trial sequence analysis

试验序列分析
  • 文章类型: Journal Article
    连花清温(LHQW)颗粒,植物药物制剂,经常用作肺炎支原体肺炎(MPP)的辅助治疗。然而,该治疗的临床疗效和安全性仍不确定.
    本研究旨在评估LHQW颗粒联合阿奇霉素(AZM)治疗儿童MPP的疗效和安全性。
    为了确定LHQW颗粒加AZM的所有随机对照试验(RCT),在八个中文和英文数据库中进行了搜索(CNKI,万芳,VIP,Sinomed,PubMed,Embase,WebofScience,和Cochrane图书馆)从成立到2023年12月25日。采用Meta回归和亚组分析研究异质性。进行敏感性分析和试验序贯分析(TSA)以评估结果的稳健性。此外,建议评估的等级,利用开发和评估(GRADE)系统评估证据质量。
    本研究共纳入15项RCT,涉及1909名参与者。荟萃分析结果表明,LHQW颗粒与AZM联合治疗在疗效和安全性上与单纯AZM有显著差异。在以下结果中具体观察到:反应率(RR=1.17,95%CI:1.12至1.22,p<0.01),退热时间(MD=-1.32,95%CI:-1.66至-0.98,p<0.01),咳嗽消失时间(MD=-1.76,95%CI:-2.47至-1.05,p<0.01),肺部啰音消失时间(MD=-1.54,95%CI:-2.06至-1.02,p<0.01),C反应蛋白(CRP)(MD=-5.50,95%CI:-6.92至-4.07,p<0.01),降钙素原(PCT)(MD=-0.31,95%CI:-0.38至-0.24,p<0.01),白细胞介素6(IL-6)(MD=-5.97,95%CI:-7.39至-4.54,p<0.01),肿瘤坏死因子α(TNF-α)(MD=-5.74,95%CI:-7.44至-4.04,p<0.01),强迫肺活量(FVC)(SMD=0.48,95%CI:0.34至0.62,p<0.01),第一秒用力呼气量(FEV1)(SMD=0.55,95%CI:0.44至0.67,p<0.01),FEV1/FVC(SMD=0.49,95%CI:0.32至0.67,p<0.01),CD4+T淋巴细胞(CD4+)(MD=4.04,95%CI:3.09~4.98,p<0.01),CD8+T淋巴细胞(CD8+)(MD=-3.32,95%CI:4.27~2.38,p<0.01)和不良事件(RR=0.65,95%CI:0.43~0.96,p<0.01)。
    LHQW颗粒联合AZM可能是治疗儿童MPP的更好策略。然而,LHQW颗粒的临床疗效和安全性需要进一步验证.
    https://www.crd.约克。AC.英国/PROSPERO/。
    UNASSIGNED: Lianhua Qingwen (LHQW) granule, a botanical drug preparation, is frequently utilized as an adjuvant treatment for mycoplasma pneumoniae pneumonia (MPP). Nevertheless, the clinical efficacy and safety of this treatment remain uncertain.
    UNASSIGNED: This study aims to evaluate the efficacy and safety of LHQW granule combined with azithromycin (AZM) in treating MPP in children.
    UNASSIGNED: To identify all randomized controlled trials (RCTs) of LHQW granule plus AZM, a search was conducted in eight Chinese and English databases (CNKI, Wan Fang, VIP, Sinomed, PubMed, Embase, Web of Science, and Cochrane Library) from their inception until 25 December 2023. Meta-regression and subgroup analysis were employed to investigate heterogeneity. Sensitivity analysis and trial sequential analysis (TSA) were conducted to assess the robustness of the findings. Additionally, the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system was utilized to evaluate the quality of evidence.
