Objective To evaluate the effectiveness of PTD regimen (pamidronate disodium + thalidomide + dexamethasone) and TD regimen (thalidomide + dexamethasone) in the treatment of multiple myeloma. Methods The patients meeting the inclusion criteria were randomly treated with PTD and TD regimens from January 2004 to December 2008. The effectiveness and safety of the two groups were observed after 8 weeks and the statistical analyses were performed using SPSS 13.0 software. Results A total of 25 patients were included, of which 13 were treated with PTD regimen and the other 12 were treated with TD regimen. The results showed overall response rates were 84.6% and 83.3% in the PTD and TD groups, respectively, with no significant difference (Pgt;0.05). The complete response rate (5/13 vs. 1/12) and early response rate (within 2 weeks, 4/13 vs. 1/12) for bone pain in the PTD group were better than those of TD group (Plt;0.05). Conclusion Compared with TD regimen, PTD regimen has more dramatic and faster effects on bone pain relief for multiple myeloma, but for overall response rate, further larger sample size randomized controlled trials are needed.
Objective To assess the effectiveness and safety of thalidomide for treating multiple myeloma in China. Methods Randomized controlled trials (RCTs) of thalidomide for multiple myeloma were collected from CNKI (1979 to 2008), CBMdisc (1979 to 2008), and VIP (1989 to 2008) databases. Other relevant journals were also handsearched. The methodological quality of the included studies was evaluated, and data analyses were performed using the Cochrane Collaboration’s software RevMan 4.3. Results A total of 9 RCTs involving 324 patients were included. As for the total effective rate and complete remission rate, significant differences were found between thalidomide + MP vs. MP alone (RR=1.34, 95%CI 1.05 to 1.70; RR=1.77, 95%CI 1.26 to 2.49) and thalidomide + VAD vs. VAD alone (RR=1.45, 95%CI 1.20 to 1.75; RR=1.73, 95%CI 1.25 to 2.39). Conclusion According to the domestic evidence, treatment for multiple myeloma with thalidomide can improve the total effective rate and the complete remission rate. However, more high–quality, large-sample, randomized, double-blind, controlled trials are required.
目的 了解沙利度胺对白塞病黏膜损害的疗效。 方法 对2002年1月－2008年12月间61例白塞病患者的临床资料进行回顾性研究，所有纳入患者均无重要内脏器官的损害。沙利度胺治疗剂量100 mg/d，治疗疗程12周，以后逐步减量。 结果 48例完全缓解（在治疗期间无口腔及外生殖器溃疡），但停药后溃疡复发。7例出现上下肢体麻木感，停药后麻木感消失。 结论 沙利度胺对白塞病的口腔及外生殖器溃疡治疗有效，100 mg/d的治疗剂量合适。
【摘要】 目的 研究沙利度胺对人慢性粒细胞白血病急变株K562细胞凋亡及血管内皮生长因子（vascular endothelia growth factor，VEGF）分泌的影响。 方法 采用不同浓度的沙立度胺（0.5、1.0、2.0 mmol/L）作用于K562细胞24、48、72、96 h，瑞-姬（Wright-Giemsa）染色法观察细胞形态；四甲基偶氮唑盐（methylthiazolyl tetrozolium，MTT）法检测细胞增殖；流式细胞仪膜联蛋白V-异硫氰酸荧光素/碘化丙啶双染法检测凋亡率；琼脂糖凝胶电泳法检测脱氧核糖核酸梯状条带；酶联免疫吸附法检测VEGF浓度。 结果 培养24、48 h后，沙立度胺对K562细胞生长无抑制作用；作用72 h后，1.0、 2.0 mmol/L浓度组开始出现对K562细胞生长的抑制（Plt;0.001）；作用96 h后，0.5 mmol/L浓度组也产生对K562细胞生长的抑制（Plt;0.001），呈一定的浓度和时间依赖性。沙立度胺处理72 h后，K562细胞出现形态学改变，其体积缩小，出现空泡化，边缘出现突起，染色质浓缩、边集，核固缩、出现凋亡小体。经沙立度胺处理后，流式分析结果显示K562细胞凋亡率增加（Plt;0.001）。沙立度胺作用72 h后，琼脂糖凝胶电泳可见典型的DNA梯状条带。K562细胞培养48 h后，沙立度胺抑制VEGF的分泌（Plt;0.001），并且VEGF浓度与凋亡率呈负相关（r=-0.789）。 结论 沙利度胺抑制K562细胞的增殖，呈一定的浓度和时间依赖性；沙利度胺对K562细胞凋亡有明显诱导作用；沙利度胺抑制K562细胞VEGF的分泌。【Abstract】 Objective To investigate the effect of thalidomide on apoptosis of k562 cells and its vascular endothelial growth factor secretion. Methods K562 cells were cultured in vitro with 0.5, 1.0, and 2.0 mmol/L thalidomide for 24, 48, 72, and 96 hours. Morphology of the K562 cells was observed by the Wright-Giemsa staining method. Methylthiazolyl tetrozolium （MTT） assay was used to determine the cell growth. The rate of apoptosis was analyzed by flow cytometry (FCM) with annexin V-fluorescein isothiocyanate/propidium iodide （AnnexinV-FITC/PI）double-staining method. Agarose gel electrophoresis was used to detected Deoxyribonucleic acid Ladder（DNA Ladder）. The