本文選題：喜炎平注射液 + 熱毒寧注射液��； 參考：《廣州中醫(yī)藥大學(xué)》2017年碩士論文

【摘要】：目的:(1)對(duì)喜炎平注射液與熱毒寧注射液治療兒童手足口病進(jìn)行臨床療效及安全性評(píng)價(jià),促進(jìn)臨床合理用藥,為手足口病的臨床診治、藥品說(shuō)明書的補(bǔ)充與修訂提供循證依據(jù)。(2)通過(guò)構(gòu)建決策樹模型和采用成本-效果分析方法對(duì)使用喜炎平注射液、熱毒寧注射液治療兒童手足口病進(jìn)行藥物經(jīng)濟(jì)學(xué)評(píng)價(jià),控制藥品費(fèi)用,提高醫(yī)藥衛(wèi)生資源利用率,為藥品定價(jià)與醫(yī)療保險(xiǎn)目錄的選擇提供科學(xué)依據(jù)。方法:(1)計(jì)算機(jī)檢索中國(guó)知網(wǎng)、維普、萬(wàn)方、Cochrane Library、PubMed數(shù)據(jù)庫(kù)自建庫(kù)至2015年8月關(guān)于喜炎平注射液或熱毒寧注射液治療兒童手足口病的隨機(jī)對(duì)照試驗(yàn)和半隨機(jī)對(duì)照試驗(yàn);通過(guò)文獻(xiàn)管理軟件EndNote X7進(jìn)行文獻(xiàn)篩選;對(duì)納入文獻(xiàn)進(jìn)行數(shù)據(jù)提取及文獻(xiàn)質(zhì)量評(píng)價(jià);并采用Review Manager5.3對(duì)退熱時(shí)間、退疹時(shí)間、口腔潰瘍/皰疹消退時(shí)間、總有效率、住院時(shí)間、總病程、不良反應(yīng)發(fā)生率進(jìn)行meta分析。(2)成本的計(jì)算包括直接成本、間接成本和隱性成本。在現(xiàn)有循證資料的基礎(chǔ)上,運(yùn)用TreeAge Pro 2011構(gòu)建決策樹模型,進(jìn)行成本-效果分析;對(duì)所有變量進(jìn)行Tornado Diagram分析,并進(jìn)行單因素和雙因素敏感度分析。結(jié)果:(1)共納入喜炎平注射液治療兒童手足口病的文獻(xiàn)18篇,其中干預(yù)措施為喜炎平注射液對(duì)比利巴韋林注射液的文獻(xiàn)6篇,干預(yù)措施為喜炎平注射液聯(lián)合利巴韋林注射液對(duì)比利巴韋林注射液的文獻(xiàn)12篇。退熱時(shí)間的meta分析結(jié)果顯示:單用組的退熱時(shí)間比對(duì)照組短,差異具有統(tǒng)計(jì)學(xué)意義[WMD=-1.41,95%CI(-2.60,-0.22),P=0.020.05];聯(lián)用組的退熱時(shí)間比對(duì)照組短,差異具有統(tǒng)計(jì)學(xué)意義[WMD=-1.58,95%CI(-1.95,-1.21),P0.00001]。退疹時(shí)間的meta分析結(jié)果顯示:單用組的退疹時(shí)間比對(duì)照組短,差異具有統(tǒng)計(jì)學(xué)意義[WMD=-1.58,95%CI(-2.42,-0.74),P=0.00020.01];聯(lián)用組的退疹時(shí)間比對(duì)照組短,差異具有統(tǒng)計(jì)學(xué)意義[WMD=-1.54,95%CI(-1.91,-1.17),P0.00001]�？谇粷�/皰疹消退時(shí)間的meta分析結(jié)果顯示:1篇文獻(xiàn)報(bào)道了喜炎平注射液對(duì)比利巴韋林注射液治療兒童手足口病的口腔潰瘍/皰疹消退時(shí)間,不能進(jìn)行meta分析;聯(lián)用組的口腔潰瘍/皰疹消退時(shí)間比對(duì)照組短,差異具有統(tǒng)計(jì)學(xué)意義[WMD=-1.22,95%CI(-1.75,-0.69),P0.00001]�？傆行实膍eta分析結(jié)果顯示:單用組優(yōu)于對(duì)照組,結(jié)論具有統(tǒng)計(jì)學(xué)意義[OR=3.51,95%CI(2.08,5.92),P0.00001];聯(lián)用組優(yōu)于單用組,結(jié)論具有統(tǒng)計(jì)學(xué)意義[OR=3.83,95%CI(2.68,5.46),P0.00001]。住院時(shí)間的meta分析結(jié)果顯示..單用組的住院時(shí)間比對(duì)照組短,差異具有統(tǒng)計(jì)學(xué)意義[WMD=-1.87,95%CI(-3.16,-0.58),P=0.0040.05];聯(lián)用組的住院時(shí)間比對(duì)照組短,差異具有統(tǒng)計(jì)學(xué)意義[WMD=-2.01,95%CI(-2.71,-1.31),P0.00001]。不良反應(yīng)發(fā)生率的meta分析結(jié)果顯示:2篇文獻(xiàn)報(bào)道了喜炎平注射液對(duì)比利巴韋林注射液治療兒童手足口病未出現(xiàn)不良反應(yīng);聯(lián)用組的不良反應(yīng)發(fā)生率與對(duì)照組相同[OR=5.05,95%CI(0.58,43.57),P=0.140.05]。(2)共納入熱毒寧注射液治療兒童手足口病的文獻(xiàn)15篇,其中干預(yù)措施為熱毒寧注射液對(duì)比利巴韋林注射液的文獻(xiàn)10篇,干預(yù)措施為熱毒寧注射液聯(lián)合利巴韋林注射液對(duì)比利巴韋林注射液的文獻(xiàn)5篇。退熱時(shí)間的meta分析結(jié)果顯示:單用組的退熱時(shí)間比對(duì)照組短,差異具有統(tǒng)計(jì)學(xué)意義[WMD=-0.96,95%CI(-1.09,-0.82),P0.00001];聯(lián)用組的退熱時(shí)間比對(duì)照組短,差異具有統(tǒng)計(jì)學(xué)意義[WMD=-1.45,95%CI(-2.33,-0.56),P=0.0010.01]。退疹時(shí)間的meta分析結(jié)果顯示:單用組的退疹時(shí)間比對(duì)照組短,差異具有統(tǒng)計(jì)學(xué)意義[WMD=-1.57,95%CI(-1.73,-1.42),P0.00001];聯(lián)用組的退疹時(shí)間比對(duì)照組短,差異具有統(tǒng)計(jì)學(xué)意義[WMD=-1.46,95%CI(-1.68,-1.25),P0.00001]�？