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find Keyword "安全性" 239 results
  • Making Great Effects to Study on the Project of Safety Administration of Conception Control Device and Medicine Supported by The National Key Technologies R&D Program of China During the 10th Five-year Plan Period

    Release date:2016-09-07 02:26 Export PDF Favorites Scan
  • Efficacy and safety of laparoscopic versus open hepatectomy for hepatocellular carcinoma: a meta-analysis

    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.

    Release date:2017-10-16 11:25 Export PDF Favorites Scan
  • Efficacy and safety of massage for cervical spondylotic radiculopathy: an overview of systematic reviews

    ObjectiveTo provide an overview of systematic reviews on the efficacy and safety of massage for the treatment of cervical spondylotic radiculopathy.MethodsCNKI, WanFang Data, VIP, CBM, PubMed, The Cochrane Library and EMbase databases were electronically searched to collect the systematic reviews on the efficacy and safety of massage for the treatment of cervical spondylotic radiculopathy from inception to December 30th, 2018. Two reviewers independently screened the literature and extracted the data, applied the AMSTAR2 scale to evaluate its methodological quality, and GRADE to evaluate the quality of the evidence.ResultsA total of 7 systematic reviews/meta-analysis were included. The AMSTAR2 scale evaluation showed that the quality of the included studies was extremely low. The GRADE evidence grading results showed that the quality of the VAS score outcome index of the two literatures was intermediate, and the quality of the OASCSR outcome index of one literature was intermediate. The quality of the remaining outcome indicators reported is low or very low.ConclusionThe available evidence shows that the efficacy and safety of manual treatment of cervical spondylotic radiculopathy is acceptable, but the overall methodological quality of the systematic review is extremely low, and the quality level of evidence is generally low. The future clinical trials and systematic reviews should be strictly followed. The scientific research design of the medical science provides high-quality evidence and provides reference for clinical practice.

    Release date:2019-07-31 02:24 Export PDF Favorites Scan
  • Efficacy and safety of immune checkpoint inhibitors combined with chemotherapy in the treatment of triple-negative breast cancer: a meta-analysis

    Objective To systematically review the efficacy and safety of immune checkpoint inhibitors combined with chemotherapy in the treatment of triple-negative breast cancer. Methods The PubMed, Cochrane Library, Embase, Web of Science, CNKI, WanFang Data and VIP databases were searched for randomised controlled trials (RCTs) of immune checkpoint inhibitors combined with chemotherapy versus chemotherapy alone for triple-negative breast cancer from inception to April 1, 2024. Two reviewers independently screened the literature, extracted data, and assessed the risk of bias of the included studies. Meta-analysis was then performed by using RevMan 5.4 software. Results A total of 13 RCTs involving 5 416 patients were included. The results of meta-analysis showed that the pathologic complete response rate (pCR) (OR=2.09, 95%CI 1.37 to 3.19, P<0.01), progression-free survival (PFS) (HR=0.75, 95%CI 0.67 to 0.83, P<0.01) and overall survival (OS) (HR=0.87, 95%CI 0.79 to 0.96, P<0.01) were significantly better than those in the control group. The results of subgroup analysis showed that there were statistically significant differences in PFS (P<0.01) and OS (P=0.02) between PD-L1-positive and PD-L1-negative patients, but there was no statistically significant difference in pCR between PD-L1-positive patients and PD-L1-negative patients (P=0.36). There was a statistically significant difference in pCR between node-positive patients and node-negative patients (P=0.03). There was no statistically significant difference in pCR between patients treated with PD-1 inhibitors and PD-L1 inhibitors (P=0.32); and there was no significant difference in PFS (P=0.19) or OS (P=0.99) between patients treated with PD-1 inhibitors and PD-L1 inhibitors. Compared with those in the control group, the incidences of serious adverse events (RR=1.36, 95%CI 1.09 to 1.70, P<0.01) and immune-related adverse events (RR=2.98, 95%CI 1.66 to 5.35, P<0.01) were higher in the experimental group, and the common immune-related adverse events were hypothyroidism and hyperthyroidism.Conclusion The existing evidence shows that immune checkpoint inhibitors combined with chemotherapy are more effective than chemotherapy alone in the treatment of triple-negative breast cancer, and the combination therapy has a higher incidence of adverse reactions. Due to the limited quantity and quality of the included studies, more high-quality studies are needed to verify the above conclusion.

