心脉隆注射液对蒽环类药物所致心脏毒性的预防效果研究

摘要

目的：探讨心脉隆注射液对蒽环类药物所致心脏毒性的预防效果。方法选取2013年4-12月就诊于河北省人民医院经病理组织学和细胞学确诊的恶性肿瘤患者60例，将患者按随机抽号法分为治疗组和对照组，每组30例。对照组给予单纯蒽环类药物化疗，治疗组在单纯化疗基础上联合应用心脉隆注射液，两组均以21 d为1个治疗周期，连续完成6个周期治疗。两组分别于治疗前及治疗3、6周期结束后进行超声心动图检查〔左心室舒张末期内径（ LVIDD），左心室收缩末期内径（ LVISD），舒张早期与晚期充盈速度比值（ E/A），左心室射血分数（ LVEF）〕、心电图检查〔非特异性ST-T段和T波改变、QRS 低电压及各种心律失常（各种期前收缩、心动过速、房室传导阻滞等）情况〕，检测血清肌钙蛋白I（ cTnI）水平。结果对照组2例患者因肿瘤进展未完成6个周期的治疗，治疗组1例患者死亡，以上患者均剔除研究，最终对照组28例，治疗组29例。两组患者治疗前及治疗3、6周期后LVEF、E/A、LVIDD、LVISD比较，差异均有统计学意义（ P<0.05）。组间比较显示，治疗前LVEF、E/A、LVIDD、LVISD比较，差异无统计学意义（P>0.05）；治疗6周期后两组E/A、LVIDD、LVISD比较，差异有统计学意义（P<0.05）。组内比较显示，对照组治疗6周期后LVIDD、LVISD均高于治疗前（P<0.05）。对照组患者治疗前心电图异常0例；治疗3周期后心电图异常10例，异常率为35.7%；治疗6周期后心电图异常18例，异常率为64.3%。治疗组患者治疗前心电图异常0例；治疗3周期后心电图异常4例，异常率为13.8%；治疗6周期后心电图异常5例，异常率为17.2%。组间比较显示，治疗3周期后两组心电图异常率比较，差异无统计学意义（χ2=3.695，P=0.055）；治疗6周期后心电图异常率比较，差异有统计学意义（χ2=13.099，P<0.001）。组内比较显示，对照组治疗前心电图异常率低于治疗3、6周期后（χ2=12.174、25.526，P<0.001），治疗3周期后低于治疗6周期后（χ2=4.571，P=0.033）；治疗组治疗前心电图异常率低于治疗3、6周期后（χ2=4.296、5.472，P=0.035、0.019）。两组患者治疗前及治疗3、6周期后血清cTnI水平比较，差异均有统计学意义（ P<0.05）。组间比较显示，治疗前两组血清cTnI水平比较，差异无统计学意义（P>0.05）；治疗3、6周期后两组血清cTnI水平比较，差异均有统计学意义（P<0.05）。组内比较显示，两组治疗3、6周期后血清cTnI水平均高于治疗前（ P<0.05）。结论心脉隆注射液能够减轻蒽环类药物的心脏毒性，增强患者对蒽环类药物化疗的耐受性，对蒽环类化疗药物所致心脏毒性有一定的预防效果，为临床进一步研究提供了参考依据。%Objective To explore the preventive effects of Xinmailong injection on anthracyclines induced cardiac tox-icity. Methods Sixty malignant tumor patients in People's Hospital of Hebei Province from April to December 2013 were divided randomly into groups therapy,control,30 in each. Control group were given only anthracycline chemotherapy,therapy group combined with Xinmailong injection,21 d as a therapeutic cycle,altogether 6 cycles. Underwent echocardiogranphy left ventric-ular internal diameter at end-diastole( LVIDD),left ventricular internal end-systolic dimension( LVISD),early and late diastolic filling velocity ratio( E/A),left ventricular ejection fraction( LVEF),ECG〔non-specific ST-T segment and T wave changes,QRS low voltage and vatious arrhythmias( proiosystole,tachycardia,atrioventricular block,etc. )〕and deter-mined serum cardiac troponin I( cTnI)level before treatment,after 3,6 treatment cycles. Results 2 patients in control group,1 in therapy group died due to tumor progression. There were 28 cases in control group,29 in therapy group after exclu-ding the above cases. There was significant difference in LVEF,E/A,LVIDD,LVISD between 2 groups before therapy,after 3,6 therapy cycles(P<0. 05). In group comparison,there was no difference in LVEF,E/A,LVIDD,LIVSD before treat-ment(P>0. 05);there was in E/A,LVIDD,LVISD between 2 groups after a cycles(P<0. 05). In intra-group compari-son,LVIDD,LVISD were higher after 6 cycles than before treatment in control group(P<0. 05). In control group,no pa-tients had ECG abnormalities before treatment,10 had after 3 treatment cycles(35. 7%),18 had after 6 cycles(64. 3%), and in therapy group,0,4(13. 8%),5(17. 2%),respectively. There was no significant difference in ECG abnormality between 2 groups after 3 cycles(χ2 =3. 695,P=0. 055);there was after 6 cycles(χ2 =13. 099,P=0. 000). In control group,ECG abnormality was lower before treatment than after 3,6 treatment cycles(χ2 =12. 174,25. 526,P =0. 000, 0. 000),lower after 3 cycles than after 6 cycles(χ2 =4. 571,P=0. 033);in therapy group,ECG abnormality was lower be-fore treatment than after 3,6 cycles(χ2 =4. 29,5. 472,P=0. 035,0. 019). There was difference in serum cTnI between 2 groups before treatment and after 3,6 cycles(P <0. 05). In group comparison,there was no difference in cTnI between 2 groups before treatment(P>0. 05);there was after 3,6 treatment cycles(P<0. 05). In intra-group comparison,cTnI was higher after 3,6 cycles than before treatment(P<0. 05). Conclusion Xinmailong injection can reduce anthracycline induced cardiac toxicity,enhance patients' tolerance to anthracycline chemotherapy. It is of some preventive effects on anthracycline chemotherapy-induced cardiotoxicity.