摘要目的 探讨清肺化瘀通腑方对脓毒症相关急性呼吸窘迫综合征(ARDS)患者氧合的影响以及对肺纤维化的干预作用.方法 采用前瞻性随机对照临床试验(RCT),选择2015年7月至2017年2月南京中医药大学附属医院重症医学科(ICU)收治的中重度急性呼吸窘迫综合征(ARDS)患者,并按随机数字表法分为清肺化瘀通腑方组(入组后第1天开始鼻饲清肺化瘀通腑方,浓煎200 mL,每日1剂,连服7 d)和安慰剂对照组.两组ARDS常规治疗一致.于治疗1、3、7、14、28 d测定患者的氧合指数(PaO2/FiO2)、血清Ⅲ型前胶原(PCⅢ)及脯氨酸肽酶(PLD)含量,记录患者机械通气时间、ICU住院时间及60 d生存情况.结果 共入选32例ARDS患者,两组各16例,其基线资料均衡可比.两组ARDS患者随时间延长,PaO2/FiO2均逐渐下降,血清PCⅢ和PLD水平逐渐升高.与安慰剂对照组比较,清肺化瘀通腑方组治疗14 d和28 d PaO2/FiO2明显升高〔mmHg(1 mmHg＝0.133 kPa):185.81±65.07比137.19±55.72,250.56±102.72比178.25±80.97,均P＜0.05〕,治疗14 d和28 d血清PCⅢ水平明显降低(μmol/L :197.13±26.61比240.81±45.27,169.06±36.34比234.75±46.30,均P＜0.01),治疗28 d血清PLD水平明显降低(U/L :1 166.31±304.84比1 468.81±387.65, P＜0.05),且机械通气时间(d:18.20±5.20 比23.38±7.57)及ICU住院时间(d:23.7±5.7 比31.0±7.9)明显缩短(均P＜0.05).Kaplan-Meier生存曲线分析显示,清肺化瘀通腑方组60 d累积生存率与安慰剂对照组比较差异无统计学意义〔81.25%(13/16)比68.75%(11/16),χ2＝0.667,P＝0.505〕.结论 清肺化瘀通腑方可改善ARDS患者氧合,降低血清PCⅢ及PLD含量,抑制肺纤维化,从而改善预后.

abstractsObjective To investigate the effect of Qingfeihuayutongfu prescription on oxygenation and pulmonary fibrosis in patients with sepsis-associated acute respiratory distress syndrome (ARDS). Methods A prospective randomized controlled trial was performed. Patients with moderate to severe ARDS admitted to intensive care unit (ICU) of Affiliated Hospital of Nanjing University of Chinese Medicine from July 2015 to February 2017 were enrolled, and randomly divided into Qingfeihuayutongfu prescription group (observation group, 200 mL of Qingfeihuayutongfu prescription was given through nasal feeding on the first day after admission, one dose per day for 7 days) and placebo control group. Routine treatment of ARDS in both groups was the same. The oxygenation index (PaO2/FiO2), levels of serum procollagen Ⅲ (PC Ⅲ) and prolidase (PLD) were measured at 1, 3, 7, 14 and 28 days after treatment, duration of mechanical ventilation, the length of ICU stay and 60-day survival rate were recorded. Results A total of 32 patients with ARDS were selected, with 16 in each group, and their baseline data were balanced and comparable. As time went on, PaO2/FiO2in both groups was decreased gradually, and serum levels of PC Ⅲand PLD were increased gradually. Compared with placebo control group, PaO2/FiO2was significantly increased at 14 days and 28 days after treatment in observation group [mmHg (1 mmHg = 0.133 kPa): 185.81±65.07 vs. 137.19±55.72, 250.56±102.72 vs. 178.25±80.97, both P < 0.05], the levels of serum PC Ⅲ were significantly decreased at 14 days and 28 days after treatment (μmol/L: 197.13±26.61 vs. 240.81±45.27, 169.06±36.34 vs. 234.75±46.30, both P < 0.01), the levels of serum PLD was significantly decreased at 28 days after treatment (U/L: 1 166.31±304.84 vs. 1 468.81±387.65, P < 0.05), duration of mechanical ventilation (days: 18.20±5.20 vs. 23.38±7.57) and the length of ICU stay (days: 23.7±5.7 vs. 31.0±7.9 ) were significantly shortened (both P < 0.05). Kaplan-Meier survival curve analysis showed that there was no significant difference in the 60-day survival rate between the observation group and placebo control group [81.25% (13/16) vs. 68.75% (11/16), χ2= 0.667, P = 0.505]. Conclusion The Qingfeihuayutongfu prescription may improve oxygenation of ARDS patients, reduce the levels of serum PC Ⅲ and PLD, and inhibit pulmonary fibrosis, thus improve prognosis.