    Release date:2025-01-21 09:54 Export PDF Favorites Scan
  • Glucocorticoids for Duchenne Muscular Dystrophy: A Meta-Analysis

    ObjectiveTo systematically review the therapeutic effects and safety of glucocorticoids (GC) for Duchenne muscular dystrophy (DMD). MethodsDatabases such as PubMed, EMbase, CENTRAL, CNKI, WanFang Data, VIP and CBM were electronically searched from the establishment of the databases till December 2011. All randomized controlled trials (RCTs) about GC for DMD were included. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data, and evaluated the methodological quality of the included studies. Then meta-analysis was performed using RevMan 5.0.2 software. ResultsA total of 6 studies involving 303 DMD children were included. The results of meta-analysis showed that after 6 month treatment of GC (deflazacort), patients' symptoms were obviously improved in average muscle strength, lift weight ability, forced vital capacity (FVC) of the lung, emotional factor scores and total scores in Quality of life (QoL), Gower's time, nine meters walking time (T9 m), and four-stair climbing time (T4 s). However, the trial group showed more weight gain, behavioural changes, increased appetite, cushingoid appearance, and excessive hair growth. The incidences of osteoporosis/fracture, hypertension, diabetes, and cataract were not increased. ConclusionGC could improve muscle strength and function, stabilize pulmonary function, prolong independent walk time, and improve QoL of DMD patients. However, adverse reaction caused by GC should be taken caution.

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  • The efficacy and safety of laryngeal mask versus endotracheal tubes for laparoscopic surgery: a meta-analysis

    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.

    Release date:2017-08-17 10:28 Export PDF Favorites Scan
  • Efficacy and safety of microwave ablation via different approaches for pulmonary nodules: A retrospective cohort study

    ObjectiveTo compare the efficacy and safety of computed tomography (CT)-guided percutaneous versus electromagnetic navigation bronchoscopy (ENB)-guided microwave ablation (MWA) for the treatment of pulmonary nodules. MethodsA retrospective analysis was conducted on the data of high-risk pulmonary nodule patients who underwent MWA at the Nanjing Drum Tower Hospital between 2022 and 2023. The pathological diagnosis rate, complications, and progression-free survival (PFS) rate were compared between the CT group and the ENB group. ResultsThere were 61 patients in the CT group, including 30 males and 31 females, with an average age of (67.22±9.13) years. There were 53 patients in the ENB group, including 29 males and 24 females, with an average age of (65.29±13.76) years. The pathological diagnosis rate in the CT group was slightly higher than that in the ENB group (88.52% vs. 71.69%, P=0.03). However, the ENB group exhibited a lower incidence of perioperative complications, including pneumothorax (16.39% vs. 3.77%, P=0.03), hemoptysis (19.67% vs. 5.66%, P=0.05), and pain (22.95% vs. 7.55%, P=0.03). There was no statistically significant difference in PFS rate between the two groups [HR=1.17, 95%CI (0.23, 5.81), P=0.85]. ConclusionBoth CT-guided and ENB-guided MWA are effective treatment modalities for high-risk pulmonary nodules.