concentration of VEGF was quantified by the enzyme-linked immunosorbent assay (ELISA). Results Cultured for 24 or 48 hours, thalidomide had no effect on the proliferation of the K562 cells. But after cultured for 72 hours, thalidomide began to inhibit the growth of the K562 cells at the concentration of 1.0 and 2.0 mmol/L （Plt;0.001）. After cultured for 96 hours, the proliferation of the K562 cells was inhibited too at the concentration of 0.5 mmol/L thalidomide （Plt;0.001）. Thus, thalidomide inhibited the growth of the K562 cells with a dose-and time-dependent manner to some extent. After exposure to thalidomide for 72 hours, K562 cells underwent typical morphological changes of apoptosis such as vaculization, the budding of cytoplasm, chromatin condensation, margination, shrunken nucleus and apoptotic body. The results of flow cytometry showed that thalidomide could obviously increase the rates of the apoptosis of K562 cells （Plt;0.001）. After treated with thalidomide for 72 hours, DNA was extracted for Agarose gel electrophoresis and typical DNA ladder strips were observed. The secretion of VEGF was inhibited when exposure to thalidomide for 48 hours（Plt;0.001）, and there was negative correlation between VEGF concentrations and apoptotic rates（r=-0.789）. Conclusions Thalidomide could inhibite the growth of the K562 cells with a dose-and time-dependent manner to some extent. Thalidomide could obviously induce the apoptosis of the K562 cells and inhibit its secretion of VEGF.
目的:观察沙利度胺联合地塞米松(TD)治疗初治多发性骨髓瘤(MM)的疗效和毒副反应。方法:25例初治MM患者,给予沙利度胺(100mg/d起,每周增加50mg~100mg/d到200mg/d)联合地塞米松40mg/d(d1~4,9~12,17~20),28天为一疗程,至少2个疗程。与既往18例使用VAD方案治疗MM初治患者作对照。结果:观察组25例中,14例部分缓解(56％),6例进步(24％),总有效率80%。对照组18例中,部分缓解13例,进步2例,总有效率83.3%。两组总有效率无显著性差异(Pgt;0.05),但主要副作用发生率观察组明显少于对照组(Plt;0.05)。结论:沙利度胺联合地塞米松(TD)治疗多发性骨髓瘤疗效高、副作用少和耐受性好,值得进一步的临床观察和推广。老年患者(年龄gt;65岁),地塞米松减量应用,可减少副作用,且不影响疗效的发挥。
ObjectiveTo investigate the efficacy of sulfasalazine combined with thalidomide in the treatment of spondyloarthropathy (SpA), and to probe whether the treatment can reach and maintain clinical remission for the patients. MethodBetween January 2011 and June 2013, we used a prospective, non-intervention and regular follow-up study to observe and assess 70 SpA patients on their Bath ankylosing spondylitis disease activity index, visual analogue scale score, peripheral arthritis, blood sedimentation, and C-reactive protein. All the patients had taken sulfasalazine, thalidomide and non-steroidal anti-inflammatory drugs for 24 weeks. Multivariate analysis of factors affecting the efficacy of the program was our object of this study. ResultsAfter 24 weeks, the total clinical remission rate of these patients was 72.9%. Clinical remission rate of 40 patients with short duration of SpA was 90.0%, while it was 50.0% for the other 30 patients with a non-short duration of SpA. Observation indexes before and after treatment in both groups of patients had significant differences (P<0.05). For patients with non-short duration SpA, the curative effect for female was obviously better than male, but the difference between male and female patients with short-duration SpA was not so obvious. Clinical remission rate for youth was similar with that for non-youth patients. Binary logistic regression analysis showed that whether the disease had a short duration[OR=3.408, 95%CI (1.637, 7.437), P=0.001] and whether the patients were urban residents[OR=4.163, 95%CI (2.011, 8.761), P=0.001] were statistically significant (P<0.05). ConclusionsClinical remission of spondyloarthropathy can be maintain by sulfasalazine combined with thalidomide. Clinical remission rate of the scheme is affected by duration of disease and residency except age and gender of the patients. Short duration and urban residency are independent factors for reaching clinical remission after treatment.
