Comprehensive clinical evaluation of moxifloxacin: A retrospective study

Abstract

The objective was to provide a basis for the rational clinical application of moxifloxacin through its comprehensive clinical evaluation, and to serve as a reference for the clinical comprehensive evaluation of relevant drugs in the future. We obtained data from 91 community-acquired pneumonia patients admitted to Weifang people’s hospital from April 2020 to November 2021, including 46 in the evaluation group and 45 in the control group. Based on the requirements of the “Guidelines for the Management of Comprehensive Clinical Evaluation of Drugs” (for trial implementation), systematic evaluations are conducted in terms of drug safety, effectiveness, economy, innovation, suitability, and accessibility. The incidence of adverse drug reactions was low, drug quality, safety and stable efficacy; treatment efficiency was 91.3% and 93.3%, respectively (P > .05); the average total cost of the evaluation group was 9765.28RMB and 10250.69RMB, respectively; efficient cost-effectiveness ratio was 104.67 and 112.52 and cost-effectiveness ratio was 242.71. The economy of the evaluation group had a low price and was highly available.

1. Introduction

Infectious pulmonary parenchymal inflammation caused by community-acquired pneumonia (CAP) is a common condition that can quickly result in cardiac and respiratory failure. In the elderly crowds, CAP is quite prevalent. The primary cause of this illness is bacterial infection.^[1,2] The primary pathogens causing CAP include respiratory viruses including influenza A, influenza B, and adenoviruses, as well as bacteria like streptococcus pneumoniae and Haemophilus influenza.^[3] Every year, between 6.5 million and 15 million individuals in China are affected by this illness, and more than 200,000 people may be away as a result. Hospitalization costs are in the tens of billions annually.^[4] The 4th-generation fluoroquinolone antibacterial medication moxifloxacin, sometimes known as “respiratory quinolones,” has a high sensitivity to common pathogenic microorganisms for CAP patients.^[5] According to the “Administrative Guidelines for Comprehensive Clinical Evaluation of Drugs” (for trial implementation) prepared by the National Center for Comprehensive Evaluation of Drugs and Health Technology and the Center for Drug and Appliance Management of the National Health Commission in China, a systematic evaluation is carried out from the aspects of drug safety, effectiveness, economy, innovation, suitability and accessibility. The objective of this study was to provide a basis for the rational clinical application of moxifloxacin through its comprehensive clinical evaluation, and to serve as a reference for the clinical comprehensive evaluation of relevant drugs in the future.

1.1. Drugs

The evaluation drug was moxifloxacin sodium chloride injection (Mokexin) 250 mL: 0.4 g, Hainan Aike Pharmaceutical, approval number H20203091, 35.27 RMB/bottle. The control drug was moxifloxacin sodium chloride injection (Baifule) 250 mL: 0.4 g, Bayer Pharma, approval number J2014011, 196.7 RMB/bottle. The treatment plan was intravenous drip once a day, and each dose was 0.4g: 250 mL.

1.2. Meta-analysis

Search strategies were developed and applied to some electronic bibliographic databases, such as CNKI, Medline, China Wanfang, using “moxifloxacin” and “community-acquired pneumonia” as the keywords, and then 867 related literatures were retrieved including 272 articles in CNKI and 318 articles in China Wanfang, where there are 277 articles in English. After screening, the duplicate and invalid literatures were eliminated. Then, a total of 196 literatures were obtained. Among them, 68 for safety, 54 for effectiveness, 37 for economy, 4 for innovation, and 33 for suitability.

1.3. Data source

The data of non-severe CAP inpatients treated with moxifloxacin sodium chloride injection in Weifang people’s hospital were collected from April 2020 to November 2021. According to “the guidelines for diagnosis and treatment of community-acquired pneumonia in Chinese adults (2016 Edition),” patients who met the following conditions were selected in this project: CAP patients required hospitalization diagnosed by doctors, and moxifloxacin injection was selected for treatment; No antibiotics were used within 3 days before hospitalization; No history of fluoroquinolones allergy, liver and cardiovascular diseases. Finally, there were 46 cases in the evaluation group and 45 cases in the control group. According to the PSI, there was no statistical difference between the 2 groups in terms of basic situation, disease diagnosis and disease severity as shown in Table 1.

Table 1.

Comparison of general information between the 2 groups.

