Conditioning regimens in autologous stem cell transplantation for multiple myeloma: a comparative study of efficacy and toxicity from the Spanish Registry for Transplantation in Multiple Myeloma

High-dose chemoradiotherapy conditioning regimens for autologous stem cell transplantation (ASCT) are generally held to give similar results in multiple myeloma (MM), but no specific comparative study has been published. We addressed this issue by comparing the main high-dose chemoradiotherapy regimens used in the Spanish Registry. Patient cohorts included 315 cases treated with 200 mg/m2 melphalan (MEL200), 127 patients with 140 mg/m2 melphalan plus total body irradiation (MEL140 + TBI) and 121 cases with 12 mg/kg busulphan plus 140 mg/m2 melphalan (BUMEL). After ASCT, granulocyte and platelet recovery time was similar in all conditioning groups. There were no differences in transplant-related mortality. All regimens yielded a similar response in reference to pre-ASCT MM status, although BUMEL produced a slightly better overall response when compared with the other regimens (97% vs. 89% and 92%, P = 0.003). The 5-year overall survival (OS) with BUMEL was 47% [95% confidence interval (CI) 26-68] compared with 43% (CI 31-54) for MEL140 + TBI and 37% (CI: 18-56) for MEL200. The median survival for the BUMEL group was 64 months compared with 45 and 37 months for the MEL200 and MEL140 + TBI groups respectively. These differences were non-significant (P = 0.2). The median event-free survival (EFS) was better for BUMEL (32 months) than for MEL200 (22 months) or for MEL140 + TBI (20 months). The differences in EFS between BUMEL and the other conditioning regimens reached statistical significance (P = 0.01). Nevertheless, the adjusted multivariate analysis for OS and EFS revealed that the conditioning regimens had no independent prognostic value. We concluded that three different conditioning regimens, commonly used for ASCT in MM, have a similar antimyeloma effect. However, the trend for better results observed in our series with BUMEL requires a prospective trial.     

曲妥珠单抗联合IP方案或SOX方案化疗在人类表皮生长因子受体-2阳性晚期胃癌中的有效性和安全性比较

目的 探讨人类表皮生长因子受体-2(HER-2)阳性晚期胃癌中曲妥珠单抗联合IP方案或SOX方案化疗的有效性和安全性。方法 连续性纳入自2015年6月至2017年6月内蒙古医科大学附属医院收治的58例HER-2阳性晚期胃癌,利用随机数字表法分为SOX组和IP组,每组29例。SOX组给予曲妥珠单抗联合替吉奥+奥沙利铂治疗;IP组给予曲妥珠单抗联合伊立替康+顺铂治疗,比较两个疗程后两组病人血清肿瘤标志物和新生血管标志物的变化,以及化疗效果和不良反应差异。结果 两个治疗疗程后,两组病人血清肿瘤标志物癌胚抗原(CEA),糖类蛋白19-9(CA19-9),糖类抗原125(CA125)以及组织多肽特异性抗原(TPS)水平均差异无统计学意义(t=0.628,P=0.532;t=0.879,P=0.383;t=0.828,P=0.411;t=0.719,P=0.476);新生血管标志物内皮生长因子(VEGF)、血管生成素-2(Ang-2)、内皮抑素(ES)、色素上皮衍生因子(PEDF)水平亦差异无统计学意义(t=0.701,P=0.486;t=0.955,P=0.343;t=1.803,P=0.077;t=0.991,P=0.326;);SOX组客观有效率(ORR)及病控制率(DCR)分别为44.83%和82.76%;IP组ORR及DCR分别为34.48%和69.97%,均差异无统计学意义(χ²=0.648,P=0.421;χ²=1.506,P=0.219)。但IP组骨髓抑制(58.62%)和恶心呕吐(3.45%)发生率明显高于SOX组(31.03%,6.90%),差异有统计学意义(χ²=4.461,P=0.035;χ²=5.836,P=0.016)。结论 曲妥珠单抗联合SOX化疗方案或IP方案在HER-2阳性晚期胃癌病人中疗效相当,但SOX方案不良反应发生率较少,值得临床推广。     

Impacto da frequência posológica na adesão terapêutica em doenças cardiovasculares crónicas: revisão sistemática e meta‐análise

