ObjectivesUsing systematic literature review to analyze the effects of levetiracetam (LEV) on neonatal safety during early pregnancy.MethodsThe scope of the literature must be English literature, published from 1997 to 2018. Meta-analysis was performed by random effects models.ResultsSeven literatures were included. A total of 672 cases exposed to LEV in treatment group and 772 234 cases in control groups were selected for meta-analysis. There was no significant difference in neonatal malignancy between treatment group and control group［OR=1.05, 95% CI (0.54, 2.02), P=0.37］. Further, we evaluated the effect of LEV monotherapy and polytherapy on neonatal safety, a total of 464 monotherapy cases and 632 polytherapy cases respectively were selected for meta-analysis. The results showed that there was no significant difference between these two therapies in neonatal malignancy ［OR=0.54, 95% CI(0.31, 0.96), P=0.32］.ConclusionsAs the papers we included, levetiracetam in the treatment of epilepsy during pregnancy is relatively safe for newborn.
Objective To systematically evaluate the effectiveness and safety of minimally invasive video-assisted thyroidectomy (MIVAT) and conventional open thyroidectomy (COT) in treatment of thyroid carcinoma without lymph node metastasis. Methods Databases including PubMed, EMbase, The Cochrane Library (Issue 3, 2015), WanFang, CBM, VIP and CNKI were searched to collect the randomized controlled trails (RCTs) and non-RCTs about MIVAT and COT in treatment of thyroid carcinoma without lymph node metastasis. The retrieval time was from inception to October 2015. The studies were screened according to the inclusion and exclusion criterias, and the data was extracted and the quality of studies was evaluated by 2 reviewers independently. Then the Meta-analysis was conducted by using RevMan 5.2 software. Results A total of 13 non-RCTs involving 3 083 cases were included. The results of Meta-analysis showed that: compared with COT group, operative time of MIVAT group was longer (MD=31.36, 95% CI: 27.68-35.03, P<0.05), hospital stay (MD=-0.16, 95% CI: -0.28--0.04, P=0.01) and length of scar (MD=-1.51, 95% CI: -1.63--1.39, P<0.05) of MIVAT group were shorter, but there was no significant difference in the incidences of transient hypocalcemia (OR=1.29, 95% CI: 0.93-1.78, P=0.13), transient laryngeal nerve palsy (OR=1.42, 95% CI: 0.93-2.17, P=0.11), hemotoma (OR=1.21, 95% CI: 0.64-2.29, P=0.56), recurrence (OR=0.61, 95% CI: 0.28-1.33, P=0.22), number of retrieved central lymph nodes (MD=-0.10, 95% CI: -0.98-0.78, P=0.82), and the size of tumors (MD=-0.02, 95% CI: -0.06-0.02, P=0.39) between the 2 groups. Conclusion MIVAT is safe and feasible in treatment of thyroid carcinoma without lymph node metastasis when its indications are strictly controlled.
ObjectiveTo observe effect and safety of interstitial chemotherapy with 5-fluorouracil sustained release agent in radical operation of colorectal cancer. MethodsOne hundred and sixty patients with colorectal cancer from October 2011 to December 2013 were randomly divided into observation group and control group according to an incomplete random method, 78 cases of them were in the observation group and 82 cases of them were in the control group. All the patients were performed radical resection of colorectal cancer. The abdominal cavity and pelvic cavity were washed after surgery. 5-fluorouracil sustained release agent was implanted in the observation group patients for interstitial chemotherapy, the implant site was at the tumor resection area and the mesenteric artery. Routine chemotherapy was performed in these two groups after operation. The postoperative complications were observed. The postoperative local recurrence rate, liver metastasis rate, and 24-month survival rate were recorded. ResultsThe rates of abdominal complications and toxic effects had no significant differences between these two groups (P > 0.05). The rates of 12-month and 24-month local recurrence and the rate of liver metastasis in the observation group were significant lower than those in the control group[1.3% (1/78) versus 8.5% (7/82), x2=8.934, P=0.023; 5.2% (4/78) versus 23.2% (19/82), x2=14.834, P=0.004; 10.3% (8/78) versus 18.3% (15/82), x2=12.034, P=0.016]. The rate of 24-month survival in the observation group was significant higher than that in the control group[94.9% (74/78) versus 84.1% (69/82), x2=11.465, P=0.010]. ConclusionThe good safety of interstitial chemotherapy with 5-fluorouracil sustained release agent could effectively decrease local recurrence rate and liver metastasis rate of colorectal cancer after radical operation and improve survival time of patients.