Group	Case	Average age	Course (d)	Gender
				Man	Women
Evaluation group	46	48.02 ± 16.54	9.91 ± 4.1	25	21
Control group	45	52.96 ± 16.34	10.64 ± 4.35	23	22

From the perspective of statistical analysis, the x² test was used to compare the differences in “age” and “gender” between the evaluation group and the control group. We concluded that P > .05 and the difference was not statistically significant. All details are shown in Tables 2–5.

Table 2.

Crosstabulation count of “age” and “group.”

Age	Group		Total
	Import	National centralized purchase
20–40	14	18	32
41–60	13	15	28
61	18	13	31
Total	45	46	91

Table 5.

Chi-Square test of “gneder” and “group.”

	Value	df	Asymp. sig. (2-sided)	Exact sig. (2-sided)	Exact sig. (1-sided)
Person Chi-Square	0.0962	1	0.757
Continuity correction	0.010	1	0.921
Likelihood ratio	0.096	1	0.757
Fisher exact test				0.835	0.461
Linear-by-linear association	0.095	1	0.758
N of valid cases	91

Table 3.

Chi-Square test of “age” and “group.”

	Value	df	Asymp. sig. (2-sided)
Person Chi-Square	1.4382	2	0.487
Likelihood ratio	1.443	2	0.486
Linear-by-linear association	1.269	1	0.260
N of valid cases	91

Table 4.

Crosstabulation count of “gender” and “group.”

Gender	Group		Total
	Import	National centralized purchase
Man	23	25	48
Woman	22	21	43
Total	45	46	91

1.4. Safety evaluation

We collected the safety information of drugs both before and after marketing, as well as the information of adverse reactions, including the type, incidence, and severity. Then we comprehensively judged the safety and efficacy of drugs.

1.5. Effectiveness evaluation

The evaluation criteria for patient efficacy were formulated according to “Guidelines for Clinical Application of Antibacterial Drugs” (2015 edition) and “Guidelines for the diagnosis and treatment of community-acquired pneumonia in Chinese adults” (2016 edition), that is, Markedly effective: clinical symptoms disappeared completely, inflammatory lesions were completely absorbed, and sputum culture results turned negative; Effective: clinical symptoms improved to varying degrees, inflammatory lesions were absorbed to varying degrees, sputum culture results became negative, or one of the pathogenic bacteria disappeared; Invalid: clinical symptoms, inflammatory lesions, and sputum culture results had no obvious change after treatment or even disease progresses.

1.6. Economic evaluation

The cost-effectiveness analysis (CEA) was selected because the evaluation drugs and the reference drugs have the same clinical output indicators in this study. We used multi-disciplinary knowledge such as epidemiology, health statistics, economics, to comprehensively judge the economic performance.

1.7. Innovation evaluation

Through screening literatures and analyzing the clinical off-label usage, the degree to which the drug and the reference drug meet the clinical needs was judged, and the innovative evaluation of the drug was carried out.

1.8. Suitability evaluation

The evaluation focused on the suitability of the technical characteristics and the suitability of the usage. One included drug labeling, drug instructions, storage conditions, etc. The other included the compliance of usage and the rationality of usage.

1.9. Accessibility evaluation

With reference to the WHO/HAI standardization method for drug accessibility, a comprehensive evaluation was carried out from the aspects of drug price, availability, and affordability.

2. Results

2.1. Safety

The premarket safety information, the safety information of similar products, the post-market safety information provided by the manufacturer, and the safety information of the enrolled patients basically overlapped. The adverse drug reactions of Mokexin were mainly rash, itching, nausea, vomiting, etc. They were usually mild and transient. The most common adverse drug reaction was rash, occurring in 0.1% to < 1%. Mokexin had sufficient evidence of safety, low incidence of ADR, quality standard and controllable, and stable and reliable efficacy.

2.2. Effectiveness

In this study, the effective rate of treatment in the evaluation group was 91.3% and that in the control group was 93.3%, which are both higher than the 86% reported in clinical randomized controlled studies.^[6] It was proved that Mokexin and Baifule have similar curative effects in the treatment of CAP. It was found that moxifloxacin has excellent efficacy in the treatment of CAP and severe CAP patients with chronic obstructive pulmonary disease and asthma.^[7]

2.3. Economy

In the process of clinical diagnosis and treatment, there are often differences in the choice of domestic drugs and imported drugs. This study has shown that the clinical efficacy of the evaluation group in the treatment of CAP is similar to that of the control group. The average treatment cost of the evaluation group was 9765.28 RMB, and that of the control group was 10250.69 RMB. Cost-effectiveness ratio (C/E) value of the evaluation group was 104.67, and that of the control group was 112.52. The cost-effectiveness results of the evaluation group were better than those of the control group, and the sensitivity results are also better. Therefore, it can be concluded that the choice of Mokexin in the treatment of CAP is an advantageous solution, which has more economic advantages and social benefits.

