| Objective:To observe the clinical efficacy of modified Liuwei Dihuang granules combined with the Bortezomib-based PAD regimen in treating liver-kidney Yin deficiency type multiple myeloma,and to further explore it’s immunomodulatory mechanism.Methods:40 definitely diagnosed multiple myeloma patients with the traditional Chinese medicine(TCM)syndrome of liver-kidney Yin deficiency were randomly divided into two groups,including the research group(modified Liuwei Dihuang granules combined with the PAD regimen treatment group,n=21)and the control group(PAD regimen treatment group,n=19).Patients in research group were given oral administration of modified Liuwei Dihuang granules(150 ml each time for twice a day for 8 weeks continuously,initiating on day 1 of chemotherapy)based on the PAD regimen.Control group:PAD regimen:subcutaneous injection of Boitezomib for injection(1.3mg/m2,at days 1,4,8 and 11;combined with intravenous injection of Epirubicin Hydrochloride Injection(40 mg)at day 1;and intravenous injection of Dexamethasone Sodium Phosphate for Injection(20 mg)at days 1-2,days 4-5,days 8-9 and days 11-12.The other treatments were the same in both groups,patients were treated for two courses,with 4 weeks in a course of treatment,and they would be evaluated after two courses of treatment.The clinical efficacy,TCM syndrome efficacy,ostealgia score,lymphocyte subset and interleukin(IL)-6 level in both groups after treatment were observed,and the differences in the above indicators between two groups were analyzed.Result:A total of 40 cases were enrolled in this study,including 21 in research group and 19 in control group,with no drop-out case.With regard to the clinical efficacy after 8 weeks of treatment,the overall response rate(ORR)in research group was 76.19%,while that in control group was 68.42%,and the responses rate in the two groups were similar.As for TCM syndrome efficacy,the ORR in research group was 90.48%,while that in control group was 52.63%,and the efficacy in research group was superior to that in control group.The ostealgia score before treatment in research group was 5.57±1.47,while that in control group was 5.42±1.57,and the difference was not statistically significant(P>0.05);meanwhile,the ostealgia score after treatment was 2,57±1.40 in research group,while that was 3.68±1.49 in control group.The reduction in ostealgia score in research group was superior to that in control group(P<0.05).As for lymphocyte subsets:the total T-lymphocyte count was 69.13±11.49 and the CD4+T lymphocyte count was 32.68±4.45 in research group before treatment;while those in control group were 68.15±8.85 and 32.29±4.60,respectively,and the difference was not statistically significant(P>0.05).After treatment,the total T-lymphocyte count and the CD4+T lymphocyte count in research group were 58.35±13.27 and 25.00±2.80,respectively;while those in control group were 50.50±1 0.09 and 21.1 6±1.58,respectively.The reductions in the total T-lymphocytes and CD4+T lymphocytes in research group were better than those in control group(P<0.05).The interleukin(IL)-6 level in research group before treatment was 14.45(7.78,28.31),and that in control group was 14.52(10.19,34.56),and the difference was not statistically significant(P>0.05).The IL-6 level in research group after treatment was 6.22(5.39,8.16),and that in control group was 8.84(7.93,10.30);clearly,the IL-6 level could be better reduced in research group(P<0.05).Conclusion:Modified Liuwei Dihuang granules combined with the PAD regimen chemotherapy can alleviate the TCM liver-kidney Yin deficiency symptoms,especially for the ostealgia symptom;meanwhile,it can mitigate the immunosuppression of Bortezomib on the body,enhance the immune function,and exert the toxicity reducing and efficacy enhancing effects. |
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