谇粷�/皰疹消退時(shí)間的meta分析結(jié)果顯示:單用組的口腔潰瘍/皰疹消退時(shí)間比對(duì)照組短,差異具有統(tǒng)計(jì)學(xué)意義[WMD=-1.75,95%CI(-2.12,-1.38),P0.00001];聯(lián)用組的口腔潰瘍/皰疹消退時(shí)間比對(duì)照組短,差異具有統(tǒng)計(jì)學(xué)意義[WMD=-1.77,95%CI(-2.05,-1.48),P0.00001]�？傆行实膍eta分析結(jié)果顯示:單用組優(yōu)于對(duì)照組,結(jié)論具有統(tǒng)計(jì)學(xué)意義[OR=5.16,95%CI(3.49,7.64),P0.00001];聯(lián)用組優(yōu)于對(duì)照組,結(jié)論具有統(tǒng)計(jì)學(xué)意義[OR=4.73,95%CI(2.47,9.03),P0.00001]�？偛〕痰膍eta分析結(jié)果顯示:單用組的總病程比對(duì)照組短,差異具有統(tǒng)計(jì)學(xué)意義[WMD=-2.22,95%CI(-3.40,-1.05),P=0.00020.01];聯(lián)用組的總病程比對(duì)照組短,差異具有統(tǒng)計(jì)學(xué)意義[WMD=-2.14,95%CI(-2.54,-1.74),P0.00001]。不良反應(yīng)發(fā)生率的meta分析結(jié)果顯示:單用組的不良反應(yīng)發(fā)生率低于對(duì)照組,結(jié)論具有統(tǒng)計(jì)學(xué)意義[OR=0.45,95%CI(0.21,0.97),P=0.040.05];聯(lián)用組的不良反應(yīng)發(fā)生率與對(duì)照組相等[OR=0.97,95%CI(0.31,3.05),P=0.960.05]。(3)喜炎平注射液經(jīng)濟(jì)學(xué)評(píng)價(jià)結(jié)果:實(shí)驗(yàn)組和對(duì)照組的總成本分別為2887.53元、3058.72元,總有效率分別為92.49%、78.12%。敏感度分析結(jié)果顯示:實(shí)驗(yàn)組療程對(duì)結(jié)果影響最大,其次是實(shí)驗(yàn)組住院時(shí)間、對(duì)照組住院時(shí)間、對(duì)照組療程和對(duì)照組總有效率。在實(shí)驗(yàn)組療程小于6.9天時(shí),結(jié)局穩(wěn)定;實(shí)驗(yàn)組住院時(shí)間小于5.9天或?qū)φ战M住院時(shí)間大于6.1天時(shí),結(jié)局穩(wěn)定;在對(duì)照組療程波動(dòng)范圍內(nèi),結(jié)局都是穩(wěn)定的。(4)熱毒寧注射液經(jīng)濟(jì)學(xué)評(píng)價(jià)結(jié)果:實(shí)驗(yàn)組和對(duì)照組的總成本分別為2769.35元、3062.98元,總有效率分別為95.00%、78.70%。敏感度分析結(jié)果顯示:對(duì)照組的總有效率對(duì)結(jié)果影響最大,其次是實(shí)驗(yàn)組住院時(shí)間、對(duì)照組住院時(shí)間、實(shí)驗(yàn)組療程,其他因素影響較小。當(dāng)對(duì)照組的總有效率、實(shí)驗(yàn)組住院時(shí)間和實(shí)驗(yàn)組療程波動(dòng)變化時(shí),結(jié)局仍穩(wěn)定;當(dāng)對(duì)照組的住院時(shí)間大于5.49天時(shí),結(jié)局穩(wěn)定。結(jié)論:在療效方面,喜炎平注射液和熱毒寧注射液治療兒童手足口病優(yōu)于利巴韋林注射液;在安全性方面,喜炎平注射液治療兒童手足口病的安全性與利巴韋林注射液相當(dāng),而熱毒寧注射液的安全性比利巴韋林注射液高;在經(jīng)濟(jì)性方面,喜炎平注射液和熱毒寧注射液比利巴韋林注射液更具有成本-效果。
[Abstract]:Objective: (1) to evaluate the clinical efficacy and safety of Xi Yanping injection and hining injection in the treatment of hand foot and mouth disease (HFMD) for children, promote clinical rational use of drugs, provide evidence-based evidence for the clinical diagnosis and treatment of hand foot and mouth disease, supplement and revision of drug instructions. (2) the use of decision tree model and cost effect analysis method are used in the use of the evidence. In the treatment of children's hand foot and mouth disease (HFMD), the pharmacoeconomic evaluation of the treatment of children's hand foot and mouth disease (HFMD), the control of drug cost, the utilization of medical and health resources, and the scientific basis for the selection of drug pricing and medical insurance catalogues are provided. Methods: (1) the computer retrieval of Chinese knowledge net, VIP, Wanfang, Cochrane Library, PubMed database In August 2015, the randomized controlled trial and semi randomized controlled trial of yanyanping injection or hot toxic Ning Injection in the treatment of hand foot and mouth disease in children were carried out by literature management