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FDA日前批准Medlmmune公司的帕利珠单抗（Synagis，palivizumab）增加新的适应证。 Palivizumab is used for: Preventing serious lower respiratory tract infection caused by respiratory syncytial virus (RSV) in children at high risk of RSV disease. Palivizumab is a monoclonal antibody. It works by preventing RSV from reproducing. Do NOT use Palivizumab if: Before using Palivizumab : if you are pregnant, planning to become pregnant, or are breast-feeding This may not be a complete list of all interactions that may occur. Ask your health care provider if Palivizumab may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine. How to use Palivizumab : An extra patient leaflet is available with Palivizumab . Talk to your pharmacist if you have questions about this information. Important safety information: Cough; diarrhea; mild fever; minor pain, redness, swelling, or warmth at the injection site; runny or stuffy nose; upset stomach; vomiting. Seek medical attention right away if any of these SEVERE side effects occur: This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch. If OVERDOSE is suspected: Proper storage of Palivizumab : General information:
Synagis（帕利珠单抗，palivizumab）说明书 一次性使用瓶（密码）-1
Jorge Sallent博士等研究结果显示，Synagis可有效地降低呼吸道合胞病毒（RSV）感染高危婴儿的住院率。 结果还表明，按照推荐的每月注射时间用药是治疗成功的关键。对于某些高危患儿，为了预防RSV感染，治疗一个季节以上是有益的。在予Synagis预防的24例患儿中，仅有7例（2.8%）因RSV而入院。这与RSV影响试验所观察的住院率相吻合。 本研究7例住院患儿的4例，没以按上述推荐的方法治疗，在住院前至少有一次没有给药。另3例为在RSV感染的第一季节开始治疗的患儿，这3例患儿在RSV感染的第二季节未再接受Synagis治疗。这提示某些患儿在继之RSV感染的季节里，预防性应用Synagis是有益的。 Alber marchetli博士等的论文《非Palivizumab预防疗法RSV感染婴儿住院费用的观察》的研究结果表明：对因RSV感染入院并接受Synagis预防疗法的少数患儿，其住院费用明显少于非预防疗法患儿的费用。在这项对20例RSV感染住院的前瞻性研究中，有10例入院前Synagis预防疗法，另10例未予Synagis。 接受Synagis 治疗患儿平均住院费用8,492美元、住院期4.1天；而非其疗法的患儿住院费用为15,786美元、住院期6.8天。 其它研究结果亦显示，Synagis可有效的降低RSV高危患儿的住院率。本研究的结论表明：对于少数几例预防用药后仍病毒感染入院的患者，Synagis降低了RSV感染的严重程度，从而降低了医疗费用。 Robetter Hirsch Ｍedimmune博士亦在论文中阐述，“临床实践表明，Synagis可降低高危患儿RSV感染所致的全身并发症”。研究结果还显示,高危患儿预防性用药可大大降低医疗费用。相信这些研究能引起儿科医生对早产儿及其他高危婴儿治疗的高度重视。
SYNAGIS® (PALIVIZUMAB) Rx only DESCRIPTION: Synagis (palivizumab) is a humanized monoclonal antibody (IgG1κ ) produced by recombinant DNA technology, directed to an epitope in the A antigenic site of the F protein of respiratory syncytial virus (RSV). Synagis is a composite of human (95%) and murine (5%) antibody sequences. The human heavy chain sequence was derived from the constant domains of human IgG1 and the variable framework regions of the VH genes Cor (1) and Cess (2). The human light chain sequence was derived from the constant domain of Cκ and the variable framework regions of the VL gene K104 with Jκ -4 (3). The murine sequences were derived from a murine monoclonal antibody, Mab 1129 (4), in a process that involved the grafting of the murine complementarity determining regions into the human antibody frameworks. Synagis is composed of two heavy chains and two light chains and has a molecular weight of approximately 148,000 Daltons. Synagis is supplied as a sterile, preservative-free liquid solution at 100 mg/mL to be administered by intramuscular injection (IM). Thimerosal or other mercury containing salts are not used in the production of Synagis. The solution has a pH of 6.0 and should appear clear or slightly opalescent. Each 100 mg single-dose vial of Synagis liquid solution contains 100 mg of Synagis, 3.9 mg of histidine, 0.1 mg of glycine, and 0.5 mg of chloride in a volume of 1 mL. Each 50 mg single-dose vial of Synagis liquid solution contains 50 mg of Synagis, 1.9 mg of histidine, 0.06 mg of glycine, and 0.2 mg of chloride in a volume of 0.5 mL. CLINICAL PHARMACOLOGY: Mechanism of Action: Synagis exhibits neutralizing and fusion-inhibitory activity against