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2，具体到该研究报告的内容，有一些很不严谨的内容，比如提到的疗法，并没有具体的治疗标准或者具体的药物，这样是无法评判有效无效的。
阅读整篇论文:
材料和方法
该 NMA 是按照系统评价和元分析的首选报告项目 (PRISRMA) 声明 (Liberati et al., 2009) (补充信息 S1) 执行的。
数据源和搜索策略
我们检索了 PubMed、MEDLINE Complete、OVID EMBASE、Scopus、Web of Science、Google Scholar、中国知网（CNKI）和万方数据等电子数据库，从它们成立到 2021 年 8 月 17 日。没有语言限制。最初的搜索策略如下：“中药”、“中药”、“草药”、“草药”、“扶正化瘀”、“大黄哲虫”、“安络化仙”、“别家软肝” 、“抗病毒药物/制剂”、“恩替卡韦”、“阿德福韦”、“慢性乙型肝炎肝纤维化”、“慢性乙型肝炎”、“乙型肝炎病毒”、“肝纤维化”、“肝纤维化”和“随机对照试验（RCT）。”所有电子数据库的详细信息显示在补充信息 S2 中。
纳入和排除标准
两位研究者（戴云凯和范海娜）独立阅读摘要和全文。按照标准（参与者、干预措施、比较、结果和研究设计，PICOS），我们在本研究中纳入了某些项目：随机对照试验；干预中的中药或核仁 (t) ide 类似物；只有成年人;疗程>1个月； Jadad 评分 >2。同时，应排除一些项目： HBV 阴性；失代偿性肝硬化；结果中没有肝纤维化的血清指标；荟萃分析或系统评价；仅限会议摘要或摘要；病例报告；单性别研究；动物实验或基础实验研究；信息不完整或错误；科技成果；非药物治疗；和重复。
数据抽象和质量评估
两人（戴云凯和胡永红）分别提取相关数据并评价方法学质量。详细信息摘要如下：第一作者和发表年份、患者年龄和性别、疾病严重程度、病程和治疗、干预措施和结果（临床疗效、肝纤维化血清生物标志物和血清参数肝功能）、给药途径和副作用。通过与第一作者或通讯作者取得联系来弥补缺失的信息。通过 Cochrane Collaboration Recommendations 评估工具 (Higgins et al., 2011) 对每篇文献的方法学质量评估进行了评估。偏倚风险评估包括六个领域：随机序列生成、分配隐藏、参与者和人员的盲法、结果评估的盲法、不完整的结果数据和选择性报告。这些领域的每个元素都用于评估纳入试验的低、不清楚或高风险。同时，采用在线指南“https://gdt.gradepro.org/app/”的建议评估、制定和评估分级（GRADE）来评估证据质量，分为高、中、低和非常低。 （Puhan 等人，2014 年）。
统计分析
使用Stata 13.0版软件比较不同中药在纳入研究中的疗效和安全性。基于贝叶斯框架和马尔可夫链蒙特卡罗（MCMC）方法，使用WinBUGS 1.4.3版本对研究数据进行先验评估和处理。为了适应该模型，应用了三个链和非信息性均匀和正态先验分布（Ades 等人，2006；Sutton 等人，2008）。之后，为了获得它们的后验分布，每个链都设置了 10 个细化间隔和 50,000 次迭代。对于模拟迭代，前 20,000 次用于退火，以消除初始值的影响，而后 30,000 次用于采样。至于效应量，为连续变量数据生成标准化平均差 (SMD)，并为二分类结果汇总相对风险 (RR)。他们都进行随机效应模型以最小化风险，用于总结每个比较效应，以及相应的 95% 置信区间 (CI) 和网络图，其中节点大小代表患者的数量，虽然连接大小与 RCT 的数量有关，但用于检查涉及多重干预比较的直接和间接证据。使用潜在比例缩减因子 (PSRF) 值进行 Brooks-Gelman-Rubin 统计以评估模型收敛性。同时，计算节点分裂分析以评估一致性。不一致性指数统计量 (I2) 用于量化不同治疗策略之间的异质性。为了研究结果的稳定性，进行了敏感性分析。此外，对累积排序曲线下的曲面 (SUCRA) 进行排序，以检查每个结果中所有包含策略的有效性和安全性。
结果
文献筛选
按照检索策略的纳入和排除标准，使用五个数据库共识别出5017篇出版物，其中1993条因重复而被删除，928条因浏览标题和摘要而被排除，2067条因阅读全文而被删除.最后，该 NMA 收录了 29 篇文章（Wang et al., 2004; Wang, 2005; Zhang et al., 2006; Wang et al., 2010; Zhang et al., 2016; Gu, 2018; Li, 2018;肖和胡，2018；徐等，2018；张等，2018；赵，2018；陈等，2019；梁，2019；石，2019；狄和夏，2020；李等， 2020；Rong 等，2020；Wang，2020；Yin 等，2020；Yu 等，2020；Zhang，2020；Zhang 和 Li，2020；Du 等，2021；Huang，2021；Li 等al., 2021; Wang, 2021; Zhang, 2021; Zhao, 2021; Zhu et al., 2021)。研究选择的详细信息见图 1，纳入 RCT 的特征总结于表 1。每个配方的成分和所有纳入出版物中的质量控制措施见表 2。因此，四个代表性的组成“扶正化瘀片/胶囊”、“大黄哲虫丸”、“安络化纤丸”、“别加软肝片”等方剂见补充资料S3。
Materials and methods
This NMA was performed following the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISRMA) statement (Liberati et al., 2009) (Supplementary Information S1).
