ObjectiveTo compare the therapeutic effect of dual-chamber pacing (DDD) and ventricular single-chamber pacing (VVI) on arrhythmia via systematic evaluation. MethodsWith the method of Cochrane system evaluation, we searched Medline, Embase, CNKI, PubMed and Wanfang database (the searching time was up to June 30, 2016) for randomized controlled trials comparing DDD with VVI treatingcardiac arrhythmias. Meta analysis was performed using RevMan5.3 software. ResultsWe collected 12 randomized controlled trials of DDD and VVI pacing treating cardiac arrhythmia including 1 704 patients, but the quality of the studies were not good. The results of Meta analysis showed that:compared with VVI pacing mode, DDD pacing mode reduced the risk of atrial fibrillation[RR=0.36, 95%CI (0.22, 0.59), P < 0.000 1]; besides, it reduced the left atrial diameter[SMD=-0.43, 95%CI (-0.68, -0.17), P=0.001], the left ventricular end diastolic dimension[SMD=-0.33, 95%CI (-0.61, -0.05), P=0.02] and increased the left ventricular ejection fraction[SMD=1.03, 95%CI (0.49, 1.57), P=0.000 2]. ConclusionsComparing DDD with VVI on the treatment of cardiac arrhythmia in patients with cardiac arrhythmia, DDD pacing can reduce the incidence of atrial fibrillation and thrombosis, enhance heart function and improve blood supply. But because of the low quality of the included studies, the curative effect cannot be confirmed, and more randomized controlled trials with high quality needs to be carried out in the future.
Objective To assess the efficacy and safety of efalizumab in the treatment of psoriasis. Methods Randomized controlled trials (RCT) on efalizumab in the treatment of psoriasis were identified from The Cochrane Library ( issue 1, 2006) , specialized trials registered in Cochrane Skin Group (2006), MEDLINE (1966 - 2006) and EMBASE (1974 - 2006). The quality of the trials was assessed by two reviewers independently. RevMan 4.2.7 software provided by the Cochrane Collaboration was used for statistical analysis. Results Three RCTs involving 1 651 patients were included, all of which were of high methodological quality. All the patients were diagnosed as chronic moderate to severe plaque psoriasis with the age of 18-75 years. Meta-analysis indicated that at week 12, significantly more patients in both 1mg/kg/w and 2 mg/kg/w efalizumab subcutaneous groups achieved PASI50, PASI75, PASI90 improvement compared to the placebo group (Plt;0.0001), while there was no significant difference in PASI50, PASI75 and PASI90 responses between 1mg and 2mg efalizumab groups (P gt;0.05). No serious adverse effects were identified. Extended treatment for another 12w may contribute to further efficacy without increasing toxicty. Conclusions Efalizumab 12w therapy is safe and effective for treating adult patients with moderate to severe plaque psoriasis. More RCTs are required to assess the efficacy of the extended treatment.
Objectives To assess the effectiveness and safety of additional bedtime H2-receptor antagonists (H2RAs) in suppressing nocturnal gastric acid breakthrough (NAB). Methods We identified eligible trials by searching The Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMbase and CINAHL. We handsearched the data from the proceedings of correlated conferences, eight kinds of important Chinese journals and references of all included trials. All randomized controlled trials evaluating H2RAs for the control of NAB were eligible for inclusion. The systematic review was conducted using methods recommended by The Cochrane Collaboration. Results Only two randomized crossover studies including 32 participants met the inclusion criteria. Because the design, dosage and duration of the treatment were different between the studies, it was impossible to conduct Meta-analysis. There was no consistent conclusion between the two included studies in evaluating H2RAs for the control of NAB. Conclusion We can not conclude any implications for practice at this stage. Appropriately designed large-scale randomized controlled trials with long-term follow-up are needed to decide the effects of additional bedtime H2RAs in suppressing NAB.
High-quality randomized controlled trials (RCTs) are regarded as the gold standard for assessing the efficiency and safety of drugs. However, conducting RCTs is expensive and time consumed, and providing timely evidence by RCTs for regulatory agencies and medical decision-makers can be challenging, particularly for new or emerging serious diseases. Additionally, the strict design of RCTs often results in a weakly external validity, making it difficult to provide the evidence of the clinical efficacy and safety of drugs in a broader population. In contrast, large simple clinical trials (LSTs) can expedite the research process and provide better extrapolation and reliable evidence at a lower cost. This article presents the development, features, and distinctions between LSTs and RCTs, as well as special considerations when conducting LSTs, in accordance with literature and guidance principles from regulatory agencies both from China and other countries. Furthermore, this paper assesses the potential of real-world data to bolster the development of LSTs, offering relevant researchers’ insight and guidance on how to conduct LSTs.
