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.
Background As part of the core outcome set (COS), the core traditional Chinese medicine (TCM) syndrome set can improve the consistency of syndrome efficacy evaluation outcomes in TCM clinical research. Previous studies proposed and empirically verified a method of developing core TCM syndrome sets based on complex syndromes under the disease-syndrome combination research model. However, this method is developed on the basis of syndrome types, which has the limitation that the finally included syndrome types are too single to adapt to the complexity of clinical syndromes. Therefore, it is urgent to optimize the existing development method to balance the complexity of clinical syndromes and methodological feasibility. Methods This study adopted qualitative research methods to obtain opinions from TCM clinicians and researchers on developing methods, efficacy evaluation criteria, and construction forms through expert steering committee meetings and semi-structured interviews. The sample size of semi-structured interviews was determined until data saturation was reached, and thematic analysis was used to analyze the transcription results. Results In the expert steering committee meeting, 60% (3/5) of the experts believed that developing in the form of syndrome elements was more operable; in the semi-structured interviews, 77.78% (7/9) of the experts supported developing in the form of syndrome elements, considering it convenient to use. Meanwhile, the research team added an expert semi-structured interview link in the development process, which complemented the cross-sectional survey used in previous studies to jointly improve the original list of TCM syndrome elements. Conclusion The method of developing core TCM syndrome sets based on syndrome elements formed in this study can consider clinical practice while improving the unity of TCM syndrome efficacy evaluation standards, which is helpful to promote the standardized development of TCM clinical research.
Objective To systematically review the efficacy and safety of interferon based antiviral therapy for children with hepatitis B. Methods PubMed, EMbase, The Cochrane Library, WanFang Data and CNKI databases were searched to collect randomized controlled trials (RCTs) of interferon based antiviral therapy for children with hepatitis B from inception to December 2016. 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 12 studies involving 723 patients were included. The results of meta-analysis showed that: follow-up <12 months, the virological response rate (RR=2.82, 95%CI 1.98 to 4.02, P<0.000 01), serum HBeAg clearance rate (RR=3.02, 95%CI 1.95 to 4.67,P<0.000 01) and ALT normalization rate (RR=1.42, 95%CI 1.19 to 1.70,P=0.000 1) were significantly higher in the interferon group than the control group. Follow-up >12 months, the virological response rate (RR=1.75, 95%CI 1.18 to 2.60, P=0.006) and serum HBeAg clearance rate (RR=2.17, 95%CI 1.28 to 3.65, P=0.004) were also significantly higher in the interferon group. Severe adverse effects were not reported in included studies. Conclusion Current evidence shows that higher virological response is found in HBV infected children with interferon treatment. Due to limited quality and quantity of the included studies, more high quality studies are needed to verify above conclusion.
ObjectiveTo evaluate the clinical efficacy of medical absorbent pads in the treatment of wouds. MethodsA total of 200 patients treated in the Wound Treating Center of a first-class hospital between November 2014 and August 2015 were randomly divided into trial group and control group with 100 patients in each. Patients in the trial group received medical absorbent pads, while patients in the control group received the treatment of Zetuvitò E. All patients received four times of treatment. Then we used self-made observation record form to evaluate such indexes as water absorption and compliance of the dressing, patients' pain and secondary trauma scores and the score of skins around the wounds. ResultsThere was no significant difference in water absorption property and compliance between the two groups (P>0.05). But the score of visual analogue scale was lower in the trial group than that in the control group at the fourth dressing changing (P<0.05), and the score of secondary trauma was also lower in the trial group than that in the control group at the third and fourth dressing changing (P<0.05). ConclusionThe medical absorbent pads used in the trial group can relieve pain and promote wound healing. It can be used for the treatment of wounds, and also has better effectiveness and safety.
Objective To evaluate the efficacy and safety of different doses of metoprolol in the treatment of primary hypertension.Methods We searched for randomized controlled trials of different doses of metoprolol in the treatment of primary hypertension. We screened relevant studies according to predefined inclusion and exclusion criteria, evaluated the quality of the included studies, and performed meta-analyses by using The Cochrane Collaboration’s Revman 4.2.8 software. Results Five randomized controlled trials of different doses of metoprolol in the treatment of primary hypertension were included. Two were of high quality and the other three were of low quality. No study reported mortality or the incidence of cardiovascular events, but four studies reported the means and standard deviations of systolic and diastolic blood pressures and heart rate. Based on the two self-control studies, meta-analyses of the levels of systolic and diastolic blood pressures before and after treatment of different doses of metoprolol showed that the combined OR for systolic blood pressure levels was -4.62 [95%CI (-7.77, -1.47), P=0.004]; and for the diastolic blood pressure levels, the combined OR was -5.71 [95%CI (-6.75, -4.68), Plt;0.000 01]. Four studies reported adverse reactions, and meta-analysis of the incidence of non-specific adverse reactions showed that the combined OR was 2.61 [95%CI (1.33, 5.13), P=0.005]. Conclusion A dose-effect relationship may exist between the dose of metoprolol and antihypertensive effect in the treatment of hypertension. When the antihypertensive effect of low-dose metoprolol was inadequate, an increase in the dose may lower blood pressure further. Although high-dose metoprolol has higher incidence of adverse reactions, it can be tolerated by most patients. Therefore, in the treatment of hypertension with metoprolol, an individualized dosing regimen can be applied according to the patient’s tolerance, and blood pressure may be controlled ideally by a gradual increase of the metoprolol dose to its maximum tolerated dose.
