Medical pretreatment relieves chemotherapy-induced vomiting in lung cancer patients
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摘要:
目的 评估药物干预化疗致呕吐的“前驱症状”能否有效预防呕吐发生、并筛选预防呕吐的有效干预方案。 方法 前瞻性临床观察,按1:1比例随机匹配229例肺癌患者进入干预组与对照组;两组均于化疗当日开始使用5-HT3受体拮抗剂,持续至化疗结束。干预组与化疗同时开始规定方案治疗、至化疗结束,规定干预方案组为:①“胃复安+苯海拉明+麻仁软胶囊+甲羟孕酮”;②单药“胃复安”。对照组在化疗后不良反应程度达到2级及以上时(CTCEA v4.0)给予经验性药物干预。控制呕吐疗效为4级:0级为不呕吐,1级为24 h内1~2次发作,2级为24 h内3~5次发作,3级为24 h内≥6次发作。以0级和1级为控制有效、2级和3级为控制失败。采用秩和检验比较干预及对照组控制呕吐疗效,并对不同亚组进行两两比较。结果共进行化疗305个周期,干预组150个周期:执行①方案76个周期、②方案74个周期;对照组155个周期。多样本比较秩合检验(Kruskal-Wallis法)。 结果 ①、②干预组与对照组的平均秩次分别为93.39,150.13,183.60,差异有统计学意义(P < 0.05)。①与②方案平均秩次之差为56.74(P < 0.001);控制呕吐有效率①方案优于②方案,且有统计学差异(P=0.015)。经χ2检验,干预组与对照组化疗前后KPS评分变化的差异有统计学意义(P < 0.001)。 结论 干预“前驱症状”可减轻化疗致呕吐、提高患者生活质量;“胃复安+苯海拉明+麻仁软胶囊+甲羟孕酮”方案疗效优于单药“胃复安”方案,出现多种“前驱症状”时可被推荐为预防化疗所致呕吐的药物干预方案。 Abstract:Objective To investigate whether medical interventions on the gastrointestinal symptoms before chemotherapy-induced vomiting can relieve vomiting, and to identify the optimal measures to prevent chemotherapy-induced vomiting. Methods Data from 229 cases undergoing chemotherapy were enrolled into this clinical study. Patients were randomly assigned into two groups at a ratio of 1:1, and recognized 5-HT3 receptor antagonists were administered to the patients during chemotherapy. In the intervention group, the protocols were also conducted during chemotherapy, which were designed as the combined agents metoclopramide, diphenhydramine, mziren capsule, and medroxyprogesterone in group 1 and only metoclopramide in group 2. Empirical medicines were given to the control group only when grade 2 (CTCEA v4.0) or stronger gastrointestinal symptoms occurred. The antiemetic efficacy was defined to have four levels, '0' means no vomiting, '1'means 1 to 2 episodes occurred in 24 hours, '2' means 3 to 5 episodes in 24 hours, and '3' means 6 or more episodes in 24 hours. Levels 0 and 1 are regarded as response to the treatment, and levels 2 and 3 as failure. The vomit prevention effects in the two groups were compared using the Multi-sample Rank Sum Test, and the effects in the subgroups were compared in a pairwise manner. Results A total of 305 chemotherapeutic cycles were carried out, including 150 cycles in the intervention group: protocol 1 was performed using 76 cycles, and protocol 2 was performed using 74 cycles. There were 155 cycles in the control group. The multi-sample rank sum test (Kruskal-Wallis test) shows that the mean ranks of the antiemetic effects are 93.39, 150.13, and 183.60 in subgroups 1 and 2, and the control group, respectively. The difference between groups 1 and 2 was 56.74 (P < 0.001). The response rate of group 1 was significantly superior to that of group 2 (P=0.015). The Chi-square test shows that the differences of KPS before and after the chemotherapy are significant (P < 0.001). Conclusion Medical intervention on the premonitory symptoms can significantly relieve chemotherapy-induced vomiting, improve the quality of life of the patient, and ensure a smooth progress in the chemotherapy. The vomiting relieving effect of the metoclopramide, diphenhydramine, mziren capsule, and medroxyprogesterone treatment is better than the single-agent protocol and should be recommended as the regimen of preventing chemotherapy-induced vomiting as multiple premonitory symptoms occur. -
表 1 229例肺癌患者基线临床资料
Table 1. Clinical data of 229 lung cancer patients
表 2 各组控制呕吐疗效的秩和检验
Table 2. Mean ranks of the antiemetic effects on the groups(rank sum test) Group
表 3 两组化疗前、后KPS评分构成比的变化
Table 3. Change of the constituent ratio of KPS before and after chemotherapy
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