Introduction and ObjectiveNon‐adherence to drug treatment is a major health problem. In Europe, it has been estimated that 9% of cardiovascular events can be attributed to non‐adherence. The complexity of dosing regimens is one of the factors identified as contributing to non‐adherence. In this systematic review we aimed to assess the impact of dosing frequency on adherence to drug treatment in patients with chronic cardiovascular disease.MethodsMEDLINE and the Cochrane Library (November 2013) were searched for randomized controlled trials (RCTs) comparing different dosing regimens (once‐daily administration vs. two or more daily administrations) and assessing adherence to therapy in patients with chronic cardiovascular disease. Only trials with at least five months of follow‐up were included. The results of the studies were pooled through a random effects meta‐analysis. Relative risk (RR) and 95% confidence interval (CI) were derived. Statistical heterogeneity was calculated using the I² test.ResultsFour RCTs (a total of 2557 patients) were included. Dosing regimens with once‐daily administration were associated with a significant 56% reduction in risk of non‐adherence to drug therapy (RR: 0.44; 95% CI: 0.35‐0.54, I²=25%).ConclusionsFew clinical trials have assessed the long‐term impact of dosing frequency on medication adherence in chronic cardiovascular disease. The best available evidence suggests that taking medication once daily decreases the risk of non‐adherence to treatment by approximately 50%. The impact on clinical outcomes remains to be established.     

Upfront Consolidation Combining Yttrium-90 Ibritumomab Tiuxetan and High-Dose Therapy with Stem Cell Transplantation in Poor-Risk Patients with Diffuse Large B Cell Lymphoma

We evaluated the safety and efficacy of standard-dose yttrium-90 (Y⁹⁰) ibritumomab tiuxetan combined with high-dose BEAM (carmustine, etoposide, cytarabine, and melphalan) after first-line induction treatment in young patients with poor prognoses diffuse large B cell lymphoma (DLBCL) (clinicaltrials.gov: NCT00689169). Seventy-five high-risk (≥2 International Prognostic Index [IPI] factors) consecutive DLBCL patients (≤65 years old) in complete remission (CR) or partial remission (PR) after rituximab chemotherapy were treated with Y⁹⁰ ibritumomab tiuxetan and BEAM regimen followed by autologous stem cell transplantation (ASCT). The median follow-up was 34 months. Of the 75 patients, 71 underwent ASCT and were eligible for analysis. Median time to reach a neutrophil count of >500/μL and platelet count of >20,000/μL was 11 days. Mucositis ≥3 (51%) occurred in most patients. Other adverse events were similar to those seen with BEAM alone. The overall response rate was 86%; 59 patients (83%) achieved a CR or unconfirmed CR. The 2-year event-free survival (EFS), overall survival (OS), and disease-free survival were 79%, 83%, and 91%, respectively. Disease status (CR/PR) and positron emission tomography (PET) findings before transplantation did not predict treatment failure. The IPI (2 versus >2) and maximum tumor diameter of ≥10 cm at diagnosis appeared to be prognosis factors for OS but not for EFS. Adding Y⁹⁰ ibritumomab tiuxetan to BEAM is safe and does not increase transplantation-related toxicity. First-line consolidation with Y⁹⁰ ibritumomab tiuxetan and high-dose chemotherapy induced high rates of EFS and OS in poor-prognosis patients with DLBCL, regardless of PET status after induction treatment and warrants a randomized study.     

TP方案联合热灌注化疗对老年晚期卵巢癌患者免疫功能及血清特异性指标的影响

目的探讨TP方案联合热灌注化疗对老年晚期卵巢癌患者免疫功能及血清特异性指标的影响。方法选取2016年10月至2018年10月于我院接受治疗的老年晚期卵巢癌患者84例,随机将其等分成对照组和观察组,对照组行TP方案,观察组在对照组基础上行腹腔热灌注化疗(IPHC)。比较两组近期疗效、免疫功能、血清指标情况。结果观察组疗效较对照组高,差异有统计学意义(P<0.05);观察组血清YKL、CA125、HE4及CD8+含量较对照组降低,血清CD4+、CD3+及CD4+/CD8+比值较对照组升高(P<0.05)。结论TP方案联合热灌注化疗可有效提升老年晚期卵巢癌近期疗效,降低血清特异性指标,提升机体免疫功能。     

基于文献分析的欧龙马滴剂儿童国内给药方案调查

目的 分析欧龙马滴剂在儿童中的给药方案,为临床安全合理用药提供数据支持.方法 检索2005年1月1日至2020年6月30日期间,中国期刊全文数据库、中文科技期刊全文数据库、万方数据库和中国生物医学文献等数据库中有关欧龙马滴剂的文献,对文献报道的儿童患者诊断、年龄、用量、给药途径、疗程、合并用药等方面进行汇总分析,以探讨...     

