Objective To systematically review the effectiveness and safety of hyperthermia (HT) plus intraperitoneal hyperthermic perfusion chemotherapy (IHPC) versus IHPC alone for malignant ascites. Methods Such databases as PubMed, The Cochrane Library, EMbase, VIP, WanFang, CNKI and CBM were electronically and comprehensively searched for randomized controlled trials (RCTs) on HT plus IHPC vs. IHPC alone for malignant ascites from inception to March 2013. Two reviewers independently screened studies according to inclusion and exclusion criteria, extracted data and assessed quality of the included studies. References of the included studies were also retrieved. Then, meta-analysis was performed using RevMan 5.1 software. Results A total of 16 RCTs involving 984 patients were included. The results of meta-analysis showed that, compared with the IHPC alone group, the HT plus IHPC group had a higher effective rate of controlling ascites (OR=3.40, 95%CI 2.58 to 4.48, Plt;0.000 01), better improvement in quality of life (OR=2.77, 95%CI 1.90 to 4.05, Plt;0.000 01), with significant differences. The two groups were alike in 1-year survival with no significant difference (OR=1.80, 95%CI 0.61 to 5.31, P=0.28). As for safety, there was no significant difference between the two groups in the incidences of nausea and vomiting, abdominal distension and pain, myelosuppression, diarrhea, and constipation. Conclusion The results of this systematic review show that, compared with IHPC alone, HT plus IHPC improves the effective rate as well as the quality of life of patients with malignant ascites, and it does not increase the incidences of adverse reactions. Due to the limited quality and quantity of the included studies, more high quality RCTs with larger sample size are needed to verify the above conclusion.
Objective To systematically review the effects of enteral immunonutrition (EIN) on postoperative infection and the length of hospital stay in patients with gastrointestinal cancer after surgery, in order to provide high quality evidence for the rational perioperation nutrition plan for patients with malignant gastrointestinal tumor. Methods Randomized controlled trials (RCTs) published in English about application of EIN vs. general treatment for gastrointestinal surgery published from Jan. 1st, 1997 to Oct. 31st 2012 were retrieved in the following databases: PubMed, Ovid, and EMbase. References of the included studies were also retrieved. According to the inclusion and exclusion criteria, two reviewers independently screened studies, extracted data, and evaluated the methodological quality. Then, meta-analysis was conducted using RevMan 5.2 software. Results 19 RCTs involving 2 298 patients were included. The results of meta-analysis showed that: there was no significant difference between the postoperative EIN group and the control group in reducing the risk of postoperative infection (OR=0.91, 95%CI 0.56 to 1.47, P=0.70); But postoperative and perioperative EIN had reduced the risk of postoperative infection with a significant difference (OR=0.57, 95%CI 0.39 to 0.82, P=0.002; OR=0.52, 95%CI 0.35 to 0.76, P=0.000 9). Additionally, the results of sensitivity analysis revealed that: no matter when EIN was used (during preoperative, postoperative, or perioperative periods), it reduced the length of postoperative hospital stay with significant differences, compared to the standard nutrition group (OR= −2.39, 95%CI −3.28 to −1.49, Plt;0.000 01; OR= −2.42, 95%CI −4.07 to −0.78, P=0.004; OR= −2.76, 95%CI −3.46 to −2.06, Plt;0.000 01). Conclusion Current evidence shows that perioperative EIN can decrease postoperative infection and reduce the length of hospital stay of patients with malignant gastrointestinal tumor. Due to the limited quantity and quality of the included studies, high quality RCTs are needed to verify the above conclusion.