Objective To evaluate the effect of neoadjuvant chemotherapy (NAC) on breast conserving surgery and the outcomes of treatment for women with operable breast cancer. Methods We searched The Cochrane Library (Issue 1, 2007), CENTRAL (1970 to 2007), PUBMED (1978 to March 2007), CBM (1978 to 2006), CNKI (1994 to 2007), CMCC (1994 to May 2007) and other relevant databases and journals. We identified randomized controlled trials (RCTs) comparing NAC plus breast conserving therapy (BCT) or mastectomy versus BCT or mastectomy plus postoperative chemotherapy in women with operable breast cancer. Two reviewers independently assessed trial quality and extracted data. Meta-analyses were performed for homogenous studies by using The Cochrane Collaboration’s RevMan 4.2.10. Results Three eligible studies involving 2 391 women were included. The median follow-up in the studies ranged from 17 to 137 months. The methodological quality of the three RCTs was high. Meta-analyses showed that NAC had no significant effect on overall survival (OS) (RR 0.99, 95%CI 0.92 to 1.07), disease-free survival (RR 1.04, 95%CI 0.94 to 1.15) and ipsilateral breast cancer recurrence (RR 1.34, 95%CI 0.84 to 2.13). Two RCTs revealed that NAC significantly increased the rate of BCT in operable breast cancer patients, but the other RCT reported similar rates of BCT in both groups. One RCT indicated that NAC did not increase the incidence of surgery-related local complications. Conclusions NAC is safe for the treatment of women with operable breast cancer, which may increase the rate of BCT and help to evaluate chemosensitivity. There is insufficient evidence to assess the effect of NAC on conserving surgery procedure and survival rate in operable BCT patients. More large-scale RCTs are needed to define further the role of NAC in the treatment of operable breast cancer patients.
Objective To evaluate the efficacy and safety of the treatment of chronic prostatitis(CP) in China. Methods We search the related original studies about the treatment for Chinese CP all over the world, and only included randomized controlled trials (RCTs). MEDLINE(1966-2007.5), PubMed (1966-2007.5), EMBASE(1988-2007.05), and four Chinese databases were electronically searched and 6 related journals were handsearched. The studies included in the references of eligible studies were additionally searched. Two reviewers independently screened the studies for eligibility, evaluated the quality and extracted the data from the eligible studies, with confirmation by cross-checking. Divergences of opinion were settled by discussion or consulted by the expert. Meta-analysis was performed by using Rev Man 4.2 software.Results Nine original studies involving 917 participants met inclusion criteria. Compared withplacebo, prostant, Wenglitong, Chuanshentong, alpha-blockers, bioflabonoid and porstat could reduce the NIH-chronic prostatitis symptom index[RR1.99, 95% CI（1.60, 2.48）； RR2.76 95% CI(2.13，3.57)； RR2.49, 95% CI(1.24, 4.97)； WMD -5.90，95%CI（-8.12，-3.68）； WMD -2.50, 95%CI（-4.85，-0.15）；WMD -6.07， 95%CI(-7.92， -4.22)]. Alpha-blockers, Wengl itong, bioflabonoid and porstat can also reduce the symtom index of pain.Conclusion Drug interventions could improve NIH-CPSI and total symptoms of CP in some degree, but can not improve all symptoms, future RCTs must use an appropriate sample size and optimal duration and follow-up of participants. It is important to improve the quality of internal original studies.
Objective To compare the effects of operative versus nonoperative treatment for displaced intra-articular calcaneal fractures. Methods All randomized controlled trials (RCTs) of operative versus nonoperative treatment for displaced intra-articular calcaneal fractures were identified. Quality assessment and data extraction were performed by two reviewers independently. Results Four published trials involving 530 patients were included. All studies compared operative with nonoperative treatment. It was clear that operative treatment was superior to nonoperative treatment in terms of helping patients back to work, reducing problems wearing shoes, expanding the range of motion of subtalar joint, and improving the recovery of Bohler’s angle. As for foot pain, there was no difference between the two methods. Because the outcome measures varied across the trials, a meta-analysis could not be performed. Conclusions Both operative and nonoperative treatments produce comparable long-term outcomes in the treatment of displaced intra-articular calcaneal fractures. Because of the poor reporting of outcomes, it is not possible to determine if there is any significant difference in outcome measures apart from those listed above. More trials with high methodological quality are needed.
