中药复方对抗聚乙二醇α-2a干扰素不良作用的临床观察研究

Clinical observation and research of traditional Chinese compound prescription against adverse effect of polyethylene glycol α-2a interferon

目的探讨中药复方对抗聚乙二醇α-2a干扰素不良作用的有效性及安全性。方法 60例诊断为慢性乙型肝炎接受干扰素治疗的住院患者,随机分为治疗组及对照组,每组30例。两组患者均采用常规保肝治疗。对照组患者在常规保肝治疗基础上单用聚乙二醇干扰素α-2a,治疗组患者在常规保肝治疗基础上采用中药加聚乙二醇干扰素α-2a。对比两组患者治疗前后中医症候积分评分、乙肝病毒基因(HBV-DNA)水平、血常规、肌肉酸痛、体重下降症状的变化情况。结果治疗组治疗后3、6个月的症候积分分别为(6.25±4.56)、(2.50±1.36)分,均优于对照组的(10.15±3.11)、(6.80±3.50)分(P<0.05)。两组患者肌肉酸痛症状复常率及体重下降症状复常率比较差异具有统计学意义(P<0.01或0.05)。治疗后3个月时两组患者白细胞数目比较差异无统计学意义(P>0.05),治疗后6个月时治疗组白细胞数目为(3.09±1.12)×109/L,优于对照组的(2.40±0.49)×109/L(P<0.05);治疗后3、6个月时,治疗组血小板数目分别为(90±8)×109/L、(83±13)×109/L,优于对照组的(70±6)×109/L、(53±1)×109/L(P<0.05)。两组血清HBV-DNA转阴率比较差异无统计学意义(P>0.05)。结论中药复方能有效对抗干扰素不良作用,减轻患者痛苦,改善生活质量。

Objective To investigate effectiveness and safety by traditional Chinese compound prescription against adverse effect of polyethylene glycol α-2a interferon. Methods A total of 60 hospitalized patients with diagnosed chronic hepatitis B in interferon treatment were randomly divided into treatment group and control group, with 30 cases in each group. Both groups received conventional liver protection therapy. The control group received single polyethylene glycol α-2a interferon in addition to conventional liver protection therapy, and the treatment group received traditional Chinese medicine and polyethylene glycol α-2a interferon to conventional liver protection therapy. Comparison was made on changes of traditional Chinese medicine syndrome score, hepatitis B virus deoxyribonucleic acid（HBV-DNA） level, blood routine examination, muscular soreness and weight loss symptoms between the two groups before and after treatment. Results After 3 and 6 months of treatment, the treatment group had syndrome scores respectively as（6.25±4.56） and（2.50±1.36） points, which were all better than（10.15±3.11） and（6.80±3.50） points in the control group（P〈0.05）. The difference of normalization rates of muscular soreness and weight loss had statistical significance between the two groups（P〈0.01 or 0.05）. There was no statistically significant difference of white blood cell count after 3 months of treatment between the two groups（P〉0.05）. After 6 months of treatment, the treatment group had better white blood cell count as（3.09±1.12）×10^9/L than（2.40±0.49）×10^9/L in the control group（P〈0.05）. After 3 and 6 months of treatment, the treatment group had platelet count respectively as（90±8）×10^9/L and（83±13）×10^9/L, which were all better than（70±6）×10^9/L and（53±1）×10^9/L in the control group（P〈0.05）. There was no statistically significant difference of negative rate of serum HBV-DNA between the two groups（P〉0.05）. Conclusion Traditional Chinese compound prescription can effectively suppress adverse effect of interferon, relieve pain in patients and improve their quality of life.