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.
The incidence of myopia is increasing year by year and the trend of younger age is obvious. The situation of myopia prevention and control is very serious. The sclera is the target organ for the development of myopia. When myopia occurs and develops, the ultrastructure of the sclera tissue will undergo pathological changes, resulting in a decrease in its tensile strength, then progressive axial growth and posterior sclera expansion. Scleral collagen cross-linking can effectively increase the hardness and tensile strength of scleral tissue, which may have great potential in the prevention and control of myopia, especially pathological myopia. At present, the effectiveness of scleral collagen cross-linking technology in the prevention and treatment of pathological myopia researches are still in the stage of animal experiments, and there are a lot of controversies on the safety. The development of any new technology to ensure safety is the primary condition. A comprehensive understanding of the safety of scleral collagen crosslinking in the prevention and control of myopia can provide more basis and guidance for the further study of scleral collagen crosslinking.
Objective To evaluate the efficacy and safety of different doses of intravenous immunoglobulin (IVIG) in the treatment of relapsing-remitting multiple sclerosis (RRMS). Methods We searched for randomized controlled trials of different doses of IVIG in the treatment of RRMS. We screened the retrieved studies according to the predefined inclusion and exclusion criteria, evaluated the quality of included studies, and performed meta-analyses with The Cochrane Collaboration’s Revman 4.2.0 software. Results Three randomized controlled trials of different dose of IVIG in the treatment of RRMS were included. One was of high quality and the other two were of lower quality. Heterogeneity was identified in one study which reported IVIG in postpartum RRMS. Two studies reported the relapsefree rate and no significant difference was noted between IVIG and placebo. Two studies reported the annual relapse rate, and no significant difference was observed (OR -0.00, 95% CI -0.36 to 0.36, P=0.98). Two studies reported the MRI lesions, and no difference was identified, either. The incidence of adverse events was similar between IVIG and placebo. Conclusion There is insufficient evidence to support the dose-effect relationship of IVIG in the treatment of RRMS. Therefore, an individualized dosing regimen should be applied according to patients’ tolerance and economic status.
ObjectiveTo evaluate the safety and efficacy of lenvatinib as targeted therapy for locally advanced thyroid cancer. MethodsThe data of 17 patients with locally advanced thyroid cancer who received targeted therapy in the Department of Head and Neck Surgery, Clinical Oncology School of Fujian Cancer Hospital from September 2021 to June 2023 were prospectively collected and analyzed. ResultsSeventeen patients received lenvatinib for a median of 8 weeks (4–32 weeks), 5 patients achieved partial response, 11 patients achieved stable disease, and 1 patient experienced progressive disease. The objective response and disease control rates were 29.4% (5/17) and 94.1% (16/17) respectively, the median tumor diameter of the target lesion decreased from 43 mm before treatment to 12 mm after treatment. Five patients did not undergo surgery because of tumor progression and their refusal; R0/1 resection was achieved in 11 of the 12 remaining patients (91.7%). All patients suffered from drug-related adverse events, and the commonest drug-related adverse events were hypertension (7/17, 41.2%), diarrhea (6/17, 35.3%), and proteinuria (5/17, 29.4%). There were no major drug-related adverse events. ConclusionPreliminary analysis indicates that lenvatinib is effective and safe for targeted therapy of locally advanced thyroid cancer, with a relatively high rate of R0/1 resection.
