重组人干扰素α1b辅助治疗传染性单核细胞增多症疗效的前瞻性随机对照研究

目的 探究重组人干扰素α1b辅助阿昔洛韦治疗对传染性单核细胞增多症（IM）患儿免疫功能、炎症因子及心肌酶谱的影响。方法 将2018年1~12月收治入院的182例IM患儿通过随机数字表法分为观察组（n=91）及对照组（n=91）。对照组接受静脉滴注阿昔洛韦治疗,观察组在对照组基础上雾化吸入重组人干扰素α1b。比较两组患儿临床症状、免疫功能、炎症反应、心肌酶谱及不良反应情况。结果 观察组体温恢复正常、咽峡炎消失、颈部淋巴结肿大消失、肝大消失、脾大消失时间均短于对照组（P < 0.05）。治疗后两组患儿CD4⁺、CD4⁺/CD8⁺、CD19⁺水平均较治疗前升高,且观察组高于对照组（P < 0.05）。治疗后两组患儿CD8⁺、肿瘤坏死因子α、白细胞介素6、肌酸激酶、肌酸激酶同工酶水平均较治疗前降低,且观察组低于对照组（P < 0.05）。治疗后两组患儿不良反应发生情况比较差异无统计学意义（P > 0.05）。结论 重组人干扰素α1b辅助阿昔洛韦治疗能有效改善IM患儿免疫功能,抑制机体炎症反应,减轻心肌损伤,进而缓解患儿临床症状。     

雾化吸入重组人干扰素α1b治疗小儿急性毛细支气管炎多中心研究

目的 评价雾化吸入重组人干扰素α1b治疗小儿急性毛细支气管炎的安全性和疗效,为临床推荐合理的用法用量。方法 采用随机、对照、多中心的设计方法,2012年12月至2013年5月期间,将国内11家医院收集的330例细支气管炎患儿按启动顺序随机分配各中心的中心号,按病例入组的时间进行顺序随机入选分为3组。对照组采用常规对症治疗,观察组在此基础上分别加用每次剂量2 μg/kg（低剂量组）和 每次剂量4 μg/kg（高剂量组）的重组人干扰素α1b,雾化吸入,每日2次,疗程5～7 d,采用四级评分法分度评价病情,并进行病原学检测。结果 （1）低剂量组和高剂量组的总改善率分别为（92.3±4.5）%和（95.0±4.9）%,显著优于对照组［（85.3±6.4）%,P＜0.05）］,高剂量组的主要疗效指标（喘息、喘鸣音、三凹征）的改善率优于低剂量组, 症状消失时间显著缩短（P＜0.05）, 对三凹征的改善最为明显（P＜0.05）;（2）发病72 h内和发病72 h后干扰素α1b治疗均有效,发病72 h内干扰素α1b治疗的所有疗效指标的总改善率更高; （3）呼吸道合胞病毒（RSV）阳性的患儿主要疗效指标的改善率显著高于RSV阴性患儿,观察组的改善率均优于对照组; （4）所有患儿干扰素α1b治疗后均未见呼吸道局部刺激症状,无严重不良反应发生。结论 重组人干扰素α1b雾化吸入治疗小儿急性毛细支气管炎症状减轻,病程缩短,安全性良好,早期对因治疗效果更佳。     

83例传染性单核细胞增多症的实验室检查和并发症

目的 　分析传染性单核细胞增多症 (传单 )患儿的实验室检查与并发症 ,利于减少临床漏诊与误诊。方法　回顾性分析 1 995年 1月～ 2 0 0 2年 1 2月我科收治的83例传单患儿的实验室检查特点和并发症的发生情况。结果 　异型淋巴细胞比例增高见于 89 2 %的病例 ,提示为诊断传单简便有效的筛查手段 ,其增高程度与疾病的病情无关。EBV -VCA -IgM的阳性率为 88 5%对传单诊断有重要意义。 36 9%的病例心肌酶谱升高 ;6 8 1 %的病例血沉增快 ;53 9%的病例C -反应蛋白轻度增高 ;73 5%病例发生于 7岁以下儿童 ,7月份及 9份月为发病高峰 ;并发症发生率 78 3%尤以肝脏损害最常见。其次为肺部感染。结论 　大多数传单呈良性临床经过 ,且多具有较典型的临床表现 ,本病并发症常见且多样 ,可累及多种器官。对EBV -VCA -IgM阴性而临床高度怀疑该病病例可采用EBV -PCR扩增技术协助诊断。提高对本病实验室检查特点和并发症的认识 ,有助于减少临床误诊和漏诊。     

