ObjectiveTo investigate the efficacy and safety of recombinant human tumor necrosis factor-α receptor Ⅱ:IgG Fc fusion protein (rhTNFR:Fc) for treatment of active rheumatoid arthritis (RA). MethodsThis study included 86 patients with active rheumatoid arthritis treated between September 2011 and January 2013. They were divided into two groups randomly. Forty-three patients in the treatment group received rhTNFR:Fc (25 mg, twice a week) by subcutaneous injection and methotrexate (MTX) (10 mg, orally once a week), and the other 43 patients in the contrast group received MTX (10 mg, orally once a week), hydroxychloroquine (100 mg, orally twice daily), and leflunomide (10 mg, orally once daily). The clinical efficacy of the treatments 12 weeks later were compared between the two groups. American College of Rheumatology (ACR) 20, 50, and 70 evaluation criteria were used for efficacy evaluation. ResultsThe ACR 20, 50 and 70 effective rates in 4, 8 and 12 weeks after the treatment in the treatment group were significantly higher than those in the control group (P<0.05). The seven indicators including the duration of morning stiffness, joint tenderness index, joint swelling index, erythrocyte sedimentation rate, C-reactive protein, platelets and rheumatoid factors within 12 weeks after treatment were significantly improved in both the two groups, and the improvements in the treatment group were more significant (P<0.05). There was no significant difference in the incidence of adverse drug reactions between the two groups (P>0.05). ConclusionRhTNFR:Fc is effecive and safe in treating active RA.
直接证据来自直接比较我们关注的干预措施用于我们关注的患者人群，并测量患者重要结局的研究。间接证据可由以下4种方式之一产生。第一，患者可能与我们关注的患者不同（适用性一词常用于这类间接性）。第二，所检验的干预措施可能与我们关注的干预措施不同。有关患者和干预措施间接性的决策取决于对生物或社会因素差异是否大到可能使效应尺度出现预期的较大差异的考虑。第三，结果可能有别于最初设定的结局指标——如替代结果本身不重要，但测量之是基于替代结果的变化反映患者重要结局变化这一假设。第四类间接性在概念上与前三类不同，发生于临床医生必须在未经直接比较的两种干预措施间做出选择时。这种情况下比较治疗方案需要特定的统计方法，并根据患者人群、联合干预措施、结局测量指标及备选干预措施试验方法的差异程度，将证据级别降低1或2级。
【摘要】 目的 评价舒林酸治疗结直肠息肉的有效性和安全性。 方法 计算机检索PubMed、Cochrane Iibrary、Embase、SCI、CNKI、万方、维普、CBM数据库。按Cochrane系统评价的方法评价纳入研究质量，并进行Meta分析。 结果 共纳入7个随机对照试验（RCT），共235例患者。Meta分析结果显示舒林酸治疗腺瘤性息肉病（FAP）在有效率、息肉消失率方面与安慰剂比较，差异无统计学意义（Pgt;0.05）；治疗散发性结肠腺瘤性息肉病（SCAP）在有效率、息肉消失率、腺瘤直径变化方面与安慰剂比较，差异有统计学意义（Plt;0.05）；舒林酸的不良反应多为消化道症状，与安慰剂比较差异有统计学意义（Plt;0.05）。 结论 系统评价结果显示舒林酸对于家族性FAP的疗效尚不确切，而对SCAP有一定的疗效。【关键词】结直肠息肉；舒林酸；有效性；不良反应；系统评价【Abstract】 Objective To assess the efficacy and safety of sulindac on colorectal polyps. Methods The literatures were searched from several databases including PubMed,Cochrane Iibrary,SCI,CNKI,Wanfang,VIP,and CBM. The quality of the researches was evaluated according to Cochrane systematic reviews, and the Meta analysis was performed. Results Seven RCT were enrolled with a total of 235 patients. Meta analysis showed that there was no significant difference in the effective rate and polyps disappearance rate of FAP between the two groups (Pgt;0.05). There were significant differences in the effective rate, polyps disappearance rate and size of adenomas between the two groups (Plt;0.05); the most common adverse event was the symptoms of digestive tract which differed much from that in the placebo group (Plt;0.05). Conclusion The therapeutic effect of sulindac on FAP is not sure, but it is effective on SCAP.
