中医药安全性系统综述基于PRISMA Harms清单的案例分析

中国药物警戒 ›› 2019, Vol. 16 ›› Issue (5): 301-310.

中医药安全性系统综述基于PRISMA Harms清单的案例分析

胡瑞学¹, 文玲子¹, 于明坤¹, 任毅铭², 曹卉娟¹, 高佳琪², 刘可心^2#, 赵璐明^2#, 李一琳^2#, 林子宜^2#, 张子萱^2#, 明扬^2#, 武雪岑^2#, 李迅¹, 刘建平¹, 费宇彤^1,*

1 北京中医药大学循证医学中心,北京 100029;
2 北京中医药大学,北京102488

收稿日期:2019-01-16 修回日期:2019-06-11 出版日期:2019-05-20 发布日期:2019-06-11
通讯作者: 费宇彤,女,博士,研究员,循证中医药临床研究方法学。E-mail: yutong_fei@163.com
作者简介:胡瑞学,男,硕士,循证中医药临床研究方法学。
#与第六作者同等贡献。
基金资助:
国家自然科学基金（81830115）：基于整体观和辨证论治复杂干预的中医疗效评价关键技术和结局指标研究; 北京中医药大学教育课题（XJZX17005）：科研产出型形成性评价方法在临床研究方法教学课程中的应用; 中央高校基本科研业务费专项资金（2017-JYB-JS-149）：急性下呼吸道感染治疗中中药及抗生素使用情况的处方分析及调查研究

Examples of Traditional Chinese Medicine Safety Systematic Review Based on PRISMA Harms Checklist

HU Ruixue¹, WEN Lingzi¹, YU Mingkun¹, REN Yiming², CAO Huijuan¹, GAO Jiaqi², LIU Kexin^2#, ZHAO Luming^2#, LI Yilin^2#, LIN Ziyi^2#, ZHANG Zixuan^2#, MING Yang^2#, WU Xuecen^2#, LI Xun¹, LIU Jianping¹, FEI Yutong^1,*

1 Centre for Evidence-Based Chinese Medicine, BUCM, Beijing 100029, China;
2 Beijing University of Chinese Medicine, Beijing 102488, China

Received:2019-01-16 Revised:2019-06-11 Online:2019-05-20 Published:2019-06-11

摘要/Abstract

摘要： 目的采用干预措施安全性系统综述报告规范PRISMA Harms清单,对中医药安全性系统综述的规范报告提供范例。方法通过计算机检索中国知网、万方数据、维普（VIP）三大中文数据库,提取中医药安全性系统综述的内容,并依据国际上已发表的PRISMA Harms清单对相应条目进行举例说明。结果共检索到211篇文献,最终纳入符合标准的文献116篇。根据中医药实例的筛选标准,选择出与PRISMA Harms清单报告条目的内容符合、描述较为准确、报告质量较好的文献共25篇,并从中给PRISMA Harms清单的每一个条目选取了1~2条范例。当范例存在明显局限时进行必要的补充说明。结论本研究通过检索文献列举了中医药安全性系统综述相应部分的实例,可为研究者撰写安全性系统综述提供参考,从而提高安全性系统综述的报告质量。所选取的部分实例报告质量距规范可能仍有差距,可随着最新文献的发表进行补充和替换。

关键词: 中医药, 安全性, 系统综述, PRISMA Harms, 案例

Abstract: Objective To provide examples for TCM safety systematic reviews based on PRISMA Harms checklist. Methods Three Chinese electronic databases (CNKI, WanFang and VIP) were searched from inception to October 2018. TCM safety systematic reviews were identified and extracted. Based on predefined criteria, reviews with contents that best meet the requirement of PRISMA Harms items were selected and provided as examples. One to two examples were provided for each item. Results 116 reviews were included and examples were selected from 25 papers, which were relatively consistent with the requirements of PRISMA Harms checklist items. Supplemental explanations were given when the examples had significant limitations. Conclusion Our study provided examples for the reporting of TCM safety systematic reviews according to PRISMA Harms. Examples were selected from published TCM systematic reviews, and may have limitations. An updated reporting examples will be considered with the publication of better quality systematic reviews.