ObjectiveTo systematically review the effectiveness and safety of thalidomide for ankylosing spondylitis (AS). MethodsDatabases including Ovid MEDLINE (1946 to 2014.2.1), EMbase (1947 to 2014.2.1), CENTRAL (Issue 1, 2014), CBM (1978 to 2014.2.1), CNKI (1994 to 2014.2.1), WanFang Data (1980 to 2014.2.1) and VIP (1989 to 2014.2.1) were searched for randomized controlled trials about the effectiveness and safety of thalidomide for AS. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data, and assessed methodological quality of included studies. Meta-analysis was then conducted using RevMan 5.2 software. ResultsSeven RCTs were included involving 544 patients. The results of meta-analysis showed that, compared with the blank group, thalidomide increased clinical remission, but it showed no obvious advantage in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), and secondary outcome index, with an increased total rate of withdrawal/drop-out. Compared with SSZ, thalidomide increased the rate of maintaining remission when it was used in the maintenance treatment after the patients attained ASAS20; and for other outcomes it was similar to SSZ. Compared with NSAIDs, thalidomide increased the rate of maintaining remission when it was used in the maintenance treatment after the patients attained ASAS20; it increased clinical remission; for secondary outcomes it was similar to NSAIDs; and it had a higher incidence of adverse reaction as well as an increased total rate of withdrawal/drop-out. ConclusionCompared with the blank group, thalidomide increases clinical remission, with an obviously-increased total rate of withdrawal/drop-out. Compared with SSZ, thalidomide increases the rate of maintaining remission when it is used in the maintenance treatment after patients attain ASAS20. Compared with NSAIDs, thalidomide increases the rate of maintaining remission when it is used in the maintenance treatment after patients attain ASAS20; it also increases clinical remission; but it has a higher incidence of adverse reaction as well as an increased total rate of withdrawal/drop-out. Due to limited quantity and quality of the included studies, the above conclusion needs to be verified by conducting more high quality studies.
ObjectiveTo systematically review the effect of thalidomide as first-line therapy on postrelapse survival rate of patients with multiple myeloma (MM). MethodsDatabases including PubMed, EMbase, The Cochrane Library (Issue 1, 2007) and Web of Science were searched to collect randomized controlled trials (RCTs) about thalidomide as first-line therapy for MM from 2006 to 2011. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Then, meta-analysis was performed by using RevMan 5.1 software. ResultsA total of 16 RCTs involving 6097 patients were included. The results of meta-analysis showed that, compared with the chemotherapy alone group, early application of thalidomide could significantly decrease the postrelapse survival rate (HR=1.23, 95%CI 1.05 to 1.45, P=0.002). Subgroup analysis showed that, compared with the chemotherapy alone group, thalidomide maintenance therapy after autologous stem cell transplantation (ASCT) couldn’t decrease the postrelapse survival rate (HR=0.90, 95%CI 0.57 to 1.41, P=0.64), but thalidomide induction therapy before ASCT (HR=1.21, 95%CI 1.01 to 1.45, P=0.04) and thalidomide induction therapy before ASCT combined maintenance therapy after ASCT (HR=1.41, 95%CI 1.13 to1.76, P=0.002) could significantly decrease the postrelapse survival rate. ConclusionCurrent evidence shows that, thalidomide maintenance therapy after ASCT for MM is a better therapy regimen. It couldn’t decrease the survival rate after recurrence, but could increase the disease-free survival (DFS) and overall survival (OS) of patients with MM. Due to the limited quality of included studies, the above conclusion still needs to be verified by more high quality studies.