2.4. Innovation

It can be used in the treatment of multidrug-resistant tuberculosis, severe Mycoplasma pneumoniae pneumonia and Severe infections for children under the age of 18.

2.5. Suitability

The labels of Mokexin and Baifule are standardized and comprehensive. The storage environment is shading and airtight above 15℃. After investigation, the maintenance of the pharmacies in the hospital met the requirements. The frequency of medication, course of treatment, dose, concentration, and administration time of the 91 patients in this study conformed to the diagnosis and treatment standards.

2.6. Accessibility

Compared with the products of similar manufacturers, the price of Mokexin (35.27RMB/bottle) is moderate and stable. After investigating the equipment of Mokexin in 5 cities in Shandong province, the equipment rate of Class 3 institutions is 92%, and that of Class 2 institutions is 84%, which shows high market coverage and strong availability.

3. Discussion

3.1. Safety evaluation

3.1.1. Safety information in premarket.

Mokexin was approved on March 11, 2020 according to the new chemical drug registration category 4, which is deemed to have passed the consistency evaluation. In other words, the quality and efficacy of this product are consistent with those of the reference preparation. Large-volume injections (non-special dosage forms) do not need to conduct premarketing Phase II and Phase III clinical studies, which is declared under this category. Baifule was first marketed in Germany in 1999, and a full clinical trial study was conducted before it was approved. Studies have shown that the most common adverse drug reactions are rash, nausea, diarrhea, headache, and dizziness.

3.1.2. Safety information of similar products.

The relevant literature showed that the adverse reactions of moxifloxacin are mainly manifested in the gastrointestinal system,^[8] skin and mucous membranes,^[9,10] nervous/mental system,^[11,12] respiratory system, systemic damage, cardiovascular system, Vascular disease, and liver/renal system.^[13–15] The specific clinical manifestations and the proportions are shown in Table 6.

Table 6.

Types of adverse drug reactions in literatures.

Organ/system	Clinical symptom	Case	Percent (%)
Skin	Rash, pruritus, erythema	75	22.94
Gastrointestinal system	Nausea, vomiting	57	17.43
Nervous/mental system	Dizziness, hallucinations, delirium, irritability, insomnia, mental disorders, hand shaking, convulsions	49	14.98
Cardiovascular system	Palpitation, arrhythmia, prolongation of QT interval	33	10.09
Vascular disease	Phlebitis	22	6.73
Liver/kidney system	Abnormal liver function and renal function	17	5.20
Systemic damage	Allergic reaction, limb pain, fever	7	2.14
respiratory system	Chest tightness, shortness of breath, dyspnea	4	1.22
Others	White blood cells and blood potassium decreased	63	19.27
Total	Data	327	100

The adverse drug events of moxifloxacin injection reported by some Grade 3 and Class A comprehensive hospitals have been inquired in the past 3 years, and it was found that the main manifestations were related to the nervous/mental system, cardiovascular system, skin and mucous system, and cardiovascular system, as shown in Table 7.

Table 7.

Types of adverse drug reactions reported by some hospitals.

Organ/system	Symptom	Case	Percent (%)
Nervous/mental system	Dizziness, hallucinations, delirium, irritability, insomnia, mental disorders, hand shaking, convulsions	18	36
Cardiovascular system	Palpitation, arrhythmia and prolongation of QT interval	11	22
Skin	Rash, pruritus, erythema	6	12
respiratory system	Chest tightness, shortness of breath, dyspnea	6	12
Gastrointestinal system	Nausea, vomiting	4	8
Systemic damage	Limb pain, weakness	2	4
Liver/ kidney system	Abnormal liver function and renal function	2	4
Others	Extravertebral response	1	2
Total		50	100

3.1.3. Safety information in post-market.

Hainan Aike Pharmaceutical (Mokexin) provided adverse reaction data from March 2020 to June 2021 in China. About 4589,970 bags were sold, the number of users was about 523,336. Meanwhile, 3039 cases of adverse reactions were collected, with a total of 2231 users. The total incidence of adverse reactions was 0.43%, as shown in Table 8.

