摘要
目的:观察国产胸腺五肽(TP5)的疗效和不良反应。方法:在化疗的肿瘤患者中采用配对设计进行双盲随机对照临床研究。结果:化疗可引致明显的淋巴细胞转化率(LTT)和自然杀伤(NK)细胞活性降低,TP5可明显改善化疗所致的LTT和NK下降。安慰剂组30例中有6例LTT下降31%或更多,5例NK平均下降4.4%;而在TP5组30例中均未见到上述的LTT和NK降低。CD4+细胞在安慰剂组化疗后平均降低7.6%,而TP5组无明显下降。化疗引致的白细胞减少在TP5组也有明显改善,TP5组及安慰剂组的抗肿瘤有效率分别为50.0%和43.3%,TP5组30例患者连续应用1个月未观察到有不良反应发生。结论:TP5在化疗中可改善机体免疫功能,可作为肿瘤的辅助治疗药物。
OBJECTIVE:To evaluate the efficacy and tolerability of thymopentin(TP 5)in patients receiving chemotherapy.METHODS:The double blind,controlled,and paired design clinical trial was conducted in 60 cancer patients receiving chemotherapy.RESULTS:Chemotherapy induced decrease in lymphocyte transformation rate(LTT)and natural killer cell activity(NK)were significantly improved by TP 5.No ADRs and decrease in LTT and NK were observed in the active group( n =30)and the corresponding decreases in the control group were >31%( n =6)and 4.4%( n =4)respectively.No obvious decrease in CD4 +cells were observed in TP 5 treated group and 7.6% decrease in control group.Tumor response rate in TP 5 and control group were 50.0% and 43.3% respectively.CONCLUSION:Organic immunologic function in cancer patients who are receiving chemotherapy can be improved by TP 5 and it may be used as an adjuvant in chemotherapy.
出处
《中国新药杂志》
CAS
CSCD
1999年第5期321-323,共3页
Chinese Journal of New Drugs