Ag85B DNA/H37Ra序贯免疫效果的探讨

目的：初步探讨含结核分枝杆菌Ag85B成熟蛋白的DNA（pTB30m）和结核菌H37Ra序贯免疫小鼠产生的特异性免疫应答。方法：重组质粒pTB30m用碱裂解法制备后进行质量鉴定。用pTB30m肌注初次免疫小鼠2周后,H37Ra皮内加强免疫作为DNA-85B/H37Ra组,同时设定DNA-85B/BCG组、H37Ra组、BCG组及未免疫组。免疫4周或8周后,用ELISA法检测小鼠血清中抗PPD IgG抗体的水平和MTT法检测其脾淋巴细胞的刺激指数（SI）。结果：酶切鉴定pTB30m所含外源基因片段大小正确,并且纯度较高。DNA-85B/H37Ra组小鼠血清中抗PPD IgG水平、脾淋巴细胞的SI均显著高于未免疫组（P〈0.05）;其抗PPD IgG水平稍高于DNA-85B/BCG组、H37Ra组及BCG组,但它们之间无显著性差异（P〉0.05）;其脾淋巴细胞的SI显著高于H37Ra、BCG组（P〈0.05）,而与DNA-85B/BCG组比较,仅在4周有显著性差异。在DNA-85B/H37Ra组内,SI在4周显著高于8周（P〈0.05）,而血清中抗PPD IgG水平8周均显著高于4周（P〈0.05）。结论：DNA-85B/H37Ra序贯免疫策略可以诱导小鼠产生特异性体液免疫和细胞免疫,初步证明其免疫效果略优于BCG。     

不同药物方案治疗儿童双相情感障碍疗效比较及代谢指标观察

目的 探讨儿童双相情感障碍经不同药物方案治疗后代谢指标的变化及治疗疗效。方法 回顾性分析2017年1月至2020年1月于该院就诊的220例儿童双相情感障碍患儿的临床资料。根据治疗方法分组,单纯采用非典型抗精神病药物治疗的112例患儿纳入对照组,采用非典型抗精神病药物联合心境稳定剂治疗的108例患儿纳入研究组。比较两组基线资料水平,治疗前后代谢指标空腹胰岛素（FIN）、糖化血红蛋白（HbAlc）、总胆固醇（TC）、三酰甘油（TG）、高密度脂蛋白胆固醇（HDL-C）、低密度脂蛋白胆固醇（LDL-C）水平变化,以及代谢综合征发生情况及临床疗效。结果 两组患儿年龄、性别、病程等基线资料比较差异均无统计学意义（P > 0.05）。研究组总有效率为92.6%,高于对照组（82.1%,P < 0.05）。治疗前,两组FIN、HbAlc水平比较差异无统计学意义（P > 0.05）;治疗后,对照组FIN水平高于治疗前,且高于研究组（P < 0.05）;但研究组治疗前后FIN水平比较差异无统计学意义（P > 0.05）;两组治疗前后HbAlc水平比较差异无统计学意义（P > 0.05）。治疗前,两组TC、TG、HDL-C、LDL-C水平比较,差异无统计学意义（P > 0.05）;治疗后,对照组TC、TG水平均高于治疗前,且高于研究组（P < 0.05）;但研究组治疗前后TC、TG水平比较差异无统计学意义（P > 0.05）;两组治疗前后HDL-C、LDL-C水平比较差异无统计学意义（P > 0.05）。研究组代谢综合征发生率（2.8%）低于对照组（9.8%）（P < 0.05）。结论 儿童双相情感障碍采用非经典抗精神病药物联合心境稳定剂治疗对代谢指标水平影响较小,且疗效显著。