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美洲大蠊(康复新液)治疗压疮的药物制剂:一项荟萃分析。

Pharmaceutical preparations of Periplaneta americana (KangFuXin liquid) in the treatment of pressure ulcer: A meta-analysis.

机构信息

Department of Dermatology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.

出版信息

Int Wound J. 2023 Sep;20(7):2855-2868. doi: 10.1111/iwj.14123. Epub 2023 Feb 27.

DOI:10.1111/iwj.14123
PMID:36851877
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10410340/
Abstract

Pressure ulcers often become chronic wounds that are difficult to treat and that tend to recur after healing. In China, convincing data from randomised trials have demonstrated that the pharmaceutical preparations of Periplaneta americana (KangFuXin Liquid, KFX) have a significant efficacy for pressure ulcers. To provide more reference to the clinicians and experts, we conducted a meta-analysis based on the existing randomised controlled trials (RCTs). We searched the RCTs about KFX for the treatment of pressure ulcers published up to July 2022 in major English and Chinese databases with no language restriction, including PubMed, EMBASE, Web of Science (WOS), Cochrane Central Register of Controlled Trials (CENTRAL), China Network Knowledge Infrastructure (CNKI), Chinese Biomedicine (CBM), Chinese Scientific Journals Database (VIP), and WanFang database. Cochrane Handbook guidelines were used to assess the risk of bias and to evaluate the methodological quality of included RCTs. Estimates of the intervention's effects are expressed as the risk ratio (RR) (95% CI) for binary outcomes and mean difference or standardised mean difference (95% CI) for continuous outcomes. We applied fixed or random effects models, and all analyses were performed using Review Manager version 5.4 and Stata/SE version 12.0. We included 22 studies with a total of 1575 participants. Compared with controls, KFX combined with basic wound care or KFX combined with basic wound care and another topical drug or physical treatment significantly increase clinical efficacy (RR: 1.17; 95% CI, 1.06-1.28; P = 0.001; I  = 81%) and shorten the complete healing time (MD = -5.11; 95% CI [-8.19, -2.02]; P = 0.001) for pressure ulcers. Subgroup analysis showed a significant difference in the total clinical effect rate between KFX combined with basic wound care and controls. (n = 1018, RR 1.21, 95% CI [1.07, 1.36], I  = 82%, P = 0.003). No difference was found in the total clinical effective rate between patients using KFX combined with basic wound care and another topical drug or physical treatment with controls (KFX combined with basic wound care and topical physical treatment: n = 267, RR 1.15, 95% CI [0.86, 1.52], I  = 87%, P = 0.34; KFX combined with basic wound care and topical drug: n = 290, RR 1.05, 95% CI [0.80, 1.37], I  = 86%, P = 0.71). Based on treatment duration, subgroup analysis indicated that increasing treatment duration increased the total clinical effective rate when treatment duration was not long. (treatment duration: 14 days: n = 158, OR 5.48, 95% CI [1.47, 20.43], I  = 0%, P = 0.01; 21 days: n = 132, OR 5.93, 95% CI [1.86, 18.91], I  = 65%, P = 0.003). When treatment duration was 28 days or 30 days, the results showed that there was no significant difference in total clinical effective rate between interventions and controls (treatment duration: 28 days: n = 107, OR 3.04, 95% CI [0.25, 37.32], I  = 50%, P = 0.38; 30 days: n = 256, OR 0.58, 95% CI [0.11, 3.15], I  = 65%, P = 0.53). No data on side effects were reported in any of the 22 studies. The conclusion is that the combination of KFX and basic wound care is effective in increasing the total clinical effectiveness and shortening the complete healing time of pressure ulcers.

摘要

压疮常常成为难以治疗且易于复发的慢性伤口。在中国,来自随机对照试验的令人信服的数据表明,美洲大蠊(康复新液,KFX)的药物制剂对压疮具有显著疗效。为了给临床医生和专家提供更多的参考,我们对现有的关于 KFX 治疗压疮的随机对照试验(RCTs)进行了荟萃分析。我们在主要的英文和中文数据库中搜索了截至 2022 年 7 月发表的关于 KFX 治疗压疮的 RCTs,没有语言限制,包括 PubMed、EMBASE、Web of Science(WOS)、Cochrane 中央对照试验注册库(CENTRAL)、中国知网(CNKI)、中国生物医学文献数据库(CBM)、中国科技期刊数据库(VIP)和万方数据库。我们使用 Cochrane 手册指南来评估偏倚风险,并评估纳入 RCTs 的方法学质量。干预效果的估计值表示为二分类结局的风险比(RR)(95%CI)和连续结局的均数差或标准化均数差(95%CI)。我们应用固定或随机效应模型,所有分析均使用 Review Manager 版本 5.4 和 Stata/SE 版本 12.0 进行。我们纳入了 22 项研究,共纳入 1575 名参与者。与对照组相比,KFX 联合基础伤口护理或 KFX 联合基础伤口护理和另一种局部药物或物理治疗显著提高了临床疗效(RR:1.17;95%CI,1.06-1.28;P=0.001;I²=81%),并缩短了完全愈合时间(MD=-5.11;95%CI[-8.19,-2.02];P=0.001)。亚组分析显示,KFX 联合基础伤口护理与对照组在总临床有效率方面存在显著差异。(n=1018,RR 1.21,95%CI [1.07,1.36],I²=82%,P=0.003)。KFX 联合基础伤口护理与另一种局部药物或物理治疗与对照组的总临床有效率无差异(KFX 联合基础伤口护理和局部物理治疗:n=267,RR 1.15,95%CI [0.86,1.52],I²=87%,P=0.34;KFX 联合基础伤口护理和局部药物:n=290,RR 1.05,95%CI [0.80,1.37],I²=86%,P=0.71)。基于治疗持续时间,亚组分析表明,当治疗持续时间不长时,增加治疗持续时间会提高总临床有效率。(治疗持续时间:14 天:n=158,OR 5.48,95%CI [1.47,20.43],I²=0%,P=0.01;21 天:n=132,OR 5.93,95%CI [1.86,18.91],I²=65%,P=0.003)。当治疗持续时间为 28 天或 30 天时,干预措施与对照组之间在总临床有效率方面没有显著差异(治疗持续时间:28 天:n=107,OR 3.04,95%CI [0.25,37.32],I²=50%,P=0.38;30 天:n=256,OR 0.58,95%CI [0.11,3.15],I²=65%,P=0.53)。在这 22 项研究中,没有报告任何副作用的数据。结论是,KFX 联合基础伤口护理在提高压疮总临床疗效和缩短完全愈合时间方面是有效的。

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