RSV. These activities inhibit RSV replication in laboratory experiments. Although resistant RSV strains may be isolated in laboratory studies, a panel of 57 clinical RSV isolates were all neutralized by Synagis (5). Synagis serum concentrations of ≥ 40 mcg/mL have been shown to reduce pulmonary RSV replication in the cotton rat model of RSV infection by 100-fold (5). The in vivo neutralizing activity of the active ingredient in Synagis was assessed in a randomized, placebo-controlled study of 35 pediatric patients tracheally intubated because of RSV disease. In these patients, Synagis significantly reduced the quantity of RSV in the lower respiratory tract compared to control patients (6). Pharmacokinetics: In pediatric patients < 24 months of age without congenital heart disease (CHD), the mean half-life of Synagis was 20 days and monthly intramuscular doses of 15 mg/kg achieved mean ±SD 30 day trough serum drug concentrations of 37± 21 mcg/mL after the first injection, 57 ± 41 mcg/mL after the second injection, 68 ± 51 mcg/mL after the third injection and 72 ± 50 mcg/mL after the fourth injection (7). Trough concentrations following the first and fourth Synagis dose were similar in children with CHD and in non-cardiac patients. In pediatric patients given Synagis for a second season, the mean ±SD serum concentrations following the first and fourth injections were 61 ± 17 mcg/mL and 86 ± 31mcg/mL, respectively. In 139 pediatric patients ≤ 24 months of age with hemodynamically significant CHD who received Synagis and underwent cardio-pulmonary bypass for open-heart surgery, the mean ± SD serum Synagis concentration was 98+ 52 mcg/mL before bypass and declined to 41+ 33 mcg/mL after bypass, a reduction of 58% (see DOSAGE AND ADMINISTRATION). The clinical significance of this reduction is unknown. Specific studies were not conducted to evaluate the effects of demographic parameters on Synagis systemic exposure. However, no effects of gender, age, body weight or race on Synagis serum trough concentrations were observed in a clinical study with 639 pediatric patients with CHD (≤24 months of age) receiving five monthly intramuscular injections of 15 mg/kg of Synagis. The pharmacokinetics and safety of Synagis liquid solution and Synagis lyophilized formulation administered IM at 15 mg/kg were studied in a cross-over trial of 153 pediatric patients ≤6 months of age with a history of prematurity. The results of this trial indicated that the trough serum concentrations of palivizumab were comparable between the liquid solution and the lyophilized formulation, which was the formulation used in the clinical studies described below. CLINICAL STUDIES: The safety and efficacy of Synagis were assessed in two randomized, double-blind, placebo-controlled trials of prophylaxis against RSV infection in pediatric patients at high risk of an RSV-related hospitalization. Trial 1 was conducted during a single RSV season and studied a total of 1,502 patients ≤ 24 months of age with bronchopulmonary dysplasia (BPD) or infants with premature birth (≤ 35 weeks gestation) who were ≤ 6 months of age at study entry (7). Trial 2 was conducted over four consecutive seasons among a total of 1287 patients ≤ 24 months of age with hemodynamically significant congenital heart disease. In both trials participants received 15 mg/kg Synagis or an equivalent volume of placebo IM monthly for five injections and were followed for 150 days from randomization. In Trial 1, 99% of all subjects completed the study and 93% completed all five injections. In Trial 2, 96% of all subjects completed the study and 92% completed all five injections. The incidence of RSV hospitalization is shown in Table 1.
