单硝酸异山梨酯缓释胶囊对比单硝酸异山梨酯片剂治疗冠心病心绞痛的网状Meta分析与药物经济学评价

doi:10.5246/jcps.2025.04.028

中国药学(英文版) ›› 2025, Vol. 34 ›› Issue (4): 370-384.DOI: 10.5246/jcps.2025.04.028

单硝酸异山梨酯缓释胶囊对比单硝酸异山梨酯片剂治疗冠心病心绞痛的网状Meta分析与药物经济学评价

张慧¹^,², 罗丹霞¹^,², 周学兰¹^,², 曾小芳¹^,², 熊然¹^,², 许业友¹^,²^,^*()

^1. 广东药科大学医药商学院, 广东广州 510006
^2. 广东药科大学卫生经济与健康促进研究中心, 广东广州 510006

收稿日期:2024-11-08 修回日期:2025-02-27 接受日期:2025-03-06 出版日期:2025-05-02 发布日期:2025-05-02
通讯作者: 许业友

Cost-effectiveness of sustained-release isosorbide mononitrate capsules for coronary heart disease: A network meta-analysis

Hui Zhang¹^,², Danxia Luo¹^,², Xuelan Zhou¹^,², Xiaofang Zeng¹^,², Ran Xiong¹^,², Yeyou Xu¹^,²^,^*()

¹ School of Medical Business, Guangdong Pharmaceutical University, Guangzhou 510006, Guangdong, China
² Guangdong Health Economics and Health Promotion Research Center, Guangzhou 510006, Guangdong, China

Received:2024-11-08 Revised:2025-02-27 Accepted:2025-03-06 Online:2025-05-02 Published:2025-05-02
Contact: Yeyou Xu
Supported by:
The 2022 Ministry of Education General Project for Humanities and Social Sciences Research (Grant No. 22YJAZH147); the General Subject of Guangzhou Philosophy and Social Science Development "14th Five-Year Plan" in 2023 (Grant No. 2023GZYB68); China University Industry-Academia-Research Innovation Fund-Huatong Guokang Medical Research Special Project (Grant No. 2023HT017); 2024 Guangdong Province General Project for the Planning of Philosophy and Social Sciences (Grant No. GD24CGL29); the Innovation Team Project of Colleges and Universities in Guangdong Province (Grant No. 2022WCXTD011).

摘要/Abstract

摘要：

不同的剂型的药物在体内具有不同的药代动力学, 可能引起不同的疗效和不良反应。本研究旨在评价单硝酸异山梨酯缓释胶囊(IMSRC)联合常规制剂与单硝酸异山梨酯片剂(IMT)联合常规制剂治疗冠心病心绞痛的有效性、安全性和经济性。采用网状Meta分析评价IMSRC和IMT的有效性和安全性。我们检索了PubMed、Embase、Cochrane Library、ScienceDirect、Web of Science、CNKI、Wanfang、VIP等自成立至2023年7月的相关文献。成本效果分析基于中国医疗体系的视角, 其中效果输入的数据来自网状Meta。共纳入15项研究。网状Meta结果显示, IMSRC加常规制剂与IMT加常规制剂的有效性和安全性无显著差异, 但均优于不加单硝酸异山梨酯的常规制剂。三组之间的安全性没有差异。然而, 根据网状Meta的SUCRA结果显示, IMT在心绞痛总有效率上略优于IMSRC, 而IMSRC心绞痛显著有效率和心电图有效率的概率均高于IMT。不良事件发生率依次为IMT > 常规制剂 > IMSRC。成本效果分析显示, 心绞痛显效率ICERs为–133.41, 总有效率为–260.20。心电图有效率ICERs分别为–83.34和–234.24。综上所述, IMSRC联合常规制剂与IMT联合常规制剂的疗效和安全性相似, 但前者更具经济性。

关键词: 单硝酸异山梨酯缓释胶囊, 网状Meta, 药物经济学, 冠心病

Abstract:

Different dosage forms can significantly impact pharmacokinetics in vivo, leading to varied effects and potential adverse reactions. This study aimed to evaluate the efficacy, safety, and cost-effectiveness of isosorbide mononitrate sustained-release capsules (IMSRC) combined with conventional treatments, compared to isosorbide mononitrate tablets (IMT) combined with conventional treatments, for managing angina pectoris in patients with coronary heart diseases. A network meta-analysis (NMA) was conducted to assess the efficacy and safety of IMSRC and IMT. Relevant literature was sourced from databases, including PubMed, Embase, Cochrane Library, ScienceDirect, Web of Science, CNKI, Wanfang, and VIP, covering publications up to July 2023. The cost-effectiveness analysis (CEA) was performed from the perspective of China’s healthcare system, utilizing inputs derived from the NMA. The analysis included 15 studies. The NMA results revealed no significant difference in efficacy and safety between IMSRC plus conventional treatments and IMT plus conventional treatments. However, both combinations were more effective than conventional treatments without isosorbide mononitrate. No differences in safety were observed among the three groups. The surface under the cumulative ranking (SUCRA) of the NMA indicated that IMT had a slight edge over IMSRC in the total effective rate of angina pectoris, whereas IMSRC showed higher probabilities for markedly effective rate and ECG effective rate compared to IMT. The incidence of adverse events was ranked as IMT > conventional preparation > IMSRC. The CEA results highlighted that the incremental cost-effectiveness ratios (ICERs) for the markedly effective and total effective rates of angina pectoris were –133.41 and –260.20, respectively. The ICERs for ECG effective rates were –83.34 and –234.24, respectively. In conclusion, while IMSRC combined with conventional treatments and IMT combined with conventional treatments were similar in efficacy and safety, IMSRC proved to be more economical.

Key words: Isosorbide mononitrate sustained-release capsules, Network meta-analysis, Cost-effectiveness, Coronary heart disease

Supporting: /attached/file/20250504/20250504143422_81.pdf

张慧, 罗丹霞, 周学兰, 曾小芳, 熊然, 许业友. 单硝酸异山梨酯缓释胶囊对比单硝酸异山梨酯片剂治疗冠心病心绞痛的网状Meta分析与药物经济学评价[J]. 中国药学(英文版), 2025, 34(4): 370-384.

Hui Zhang, Danxia Luo, Xuelan Zhou, Xiaofang Zeng, Ran Xiong, Yeyou Xu. Cost-effectiveness of sustained-release isosorbide mononitrate capsules for coronary heart disease: A network meta-analysis[J]. Journal of Chinese Pharmaceutical Sciences, 2025, 34(4): 370-384.

图/表 8

Figure 1. Flow diagram of the study selection process.

Table 1. biaoti

Figure 2. Literature quality evaluation chart. (A) Risk of bias graph; (B) Risk of bias summary.

Figure 3. Comparative network plots. (A) Comparisons on the markedly effective rate of angina pectoris in patients with CHD; (B) Comparisons on the total effective rate of angina pectoris in patients with CHD; (C) Comparisons on the markedly effective rate of ECG in patients with CHD; (D) Comparisons on the total effective rate of ECG in patients with CHD; (E) Comparisons on the incidence of adverse events in patients with CHD.

Figure 4. ORs (gray and brown cell) and P-values (blue cell) of the NMA. (A) Pooled ORs (95% CI) for the markedly effective rate of angina pectoris; (B) Pooled ORs (95% CI) for the total effective rate of angina pectoris; (C) Pooled ORs (95% CI) for the markedly effective rate of ECG; (D) Pooled ORs (95% credible intervals) for the total effective rate of ECG; (E) Pooled ORs (95% CI) for the incidence of adverse events.

Figure 5. Bayesian ranking profiles of comparable treatments on efficacy and safety for patients with CHD. Profiles indicate the probability of each comparable treatment being ranked from first to last on IMT plus conventional preparation, IMSRC plus conventional preparation, conventional preparation. Ranking curves are described according to the Bayesian ranking results presented in the Supplementary Material Figure 2.

Table 2. Baseline results.

Figure 6. One-way sensitivity analysis chart (C_srcapsules, the cost of IMSRC plus conventional preparation; C_tablets, the cost of IMT plus conventional preparation; AME_srcapsules, the markedly effective rate of IMSRC plus conventional preparation; AME_tablets, the markedly effective rate of IMT plus conventional preparation; ETE_srcapsules, the total effective rate of IMSRC plus conventional preparation; ETE_tablets, the total effective rate of IMT plus conventional preparation).