Objective To evaluate the safety and efficacy of steroid withdrawal in modern triple immunosuppressant (Cycloproine/Tacrolimus, Mycophenolate Mofetil and Steroid) on renal transplantation recipients. Methods We searched MEDLINE (1966-Sep. 2005), OVID (1966-2004), EMBASE (1984-2004), The Cochrane Library (Issue 4, 2005), CBMdisc (1994-2005), and handsearched 7 Chinese Journals. Randomized controlled trials (RCTs) adopting modern triple immunosuppressant, and comparing steroid withdrawal (SW), group and steroid continuing group (SC) were selected. The quality of included studies was evaluated and graded according to Cochrane Reviewer’s Handbook 4.2.5, and meta-analysis was performed by using RevMan 4.2.7 software. Results Nine RCTs including 1 681 patients (845 in SW and 836 in SC) were identified. The average follow-up time was 6-12 months. No significant difference was found in using CsA or Tac in modern triple immunosuppressant. The results of our meta-analysis showed: ① the risk of acute rejection was two times higher in SW than SC (RR 2.05, 95% CI 1.54 to 2.72, P lt;0.000 01), mainly Banff grade I (mild) (RR 1.92, 95% CI 1.16 to 3.17, P =0.01); but no significant differences were found on Banff grade II and III between the two groups. ② the rate of graft and patient survival and chronic rejection were the same between two groups. ③ Steroid withdrawal decreased the incidence of opportunistic infection (mainly caused by simplex herpes virus and Candida) and urinary tract infection. While the incidence of CMV and sepsis infection has no significant difference between two groups. Conclusion Steroid withdrawal within 3 months in modern immunosuppressive regimen ① increases the risk of Banff Grade I rejection reaction, but the moderate and severe rejection are similar between the two groups; ② doesn’t affect the rate of graft, patient survival, and chronic rejection; ③ decreases the incidence of opportunistic and urinary tract infection, but doesn’t improve the CMV infection and sepsis. To prophylaxis serious infection, steroid withdrawal is worth considering under sufficient immunosuppressive regimen. The key point is to balance the benefit and harm for individual recipients.
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.
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 explore the efficacy of humidified high flow nasal cannula ( HHFNC) for respiratory failure after ventilator weaning in post-operative newborns and infants with congenital heart disease. Methods FromJanuary 2010 to August 2010, 33 newborns and infants [ ( 7. 8 ±8. 4) months, range 3 days to 36 months; weight ( 6. 6 ±3. 6) kg, range 2. 2 to 19. 6 kg] were treated with HHFNC ( 22 cases) and routine oxygen therapy ( 11 cases) for respiratory failure following ventilator weaning after operation of congenital heart disease. Symptoms, blood oxygen saturation ( SpO2 ) , partial pressure of oxygen( PaO2 ) , partial pressure of carbondioxide ( PaCO2 ) , incidence rate of re-intubation, duration of ICU, and hospital stay were assessed and compared between the HHFNC group and the routine oxygen therapy group.Results There were no statistical significance in the duration of ICU, hospital stay, duration of mechanical ventilation, or infection rate between the HHFNC group and the routine oxygen therapy group ( P gt; 0. 05) . But the incidence rate of re-intubation was lower in the HHFNC group than that in the routine oxygen therapy group. Meanwhile SpO2 and PaO2 increased and PaCO2 decreased significantly in the HHFNC group ( P lt;0. 05) . Conclusion HHFNC shows a clinical improvement rapidly and efficiently in preventing respiratory failure after ventilator weaning in post-operative newborns and infants with congenital heart disease.