In Trial 1, the reduction of RSV hospitalization was observed both in patients with BPD (34/266 [12.8%] placebo vs. 39/496 [7.9%] Synagis), and in premature infants without BPD (19/234 [8.1%] placebo vs. 9/506 [1.8%] Synagis). In Trial 2, reductions were observed in acyanotic (36/305 [11.8%] placebo versus 15/300 [5.0%] Synagis) and cyanotic children (27/343 [7.9%] placebo versus 19/339 [5.6%] Synagis). The clinical studies do not suggest that RSV infection was less severe among RSV hospitalized patients who received Synagis compared to those who received placebo. INDICATIONS AND USAGE: Synagis is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients at high risk of RSV disease. Safety and efficacy were established in infants with bronchopulmonary dysplasia (BPD), infants with a history of premature birth (≤ 35 weeks gestational age), and children with hemodynamically significant congenital heart disease (CHD) (see CLINICAL STUDIES). CONTRAINDICATIONS: Synagis should not be used in pediatric patients with a history of a severe prior reaction to Synagis or other components of this product. WARNINGS: Very rare cases of anaphylaxis including anaphylactic shock (<1 case per 100,000 patients) have been reported following initial exposure or re-exposure to Synagis (see ADVERSE REACTIONS, Post-Marketing Experience). Severe acute hypersensitivity reactions, estimated to be rare, (<1 case per 1,000 patients) have also been reported on initial exposure or re-exposure to Synagis (see ADVERSE REACTIONS, Post-Marketing Experience). If a severe hypersensitivity reaction occurs, therapy with Synagis should be permanently discontinued. If milder hypersensitivity reactions occur, caution should be used on readministration of Synagis. If anaphylaxis or severe allergic reactions occur, administer appropriate medications (e.g., epinephrine) and provide supportive care as required. PRECAUTIONS: General: Synagis is for intramuscular use only. As with any intramuscular injection, Synagis should be given with caution to patients with thrombocytopenia or any coagulation disorder. The safety and efficacy of Synagis have not been demonstrated for treatment of established RSV disease. The single-dose vial of Synagis does not contain a preservative. Administration of Synagis should occur immediately after dose withdrawal from the vial. The vial should not be re-entered. Discard any unused portion. Drug Interactions: No formal drug-drug interaction studies were conducted. In Trial 1, the proportions of patients in the placebo and Synagis groups who received routine childhood vaccines, influenza vaccine, bronchodilators or corticosteroids were similar and no incremental increase in adverse reactions was observed among patients receiving these agents. Carcinogenesis, Mutagenesis, Impairment of Fertility: Carcinogenesis, mutagenesis and reproductive toxicity studies have not been performed. Pregnancy: Pregnancy Category C: Synagis is not indicated for adult usage and animal reproduction studies have not been conducted. It is also not known whether Synagis can cause fetal harm when administered to a pregnant woman or could affect reproductive capacity. ADVERSE REACTIONS: The most serious adverse reactions occurring with Synagis treatment are anaphylaxis and other acute hypersensitivity reactions (see WARNINGS). The adverse reactions most commonly observed in Synagis-treated patients were upper respiratory tract infection, otitis media, fever, rhinitis, rash, diarrhea, cough, vomiting, gastroenteritis, and wheezing. Upper respiratory tract infection, otitis media, fever, and rhinitis occurred at a rate of 1% or greater in the Synagis group compared to placebo (Table 2). Because clinical trials are conducted under widely varying conditions, adverse event rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information does, however, provide a basis for identifying the adverse events that appear to be related to drug use and a basis for approximating rates. The data described reflect Synagis exposure for 1641 pediatric patients of age 3 days to 24.1 months in Trials 1 and 2. Among these patients, 496 had bronchopulmonary dysplasia, 506 were premature birth infants less than 6 months of age, and 639 had congenital heart disease. Adverse events observed in the 153 patient crossover study comparing the liquid and lyophilized formulations were similar between the two formulations, and similar to the adverse events observed with Synagis in Trials 1 and 2.
