ObjectiveTo summary the safety and efficiency of the minimally invasive direct cardiac surgery (MIDCS) approach in elderly patients with heart disease. MethodsWe retrospectively analyzed the clinical data of 60 patients underwent MIDCS in Beijng Anzhen Hospital between April 2010 and January 2013. There were 34 males and 26 females with mean age of 66.4±4.8 years and mean weight of 66.1±10.6 kg. ResultsMean cardiopulmonary bypass time and aortic cross-clamp time was 141.2±57.2 minutes and 99.8±37.6 minutes respectively. A total of 37 patients (90.2%) recovered to beat automatically after heart ceased operation. Median mechanical ventilation time was 17.1±9.1 hours. Mean intensive care unit stay was 22.1±12.2 hours. Mean post operative hospital stay was 7.0±2.5 days. Mean incision length was 5.3±0.9 cm. Mean pericardial draining volume was 466.6±412.1 ml in the first day after operation. No transfusion occurred in 27 (45.0%) patients. Early postoperative mortality was 3.3% (2/60). There were 2 patients of reexplorations for bleeding, 1 patient of the twice tracheal intubation, 1 patient of cardiac arrest after operation, 2 patients of poor healing of skin incision, and 1 patient of injury of right phrenic nerve. When leaving hospital, 47 patients were in heart functional class Ⅰ, 8 patients in class Ⅱ, and 3 patients in class Ⅲ. ConclusionMIDCS is associated with good operative effect in the near future with superior safety and broad application range in elderly patients with heart disease.
ObjectiveTo evaluate the safety and efficacy of preoperation administration of enteral nutrition enriched ω-3 fatty acids for gastric cancer patients. MethodsA single center randomized controlled clinical trial was performed in 60 cases of gastric cancer in West China Hospital during January 2014 to June 2014, and cases were equally randomized divided into treatment group and control group. Cases of treatment group were given enteral nutrition enriched ω-3 fatty acids which was manufactured by Fresenius Kabi Deutschland GmbH for 5 consecutive days before operation, and cases of control group were given an isocaloric and isonitrogenous homogenized diet for 5 consecutive days before operation. The laboratory indexes of nutritional status and imflammatory factors were observed and compared between 2 groups on admission, preoperative day 1, postoperative day 3, and postoperative day 5. Liver and kidney function indexes which as the safety indexes were detected on admission and preoperative day 1. Vomiting, diarrhea, and infectious complications were recorded in addition. ResultsOn 3 days after operation, levels of interleukin-6 (IL-6) and α-acid glycoprotein (AAG) of treatment group were both lower than those of control group (P<0.05); on 5 days after operation, levels of C-reactive protein (CRP) of treatment group was lower than that of control group too (P<0.05); but at other time points, there were no significant differences in any index between the 2 groups (P>0.05). During the period of enteral nutrition, only 1 case suffered from bloating and 1 case suffered from diarrhea, both in treatment group, and the incidence of adverse reactions didn't differed between treatment group[6.7% (2/30)]and control group[0 (0/30)], P>0.05. Moreover, there were no significant differences between treatment group and control group in incidences of wound infection[3.3% (1/30) vs. 10.0% (3/30)], abdominal infection[0 (0/30) vs. 3.3% (1/30)], urinary infection[0 (0/30) vs. 3.3% (1/30)], and pulmonary infection[0 (0/30) vs. 6.7% (2/30)], but the total incidence of complication was lower in treatment group than that of control group[3.3% (1/30) vs. 23.3% (7/30)], P=0.026. ConclusionEnteral nutrition enriched ω-3 fatty acids can reduce the rate of infection-related complication for patients with gastric cancer, and has a sense of safety.
