ObjectiveTo investigate the predicting effect of PIK3CA mutations for the efficacy and prognosis of hepatocellular carcinoma (HCC) patients received surgical resection. MethodsPCR and DNA sequencing were used to detect the PIK3CA mutation status of 79 HCC tissues, its impact on the short and long term effects of the patients were analyzed. ResultsIn this group of patients, mutation rate of PIK3CA gene exon 9 was 39.24% (31/79), PIK3CA mutation rate correlated with lymph node status and tumor differentiation (P < 0.05). The therapeutic effect of patients with PIK3CA mutation was significantly poor than that of the non-mutated group (P < 0.05). The three-year cumulative survival of patients with PIK3CA mutation (33.33%) was significantly lower than non-mutated group's (60.00%) by Kaplan-Meier (P < 0.05). ConclusionPIK3CA gene mutation in exon 9 could impact the efficiency of surgical resection in patients with HCC and could predict a poor survival prognosis.
Objective To systematically review the efficacy and safety of glucocorticoids for severe COVID-19 and to provide references for the treatment strategy of severe COVID-19 patients. Methods PubMed, EMbase, The Cochrane Library, Web of Science, ClinicalTrials.gov, WanFang Data and CNKI databases were electronically searched to collect randomized controlled trials (RCTs) that reported glucocorticoid therapy for severe COVID-19 patients from inception to August 26th, 2021. Two reviewers independently screened the literature, extracted data, and assessed the risk of bias of the included studies. Meta-analysis was then performed using RevMan 5.3 software. Results A total of 7 RCTs involving 6 236 patients were included. The meta-analysis results showed that compared with usual care, glucocorticoids significantly reduced the all-cause mortality of severe COVID-19 (RR=0.84, 95%CI 0.77 to 0.91, P<0.000 1), whereas no significant difference was found in the progression of complex diseases between the two groups (RR=0.84, 95%CI 0.69 to 1.01, P=0.06). Glucocorticoids did not increase adverse effects in severe COVID-19 compared with usual care (general adverse events: RR=1.15, 95%CI 0.66 to 2.03, P=0.62; serious adverse events: RR=1.13, 95%CI 0.54 to 2.38, P=0.75). Conclusion Current evidence suggests that glucocorticoids are effective in treating severe COVID-19 without significantly increasing adverse events. However, due to the limited quantity and quality of the included studies, more high-quality studies are needed to verify the conclusion.
ObjectiveTo evaluate the efficacy and safety of Xueshuantong combined with conventional western medicine for angina pectoris in coronary heart disease (CHD) patients. MethodsWe searched the Cochrane Library (2013.12), Medline (2013.10), EMbase (unlimited-2013.10), China Nation Knowledge Infrastructure (unlimited-2013.10) and the Wanfang Database (unlimitied-2013.10), Weipu Database (unlimited-2013.10), and CBM (unlimited-2013.10) on computers for parallel group randomized controlled trials (RCTs) comparing Xueshuantong and placebo for patients with angina pectoris. Three researchers selected the trials based on the inclusion and exclusion criteria and then extracted the data, assessed the quality of each trial independently. After cross checking, the Cochrane Collaboration's RevMan 5.1 software was used to perform Meta-analysis. ResultsThirteen RCTs and a total of 1 298 participants were involved. Meta-analysis showed that Xueshuantong combined with the conventional western medicine had better curative effect on angina pectoris for CHD than conventional therapy; stable angina pectoris [RR=1.24, 95%CI (1.12, 1.37), P<0.000 1]; unstable angina pectoris [RR=1.22, 95%CI (1.15, 1.29), P<0.000 01]. There was also significant difference in total curative effect between the two groups [RR=1.22, 95%CI (1.16, 1.29), P<0.000 01]. Xueshuantong also had better curative effect on improving performance of electrocardiogtram (ECG): stable angina pectoris [RR=1.30, 95%CI (1.11, 1.51), P=0.000 8]; unstable angina pectoris [RR=1.18, 95%CI (1.10, 1.28), P<0.000 1]. There was also significant difference in total curative effect on improving performance of ECG between the two groups [RR=1.21, 95%CI (1.13, 1.29), P<0.000 01]. But there was no significant difference in adverse effects rate between the two groups [RR=4.50, 95%CI (0.99, 20.53), P=0.05]. ConclusionCompared with conventional therapy, Xueshuantong combined with conventional western medicine has better curative effect with improved performance of ECG. The adverse effect rate between the two groups is not significantly different. But because of the small scale, inferior quality, and bias risk of these trials, large-scale, rational designed, multicenter RCTs are needed to confirm our conclusions.