    UNASSIGNED: A total of 15 RCTs involving 1909 participants were included in this study. The meta-analysis results indicated combination therapy of LHQW granule and AZM is significant different from AZM alone in both efficacy and safety, which are specifically observed in the following outcomes: response rate (RR = 1.17, 95% CI: 1.12 to 1.22, p < 0.01), antipyretic time (MD = -1.32, 95% CI: -1.66 to -0.98, p < 0.01), cough disappearance time (MD = -1.76, 95% CI: -2.47 to -1.05, p < 0.01), pulmonary rale disappearance time (MD = -1.54, 95% CI: -2.06 to -1.02, p < 0.01), c-reactive protein (CRP) (MD = -5.50, 95% CI: -6.92 to -4.07, p < 0.01), procalcitonin (PCT) (MD = -0.31, 95% CI: -0.38 to -0.24, p < 0.01), interleukin 6 (IL-6) (MD = -5.97, 95% CI: -7.39 to -4.54, p<0.01), tumor necrosis factor α (TNF-α) (MD = -5.74, 95% CI: -7.44 to -4.04, p < 0.01), forced vital capacity (FVC) (SMD = 0.48, 95% CI: 0.34 to 0.62, p < 0.01), forced expiratory volume in the first second (FEV1) (SMD = 0.55, 95% CI: 0.44 to 0.67, p < 0.01), FEV1/FVC (SMD = 0.49, 95% CI: 0.32 to 0.67, p < 0.01), CD4+ T lymphocyte (CD4+) (MD = 4.04, 95% CI: 3.09 to 4.98, p < 0.01), CD8+ T lymphocyte (CD8+) (MD = -3.32, 95% CI: 4.27 to 2.38, p < 0.01) and adverse events (RR = 0.65, 95% CI: 0.43 to 0.96, p < 0.01).
    UNASSIGNED: The combination therapy of LHQW granule and AZM may be a better strategy to treat MPP in children. However, the clinical efficacy and safety of LHQW granule require further validation.
    UNASSIGNED: https://www.crd.york.ac.uk/PROSPERO/.
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  • 文章类型: Journal Article
    方法:系统评价和荟萃分析。
    目的:关于降钙素(CT)对腰椎管狭窄症(LSS)的影响存在争议。本系统综述和荟萃分析旨在评估支持使用CT治疗LSS患者的证据的强度。
    方法:我们通过4个数据库进行了电子搜索,描述了从数据库创建之日起至2023年1月的随机对照试验(RCT)。3名不同的研究人员进行了独立的文献筛选,数据提取,和质量评估。结果测量包括视觉模拟量表(VAS),步行距离,和奥斯威西残疾指数(ODI)。使用RevMan5.4,Stata16.0和TSA0.9进行Meta分析和试验序列分析(TSA)。3.6级用于评估证据质量。
    结果:我们接受了9项研究,共有496名参与者。荟萃分析显示,CT在VAS方面没有显着改善,步行距离,或ODI患者的LSS。
    结论:没有证据表明CT对LSS患者有益处,单独或与其他治疗相结合,或者根据给药途径,根据相关随机对照试验的系统评价和荟萃分析。
    METHODS: Systematic review and meta-analysis.
    OBJECTIVE: There is some controversy about the effects of calcitonin (CT) on lumbar spinal stenosis (LSS). This systematic review and meta-analysis is to assess the strength of the evidence supporting the use of CT in the treatment of patients with LSS.
    METHODS: We performed an electronic search depicting randomized controlled trials (RCTs) through 4 databases from the date of database creation to January 2023. 3 different researchers conducted independent literature screening, data extractions, and quality assessments. The outcome measures included visual analogue scale (VAS), walking distance, and oswestry disability index (ODI). Meta-analysis and trial sequence analysis (TSA) were carried out using RevMan 5.4, Stata 16.0, and TSA 0.9. GRADE 3.6 was used to evaluate the evidence quality.
    RESULTS: We accepted 9 studies with 496 participants. The meta-analysis revealed that CT offered no significant improvement in VAS, walking distance, or ODI in patients with LSS.
    CONCLUSIONS: There is no evidence that CT has a benefit in patients with LSS, either alone or in combination with other treatments, or depending on the route of administration, according to the systematic review and meta-analysis of relevant RCTs.
