CAJ | 학술논문

目的：系统评价血必净注射液治疗重症急性胰腺炎（SAP）的临床有效性及安全性。方法通过系统检索Cochrane 临床试验数据库、荷兰医学文摘EMbase数据库、中国生物医学文献数据库（CBM）、中国知网CNKI、维普和万方数据库自建库到2014年3月所有关于血必净治疗SAP的随机对照临床试验（RCT）文献。由两位研究者参照改良Jadad量表独立对文献进行质量评价并资料提取。对照组采用常规治疗方法，血必净组在常规治疗基础上联合应用血必净注射液治疗。采用RevMan 5.2软件对血必净注射液治疗SAP患者的病死率、并发症发生率、治疗有效率、住院时间及安全性进行系统评价。结果最终纳入15篇RCT文献，但用研究方法学评价其质量均不高。Meta分析显示：与常规治疗比较，常规治疗基础上联合血必净注射液可明显降低SAP患者的病死率〔优势比（OR）＝0.37，95%可信区间（95%CI）＝0.17～0.77，P＝0.008〕和并发症发生率（OR＝0.26，95%CI＝0.14～0.45，P＜0.00001），明显提高治疗有效率〔相对危险度（RR）＝0.85，95%CI＝0.80～0.91，P＜0.00001〕，且住院时间明显缩短〔均数差（MD）＝-5.28，95%CI＝-6.69～-3.86，P＜0.00001〕。15个研究中有2个报告了血必净注射液治疗的不良反应，一个研究为1例患者出现头痛、恶心症状，调整滴速后缓解；另一个研究为1例患者出现轻微皮疹，停药后缓解。结论在常规治疗基础上联用血必净注射液治疗SAP患者具有明显的优势。但由于纳入评价的文献质量较低，尚需要大规模、高质量的RCT提供更可靠的证据。
목적：계통평개혈필정주사액치료중증급성이선염（SAP）적림상유효성급안전성。방법통과계통검색Cochrane 림상시험수거고、하란의학문적EMbase수거고、중국생물의학문헌수거고（CBM）、중국지망CNKI、유보화만방수거고자건고도2014년3월소유관우혈필정치료SAP적수궤대조림상시험（RCT）문헌。유량위연구자삼조개량Jadad량표독립대문헌진행질량평개병자료제취。대조조채용상규치료방법，혈필정조재상규치료기출상연합응용혈필정주사액치료。채용RevMan 5.2연건대혈필정주사액치료SAP환자적병사솔、병발증발생솔、치료유효솔、주원시간급안전성진행계통평개。결과최종납입15편RCT문헌，단용연구방법학평개기질량균불고。Meta분석현시：여상규치료비교，상규치료기출상연합혈필정주사액가명현강저SAP환자적병사솔〔우세비（OR）＝0.37，95%가신구간（95%CI）＝0.17～0.77，P＝0.008〕화병발증발생솔（OR＝0.26，95%CI＝0.14～0.45，P＜0.00001），명현제고치료유효솔〔상대위험도（RR）＝0.85，95%CI＝0.80～0.91，P＜0.00001〕，차주원시간명현축단〔균수차（MD）＝-5.28，95%CI＝-6.69～-3.86，P＜0.00001〕。15개연구중유2개보고료혈필정주사액치료적불량반응，일개연구위1례환자출현두통、악심증상，조정적속후완해；령일개연구위1례환자출현경미피진，정약후완해。결론재상규치료기출상련용혈필정주사액치료SAP환자구유명현적우세。단유우납입평개적문헌질량교저，상수요대규모、고질량적RCT제공경가고적증거。
ObjectiveTo assess the efficacy and safety of Xuebijing injection for the treatment of severe acute pancreatitis (SAP).Methods An extensive search of related literatures from the Cochrane Library, EMBASE, China Biology Medicine (CBM), CNKI, VIP and Wanfang data up to March 2014 was performed. Randomized controlled trials (RCTs) regarding Xuebijing injection for the treatment of SAP were collected regardless of languages. Jadad scale was taken for quality evaluation of the included studies by two researchers. The patients in control group were given conventional treatment, and those of the Xuebijing group were given Xuebijing injection on the top of conventional treatment. The Cochrane Collaboration RevMan 5.2 software was used for data analysis regarding the effect of Xuebijing injection on the mortality, incidence of complication, effective rate, the length of stay in hospital, and the safety of the drug in patients with SAP.Results A total of 15 published reports meeting the inclusion criteria were enrolled. The methodological quality of the trials was low. Meta analysis showed that the mortality in Xuebijing group was significantly lower [odds ratio (OR) = 0.37, 95% confidence interval (95%CI) =0.17 - 0.77,P = 0.008], and the incidence of complication was also significantly decreased (OR = 0.26, 95%CI =0.14 - 0.45,P< 0.000 01) as compared with those of control group. The effective rate in Xuebijing group was significantly higher than that of the control group [relative risk (RR) = 0.85, 95%CI = 0.80-0.91,P< 0.000 01]. The length of stay in hospital in Xuebijing group was significantly shorter than that of the control group [mean difference (MD) = -5.28, 95%CI = -6.69 to -3.86,P< 0.000 01]. Adverse reactions of Xuebijing injection were reported in 2 studies. The adverse reaction in one study was headache and nausea, which were relieved by adjusting the speed of intravenous infusion, and mild rash was reported in another case, and it disappeared after the withdrawal of Xuebijing. Conclusions The currently available evidence shows that Xuebijing injection may have some therapeutic effect on SAP. Because of the low methodological quality of the included trials, multi-center and high-quality RCTs with large sample sizes are needed to provide stronger evidence.