Precision medicine is a personalized medical system based on patients' individual biological information, clinical symptoms and signs, forming a new clinical research model and medical practice path. The basic idea of traditional Chinese medicine and the concept of precision medicine share many similarities. The basket trial developed for precision medicine is also suitable for clinical trials and evaluation of the efficacy of traditional Chinese medicine syndrome differentiation and treatment systems. Basket trials are used to evaluate the efficacy of a drug in the treatment of multiple diseases or disease subtypes. It has the advantages of sharing a master protocol, unifying management of subsidiary studies, simplifying the test implementation process, unifying statistical analysis, saving resources, reducing budgets and accelerating the drug evaluation progress. This is similar to the concept of using the "same treatment for different diseases" found in traditional Chinese medicine. This paper introduced the concept and method of basket trials and explored their application and advantages in clinical research into traditional Chinese medicine. This study is expected to provide references for the methodological innovation of clinical research into traditional Chinese medicine.
ObjectiveTo systematically review the efficacy and safety of JAK inhibitor in the treatment of axial spondyloarthritis (axSpA). MethodsThe PubMed, Cochrane Library, Embase, CNKI, WanFang Data, and VIP databases were electronically searched to collect randomized controlled trials (RCTs) on the efficacy and safety of JAK inhibitors in patients with axSpA from inception to December, 2023. Two reviewers independently screened the literature, extracted data, and assessed the risk of bias of the included studies Meta-analysis was then performed using RevMan 5.3 software. ResultsA total of 7 RCTs involving 1 602 patients were included, including 852 patients in the experimental group and 750 patients in the placebo group. The results of meta-analysis showed that in terms of clinical efficacy, ASAS20 (RR=1.67, 95%CI 1.50 to 1.86, P<0.01), ASAS40 (RR=2.30, 95%CI 1.93 to 2.73, P<0.01), ΔBASFI (MD=−1.04, 95%CI −1.21 to −0.87, P<0.01), and ΔBASMI (MD=−0.30, 95%CI −0.41 to −0.19, P<0.01) of JAK inhibitors in the treatment of axSpA patients were significantly higher than those in the placebo group. In terms of safety, adverse event (RR=1.09, 95%CI 0.97 to 1.21, P=0.14) and major adverse events, such as diarrhea (RR=1.18, 95%CI 0.55 to 2.51, P=0.67), nasopharyngitis (RR=0.98, 95%CI 0.55 to 1.75, P=0.96), liver enzyme abnormalities (RR=1.83, 95%CI 0.84 to 3.99, P=0.13), and headache (RR=1.94, 95%CI 0.77 to 4.87, P=0.16) were statistically insignificant. ConclusionCurrent evidence shows that JAK inhibitors can improve the clinical efficacy in the axSpA patients, and the safety is high. Due to the limited quality and quantity of the included studies, more high quality studies are needed to verify the above conclusion.
ObjectiveTo systematically review the efficacy of immunoglobulin for treatment of clinical diagnosed viral encephalitis in China.MethodsCNKI, VIP, WanFang Data, PubMed, ScienceDirect, The Cochrane Library and EMbase databases were electronically searched to collect randomized controlled trials (RCTs) of immunoglobulin for treatment of clinical diagnosed viral encephalitis in China from inception to January 2021. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Meta-analysis was then performed by using RevMan 5.4 software.ResultsA total of 57 RCTs involving 4 431 patients were included. The results of meta-analysis showed that in both children and adults of clinically diagnosed viral encephalitis, the combination of immunoglobulin could reduce the mean recovery time of fever, unconsciousness, convulsion, emesis, average hospitalization time, and non-effective rate. Moreover, there was no difference in the incidence of adverse effects between the two groups.ConclusionsCurrent evidence shows that immunoglobulin is superior to conventional therapies both in adults and children patients of clinically diagnosed viral encephalitis. Due to the limited quality and quantity of the included studies, more high-quality studies are needed to verify the above conclusions.
ObjectiveTo investigate the efficacy and safety of internal rib fixation for patients with multiple rib fractures. MethodsA total of 141 patients with multiple rib fractures who were admitted to Department of Thoracic Surgery of the Sixth Affiliated Hospital of Xinjiang Medical University between January 2010 and January 2013 and whose chest trauma score (AIS-ISS) was 9-20 (16±2) were recruited in this study. Using the random number generator of SPSS, all the patients were randomly divided into an internal fixation group [69 patients including 41 males and 28 females with their age of 25-61 (37±4) years] who underwent internal rib fixation, and a control group [72 patients including 43 males and 29 females with their age of 24-63 (35±5) years] who received conservative therapy. Plasma C-reactive protein (CRP) patients' satisfaction degree with thoracic appearance,incidence of lung infection,pain-relieving efficacy,postoperative chest drainage duration and length of hospital stay were compared between the 2 groups. ResultsPlasma CRP levels of the internal fixation group were not statistically different from those of the control group in 1-3 days after injury (P>0.05) but were significantly lower than those of the control group in 4-12 days after injury (P<0.05). Patients' satisfaction degree with thoracic appearance (97.1% vs. 48.6%,P<0.05) and pain-relieving efficiency (91.3% vs. 68.1%,P<0.05) of the internal fixation group were significantly higher than those of the control group. Incidence of lung infection of the internal fixation group was significantly lower than that of the control group(11.6% vs. 37.5%,P<0.01). Postoperative chest drainage duration [(3±2) d vs. (7±4) d,P<0.05] and length of hospital stay [(9±4) d vs. (15±7) d,P<0.05] of the internal fixation group were significantly shorter than those of the control group. ConclusionsFor patients with multiple rib fractures and stable vital signs,internal fixation surgery is helpful to shorten length of hospital stay, relieve chest pain and improve thoracic appearance. It can also reduce lung inflammation and increase surgical safety so as to improve treatment outcomes of multiple rib fractures.
