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 evaluate the efficacy of intravertebral analgesia for external cephalic version. Methods We electronically searched The Cochrane Library (Issue 4, 2009), PubMed (1980 to 2009), Ovid MEDLINE (1950 to 2009), Ovid EBM Database (1991 to 2009), EMbase (1980 to 2009), CBM (1978 to 2009) and CNKI (1979 to 2009) to collect literature about intravertebral analgesia for external cephalic version. We screened randomized controlled trials (RCTs) according to the predefined inclusion and exclusion criteria, extracted data and evaluated the quality of the included studies, and then performed meta-analyses by using RevMan 5.0.13 software. Results Seven RCTs involving 620 women met the inclusion criteria. Five trials were of relatively high quality, and 1 of low quality and 2 not clear. The result of meta-analyses showed that intravertebral analgesia was superior in external cephalic version with a RR 1.53 and 95%CI 1.24 to 1.88. Conclusion Intravertebral analgesia can increase the successful rate of external cephalic version in the treatment of breech presentation compared with intravenous medicine for systematic use or no analgesia.
Objective To investigate the efficacy and influential factors of interventional therapy for post-intubation tracheal stenosis. Methods The clinical data of 69 patients with tracheal stenosis after tracheal intubation in the First Affiliated Hospital of Guangzhou Medical University from February 2010 to March 2015 were retrospectively analyzed. The effects of interventional treatment for tracheal stenosis after intubation were evaluated by reviewing the medical records and telephone follow-up for more than 1 year. Multivariate logistic regression model was used to analyze the influential factors. Results The study recruited 69 patients with the median age of 44 years. After the interventional treatment, ATS dyspnea score decreased from (2.41±0.76) points to (0.65±0.62) points ( P<0.01), the diameter of airway lumen increased from (4.24±2.05)mm to (10.57±3.14)mm ( P<0.01). The short-term effective rate of interventional therapy was 92.8% (64/69) but the restenosis rate in 1 month, 3 months and 1 year after interventional treatment were 56.5%, 26.1% and 36.2%, respectively. Multivariate logistic regression analysis showed that diabetes (OR=2.819, 95%CI 1.973-4.062）, shortness of breath score >3 points (OR=13.816, 95%CI 5.848-32.641）, trachea stenosis diameter <4.5 mm (OR=7.482, 95%CI 4.015-13.943), tracheal stenosis grade ≥4 (OR=3.815, 95%CI 2.258-6.447), stenosis in the upper trachea (OR=5.173, 95%CI 3.218-8.316) were risk factors of interventional therapy for post-intubation tracheal stenosis. Conclusions The general efficacy of interventional treatment for tracheal stenosis after tracheal intubation is poor, and the recurrence rate is still high. The high degree of tracheal stenosis, diabetes mellitus and upper tracheal stenosis are important factors that affect the efficacy of respiratory interventional therapy.
ObjectiveTo systematically review the efficacy and safety of laryngeal mask versus endotracheal tubes for laparoscopic surgery.MethodsPubMed, EMbase, The Cochrane Library, CNKI, WanFang Data and CBM databases were electronically searched to collect the randomized controlled trials (RCTs) about the efficacy and safety of laryngeal mask versus endotracheal tubes for laparoscopic surgery from inception to April, 2017. 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.ResultsA total of 16 RCTs involving 1 593 patients were included. The results of meta-analysis showed that: there was no significant difference in the success rate of the first insertion (RR=0.99, 95%CI 0.96 to 1.02, P=0.55). The airway pressure of patients whose position were head higher than foot was significantly lower in the laryngeal mask group than in the tracheal intubation group (MD=–1.20, 95%CI –1.81 to –0.59, P=0.000 1), but there was no significant difference between two groups in reverse position patients (MD=0.48, 95%CI –0.90 to 1.87, P=0.49). The incidence of sore throat (RR=0.58, 95%CI 0.46 to 0.74, P<0.000 01), the incidence of blood stain (RR=0.48, 95%CI 0.30 to 0.77, P=0.002), the incidence of laryngeal spasm/bronchial spasm (OR=0.30, 95%CI 0.11 to 0.80, P=0.02) and the incidence of cough/hiccup (RR=0.10, 95%CI 0.07 to 0.15, P<0.000 01) in the laryngeal mask group were significantly lower than those in the tracheal intubation group.ConclusionThe current evidence shows that compared with tracheal intubation, laryngeal mask can effectively reduce airway pressure of patients whose position are head higher than foot. The risks of various complications are significant higher in tracheal intubation in laparoscopic surgery. Laryngeal mask can maintain patients' normal respiratory functions while reduce damage and do not increase the occurrence of reflux aspiration. Due to limited quantity and quality of the included studies, more high quality studies are needed to verify above conclusion.
ObjectiveTo systematically review the efficacy and safety of vaccines for the coronavirus disease 2019 (COVID-19) . Methods The CNKI, VIP, WanFang Data, PubMed, EMbase and Web of Science databases were electronically searched to collect randomized controlled trials (RCTs) on the safety and efficacy of COVID-19 vaccines from their inception to June 30th, 2022. 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 and Stata 12.0 software. Results A total of 13 RCTs involving 139 015 subjects were included. The results of meta-analysis showed that the sero-antibody conversion rate (RR=37.883, 95%CI 8.086 to 177.491, P<0.001) and infection prevention rate (RR=1.011, 95%CI 1.006 to 1.017, P<0.001) of the vaccine group were higher than those of the placebo group. The incidence of adverse reactions in the vaccine group was higher than that in the placebo group (OR=1.839, 95%CI 1.165 to 2.903, P=0.009), which mainly included pain, redness, swelling, fever, headache and itching (P<0.05). However, the incidence of serious adverse reactions was not significantly different from that of the placebo group. Conclusion The current evidence shows that the efficacy of the COVID-19 vaccines is high. The most prevalent adverse reactions are mild and moderate, and severe adverse reactions are the same as those of the placebo group. Due to the limited quality and quantity of the included studies, more high-quality studies are required to verify the above conclusion.