Objective To evaluate the curative effectiveness and safety of transanal endoscopic microsurgery (TEM) vs. radical surgery (RS) for the patients with rectal malignant tumor, and to provide information for clinical research and practice. Methods Through computer searching The Cochrane Central Register of Controlled Trials, PubMed, OVID, CBM and CNKI from inception to April 2010, and hand searching relevant journals including Chinese Journal of Surgery and Chinese Journal of Evidence-Based Medicine, the randomized controlled trails (RCTs) and non-randomized controlled trails (NRCTs) comparing TEM with RS for rectal malignant tumor were collected. Data were extracted and evaluated by two reviewers independently according to the Cochrane Handbook for Systematic Reviews. Meta-analyses were conducted using the Cochrane collaboration’s software RevMan 5.0. Results One RCT and four NRCTs met the selection criteria, involving 929 patients. The methodological quality of all trials was low with possibility of bias. The meta-analyses showed that: a) Three studies reported local recurrence in T1 stage patients. There was a significant difference in local recurrence between the two groups (OR=12.61, 95%CI 2.59 to 61.29, P=0.002); b) Two studies reported disease-free survival in T1 stage patients. There was no significant difference between the two groups in disease-free survival (OR=1.12, 95%CI 0.31 to 4.12, P=0.86); c) Three studies reported overall survival in T1 stage patients. There was no significant difference between the two groups (OR=1.09, 95%CI 0.57 to 2.08, P=0.80); and d) Three studies reported postoperative complications in T1 stage patients. There was a significant difference between the two groups in terms of complications (OR=0.05, 95%CI 0.02 to 0.10, Plt;0.00001). Conclusion For T1 stage patients, TEM is associated with less injury of tissue, less operative bleeding, short duration of hospital stay, and low incidence of postoperative complications. The disease-free and overall survivals are comparable to those of RS, but the local recurrence rate is higher. The role of TEM in T2 stage patients is still under discussion. However, the trails available for this systematic review are of lower methodological quality, and bias may exist due to NRCTs. Therefore, more high quality RCTs are required.
Objective To evaluate the relationship between body mass index (BMI) and malignant lymphoma by means of Meta-analysis. Methods Such databases as Web of Science, PubMed, EBbase, CNKI, Wanfang, VIP and CBM were searched from the date of their establishment to April 2011 to collect the case control studies on the relationship between BMI and malignant lymphoma. Two researchers independently selected studies, extracted data and assessed the quality according to the inclusive and exclusive criteria, and then conducted Meta-analyses by using RevMan5.0 software for heterogeneity test and pooled OR calculation. Results Seven case control studies involving 8416 malignant lymphoma patients and 14760 other patients were included. The quality of all studies scored 4, indicating reliable quality. Meta-analyses of the low BMI, overweight and obesity population were OR=0.8, 95%CI 0.79 to 0.95, P=0.003; OR=1.04, 95%CI 0.98 to 1.11, P=0.16; and OR=1.22 95%CI 1.04 to 1.43, P=0.01, respectively. The stratified Meta-analysis on histological subtypes showed that obesity was associated with a significantly increased risk of diffuse large B cell lymphoma (OR=1.33 95%CI 1.18 to 1.50, Plt;0.000 01), but was not associated with the follicular lymphoma or small lymphocytic lymphoma/chronic lymphocytic leukemia. Conclusion These findings demonstrate that low BMI is associated with the decrease of malignant lymphoma, and obesity is an increasing risk of malignant lymphoma, especially, the diffuse large B cell lymphoma.
Objective To assess the methodological quality of clinical studies using Shen-Mai injection as an adjunct therapy to tumor chemotherapy and to evaluate its efficacy and safety. Methods A comprehensive search strategy was designed to identify all randomized controlled trials (RCT) comparing Shen-Mai injection plus routine chemotherapy versus routine chemotherapy alone by searching for the CBMdisc (issue 3) and TCMLRS database (1981-2001). The methodological quality of the trials was assessed by two reviewers independently for which a meta analysis was perfermed. Results Thirteen RCTs met the inclusion criteria. methodological quality was poor (all the trials included were level C). Compared with the control group, the combined outcome of Shen-Mai injection increased the effect of chemotherapy (OR 1.73 95%CI 1.27 to 2.34, P＝0.000 4), reduced the side effect of bone marrow inhibition (OR 0.29, 95%CI 0.16 to 0.52, P＝0.000 04) in WBC counting and (OR 0.11, 95%CI 0.02 to 0.49, P＝0.004 in PLT count. And Shen-Mai injection relieved the symptoms of nausea and vomiting (OR 0.26, 95%CI 0.16 to 0.43, Plt;0.000 01). Conclusions The methodological quality of the trails using Shen-Mai injection should be improved. Based on the results of the review and the meta-analysis, Shen-Mai injection may have positive effects on chemotherapy in patients with malignant tumor, although the evidence is weak. No serious adverse events are reported. Further well-designed clinical trials should be performed.
