ࡱ>  fbjbjޥ 4ǴǴ^vvvvv,|gJ22222   ggggggg$hkhCgv  Cgvv22Xg   Rv2v2g g  ` f2`X=Ujb: gng0g+cljltflvf huJ <   CgCg   gl          <: Appendix A ConditionIndicationsAcute disseminated encephalomyelitisIVIG may be considered medically necessary in persons with acute disseminated encephalomyelitis who have an insufficient response to intravenous corticosteroid treatmentAutoimmune hemolytic anemia, refractoryIVIG may be considered medically necessary in persons with warm-type autoimmune hemolytic anemia that does not respond to corticosteroids or splenectomy, or those for whom the latter two treatments are contraindicated.Bacterial infection in HIV-infected childrenConsistent with recommendations of the Working Group on Antiretroviral Therapy of the National Pediatric HIV Resource Center IVIG is considered medically necessary in children with HIV-infection who meet any of the following criteria: Those with hypogammaglobulinemia, i.e., serum IgG concentration less than 250 mg/dL; Those with recurrent serious bacterial infections, i.e., defined as two or more infections such as bacteremia, meningitis, or pneumonia in a 1-year period; Those who fail to form antibodies to common antigens, such as measles, pneumococcal, and/or Haemophilus influenzae type b vaccine; Those living in areas where measles is highly prevalent and who have not developed an antibody response after two doses of measles, mumps, and rubella virus vaccine live; Single dose for HIV-infected children who are exposed to measles; HIV-infected children with chronic bronchiectasis that is suboptimally responsive to antimicrobial and pulmonary therapy.Birdshort (vitiligenous) retinochoroidopathyIVIG is considered medically necessary for birdshot (vitiligenous) retinochoroidopathy that is not responsive to immunosuppressives (e.g.,corticosteroids, cyclosporine).Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), also known as Chronic Relapsing Polyneuropathy, including diabetes mellitus-CIDP and multifocal acquired demyelinating sensory and motor neuropathy (MADSAM) variantSymmetric or focal neurologic deficits with slowly progressive or relapsing course over 2 months or longer with neurophysiological abnormalities). Note: A metaanalysis comparing the efficacy if IVIG, plasma exchange, and oral glucocorticoids found equivalence between all three, at least within the first 6 weeks of therapy (Van Schaik, et al., 2002). IVIG is considered under accepted guidelines as the preferred treatment, particularly in children, when there is difficulty with venous access for plasmapheresis, and those susceptible to the complications of long-term corticosteroid therapy (Orange, et al., 2006). Persons typically respond to IVIG or plasma exchange within the first several weeks of treatment and may demonstrate sustained improvement for many weeks or months. Relapses may require periodic isolated treatments with a single dose of IVIG or single plasma exchange. If a person responds successfully to infrequent booster treatments of either IVIG or plasma exchange, it is reasonable to maintain this form of treatment rather than adding corticosteroids or other immunosuppressants.Chronic Lymphocytic Leukemia (CLL) in patients with hypogamma-globulinemiaIgG level less than 600mg/dL; and: I. 1 severe bacterial infection within preceding 6 months or 2 or more bacterial infections in one year; or II. Evidence of specific antibody deficiency. Dermatomyositis, Polymyositis (includes Juvenile)Members presenting at least one item from the 1st criterion and four items from the 2nd through 9th criteria are said to have dermatomyositis. Patients presenting no items from the 1st criterion and at least four items from the 2nd through 9th criteria are said to have polymyositis. Skin lesions Heliotrope rash (red purple edematous erythema on the upper palpebra) Gottron's sign (red purple keratotic, atrophic erythema, or macules on the extensor surface of finger joints) Erythema on the extensor surface of extremity joints: slightly raised red purple erythema over elbows or knees Proximal muscle weakness (upper or lower extremity and