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目的:观察芪参二莲汤联合拉米夫定对高病毒载量慢性乙型病毒性肝炎患者病毒学、血清学、肝功能、免疫因子及对核苷类抗病毒药耐药性的影响。方法:将纳入标准的87例慢性乙型病毒性肝炎患者按照随机数字表法分为治疗组(44例)和对照组(43例),其中治疗组给予芪参二莲汤联合拉米夫定治疗,对照组给予拉米夫定治疗,两组患者均治疗48周。观察两组患者治疗前、后症状体征,病毒血清学及肝功能改变,免疫因子水平变化,及耐药率比较,并观察记录两组患者的不良反应。结果:治疗组总有效率为84.09%,对照组总有效率为67.44%,两组疗效比较差异有统计学意义(P<0.05)。治疗组经12、24、48周治疗后HBeAg转阴数、HBeAg转换数、HBsAg转阴数、HBV-DNA转阴例数与治疗前比较,差异均具有统计学意义(P<0.05)。两组治疗后ALT、AST、TBIL、ALB均较治疗前下降,治疗组治疗12周、48周较治疗前比较差异均具有明显有统计学意义(P<0.01),两组治疗后CD_3~+、CD_4~+、CD_4~+/CD_8~+、NK较前均上升,治疗12周时较治疗前均无明显统计学差异(P>0.05),治疗48周时较治疗前差异具有统计学意义(P<0.05),两组治疗后12周时CD_8~+较治疗前无明显变化,不具统计学差异(P>0.05),且组间比较差异无统计学意义(P>0.05),两组48周时CD_8~+较治疗前下降,差异具有统计学意义(P<0.05),治疗组总耐药率为11.31%;对照组总耐药率为32.56%。两组耐药率比较差异具有统计学意义(P<0.05)。结论:芪参二莲汤联合拉米夫定不仅能够更加显著的抑制HBV-DNA复制,提高HBsAg、HBeAg转阴率,有效改善肝功能,还能调节免疫功能、减少HBV耐药变异,值得临床进一步大推广应用。
OBJECTIVE: To observe the influence of Qi-Shen-Erlian Decoction combined with lamivudine on virological, serological, hepatic function, immune factors and drug resistance to nucleoside antiviral agents in patients with chronic viral hepatitis B virus infection. Methods: Eighty-seven patients with chronic hepatitis B who were included in the standard were divided into treatment group (44 cases) and control group (43 cases) according to random number table. The treatment group was treated with Qishen-Erlian Decoction combined with lamivudine The control group was treated with lamivudine, and both groups were treated for 48 weeks. The symptoms and signs, the changes of virus serology and liver function, the changes of immune factors and the drug resistance rate were observed before and after treatment in both groups. The adverse reactions of the two groups were observed and recorded. Results: The total effective rate was 84.09% in the treatment group and 67.44% in the control group. The difference between the two groups was statistically significant (P <0.05). After treatment for 12, 24 and 48 weeks, the number of HBeAg negative conversion, HBeAg conversion, HBsAg negative conversion and HBV-DNA negative conversion in treatment group were significantly different from those before treatment (P <0.05). After treatment, ALT, AST, TBIL and ALB in both groups decreased compared with those before treatment. The difference between the two groups was statistically significant at 12 and 48 weeks after treatment (P <0.01) CD_4 ~ +, CD_4 ~ + / CD_8 ~ + and NK increased compared with those before treatment, and there was no significant difference between before treatment and 12 weeks after treatment (P> 0.05). There was a significant difference between the two groups (P <0.05). There was no significant difference between the two groups at 12 weeks after treatment (P> 0.05), and there was no significant difference between the two groups (P> 0.05) At 48 weeks, CD_8 ~ + decreased compared with that before treatment, and the difference was statistically significant (P <0.05). The total drug resistance rate in the treatment group was 11.31%. The total drug resistance rate in the control group was 32.56%. There was significant difference between two groups (P <0.05). Conclusion: Qishenlilian decoction combined with lamivudine not only can significantly inhibit HBV-DNA replication, improve HBsAg and HBeAg negative conversion rate, effectively improve liver function, but also regulate immune function and reduce HBV resistance variation, which is worth clinical Further promotion of large applications.