Immunogenicity In Trial 1, the incidence of anti-Synagis antibody following the fourth injection was 1.1% in the placebo group and 0.7% in the Synagis group. In pediatric patients receiving Synagis for a second season, one of the fifty-six patients had transient, low titer reactivity. This reactivity was not associated with adverse events or alteration in serum concentrations. Immunogenicity was not assessed in Trial 2. These data reflect the percentage of patients whose test results were considered positive for antibodies to Synagis in an ELISA assay, and are highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody positivity in an assay may be influenced by several factors including sample handling, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to Synagis with the incidence of antibodies to other products may be misleading. With any monoclonal antibody, the possibility exists that a liquid solution may be more immunogenic than a lyophilized formulation. The relative immunogenicity rates between the lyophilized formulation, used in Trials 1 and 2 above, and the liquid solution have not yet been established. Post-Marketing Experience The following adverse reactions have been identified and reported during post-approval use of Synagis. Because the reports of these reactions are voluntary and the population is of uncertain size, it is not always possible to reliably estimate the frequency of the reaction or establish a causal relationship to drug exposure. Blood and Lymphatic System Disorders: severe thrombocytopenia (platelet count < 50,000/microliter) General Disorders and Administration Site Conditions: injection site reactions Immune System Disorders: severe acute hypersensitivity reactions and anaphylaxis (including dyspnea, cyanosis, respiratory failure, urticaria, pruritus, angioedema, hypotonia, hypotension and unresponsiveness) have been reported (see WARNINGS). None of the reported hypersensitivity reactions were fatal. The relationship between these reactions and the development of antibodies to Synagis is unknown. Limited information from post-marketing reports suggests that, within a single RSV season, adverse events after a sixth or greater dose of Synagis are similar in character and frequency to those after the initial five doses. OVERDOSAGE: No data from clinical studies are available on overdosage. No toxicity was observed in rabbits administered a single intramuscular or subcutaneous injection of Synagis at a dose of 50 mg/kg. DOSAGE AND ADMINISTRATION: The recommended dose of Synagis is 15 mg/kg of body weight. Patients, including those who develop an RSV infection, should continue to receive monthly doses throughout the RSV season. The first dose should be administered prior to commencement of the RSV season. In the northern hemisphere, the RSV season typically commences in November and lasts through April, but it may begin earlier or persist later in certain communities. Synagis serum levels are decreased after cardio-pulmonary bypass (see CLINICAL PHARMACOLOGY). Patients undergoing cardio-pulmonary bypass should receive a dose of Synagis as soon as possible after the cardio-pulmonary bypass procedure (even if sooner than a month from the previous dose). Thereafter, doses should be administered monthly. Synagis should be administered in a dose of 15 mg/kg intramuscularly using aseptic technique, preferably in the anterolateral aspect of the thigh. The gluteal muscle should not be used routinely as an injection site because of the risk of damage to the sciatic nerve. The dose per month = patient weight (kg) x 15 mg/kg ÷ 100 mg/mL of Synagis. Injection volumes over 1 mL should be given as a divided dose. Administration of Synagis
HOW SUPPLIED: Synagis is supplied in single-dose vials as a preservative-free, sterile liquid solution at 100 mg/mL for IM injection. 50 mg vial NDC 60574-4114-1 100 mg vial NDC 60574-4113-1 There is no latex in the rubber stopper used for sealing vials of Synagis. Upon receipt and until use, Synagis should be stored between 2ºC and 8ºC (35.6ºF and 46.4ºF) in its original container. DO NOT freeze. DO NOT use beyond the expiration date. REFERENCES:
Synagis® is a registered trademark of MedImmune, LLC Manufactured by: MedImmune, LLC Revision Date: July 2010 RAL-SYNV13 INFORMATION FOR PATIENTS AND THEIR CAREGIVERS SYNAGIS® (SĬ-nă-jĭs) (palivizumab) Read this Patient Information before your child starts receiving SYNAGIS and before each injection. The information may have changed. This leaflet does not take the place of talking with your child’s healthcare provider about your child’s condition or treatment. What is SYNAGIS? SYNAGIS is a prescription medication that is used to help prevent a serious lung disease caused by Respiratory Syncytial Virus (RSV). Your child is prescribed SYNAGIS because he or she is at high risk for severe lung disease from RSV. SYNAGIS contains man-made, disease-fighting proteins called antibodies. These antibodies help prevent RSV disease. Children at high risk for severe RSV disease often do not have enough of their own antibodies. SYNAGIS is used in certain groups of children to help prevent severe RSV disease by increasing protective RSV antibodies. SYNAGIS is not used to treat the symptoms of RSV disease, once a child already has it. It is only used to prevent RSV disease. SYNAGIS is not for adults.