参考文献 43

[1]	National Center for Cardiovascular Diseases. China Cardiovascular Health and Disease Report 2022. Beijing: China Union Medical University Press. 2023.
[2]	National Health Commission. China Health Statistics Yearbook: 2021. China Union Medical University Press. 2021.
[3]	Ding, J.M.; Zhang, X.Z.; Hu, X.J.; Chen, H.L.; Yu, M. Analysis of hospitalization expenditures and influencing factors for inpatients with coronary heart disease in a tier-3 hospital in Xi’an, China: a retrospective study. Medicine. 2017, 96, e9341.
[4]	Chen, W.W.; Gao, R.L.; Liu, L.S.; Zhu, M.L.; Wang, W.; Wang, Y.J.; Wu, Z.S.; Li, H.J.; Gu, D.F.; Yang, Y.J.; Zheng, Z.; Jiang, L.X.; Hu, S.S. China cardiovascular diseases report 2015: a summary. J. Geriatr. Cardiol. 2017, 14, 1–10.
[5]	Gheorghe, A.; Griffiths, U.; Murphy, A.; Legido-Quigley, H.; Lamptey, P.; Perel, P. The economic burden of cardiovascular disease and hypertension in low- and middle-income countries: a systematic review. BMC Public Health 2018, 18, 975.
[6]	Parker, J.D.; Parker, J.O. Nitrate therapy for stable angina pectoris. N. Engl. J. Med. 1998, 338, 520–531.
[7]	Ignarro, L.J.; Lippton, H.; Edwards, J.C.; Baricos, W.H.; Hyman, A.L.; Kadowitz, P.J.; Gruetter, C.A. Mechanism of vascular smooth muscle relaxation by organic nitrates, nitrites, nitroprusside and nitric oxide: evidence for the involvement of S-nitrosothiols as active intermediates. J. Pharmacol. Exp. Ther. 1981, 218, 739–749.
[8]	Kukovetz, W.R.; Holzmann, S. Mechanism of nitrate-induced vasodilation and tolerance. Z. Kardiol. 1983, 72, 14–19.
[9]	Murad, F. Cyclic guanosine monophosphate as a mediator of vasodilation. J. Clin. Invest. 1986, 78, 1–5.
[10]	Thadani, U. Oral nitrates: more than symptomatic therapy in coronary artery disease? Cardiovasc. Drugs Ther. 1997, 11, 213–218.
[11]	Silber, S. Nitrates: why and how should they be used today? Current status of the clinical usefulness of nitroglycerin, isosorbidedinitrate and isosorbide-5-mononitrate. Eur. J. Clin. Pharmacol. 1990, 38, S35–S51.
[12]	Thadani, U. Nitrate tolerance, rebound, and their clinical relevance in stable angina pectoris, unstable angina, and heart failure. Cardiovasc. Drugs Ther. 1997, 10, 735–742.
[13]	Waller, D.G. Optimal nitrate therapy with a once-daily sustained-release formulation of isosorbide mononitrate. J. Cardiovasc. Pharmacol. 1999, 34, S21–S31.
[14]	Schindler, T.H.; Fearon, W.F.; Pelletier-Galarneau, M.; Ambrosio, G.; Sechtem, U.; Ruddy, T.D.; Patel, K.K.; Bhatt, D.L.; Bateman, T.M.; Gewirtz, H.; Shirani, J.; Knuuti, J.; Gropler, R.J.; Chareonthaitawee, P.; Slart, R.H.J.A.; Windecker, S.; Kaufmann, P.A.; Abraham, M.R.; Taqueti, V.R.; Ford, T.J.; Camici, P.G.; Schelbert, H.R.; Dilsizian, V. Myocardial perfusion PET for the detection and reporting of coronary microvascular dysfunction A JACC: cardiovascular imaging expert panel statement. JACC Cardiovasc. Imag. 2023, 16, 536–548.
[15]	Peng, C.Y; Chen, J.; Li, S.N; Li, J.H; Peng, L.B. Evidence-based pharmacoeconomic evaluation of palbociclib in combination with letrozole versus docetaxel in combination with epirubicin in the first-line treatment of advanced breast cancer with epirubicin. J. Chin. Pharm. Sci. 2023, 32, 214–222.
[16]	Han, S.; Shi, L.W. Economic evaluation of soft silicon foam dressings versus sterile gauze for the treatment of pressure ulcers in China. J. Chin. Pharm. Sci. 2013, 22, 456–460.
[17]	Clinical Pharmacology Base of Cardiovascular system of the Ministry of Health. Guiding principles for clinical research of cardiovascular system drugs. Chin. J. Clin. Pharmacol. 2018, 4, 245–255.
[18]	Cumpston, M.; Li, T.J.; Page, M.J.; Chandler, J.; Welch, V.A.; Higgins, J.P.; Thomas, J. Updated guidance for trusted systematic reviews: a new edition of the Cochrane Handbook for Systematic Reviews of Interventions. Cochrane Database Syst. Rev. 2019, 10, ED000142.
[19]	Lu, J.S; Xie, P.S; Wang, R.Z; Zhang, H.S. Clinical observation of domestic isosorbidemononitrate in the treatment of 100 cases of angina pectoris of coronary heart disease. J. Pharm. Res. 1998, 02, 52–53.
[20]	He, M. Effect analysis of isosorbidemononitrate in the treatment of 45 cases of angina pectoris. Modern Diagn. Treat. 2012, 23, 2.