This article discusses the concret implementation of day surgery in Ophthalmology Center, Beijing Tongren Hospital, Capital Medical University during the coronavirus disease 2019 epidemic and under the regular prevention and control, so as to provide a basis for ensuring the safety and effectiveness of clinical work in the special period. According to the requirements of health administration departments and the hospital for the prevention and control of epidemic, combining with the characteristics of concret work, the Ophthalmology Center carried out and accurately implemented a series of prevention and control management measures, and obtained good results in the clinical work on the basis of comprehensive security protection. From February to October, 2020, there were a total of 16 507 cases who underwent the day surgery in the Ophthalmology Center, with no surgical infection or suspected case of coronavirus disease 2019. The safety and quality management of epidemic prevention and control has played an active and effective role in the active development of day surgery in this center. The safe and optimized diagnosis and treatment process has reassured the patients and their families, and the strict implementation of protective measures by medical staff has ensured the safety of surgery and the work being proceed with smooth progress and high efficacy.
ObjectiveTo systematically review the efficacy and safety of acupuncture on postpartum depression (PPD).MethodsPubMed, EMbase, The Cochrane Library, Web of Science, CNKI, WanFang Data and VIP databases were electronically searched to collect randomized controlled trials (RCTs) on the efficacy and safety of acupuncture in treatment of PPD from inception to February 2021. Two reviewers independently screened literature, extracted data and assessed risk of bias of included studies. Meta-analysis was then performed by using Stata16.0 software.ResultsA total of 13 RCTs involving 899 patients were included. The results of meta-analysis showed that there was no significant difference between hand acupuncture and fluoxetine hydrochloride in HAMD score (MD=0.45, 95%CI ?0.52 to 1.41, P=0.36), clinical effective rate (RR=0.93, 95%CI 0.70 to 1.23, P=0.59), and clinical cure rate (RR=0.88, 95%CI 0.44 to 1.76, P=0.73). However, hand acupuncture was superior in safety to fluoxetine hydrochloride (RR=0.04, 95%CI 0.01 to 0.28, P<0.05). There was no significant difference in clinical effective rate (RR=1.08, 95%CI 0.87 to 1.36, P=0.49) and cure rate (RR=1.31, 95%CI 0.84 to 2.04, P=0.24) between both groups.ConclusionsThe current evidence shows that there are no differences between hand acupuncture and non-acupuncture in reducing HAMD score, improving the clinical effective rate and clinical cure rate. Due to the limited quality and quantity of the included studies, more high-quality studies are needed to verify the above conclusions.
ObjectivesTo evaluate the efficacy and safety of four antiplatelet regimens after coronary drug-eluting stents by network meta-analysis.MethodsPubMed, The Cochrane Library, EMbase and Web of Science databases were electronically searched to collect randomized controlled trials (RCTs) of the comparison of different antiplatelet regimens after coronary drug-eluting stenting from inception to December 31st, 2019. Two reviewers independently screened literature, extracted data and assessed risk bias of included studies. Network meta-analysis was then performed by using Gemtc14.3 software, Stata16.0 software and RevMan5.3 software.ResultsA total of 23 RCTs involving 45 837 patients were included. The results of network meta-analysis showed that: in terms of prevention of myocardial infarction (MI) recurrence, the aspirin monotherapy after short-term dual antiplatelet therapy was inferior to the triple antiplatelet therapy (OR=2.13, 95%CI 1.08 to 4.03). In terms of reducing the incidence of ischemic compound events, the triple antiplatelet therapy was superior to the standard dual antiplatelet therapy (OR=0.53, 95%CI 0.39 to 0.72), the aspirin monotherapy after short-term dual antiplatelet therapy (OR=0.49, 95%CI 0.35 to 0.69) and the P2Y12 inhibitor monotherapy after short-term dual antiplatelet therapy (OR=0.51, 95%CI 0.35 to 0.73). There was no statistically significant difference among the four interventions in reducing the rate of in-stent thrombosis and all-cause mortality (P>0.05). In terms of safety, the bleeding rate of aspirin monotherapy after short-term dual antiplatelet therapy was lower than that of standard dual antiplatelet therapy (OR=0.70, 95%CI 0.55 to 0.86) and triple antiplatelet therapy (OR=0.58, 95%CI 0.36 to 0.90), and the bleeding rate of P2Y12 inhibitor monotherapy after short-term dual antiplatelet therapy was also lower than that of standard dual antiplatelet therapy (OR=0.51, 95%CI 0.39 to 0.65) and triple antiplatelet therapy (OR=0.43, 95%CI 0.26 to 0.67). The probability ranking diagram showed that: in terms of the recurrence rate of MI, the rate of in-stent thrombosis and the incidence of ischemic compound events, triple antiplatelet therapy was the lowest and aspirin monotherapy after short-term dual antiplatelet therapy was the highest. However, in terms of all-cause mortality and bleeding rate, aspirin or P2Y12 inhibitor monotherapy after short-term dual antiplatelet therapy was the lowest and triple antiplatelet therapy was the highest.ConclusionsThe available evidence suggests that when the risk of ischemia is low, we should choose aspirin or P2Y12 inhibitor monotherapy after short-term dual antiplatelet therapy, and P2Y12 inhibitor monotherapy may have a lower risk of ischemia and bleeding. When the risk of ischemia is high and bleeding is low, the triple or standard dual antiplatelet therapy should be selected, and the efficacy of triple antiplatelet therapy is superior, while the safety may be inferior.
