目的 探讨PAD方案治疗初发多发性骨髓瘤(MM)有效性及安全性。方法 统计54例接受PAD方案治疗的初发MM患者临床资料,采用回顾性分析方法。PAD方案:P(硼替佐米)1.3 mg/m²,第1、4、8、11天皮下注射,A(脂质体阿霉素)25～30 mg/m²,第1天静脉滴注,D(地塞米松)40 mg,第1～4 天静脉滴注或口服,每21天为1个疗程。采用IMWG疗效标准判定疗效,按NCICTCAE(第3版)标准判断不良反应。结果 ①总体疗效:平均4(2~8)个疗程后,47例(87.0%)患者获部分缓解(PR)以上疗效,其中完全缓解(CR)20例(37.0%),很好的部分缓解(VGPR)19例(35.2%),部分缓解(PR)8例(14.9%),疾病稳定(SD)5例(9.3%),病情进展率(PD)2例(3.7%)。②亚组疗效:54例患者中,35例治疗4个以上疗程,19例小于4个疗程,ORR分别为97.1%(34/35)、68.4%(13/19)(P=0.003)。按照年龄、肾功能、骨破坏数目、骨髓浆细胞比例、ALB、LDH、β2-MG、细胞遗传学、ISS分期、临床分型进行队列亚组疗效比较,结果提示亚组疗效差异无统计学意义(P＞0.05);③总体安全性:中性粒细胞减少8例(14.8%),血小板减少8例(14.8%),周围神经病变16例(29.6%),腹泻2例(3.7%),便秘2例(3.7%),带状疱疹4例(7.4%),细菌感染5例(9.3%),以上不良反应经对症治疗后症状减轻或消失。④亚组安全性:按照年龄和疗程数进行亚组比较,年龄大于60岁患者和年龄小于60岁患者总不良反应发生率和3/4级不良反应发生率分别是47.4% vs 60.0% 和15.8% vs 20.1%,(P=0.404和P=1.00);治疗4个以上疗程患者和小于4个疗程患者总不良反应发生率和3/4级不良反应发生率分别是57.9% vs 54.3%和21.2% vs 17.1%,(P=1.00和P=0.728)。结论 PAD方案治疗初发MM效果显著,缓解率和疗程数有相关性,疗效与传统的生存预后因素无关,可作为MM诱导治疗的一线方案。脂质体阿霉素心脏毒性小,替代传统蒽环类药物阿霉素,不良反应可控,耐受性良好,更适用于老年MM患者。

Objective To investigate the efficacy and safety of PAD regimen in previously untreated patients with multiple myeloma(MM). Methods We retrospectively analyzed 54 patients with newly-diagnosed MM,who were treated with PAD regimen: Bortezomib 1.3mg/m² subcutaneously on day 1,4,8,11. Liposomal doxorubicin 25～30 mg/m² intravenously on the first day. Dexamethasone 40 mg/d intravenously or orally on days 1～4. Treatment was repeated every 21 days. Response was evaluated according to the International Uniform Response Criteria for MM.Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria,version 3.0. Results ①Overall response:after median 4(2～8) courses of PAD,47patients(87.0%)responsed,including complete response (CR) in 20 (37.0%),very good partial response (VGPR) in 19 (35.2%),partial response (PR) in 8 (14.9%),stable disease (SD) in 5 (9.3%) and progressive disease (PD) in 2 (3.7%). ②Subgroups efficacy: among the 54 patients,35 patients received more than 4 therapeutic courses,and 19 patients received less than 4 courses.The ORR was 97.1% (34/35) and 68.4% (13/19) respectively (P=0.003). Subgroups efficacy were compared according to age,renal function,number of bone destruction,proportion of bone marrow plasma cells,ALB,LDH,β2-MG,cytogenetics,ISS staging and clinical classification. The results indicated that there was no statistical difference(P>0.05). ③Overall safety: adverse events included neutropenia in 8 (14.8%),thrombocytopenia in 8 (14.8%),peripheral neuropathy in 16 (29.6%),diarrhea in 2 (3.7%),constipation in 2 (3.7%),herpes zoster in 4 (7.4%) and bacterial infection in 5 (9.3%). The adverse events relieved or disappeared after symptomatic treatment. ④Subgroups safety: compared by age and courses of treatment,the incidence of overall adverse events and grade 3/4 adverse events in patients older than 60 years and ones younger than 60 were 47.4% vs 60.0% and 15.8% vs 20.1% respectively,(P=0.404,P=1.00). The incidence of overall adverse events and grade 3/4 adverse events in patients with more than 4 therapeutic courses and ones with less than 4 courses were 57.9% vs 54.3% and 21.2% vs 17.1% respectively,(P=1.00和P=0.728). Conclusion PAD regimen has really curative effect in treating patients with newly diagnosed MM. There is a correlation between remission rate and therapeutic courses. It can be used as the first selected protocol for the induction therapy of MM. Its efficacy is independent of traditional prognostic factors.Liposomal doxorubicin has almost no cardiotoxicity. Replacing traditional anthracycline doxorubicin,the adverse events are controllable and the tolerance is generally well. PAD regimen is more proper to be applied to older patients with MM.

