Biling Weitong Granules

  • 文章类型: Meta-Analysis
    本研究旨在评价碧灵胃痛颗粒治疗胃痛症的疗效和安全性。从数据库开始至2022年6月10日,从中英文电子数据库和试验注册平台中检索出必灵胃痛颗粒治疗以胃痛为主要症状的消化系统疾病的随机对照试验(RCT)。两名研究者根据筛选标准进行文献筛选和数据提取。Cochrane偏倚风险工具(v2.0)用于评估纳入研究的偏倚风险。使用RevMan5.4和R4.2.2进行分析,并使用固定或随机效应模型测量汇总估计值。主要结局指标为视觉模拟评分(VAS)评分和胃痛障碍症状评分。次要转归指标为临床恢复率,幽门螺杆菌(Hp)根除率,和不良反应/事件。纳入27个RCT,样本量为2902例。Meta分析结果显示,与常规西药治疗或安慰剂治疗相比,碧灵胃痛颗粒可改善VAS评分(SMD=-1.90,95CI[-2.18,-1.61],P<0.00001),胃痛障碍症状评分(SMD=-1.26,95CI[-1.71,-0.82],P<0.00001),临床恢复率(RR=1.85,95CI[1.66,2.08],P<0.00001),和Hp根除率(RR=1.28,95CI[1.20,1.37],P<0.00001)。安全性评价显示,碧灵胃痛颗粒的主要不良事件包括恶心和呕吐,皮疹,腹泻,食欲不振,和苦涩的嘴,未报告严重不良事件.艾格检验无统计学意义,表明没有出版偏见。结果表明,碧灵胃痛颗粒治疗以胃痛障碍为首发症状的消化系统疾病,可提高患者的VAS评分和胃痛障碍症状评分,缓解胃痛,提高临床治愈率和Hp根除率,安全性好,无严重不良反应。然而,原始研究的质量较低,存在一定的局限性.未来研究应采用统一、规范的检测方法和结果指标评价标准,注意研究设计和实施的严谨性,并突出该药的临床安全性,为临床应用提供更可靠的临床证据支持。
    This study aimed to evaluate the efficacy and safety of Biling Weitong Granules in the treatment of stomach ache disorder. Randomized controlled trial(RCT) of Biling Weitong Granules in the treatment of digestive diseases with stomach ache disorder as the primary symptom was retrieved from Chinese and English electronic databases and trial registration platforms from database inception to June 10, 2022. Two investigators conducted literature screening and data extraction according to the screening criteria. The Cochrane risk-of-bias tool(v 2.0) was used to assess the risk of bias in the included studies. Analyses were performed using RevMan 5.4 and R 4.2.2, with summary estimates measured using fixed or random effects models. The primary outcome indicators were the visual analogue scale(VAS) scores and stomach ache disorder symptom scores. The secondary outcome indicators were clinical recovery rate, Helicobacter pylori(Hp) eradication rate, and adverse reaction/events. Twenty-seven RCTs were included with a sample size of 2 902 cases. Meta-analysis showed that compared with conventional western medicine treatments or placebo, Biling Weitong Granules could improve VAS scores(SMD=-1.90, 95%CI[-2.18,-1.61], P<0.000 01), stomach ache disorder symptom scores(SMD=-1.26, 95%CI[-1.71,-0.82], P<0.000 01), the clinical recovery rate(RR=1.85, 95%CI[1.66, 2.08], P<0.000 01), and Hp eradication rate(RR=1.28, 95%CI[1.20, 1.37], P<0.000 01). Safety evaluation revealed that the main adverse events in the Biling Weitong Granules included nausea and vomiting, rash, diarrhea, loss of appetite, and bitter mouth, and no serious adverse events were reported. Egger\'s test showed no statistical significance, indicating no publication bias. The results showed that Biling Weitong Granules in the treatment of digestive system diseases with stomach ache disorder as the primary symptom could improve the VAS scores and stomach ache disorder symptom scores of patients, relieve stomach ache disorder, and improve the clinical recovery rate and Hp eradication rate, with good safety and no serious adverse reactions. However, the quality of the original studies was low with certain limitations. Future studies should use unified and standardized detection methods and evaluation criteria of outcome indicators, pay attention to the rigor of study design and implementation, and highlight the clinical safety of the medicine to provide more reliable clinical evidence support for clinical application.