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  • Short-term effectiveness of Mako robot-assisted total hip arthroplasty via posterolateral approach

    ObjectiveTo explore the short-term effectiveness of Mako robot-assisted total hip arthroplasty (THA) via posterolateral approach.MethodsThe clinical data of 64 patients (74 hips) treated with Mako robot-assisted THA via posterolateral approach (robot group) between May 2020 and March 2021 were retrospectively analyzed and compared with the clinical data of 52 patients (55 hips) treated with traditional THA via posterolateral approach (control group) in the same period. There was no significant difference in general data such as gender, age, side, body mass index, disease type, and preoperative Harris score between the two groups (P>0.05). The operation time, intraoperative blood loss, and complications were recorded and compared between the two groups. Acetabular inclination angle, acetabular anteversion angle, and lower limbs discrepancy were measured after operation. At last follow-up, the improvement of hip pain and function was evaluated by visual analogue scale (VAS) score, Harris score, and forgetting joint score (FJS-12).ResultsIn the robot group, 3 patients (including 1 patient with acetabular fracture during operation) were converted to routine THA because the pelvic data array placed at the anterior superior iliac spine was loose, resulting in data error and unable to register the acetabulum; the other patients in the two groups completed the operation successfully. The operation time and intraoperative blood loss in the robot group were significantly higher than those in the control group (P<0.05). All patients were followed up 1-10 months, with an average of 4.6 months. In the robot group, 1 patient with ankylosing spondylitis had acetabular prosthesis loosening at 2 days after operation, underwent surgical revision, and 10 patients had lower limb intermuscular vein thrombosis; in the control group, 1 patient had left hip dislocation and 5 patients had lower extremity intermuscular vein thrombosis; there was no complication such as sciatic nerve injury, incision exudation, and periprosthetic infection in both groups. There was no significant difference in the incidence of complications between the robot group and the control group (17.2% vs.11.5%) (χ2=0.732, P=0.392). At last follow-up, the acetabular anteversion angle and FJS-12 score in the robot group were was significantly greater than those in the control group, and the lower limbs discrepancy was significantly less than that in the control group (P<0.05); there was no significant difference in acetabular inclination angle and VAS score between the two groups (P>0.05). The Harris scores of the two groups were significantly improved when compared with those before operation (P<0.05), but there was no significant difference in the difference of pre- and post-operative score between the two groups (t=1.632, P=0.119).ConclusionCompared with traditional surgery, Mako robot-assisted THA can optimize the accuracy and safety of acetabular cup implantation, reduce the length difference of the lower limbs, and has a certain learning curve. Its long-term effectiveness needs further research to confirm.

    Release date:2021-10-28 04:29 Export PDF Favorites Scan
  • Efficacy and safety of SGLT2 inhibitors for heart failure: a network meta-analysis

    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.

    Release date:2022-03-29 02:59 Export PDF Favorites Scan
  • Donor Safety in Living Donor Liver Transplantation: A Single Center Analysis of 356 Cases

    ObjectiveTo evaluate donor safety in living donor liver transplantation. MethodsThe clinical data of 356 donors underwent living liver donation in our center from January 2001 to September 2015 were retrospectively analyzed. These patients were divided into pre-2008 group(before January 2008) and post-2008 group(after January 2008). The donor safety was evaluated with regard to three aspects, i.e. complications, liver function, and quality of life. Results①There was no donor death in our center.②The overall complications rate was 23.3%(83/356). The proportion of ClavienⅠ, Ⅱ, Ⅲ, andⅣcomplications was 50.6%(42/83), 26.5%(22/83), 21.7%(18/83), and 1.2%(1/83), respectively. In all the donors, the incidence of ClavienⅠ, Ⅱ, Ⅲ, andⅣcomplications was 11.8%(42/356), 6.2%(22/356), 5.1%(18/356), and 0.3%(1/356), respectively. The overall complications rate in the post-2008 group was significantly lower than that in the pre-2008 group〔18.1%(41/227) versus 32.6%(42/129), P < 0.01〕. The most common complication was the biliary complication with an incidence of 8.4%(30/356).③The postoperative liver dysfunction was transient and generally retur-ned to normal level within a week.④The donor's quality of life was generally satisfied as assessed by the SF-36 tool, and 94.8%(239/252) of them would donate again if necessary. ConclusionEver improving surgical and anesthetic techniques, together with strict donor selection and specialized perioperative management, could guarantee a low donor morbidity and a satisfactory long-term prognosis.

    Release date:2021-06-24 01:08 Export PDF Favorites Scan
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