硼替佐米不同给药频率治疗多发性骨髓瘤的临床研究

蔡德丰; 孙蕾

硼替佐米不同给药频率治疗多发性骨髓瘤的临床研究

蔡德丰,
孙蕾

Clinical Study of Bortezomib in the Treatment of Multiple Myeloma at Different Dose-frequency Schedule

摘要

摘要:
目的观察硼替佐米不同给药频率治疗多发性骨髓瘤的临床效果。
方法纳入2011年2月至2017年2月于我院收治的86例多发性骨髓瘤患者为对象，按照随机数表法分为对照组和试验组各43例，其中对照组予以硼替佐米大剂量治疗，硼替佐米1.6 mg/m²，第1、8、15、22天给药，以35 d为1个化疗周期；试验组实施减低剂量治疗，硼替佐米1.0~1.3 mg/m²，第1、4、8、11天给药，以21 d为1个化疗周期。同时，两组均于第1~4天静脉滴注地塞米松40 mg/d+阿霉素10 mg/m²，于化疗间歇期均口服沙利度胺100 mg/d，均持续治疗6个周期。对比两组临床疗效，观察治疗期间不良反应发生率。
结果试验组总反应率(overall response rate，ORR)、疾病控制率(disease control rate，DCR)分别为88.37%、95.35%，对照组ORR、DCR分别为81.40%、90.70%，两组ORR、DCR比较差异均无统计学意义。两组白细胞减少、血小板减少、中性粒细胞减少发生率差异无统计学意义；试验组Ⅲ~Ⅳ级周围神经病、带状疱疹、乏力、腹胀发生率分别为2.33%、4.65%、13.95%、2.33%，对照组分别为16.28%、27.91%、34.88%、18.60%，差异均有统计学意义(P＜0.05)。所有患者均获得有效随访24月，试验组1年、2年总生存(overall survival，OS)率、无进展生存(progression-free survival，PFS)率、累计复发率与对照组比较差异均无统计学意义。
结论硼替佐米不同给药频率治疗多发性骨髓瘤疗效相似，但患者对减低剂量硼替佐米治疗(第1、4、8、11天给药)具有更好的耐受性，能有效减少不良反应发生率。

Abstract:
Objective To evaluate the clinical effect of bortezomib with different dose-frequency in the treatment of multiple myeloma.
Methods 86 patients with multiple myeloma in our hospital from February 2011 to February 2017 were included in the study. The patients were randomly divided into the experimental group (43 cases) and the control group (43 cases). The patients in the control group were treated with high dose bortezomib (1.6 mg/m²) on day 1, day 8, day 15 and day 22, with 35 d as a chemotherapy cycle. The patients in experimental group was treated with low dose bortezomib (1.0-1.3 mg/m²) on day 1, day 4, day 8 and day 11, with 21 d as a chemotherapy cycle. The patients in both groups were given dexamethasone(40 mg/d) and doxorubicin (10 mg/m²) from day 1 to day 4, and thalidomide was given orally at the intervals of 6 chemotherapy cycles. The clinical effect and the incidence of adverse drug reactions were compared between the two groups.
Results The overall response rate (ORR) and disease control rate (DCR) were 88.37% and 95.35% respectively in the experimental group, while those of the control group were 81.40% and 90.70% respectively. There was no significant difference in ORR and DCR between the two groups. In the incidence of leukopenia, thrombocytopenia and neutropenia showed no significant difference between the two groups. The incidences of grade Ⅲ to grade Ⅳ peripheral neuropathy, herpes zoster, fatigue and abdominal distension in the experimental group were 2.33%, 4.65%, 13.95% and 2.33% respectively, while those of the control group were 16.28%, 27.91%, 34.88% and 18.60% respectively. The differences of the above incidences between the two groups were significant (P < 0.05). All the patients were followed up for 24 months. There was no significant difference in the overall survival (OS) rate, progression-free survival (PFS) rate and cumulative recurrence rate between the two groups.
Conclusion The effect of bortezomib in the treatment of multiple myeloma was similar at different dose-frequency group. The patients treated with low dose bortezomib (day 1, day 4, day 8 and day 11) had the better tolerance and lower incidences of adverse drug reactions.

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