software EndNote X7; data extraction and literature quality evaluation were carried out in the included literature, and Review Manager5.3 was used for antipyretic time, time of retreating and oral ulceration. Meta analysis of total efficiency, total efficiency, time of hospitalization, total duration of hospitalization, the incidence of adverse reactions. (2) the cost calculation included direct cost, indirect cost and recessive cost. Based on the existing evidence-based data, the decision tree model was constructed with TreeAge Pro 2011, and the cost effect analysis was carried out, and Tornado Diag for all variables was carried out. Ram analysis, and analysis of single factor and double factor sensitivity. Results: (1) 18 articles were included in the treatment of children's hand foot and mouth disease with yanyanping injection. The intervention measures were 6 articles of yanyanping injection compared with Ribavirin Injection, and the intervention measures were the combination of yanyanping injection and Ribavirin Injection contrast Ribavirin Injection. The meta analysis of the antipyretic time showed that the antipyretic time of the single use group was shorter than the control group, and the difference was statistically significant [WMD=-1.41,95%CI (-2.60, -0.22), P=0.020.05], and the time of heat removal in the combined group was shorter than that of the control group, and the difference was statistically significant [WMD= -1.58,95%CI (-1.95, -1.21), and meta analysis of P0.00001]. rash time The results showed that the time of rash withdrawal in the single group was shorter than the control group, the difference was statistically significant [WMD=-1.58,95%CI (-2.42, -0.74), P=0.00020.01]. The time of retreating in the combined group was shorter than the control group, and the difference was statistically significant [WMD=-1.54,95%CI (-1.91, -1.17). The meta analysis of the time of P0.00001]. oral cavity ulcer / herpes regression showed that 1 papers were reported. The time of oral ulcer / herpes regression in children's hand foot and mouth disease treated with Ribavirin Injection injection was compared with that of Ribavirin Injection. The time of oral ulcer / herpes regression in the combined group was shorter than that of the control group, the difference was statistically significant [WMD=-1.22,95%CI (-1.75, -0.69), and the meta analysis of the total effective rate of P0.00001]. showed that: The single use group was better than the control group, the conclusion was statistically significant [OR=3.51,95%CI (2.08,5.92), P0.00001]. The combined group was better than the single use group, and the conclusion had statistical significance [OR=3.83,95%CI (2.68,5.46). The result of meta analysis of the time of hospitalization of P0.00001]. showed that the hospitalization time between the single use group was shorter than the