Key words: traditional Chinese medicine (TCM), safety, systematic review, PRISMA Harms, example

中图分类号:

R994.11

胡瑞学, 文玲子, 于明坤, 任毅铭, 曹卉娟, 高佳琪, 刘可心, 赵璐明, 李一琳, 林子宜, 张子萱, 明扬, 武雪岑, 李迅, 刘建平, 费宇彤. 中医药安全性系统综述基于PRISMA Harms清单的案例分析[J]. 中国药物警戒, 2019, 16(5): 301-310.

HU Ruixue, WEN Lingzi, YU Mingkun, REN Yiming, CAO Huijuan, GAO Jiaqi, LIU Kexin, ZHAO Luming, LI Yilin, LIN Ziyi, ZHANG Zixuan, MING Yang, WU Xuecen, LI Xun, LIU Jianping, FEI Yutong. Examples of Traditional Chinese Medicine Safety Systematic Review Based on PRISMA Harms Checklist[J]. Chinese Journal of Pharmacovigilance, 2019, 16(5): 301-310.

参考文献

[1] Zorzela Liliane, Loke Yoon K, Ioannidis John P, et al. PRISMA harms checklist: improving harms reporting in systematic reviews[J]. BMJ, 2016; 352 :i157.[PMID:26830668]
[2] 胡瑞学,梁宁,柴倩云,等.PRISMA危害报告清单:改进系统综述中危害的报告(一)[J].中国药物警戒,2018,15(6):377-384.
[3] 胡瑞学,梁宁,柴倩云,等.PRISMA危害报告清单:改进系统综述中危害的报告(二)[J].中国药物警戒,2018,15(7):445-448.
[4] 胡瑞学,梁宁,柴倩云,等.PRISMA危害报告清单:改进系统综述中危害的报告(三)[J].中国药物警戒,2018,15(8):506-512.
[5] Liberati A, Altman D G, Tetzlaff J, et al.The PRISMA Statement for Reporting Systematic Reviews and Meta-Analyses of Studies That Evaluate Health Care Interventions: Explanation and Elaboration[J].BMJ,2009,339:b2700. Doi: 10.1136/bmj.b2700.[PMID:19622552].
[6] Moher David, Hopewell Sally, Schulz Kenneth F, et al.CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials[J]. BMJ, 2010, 340 :c869. Doi: 10.1136/bmj.c869.[PMID:20332511].
[7] 张建英,杨继国,王海军,等.补肾中药治疗强直性脊柱炎安全性系统评价[J].世界中西医结合杂志,2011,6(1):71-73.
[8] 赵琦,李海松,冀美琦,等.推拿治疗原发性高血压的疗效和安全性系统综述及Meta分析[J].中医杂志,2018,59(18):1568-1573.
[9] 刘剑,高颖,阚保红,等.中药治疗多发性硬化随机对照试验的系统综述和meta分析[J].中西医结合学报,2012,10(2):141-153.
[10] 伍新诚,马晓聪,卓小媛,等.复方丹参滴丸联合曲美他嗪治疗冠心病心绞痛疗效和安全性Meta分析[J].辽宁中医药大学学报,2017,19(4):72-77.
[11] Lv M, Deng J, Tang N, et al.Efficacy and Safety of Tripterygium Wilfordii Hook F on Psoriasis Vulgaris: A Systematic Review and Meta-Analysis of Randomized Controlled Trials[J]. Evidence-Based Complementary and Alternative Medicine,2018,2018:1-10. Doi: 10.1155/2018/2623085.[PMID:29849698].
[12] 胡宇才,王永霞,李彬,等.参仙升脉口服液治疗心动过缓疗效及安全性系统评价[J].中西医结合心脑血管病杂志,2015,13(2):137-141.
[13] 严晓艺,贾丽燕,赵楠琦,等.中药治疗糖尿病视网膜病变的安全性系统评价[J].药物流行病学杂志,2017,26(3):153-161.
[14] He M, Lv Z, Yang Z W, et al.Efficacy and safety of Chinese herbal medicine Wenxin Keli for ventricular premature be ats: A systematic review[J]. Complementary Therapies in Medicine, 2016,29:181-189. Doi: 10.1016/j.ctim.2016.10.007.[PMID:27912945].