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  • 文章类型: Systematic Review
    未经评估:本荟萃分析旨在研究针灸缓解肾绞痛和降低镇痛相关并发症风险的疗效。
    UNASSIGNED:比较针刺(针刺组)与常规干预(对照组)疗效的随机对照试验(RCT)从MEDLINE,EMBASE,Cochrane图书馆数据库,中国知网(CNKI),和Airiti图书馆到2022年7月15日。主要结果是有效疼痛缓解率(缓解率),而次要结局包括疼痛缓解的时间,视觉模拟评分(VAS)在30-60分钟和副作用的风险。
    UNASSIGNED:分析了1992年至2021年间发表的13项符合条件的研究,涉及1,212名参与者。与对照组相比,接受针灸治疗的患者有较高的总体反应率[风险比(RR)=1.12,95%CI:1.05-1.19,p=0.0002,I2=41%,1,136例患者(主要结果)和更快的疼痛缓解[MD=-10.74分钟,95%CI:-12.65至-8.82,p<0.00001,I2=87%,839名患者]。接受针灸治疗的患者疼痛评分较低[MD=-0.65,95%CI:-1.09至-0.21,p=0.21,I2=55%,327例患者]和副作用的风险(RR=0.11,95%CI:0.04-0.26,p<0.00001,I2=0,314例)与接受常规干预的患者相比。试验序列分析的结果表明,有足够的证据支持针灸对反应率的有益作用,时间来缓解疼痛,和疼痛评分在30-60分钟。
    UNASSIGNED:与基于常规镇痛的干预措施相比,针刺可以更有效地缓解肾绞痛,不良反应更少。纳入研究的数量和质量有限,需要更多的临床随机对照试验来支持我们的发现。
    UNASSIGNED:https://www。crd.约克。AC.英国/普华永道/,标识符CRD42022346714。
    UNASSIGNED: This meta-analysis aimed at investigating the efficacy of acupuncture for relieving renal colic and reducing the risk of analgesic-related complications.
    UNASSIGNED: Randomized controlled trials (RCTs) comparing the efficacy of acupuncture (acupuncture group) with conventional interventions (control group) were screened from MEDLINE, EMBASE, Cochrane library databases, China Knowledge Network (CNKI), and Airiti Library till July 15, 2022. The primary outcome was the rate of effective pain relief (response rate), while secondary outcomes included the time of onset of pain relief, visual analog scale (VAS) at 30-60 min and risk of side effects.
    UNASSIGNED: Thirteen eligible studies involving 1,212 participants published between 1992 and 2021 were analyzed. Compared with the control group, patients receiving acupuncture had a higher overall response rate [risk ratio (RR) = 1.12, 95% CI: 1.05-1.19, p = 0.0002, I 2 = 41%, 1,136 patients] (primary outcome) and a faster pain relief [MD = -10.74 min, 95% CI: -12.65 to -8.82, p < 0.00001, I 2 = 87%, 839 patients]. Patients receiving acupuncture had a lower pain score [MD = -0.65, 95% CI: -1.09 to -0.21, p = 0.21, I 2 = 55%, 327 patients] and risk of side effects (RR = 0.11, 95% CI: 0.04-0.26, p < 0.00001, I 2 = 0, 314 patients) compared to those receiving conventional interventions. Results from trial sequence analysis revealed sufficient evidence supporting the beneficial effects of acupuncture on response rate, time to pain relief, and pain score at 30-60 min.
    UNASSIGNED: Compared with conventional analgesic-based interventions, acupuncture can more efficiently relieve renal colic with fewer adverse effects. The limited number and quality of included studies warrant more clinical RCTs to support our findings.
    UNASSIGNED: https://www.crd.york.ac.uk/prospero/, identifier CRD42022346714.
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  • 文章类型: Journal Article
    背景:随机对照试验(RCT)已经证明,积极的水合乳酸林格氏液(LR)可降低内镜下逆行胰胆管造影术(ERCP)后胰腺炎(PEP)的发生频率和严重程度。在这项试验序贯分析(TSA)中,我们旨在评估在特定患者亚组中积极水化对PEP的预防效果,并确定是否需要额外的RCTs.
    方法:我们进行了系统而全面的搜索,以确定到2021年8月发表的所有随机对照研究,这些研究检查了积极的水合作用预防PEP的有效性。主要结果是PEP的频率。我们还进行了TSA以计算所需的信息大小并评估我们的结果是否是结论性的。
    结果:分析包括12项研究,涉及2,501例患者。根据TSA,积极水化组(5.6%;1,327例患者中的74例)的PEP总体频率显著低于对照组(13.1%;1,174例患者中的154例)(风险比[RR]:0.458;95%置信区间[CI]:0.350~0.599).在平均风险患者的亚组分析中,累积Z曲线穿过常规试验边界和试验序贯监测边界.然而,在高危人群和中度至重度PEP患者中,Z曲线未穿过试验序贯监测边界.
    结论:该TSA表明积极的水合作用在PEP的整体预防中是有效的。然而,在高危人群中,需要额外的随机对照试验来检查LR积极水化对PEP的预防作用.
