[关键词]
[摘要]
目的 基于贝叶斯网状 Meta 分析 (Bayesian Network Meta-analysis,BNMA) 方法,评价临床常用的口服 或鼻饲中成药治疗脑出血(Intracerebral haemorrhage,ICH)术后的有效性及安全性。方法 检索中国知网 (CNKI) 、万方数据知识服务平台 (Wanfang) 、维普中文期刊 (VIP) 、中国生物医学文献服务系统 (SinoMed) 、 PubMed、Embase、Cochrane Library、Web of Science 建库至 2023 年 8 月 25 日有关中成药干预 ICH 术后的随机 对照试验 (randomized controlled trial,RCT) ;使用 ROB 2.0 进行偏倚风险评估,运用 R 4.2.2 加载 BUGSnet 1.1.0 程序包进行 BNMA。结果 共纳入 28 项 RCT,总样本量 2 530 例,涵盖 9 种口服中成药[安宫牛黄丸 (AGNH) 、 苏合香丸 (SHX) 、脑血疏口服液 (NXS) 、脑心通胶囊 (NXT) 、脑血康片 (NXK) 、消瘀康胶囊 (XYK) 、养血清脑 颗粒(YXQN)、通天口服液(TT)、三七通舒胶囊(SQTS) ],所有患者均行手术治疗和术后常规西医治疗 (conventional western medicine treatment,CWMT) ,试验组加用口服或鼻饲中成药。BNMA 结果显示,AGNH+ CWMT 组在降低短期病死率、美国国立卫生研究院卒中量表评分(National Institute of Health stroke scale, NIHSS) 和脑血肿周围水肿量方面排第 1 位,与 CWMT 组比较 P<0.05;SHX+CWMT 组在提高总有效率方面排 第 1 位,与 CWMT 组比较 P<0.05;TT+CWMT 组在增加格拉斯哥昏迷评分 (Glasgow Coma Scale,GCS) 方面排 第 1 位,与 CWMT 组比较 P<0.05;YXQN+CWMT 组在提高巴塞尔指数 (Barthel index,BI) 方面排第 1 位,与 CWMT 组比较 P<0.05;NXS+CWMT 组在促进脑血肿吸收量方面排第 1 位,与 CWMT 组比较 P>0.05;NXT+ CWMT 组在缩短平均住院时间方面排第 1 位,与 CWMT 组比较 P>0.05。结论 与 CWMT 组比较,脑出血术 后患者在 CWMT 基础上联用中成药治疗在提高总有效率,降低病死率、NIHSS 评分,提高 GCS 评分、BI 指数 方面疗效确切,但在促进血肿吸收和缩短平均住院时间方面差异无统计学意义。AGNH 综合疗效较好,可能为 治疗 ICH 术后综合疗效最优的中成药。但由于纳入研究质量和方法学的局限性,所得结论仍需进一步验证。
[Key word]
[Abstract]
Objective To evaluate postoperative efficacy and safety of oral or nasal feeding Chinese patent medicine in the treatment of intracerebral haemorrhage (ICH) based on Bayesian network meta-analysis (BNMA). Methods The randomized controlled trial(RCT)study of Chinese patent medicine for intervening in post-operative patients of ICH was retrieved from CNKI,Wanfang,VIP,SinoMed,PubMed,Embase,Cochrane Library,and Web of Science. The retrieval time is from the establishment of databases to August 25,2023. ROB 2.0 was used for risk of bias assessments. BNMA was performed by using R 4.2.2 loaded with the BUGSnet 1.1.0 package. Results A total of 28 RCTs were included,with a total sample size of 2 530 cases,including 9 kinds of Chinese patent medicines [Angong Niuhuang Pills (AGNH), Suhexiang Pills (SHX), Naoxueshu Oral Liquid (NXS), Naoxintong Capsules (NXT),Naoxuekang Tablets (NXK),Xiaoyukang Capsules (XYK),Yangxue Qingnao Granules (YXQN), Tongtian Oral Liquid (TT), Sanqi Tongshu Capsules (SQTS)]. All patients underwent surgical treatment and postoperative treatment of conventional western medicine (CWMT),the experimental group was additionally given Chinese patent medicine orally or by nasal feeding. The BNMA results showed that AGNH+ CWMT group ranked first in reducing short-term mortality,NIHSS score,and perihematomal edema,with P<0.05 compared to CWMT group. SHX+CWMT group ranked first in improving total effective efficiency,with P<0.05 compared to CWMT group. TT+CWMT group ranked first in increasing GCS scores,with P<0.05 compared to CWMT group. YXQN+CWMT group ranked first in improving BI index,with P<0.05 compared to CWMT group. NXS+CWMT group ranked first in promoting the absorption of cerebral hematoma,with P>0.05 compared to CWMT group. NXT+CWMT group ranked first in shortening the average length of hospital stay,with P>0.05 compared to CWMT group. Conclusion Compared with CWMT group,the combined use of Chinese patent medicine and CWMT is effective in improving the total effective rate,reducing mortality and NIHSS score,increasing GCS score and BI after operation in patients with ICH. There is no significant difference in promoting hematoma absorption and shortening the average length of hospital stay. AGNH has good effect, which may be the best Chinese patent medicine in the post-operative treatment of ICH patients. However,due to limitations in quality and methodology of included research,the conclusions obtained still need further validation.
[中图分类号]
R285.6
[基金项目]
中医药传承与创新“百千万”人才工程(岐黄工程)——国家中医药领军人才支持计划项目(国中医药人教发[2018]284号);河南省 “双一流”创建学科中医学科学研究专项(HSRP-DFCTCM-2023-5-07);河南中医药大学2023年度研究生科研创新项目(2023KYCX035)