control group, and the difference was statistically significant [WMD=-1.87,95%CI (the difference was statistically significant). -3.16, -0.58), P=0.0040.05]; the hospitalization time of the combined group was shorter than the control group, and the difference was statistically significant [WMD=-2.01,95%CI (-2.71, -1.31). The meta analysis of the incidence of P0.00001]. ADR showed that the 2 papers reported that the yanyanping injection did not have adverse reactions to Ribavirin Injection in the treatment of children's hand foot and mouth disease. The incidence of adverse reactions was the same as that of the control group ([OR=5.05,95%CI (0.58,43.57)), and P=0.140.05]. (2) included 15 literature for the treatment of hand foot and mouth disease in children by P=0.140.05]. (2), and the intervention measures were 10 articles compared with the literature of hot toxic Ning injection compared to the combination of hot toxic Ning Injection and Ribavirin Injection. 5 articles from Ribavirin Injection. The results of meta analysis of antipyretic time showed that the antipyretic time of the single group was shorter than that of the control group, and the difference was statistically significant [WMD=-0.96,95%CI (-1.09, -0.82), P0.00001], the time of heat removal in the combined group was shorter than that of the control group, and the difference was statistically significant [WMD=-1.45,95%CI (-2.33, -0.56), and P=0.0010.01]. regression time. The results of meta analysis showed that the time of rash withdrawal from the single group was shorter than the control group, the difference was statistically significant [WMD=-1.57,95%CI (-1.73, -1.42), P0.00001], the time of retreating in the combined group was shorter than the control group, the difference was statistically significant [WMD=-1.46,95%CI (-1.68, -1.25), and the meta analysis of the P0.00001]. oral ulcer / herpes regression time showed that the meta analysis results showed The time of oral ulcer / herpes regression in single use group was shorter than that of the control group, the difference was statistically significant [WMD=-1.75,95%CI (-2.12, -1.38), P0.00001]. The time of oral ulcer / herpes regression in the combined group was shorter than that of the control group, the difference was statistically significant [WMD=-1.77,95%CI (-2.05, -1.48), and the meta analysis results of P0.00001]. total effective rate showed: single use The group was better than the control group, the conclusion was statistically significant [OR=5.16,95%CI (3.49,7.64), P0.00001], and the combined group was superior to the control group. The conclusion was statistically significant [OR=4.73,95%CI (2.47,9.03). The results of meta analysis of the total course of P0.00001]. showed that the total course of disease in the single use group was shorter than the control group, and the difference was statistically