消癌平注射液辅助化疗治疗非霍奇金淋巴瘤的临床分析

Clinical Analysis of Xiao Ai Ping Injection Adjunct to Chemotherapy in Treating Non-Hodgkin’s Lymphoma

【目的】评价消癌平注射液联合中医辨证治疗辅助化疗方案对非霍奇金淋巴瘤(NHL)的疗效及安全性。【方法】回顾分析南京中医药大学附属医院血液科2009~2014年经CHOP方案化疗2~3个疗程的NHL患者79例,根据治疗方法的不同将患者分为观察组38例和对照组41例。对照组单纯接受CHOP方案化疗,观察组在对照组基础上给予消癌平注射液(中药乌骨藤提取物)联合中医辨证治疗(根据寒痰凝结、气郁痰结、阴虚痰瘀和阴阳俱虚4型,分别给予阳和汤、柴胡疏肝散、壮骨丸、肾气丸加减治疗),比较2组的近期疗效和不良反应,并进一步将观察组按照病理类型、病情分期、侵袭程度、危险度及中医辨证等分层,比较其疗效差异。【结果】(1)观察组的总有效率和疾病控制率分别为71.1%和84.2%,明显高于对照组的58.5%、73.2%,差异有统计学意义(P <0.05)。(2)分层比较结果显示,观察组对B细胞淋巴瘤的有效率(78.1%)和疾病控制率(90.6%)均高于T细胞淋巴瘤(40.0%、40.0%),对低-中/中危组淋巴瘤的有效率(87.0%)和疾病控制率(95.7%)均高于中-高/高危组淋巴瘤(46.7%、66.7%),对惰性和初发淋巴瘤的疾病控制率(100.0%、91.7%)高于侵袭性和难治/复发淋巴瘤(78.6%、71.4%),差异均有统计学意义(P <0.05)。(3)观察组对气郁痰结和阴虚痰瘀组的有效率分别为81.8%、90.0%,对气郁痰结和阴虚痰瘀组的疾病控制率分别为90.9%、100.0%,均高于寒痰凝结组和阴阳两虚组,差异均有统计学意义(P <0.01)。(4)观察组在血小板减少、贫血和发热的发生率方面均明显低于对照组,差异均有统计学意义(P <0.05),而2组在其他毒副反应方面的发生率比较,差异均无统计学意义(P>0.05)。【结论】消癌平注射液联合中医辨证治疗与化疗方案治疗NHL具有协同作用,对B细胞、惰性、初发、气郁痰结组和阴虚痰瘀淋巴瘤具有一定优势和潜在治疗价值。

Objective To evaluate the effectiveness and safety of Xiao Ai Ping Injection plus traditional Chinese medicine(TCM)syndrome differentiation and treatment as an adjunct to chemotherapeutics for non-Hodgkin’s lymphoma(NHL). Methods A retrospective analysis was conducted among 79 patients with NHL who were treated by CHOP chemotherapeutic regimen for 2-3 courses in the Affiliated Hospital of Nanjing University of Chinese Medicine from 2009 to 2014. The patients were assigned to trial group(38 cases)and control group(41 cases). The control group was treated with CHOP regimen alone,and the trial group was treated with CHOP regimen,Xiao Ai Ping Injection(the extract from Caulis Marsdeniae Tenocissimae)plus TCM differentiation and treatment(the patients were treated with Yanghe Decoction,Chaihu Shugan Powder,Zhuangu Pills,Shenqi Pills respectively for the syndromes of cold phlegm accumulation, Qi stagnation with phlegm accumulation, yin deficiency with phlegm stasis,deficiency of both yin and yang). The short-term clinical efficacy and adverse reaction in the two groups were observed. And the patients in the trial group were stratified by pathological types, illness staging, invasive degree,international prognostic index and TCM syndrome types for the comparison of clinical efficacy. Results(1)The total effective rate and disease control rate(DCR)of the treatment group were 71.1% and84.2% respectively, and were higher than those of the control group(58.5% and 73.2%, respectively), the difference being statistically significant(P < 0.05).(2)The comparison of the efficacy in the trial group based on the stratification showed that the effective rate and DCR of Xiao Ai Ping Injection for B-cell lymphoma were 78.1%and 90.6%,respectively,and were higher than those for T-cell lymphoma(40.0 % and 40.0 %,respectively),the difference being statistically significant(P < 0.05). Xiao Ai Ping Injection had higher effective rate and CDR for low-intermediate risk/intermediate risk lymphoma group(87.0% and 95.7%, respectively)than those for intermediate-high risk/high risk lymphoma group(46.7% and 66.7%, respectively), the difference being statistically significant(P < 0.05). DCR of Xiao Ai Ping Injection for indolent lymphoma and primary lymphoma was 100.0% and 91.7% respectively, higher than that for aggressive and refractory/relapsed lymphoma(78.6%and 71.4%,respectively),the difference being statistically significant(P < 0.05).(3)In the trial group,the effective rate of Xiao Ai Ping Injection for the syndromes of Qi stagnation with phlegm accumulation and yin deficiency with phlegm stasis was 81.8% and 90.0%,respectively,and the DCR for the two syndromes was 90.9%and 100.0%, respectively, being higher than the effective rate and DCR for the syndromes of cold phlegm accumulation and deficiency of both yin and yang,the difference being statistically significant(P < 0.01).(4)Incidence of adverse reaction such as thrombocytopenia,anemia and fever in the trial group was obviously lower than that in the control group, the difference being statistically significant(P < 0.05). The differences of incidences of other toxic and side effects between the two groups were not significant(P>0.05). Conclusion Xiao Ai Ping Injection plus TCM differentiation and treatment together with CHOP chemotherapeutic regimen exerts synergistic actions on NHL, and has certain advantages and potential efficacy for the treatment of B-cell lymphoma,indolent lymphoma,primary lymphoma,lymphoma of Qi stagnation with phlegm accumulation type,and lymphoma of yin deficiency with phlegm stasis type.