重组人干扰素α1b治疗小儿病毒性肺炎疗效观察

病毒性肺炎在小儿肺炎中至少占半数比例，其中呼吸道合胞病毒(RSV)、腺病毒(ADV)、流感病毒(IFV)、副流感病毒(PIV)是引起儿童下呼吸道感染的主要病原。我们对59例小儿病毒性肺炎运用基因重组α1b干扰素(IFN-1b，运德素)进行治疗。取得良好效果，现报告如下。     

匹多莫德口服液辅助治疗传染性单核细胞增多症的疗效分析

目的 观察匹多莫德口服液辅助治疗传染性单核细胞增多症的疗效及对T淋巴细胞亚群的影响。方法 选取2016年7月至2017年6月收治的传染性单核细胞增多症患儿共76例为研究对象,随机分为常规治疗组和匹多莫德组各38例,常规治疗组给予注射用更昔洛韦抗病毒及常规对症治疗,匹多莫德组在此基础上加用匹多莫德口服液,疗程2周。分别比较两组临床指标的恢复情况及外周血T淋巴细胞亚群的变化。结果 匹多莫德组患儿热退时间、扁桃体炎消退时间、肿大淋巴结缩小时间、肿大肝脾缩小时间及住院时间均较常规治疗组显著缩短（P < 0.05）。匹多莫德组治疗后CD3⁺、CD8⁺水平较治疗前及常规治疗组治疗后下降（P < 0.001）;CD4⁺水平、CD4⁺/CD8⁺比值较治疗前及对照组治疗后上升（P < 0.001）。对照组在治疗2周后T淋巴细胞亚群较治疗前无明显变化（P > 0.05）。结论 匹多莫德口服液辅助治疗传染性单核细胞增多症有良好的临床疗效,并能改善细胞免疫功能,值得临床推广应用。     

儿童传染性单核细胞增多症临床特征及T细胞亚群分析

目的探讨儿童传染性单核细胞增多症(IM)的临床特征和T细胞亚群变化规律,分析其临床意义。方法回顾性分析2015年1月-2016年12月收治的59例IM患儿的临床资料,比较患儿初诊及治疗后的临床特征和实验室检测指标。结果初诊患儿临床表现以发热(93.2%)、淋巴结肿大(62.7%)和咽峡炎(52.5%)多见;实验室检查以外周血WBC1010~9/L(84.7%)、外周血异型淋巴细胞10%(81.3%)和ALT升高(52.5%)多见;与初诊时比较,治疗后淋巴结肿大阳性率差异无显著性(P0.05),其他项目差异均具有显著性(P0.05)。初诊患儿DNT细胞、CD3~+T细胞、CD3~+CD8~+T细胞百分比均显著高于对照组(P0.01),CD3~+CD4~+T细胞百分比显著低于对照组(P0.01)。治疗后患儿DNT细胞、CD3~+T细胞、CD3~+CD4~+T细胞、CD3~+CD8~+T细胞与正常对照组相比差异无显著性(P0.05)。结论 IM起病时症状多样,存在明显的免疫失衡,监测患儿不同时期临床特点及T细胞亚群变化,能够为IM患儿临床免疫治疗提供理论依据。     

抗病毒治疗对儿童传染性单核细胞增多症的价值探讨

目的：比较抗病毒治疗与未抗病毒治疗对儿童传染性单核细胞增多症（IM）的近期疗效及远期随访结果,以探讨抗病毒治疗对儿童IM的价值。方法：回顾性复习1999～2009年住院IM患儿病历,符合纳入条件并随访1年以上的病例共172例。根据患儿治疗方案,分为更昔洛韦组(49例)、阿昔洛韦组(72例)和对照组(51例)。更昔洛韦组予静脉滴注更昔洛韦每日10 mg/kg,分2次给予;7 d后改为每日5 mg/kg,每日1次;总疗程10～14 d。阿昔洛韦组予口服阿昔洛韦片,每日20 mg/kg,分3次口服;总疗程10～14 d。对照组仅使用对症治疗。观察各组热程、咽峡炎症状改善、肝脾淋巴结回缩时间、异型淋巴细胞数回降时间及用药后粒细胞数改变等指标。远期随访包括复查血常规、肝功能、肝脾B超,并统计治愈率、复发率和死亡率。结果：急性期3组在热程、咽峡炎的改善、肝脾淋巴结开始回缩时间、异型淋巴细胞数降至10%以下的时间等指标差异均无统计学意义（P>0.05）。随访1年至8年10个月,3组间治愈率、复发率、死亡率差异无统计学意义（P>0.05）。结论：抗病毒治疗与非抗病毒治疗对儿童IM的疗效无明显差异,抗病毒治疗未能使IM患儿获益。     