Your child should not receive SYNAGIS if they have ever had a severe allergic reaction to it or any of its ingredients. Signs and symptoms of a severe allergic reaction could include:
See the end of this leaflet for a list of ingredients in SYNAGIS. What should I tell my child’s healthcare provider before my child receives SYNAGIS? Tell your child’s healthcare provider about:
How is SYNAGIS given?
What are the possible side effects of SYNAGIS? Over one million babies have been given SYNAGIS. Like all medicines, SYNAGIS has been associated with side effects in some patients. Most of the time, the side effects are not serious. If side effects do occur, your child may need medical attention. Possible, serious side effects include:
Call your child’s healthcare provider or get medical help right away if your child has any of the serious side effects listed above after any dose of SYNAGIS. Common side effects of SYNAGIS include:
Other possible side effects include skin reactions around the area where the shot was given (like redness, swelling, warmth, or discomfort). In children born with certain types of heart disease, other possible side effects include bluish color of the skin, lips or under fingernails and abnormal heart rhythms. These are not all the possible side effects of SYNAGIS. Tell your child’s healthcare provider about any side effect that bothers your child or that does not go away. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or call MedImmune at 1-877-633-4411. General Information about SYNAGIS Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. This leaflet summarizes important information about SYNAGIS. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about SYNAGIS that is written for health professionals. For more information, go to www.synagis.com or call 1-877-633-4411. What are the ingredients in SYNAGIS? Active Ingredient: palivizumab Inactive Ingredients: histidine, glycine, and chloride What is RSV? Respiratory Syncytial Virus (RSV) is a common virus that is easily spread from person to person. RSV infects nearly all children by their second birthday. In most children, RSV infection is usually no worse than a bad cold. For some children, RSV