ObjectiveTo evaluate the efficacy and safety of glucosamine hydrochloride in the treatment of osteoarthritis. MethodsA total of 150 patients with osteoarthritis treated between April 2014 and April 2015 were randomly divided into control group and trial group with 75 in each. Patients in the trial group accepted oral glucosamine hydrochloride, while those in the control group were given diclofenac sodium. Lequesne index, total effective rate and the incidence of adverse reactions of both groups were calculated before and 2, 4, 6 and 8 weeks after treatment, and 2 weeks after drug withdrawal. ResultsIn both groups, Lequesne index started to decrease after 2 weeks of treatment (P<0.05), and reached the minimum value at treatment week eight (P<0.05). The Lequesne index 2 weeks after drug withdrawal was still obviously lower than that before treatment (P<0.05). There was no significant differences in the total effective rate at treatment week eight (83.1% for the control group and 80.9% for the trial group) or the total effective rate 2 weeks after drug withdrawal (80.0% for the control group and 79.4% for the trial group) between the control group and the trial group (P>0.05). The incidence of adverse reactions of the trial group (6.7%) was significantly lower than that of the control group (21.3%) (P<0.05). ConclusionGlucosamine hydrochloride is effective and safe in the treatment of osteoarthritis, which is suitable for long-term treatment.
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.
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.
ObjectivesTo systematically review the efficacy and safety of dapagliflozin combined with hypoglycemic drugs in the treatment of diabetes patients.MethodsPubMed, The Cochrane Library, EMbase, WanFang Data, VIP, CNKI and CBM databases were electronically searched to collect randomized controlled trials (RCTs) on the efficacy and safety of dapagliflozin combined with hypoglycemic drugs in the treatment of diabetes patients from inception to December, 2018. Two reviewers independently screened literature, extracted data, and assessed the risk of bias of included studies. Then, meta-analysis was performed using RevMan 5.3 software and Stata 14.0 software.ResultsA total of 16 RCTs involving 5 388 patients were included. The results of meta-analysis showed that, compared with control group, intervention group provided more reduction in HbAlc (MD=−0.55, 95%CI −0.63 to −0.48, P<0.000 01) and body weight (MD=−2.17, 95%CI −2.46 to −1.88, P<0.000 01). There were no significant differences in hypoglycaemia (RR=1.05, 95%CI 0.93 to 1.18, P=0.44) and hypotension (RR=1.63, 95%CI 0.73 to 3.65, P=0.23). The incidence of urinary tract infection (RR=1.29, 95%CI 1.03 to 1.61, P=0.02) and genital infection (RR=3.89, 95%CI 2.86 to 5.29, P< 0.000 01) in intervention groups were higher than those in the control groups.ConclusionsCurrent evidence shows that dapagliflozin as an add-on drug to conventional antidiabetic drugs can more effectively reduce glycated hemoglobin and body weight in diabetic patients and does not increase the incidence of hypoglycemia and hypotension, however, with an increased risk for development of urinary tract infection and genital infections. Due to limited quality and quantity of the included studies, more high-quality studies are required to verify above conclusions.
Objective To develop a preliminary "pulmonary nodule symptom scale" based on the Delphi method, providing a tailored, standardized, normalized, and promotable symptomatic evaluation tool for the efficacy assessment of pulmonary nodule patients treated with traditional Chinese medicine or integrated traditional Chinese and Western medicine interventions. Methods A preliminary pool of scale items was formed through literature review, interviews with doctors and patients, and reference to guidelines and consensus on pulmonary nodules and patient-reported outcome (PRO) scales related to lung cancer. Two rounds of expert consultation were conducted using the Delphi method. Based on the concentration and variation indicators of expert evaluations, and considering experts’ suggestions for specific item deletions and modifications, a core group meeting was held to screen and refine the scale items. Results Invitations were sent to 54 experts, with 51 accepting the consultation. The active coefficient for the first round of consultation was 94.4%, and for the second round, it was 100%. The average authority coefficient for the 51 experts was 0.896. The Kendall’s coefficient of concordance and the average coefficient of variation for the first and second rounds of consultation were 0.215 (P<0.001) and (0.34±0.07), 0.162 (P<0.001) and (0.24±0.05), respectively. Through two rounds of Delphi expert consultation, a preliminary "pulmonary nodule symptom scale" covering 17 items across four dimensions - respiratory symptoms, systemic manifestations, psychological state, and overall assessment - was formed. Conclusion The experts participating in this Delphi consultation had high authority and enthusiasm, and they have a good level of acceptance and consistency for the preliminary "pulmonary nodule symptom scale". Subsequent empirical research will be conducted on a large sample cohort of pulmonary nodule patients to verify the scale’s stability and effectiveness.