significant [WMD=-2.22,95%CI (-3.40, -1.05). P=0.00020.01], the total course of disease in the combined group was shorter than the control group, and the difference was statistically significant [WMD=-2.14,95%CI (-2.54, -1.74). The meta analysis of the incidence of P0.00001]. ADR showed that the incidence of adverse reactions in the single use group was lower than that of the control group, and the conclusion had statistical meaning [OR=0.45,95%CI (0.21,0.97), P=0.040.05], and the adverse effect of the combination group. The incidence of the reaction was equal to that of the control group [OR=0.97,95%CI (0.31,3.05), P=0.960.05]. (3) the economic evaluation results of the yanyanping injection: the total cost of the experimental group and the control group was 2887.53 yuan, 3058.72 yuan, and the total effective rate was 92.49% respectively. The results of the 78.12%. sensitivity analysis showed that the experimental group had the most effect on the result, followed by the experimental group. Hospital time, control group time, control group and control group were effective. The outcome was stable when the course of treatment was less than 6.9 days. The outcome of the experimental group was less than 5.9 days or the control group was more than 6.1 days. The outcome was stable. (4) the economic evaluation of the injection of hot toxic Ning Injection. Results: the total cost of the experimental group and the control group was 2769.35 yuan, 3062.98 yuan, and the total effective rate was 95% respectively. The 78.70%. sensitivity analysis showed that the total effective rate of the control group had the greatest impact on the results, followed by the time of hospitalization in the experimental group, the time of the control group, the course of treatment in the experimental group, and the other factors. Rate, the outcome of the time of hospitalization in the experimental group and the fluctuation of the experimental group was still stable, and the outcome was stable when the time of hospitalization of the control group was greater than 5.49 days. Conclusion: in the effect, the treatment of hand foot and mouth disease in children is better than that of Ribavirin Injection. The safety of foot and mouth disease is equal to that of Ribavirin Injection, and the safety of the injection is higher than that of Ribavirin Injection. In the economic aspect, the injection and the hot poison Ning injection are more cost effective than that of Ribavirin Injection.

【學(xué)位授予單位】：廣州中醫(yī)藥大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2017
【分類號(hào)】：R725.1

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10 楊帆;痰熱清注射液聯(lián)合抗病毒藥 治療兒童手足口病的臨床療效分析[N];健康報(bào);2011年

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5 伏瑾;腸道病毒感染在兒童手足口病及下呼吸道感染疾病中的研究[D];中國(guó)協(xié)和醫(yī)科大學(xué);2010年

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