infection can cause serious lung disease (like pneumonia and bronchiolitis) or breathing problems, and affected children may need to be admitted to the hospital or need emergency care. Children who are more likely to get severe RSV disease (high risk children) include babies born prematurely (35 weeks or less), or babies born with certain heart or lung problems. SYNAGIS® PALIVIZUMAB 100 mg/mL SYNAGIS® PALIVIZUMAB 50 mg/ 0.5 mL 美国儿科学会细支气管炎诊治指南(二) 6a:应评价患儿脱水情况及是否能口服补液(X级)。 6b:不推荐常规进行胸部理疗(B级)。 仅有轻度呼吸窘迫的患儿(特别是进食未受影响者),给予密切观察即可。呼吸频率>60~70次/分的患儿(特别是鼻分泌物增多者),进食往往会受到影响。呼吸困难患儿可出现鼻翼扇动、三凹征、呼吸相哮鸣音和呼气相延长,误吸的危险也增加。因呼吸窘迫不能安全进食者应给予静脉补液。液体潴留会导致抗利尿激素分泌增加并出现相应的症状,此时应及时调整治疗方案。 细支气管炎可伴有气道水肿和气道上皮细胞脱落至气道中,从而导致肺过度充气。有时也可出现肺不张,但肺不张并非该病的特征性表现。一项Cochrane系统评价对3项观察胸部理疗对细支气管炎住院患儿疗效的随机对照研究(RCT)进行了分析,结果并未发现胸部理疗有明显的临床疗效。 建议7 先前体健的患儿若脉搏容积血氧饱和度(SpO2)降至90%以下,则为氧疗指征;若SpO2持续低于90%,则应通过足够的氧疗使SpO2升至90%或以上;若患儿的SpO2≥90%且进食良好,仅有轻微呼吸窘迫,则可停用氧疗(D级)。 若患儿临床状况改善,则无需持续监测SpO2(D级)。 对于有明显血流动力学异常的心肺疾病史或早产史的患儿,在准备停用氧疗时应给予密切监测(B级)。 虽然健康婴儿的SpO2可一过性降至89%以下,但一般都在95%以上。罹患细支气管炎时,气道水肿和上皮细胞脱落导致通气血流比(V/Q)失调,氧合指标[包括SpO2和动脉血氧分压(PaO2)]下降。 问题由此产生:如何单纯依据SpO2来判断细支气管炎患儿是否应住院治疗或给予氧疗? 建议8 早产儿(<35周)或先天性心脏病患儿可给予帕利珠单抗(palivizumab)预防治疗(A级)。 帕利珠单抗用药方案为每次15 mg/kg肌注,1次/月,连用5个月,多始于每年的11月或12月(C级)。 感染疾病委员会在其2006年报告中推荐这样使用帕利珠单抗: 1. 在6个月以内因慢性肺病(CLD)接受过治疗(氧疗、支气管扩张剂、利尿剂或皮质类固醇治疗)的早产儿,在2岁以内,在呼吸道合胞病毒(RSV)流行季节前应预防性使用帕利珠单抗。 2. 胎龄≤32周的早产儿即使没有CLD,也可从帕利珠单抗预防治疗中获益。对这部分婴幼儿,需考虑的主要因素包括出生时的胎龄以及RSV流行季节开始时的月龄。帕利珠单抗预防治疗可使≤28周早产儿在第一个RSV流行季节(无论在该流行季节期间其月龄如何)中获益。29~32周早产儿在<6个月时接受帕利珠单抗预防治疗,疗效较好。 3. 尽管有研究表明,帕利珠单抗预防治疗可降低32~35周早产儿的住院危险,但考虑到治疗费用,故大多数专家推荐,严重感染高危儿和在RSV流行季节开始时月龄<6个月者应接受帕利珠单抗预防治疗。流行病学证据显示,存在下列危险因素者为严重感染高危儿:入托者,有学龄年龄同胞者,接触环境空气污染物者,存在气道先天异常者,或存在严重神经肌肉疾病者。至少存在2种危险因素的32~35周早产儿才应考虑给予预防治疗。高危婴幼儿应避免暴露于烟草烟雾。许多研究表明,母乳喂养可抵抗多种病毒感染,但母乳是否可以预防RSV感染尚无统一结论。高危婴幼儿还应避免群居或接触感染者。在RSV流行季节应禁止高危婴幼儿入托,并指导其父母注意手部卫生。所有高危婴幼儿及其接触者都应在6个时开始接受帕利珠单抗预防治疗。 4. 北半球(特别是美国)的RSV流行季节主要为11月至次年3月。目前,尽管可以预测RSV流行季节的出现,但还不能准确预测其严重程度、开始时间、达峰时间和结束时间。同一社区不同年份或同一年份不同社区的RSV感染暴发时间,也各不相同。一般来说,RSV流行季节从11~12月开始,次年1~2月达峰,3月末(有时为4月)结束,持续13~20周。临床研究表明,大部分婴幼儿在第5次肌注帕利珠单抗后,血清帕利珠单抗谷浓度仍持续高于有效保护浓度30天以上,也就是说,帕利珠单抗预防治疗5个月可提供大于20周的保护效应,即使RSV流行季节的起始存在变动,也可以覆盖大部分流行季节。帕利珠单抗用药方案不宜轻易改变,必须充分权衡利弊后方可考虑改变。 5. 合并明显血液动力学异常的≤24个月青紫型或非青紫型先天性心脏病患儿也可从帕利珠单抗预防治疗中获益。