Data sources and search strategy
We retrieved electronic databases of PubMed, MEDLINE Complete, OVID EMBASE, Scopus, Web of Science, Google Scholar, China National Knowledge Infrastructure (CNKI), and WanFang Data from their establishment to 17 Aug 2021. No language limitation was applied. The initial search strategies were performed as follows: “traditional Chinese medicine (TCM),” “Chinese medicine,” “herbs,” “herbal medicine,” “Fuzheng Huayu,” “Dahuang Zhechong,” “Anluo Huaxian,” “Biejia Ruangan,” “antiviral drugs/agents,” “entecavir,” “adefovir,” “chronic hepatits B liver fibrosis,” “chronic hepatits B,” “hepatitis B virus,” “liver fibrosis,” “hepatic fibrosis,” and “randomized controlled trials (RCTs).” Detailed information of all electronic databases is displayed in Supplementary Information S2.
Inclusion and exclusion criteria
Two investigators (Yun-kai Dai and Hai-na Fan) independently read the abstracts and full articles. Following the criteria (participants, interventions, comparisons, outcomes, and study design, PICOS), we included certain items in this research: RCTs; TCMs or nucleos (t) ide analogs in interventions; adults only; course of treatment >1 month; and Jadad score >2. Meanwhile, some items should be excluded: HBV negative; decompensated liver cirrhosis; no serum indicator of liver fibrosis in outcomes; meta-analyses or systematic reviews; conference summaries or abstracts only; case reports; single-sex researches; animal experiments or fundamental experiment studies; incomplete or error information; scientific and technological achievements; non-pharmaceutical therapy; and duplicates.
Data abstraction and quality evaluation
Two people (Yun-kai Dai and Yong-hong Hu), respectively, extracted relevant data and evaluated the methodological quality. Detailed information to be abstracted were listed as follows: first author and year of publication, patients’ age and gender, severity of the disease, courses of disease and treatment, interventions and outcomes (clinical efficacy, serum biomarkers of liver fibrosis, and serum parameters for liver function), administration route, and side effects. Missing information was remedied by getting in touch with the first or corresponding authors. Methodological quality evaluation of each literature was evaluated by means of the Cochrane Collaboration Recommendations assessment tool (Higgins et al., 2011). The assessment of risk of bias includes six domains: random sequence generation, allocation concealment, blinding of participants and personnel, blinding of outcomes assessment, incomplete outcome data, and selective reporting. Each element of these domains was used to evaluate the included trials as low, unclear, or high risk. Meanwhile, the Grading of Recommendations Assessment, Development, and Evaluation (GRADE), online guideline “https://gdt.gradepro.org/app/”, was applied to assess the evidence quality as high, moderate, low, and very low (Puhan et al., 2014).
Statistical analysis
Stata version 13.0 software was used to compare the efficacy and safety of different TCM drugs across the included studies. Based on the Bayesian framework and the Markov chain Monte Carlo (MCMC) method, WinBUGS version 1.4.3 was used for the evaluation and procession of research data a priori. In order to accommodate the model, three chains and non-informative uniform and normal priori distributions were applied (Ades et al., 2006; Sutton et al., 2008). After that, to gain their posterior distributions, 10 thinning intervals each chain and 50,000 iterations were all set. As for the simulation iterations, the top 20,000 were used for annealing in order to eliminate the impacts of the initial value, while the bottom 30,000 were applied to sampling. As for effect sizes, the standardized mean difference (SMD) was produced for continuous variable data, and the relative risk (RR) was pooled for dichotomous outcomes. Both of them, conducting a random effects model to minimize the risk, were used for the summarization of each comparison effect, with their corresponding 95% confidence intervals (CIs), and a network plot, where node sizes are representative of the number of sufferers, while connection sizes are related to the number of RCTs, was produced to examine the direct and indirect evidence involving in multiple-intervention comparisons. The Brooks–Gelman–Rubin statistic using the potential scale reduction factor (PSRF) value was conducted to assess model convergence. Meanwhile, the node-splitting analysis was calculated to evaluate the consistency. The inconsistency index statistic (I2) was used to quantify the heterogeneity between different treatment strategies. In order to investigate the stability of results, a sensitivity analysis was carried out. In addition, the surface under the cumulative ranking curve (SUCRA) was ranked to examine the efficacy and safety of all included strategies in each outcome.
Results
Literature screening
Following the inclusion and exclusion criteria in search strategies, a total of 5,017 publications were identified using five databases, of which 1,993 records were removed because of duplicates, 928 were excluded by browsing titles and abstracts, and 2,067 were removed by reading full-text articles. Finally, 29 articles were included in this NMA (Wang et al., 2004; Wang, 2005; Zhang et al., 2006; Wang et al., 2010; Zhang et al., 2016; Gu, 2018; Li, 2018; Xiao and Hu, 2018; Xu et al., 2018; Zhang et al., 2018; Zhao, 2018; Chen et al., 2019; Liang, 2019; Shi, 2019; Di and Xia, 2020; Li et al., 2020; Rong et al., 2020; Wang, 2020; Yin et al., 2020; Yu et al., 2020; Zhang, 2020; Zhang and Li, 2020; Du et al., 2021; Huang, 2021; Li et al., 2021; Wang, 2021; Zhang, 2021; Zhao, 2021; Zhu et al., 2021). Detailed information of study selection can be found in Figure 1, and characteristics of the included RCTs are concluded in Table 1. Ingredients of each formula and quality control measures in all included publications are shown in Table 2. Accordingly, the composition of the four representative formulas including “Fuzheng Huayu tablet/capsule,” “Dahuang Zhechong pill,” “Anluo Huaxian pill,” and “Biejia Ruangan tablet” is listed in Supplementary Information S3.
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楼主: 梦回白驼山
发表于 2022-9-9 05:19