trunk) Elevated serum CK (creatine kinase) or aldolase level Muscle pain on grasping or spontaneous pain Myogenic changes on EMG (short-duration, polyphasic motor unit potentials with spontaneous fibrillation potentials) Positive anti-Jo-1 (histadyl tRNA synthetase) antibody Non-destructive arthritis or arthralgias Systemic inflammatory signs (fever: more than 37 C at axilla, elevated serum CRP level or accelerated ESR of more than 20 mm/h by the Westergren method) Pathological findings compatible with inflammatory myositis (inflammatory infiltration of skeletal evidence of active regeneration may be seen AND Member has severe active illness; and Member is intolerant or refractory to 1st and 2nd line therapies: 1st line therapy - Corticosteroids (e.g., prednisone); 2nd line therapy - Immuno-suppressants (e.g., methotrexate, azathioprine, cyclophosphamide, and cyclosporine).Enteroviral meningoencephalitisIVIG is considered medically necessary in severe cases of enteroviral meningoencephalitis lacking other therapeutic options.Fetal Alloimmume Thrombocytopenia (FAIT)Maternal and paternal platelet typing reveals the father has a platelet antigen that the mother lacks and the mother has detectable antibodies to this antigen (to HPA 1a are the most common cause of FAIT); and At 20 weeks or later, cordocentesis reveals fetal platelets less than 20 x 1000/mL(3); or Previous pregnancy affected by FAIT Guillain Barre Syndrome (GBS) - a.k.a. acute infective polyneuritis (includes GBS variants: Miller-Fisher syndrome [MFS], pan autonomic polyneuropathy, acute pandysautonomia, acute motor axonal neuropathy (AMAN), and acute motor and sensory axonal neuropathy (AMSAN))Severe GBS with significant weakness such as inability to stand or walk without aid, respiratory or bulbar weakness, or Miller-Fisher syndrome (MFS); and The disorder has been diagnosed during the first 2 weeks of the illness; and IVIG is initiated within one month of symptom onset. Note: Based on the 2003 AAN guidelines, IVIG should usually be initiated within 2 weeks and no longer than 4 weeks of onset of neuropathic symptoms. Hematopoietic Stem Cell Transplant (HSCT) or Bone Marrow Transplant (BMT)IVIG is considered medically necessary for prophylaxis in allogeneic or syngeneic transplant recipients within the first 100 days post-transplant; after 100 days post-transplant IVIG is indicated for treatment of recipients who are markedly hypogammaglobulinemic (IgG level less than 400 mg/dL) or who have CMV or RSV infection. IVIG is considered medically necessary for steroid-resistant graft-versus-host disease in BMT recipients 20 years of age or older, in the first 100 days post transplant, and who are hypogammaglobinemic (IgG level less than 400 mg/dL).HIV-associated Thrombocytopenia - AdultSignificant bleeding in thrombo-cytopenic patients or platelet count less than 20,000/ul; and Failure of RhIG in Rh-positive patients. HIV-associated Thrombocytopenia - PediatricInfants and children < 13 years of age whose IgG level is < 400 mg/dL; and 2 or more bacterial infections in a 1-year period despite antibiotic chemoprophylaxis with TMP-SMZ or another active agent; or Child has received 2 doses of measles vaccine and lives in a region with a high prevalence of measles; or Member has HIV-associated thrombocytopenia despite antiretroviral therapy; or Member has chronic bronchiectasis that is suboptimally responsive to antimicrobial and pulmonary therapy; or T4 cell count is greater than or equal to 200/mm3. Hemolytic Disease of the NewbornNot responding to phototherapy to decrease the need for exchange transfusion. Physician discretion important in deciding.Hyperimmunoglobulin E Syndrome (Jobs syndrome; Hyper IgE syndrome)Recurrent staphylococcal abscesses and markedly elevated serum IgE with normal IgG, IgA, and IgM concentrations.Idiopathic Thrombocytopenic Purpura (ITP) - AdultOther causes of thrombocytopenia have been ruled out by history and peripheral smear; and Unresponsive to corticosteroid therapy; and Management of acute bleeding due to severe thrombocytopenia (platelet counts less than 30,000/ul); or