更昔洛韦治疗小儿传染性单核细胞增多症临床疗效分析

目的：观察更昔洛韦治疗小儿传染性单核细胞增多症的临床效果。方法：将42例病例随机分为更昔洛韦治疗组和对照组,然后进行临床观察。结果：治疗组白细胞总数及异型淋巴细胞恢复正常时间、平均住院日、体温降至正常时间、肝脾淋巴结缩小时间均明显缩短,与对照组相比差异有显著性意义。结论：更昔洛韦治疗小儿传染性单核细胞增多症能明显提高疗效。     

荧光定量PCR检测传染性单核细胞增多症EB病毒的评价

目的 研究荧光定量PCR检测传染性单核细胞增多症(以下简称传单)EB病毒(EBV)DNA量的意义,了解EBV DNA拷贝量与病情程度的相关性.方法 采用荧光定量PCR检测2004年6月至2006年6月在湖南省人民医院儿科住院的68例传单患儿外周血单个核细胞(PBMCs)EBV DNA量,根据病情将患儿分为单器官系统组和多器官系统组,比较两组EBV DNA量.结果 (1)传单患儿EBV DNA阳性率为86.8%,拷贝量均值为13200拷贝/mL.(2)EBV DNA量在单器官系统组和多系统组差异有统计学意义(P＜0.05).传单患儿器官损害越多,EBV DNA拷贝量越高.结论 PBMCs荧光定量PCR检测EBV DNA量是有助传单诊断、治疗的较好手段.监测EBV DNA量对及早评估病情、及早治疗有一定指导意叉.     

白芍总苷辅助治疗儿童紫癜性肾炎的疗效及其机制探讨：前瞻性随机对照研究

目的 探讨白芍总苷（TGP）辅助治疗儿童紫癜性肾炎（HSPN）的临床疗效及其机制。方法 选取中度蛋白尿型HSPN患儿共64例,按随机数字表法分为TGP治疗组（TGP组,n=34）和常规治疗组（常规组,n=30）,同期选取正常体检儿童30例作为健康对照组。两组患儿同时予常规治疗,观察组在常规治疗基础上加用TGP。比较两组患儿在治疗4周后的临床疗效,同时检测健康儿童及患儿外周血中滤泡辅助性T（Tfh）细胞比例及白细胞介素（IL）-21、IL-4水平,以及患儿血清胱抑素C（CysC）及尿α1微球蛋白（A1M）水平的变化。结果 HSPN患儿治疗前Tfh细胞比例及IL-21、IL-4表达水平较健康对照组明显升高（P < 0.01）。治疗后,TGP组的总有效率为94%,明显高于常规组（67%,P < 0.05）。两组患儿外周血中Tfh细胞比例及IL-21、IL-4水平,以及血清CysC、尿A1M水平均较治疗前有所下降,且TGP组患儿治疗后的上述指标较常规组患儿下降更为显著（P < 0.01）。结论 TGP治疗HSPN疗效显著,可能通过抑制Tfh细胞的增殖,下调IL-21、IL-4的表达,从而减轻肾脏炎症反应,起到保护肾脏的作用。     

In vivo effect of recombinant human granulocyte colony-stimulating factor on neutrophilic expression of CD11b in septic neonates: a randomized controlled trial