目的 对晚期非小细胞肺癌(NSCLC)患者进行回顾性分析,探讨参一胶囊维持治疗对患者炎症因子的影响。方法 经参一胶囊联合化疗一线治疗后取得缓解或稳定的37名晚期NSCLC患者意向性分为治疗组(A组,21人)和对照组(B组,16人)。A组继续服用参一胶囊每天2次,每次20 mg,服药至疾病进展或无法耐受;B组未予特殊治疗。分别于第1 d、90 d采血,检测白细胞计数、中性粒细胞计数、C反应蛋白、肿瘤坏死因子α(TNF-α)、白细胞介素1β(IL-1β)、白细胞介素1α(IL-1α)、白细胞介素6(IL-6)和白细胞介素10(IL-10)。结果 治疗前后比较,治疗组各项炎症指标均未发生明显变化(P>0.05);而对照组的TNF-α、IL-1β、IL-6上升(P值分别为<0.001、0.032、0.001),IL-10下降(P=0.035);治疗后两组间比较,对照组TNF-α、IL-1β、IL-6上升(P值分别为<0.001、0.001、0.004),IL-10则下降(P=0.002)。两组间IL-1α及白细胞计数、中性粒细胞计数、C反应蛋白无变化(P>0.05)。结论 参一胶囊维持治疗可使晚期NSCLC患者TNF-α、IL-1β及IL-6的低表达,提示调节炎症反应可能是参一胶囊维持治疗抑制NSCLC进展的机制之一。

Objective To retrospectively investigate the influence of Shenyi Capsule maintenance therapy on inflammatory factors in patients with advanced NSCLC. Methods Thirty seven patients with advanced NSCLC, who had become palliative or stable after first-line treatment with combined Shenyi capsule chemotherapy, were intentionally assigned to treatment group (group A, 21 patients) and control group (group B, 16 patients). Shenyi capsule was given to group A (20mg p.o., bid) until appearance of deterioration or intolerance, while no special treatment was given to group B. Leukocytes, neutrophils, C-reactive protein, tumor necrosis factor α (TNF-α), interleukin-1β(IL-1β), interleukin-1α (IL-1α),interleukin-6(IL-6) and interleukin-10(IL-10) were tested by blood specimens taken respectively on 1st day and 90th day. Results There were no statistical differences (P>0.05) between the level of inflammatory factors on 1th day and 90th day in treatment group. In control group, however, TNF-α、IL-1β and IL-6 increased (P<0.001, P=0.032、P=0.001 respectively) and IL-10 decreased significantly (P=0.035). Furthermore, the level of TNF-α、IL-1β and IL-6 in treatment group were also higher (P<0.001, P=0.001, P=0.004 respectively), while IL-10 was lower (P=0.002)than control group on 90th day. There were no statistical differences(P>0.05)between the two groups in the level of IL-1α, leukocyte, neutrophils or C reactive protein on 1th day and 90th day. Conclusion Shenyicapsule maintenance therapy could lower the expression of TNF-α、IL-1β and IL-6 in patients with advanced NSCLC, which indicates that the regulation of inflammatory reaction may be one of the mechanisms of inhibition from NSCLC progression in Shenyi capsule maintenance therapy.