Objective To investigate the advances and clinical efficacy evaluation method on neoadjuvant chemotherapy in patients with gastric cancer. Methods Literatures on the advances and clinical efficacy evaluation method on neoadjuvant chemotherapy in patients with gastric cancer were reviewed and analyzed. The agreement between computed tomography (CT), endoscopic ultrasound (EUS), magnetic resonance imaging (MRI) and positron emission tomography (PET) and the results of histopathology and survival was analyzed.Results CT and EUS were the method of efficacy evaluation commonly used at present, but the evaluation indexes and criteria were controversial, and the criteria for solid tumors seemed to be not feasible for gastric cancer. Diffusionweighted imaging (DWI) method needed more investigation, while PET held advantage in early selection of patients without response accurately.Conclusion There is no uniform standard for clinical efficacy evaluation yet, so an integration of diverse imaging methods may be the best choice to improve the accuracy of neoadjuvant chemotherapy in patients with gastric cancer.
Objective To systematically review the efficacy and safety of different SGLT2 inhibitors in the treatment of heart failure. Methods The Cochrane Library, Web of Science, PubMed and EMbase databases were searched for randomized controlled trials on the efficacy and safety of SGLT2 inhibitors in patients with heart failure from inception to July 2, 2021. Two researchers independently screened literature, extracted data and evaluated the risk of bias of the included studies. Network meta-analysis was then performed using Stata 16.0 software. Results A total of 16 randomized controlled trials, including 15 312 patients, involving 5 interventions, namely dapagliflozin, empagliflozin, canagliflozin, sotagliflozin and ertugliflozin were included. Results of network meta-analysis showed that there was no significant difference in the compound outcome of hospitalization for heart failure or cardiovascular death, hospitalization for heart failure, all-cause mortality, risk of cardiovascular mortality and serious adverse reactions among patients with heart failure among 5 different SGLT2 inhibitors (P>0.05). Compared with placebo, both selective and non-selective SGLT2 inhibitors improved the risk of hospitalization for heart failure, hospitalization for heart failure, or compound cardiovascular mortality (P<0.05), while only selective SGLT2 inhibitors improved the risk of cardiovascular mortality, all-cause mortality, and serious adverse events (P<0.05). However, there was no significant difference between them (P>0.05). The area under the cumulative ordering probability curve of selective and non-selective SGLT2 inhibitors ranked first and second, except for the combined outcome of heart failure or cardiovascular death. Conclusion The current evidence indicates that there is no significant difference in the efficacy and safety of the 5 different SGLT2 inhibitors in the treatment of heart failure, and there is no significant difference between selective SGLT2 inhibitors and non-selective SGLT2 inhibitors. Due to the limited quantity and quality of included studies, more high-quality studies are needed to verify the above conclusion.
ObjectivesTo systematically review the efficacy and safety of iguratimod compared with methotrexate in the treatment of rheumatoid arthritis.MethodsPubMed, EMbase, The Cochrane Library, VIP, CBM, WanFang Data and CNKI databases were electronically searched to collect randomized controlled trials (RCTs) of the efficacy and safety of iguratimod compared with methotrexate in the treatment of rheumatoid arthritis from inception to June 2018. 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.ResultsA total of 10 RCTs involving 970 patients were included. The results of meta-analysis showed that: there was no statistical difference between iguratimod and methotrexate in ACR20 (RR=1.06, 95%CI 0.91 to 1.23, P=0.49), ACR50 (RR=0.93, 95%CI 0.73 to 1.19, P=0.55), ACR70 (RR=0.92, 95%CI 0.62 to 1.39, P=0.70), morning stiffness time (MD=0.45, 95%CI –0.26 to 1.16, P=0.22), tender joint count (MD=0.07, 95%CI –2.31 to 2.45, P=0.95), swollen joint count (MD=–0.30, 95%CI –1.44 to 0.84, P=0.61), health assessment questionnaire (MD=0.01, 95%CI –0.05 to 0.07, P=0.73) and the rate of adverse effects (RR=0.66, 95%CI 0.41 to 1.07, P=0.09). Meta-analysis of 2 RCTs using double-blind method showed that, iguratimod was superior to methotrexat in the patient (MD=4.11, 95%CI 0.11 to 8.10, P=0.04) and physician (MD=4.81, 95%CI 0.93 to 8.69, P=0.01) global assessment of disease activities.ConclusionsCurrent evidence shows that the efficacy and safety of iguratimod in the treatment of rheumatoid arthritis are similar to methotrexate. And iguratimod is superior in global assessment of disease activities by patients and doctors. Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusions.
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.
The prominent feature and form of clinical diagnosis and treatment of traditional Chinese medicine is individualization, which has generated difficulty for clinical evaluation and has restricted the production of high-level evidence for traditional Chinese medicine for a long time. Based on the complexity and dynamics of individualized information under the characteristics of time and space, this paper references the theory of space-time of system science to analyze the individualized data of diagnosis and treatment of traditional Chinese medicine and summarizes the concept of the long time course for clinical evaluation. Based on the concept of the long time course, this paper starts with the origin of clinical evaluation, which is the construction of clinical problem elements named PICO, introduces dynamic evaluation factors, explores the construction of individualized dynamic evaluation method of traditional Chinese medicine, and provides demonstration and examples for the design and implementation of individualized clinical research in future.