Benefit-risk evaluation of self-designed Cuyu Waiyong Prescription enema combined with mesalazine in the treatment of ulcerative colitis based on multi-criteria decision making
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摘要: 目的 探讨基于多准则决策的自拟促愈外用方灌肠联合美沙拉嗪治疗溃疡性结肠炎(UC)的效益-风险评价。方法 选取2019年5月-2022年5月收治的104例UC患者为研究对象，采用随机数字表法(1：1的比例)将研究对象分为研究组(n=52)和对照组(n=52)。建立自拟促愈外用方灌肠联合美沙拉嗪治疗UC的多准则决策模型。结果 两组患者的年龄、性别、病程和治疗前的中医证候积分(脓血便、腹泻腹痛、里急后重、脘腹胀满)、IL-6、IL-8、TNF-α、IgG、IgA、疾病活动指数(DAI)评分、内镜评分比较差异无统计学意义(P＞0.05)。治疗后，研究组的中医证候积分(脓血便、腹泻腹痛、里急后重、脘腹胀满)、IL-6、IL-8、TNF-α、IgG、IgA、DAI评分、内镜评分均低于对照组，临床疗效及不良反应的改善均优于对照组(P＜0.05)。通过计算两组的效益值、风险值以及效益-风险总值发现，研究组的效益高、风险低。当效益与风险同等重要时，研究组和对照组的效益-风险总值分别为74和60，且研究组100%优于对照组。结论 对于UC患者的治疗，自拟促愈外用方灌肠联合美沙拉嗪较单用美沙拉嗪效果更好，患者不良反应发生率显著降低，安全性较高，值得临床推广应用。Abstract: Objective To explore the benefit-risk evaluation of self-designed Cuyu Waiyong Prescription enema combined with mesalazine in treating ulcerative colitis(UC) based on multi-criteria decision-making.Methods A total of 104 patients with UC admitted to our hospital from May 2019 to May 2022 were selected as the research objects. The subjects were divided into the study group(n=52) and the control group(n=52) by random number table method(1 : 1 ratio). To establish a multi-criteria decision-making model for treating UC with a self-designed Cuyu Waiyong Prescription enema combined with mesalazine.Results The age, gender, course of disease and Traditional Chinese Medicine(TCM) syndrome score before treatment(pus and blood stool, diarrhea and abdominal pain, tenescentemia, abdominal distension), interleukin-6(IL-6), interleukin-8(IL-8), tumor necrosis factor-alpha(TNF-α), immunoglobulin G(IgG), immunoglobulin A(IgA), disease activity index(DAI) score and endoscopy score of the two groups had no significant differences(P > 0.05). After treatment, the TCM syndrome scores(pus and blood stool, diarrhea and abdominal pain, tenesticemia, epigastric distension), IL-6, IL-8, TNF-α, IgG, IgA, DAI and endoscopic scores in the study group were significantly lower than those in the control group, while the improvement of clinical efficacy and adverse reactions were significantly better than those in the control group(P < 0.05). By calculating the benefit value, risk value and benefit-risk value of the two groups, it was found that the benefit of the study group was high and the risk was low. When benefit and risk are equally important, the total benefit-risk value of study group and control group is 74 and 60, respectively, and the study group is 100% better than the control group.Conclusion For the treatment of UC patients, the self-designed Cuyu Waiyong Prescription enema combined with mesalazine is more effective than mesalazine alone, the incidence of adverse reactions is significantly reduced, and the safety is higher, which is worthy of clinical promotion.
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表 1 两组患者治疗前后的临床资料比较