[15] 许笑雯,李益萍,阮小芬,等.养心氏片治疗心律失常临床疗效及安全性的Meta分析[J].中西医结合心脑血管病杂志,2018,16(12):1633-1638.
[16] 伍新诚,马晓聪,卓小媛,等.参松养心胶囊联合西药治疗阵发性房颤疗效和安全性的Meta分析[J].中华中医药学刊,2017,35(5):1184-1189.
[17] 张耀文,方任飞,杨超,等.通心络胶囊用药安全性的系统评价[J].中国循证心血管医学杂志,2013,5(4):337-342,348.
[18] 赵钟辉,王建伟,高维,等.补中益气汤联合常规西药治疗重症肌无力疗效和安全性Meta分析[J].新中医,2018,50(6):42-46.
[19] 胡昊,唐海沁,李洁华,等.参松养心胶囊抗心律失常的疗效和安全性系统评价[J].中国循证医学杂志,2011,11(2):168-173.
[20] 刘颖,钟成梁,蔡秋晗,等.智杞颗粒治疗儿童高铅血症和铅中毒有效性和安全性的Meta分析[J].中国医院药学杂志,2016,36(20):1773-1777.
[21] 刘慧敏,王宪波,常玉娟,等.中西医结合治疗慢性重型肝炎随机对照试验的系统评价和meta分析[J].中西医结合学报,2012,10(11):1211-1228.
[22] 季昭臣,杨丰文,张立双等.保妇康栓治疗宫颈高危型人乳头瘤病毒感染性疾病有效性和安全性系统评价[J].天津中医药,2018,35(3):195-199.
[23] 卞丽玲,杨丰文,王媛,等.蒲地蓝消炎口服液治疗小儿化脓性扁桃体炎有效性及安全性的系统评价[J].中国中药杂志,2017,42(8):1482-1488.
[24] 章轶立,廖星,刘福梅,等.仙灵骨葆胶囊上市后用药安全性系统评价[J].中国中药杂志,2017,42(15):2845-2856.
[25] 吴亚琴,赵静雅,陈钦,等.雷公藤治疗小儿紫癜性肾炎疗效及安全性系统评价和Meta分析[J].中华中医药学刊,2016,34(6):1497-1503.
[26] 温万鑫,李显生,郭新峰,等.针刺治疗室上性心动过速有效性与安全性系统评价与Meta分析[J].中国针灸,2014,34(11):1146-1150.
[27] 谢雁鸣,朱芸茵,吴泰相.中医药治疗绝经后骨质疏松的疗效及安全性系统评价[J].中国循证医学杂志,2005(1):29-41,74.
[28] 王冀东,谢雁鸣,廖星,等.心元胶囊用药安全性系统评价[J].中国中药杂志,2016,41(9):1744-1753.
[29] 李丹艳,胡玲,代云凯,等.润肠方药治疗便秘型肠易激综合征疗效及安全性的系统评价与Meta分析[J].中药新药与临床药理,2018,29(3):353-360.
[30] 胡华,杨元元,刘晶,等.丹红注射液联合依达拉奉治疗急性脑梗死的疗效和安全性系统评价[J].中华中医药杂志,2017,32(10):4683-4689.
[31] Pang B, Lian F M, Zhao X Y, et al.Prevention of type 2 diabetes with the traditional Chinese patent medicine: A systematic review and meta-analysis[J]. Diabetes Therapy, 2017, 8(6):1227-1242. Doi: 10.1016/j.diabres.2017.07.020.[PMID: 28780370].
[32] 黄科,贺梅红,张玉霞,等.九味镇心颗粒治疗广泛性焦虑障碍疗效与安全性系统评价[J].山东中医杂志,2018,37(6):462-468.
[33] 李佳,欧敏,许珊,等.热毒宁注射液治疗毛细支气管炎的疗效与安全性系统评价[J].转化医学杂志,2016,5(2):106-111.
[34] 陈志威,谢雁鸣,廖星,等.注射用丹参多酚酸盐安全性系统评价[J].中国中药杂志,2016,41(19):3686-3695.
[35] Dube, Catherine. The Use of Aspirin for Primary Prevention of Colorectal Cancer: A Systematic Review Prepared for the U.S. Preventive Services Task Force[J]. Annals of Internal Medicine, 2007, 146(5):365-375.
[36] Critchley J.Haemoglobin colour scale for anaemia diagnosis where there is no laboratory: a systematic review[J]. International Journal of Epidemiology, 2005, 34(6):1425-1434.
[37] Higgins J P T, Green S. Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [M/OL]. (2011-03)[2019-03-11].http://handbook.cochrane.org.