Acute Ischemic Stroke Obtains New Evidence from China to Help Realize "Healthy China 2030"

*Only for medical professionals to read for reference, Cinepazide Maleate Injection brings treatment options based on high-quality evidence-based evidence for patients with ischemic stroke
.

The number of stroke patients in China is increasing at an annual rate of 8.
7% [1].
The disease is characterized by high incidence, high disability, high death, high recurrence, and high burden
.

Reviewing stroke guidelines at home and abroad, early thrombolytic therapy is the most important means to improve cerebral blood circulation in patients with acute ischemic stroke.
However, in clinical practice, thrombolytic therapy has problems such as a narrow time window and limited application of patients.
There are huge and unmet clinical needs for stroke patients in China
.

Cinepezide maleate is a piperazine calcium ion antagonist.
In 2002, Beijing Sihuan Pharmaceutical Co.
, Ltd.
was launched in China for the first imitation (trade name: Kelinao) for the treatment of cerebrovascular and cardiovascular diseases.
And peripheral vascular disease
.

In October 2020, based on the results of large-scale confirmatory clinical studies after the market, the new indication of Cinepazide Maleate injection was approved by the National Medical Products Administration: used to improve neurological symptoms caused by acute ischemic stroke , Activities of daily living and dysfunction
.

On July 10, 2021, during the Seventh Academic Annual Meeting of the Chinese Stroke Society and the Tiantan International Cerebrovascular Disease Conference, Sihuan Medicine held a press conference on the new evidence-based research results of cinepazide maleate injection
.

Professor Yang Yi, Deputy Secretary of the Party Committee and Deputy Dean of Jilin University First Hospital of the Seventh Academic Annual Meeting of the Chinese Stroke Society, said in the opening speech: “Stroke is the main cause of death and disability among adults in China.
It is listed as a major special project of the national medical reform
.

In order to promote the in-depth development of stroke prevention and treatment, the National Health Commission began to implement and promote the "Project to Reduce Millions of New Disabilities" in 2019
.

The project plans to achieve the goal of reducing 1 million new disabled patients in five years
.

Effective prevention and control of stroke will be crucial to achieving the healthy goals of Healthy China 2030 and sustainable development
.
”
Professor Yang Yi then, Professor Ni Jun from Peking Union Medical College Hospital shared the treatment of cinepazide maleate injection in the treatment of acute ischemic brain New evidence-based study results of stroke
.

Professor Ni Jun’s high-quality, large-sample randomized controlled study showed that cinepazide maleate had a definite effect and improved the lives of patients with ischemic stroke ■ Post-marketing large-scale confirmatory clinical study: Malay The post-marketing confirmatory clinical study of Cinepezide Injection was led by Professor Cui Liying of Peking Union Medical College Hospital who was the chairman of the Neurology Branch of the Chinese Medical Association.
It lasted 3 years and included 1301 subjects in 65 centers
.

Patient Press A 1:1 ratio was randomly assigned to the cinepazide group or the control group, and received a 14-day intravenous infusion of 320 mg cinepazide maleate injection or placebo
.
The
primary endpoint of the study was the modified Rankin scale on day 90 (MRS) The proportion of subjects with a score of ≤2, and the secondary endpoints include changes in the Barthel Index (BI) score on the 14, 30, and 90 days
.
The
results of the study showed that cinepazide was included in the 937 patients included in the FAS set.
The proportion of patients with mRS score ≤2 on the 90th day after treatment in the group was significantly better than that in the control group (60.
9% vs.
50.
1%, OR=0.
607; P=0.
0004, P=0.
001 after adjusting for age), suggesting that cinepezil maleate It significantly improves the neurological deficits in patients with acute ischemic stroke and reduces the disability rate
.

On the 90th day after treatment, the proportion of patients with BI score ≥95 points, the cinepazide group was significantly better than the control group (53.
4% ​​vs.
46.
7%, OR=0.
719; P=0.
0230, P=0.
012 after adjusting for age), suggesting horses Cinepezide can significantly improve the activities of daily living of patients with ischemic stroke, help the recovery of patients' self-care ability, help patients to return to social life, and reduce family and social burdens
.

In terms of safety, there was no significant difference in the incidence of adverse events and serious adverse events between the cinepazide group and the control group
.

Cinpezide is safe and well tolerated, and no unexpected adverse events have been found [2]
.

Professor Ni Jun emphasized that although it is a post-marketing confirmatory clinical study, the study adopted a high-quality and even more rigorous protocol design than the phase III clinical study; in addition, the study included a total of 1301 patients, and the sample size was acutely lacking in China.
Clinical research on bloody stroke can be called large-scale
.

The results of the study were published in BMC Neurology, a journal of the British BMC Group's neurology specialty, in July 2020
.

■ Early (14 days) subgroup analysis for improving the disability level of patients: Although the internationally recognized index for judging the therapeutic effect of acute stroke is the 90-day mRS score, the domestic situation is different from that of foreign countries.
The hospitalization time of patients with acute ischemic stroke is generally 14 days.
Within days, therefore, based on the current treatment status of Chinese patients, the researchers evaluated the improvement of patient function after 14 days of treatment with cinepazide maleate
.

