).Only 27.27% described the authentication and qualitative test of Chinese medicine.The average compliance of trials on the acupuncture and moxibustion to STRICTA checklist was 67.06%，with the maximum of 82.35%，and no trial described the qualification or years in acupuncture practice of participating acupuncturists.Conclusion:RCTs on Chinese medicine in the treatment of HIV/AIDS-associated HZ and postherpetic neuralgia generally showed high risk of bias and low reporting quality，but reporting quality of interventions was relatively high.It is recommended that future studies should follow the CONSORT 2010 Statement，CONSORT Extension for Reporting Chinese Herbal Medicine Formulas，and STRICTA checklist.In particular，registration and reporting of random sequence generation，blinding，and qualification or years in acupuncture practice of participating Chinese medicine practitioners and acupuncturist should be emphasized. |
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