    Randomized controlled trials (RCTs) have demonstrated that aggressive hydration with lactated Ringer\'s (LR) solution reduces the frequency and severity of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). In this trial sequential analysis (TSA), we aimed to evaluate the prophylactic effect of aggressive hydration on PEP in specific patient subgroups and to determine the need for additional RCTs.
    We conducted a systematic and comprehensive search to identify all randomized controlled studies published through August 2021 that examined the effectiveness of aggressive hydration for preventing PEP. The primary outcome was the frequency of PEP. We also performed TSA to calculate the required information size and assess whether our results were conclusive.
    The analysis included 12 studies involving 2,501 patients. According to the TSA, the overall frequency of PEP was significantly lower in the aggressive hydration group (5.6%; 74 of 1,327 patients) than in the control group (13.1%; 154 of 1,174 patients) (risk ratio [RR]: 0.458; 95% confidence interval [CI]: 0.350-0.599). In the subgroup analysis of patients with average risk, the cumulative Z curve crossed both the conventional test boundary and the trial sequential monitoring boundary. However, in the high-risk group and in patients with moderate-to-severe PEP, the Z curve did not cross the trial sequential monitoring boundary.
    This TSA indicates that aggressive hydration is effective in the overall prevention of PEP. However, additional RCTs are required to examine the prophylactic effect of aggressive hydration with LR on PEP in high-risk populations.
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  • 文章类型: Systematic Review
    Background: Conservative oxygen therapy can prevent both hypoxemia and hyperoxemia, but the effect on the prognosis of patients admitted to the intensive care unit (ICU) remains controversial. Methods: All controlled studies comparing conservative oxygen therapy and conventional oxygen therapy in adult patients admitted to the ICU were searched. The primary outcome was mortality, and the secondary outcomes were length of ICU stay (ICU LOS), length of hospital stay (hospital LOS), length of mechanical ventilation (MV) hours, new organ failure during ICU stay, and new infections during ICU stay. Results: Nine trials with a total of 5,759 patients were pooled in our final studies. Compared with conventional oxygen therapy, conservative oxygen therapy did not reduce overall mortality (Z = 0.31, p = 0.75) or ICU LOS (Z = 0.17, p = 0.86), with firm evidence from trial sequential analysis, or hospital LOS (Z = 1.98, p = 0.05) or new infections during the ICU stay (Z = 1.45, p = 0.15). However, conservative oxygen therapy was associated with a shorter MV time (Z = 5.05, p < 0.00001), reduction of new organ failure during the ICU stay (Z = 2.15, p = 0.03) and lower risk of renal replacement therapy (RRT) (Z = 2.18, p = 0.03). Conclusion: Conservative oxygen therapy did not reduce mortality but did decrease MV time, new organ failure and risk of RRT in critically ill patients. Systematic Review Registration: identifier [CRD42020171055].
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  • 文章类型: Journal Article
    Cancer is the leading cause of death in economically developed countries and the second leading cause of death in developing countries. The relationship between genetic polymorphisms and the risk of cancers has been widely researched. Excision repair cross-complementing group 2 (ERCC2) gene plays important roles in the nucleotide excision repair pathway. There is contrasting evidence on the association between the ERCC2 Asp312Asn polymorphism and the risk of cancer. We conducted a comprehensive meta-analysis in order to assess the correlation between these factors. We searched the PubMed, EMBASE, Science Direct, Web of Science, and CNKI databases for studies published from January 1, 2005 to January 1, 2016. Finally, 86 articles with 38,848 cases and 48,928 controls were included in the analysis. The overall analysis suggested a significant association between the ERCC2 Asp312Asn polymorphism and cancer risk. Furthermore, control source, ethnicity, genotyping method, and cancer type were used for subgroup analysis. The result of a trial sequential analysis indicated that the cumulative evidence is adequate; hence, further trials were unnecessary in the overall analysis for homozygote comparison. In summary, our results suggested that ERCC2 Asp312Asn polymorphism is associated with increased cancer risk. A significantly increased cancer risk was observed in Asian populations, but not in Caucasian populations. Furthermore, the ERCC2 Asp312Asn polymorphism is associated with bladder, esophageal, and gastric cancers, but not with breast, head and neck, lung, prostate, and skin cancers, and non-Hodgkin lymphoma. Further multi-center, well-designed studies are required to validate our results.
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