[21]	Meng, Y. Efficacy of isosorbidemononitrate sustained-release capsules in treatment of angina pectoris. Know. Prevent. Treat. Cardiovasc. Dis. Acad. Edit. 2014, 11, 3.
[22]	Weng, J.L. Observation on the efficacy, safety and clinical compliance of isosorbidemononitrate sustained release capsule in the treatment of angina pectoris. J. Guizhou Univ. Tradit. Chin. Med. 2014, 36, 62–64.
[23]	Yan, X. Clinical observation on 39 cases of angina pectoris treated with isosorbidemononitrate sustained release capsule. Chinese Journal of Ethnomedicine and Ethnopharmacy. 2014, 23, 103.
[24]	Cai, Q.L. Observation on the effect of isosorbidemononitrate in the treatment of coronary heart disease and cardiac dysfunction. Henan Med. Res. 2015, 24, 121.
[25]	Luo, X.Y. Clinical observation of isosorbidemononitrate sustained release capsule in the treatment of angina pectoris. Journal of China Prescription Drug. 2015, 13, 63.
[26]	Zhu, Y.F. Clinical Diagnosis and Treatment of Coronary Heart Disease With angina pectoris. China Continuing Medical Education. 2015, 7, 115–116.
[27]	Guo, C. Clinical effect of isosorbidemononitrate tablets in the treatment of angina pectoris. World’s latest Med. Inform. Abstr. 2016, 93, 2.
[28]	Shi, Q.T. Observation on the efficacy of isosorbide mononitrate capsule in the treatment of angina pectoris of coronary heart disease. Electron. J. Cardiovasc. Dis. Integr. Tradit. Chin. West. Med. 2016, 4, 58–59.
[29]	Wang, T. Clinical evaluation of isosorbidemononitrate capsule in the treatment of angina pectoris of coronary heart disease. World Biotechnol. 2016, 1, 1.
[30]	Geng, Z.Y. Clinical value of isosorbide mononitrate sustained release capsule in the treatment of angina pectoris. Electronic J. Clin. Med. Literat. 2017, 4, 2709.
[31]	Ma, D.L. Clinical observation of Isosorbide Mononitrate Sustained Release Tablets in treatment of angina pectoris of coronary heart disease of 30 patients. World’s latest Med. Inform. Abst. 2005.
[32]	Gao, Y. Clinical observation of isosorbidemononitrate sustained release capsule in the treatment of angina pectoris. J. Aero. Med. 2019, 30, 845–846.
[33]	Meng, L; Wang, J; Han, J. To study the clinical efficacy and adverse reactions of isosorbidemononitrate capsule in the treatment of angina pectoris of coronary heart disease. World Dia. 2021, 018, 85.
[34]	Wu, Y.H.; Liu, Y.P.; Pang, J.Z. Clinical observation of isosorbidemononitrate combined with Kudiezi in the treatment of 230 cases of angina pectoris of coronary heart disease. Shandong Med. J. 2008, 48, 64–65.
[35]	Zhao, J; Zhang, L; Ren, H. Clinical observation of combination of traditional Chinese and western medicine in the treatment of coronary heart disease and angina pectoris. China Med. Guide. 2013, 15, 1751–1752.
[36]	Xu, J; Chang, X; Ding, R. Observation on the efficacy of integrated traditional Chinese and western medicine in the treatment of 60 cases of coronary heart disease and angina pectoris. Chin. J. Biochem. Drugs. 2014, 34, 111–113.
[37]	Waller, D.G. Optimal nitrate therapy with a once-daily sustained-release formulation of isosorbide mononitrate. J. Cardiovasc. Pharmacol. 1999, 34, S21–S27.
[38]	Willich, S.N. European survey on circadian variation of angina pectoris (ESCVA): design and preliminary results. J. Cardiovasc. Pharmacol. 1999, 34, S9–S13.
[39]	Prakash, A.; Markham, A. Long-acting isosorbide mononitrate. Drugs. 1999, 57, 93–99.
[40]	He, X; Wu, J; Zhang, C. 5-isosorbide mononitrate sustained release agent in the treatment of angina pectoris. Lingnan J. Cardiovasc. Dis. 1999, 5, 214.
[41]	Zhu, Z; Jiang, L. Clinical therapeutic advantages of long-acting Isosorbide-5-mononitrate sustained-release capsules and their use in asymptomatic myocardial ischemia. North. Pharm. 2013, 10, 2.
[42]	Meng, X; Yan, X; Li, D. Circadian rhythm and countermeasures of acute cardiac events. China J. Circulat. 2003, 18, 472–473.
[43]	Chen, M. Observation on efficacy and clinical compliance of isosorbidemononitrate sustained-release capsule in the treatment of angina pectoris. Fam. Psychiat. 2015, 11, 2.

单硝酸异山梨酯缓释胶囊对比单硝酸异山梨酯片剂治疗冠心病心绞痛的网状Meta分析与药物经济学评价

Cost-effectiveness of sustained-release isosorbide mononitrate capsules for coronary heart disease: A network meta-analysis

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