ObjectiveTo investigate the feasibility and safety of transcatheter aortic valve replacement (TAVR) through apical approach for aortic regurgitation of large annulus.MethodsFrom November 2019 to May 2020, 10 male patients aged 64.50±4.20 years with aortic valve insufficiency (AI) underwent TAVR in the Department of Cardiovascular Surgery, Xijing Hospital. The surgical instruments were 29# J-valveTM modified and the patients underwent TAVR under angiography. The preoperative and postoperative cardiac function, valve regurgitation, complications and left ventricular remodeling were summarized by ultrasound and CT before and after TAVR.ResultsA total of 10 valves were implanted in 10 patients. Among them, 1 patient was transferred to the aortic arch during the operation and was transferred to surgical aortic valve replacement; the other 9 patients were successfully implanted with J-valve, with 6 patients of cardiac function (NYHA) class Ⅱ, 4 patients of grade Ⅲ. And there was a significant difference between preoperation and postoperation in left ventricular ejection fraction (44.70%±8.78% vs. 39.80%±8.48%, P<0.05) or aortic regurgitation (1.75±0.72 mL vs. 16.51±8.71 mL, P<0.05). After 3 months, the patients' cardiac function was good.ConclusionTAVR is safe and effective in the treatment of severe valvular disease with AI using J-valve.
Objective To evaluate the effectiveness of GnRH antagonist on vitro fertilization-embryo transfer (IVF-ET). Methods We searched CBMdisc (1979 to 2010), Wanfang (1994 to 2010), CNKI (1994 to 2010), VIP (1989 to 2010), PubMed (1997 to 2010), PML (1997 to 2010), FMJS (2000-2010), and 9 related journals to identify randomized controlled trials (RCTs) on the comparison between GnRH antagonist (GnRHA) and GnRH agonist (GnRHa). The quality of included trials was critically appraised. RevMan 4.2.7 software was used for statistical analysis. Results Six published RCTs involving 1 208 participants were included. Compared with the GnRHa group, stimulation duration in the GnRHA group was lower (WMD= –1.07, 95%CI –1.38 to –0.76), dose of gonadotrophins (Gns) in the GnRHA group was slightly lower (WMD= –0.49, 95%CI –1.63 to 0.66), endometrial thickness at the time of HCG administration was no significant difference in the two groups (WMD= –0.09, 95%CI –0.42 to 0.24), number of oocytes retrieved in the GnRHA group was lower (WMD= –1.80, 95%CI –2.48 to –1.12), OHSS rate in the GnRHA group was slightly lower (Peto OR= 0.77, 95%CI 0.35 to 1.72), pregnancy rate in the GnRHA group was slightly lower (Peto OR= 0.83, 95%CI 0.65 to 1.05), miscarraige rate as no significant difference in the two groups (Peto OR= 1.49, 95%CI 0.79 to 2.82). Conclusions Compared with GnRHa, GnRHA requires shorter stimulation duration and less Gn, less affected the pregnancy rate, and reduces the incidence of OHSS. The use of GnRHA in clinical practice is relatively flexible with good acceptability. GnRHA for the superovulation IVF-ET offers an alternative treatment. The above conclusion still needs more well-designed, multi-center, and large-scale RCTs to confirm and update.
【摘要】 目的 评价中药治疗贝尔（Bell’s）面瘫的有效性和安全性。 方法 以中药、中西医结合、Bell’s面瘫、特发性面瘫、面神经疾病和（或）麻痹、颅神经、颅神经疾病/麻痹为主题词，检索ECSCO数据库系列的ASP（Academic Source Premier）、 NSTL数据库系列的ACP美国医师协会电子期刊数据库及Medicines Complete英国医药出版社医药数据库、MEDLINE数据库、CNKI中国期刊全文数据库、VIP中文科技期刊全文数据库和万方数据库，并在因特网上检索相关学位论文和正在进行的研究。相关的学术会议论文和学位论文汇编也同时予以检索。鉴定相关文章附录的参考文献作为补充检索。 结果 所有以中药治疗Bell’s面瘫的随机对照试验均被纳入。 结论 对纳入的随机对照试验进行方法学质量的评估，数据提取和数据分析。【Abstract】 Objective To evaluate the efficacy and safety of Chinese herbs on Bell’s palsy. Methods With the searching terms including chinese herbs, integrated chinese and western medicine, Bell’s palsy, peripheral facial palsy,facial nerve disease/paralysis, cranial nerve,cranial nerve disease/paralysis were searched in the database of ASP, ACP, Medicines Complete, MEDLINE, CNKI,VIP and Wanfang. While to search the related academic dissertation and ongoing researches on internet. Relevant academic conference and dissertation proceedings have also been searched. Results All randomized trials about Chinese herbs for Bell’s palsy were included in this review. Conclusion Assessment of methodological quality, data extraction and syntheses were carried out.