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目的:观察灵猫方联合替比夫定治疗慢性乙型肝炎(CHB)患者的临床疗效及其对患者外周血自然杀伤细胞(NK)数量、功能的影响,探讨灵猫方治疗CHB的免疫调节机制。方法:纳入54例符合标准的CHB患者,随机分为单用组27例和联合组27例,同时纳入10例健康志愿者作为健康对照组。两组均给予口服替比夫定治疗,联合组加服灵猫方,疗程为24周。治疗3个月、6个月时,评价两组患者的中医证候积分,检测两组患者的谷丙转氨酶(ALT)、谷草转氨酶(AST)、HBV-DNA定量、HbeAg、外周血NK细胞数量及细胞表面和胞内Toll样受体(TLRs)的表达水平,比较两组患者的ALT、AST复常率,HBV-DNA阴转率和HBeAg血清转换率。结果:治疗3个月、6个月后,两组患者的中医证候积分较治疗前均显著降低(P<0.05,P<0.01),且联合组患者的中医证候积分明显低于单用组(P<0.01)。治疗3个月、6个月后,两组患者的ALT、AST水平均显著降低(P<0.01),且治疗3个月时,联合组患者的ALT、AST水平低于单用组(P<0.05),ALT、AST复常率明显高于单用组(P<0.05)。治疗3个月、6个月后,两组患者的HBVDNA、HBeAg水平均明显降低(P<0.01),但两组患者的HBV-DNA转阴率、HBeAg血清转换率比较,差异无统计学意义(P>0.05)。与健康对照组比较,CHB患者的外周血NK细胞数量明显减少(P<0.05),NK细胞胞内TLR3、TLR9表达水平显著降低(P<0.05);治疗3个月、6个月后,两组患者的NK细胞数量及胞内、胞外TLR3、TLR9表达水平较治疗前均明显提高(P<0.05),且联合组患者NK细胞数量及其胞内TLR3表达水平明显高于单用组(P<0.05)。结论:灵猫方联合替比夫定可显著改善CHB患者的中医证候和肝功能,灵猫方的作用机制可能与提高患者的NK细胞数量及其胞内外TLR3的表达水平,从而调节机体的免疫功能有关。
OBJECTIVE: To observe the clinical effect of Lingcifang combined with telbivudine in treatment of patients with chronic hepatitis B (CHB) and its effect on the number and function of natural killer cells (NK) in peripheral blood of patients with chronic hepatitis B (CHB). Methods: Fifty-four CHB patients were enrolled in this study. They were randomly divided into single use group (n = 27) and combination group (n = 27), and 10 healthy volunteers were enrolled as healthy control group. Both groups were given oral telbivudine treatment, the combined group plus service cats, the course of treatment for 24 weeks. At 3 months and 6 months after treatment, the TCM syndrome scores of two groups were evaluated. The levels of ALT, AST, HBV-DNA, HbeAg, NK cells in peripheral blood were measured in two groups And the expression of TLRs and cell surface. The ALT, AST normalization rate, HBV-DNA negative rate and HBeAg seroconversion rate were compared between the two groups. Results: After 3 months and 6 months of treatment, the scores of TCM syndromes in both groups were significantly lower than those before treatment (P <0.05, P <0.01), and the scores of TCM syndromes in the combination group were significantly lower than those in the single group Group (P <0.01). At 3 months and 6 months after treatment, the levels of ALT and AST were significantly decreased in both groups (P <0.01). At 3 months, the levels of ALT and AST in the combined group were lower than those in the single group (P < 0.05). The normalization rate of ALT and AST was significantly higher than that of the single use group (P <0.05). The levels of HBVDNA and HBeAg in both groups were significantly decreased after treatment for 3 months and 6 months (P <0.01), but there was no significant difference between the two groups in HBV-DNA negative rate and HBeAg seroconversion rate (P> 0.05). Compared with the healthy control group, the number of NK cells in peripheral blood of patients with CHB was significantly decreased (P <0.05), and the expression of TLR3 and TLR9 in NK cells was significantly decreased (P <0.05). After treated for 3 months and 6 months, The number of NK cells and the expressions of TLR3 and TLR9 in both groups were significantly higher than those before treatment (P <0.05), and the number of NK cells and TLR3 expression in the combination group were significantly higher than those in the control group P <0.05). CONCLUSION: Lingcifang combined with telbivudine can significantly improve TCM syndromes and liver function in patients with CHB, and its mechanism may be related to increasing the number of patients with NK cells and the expression of TLR3 in vitro and in vivo, so as to regulate the immune function related.