Objective To assess the efficacy and safety of Shenmai injection for children with viral myocarditis. Methods All randomized and quasi-randomized controlled trials (RCTs and quasi-RCTs) of Shenmai injection for children with viral myocarditis were searched from CBM (1981 to November 2009), CNKI (1980 to November 2009) and VIP (1989 to November 2009), The Cochrane Library (Issue 1,2010), PubMed (1966 to 2009), EMbase (1966 to 2009). Cochrane systematic reviews Handbook 5.0.1 was taken as a reference to quality evaluation of the included studies, and the Cochrane Collaboration’s RevMan 5.0 software was used for data analyses. Results A total of 15 RCTs were included. The quality of the included trials was low. The result of meta-analyses showed that: (1) The effective rate (RR 1.16, 95%CI 1.07 to 1.25) and the ECG improvement rate (RR 1.55, 95%CI 1.25 to 1.93) in Shenmai injection group were better than those in the control group. CK and CK-MB in Shenmai injection were lower than those in the control group, but the AST level was similar in the two groups. (2) The effective rate (RR 1.12, 95%CI 1.01 to 1.25) and the ECG improvement rate (RR 1.35, 95%CI 1.07 to 1.70) in Shenmai injection group were better than those in the western medicine plus routine therapy (RT) group. CK, AST and LDH in Shenmai injection group were lower than those in the western medicine plus RT group, but CK-MB was similar in the two groups. (3) The effective rate (RR 1.26, 95%CI 1.12 to 1.42) in Shenmai injection plus RT and western medicine group was better than that in RT and western medicine group. CK and LDH-1 in Shenmai injection plus RT and western medicine group were lower than those in RT and western medicine group. Adverse reactions of Shenmai injection in 4 studies included mild rash, rubicundity and chest distress. No severe adverse reactions were reported. Conclusion The evidence currently available shows that Shenmai injection may have some effect on children with viral myocarditis, including improving the effective rate, reducing myocardial enzymes and improving the ECG improvement rate. However, because of the low methodological quality of the included trials, this conclusion needs to be interpreted cautionsly, and more well-designed, high-quality RCTs need to be performed.
Objective To observe the efficacy and safety of sildenafil in one case of PoPH patients. Methods A case of PoPH patient who was successfully treated with sildenafil was retrospectively analyzed，and literatures related sildenafil and PoPH were reviewed. Results A case of PoPH patient admitted with dyspnea on extetion was diagnosed with echocardiography，gastroscrope and other examinations. She was treated with sildenafil and responded well by decreased pulmonary arterial pressure，improved exercise tolerance and life quality，without obvious side effects. Literatures review suggested that PoPH is an under-recognized but life-threatening complication of cirrhosis or noncirrhotic portal hypertension with poor prognosis which exists in decompensated chronic liver diseases patients. The most classic symptoms of PoPH is progressive dyspnea on extertion. PoPH patients may benefit from sildenafil therapy with decreased pulmonary arterial pressure and improved life quality. Conclusions Theawareness of PoPH should be increased and Sildenafil may be effective and safe for PoPH patients. However，more evidences from clinical trials are needed.
Objective To systematically review the efficacy and safety of laparoscopic hepatectomy (LH) and open hepatectomy (OH) for patients with hepatocellular carcinoma (HCC). Methods PubMed, EMbase, The Cochrane Library, CBM, WanFang Data, CNKI databases were electronically searched to collect the case-control studies about LH vs. OH for patients with HCC 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 performed by using RevMan 5.3 software. Results A total of 28 studies involving 1 908 patients were included. The results of meta-analysis showed that: the LH group was superior to OH group on complications (OR=0.35, 95%CI 0.26 to 0.48, P<0.000 01), hospital stay (MD=–4.18, 95%CI (–5.08, –3.29),P<0.000 01), and five years overall survival rate (OR=1.65, 95%CI 1.23 to 2.19,P=0.000 7) and disease-free survival rate (OR=1.51, 95%CI 1.12 to 2.03, P=0.006). However, no significant differences were found in one year and three years overall survival rate, disease-free survival rate, and postoperative recurrence rate. Conclusion Current evidence shows that the LH is superior to OH for the treatment of HCC, and may be amenable to surgery because of its safety and longtime efficacy. Due to limited quality and quantity of the included studies, more high quality studies are needed to verify above conclusion.