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康莱特注射液联合一线含铂化疗方案治疗晚期非小细胞肺癌的有效性和安全性的系统评价和 Meta 分析:32 项 RCT 的汇总分析。

Efficacy and safety of Kanglaite injection combined with first-line platinum-based chemotherapy in patients with advanced NSCLC: a systematic review and meta-analysis of 32 RCTs.

机构信息

Guang'anmen Hospital, Beijing, China; Beijing University of Chinese Medicine, Beijing, China.

Guang'anmen Hospital, Beijing, China.

出版信息

Ann Palliat Med. 2020 Jul;9(4):1518-1535. doi: 10.21037/apm-20-616. Epub 2020 Jul 20.

Abstract

BACKGROUND

As a Chinese medicine injections, Kanglaite injection (KLT) is a complementary or alternative therapy for first-line platinum-based chemotherapy. However, the effect that certain factors, including the dose of KLT, chemotherapy cycles, evaluation criteria, or supportive treatment, have on the efficacy of the objective response rate (ORR), median survival time (MST), and adverse reactions is still unknown.

METHODS

Eight databases were systematically searched from the inception dates to December 1, 2019, using the keywords Kanglaite, chemotherapy, and non small cell lung carcinoma to identify randomized clinical trials (RCTs). Analyses were performed using Review Manager 5.3 and Stata 15.1.

RESULTS

There were 32 randomized controlled trials, involving 2,577 participants, that fulfilled the inclusion criteria. Compared with first-line platinum-based chemotherapy alone, KLT combined with chemotherapy could increase the ORR [risk ratio (RR), 1.41 (95% CI: 1.28 to 1.56); absolute risk difference (ARD), 0.13 (95% CI: 0.1 to 0.17)], decrease the risk ratio of adverse reactions [nausea and vomiting: RR, 0.58 (95% CI: 0.42 to 0.81); ARD, -0.17 (95% CI: -0.26 to -0.08); leukopenia: RR, 0.61 (95% CI: 0.44 to 0.86); ARD, -0.16 (95% CI: -0.24 to -0.08)], prolong MST, and increase disease control rate and Karnofsky performance status. According to the subgroup analyses, KLT combined with cisplatin or paraplatin plus paclitaxel (TP) failed to demonstrate a significant association with the ORR. And when lacking the use of supportive treatment, this combination would not decrease the RR of both adverse reactions compared with chemotherapy alone.

CONCLUSIONS

KLT plus first-line platinum-based chemotherapy, except when chemotherapy regimens were TP, increased efficacy and quality of life in patients with advanced NSCLC. We are unsure whether this combination offers a low risk of adverse reactions. Additional high-quality RCTs are warranted to assess the effects of the combined therapy further.

摘要

背景

康莱特注射液(KLT)作为一种中药注射剂,是铂类一线化疗的补充或替代疗法。然而,KLT 的剂量、化疗周期、评价标准或支持性治疗等因素对客观缓解率(ORR)、中位生存时间(MST)和不良反应的疗效的影响尚不清楚。

方法

系统检索了从成立日期到 2019 年 12 月 1 日的 8 个数据库,使用关键词康莱特、化疗和非小细胞肺癌来识别随机对照试验(RCTs)。使用 Review Manager 5.3 和 Stata 15.1 进行分析。

结果

共有 32 项随机对照试验,涉及 2577 名参与者,符合纳入标准。与单纯一线铂类化疗相比,KLT 联合化疗可提高 ORR[风险比(RR),1.41(95%CI:1.28 至 1.56);绝对差值(ARD),0.13(95%CI:0.1 至 0.17)],降低不良反应的风险比[nausea and vomiting:RR,0.58(95%CI:0.42 至 0.81);ARD,-0.17(95%CI:-0.26 至 -0.08);leukopenia:RR,0.61(95%CI:0.44 至 0.86);ARD,-0.16(95%CI:-0.24 至 -0.08)],延长 MST,并提高疾病控制率和卡氏功能状态评分。根据亚组分析,KLT 联合顺铂或卡铂加紫杉醇(TP)未能显示与 ORR 有显著关联。而且在缺乏支持性治疗的情况下,与单纯化疗相比,这种联合治疗并不能降低不良反应的风险比。

结论

KLT 联合一线铂类化疗,除了化疗方案为 TP 外,还能提高晚期 NSCLC 患者的疗效和生活质量。我们不确定这种联合治疗是否具有较低的不良反应风险。需要更多高质量的 RCT 来进一步评估联合治疗的效果。

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