摘要
目的 评价国产重组人血小板生成素 (rhTPO)治疗恶性实体瘤化疗后血小板减少症的疗效和安全性。方法 1 7例恶性实体瘤患者每例接受 3周期化疗。第 1周期化疗后出现血小板减少 ,即采用随机交叉、自身对照的研究方法分别进入A、B组。A组在第 2周期化疗结束后 6～ 2 4h ,皮下注射rhTPO 1 .0 μg·kg-1 ·d-1 ) ,疗程 1 4d,如血小板计数≥ 1 0 0× 1 0 9/L则停用rhT PO ;第 3周期化疗后不注射rhTPO ,作为自身对照。B组与A组相反。另 9例患者化疗后血小板减少直接进入非随机的C组。化疗 2周期 ,第 1周期为对照周期 ,第 2周期化疗后注射rhTPO。结果 化疗后rhTPO试验周期与对照周期比较 ,血小板计数的最低值比对照周期略升高 [(5 1 .1± 2 2 .4 )× 1 0 9/Lvs (4 6 .5± 1 9.9)× 1 0 9/L ,P >0 .0 5 ];血小板恢复至 75× 1 0 9/L以上天数显著缩短 [(1 0 .6 6± 4 .5 5 )vs (1 9.33± 8.72 ) ,P <0 .0 0 1 ]。2例患者在对照周期需要输注血小板 ,而rhTPO试验周期无 1例需要输注血小板。本组 2 6例患者均未发现与rhTPO相关的不良反应 ,血清rhTPO抗体测定阴性。结论 国产rhTPO可以减轻化疗引起的血小板降低程度和持续时间 ,减少血小板的输注 ,不良反应罕见 。
Objective To evaluate the efficacy and safety of domestic recombinant human thrombopoietin(rhTPO) in treating thrombocytopenia caused by chemotherapy in patients with solid tumors.Methods Seventeen patients were received 3 cycles of chemotherapy.They who have previously experienced thrombocytopenia after chemotherapy in the 1 st cycle were randomly divided into A or B group.Group A was treated with chemotherapy plus rhTPO and chemotherapy alone in the 2nd and 3rd cycle,respectively.The treatment of group B was just contrary to group A.rhTPO at a dosage of 1μg·kg -1 ·d -1 ) was subcutaneously injected 6-24h after completion of the 2 nd chemotherapy cycle over 14 consecutive days or continuing until platelet count was ≥100×10 9/L.Another 9 patients who have previously experienced thrombocytopenia after chemotherapy entered into group C open study,and 2 cycles of chemotherapy were given to these patients.No rhTPO was given in cycle 1,and rhTPO administration was the same as above in cycle 2.Results In patients who received rhTPO,although the mean platelet count was only little higher[(51.1±22.4)×10 9/L vs ( 46.5 ±19.9)×10 9/L, P >0.05],the days that was needed for platelet count recovery to ≥75×10 9/L were decreased significantly[( 10.7 ±4.6) vs (19.3±8.7), P <0.001] with comparison to the control cycle.Patients who received rhTPO did not require platelet transfusions,compared with 2 units of platelet transfusion in control group.No severe adverse event or neutralizing antibody to rhTPO was found during the national multicenter phase Ⅲ clinic trial.Conclusion The results indicate that the domestic rhTPO is effective and safe to alleviate the degree of thrombocytopenia and to shorten the duration of thrombocytopenia caused by chemotherapy in patients with solid tumor.
出处
《重庆医学》
CAS
CSCD
2004年第7期997-999,共3页
Chongqing medicine