To increase platelet counts prior to invasive major surgical procedures (e.g., splenectomy), or To defer or avoid splenectomy; or In members with severe thrombocytopenia (platelet counts less than 20,000/ul) considered to be at risk for intracerebral hemorrhage. Idiopathic Thrombocytopenic Purpura (ITP) - PediatricAcute ITP: IVIG as initial therapy if platelet count < 20,000/ul, especially when member has emergency bleeding or is at risk for severe life-threatening bleeding; or Persons with severe thrombo-cytopenia (platelet counts less than 20,000/ul) considered to be at risk for intracerebral hemorrhage. Note: IVIG not indicated if only mild manifestations of bleeding. Chronic ITP: In high risk persons when platelet count low or person symptomatic; and Failure of other therapies, or Member is a high risk for post-splenectomy sepsis. Idiopathic Thrombocytopenic Purpura (ITP), Chronic RefractoryAge of 10 years or older; and Duration of illness of greater than six months; and No concurrent illness/disease explaining thrombocytopenia; and Prior treatment with corticosteroids and splenectomy has failed or member is at high risk for post-splenectomy sepsis. Immune Thrombocytopenic Purpura (ITP) in PregnancyRefractory to steroids with platelet counts < 10,000/ul in the third trimester; or Platelet counts < 30,000/ul associated with bleeding before vaginal delivery or C-section; or Pregnant women who have previously delivered infants with autoimmune thrombocytopenia; or Pregnant women who have platelet counts less than 50,000/ul during the current pregnancy; or Pregnant women with past history of splenectomy. Immunosuppressed PatientsTo prevent or modify recurrent bacterial or viral infections (e.g., CMV) in members with iatrogenically induced, or disease associated immunosuppression (IgG < 400 mg/dL) with one of the following: Solid organ transplants or extensive surgery with immunosuppression (Note: In particular, IVIG may be medically necessary in persons undergoing multiple courses of plasmapheresis as a treatment for allograft rejection or for other indications; these persons may receive IVIG at the completion of therapy if their IgG level is less than 400 mg/dL); or Hematological malignancy; or Extensive burns; or Collagen-vascular disease. Kawasaki disease (Mucocutaneous Lymph Node Syndrome [MCLS])Diagnosis must be established - no specific lab test - diagnosis is established by meeting the following criteria: Fever present for at least five days; and Four of the following five conditions are met: Mucous membrane changes such as a red tongue and dry fissured lips; Swelling of the hands and feet; Enlarged lymph nodes in the neck; Diffuse red rash covering most of the body; Redness of the eyes. Lambert-Eaton Myasthenic Syndrome (LEMS)No response to anticholinesterases and Diaminopyridine); and Used as an alternative to plasma exchange if weakness is severe; or When there is difficulty with venous access for plasmapheresis. Myasthenia GravisTreatment of acute myasthenic crisis with decompensation (respiratory failure, or disabling weakness requiring hospital admission) Note: For management of myasthenic crises, IVIG is administered over 2 to 5 days. Use of IVIG as maintenance therapy is considered experimental and investigational.Moersch-Woltmann (Stiff-man) SyndromePresence of Anti-GAD antibody; and Benzodiazepines (e.g., Valium) and/or Baclofen, phenytoin, clonidine, tizanidine have failed. Multifocal Motor Neuropathy with Conduction BlockProgressive, symptomatic multifocal motor neuropathy that has been diagnosed on the basis of electrophysiologic findings that rule out other possible conditions that may not respond to IVIG treatment.Multiple Myeloma (MM)"Plateau Phase" MM (> 3 months since diagnosis); and IgG level < 600mg/dL; and 2 or more significant infections in last year or a single life threatening infection; or Evidence of specific antibody deficiency.Multiple Sclerosis (MS) - Relapsing-remitting (not primary or secondary progressive MS)Severe manifestations of relapsing-remitting MS (not primary or secondary progressive MS); and