ObjectiveTo evaluate the effects and safety of statins in patients with acute respiratory distress syndrome (ARDS). MethodsLiteratures in English and Chinese concerning randomized controlled trials (RCTs) on statins in ARDS patients were retrieved by electronic and manual search. All related data were extracted. Meta-analysis was conducted using the statistical software RevMan 5.3 on the basis of strict quality evaluation. ResultsFive RCTs involving 1489 ARDS patients were included, with 709 patients in the statins group and 780 patients in the placebo control group. Compared with the control group, statins did not improve the survival of ARDS patients[risk ratio (RR) 1.01, 95% confidence interval (CI) 0.86 to 1.18, P=0.91), while the improvement of oxygenation[mean difference (MD) 3.92, 95%CI-14.10 to 21.94, P=0.67], ventilator-free days (MD 0.65, 95%CI-0.20 to 1.50, P=0.13) and non-pulmonary organ failure-free days (MD 1.20, 95%CI-1.46 to 3.87, P=0.38) exhibited no differences between the statins group and the control group. However statins were associated with significant elevation of creatine kinase (MD 6.92, 95%CI 5.77 to 8.07, P < 0.000 01). ConclusionThis study demonstrates that statins can not improve outcomes of ARDS patients, and the safety of statins still needs further evaluation.
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 study the efficacy and safety of combined anti-tuberculosis regimen containing bedaquiline in the treatment of multidrug-resistant tuberculosis (MDR-TB). Methods A total of 69 MDR-TB patients treated by joint regimen combined bedaquiline with other anti-tuberculosis drugs between March 2018 and August 2019 in Public Health Clinical Center of Chengdu were taken as the trial group, and 60 MDR-TB patients received treatment without bedaquiline between June 2016 and December 2017 in the same hospital were taken as the control group. The efficacy and safety of the two groups were compared. Results The 69 patients in the trial group included 44 males and 25 females, aged from 21 to 63 years, with an average of (34.6±11.0) years; 58 patients (84.1%) completed the 24-week treatment with bedaquiline, while 11 patients did not complete the treatment, including 3 deaths (4.3%), 1 loss of follow-up (1.4%), 1 withdrawal from the study (1.4%), and 6 discontinuation due to adverse events (8.7%). Among the 54 patients with positive results of tuberculosis on baseline sputum culture, 49 transformed to negative results within 24 weeks of treatment (the negative conversion rate was 90.7%), and the median negative conversion time was 13.0 weeks. The 60 patients in the control group included 45 males and 15 females, aged from 16 to 66 years, with an average of (35.5±13.2) years. Among the 53 patients with positive results of tuberculosis on baseline sputum culture, 30 transformed to negative results within 24 weeks of treatment (the negative conversion rate was 56.6%), and the median negative conversion time was 12.0 weeks. The negative conversion rate of sputum bacteria in the trial group was significantly higher than that in the control group (χ2=16.133, P<0.001). The most common adverse reactions in the trial group were liver function abnormalities (42 cases, 60.9%), prolonged QTc interval (37 cases, 53.6%), electrolyte disturbances (20 cases, 29.0%), and blood system damage (20 cases, 29.0%). In the 37 patients who experienced prolonged QTc interval, there were 8 patients with QTc intervals≥500 ms and 29 patients with QTc intervals ≥450 ms and <500 ms, with a median occurrence time of 16.0 weeks, among whom 25 patients experienced prolonged QTc interval in 4-48 weeks after the withdrawal of bedaquiline. Conclusion The negative conversion rate of tuberculosis sputum culture of patients with MDR-TB treated by bedaquiline combined with other anti- tuberculosis drugs is high, but electrocardiogram should be closely monitored during and after the treatment in order to guard against the potential cardiac toxic effects of bedaquiline.