Objective To evaluate on immunogenicity and safety of measles-mumps-rubella-varicella vaccine. Methods The PubMed, BIOSIS Previews, CDSR, The Cochrane Library, CBM, CNKI and VIP were searched between Jan. 1990 and April 2010. Studies were included in the review if they were randomized controlled trials (RCTs) about measles (M) – mumps (M) – rubella (R) and varicella (V) vaccine. Trial screening, data exaction and quality assessment of the included trials were conducted by the method recommended by Cochrane Collaboration. Statistical analyses were conducted by using RevMan 4.2.10 software. Results Five RCTs were included. Among those there were 2 trials of B degree and 3 trials of C degree. Meta-analyses showed that to different inoculation methods, (MMRV or MMR+V) the rate of pain was not significantly different with RR 0.94 and 95%CI 0.83 to 1.05 (P=0.28). The rate of redness was not significantly different with RR 1.08 and 95%CI 0.90 to 1.29 (P=0.40). The rate of hardening was not significantly different with RR 1.16 and 95%CI 0.95 to 1.43 (P=0.14). The rate of fever was significantly different with RR 1.20 and 95%CI 1.12 to 1.29 (Plt;0.000 01). The rate of skin rash was not significantly different with RR 1.18 and 95%CI 1.00 to 1.41 (P=0.05). The serum measles antibody positive rate was not significantly different with RR 1.00 and 95%CI 0.99 to 1.01 (P=0.68). The serum mumps antibody positive rate was not significantly different with RR 0.99 and 95%CI 0.50 to 1.01 (P=0.11). The serum rubella antibody positive rate was not significantly different with RR 1.00 and 95%CI 0.99 to 1.01 (P=0.68). The se-rum varicella antibody positive rate was not significantly different with RR 1.00 and 95%CI 0.99 to 1.01 (P=0.58). Conclusion Compared with MMR+V vaccine, the MMRV vaccine has the same immune effect. In respect of immune safety, in addition to higher rate of fever after vaccination, other local or systemic reaction is good. For the role of reducing vaccination times and good performance on immune effect and safety, the MMRV vaccine can be regarded as candidate vaccine for children. The fever caused by the new component should be strengthened in the following study. Limited to the quality and account for the current original documents, citing evidence of this systematic review would be cautious. Future studies would expand the sample size, fulfill the test design, increase indicators to improve the quality of research and demonstration intensity.
ObjectiveTo evaluate the mid-term clinical outcomes of covered endovascular reconstruction of aortic bifurcation (CERAB) for the treatment of complex aortoiliac occlusive disease and to evaluate the efficacy and safety of this technique. MethodsA total of 12 patients with complex aortoiliac occlusive lesions [Trans-Atlantic Inter-Society Consensus (TASC) Ⅱ C and D] who underwent CERAB reconstruction at West China Hospital of Sichuan University, from December 2020 to December 2024 were prospectively enrolled and analyzed. Baseline and procedural data and follow-up data at 1, 6, 12, and 24 month(s) were collected. Technical success and 30-day complications as well as overall survival were evaluated. Patency and freedom from target lesion revascularization rates were analyzed using Kaplan-Meier curve. ResultsAll patients were male, with an age of (66.1±8.3) years; 10 cases were TASC Ⅱ C and 2 were TASC Ⅱ D. Technical success was achieved in all procedures. There were 2 cases of the procedure-related complications: one patient developed acute ischemia of the left lower limb postoperatively and recovered after emergency thrombectomy and endarterectomy; another patient died of a cerebrovascular event on day 3 after surgery. No bleeding, renal failure, pseudoaneurysm, or dissection occurred. The cumulative overall survival rates at 6, 12, and 24 months after surgery calculated by the Kaplan-Meier method were all 91.7%, with the cumulative primary patency rates being 86.7%, 73.4%, and 73.4% respectively, and the cumulative secondary patency rates being 100%, 100%, and 92.9% respectively. No amputations occurred during follow-up. ConclusionsThe results of this cohort suggest that CERAB induces favorable mid-term efficacy and safety in the treatment of complex aortoiliac occlusive lesions (TASC Ⅱ C and D). However, the further research is required to explore its suitability for the juxtarenal lesions of TASC Ⅱ D.