Standard approaches (i.e., interferons Betaseron, Avonex, Rebif) have failed, become intolerable, or are contraindicated. Neuroblastoma associated paraneoplastic opsoclonus-myoclonus-ataxia syndromeTreatment of opsoclonus-myoclonus-atraxia associated with neuroblastoma.Opsoclonus-myoclonusMedically necessary as last-resort treatment for refractory opsoclonus-myoclonus.Erythrovirus (formerly parvovirus) B19 Infection, Chronic, with Severe Anemia (Pure Red Cell Aplasia)Severe, refractory anemia with documentederythrovirus B19 viremia.Autoimmune Mucocutaneous Blistering Diseases- includes Pemphigus vulgaris,Pemphigus foliaceus, Bullous Pemphigoid, Mucous Membrane Pemphigoid (a.k.a. Cicatricial Pemphigoid), and Epidermolysis bullosa aquisitaThe diagnosis has been proven by biopsy and confirmed by pathology report; and The condition is rapidly progressing, extensive or debilitating; and Corticosteroids, immuno-suppressive agents have failed or the member has experienced significant complications from standard treatment, such as diabetes or steroid-induced osteoporosis. Post-transfusion purpura (PTP)Decreased platelets (usually < 10,000/ul); and 2 - 14 days post transfusion with bleeding. Primary Humoral Immunodeficiencies Selective IgM Immunodeficiency Congenital hypogamma-globulinemia Immunodeficiency with near/normal IgM (absent IgG, IgA) a.k.a. Hyper IgM syndrome Other deficiency of humoral immunity Severe combined immunodeficiency disorders (e.g., X-SCID, jak3, ZAP70, ADA, PNP, RAG defects, Ataxia Telangiectasia, DiGeorge syndrome, common variable immunodeficiency Agammaglobulinemia (total IgG < 200 mg/dL or infants with BTK gene and/or absence of B lymphocytes)); or Persistent hypogammaglobulinemia(total IgG < 400 mg/dL)with recurrent bacterial infections and/or lack of response to protein or polysaccharide antigens (inability to make IgG antibody against diphtheria and tetanus toxoids, pneumococcal polysaccharide vaccine, or both): Serum antibody titres to tetanus and/or diphtheria should be obtained prior to immunization with diphtheria and/or tetanus vaccine and three to four weeks after immunization. An inadequate response is defined as less than a fourfold rise in antibody titre and lack of protective antibody level (as defined by laboratory performing the assay); and Serum antibody titres to pneumococcus should be measured prior to immunization and three to six weeks after immunization with polyvalent pneumococcal polysaccharide vaccine (e.g., Pneumovax). An inadequate response is defined as less than a 4-fold rise in titer over baseline in at least one serotype tested and lack of protective antibody level (i.e., specific IgG concentration less than 1.3 mcg/ml); or Selective IgG subclass deficiency (see criteria below); or Normal total IgG levels with severe polysaccharide nonresponsiveness and evidence of recurrent severe difficult-to-treat infections (e.g., recurrent otitis media, bronchiectasis, recurrent infections requiring IV antibiotics, multiple antibiotic hypersensitivities, chronic or recurrent sinusitis) (see table below) with a documented requirement for antibiotic therapy: Member has unexplained recurrent or persistent severe bacterial infections despite adequate treatment, including all of the following: Aggressive management of other conditions predisposing to recurrent sinopulmonary infections (eg, asthma, allergic rhinitis); Prophylactic antibiotics; Increased vigilance and appropriate antibiotic therapy for infections; and Immunization with conjugate vaccines in patients who have not responded to polysaccharide vaccines. B. Serum antibody titres to pneumococcus should be measured prior to immunization and three to six weeks after immunization with polyvalent pneumococcal polysaccharide vaccine (e.g., Pneumovax); at least 14 polysaccharide antigens should be tested. C. Polysaccharide nonresponsiveness is defined as less than 4-fold rise in antibody titer and lack of protective antibody titer (specific IgG antibody titer less than 1.3 mcg/ml) in greater than 30 percent of antigens tested (more than 50 percent in children ages 2 