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临床研究规范性对腰痛宁胶囊循证医学分析结果的影响
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| 篇名： | 临床研究规范性对腰痛宁胶囊循证医学分析结果的影响 |
| TITLE： | |
| 摘要： | 目的：探讨临床研究规范性对腰痛宁胶囊疗效评价的影响，为合理、规范地开展临床研究提供方向。方法：计算机检索中国期刊全文数据库、中文科技期刊数据库、万方数据库，收集腰痛宁胶囊治疗风湿骨病的随机对照试验（RCT），提取资料并进行质量评价后，采用Rev Man 5.3统计软件进行Meta分析，比较辩证情况、疗程、服药方式对腰痛宁胶囊疗效评价的影响，在此基础上提出综合反映临床规范性的指标——循证值概念，并考察其对腰痛宁胶囊疗效评价结果的影响。结果：共纳入71项RCT，合计11 009例患者。Meta分析结果显示，辩证情况下腰痛宁胶囊的疗效优于其他药物（P＝0.02），非辩证情况下腰痛宁胶囊的疗效劣于其他药物（P＜0.01）；疗程≤30 d时，腰痛宁胶囊的疗效劣于其他药物（P＜0.05），疗程＞30 d时，腰痛宁胶囊的疗效与其他药物无统计学差异（P＝0.99）；不按说明书服药时，腰痛宁胶囊的疗效劣于其他药物（P＜0.05），按说明书服药时，腰痛宁胶囊的疗效与其他药物无统计学差异（P＝0.94）。循证值≥5时，腰痛宁胶囊的疗效好于其他药物（P＝0.03）；循证值＝4时，腰痛宁胶囊的疗效与其他药物无统计学差异（P＝0.56）；循证值≤3时，腰痛宁胶囊的疗效劣于其他药物（P＜0.05）。结论：严格按照辩证医治的原则和规律，按疗程及说明书服用药物，是腰痛宁胶囊发挥疗效的重要保证；临床应严格按照药品说明书规范试验，以保证临床研究结果客观、公正。 |
| ABSTRACT： | OBJECTIVE： To investigate influential factors of standardization of clinical research on therapeutic efficacy of Yaotongning capsules， and to provide direction for reasonable and standard development of clinical research. METHODS： Retrieved from CJFD， VIP and Wanfang database， RCTs about Yaotongning capsules in the treatment of related disease were collected. After data extraction and quality evaluation， Meta-analysis was conducted by using Rev Man 5.3 statistical software. The effects of the dialectical situation， treatment course and route of administration on the evaluation of therapeutic efficacy of Yaotongning capsules were compared； based on this， the concepts of index evidence-based value which reflected clinical standardization were put forward， and its effects on Yaotongning capsules were investigated. RESULTS： A total of 71 RCTs were included， involving 11 009 patients. Results of Meta-analysis showed therapeutic efficacy of Yaotongning capsules was better than that of other drugs in dialectical case（P＝0.02）， while therapeutic efficacy of Yaotongning capsules was inferior to that of other drugs in non-dialectical case（P＜0.01）； therapeutic efficacy of Yaotongning capsules was inferior to that of other drugs when treatment course was shorter than 30 days（P＜0.05）， while treatment course was longer than 30 days， there was no difference in therapeutic efficacy between Yaotongning capsules and other drugs（P＝0.99）. When did not take medicine according to the instruction， therapeutic efficacy of Yaotongning capsule was inferior to that of other drugs（P＜0.05）； when taking medicine according to the instruction， there was no difference in therapeutic efficacy between Yaotongning capsules and other drugs（P＝0.94）. When evidence-based value was ≥5， therapeutic efficacy of Yaotongning capsules was better than that of other drugs（P＝0.03）； when evidence-based value was equal to 4， there was no difference in therapeutic efficacy between Yaotongning capsules and other drugs（P＝0.56）； when evidence-based value was ≤3， therapeutic efficacy of Yaotongning capsules was inferior to that of other drugs（P＜0.05），with statistical significance. CONCLUSIONS： It is an important guarantee of playing therapeutic efficacy of Yaotongning capsules to regularly use drugs strictly according to the principle of dialectical treatment， and take drugs according to treatment course and instructions. Clinical trials should be standardized strictly in accordance with the instructions， so as to provide objective and fair clinical findings. |
| 期刊： | 2017年第28卷第18期 |
| 作者： | 倪力军，董笑笑，张立国 |
| AUTHORS： | NI Lijun，DONG Xiaoxiao，ZHANG Liguo |
| 关键字： | 腰痛宁胶囊；循证医学；辩证；疗程；服药方式；循证值 |
| KEYWORDS： | Yaotongning capsules； Evidence-based medicine； Dialectical； Treatment course； Route of administration； Evidence-based value |
| 阅读数： | 288 次 |
| 本月下载数： | 1 次 |
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