Neonates are susceptible to septicemia secondary to quantitative and qualitative neutrophilic defects. Granulocyte colony-stimulating factor (G-CSF) stimulates myeloid progenitor cell proliferation and induces selective neutrophil functions. The authors aimed to evaluate the effect of G-CSF administration in septic neonates on neutrophil production and CD11b expression. Sixty septic neonates were randomized to receive intravenous G-CSF 10 μg/kg/day for 3 days (G-CSF group, n = 30), or not to receive G-CSF (non-G-CSF group, n = 30). Thirty healthy newborns were included as controls. Laboratory investigations included complete blood count, C-reactive protein, blood culture, renal and liver function tests, and assessment of neutrophilic expression of CD11b. Total leukocytes count (TLC), absolute neutrophil count (ANC), and immature myeloid cell count in G-CSF group showed significant difference between post-and pre-G-CSF levels. TLC, ANC, immature myeloid cell count and immature/total myeloid cells ratio were higher in G-CSF group compared to non-G-CSF group on days 1 and 3. Higher neutrophilic expression of CD11b was reported in both septic groups on day 0 compared to control group. On day 5, CD11b was higher in G-CSF group than non-G-CSF group. G-CSF improved CD11b% in neutropenic and non-neutropenic septic neonates. No significant difference was found between pre- and posttreatment renal and liver function tests. Lower duration of antibiotic intake and hospitalization was observed in G-CSF group compared to non-G-CSF group. G-CSF administration as an adjuvant therapy for neonatal septicemia, whether neutropenic or not, improves neutrophilic count and function and contributed to early healing from sepsis.     

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??Abstract?? Objective To evaluate effectiveness and safety of treatment for children’s acute bronchiolitis by nebulized recombinant human interferon α 1b in a multicenter clinical study??and to recommend a reasonable clinical dosage for children. Methods Withthe design of a randomized, controlled, multi-center study, totally 330 children who were hospitalized from December 2012 to May 2013 for acute bronchiolitis were randomly divided into three groups. The control group had routine and symptomatic treatment. Therapy groups inhaled human recombinant interferon α1b 2 μg/kg and 4 μg/kg respectively, twice a day plus routine treatment, for 5 to 7 days. We used four-level-scoring method to evaluate disease conditions and performed pathogen detections. Results ??1??The total improvement rates of low and high dose group were 92.3% and 95.0%, respectively, which were significantly higher than control group ??85.3%, P<0.05??. High dose group had obviously improved primary index ??wheezing, wheezing rale and three depression sign?? compared with low dose group. The disappearance time of symptoms was shortened significantly ??P<0.05??, and the improvement of three depression signs was obvious ??P<0.01??.??2??Treatments within and after 72 h were both effective, but the total improvement rate within 72 h was better.??3??The effectiveness of interferon α1b in RSV positive children was significantly better than in RSV negative children. Effectiveness of treatment group was superior to that of control group.??4??All children did not show irritation symptoms in local respiratory tracts, and no serious adverse reactions was observed. Conclusion The treatment for acute bronchiolitis in young children by nebulized human recombinant interferon α1b is effective, which shortened the duration of symptoms, with no safety problem. The effect is better when used in the early stage.     

