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毒結(jié)清口服液聯(lián)合VAD方案治療多發(fā)性骨髓瘤臨床研究

發(fā)布時間:2018-05-12 08:46

  本文選題:多發(fā)性骨髓瘤 + 毒結(jié)清口服液; 參考:《廣西中醫(yī)藥大學》2017年碩士論文


【摘要】:目的:客觀評價毒結(jié)清口服液聯(lián)合VAD方案化療治療多發(fā)性骨髓瘤(multiple myeloma,MM)的臨床療效,并觀察其安全性。方法:選取2014年10月01日至2016年06月30日在廣西中醫(yī)藥大學第一附屬醫(yī)院血液科就診的MM住院病人64例,西醫(yī)符合2015年NCCN指南MM診斷標準,中醫(yī)符合脾腎虧虛,毒瘀互結(jié)證的。采用隨機數(shù)字表法隨機分為治療組(32例)和對照組(32例),治療組:毒結(jié)清口服液(20ml/次,tid)聯(lián)合VAD化療,對照組:VAD化療。4周為1療程,共治療4療程后評價,觀察兩組病人治療后的臨床療效、中醫(yī)癥候療效,骨痛療效,生活質(zhì)量KPS評分,中醫(yī)癥候積分,骨髓漿細胞比例,β2-微球蛋白,乳酸脫氫酶,血鈣,C反應(yīng)蛋白,腎功能,血紅蛋白及不良反應(yīng)發(fā)生率。結(jié)果:研究共入組病例64例,治療過程中脫落5例,最終納入統(tǒng)計分析59例。其中,治療組30例,對照組29例。(1)兩組病人療效比較:(1)總反應(yīng)率(ORR):治療組ORR為70%,對照組ORR為58.60%,兩組ORR差別無統(tǒng)計學意義;等級資料經(jīng)秩和檢驗,治療組整體療效優(yōu)于對照組(P0.05);(2)中醫(yī)癥候療效:治療組總有效率為80%,對照組總有效率為58.60%,差別無統(tǒng)計學意義;等級資料經(jīng)秩和檢驗,治療組整體療效優(yōu)于對照組(P0.05);(3)生活質(zhì)量:治療組KPS評分總有效率為76.7%,對照組KPS評分總有效率為62.07%,兩組總有效率差別無統(tǒng)計學意義;等級資料經(jīng)秩和檢驗,治療組整體療效優(yōu)于對照組(P0.05)。(2)兩組實驗結(jié)果比較:(1)兩組病人治療后骨髓漿細胞比例較前顯著下降(P0.05),但組間療效相似(P0.05);(2)兩組病人治療后HGB均升高,β2-MG、LDH、血鈣、CRP、Scr、BUN均下降(P0.05),治療組優(yōu)于對照組(P0.05);(3)兩組病人癥候積分比較:兩組病人治療后骨痛、疲倦乏力、食少納呆、形體消瘦、四肢麻木、耳鳴積分較前下降(P0.05),其中治療組優(yōu)于對照組(P0.05);(4)不良反應(yīng):對照組有10例,其中,惡心嘔吐5例,肝功能損害2例,Ⅲ度以上骨髓抑制3例。發(fā)生率34.48%;治療組有7例,其中,惡心嘔吐3例,肝功能損害2例,Ⅲ度以上骨髓抑制2例。發(fā)生率為23.33%,組間比較無統(tǒng)計學差異(P0.05)。結(jié)論:毒結(jié)清口服液聯(lián)合VAD化療方案治療MM,可提高臨床療效;降低血β2-MG、LHD、Scr、BUN、血鈣及CRP水平,提高HGB水平。還可以有效改善患者骨痛等臨床癥狀,提高病人生活質(zhì)量。安全性好,不增加化療毒副作用。
[Abstract]:Objective: to evaluate the clinical efficacy and safety of Duqing oral liquid combined with VAD regimen in the treatment of multiple myeloma with multiple myeloma. Methods: 64 cases of MM hospitalized in hematology department of the first affiliated Hospital of Guangxi University of traditional Chinese Medicine were selected from October 01, 2014 to June 30, 2016. Western medicine met the MM diagnostic criteria of 2015 NCCN guidelines, TCM accorded with deficiency of spleen and kidney, and syndrome of toxin and blood stasis. The treatment group (n = 32) and the control group (n = 32) were randomly divided into treatment group (n = 32) and control group (n = 32). The treatment group was treated with Duqingoral liquid 20 ml / time tid) and the control group was treated with VAD for 4 weeks. The clinical effect, TCM symptom effect, bone pain effect, quality of life (QOL) score, TCM symptom score, bone marrow plasmacyte ratio, 尾 2-microglobulin, lactate dehydrogenase, serum calcium C-reactive protein, renal function were observed in both groups. Incidence of hemoglobin and adverse reactions. Results: 64 cases were included in the study, 5 cases dropped out during the course of treatment, and 59 cases were included in the statistical analysis. There were 30 cases in the treatment group and 29 cases in the control group. The total response rate of the two groups was: ORR was 70 in the treatment group and ORR was 58.60 in the control group. There was no significant difference in ORR between the two groups. The total effective rate of the treatment group was 80, the total effective rate of the control group was 58.60, the difference was not statistically significant. The overall curative effect of the treatment group was better than that of the control group (P 0.05): the total effective rate of the KPS score in the treatment group was 76.70.The total effective rate of the control group was 62.07, the difference of the total effective rate between the two groups was not statistically significant, and the rank data were tested by rank sum test. The overall curative effect of the treatment group was better than that of the control group (P0.05n. 2) the results of the two groups were compared with that of the control group (P 0.05) the ratio of bone marrow plasma cells in the two groups decreased significantly after treatment, but the curative effect was similar between the two groups (P 0.05). After treatment, the HGB of the two groups was increased, and the levels of 尾 _ 2-MGG LDH and serum calcium CRPG-Scr-BUN were all decreased (P0.05). Comparison of symptom score between the two groups: bone pain was found in the two groups after treatment. Fatigue and fatigue, eating little, wasting, limb numbness, tinnitus score decreased P0.05G, the treatment group was superior to the control group (P0.05 / 4) adverse reactions: in the control group, there were 10 cases, including 5 cases of nausea and vomiting, 2 cases of liver function damage. There were 3 cases of bone marrow suppression above degree 鈪,

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