| 摘要: |
| [目的] 梳理七十味珍珠丸（简称RNSP）临床研究的疾病分布及疗效与安全性结局报告现状，为后续临床研究方向与设计提供参考。[方法] 检索国内外8个数据库自建库至2025年11月发表的RNSP相关临床研究。对纳入研究的类型、疾病类别、治疗措施等特征进行描述性分析，并对RNSP单药治疗研究与加载设计研究的疗效与安全性结局进行描述性汇总。[结果] 共纳入65项研究，包括43项平行对照研究、20项病例系列和2项病例报告，均在中国开展并以中文发表。纳入研究涉及19种疾病，主要集中于神经系统相关疾病，其中脑卒中研究数量最多（31项，47.69%）；6种疾病与说明书所列适应证直接对应。根据干预与对照设计，24项研究（36.92%）被归入RNSP单药治疗研究或加载设计研究，包括15项随机对照试验（RCTs）、4项半随机对照试验和5项病例系列，涉及9种疾病。19项平行对照研究报告部分神经与运动功能、认知功能、日常生活活动能力及生活质量等结局的组间差异具有统计学意义，亦有部分结局的组间差异无统计学意义，5项病例系列主要报告了治疗后的疗效分级结果。5项RCTs报告治疗期间的不良反应，主要包括胃肠道不适、嗜睡、乏力及轻度头晕等，但主动、系统的不良事件监测及长期随访资料较为有限。[结论] RNSP临床研究主要集中于神经系统相关疾病，现有研究在设计与报告规范、结局指标统一性及长期安全性监测等方面仍有待进一步规范和改进。未来应优先围绕研究相对集中的疾病领域开展规范的临床研究，为进一步评价RNSP的疗效、安全性及临床应用价值提供依据。 |
| 关键词: 七十味珍珠丸 藏药 临床研究 疾病谱 结局指标 |
| DOI：10.11656/j.issn.1673-9043.2026.09.11 |
| 分类号:R291.4 |
| 基金项目:国家重点研发计划项目（2019YFC1712205）；拉萨市科技计划立项项目（LSKJ202557）。 |
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| The current status of clinical research and reporting of efficacy and safety outcomes of Rannasangpei |
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SU Youzhu, LIU Jia, WANG Mengqi, WANG Biqing, LIU Xinyi, HE Liyun
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Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China
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| Abstract: |
| [Objective] To map the disease distribution and the reporting of efficacy and safety outcomes in clinical studies of Rannasangpei（RNSP），and to inform the direction and design of future clinical research. [Methods] Eight databases were searched from inception to November 2025 for clinical studies of RNSP. Study characteristics，including study design，disease category，and interventions，were summarized descriptively. Efficacy and safety outcomes reported in RNSP monotherapy and add-on studies were further summarized descriptively. [Results] A total of 65 studies were included，comprising 43 parallel-group comparative studies，20 case series，and 2 case reports. All studies were conducted in China and published in Chinese. The included studies covered 19 diseases，predominantly neurological conditions. Stroke was the most frequently investigated condition，accounting for 31 studies（47.69%），and 6 diseases corresponded to indications listed in the package insert. Based on the intervention and comparator designs，24 studies（36.92%） were classified as monotherapy or add-on design studies，including 15 randomized controlled trials（RCTs），4 quasi-randomized controlled trials，and 5 case series，covering 9 diseases. Outcomes reported in the 19 parallel-group studies mainly included categorical clinical response，neurological and motor function，cognitive function，activities of daily living，quality of life，blood pressure，and related biological indicators. The 5 case series mainly reported post-treatment response categories. Five RCTs reported adverse events during treatment，mainly gastrointestinal discomfort，somnolence，fatigue，and mild dizziness，while active adverse-event monitoring and long-term follow-up data were limited. [Conclusion] Clinical research on RNSP has primarily focused on neurological conditions. Nevertheless，opportunities remain to improve study design and reporting，standardize outcome measures，and strengthen long-term safety monitoring. Future research should prioritize disease areas with a relatively established research base and conduct rigorously designed clinical studies to support further evaluation of the efficacy，safety，and clinical utility of RNSP. |
| Key words: rannasangpei Tibetan medicine clinical research disease spectrum outcome measures |
