复方丹参滴丸与硝酸盐类药物治疗稳定型心绞痛的比较：一项系统评价和荟萃分析
Compound danshen dripping pills vs. nitrates for stable angina pectoris: a systematic review and meta-analysis.
作者信息
Zhang Mengying, Wang Wenjia, Sun He, Zhai Jingbo, Hu Yunhui
机构信息
Tasly Pharmaceutical Group Co., Ltd., Tianjin, China.
The State Key Laboratory of Core Technology in Innovative Chinese Medicine, Tasly Academy, Tasly Holding Group Co., Ltd., Tianjin, China.
出版信息
Front Cardiovasc Med. 2023 May 22;10:1168730. doi: 10.3389/fcvm.2023.1168730. eCollection 2023.
BACKGROUND
Long-term use of nitrates for treating stable angina pectoris (SAP) may lead to patients' tolerance to nitrates. As a traditional Chinese medicine, Compound danshen dropping pills (CDDP) is beneficial for patients with SAP. This study aimed to critically assess the efficacy and safety of CDDP vs. nitrates for SAP.
METHODS
PubMed, Embase, Web of Science, Cochrane library, CNKI, Wanfang Digital Periodicals, and Chinese Science and Technology Periodicals database were searched from inception to April 2023. Randomized controlled trials (RCTs) comparing CDDP with nitrates for SAP were included. The meta-analysis was conducted to estimate the pooled effect.
RESULTS
Twenty-nine studies were included for the statistical analysis. The meta-analyses with the random-effect model indicated that CDDP could significantly increase the effective rate in symptom improvement compared with nitrates (Pooled 9 RCTs, OR = 1.95, 95% CI: 1.25-3.05, = 0.003, duration of 4 weeks; Pooled 4 RCTs, OR = 3.45, 95% CI: 1.84-6.48, = 0.0001, duration of 6 weeks; Pooled 13 RCTs, OR = 4.02, 95% CI: 2.14-7.57, < 0.0001, duration of 8 weeks). The meta-analyses with the random-effect model indicated that CDDP could significantly increase the effective rate in electrocardiogram improvement compared with nitrates (Pooled 5 RCTs, OR = 1.60, 95% CI: 1.02-2.52, = 0.04, duration of 4 weeks; Pooled 3 RCTs, OR = 2.47, 95% CI: 1.60-3.82, < 0.0001, duration of 6 weeks; Pooled 11 RCTs, OR = 3.43, 95% CI: 2.68-4.38, < 0.00001, duration of 8 weeks). The incidence of adverse drug reactions in the CDDP group was lower than that in the nitrates group (Pooled 23 RCTs, OR = 0.15, 95% CI: 0.1-0.21, < 0.00001). The results of the meta-analyses with fixed-effect model were similar with above results. The levels of the evidence ranged from very low to low.
CONCLUSION
The present study suggests that CDDP with the duration of at least 4 weeks can be considered as an alternative to nitrates for treating SAP. However, more high-quality RCTs are still needed to confirm these findings.
SYSTEMATIC REVIEW REGISTRATION
https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022352888, identifier [CRD42022352888].
背景
长期使用硝酸盐治疗稳定型心绞痛（SAP）可能导致患者对硝酸盐产生耐受性。复方丹参滴丸（CDDP）作为一种中药，对SAP患者有益。本研究旨在严格评估CDDP与硝酸盐治疗SAP的疗效和安全性。
方法
检索了从创刊至2023年4月的PubMed、Embase、Web of Science、Cochrane图书馆、中国知网、万方数据期刊和中国科技期刊数据库。纳入比较CDDP与硝酸盐治疗SAP的随机对照试验（RCT）。进行荟萃分析以估计合并效应。
结果
纳入29项研究进行统计分析。随机效应模型的荟萃分析表明，与硝酸盐相比，CDDP可显著提高症状改善的有效率（9项RCT合并，OR = 1.95，95%CI：1.25 - 3.05，P = 0.003，疗程4周；4项RCT合并，OR = 3.45，95%CI：1.84 - 6.48，P = 0.0001，疗程6周；13项RCT合并，OR = 4.02，95%CI：2.14 - 7.57，P < 0.0001，疗程8周）。随机效应模型的荟萃分析表明，与硝酸盐相比，CDDP可显著提高心电图改善的有效率（5项RCT合并，OR = 1.60，95%CI：1.02 - 2.52，P = 0.04，疗程4周；3项RCT合并，OR = 2.47，95%CI：1.60 - 3.82，P < 0.0001，疗程6周；11项RCT合并，OR = 3.43，95%CI：2.68 - 4.38，P < 0.00001，疗程8周）。CDDP组药物不良反应的发生率低于硝酸盐组（23项RCT合并，OR = 0.15，95%CI：0.1 - 0.21，P < 0.00001）。固定效应模型的荟萃分析结果与上述结果相似。证据水平从极低到低不等。
结论
本研究表明，疗程至少4周的CDDP可被视为治疗SAP的硝酸盐替代药物。然而，仍需要更多高质量RCT来证实这些发现。
系统评价注册
https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022352888，标识符[CRD42022352888]
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