ObjectivesThe primary objectives of this rapid health technology assessment (RHTA) were to assess the safety and effectiveness of Da Vinci surgical system compared with traditional e surgeries, so as to provide the currently-available best evidence for health decision makers and clinical workers. MethodsA comprehensive search of electronic databases (EMbase, PubMed, The Cochrane Library, Web of Science, CNKI, VIP, CBM and WanFang Data) and relevant professional HTA websites were conducted from inceptionto October 9, 2012. Two reviews independently screen literature according to the inclusion and exclusion criteria, extracted data, and assess the quality of included studies. The data based on secondary studies were reported, and a final recommendation and its level was made based on assessment outcome. ResultsA total of 21 studies were included, encompassing 7 HTAs and 14 systematic reviews/metaanalyses. The included studies involved radical prostatectomy, hysterectomy, nephrectomy, coronary artery bypass graft, and gastric fundoplication. Though the included HTAs and systematic reviews/meta-analyses focus on different diseases, the outcomes showed significant differences existed between Da Vinci surgical system and other routine surgery in clinical effectiveness and safety of different diseases. Compared with routine surgery, Da Vinci surgical system shortened hospital stay; decreased operation conversion rates, blood loss and blood transfusion rates during surgery; but it increased operative time. Besides, compared with traditional laparoscopic surgery, Da Vinci surgical system shortened operation time and hospital stay, and decreased operation conversion rates, blood loss and blood transfusion rates during surgery. ConclusionCurrent evidence shows that the clinical effectiveness and safety outcomes of Da Vinci surgical system differ in diseases. Currently, most included HTAs and systematic reviews/meta-analyses are based on observational studies, relevant prospective randomized controlled trials lack, and the evidence is graded as low quality, health decision makers are suggested to apply this evidence with caution on the basis of comprehensive consideration.
Objective To evaluate the efficacy and safety of percutaneous ethanol injection for hepatocellular carcinomas of 3 cm or less. Methods Randomized controlled trials (RCTs) from the Cochrane Controlled Trials Register (Cochrane Library issue 2, 2008), PubMed (1966 to 2008), EMbase (1966 to 2008), CBMdisc (1978 to 2008), and CNKI (1979 to 2008) were electronically searched. We hand searched related published and unpublished data and their references. Randomized controlled trials of percutaneous ethanol injection to treat hepatocellular carcinomas of 3 cm or less were included. Data were extracted and evaluated by two reviewers independently using a designed extraction form. RevMan 4.2.10 software was used for data analysis. Results Seven RCTs involving 891 patients were included. We conducted subgroup analyses based on outcome measures and interventions. Compared with RFA, for treatment of hepatocellular carcinomas of 3 cm or less, PEI showed statistical differences in one and three-year survival rates and one and three-year local recurrence rates after treatment(RR=0.95, 95%CI 0.91 to 1.00; RR=0.80, 95%CI 0.71 to 0.91; RR=2.18, 95%CI 1.11 to 4.30; RR=2.59, 95%CI 1.55 to 4.32). As for hepatocellular carcinomas of 2-3 cm, PEI showed statistical difference in three year cancer free survival rates after treatment (RR=0.47, 95%CI 0.24 to 0.93) .Conclusion Considering the relatively poor quality of most included trials and small sample size, insufficient evidence was obtained in this systematic review. Therefore, more randomized controlled trials with high quality are still needed to assess and verify the efficacy and safety of this treatment.