Objective To systematically review the efficacy of different exercises on inflammatory cytokines in individuals with overweight or obesity. Methods The CNKI, WanFang Data, VIP, PubMed, EBSCO, Cochrane Library, Web of Science and Embase databases were electronically searched to collect randomized controlled trials (RCTs) on the efficacy of exercise on inflammatory cytokines in individuals with overweight or obesity from January, 2000 to April, 2021. Two reviewers independently screened the literature, extracted data, and assessed the risk of bias of the included studies. The network meta-analysis was then performed using Stata 16.0 software. Results A total of 63 RCTs were included, 49 of which reported the changes in IL-6, 47 of which reported the changes in TNF-α, and 16 of which reported the changes in IL-10. The results of the network meta-analysis found that compared with those in the control group, aerobic exercise (AE) (SMD=−0.9, 95%CI −1.4 to −0.5, P<0.01) and high-intensity interval training (HIIT) (SMD=−1.3, 95%CI −2.3 to −0.3, P=0.011) significantly reduced IL-6. AE (SMD=−1.3, 95%CI −1.7 to −0.9, P<0.01), combined exercise (COM) (SMD=−0.7, 95%CI −1.3 to −0.1, P=0.02), and HIIT (SMD=−1.8, 95%CI −2.6 to −0.9, P<0.01) significantly reduced TNF-α; AE (SMD=0.8, 95%CI 0.1 to 1.5, P=0.03) significantly increased IL-10. The cumulative probability ranking results showed that HIIT was the most effective in reducing IL-6 and TNF-α and increasing IL-10, followed by AE and COM, and resistance training (RT) was the least effective. Conclusion Different exercise types have different effects on improving inflammation in individuals with overweight or obesity. HIIT can be suggested as the best exercise program to improve chronic inflammation in individuals with overweight or obesity. Due to the limited quantity and quality of the included studies, more high-quality studies are needed to verify the above conclusion.
ObjectiveTo systematically evaluate the effects of vitamin D supplementation on fasting blood glucose, insulin resistance, β cell function in type 2 diabetes mellitus. MethodsDatabases including PubMed, The Cochrane Library (Issue 12, 2015), Web of Science, ScienceDirect Online, VIP, CNKI, WanFang Data, and CBM were searched to collect randomized controlled trials (RCTs) about vitamin D supplementation for type 2 diabetes mellitus from inception to December 2015. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Then meta-analysis was conducted by RevMan 5.3 and Stata12.0 softwares. ResultsA total of 22 RCTs involving 1 756 patients were included. The results of meta-analysis showed that, compared with the control group, the vitamin D supplementation group had a significant improvement in insulin resistance (SMD=–0.68, 95%CI –1.23 to –0.12, P=0.02), but there were no significant differences in levels of FPG, HbA1c and HOMA-β between the two groups (all P value > 0.05). Subgroup analysis showed that, the levels of FPG and HOMA-IR were significantly decreased in the vitamin D supplementation group in Middle Easterners and patients whose follow-up duration was less than three months. ConclusionVitamin D supplementation could improve HOMA-IR but could not improve the levels of FPG, HbA1c and HOMA-β. However, the evidence is weak to recommend vitamin D as a means of improving glycemic control, insulin resistance and β cell function in type 2 diabetes mellitus. Further larger, high quality trials are warranted.
目的 评价不同复苏方法和不同药物、氧疗、物理疗法等对新生儿窒息复苏和复苏后的预防措施的有效性和安全性.方法 计算机检索Cochrane Library(2004年第3期),MEDLINE(1966～2002年) 关于新生儿窒息复苏时不同复苏方法、氧气的应用、以及不同药物、剂量、给药途径治疗和预防新生儿窒息的系统评价、随机和半随机对照试验.结果 正压通气时使用100%氧气和应用室内空气的复苏效果并无差异.胎粪污染羊水(MSAF)与较高的新生儿缺血缺氧性脑病(HIE)的发生率有关,而气管内有胎粪者无论稀稠均与胎粪吸入综合征发生率无关.窒息复苏后预防性给予亚低温疗法、抗惊厥药、纳洛酮、多巴胺等在降低新生儿病死率,继发HIE的严重程度等方面与对照组相比无显著差异.应用肺表面活性物质(PS)预防和治疗新生儿呼吸窘迫综合征(RDS),可减少死亡率和并发症.结论 应用PS预防和治疗RDS可明显减少新生儿死亡率,且胎龄lt;32周的早产儿预防用药比治疗用药效果更好;目前尚无充分证据证明窒息复苏后预防性给予亚低温疗法、抗惊厥药、纳洛酮、多巴胺等治疗的有效性.