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Abstract：
Objectives: Compound Kushen injection (CKI) combined with intraperitoneal chemotherapy (IPC) is widely used in the treatment of malignant ascites (MA). However, evidence about its efficacy and safety remains limited. This review aimed to evaluate the efficacy and safety of CKI combined with IPC for the treatment of MA. Methods: Protocol of this review was registered in PROSPERO (CRD42022304259). Randomized controlled trials (RCTs) on the efficacy and safety of IPC with CKI for the treatment of patients with MA were searched through 12 electronic databases and 2 clinical trials registration platforms from inception until 20 January 2023. The Cochrane risk-of-bias tool was used to assess the quality of the included trials through the risk of bias assessment. We included RCTs that compared IPC single used or CKI combined with IPC for patients with MA schedule to start IPC. The primary outcome was identified as an objective response rate (ORR), while the secondary outcomes were identified as the quality of life (QoL), survival time, immune functions, and adverse drug reactions (ADRs). The Revman5.4 and Stata17 software were used to calculate the risk ratio (RR) at 95% confidence intervals (CI) for binary outcomes and the mean difference (MD) at 95% CI for continuous outcomes. The certainty of the evidence was assessed according to the GRADE criteria. Results: A total of 17 RCTs were assessed, which included 1200 patients. The risk of bias assessment of the Cochrane risk-of-bias tool revealed that one study was rated high risk and the remaining as unclear or low risk. Meta-analysis revealed that CKI combined with IPC had an advantage in increasing ORR (RR = 1.31, 95% CI 1.20 to 1.43, p < 0.00001) and QoL (RR = 1.50, 95% CI 1.23 to 1.83, p < 0.0001) when compared with IPC alone. Moreover, the combined treatment group showed a lower incidence of myelosuppression (RR = 0.51, 95%CI 0.40-0.64, p < 0.00001), liver dysfunction (RR = 0.33, 95%CI 0.16 to 0.70, p = 0.004), renal dysfunction (RR = 0.39, 95%CI 0.17 to 0.89, p = 0.02), and fever (RR = 0.51, 95%CI 0.35 to 0.75, p = 0.0007) compared to those of the control group. The quality of evidence assessment through GRADE criteria showed that ORR, myelosuppression, and fever were rated moderate, renal dysfunction and liver dysfunction were rated low, and QoL and abdominal pain were rated very low. Conclusion: The efficacy and safety of CKI combined with IPC were superior to that with IPC alone for the treatment of MA, which indicates the potentiality of the treatment. However, more high-quality RCTs are required to validate this conclusion. Systematic Review Registration: [https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022304259], identifier [PROSPERO 2022 CRD42022304259].
摘要：
目标：复方苦参打针液（CKI）联合腹腔化疗（IPC）普遍运用于恶性腹水（MA）的医治。然而,关于其有效性和安全性的证据仍然有限.本综述旨在评价CKI联合IPC治疗MA的有效性和安全性。方法：本综述方案在PROSPERO（CRD42022304259）中注册。从开始到2023年1月20日，通过12个电子数据库和2个临床试验注册平台搜索了关于IPC与CKI治疗MA患者的有效性和安全性的随机对照试验（RCT）。使用Cochrane偏倚风险工具通过偏倚风险评估来评估纳入试验的质量。我们纳入了RCTs，这些RCTs比较了IPC单次使用或CKI与IPC联合使用的MA计划开始IPC的患者。主要结果确定为客观反应率（ORR），而次要结局被确定为生活质量(QoL)，生存时间,免疫功能，药物不良反应（ADR）。Revman5.4和Stata17软件用于计算二元结局的95%置信区间（CI）的风险比（RR）和连续结局的95%CI的平均差（MD）。根据GRADE标准评估证据的确定性。结果：共评估17项RCT，其中包括1200名患者。Cochrane偏差风险评估工具的偏差风险表明，一项研究被评为高风险，其余为不清楚或低风险。Meta分析显示，与单独IPC相比，CKI联合IPC在增加ORR（RR=1.31，95％CI1.20至1.43，p<0.00001）和QoL（RR=1.50，95％CI1.23至1.83，p<0.0001）方面具有优势。此外，联合治疗组骨髓抑制发生率较低(RR=0.51,95CI0.40-0.64,p<0.00001),肝功能障碍（RR=0.33，95CI0.16至0.70，p=0.004），肾功能不全（RR=0.39，95CI0.17至0.89，p=0.02），和发烧（RR=0.51，95CI0.35至0.75，p=0.0007）与对照组相比。通过等级标准进行的证据评估质量表明，ORR，骨髓抑制,发烧被评为中度，肾功能不全和肝功能不全被评为低，QoL和腹痛评分非常低。结论:CKI联合IPC治疗MA的疗效和安全性均优于单纯IPC,这表明了治疗的潜力。然而,需要更多高质量的RCT来验证这一结论。系统审查注册：[https://www。crd.约克。AC.uk/prospro/display_record.php?ID=CRD42022304259],标识符[PROSPERO2022CRD42022304259]。
