Zhu Fengya, Yin Shao, Zhou Li, Li Zimeng, Yan Hui, Zhong Yue, Wu Xiaohan, Luo Biao, Yang Lanying, Gan Daohui, Deng Lvyu, Che Deya, Li Liuying
Traditional Chinese Medicine Department, Zigong First People's Hospital, Zigong, China.
Clinical Medical School, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.
Front Pharmacol. 2022 Aug 10;13:883729. doi: 10.3389/fphar.2022.883729. eCollection 2022.
At present, a number of systematic reviews (SRs) on Xuebijing injection (a patent in China) in the treatment of acute pancreatitis (AP) or severe acute pancreatitis (SAP) have been published. However, the quality of evidence is uneven and has not been comprehensively evaluated. We evaluated the efficacy of Xuebijing injection for AP/SAP through an overview of SR, and to provide a scientific basis for its effectiveness and safety. We searched Cochrane Library, Embase, PubMed, SinoMed, CNKI, Wanfang, and VIP comprehensively. The retrieval period from inception to 30 November 2021, and the two reviewers independently complete the literature retrieval, data extraction and evaluation. The Assessing the Methodological Quality of Systematic Reviews 2 (AMSTAR-2) and the Preferred Reporting Item for Systematic Review and Meta-analysis (PRISMA) were used to evaluate the methodological quality and reporting quality of the SRs, respectively. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) tool was used to evaluate the quality grading of outcomes and the risk of bias in SRs was evaluated by ROBIS Tool. Finally, the RCTs involved in SRs were synthesized. Stata15.1 was used for quantitative analysis of total effectiveness rate, time until relief of abdominal pain, time until relief of abdominal distension, and serum amylase level. Nine eligible SRs were included, including 92 RCTs and 6,837 participants. The quality of SRs was relatively good, and the manuscript structures were relatively complete. However, the methodological quality of SRs was low or critically low. RoB rated 5 SRs as low risk of bias and 4 SRs as high risk of bias. In GRADE, a total of 47 results were included in the 9 SRs, of which 5 results (10.64%) were moderate quality, 22 results (46.81%) were low quality, and 20 results (42.55%) were very low quality. The results of data synthesis showed that Xuebijing injection combined treatment increased the total effectiveness rate of AP patients (RR = 1.19, 95% CI 1.17-1.23, < 0.0001), and there was no heterogeneity between studies (I = 0.0%, = 0.589). Compared with the control group, Xuebijing injection group shortened the abdominal pain and distension relief time in AP patients (WMD = -1.69, 95% CI -1.88--1.50, < 0.0001; WMD = -1.48, 95% CI -1.74--1.23, < 0.0001), with high heterogeneity (I = 84.3%, = 0.000; I = 72.2%, = 0.000). Serum amylase level was also reduced (WMD = -2.06, 95% CI -2.47--1.64, < 0.0001), with significant heterogeneity (I = 71.6%, = 0.000). A total of one SR reported adverse drug reaction (ADR), no ADRs were observed in the control group. Although the quality of the evidence is not high, it can still reflect the clinical value of Xuebijing injection as an analgesic and anti-inflammatory traditional Chinese medicine in the treatment of AP/SAP. Therefore, future clinical studies should focus on the long-term efficacy and adverse reactions of drugs. (website), identifier (registration number).
目前,已有多篇关于血必净注射液(中国专利)治疗急性胰腺炎(AP)或重症急性胰腺炎(SAP)的系统评价(SRs)发表。然而,证据质量参差不齐,尚未得到全面评估。我们通过对SRs的概述来评估血必净注射液治疗AP/SAP的疗效,为其有效性和安全性提供科学依据。我们全面检索了Cochrane图书馆、Embase、PubMed、中国生物医学文献数据库、中国知网、万方数据和维普资讯。检索时间从建库至2021年11月30日,两位评价者独立完成文献检索、数据提取和评估。分别采用系统评价方法学质量评估2(AMSTAR-2)和系统评价与Meta分析优先报告条目(PRISMA)来评估SRs的方法学质量和报告质量。采用推荐分级评估、制定和评价(GRADE)工具评估结局的质量分级,并通过ROBIS工具评估SRs中的偏倚风险。最后,对SRs中涉及的随机对照试验(RCTs)进行综合分析。使用Stata15.1对总有效率、腹痛缓解时间、腹胀缓解时间和血清淀粉酶水平进行定量分析。纳入9篇合格的SRs,包括92项RCTs和6837名参与者。SRs的质量相对较好,稿件结构相对完整。然而,SRs的方法学质量较低或极低。ROB将5篇SRs评为低偏倚风险,4篇SRs评为高偏倚风险。在GRADE中,9篇SRs共纳入47个结果,其中5个结果(10.64%)为中等质量,22个结果(46.81%)为低质量,20个结果(42.55%)为极低质量。数据综合分析结果显示,血必净注射液联合治疗可提高AP患者的总有效率(RR = 1.19,95%CI 1.17 - 1.23,P < 0.0001),且各研究间无异质性(I² = 0.0%,P = 0.589)。与对照组相比,血必净注射液组缩短了AP患者的腹痛和腹胀缓解时间(WMD = -1.69,95%CI -1.88 - -1.50,P < 0.0001;WMD = -1.48,95%CI -1.74 - -1.23,P < 0.0001),异质性较高(I² = 84.3%,P = 0.000;I² = 72.2%,P = 0.000)。血清淀粉酶水平也有所降低(WMD = -2.06,95%CI -2.47 - -1.64,P < 0.0001),异质性显著(I² = 71.6%,P = 0.000)。共有1篇SRs报告了药物不良反应(ADR),对照组未观察到ADR。虽然证据质量不高,但仍能反映血必净注射液作为一种镇痛抗炎中药在治疗AP/SAP中的临床价值。因此,未来的临床研究应关注药物的长期疗效和不良反应。(网站),标识符(注册号)