to 5 years). D. Further evidence of infection, including sinus and lung imaging, complete blood counts, C-reactive protein measurement, and erythrocyte sedimentation rate determination, may be required to support the need for IVIG supplementation. E. For persons with normal total IgG levels and severe polysaccharide nonresponsiveness,IVIG should be discontinued and the medical necessity of IVIG should be reevaluated 1 year after initiating therapy and every two years thereafter by reassessing immune response to protein and polysaccharide antigens. Immune response should be reevaluated at least 5 months after discontinuation of IVIG. IVIG should also be discontinued at that time if the number and/or severity of infections have not been reduced, as not all persons with polysaccharide nonresponsiveness benefit from IVIG The use of IVIG may not be beneficial in certain secondary immunodeficiency states; correction of the underlying condition is the preferred approach.Rasmussen EncephalitisFor children whose symptoms do not improve with antiepileptic drugs and corticosteroidsSelective IgG Subclass DeficiencyDeficiency of one or more IgG subclasses to levels less than two standard deviations below the age-specific mean (see table below). These levels should be assessed on at least two occasions while the patient is free of infections; and Member has unexplained recurrent or persistent severe bacterial infections despite adequate treatment, including all of the following: Aggressive management of other conditions predisposing to recurrent sinopulmonary infections (eg, asthma, allergic rhinitis); Prophylactic antibiotics; Increased vigilance and appropriate antibiotic therapy for infections; and Immunization with conjugate vaccines in patients who have not responded to polysaccharide vaccines. Member has demonstrated an inability to mount an adequate response to protein and polysaccharide antigens, as determined by the following criteria: Member has documented inability to mount an antibody response to protein antigens: Serum antibody titres to tetanus and/or diphtheria should be obtained prior to immunization with diphtheria and/or tetanus vaccine and three to four weeks after immunization. An inadequate response is defined as less than a fourfold rise in antibody titre and lack of protective antibody level (as defined by laboratory performing the assay); and Member has documented inability to mount an adequate antibody response to polysaccharide antigens. Serum antibody titres to at least 14 pneumococcus serotypes should be measured prior to immunization and three to six weeks after immunization with polyvalent pneumococcal polysaccharide vaccine (e.g., Pneumovax). An inadequate response is defined as less than a 4-fold rise in titer over baseline in at least 30 percent of serotypes tested (in at least 50 percent of serotypes tested in children ages 2 to 5 years) and lack of protective antibody level (i.e., specific IgG concentration less than 1.3 mcg/ml). Note: Response to polysaccharide antigens is not reliable in children less than 2 years of age. IV. IVIG should be discontinued and the medical necessity of IVIG should be reevaluated 1 year after initiating therapy and every two years thereafter by reassessing immune response to protein and polysaccharide antigens. Immune response should be reevaluated at least 5 months after discontinuation of IVIG. IVIG should also be discontinued at that time if the number and/or severity of infections have not been reduced, as not all persons with selective IgG subclass deficiencies benefit from IVIG.Staphylococcal Toxic Shock SyndromeSevere cases of toxic shock syndrome that have not responded to fluids and vasopressors.Systemic Lupus ErythematosusMembers with severe active SLE for whom first- and second-line therapies have been unsuccessful, have become intolerable, or are contraindicated. Note: Standard first-line therapy of active SLE include non-steroidal anti-inflammatory drugs, followed by low-dose corticosteroids and antimalarial compounds. Second-line therapeutic alternatives are the cytotoxic agents