是否预防性给予帕利珠单抗,还应根据患儿心血管受损程度决定。接受药物治疗的先天性心脏病患儿、中重度肺动脉高压患儿和青紫型先天性心脏病患儿更易从免疫预防治疗中获益。 2项随机、盲法的安慰剂对照研究共对2789例早产、CLD或先天性心脏病患儿进行了研究,结果显示,帕利珠单抗预防治疗使RSV感染所致住院率降低了39%~78%。上市后研究也显示,帕利珠单抗预防治疗可显著降低住院率。但值得注意的是,帕利珠单抗不能治疗RSV感染。 建议9 洗手是预防RSV院内传播的最重要措施:在与患儿直接接触前后,接触邻近患儿的物体后,以及摘手套后,均应洗手(B级)。 首选以酒精为主的擦手剂,其次为有抗微生物作用的肥皂(B级)。 医师应教育患儿及其家庭成员注意手部卫生(B级)。 应采取措施预防RSV及细支气管炎其他病原体在医疗机构(特别是医院内)的传播。在距患儿病床22英尺(6.7米)的空气中仍可检出RSV RNA。病床、床栏杆、桌面和玩具均可被患儿的分泌物污染。污染物表面病原体的活性和传染性可保持数小时。RSV及其他病毒还可通过看护人员的手传给其他人,因而,医务人员频繁洗手可减少RSV院内传播。美国疾病预防和控制中心(CDC)专门发表了洗手指南。该指南详细介绍了洗手的正确方法。如果手部没有肉眼可见的污染物,指南推荐应使用以酒精为主的擦手剂,也可用有抗微生物作用的肥皂替代。 其他有效的预防措施还包括患儿及家庭成员教育,监测RSV流行季节的开始,应用手套并经常更换以防止手套上微生物的播散,直接接触患儿时穿隔离衣等。至于口罩是否可提供额外的保护,目前还没有得到证实。对RSV感染患儿进行隔离或集中诊治尽管有效但并不切实可行。无论如何,医务人员及家庭成员严格注意手部卫生并进行相关的教育都非常重要。 建议10 婴幼儿应避免暴露于被动吸烟(B级)。 推荐母乳喂养以降低儿童下呼吸道疾病发生危险(C级)。 McConnochie等的研究显示,被动吸烟增加RSV感染危险(OR=3.87)。Strachan等的一项涉及被动吸烟与婴幼儿下呼吸道疾病关系的系统评价显示,父母有一方吸烟时,子女发生下呼吸道疾病的危险增加(OR=1.57),其中以母亲吸烟时的危险更大(OR=1.72)。Stocks等分析了20项关于婴儿肺功能的研究后发现,母亲在妊娠期间和分娩后吸烟的婴儿,其肺功能显著下降,表现为用力呼气流速(FEF)下降约20%,此外其他指标也出现不同程度的异常。父亲吸烟也同样可产生不良影响。 母乳中含有抗RSV的免疫因子,包括IgG、IgA和α干扰素(IFN-α)。母乳还有中和RSV的作用。Pullan等的研究显示,与母乳喂养的婴儿相比,非母乳喂养者的RSV感染住院危险显著升高(OR=2.2)。Downhan等也发现,在115例RSV感染住院患儿中,仅8例(7%)接受母乳喂养,而对照组的母乳喂养率为27%(46/167名)。Bachrach等的一项荟萃分析共纳入了33项研究。这些研究均表明,母乳喂养可保护婴儿免于因下呼吸道疾病而住院。对其中9项研究的汇总分析显示,非母乳喂养者的下呼吸道疾病住院危险高达母乳喂养4个月者的3倍。 建议11 临床医师应详细询问补充及替代药物(CAM)的应用(D级)。 由于证据有限,目前还不推荐应用CAM。但许多家长可能给患儿应用了各种各样的CAM,因此临床医师应详细询问这类药物的使用情况,并权衡其利弊。 该指南对2岁以下婴幼儿细支气管炎的诊断和治疗给出了以循证医学为依据的推荐。细支气管炎是一个临床诊断,无需进行诊断性试验。 目前所应用的多数治疗方法,如支气管扩张剂、皮质类固醇、利巴韦林、抗生素、胸片检查、胸部理疗和CAM,并不能有效改善疾病的临床病程。目前推荐的措施包括合理氧疗并进行血氧监测。应用帕利珠单抗进行特异性预防和一些一般预防措施(特别是洗手)预防院内感染也有一定效果。 在细支气管炎研究方面,仍然存在很多悬而未决的问题。例如,缺乏客观、重复性好且方便在医院、急诊、门诊应用的临床评分方法。再如,由于细支气管炎为一种自限性疾病,因此需要进行大规模的研究才能发现一些细微的预后变化,这就需要进行大规模多中心研究。此外还应进一步研究RSV之外的其他致细支气管炎病毒的快速、经济的测定方法,以及鉴别哪些特定人群能够从支气管扩张剂或皮质类固醇治疗中获益,决定开始氧疗的最适SpO2值,进一步探索新的疗法、RSV疫苗以及剂量更小而费用更低的免疫预防疗法。(完) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Synagis（帕利珠单抗，palivizumab）单克隆抗体注射剂简介：
Palivizumab is used for:
Preventing serious lower respiratory tract infection caused by respiratory syncytial virus (RSV) in children at high risk of RSV disease.
Palivizumab is a monocl ... 责任编辑：admin |
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