Objective To systematically evaluate the clinical effectiveness and safety of raltitrexed plus cisplatin in the treatment of malignant pleural mesothelioma (MPM) when compared with other chemotherapy regimens. Methods We electronically searched PubMed, Embase, The Cochrane Library and Chinese Biomedicine Database to March, 2007. Randomized controlled trials (RCTs) and quasi-RCTs were identified, and Revman 4.2.10 was applied for statistical analyses. Results One RCT involving 250 patients was included, which compared raltitrexed plus cisplatin versus cisplatin alone in the treatment of MPM. In the intention-to-treat population, the median survival time was statistically longer in the raltitrexed plus cisplatin group as compared to cisplatin alone group. (11.4 versus 8.8 months, P=0.048). The incidence of grade 3/4 toxicities was similar between the two groups. Conclusion The current evidence available showed that, the combination of raltitrexed and cisplatin may prolong the survival time for MPM patients, with a low incidence of grade 3/4 toxicities. However, more high-quality RCTs are required to further define its clinical effectiveness.
【摘要】 目的 采用循证医学的方法评价甘露聚糖肽联合顺铂对比单用顺铂治疗恶性胸腔积液的有效性和安全性。 方法 计算机检索中国生物医学文献数据库、中国期刊全文数据库、中文科技期刊全文数据库、万方数据库，收集甘露聚糖肽联合顺铂对比单用顺铂治疗恶性胸腔积液的随机对照试验，检索时间为各数据库建库至2011年3月。对文献进行质量评价，用RevMan 5.0软件对数据进行Meta分析。 结果 共纳入6项研究，所有文献质量均为C级。共收入388例患者，Meta分析结果显示甘露聚糖肽联合顺铂组与单用顺铂组相比，总有效率前者高于后者，差异有统计学意义（Plt;0.05）；消化道不良反应发生率两组组间差异无统计学意义（P=0.05）；骨髓抑制发生率前者低于后者，差异有统计学意义（Plt;0.05）；Karnofsky评分提高率前者高于后者，差异有统计学意义（Plt;0.05）。 结论 系统评价表明，甘露聚糖肽联合顺铂治疗恶性胸腔积液的疗效优于单用顺铂的方案。【Abstract】 Objective To assess the clinical efficacy and safety of mannatide plus cisplatin treating malignant pleural effusion. Methods Literatures were retrieved from CBM, VIP, CNKI, Wanfang databases by computer. Literatures were enrolled according to inclusion and exclusion criteria, and the quality of studies was evaluated according to the Cochrane Library handbook. The period duration of searching was between the establishment of the databases and March, 2011. Meta-analysis was conducted by RevMan 5.0 software. Results The meta-analysis of 6 included RCT, all ranked C, which involved 388 patients. The Meta-analysis showed that the total effective rate in mannatide plus cisplatin group significantly differed from that in cisplatin group (P＜0.05). There were no significant difference in the adverse reaction of digestive tract between the two intervention groups (P=0.05). The adverse reaction of marrow depression inmannatide plus cisplatin group was much lower than that in cisplatin group (P＜0.05). The increase of KPS in mannatide plus cisplatin group was higher than that in cisplatin group (P＜0.05). Conclusions The analysis indicates mannatide plus cisplatin has a better effect on malignant pleural effusion than single cisplatin. However, the reliability of this review is affected by poor quality of included studies, and large-scale randomized controlled trials of high quality are needed to confirm the conclusions above.