The results of subgroup analysis showed that the proportion of patients with mRS score ≤1 on day 14 in the cinepazide group was significantly higher than that in the control group (FAS set, 21.
89% vs.
16.
14%, OR=0.
677, 95%CI 0.
484～0.
948, P =0.
023); the proportion of patients with BI≥95 on day 14 was significantly higher than that of the control group (26.
82% vs.
19.
32%, OR=0.
632, 95%CI 0.
459～0.
869, P=0.
005) [3]
.

Subgroup analysis shows that cinepazide maleate injection can improve the disability level and activities of daily living in patients with acute ischemic stroke early, thereby shortening the rehabilitation treatment time after discharge, improving the quality of life of patients, and reducing stroke The post-family escort, therefore, has important health economics value
.

18,260 large-scale real-world studies showed that cinepazide maleate is well tolerated in a wide range of populations.
Subsequently, Professor Ni Jun introduced the real-world study of cinepazide maleate injection that was re-evaluated after it was launched on the market.
The study Led by Professor Zhai Suodi, Department of Pharmacy, Peking University Third Hospital, the purpose is to observe the clinical application of cinepazide maleate injection in the real world, and to further evaluate its adverse reaction data and clinical benefits in large-scale populations.
Ensure the safety of clinical medication and guide the rational use of medications in clinical practice
.

The Cinepezide Real World Study (RWS), which used a large-scale, multi-center, pharmacist-led, prospective cohort design for inpatient neurology patients who prescribed cinepazide maleate injection, lasted 9 years, 58 centers and 18260 patients were included
.

The results of the study confirmed that cinepazide is well tolerated in a wide range of populations, with mild to moderate adverse reactions and generally good outcomes [4]
.

The real-world study of cinepazide was the first and largest in China to fully understand the real-world drug status and safety information of cinepazide.
Real-world data proved that the clinical application of cinepazide is safe, and follow The evidence dispels the controversy about the safety of cinepazide, especially the adverse reactions of the blood system
.

Summary Professor Ni Jun said in his summary that the large-scale post-marketing confirmatory clinical study of Cinepazide Maleate Injection has been approved by the National Medical Products Administration and approved for the treatment of patients with acute ischemic stroke
.

The real-world research results of cinepazide strengthened the safety component of cinepazide on the basis of evidence-based evidence of effectiveness
.

This is not only conducive to the treatment benefits of stroke patients, but also helps more patients return to work and life in society as soon as possible, which has very important social value
.

Finally, Professor Yang Yi summarized the press conference.
He said that ischemic stroke accounts for a very high proportion of stroke patients, but there are not many clinical drugs supported by sufficient evidence-based medical evidence
.

Professor Yang Yi said that he and the First Hospital of Jilin University where he was also fortunate to participate in the post-marketing confirmatory study of cinepazide.
The strict design and standard implementation of the study were all obtained by cinepazide maleate injection.
High-level evidence-based medicine has laid the foundation, and the final research results are very encouraging
.

It is hoped that with the approval of the new statutory indications for Cinepazide Maleate injection, more stroke patients will benefit from it in the future! Expert profile Professor Yang Yi, Doctor of Medicine, Professor, Chief Physician, Doctoral Supervisor, Deputy Secretary of the Party Committee and Deputy Dean of the First Hospital of Jilin University; Member of the Standing Committee of the Neurology Branch of the Chinese Medical Association, Deputy Leader of the Cerebrovascular Disease Group; Jilin Province Medicine Chairman of the Neurology Branch of the Society; President of the Jilin Provincial Stroke Society; enjoys special government allowances from the State Council; selected for the National Ten Thousand Thousand Talents Program; Distinguished Professor of Changbai Mountain Scholars; Professor Tang Aoqing of Jilin University; Outstanding Contribution Expert of the National Health and Family Planning Commission Stroke Prevention Project ; The health system of Jilin Province has made outstanding contributions to young and middle-aged professional and technical personnel
.

Professor Ni Jun, Chief Physician, Professor, Doctoral Supervisor, Department of Neurology, Peking Union Medical College Hospital; Member of the Neurorehabilitation Group of the Neurology Branch of the Chinese Medical Association; Deputy Chairman of the Medical Quality Management and Promotion Branch of the Chinese Stroke Society; Cerebrovascular Diseases of the National Cerebral Prevention Commission special committee Standing Committee, and secretary-length; Chinese stroke Association cerebral small vessel disease branch of the Standing Committee; Chinese Medical Research Council elderly care elderly cerebrovascular disease branch of the Standing Committee; Chinese Journal of Neurology newsletter editors; JAD magazine associated editor and so on
.

References: [1]Sun H, Zou X, Liu L.
Epidemiological factors of stroke: a survey of the current status in China[J].
J Stroke.
2013 May;15(2):109-14.
[2] Jun Ni, Huisheng Chen, Guofang Chen, et al.
Efficacy and safety of cinepazide maleate injection in patients with acute ischemic stroke: a multicenter, randomized, double-blind, placebo-controlled trial[J].
BMC Neurol.
2020, 20( 1): 282.
[3] Ni Jun, Chen Huisheng, Chen Guofang, etc.
Cinepazide maleate injection significantly promotes the early functional recovery of patients with acute ischemic stroke: a multi-center, random, double-blind , Placebo-controlled phase IV clinical study[J].
Chinese Journal of Neurology, 2020, 53(10): 790-797.
[4] Zhai Suodi, etc.
Cinepazide maleate injection will be re-evaluated after the market The real-world research summary report.
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