Five-Flavor Sophora flavescens Enteric-Coated Capsules for Ulcerative Colitis: A Systematic Review and Meta-Analysis of Randomized Clinical Trials.
Five-Flavor Sophora flavescens Enteric-Coated Capsules for Ulcerative Colitis: A Systematic Review and Meta-Analysis of Randomized Clinical Trials.
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DOI：
10.1155/2022/9633048
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发表时间：
2022
期刊：
影响因子：
--
通讯作者：
Liu ZL
中科院分区：
文献类型：
--
作者：
Hou WB;Sun WJ;Zhang XW;Li YX;Zheng YY;Sun YX;Liu JP;Liu ZL
溃疡性结肠炎(UC)是一种慢性炎症性肠病，以腹痛、腹泻和粘液脓性血性大便为特征。近年来，UC的发病率和患病率呈持续上升趋势。五味苦参肠溶胶囊是一种专治UC的中成药。本综述旨在评估FSEC治疗UC的有效性和安全性。从开始到2021年3月共检索了6个电子数据库。对UC患者进行随机临床试验(RCT)，比较FSEC或FSEC加常规西药与常规西药的疗效。两位作者筛选了所有参考文献，评估了偏倚的风险，并独立提取了数据。二进制数据表示风险比(RR)，可信区间(CI)为95%，度量数据表示均值差(MD)，可信区间(CI)为95%。证据的总体确定性是按等级进行评估的。我们纳入了15个随机对照试验(1194名参与者，763名在FSEC组，431名在对照组)。疗程42~天。12项试验将FSEC与传统西药进行了比较，两项试验将FSEC加传统药物与传统药物进行了比较。另一项试验比较了FSEC加美沙拉秦与复方谷氨酰胺肠溶胶囊加美沙拉秦。FSEC的临床有效率(临床症状、结肠镜检查结果和大便改善)(RR 1.12，95%CI 1.05至1.20；729名参与者；8次试验；低质量证据)以及中医证候的有效率(RR 1.10，95%CI 1.01至1.20；452名参与者；5次试验；低质量证据)均高于美沙拉秦。FSEC组不良反应发生率与对照组比较差异无统计学意义。与传统药物相比，FSEC在UC治疗中可能显示出有效性，并且FSEC的使用可能不会增加不良事件的风险。由于临床试验的数量有限，所纳入试验的方法学质量较低，我们的研究结果必须酌情解释。
Ulcerative colitis (UC), a chronic inflammatory bowel disease, is characterized by abdominal pain, diarrhea, and mucopurulent bloody stool. In recent years, the incidence and prevalence of UC have been increasing consistently. Five-flavor Sophora falvescens enteric-coated capsule (FSEC), a licensed Chinese patent medicine, was specifically used to treat UC. This review was aimed to assess the effectiveness and safety of FSEC for the treatment of UC. Six electronic databases were searched from inception to March 2021. Randomized clinical trials (RCTs) comparing FSEC or FSEC plus conventional Western medicine with conventional Western medicine in participants with UC were included. Two authors screened all references, assessed the risk of bias, and extracted data independently. Binary data were presented as risk ratios (RRs) with 95% confidence intervals (CIs) and metric data as mean difference (MD) with 95% CI. The overall certainty of the evidence was assessed by GRADE. We included 15 RCTs (1194 participants, 763 in the FSEC group and 431 in the control group). The treatment duration ranged from 42 to 64 days. Twelve trials compared FSEC with conventional Western medicine, and two trials compared FSEC plus conventional medicine with conventional medicine. Another trial compared FSEC plus mesalazine with compound glutamine enteric capsules plus mesalazine. FSEC showed a higher clinical effective rate (improved clinical symptoms, colonoscopy results, and stools) (RR 1.12, 95% CI 1.05 to 1.20; 729 participants; 8 trials; low-quality evidence) as well as the effective rate of traditional Chinese medicine (TCM) syndromes (RR 1.10, 95% CI 1.01 to 1.20; 452 participants; 5 trials; low-quality evidence) compared to mesalazine. There was no significant difference in the adverse events between FSEC and control groups. FSEC may show effectiveness in UC treatment compared to conventional medicine, and the use of FSEC may not increase the risk of adverse events. Due to the limited number of clinical trials and low methodological quality of the included trials, our findings must be interpreted with discretion.
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DOI：
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发表时间：
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影响因子：
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DOI：
10.1155/2021/1075886
发表时间：
2021
期刊：
Evidence-based complementary and alternative medicine : eCAM
影响因子：
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作者：
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通讯作者：
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