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  • 文章类型: Journal Article
    这项研究评估和比较了疗效,4种中成药(CPM)治疗功能性消化不良(FD)的安全性和经济性的快速卫生技术评价方法。它旨在为决策者提供快速的决策信息。对8个中英文数据库进行了全面、系统的临床研究检索。对研究进行筛选和评价。总共确定了110项研究,包括95项随机对照试验(RCT),7个对照临床试验(CCT),7个系统评价/荟萃分析和1个经济评价,其中达利通颗粒28个,49是智珠宽中胶囊,3个为碧灵胃痛颗粒,30个为芪芝胃痛颗粒(片剂/胶囊)。纳入文献的质量普遍较低。四种CPM单独或联合西药治疗FD的疗效不同。达立通颗粒用于治疗FD运动障碍。止珠宽中胶囊、芪芝胃痛颗粒(片/胶囊)可治疗FD患者的焦虑、抑郁情绪。气滞胃痛颗粒(片/胶囊)主要用于围绝经期FD患者。4种CPM治疗FD的临床研究均未见严重不良反应。达立通颗粒治疗FD的效果优于莫沙必利,但成本略高。止珠宽中胶囊治疗FD伴焦虑抑郁患者的成本-效果比低于多潘立酮。就日均价格而言,七支胃痛片价格最高(每天27.00元),七支胃痛颗粒价格最低(5.04元/天),碧灵胃通颗粒价格相对较高(15.53元/天),其次是达利通颗粒(13.03元/天)。达利通颗粒的证据涵盖了疗效,安全性和经济性,与其他三种药物相比相对完整。它在FD运动障碍的治疗中具有有效的潜力。未来需要在这一领域进行进一步的研究。
    This study evaluated and compared the efficacy, safety and economy of four Chinese patent medicines(CPMs) in the treatment of functional dyspepsia(FD) using the method of rapid health technology assessment. It aims to provide decision-makers with rapid decision-making information. The eight Chinese and English databases were comprehensively and systematically searched for the relevant clinical research. Studies were screened and evaluated. A total of 110 studies were identified, including 95 randomized controlled trials(RCTs), 7 controlled clinical trials(CCTs), 7 systematic review/Meta-analysis and 1 economic evaluation, among which 28 were Dalitong Granules, 49 were Zhizhu Kuanzhong Capsules, 3 were Biling Weitong Granules and 30 were Qizhi Weitong Granules(Tablets/Capsules). The quality of the included literature was generally low. The efficacy of four CPMs alone or combined with western medicine in the treatment of FD is different. Dalitong Granules was used to treat motility disorder in FD. Zhizhu Kuanzhong Capsules and Qizhi Weitong Granules(Tablets/Capsules) can treat FD patients with anxiety and depression. Qizhi Weitong Granules(Tablets/Capsules) were mainly used in FD for perimenopausal patients. There were no serious adverse reactions in the clinical study of four CPMs in the treatment of FD. Dalitong Granules has better effects than mosapride in the treatment of FD, but the cost is slightly higher. The cost-effectiveness ratio of Zhizhu Kuanzhong Capsules in the treatment of FD patients with anxiety and depression was lower than that of Domperidone. In terms of average daily price, Qizhi Weitong Tablets has the highest price(27.00 yuan per day), Qizhi Weitong Granules has the lowest price(5.04 yuan per day), Biling Weitong Granules has a relatively high price(15.53 yuan per day), followed by Dalitong Granules(13.03 yuan per day). The evidence of Dalitong Granules covered the efficacy, safety and economy, which is relatively complete compared with the other three drugs. It has effective potential in the treatment of motility disorder in FD. Further research in this field in the future is needed.