methotrexate, azathioprine, or cyclophosphamide.Toxic epidermal necrolysis and Stevens-Johnson syndromeIVIG is considered medically necessary in severe cases of toxic epidermal necrolysis and Stevens-Johnson syndromeToxic shock syndrome or toxic necrotizing fasciitis due to group A streptococcusIVIG is considered medically necessary in persons who are sufficiently ill to require critical care unit support and have documented presence of fasciitis and microbiological data consistent with invasive streptococcal infection (culture or Gram stain). Aetna considers IVIG therapy experimental and investigational for any of the following conditions (in alphabetical order): Acquired factor VIII inhibitors Acquired von Willebrand's disease Acute lymphoblastic leukemia Acute myeloid leukemia Acute optic neuritis Adrenoleukodystrophy Alzheimers disease Amyotrophic lateral sclerosis Angioedema Antiphospholipid syndrome Aplastic anemia Asthma Autism Autoimmune autonomic neuropathy Autoimmune chronic urticaria Autoimmune inner ear disease Autoimmune liver disease Behet's syndrome Cardiomyopathy, acute Chronic fatigue syndrome Chronic sinusitis Clostridium difficile colitis Congenital heart block Convulsive syndromes Critical illness polyneuropathy Cystic fibrosis Dermatosis, autoimmune blistering Diabetes mellitus Diamond-Blackfan anemia Dysautonomia, acute idiopathic Eczema Encephalopathy Endotoxemia Epilepsy Goodpastures syndrome Hashimoto's encephalopathy Hemolytic transfusion reaction Hemolytic-uremic syndrome Hemophagocytic syndrome HTLV-1 associated myelopathy Idiopathic lumbosacral plexopathy Idiopathic pulmonary fibrosis Immune-mediated neutropenia Inclusion body myositis Intractable seizures Landau-Kleffner syndrome Leukemia, acute lymphoblastic Lower motor neuron syndrome Malignancy, non-hematologic Multiple sclerosis - primary progressive or secondary types Myalgia, myositis, unspecified Myalgic encephalomyelitis Myelopathy, HTLV-I associated Necrotizing enterocolitis Neonatal lupus syndromes Neonatal sepsis (prophylaxis) Nephritic syndrome Nephropathy, membranous Nephrotic syndrome Neuromyelitis optica (Devics disease) Neuromyotonia (Isaacs syndrome) Neurosarcoidosis Non-immune thrombocytopenia Ophthalmopathy, euthyroid Oral use of IVIG for any indication Orthostatic tachycardia syndrome Otitis media, recurrent Paraneoplastic cerebellar degeneration Paraneoplastic syndromes other than neuroblastoma Paraproteinemic neuropathy (IgM variant Parkinsons diseasePediatric autoimmune neuropsychiatric disorders associated with streptococcal infection (PANDAS) POEMS syndrome ** Polyarteritis nodosa Polyneuritis cranialis Progressive lumbosacral plexopathy Pyoderma gangrenosum Radiculoneuritis, Lyme Recurrent otitis media Recurrent fetal/pregnancy loss Red cell aplasia not due to erythrovirus B19 Rheumatic fever, carditis Refractoriness to platelet transfusion Reiter's syndrome Renal failure, acute Rheumatoid arthritis (adult and juvenile) Scleroderma Selective isolated IgA immunodeficiency Sensory neuropathy Still's disease Sydenham's chorea Systemic vasculitides Thrombocytopenia (non-immune) Thrombotic thrombocytopenic purpura (TTP) Tic disorders Transverse myelopathy/myelitis Uveitis Vasculitis associated with other connective tissue diseases Viral myocarditis Vogt-Koyanagi-Harada syndrome Wegeners granulomatosis     !#GH # ,6ѿ敆vl\Mh!gh<-CJOJQJaJ *h!gh<-CJOJQJaJ *hkh<-0Jhh<-0J hXNh<-hXNh<-CJOJQJaJhXNh<-0J# *hmh<-0JCJOJQJaJhh<-CJOJQJaJ# *h!gh<-0JCJOJQJaJ hh<-0JCJOJQJaJh<-h<-CJOJQJaJh<-0JCJOJQJaJ  "#HIkd$$IfK0v*p 06$634K` abpyt<- $Ifgd<- @&^gd<- ^UU $Ifgd<-kd$$IfK0v*p 06$634K` abpyt<- $  d ^UL888 & Fdd$If[$\$gd<- $Ifgd<- $Ifgd<-kd$$IfK0v*p 06$634K` abpyt<- . p JA8 $Ifgd<- $Ifgd<-kd$$IfK0v*p 06$634K` abpyt<- & Fdd$If[$\$gd<-6 ^ULLL $Ifgd<- $Ifgd<-kd$$IfK0v*p 06$634K` abpyt<-6:AB2301PQJKLMjY  W Y """""">#?#^#_#j##%%ԷԷԞ}ԷvvԷԷԷԷ hXNh<- *hX*Ih<-CJOJQJaJ hXNh<-0JCJOJQJaJhXNh<-0JhXNh<-7CJOJQJaJhXNh<-CJOJQJaJh<-0JCJOJQJaJh<-CJOJQJaJh!gh<-CJOJQJaJh!gh<->*CJOJQJaJ.Be^ULLL $Ifgd<- $Ifgd<-kd$$IfK0v*p 06$634K` abpyt<-3O\^UUH; 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