例(%)，X±S 临床资料 研究组(n=52) 对照组(n=52) χ2/t P 年龄/岁 45.06±8.41 43.69±7.66 0.868 0.387 性别 男 32(61.54) 30(57.69) 0.160 0.689 女 20(38.46) 22(42.31) 病程/月 48.35±10.92 52.38±14.13 1.627 0.107 脓血便/分 治疗前 5.25±1.47 5.13±1.24 0.450 0.654 治疗后 1.70±0.46 2.42±0.73 7.644 ＜0.001 腹泻腹痛/分 治疗前 5.38±1.42 5.42±1.61 0.134 0.893 治疗后 1.16±0.34 2.89±0.95 15.354 ＜0.001 里急后重/分 治疗前 2.84±0.78 2.96±0.87 0.741 0.461 治疗后 0.49±0.07 0.76±0.23 8.098 ＜0.001 脘腹胀满/分 治疗前 4.86±0.95 5.03±1.27 0.773 0.441 治疗后 0.78±0.24 1.25±0.37 7.685 ＜0.001 IL-6/(ng·L-1) 治疗前 36.84±8.25 37.46±9.27 0.360 0.719 治疗后 20.32±5.51 24.78±7.34 3.504 0.001 IL-8/(ng·L-1) 治疗前 23.87±5.72 25.71±6.36 1.551 0.124 治疗后 9.62±2.34 11.23±3.56 2.725 0.008 TNF-α/(ng·L-1) 治疗前 27.38±6.29 28.61±6.53 0.978 0.330 治疗后 12.24±3.57 14.68±4.82 2.933 0.004 IgG/(g·L-1) 治疗前 12.34±2.51 12.76±2.95 0.782 0.436 治疗后 8.42±2.18 10.02±3.16 3.005 0.003 IgA/(g·L-1) 治疗前 1.83±0.37 1.95±0.40 1.588 0.115 治疗后 1.14±0.33 1.67±0.42 7.155 ＜0.001 DAI评分/分 治疗前 6.48±1.93 6.52±2.04 0.103 0.918 治疗后 1.47±0.46 2.57±0.89 7.918 ＜0.001 内镜评分/分 治疗前 5.85±1.53 5.91±1.62 0.194 0.846 治疗后 1.28±0.36 1.56±0.45 3.504 0.001 临床疗效 痊愈 18(34.62) 7(13.46) 显效 21(40.38) 17(32.69) 有效 9(17.31) 16(30.77) 11.221 0.011 无效 4(7.69) 12(23.08) 总有效 39(75.00) 24(46.15) 不良反应 恶心呕吐 1(1.92) 2(3.85) 头晕 1(1.92) 2(3.85) 腹部不适 0 2(3.85) 4.308 0.038 消化道反应 1(1.92) 3(5.77) 皮疹 0 1(1.92) 
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表 2 自拟促愈外用方灌肠联合美沙拉嗪治疗UC的效益-风险指标及权重、最优值和最差值规定
分类 指标 权重 最优值 最差值 效益指标 脓血便 65 -40 0 腹泻腹痛 40 -50 0 里急后重 30 0 0 脘腹胀满 60 -60 0 IL-6 100 -4 0 IL-8 75 0 1 TNF-α 100 -5 0 IgG 80 -15 0 IgA 80 -10 0 DAI评分 70 -30 0 内镜评分 100 -5 0 总有效概率 85 -25 0 恶心呕吐 80 0 1 头晕 60 0 1 风险指标 腹部不适 75 0 1 消化道反应 100 0 1 皮疹 20 0 1
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表 3 研究组和对照组的各效益、风险指标合并
指标 研究组 对照组 例(%) 合并结果(95%CI) P 例(%) 合并结果(95%CI) P 效益指标 脓血便 42(80.77) -6.53(-8.54~-4.15) 0.002 40(76.92) -5.34(-8.72~-2.10) 0.004 腹泻腹痛 36(69.23) -7.89(-11.23~-5.47) 0.001 39(75.00) -6.93(-10.26~-5.59) 0.002 里急后重 29(55.77) -6.65(-9.74~-3.56) 0.003 27(51.92) -5.52(-8.72~-2.38) 0.005 脘腹胀满 19(36.54) -7.43(-9.26~-3.53) 0.002 21(40.38) -6.33(-9.51~-3.54) 0.003 IL-6 25(48.08) -5.80(-7.75~-2.68) 0.002 22(42.31) -5.13(-7.84~-2.69) 0.003 IL-8 33(63.46) -4.76(-8.37~-2.93) 0.002 24(46.15) -3.49(-6.35~-0.55) 0.004 TNF-α 17(32.69) -5.25(-7.96~-2.44) 0.003 13(25.00) -3.57(-7.63~-1.40) 0.005 IgG 26(50.00) -3.39(-6.98~-0.26) 0.002 30(57.69) -2.83(-6.45~-0.51) 0.003 IgA 28(53.85) -6.49(-9.24~-3.10) 0.001 18(34.62) -5.90(-8.35~-2.17) 0.002 DAI评分 22(42.31) -7.24(-10.49~-3.73) 0.004 17(32.69) -5.21(-9.39~-2.34) 0.006 内镜评分 25(48.08) -4.59(-7.72~-1.06) 0.001 16(30.77) -3.46(-7.64~-1.82) 0.002 总有效概率 52(100.00) -8.76(-10.71~-6.28) 0.001 52(100.00) -6.33(-9.37~-3.29) 0.003 风险指标 恶心呕吐 14(26.92) 0.69(0.38~0.91) 0.002 16(30.77) 0.53(0.33~1.21) 0.003 头晕 23(44.23) 0.82(0.56~1.10) 0.002 38(73.08) 0.85(0.67~0.99) 0.003 腹部不适 9(17.31) 0.51(0.12~1.63) 0.004 17(32.69) 0.68(0.35~1.84) 0.005 消化道反应 25(48.08) 1.06(0.72~1.39) 0.000 33(63.46) 0.93(0.64~1.21) 0.001 皮疹 27(51.92) 0.79(0.48~1.13) 0.003 41(78.85) 0.60(0.55~0.84) 0.006
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表 4 研究组与对照组治疗UC的效益值
效益指标 权重 研究组效益值 对照组效益值 相对权重 脓血便 65 48 30 5.5 腹泻腹痛 40 61 38 4.3 里急后重 30 75 57 3.2 脘腹胀满 60 45 30 6.1 IL-6 100 85 72 10.5 IL-8 75 80 63 7.5 TNF-α 100 75 60 10.2 IgG 80 63 51 7.9 IgA 80 86 70 7.4 DAI评分 70 75 50 6.3 内镜评分 100 70 59 10.5 总有效概率 85 71 65 8.2
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表 5 研究组与对照组治疗UC的风险值
风险指标 权重 研究组风险值 对照组风险值 相对权重 恶心呕吐 80 62 55 7.4 头晕 60 67 42 5.2 腹部不适 75 70 62 6.5 消化道反应 100 85 53 10.1 皮疹 20 40 25 2.7
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