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  • 文章类型: Journal Article
    背景:最近的研究表明,尽管促动力剂,酸抑制剂,对于功能性消化不良(FD)患者,幽门螺杆菌感染的根治性治疗可能有效,很大比例的患者仍然对这些治疗没有反应或可能遭受严重的不良反应。许多中草药可以调节整个身体的状态,在治疗功能性疾病方面具有特殊的优势。本研究旨在验证碧灵胃痛颗粒(BLWTG)的疗效,一种传统的中草药复方配方,在缓解FD患者的上腹痛综合征(EPS)中,以期为本病的临床治疗提供有效的方剂。
    目的:评价BLWTG治疗FD患者EPS的临床疗效和安全性。
    方法:在这个多中心中,分层,随机化,双盲,安慰剂对照,平行组临床试验,符合条件的患者被随机分为BLWTG组和安慰剂组,治疗6周.观察并比较疗效指标,包括EPS的严重程度和频率,疼痛缓解时间和安全性指标,包括不良事件。
    结果:基线人口统计学数据和临床特征,如上腹痛症状,疼痛强度,和攻击的频率,在随机化前两组之间进行匹配。治疗6周后,中心效应消除后,安慰剂组和BLWTG组的上腹痛分别为28.33%和85.59%,分别为(P<0.05)。在6周,安慰剂组和BLWTG组的上腹痛缓解率分别为15%和69.49%,分别为(P<0.05)。两组患者FD临床总评分在第2、4、6周差异均有统计学意义(P<0.05)。消除中心效应和交互效应后第6周,两组在功能性消化疾病生活质量问卷中的每个项目得分和总分均显示出显着性差异(P<0.05)。两组患者的不良事件发生率差异无统计学意义,观察期间未发现严重不良事件.
    结论:与安慰剂相比,BLWTG可明显改善FD患者的EPS,无严重不良反应。
    BACKGROUND: Recent research suggests that although prokinetic agents, acid suppressors, and radical treatment for Helicobacter pylori infection may be effective in patients with functional dyspepsia (FD), a large proportion of patients still fail to respond to these treatments or may suffer from severe adverse reactions. Many traditional Chinese medicinal herbs can regulate the status of the entire body and have special advantages in the treatment of functional diseases. The present study was designed to verify the efficacy of Biling Weitong Granules (BLWTG), a traditional Chinese medicinal herbal compound formula, in alleviating epigastric pain syndrome (EPS) in FD patients, in an attempt to provide an effective prescription for the clinical treatment of this disease.
    OBJECTIVE: To evaluate the clinical efficacy and safety of BLWTG in treating EPS in patients with FD.
    METHODS: In this multicenter, stratified, randomized, double-blind, placebo-controlled, parallel group clinical trial, eligible patients were randomized into the BLWTG and placebo groups who were treated for 6 wk. Efficacy indicators including the severity and frequency of EPS and the time to pain resolution and safety indicators including adverse events were observed and compared.
    RESULTS: The baseline demographic data and clinical characteristics, such as epigastric pain symptoms, pain intensity, and frequency of attacks, were matched between the two groups before randomization. After 6 wk of treatment and after the center effect was eliminated, the epigastric pain was significantly improved in 28.33% and 85.59% of the patients in the placebo and BLWTG groups, respectively (P < 0.05). At 6 wk, the resolution rate of epigastric pain was 15% and 69.49% in the placebo and BLWTG groups, respectively (P < 0.05). The differences of total FD clinical score between these two groups were significant (P < 0.05) at 2, 4, and 6 wk (P < 0.05). The scores of each item and the total score in the Functional Digestive Disorders Quality of Life Questionnaire showed significant differences between the two groups at 6 wk after both the center and interaction effects were eliminated (P < 0.05). There was no significant difference in the incidence of adverse events between the two groups, and no serious adverse event was noted during the observation.
    CONCLUSIONS: Compared with placebo, BLWTG markedly improved EPS in FD patients without causing serious adverse reactions.
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