重组人干扰素α2b口咽部喷雾治疗疱疹性咽峡炎的有效性和安全性多中心随机对照研究

目的评估重组人干扰素α2b(rhIFNα2b)口咽部喷雾治疗小儿疱疹性咽峡炎的有效性和安全性。方法本研究采用前瞻性、随机、开放、对照、多中心研究方法,2018年8月至2019年3月参加本研究的安徽省内11家三甲医院共收集了疱疹性咽峡炎患儿180例,按住院的时间顺序随机分为干扰素治疗组和利巴韦林对照组。在清热解毒和抗感染治疗基础上,治疗组患儿咽部喷洒rhIFNα2b 9 g/L盐水溶液[100万IU/mL,10万IU/(0.1 mL·揿)],对照组患儿咽部喷洒利巴韦林喷剂(0.5 mg/揿,150揿),2组治疗方法相同,均为每次3揿,每日4次,连续给药5 d,提前痊愈者不再给药治疗。所有患儿观察至临床痊愈,比较2组患儿的疗效、症状和体征消失时间,并评估口咽局部喷洒rhIFNα2b的安全性。结果180例患儿均完成研究,其中治疗组90例,对照组90例,2组性别、年龄、体质量和就诊前病程等方面比较差异均无统计学意义(均P>0.05),具有临床可比性。治疗组显效率[63.3%(57/90例)]显著高于对照组[38.9%(35/90例)],差异有统计学意义(χ^2=10.934,P=0.004);治疗组总有效率为96.7%(87/90例),与对照组[92.2%(83/90例)]比较差异无统计学意义(χ^2=2.924,P=0.169)。治疗组发热[(32.59±20.73)h比(45.72±26.96)h]、充血[(76.48±23.12)h比(92.44±24.31)h]、疱疹[(72.99±25.77)h比(85.09±26.62)h]、流涎[(45.44±24.96)h比(54.42±31.20)h]和畏食[(62.70±23.99)h比(78.71±30.54)h]等症状和体征持续时间均短于对照组,差异均有统计学意义(均P<0.05)。用药前2组血清肿瘤坏死因子α(TNF-α)[(13.02±4.41)ng/L比(13.57±9.27)ng/L]、白细胞介素-6(IL-6)[(26.48±11.31)ng/L比(30.15±15.55)ng/L]和C反应蛋白(CRP)[(19.34±14.11)mg/L比(19.83±14.57)mg/L]比较差异均无统计学意义(均P>0.05);治疗后,治疗组血清TNF-α和IL-6水平分别为(7.26±1.99)ng/L和(2.42±0.73)ng/L,均低于对照组[(12.09±6.39)ng/L和(7.32±11.51)ng/L],差异均有统计学意义(均P<0.05),但2组患儿血清CRP水平[(2.21±3.34)mg/L比(2.99±4.81)mg/L]比较差异无统计学意义(P>0.05)。治疗组患儿咽拭子治疗前后病毒阳性率分别为65.3%(32/49例)和40.6%(13/32例),与对照组[66.7%(36/54例)和41.0%(16/39例)]比较,差异均无统计学意义(均P>0.05)。治疗期间2组均未见严重不良反应事件,治疗组不良反应发生率为1.1%(1/90例),对照组不良反应发生率为5.6%(5/90例);对照组治疗后的血红蛋白水平显著低于治疗前和治疗组,差异均有统计学意义(均P<0.05)。结论rhIFNα2b口咽部喷雾治疗疱疹性咽峡炎相对利巴韦林可明显提高临床显效率,加快临床症状和体征消失,缩短总病程且安全性良好,值得临床应用。     

Combination trial of subcutaneous recombinant α2b interferon and oral cyclophosphamide in follicular low-grade non-Hodgkin's lymphoma

The follicular non-Hodgkin's lymphomas (NHL) have been among those tumors demonstrated to show frequent responses to alpha interferon in phase I and II clinical trials. In addition, there are data suggesting that alpha interferon demonstrates synergistic antitumor activity with alkylating agents in animal models for a number of tumors. Based on these data, Cancer and Leukemia Group B (CALGB) undertook a phase II pilot study of the combination of interferon rlFNα2b (2 × 10⁶ IU/m² s.c. tiw) and cyclophosphamide (100 mg/m² per day orally) with the ultimate purpose of examining this combination as long-term therapy of follicular lymphoma in comparison to oral cyclophosphamide alone. One hundred five advanced stage III or IV eligible patients with pathologically diagnosed International Working Formulation B or C histology were entered on CALGB 8553 to determine toxicity and response rates to the combination. Both previously chemotherapy-treated patients (32) and patients without prior chemotherapy (73) were entered on study. For patients without prior chemotherapy the overall response rate to the combination regimen was 86% with 58% of chemotherapy-treated patients achieving complete response. Chemotherapy-treated patients had a total response rate of 62% with only 25% complete responders. Complete responses in patients without prior chemotherapy were positively correlated with absence of B symptoms, and good performance status and negatively correlated with the histological subtype of follicular mixed small-cleaved and large cell histology (IWF C); only performance status was significantly correlated with response in patients who had previously had chemotherapy. Survival at 5 years is estimated to be 63% for those without chemotherapy and 39% for those previously treated with chemotherapy patients. The maximum toxicities experienced during therapy with the combination regimen of cyclophosphamide and interferon alpha were primarily related to myelosuppression. Sixty-seven percent of patients without prior chemotherapy and 65% of patients receiving prior chemotherapy experienced severe leukopenia while severe thrombocytopenia and anemia occurred in 6-31% of these patients. Non-myelosuppressive toxicities were less frequently seen. These response rates are similar to those achieved in a previous CALGB trial with oral cyclophosphamide as a single agent, although severe myelotoxicity was increased to approximately 60% of patients from less than 10% with the single-agent therapy. The combination of alpha interferon and cyclophosphamide administered in this fashion is safe when peripheral counts are carefully monitored. Randomized studies of this regimen in comparison to oral cyclophosphamide are currently in progress. © 1994 Wiley-Liss, Inc.