Table 8.

Adverse reaction symptoms and incidence.

Organ/system	ADR symptom	Case	Percent (%)
Skin and its accessories damage	Pruritus	377	0.0720
	Rash	848	0.1620
	Cold and sweaty	26	0.0049
General damage of cardiovascular system	Chest tightness	114	0.0218
Heart rhythm and arrhythmia	Palpitation	161	0.0308
	prolongation of QT interval	11	0.0025
Extracardiac vascular damage	Phlebitis, vasculitis	250	0.0477
	Flush	22	0.0042
Gastrointestinal system damage	Vomiting and nausea	335	0.0640
	Heartburn, burning sensation	16	0.0031
	Abdominal pain and stomach discomfort	93	0.0178
Liver system injury	Abnormal liver function	63	0.0120
Coagulation disorder	Thrombocytopenia	11	0.0021
Sympathetic sympathetic nervous system damage	Dry mouth	20	0.0038
	Abnormal blood pressure	24	0.0045
Metabolic and nutritional disorders	Hypokalemia	4	0.0008
	Redness	102	0.0195
Medication site damage	Numbness, pain	101	0.0193
Systemic system damage	Shiver	20	0.0038
	Anaphylaxis	34	0.0065
Musculoskeletal system impairment	Muscle weakness	1	0.0002
Visual impairment	Blurred vision	21	0.0040
Auditory and vestibular function impairment	Ear discomfort	2	0.0004
Central and peripheral nervous system damage	Dizziness, tremor	185	0.0354
	Seizures	7	0.0013
	Psychiatric abnormalities	56	0.0108
Neurological disorders	Irritability, hallucinations, gasping	53	0.0101
	Sleep problem	32	0.0062
	Consciousness problem	19	0.0036

According to the instruction of Baifule: “When the patients receiving intravenous infusion of 0.4 g, the most common adverse event leading to drug discontinuation was rash, with an incidence of 0.1% to < 1%.” From the above table, it can be seen that the main symptom of the adverse drug reaction caused by Mokexin was also rash, with an incidence rate of about 0.16%. The incidences of other adverse drug reactions were all <0.1%.

3.1.4. Comparison of adverse reactions.

During the whole treatment period, 3 cases of adverse reactions occurred in the evaluation group and the control group, which included 2 cases with skin itching and 1 case with nausea, as shown in Table 9.

Table 9.

Comparison of adverse reactions.

Group	Adverse reactions		Incidence
	Skin itching	Nausea
Evaluation group	1	1	4.34%
Control group	1	0	2.22%

3.2. Effectiveness evaluation

If the respiratory symptoms and signs, such as coughing and expectoration, as well as the pulmonary wet rales entirely vanished, the body temperature returned to normal, and the findings of a chest X-ray or CT scan revealed that the lesions were absorbed, the patients can be deemed to have cured. When respiratory symptoms are not relieved or the disease worsens, the treatment is deemed ineffective. Respiratory symptoms and signs, such as coughing up expectorant or having wet rales in the lungs, disappear, body temperature drops, and the majority of lesions are shown to have been absorbed on a chest X-ray or CT scan.

SPSS statistical software was used for data processing, count data were expressed as rate (%), and x² test was performed; P < .05 indicated a statistically significant difference.

When discharging, there was no significant difference in the total effective rate between the evaluation group and the control group (x² = 0.889, P = .641 > 0.05). All details are shown in Tables 10–12.

Table 10.

Comparison of clinical curative effect of different groups.

Group	Cured	Effective	Ineffective	total effective rate*
Evaluation group (n = 46)	16 (34.8%)	26 (58.7%)	4 (6.5%)	91.3%
Control group (n = 45)	19 (42.2%)	21 (48.9%)	5 (8.9%)	93.3%

^* Total effective rate = (Number of cured cases + number of effective cases)/Total cases*100%.

Table 12.

Chi-Square test.

	Value	df	Asymp. sig. (2-sided)
Person Chi-Square	0.5732	2	0.751
Likelihood ratio	0.574	2	0.751
Linear-by-linear association	0.550	1	0.458
N of valid cases	91

Table 11.

Crosstabulation count.

Effect	Group		Total
	Evaluation group	Control group
Cured	16	19	35
Effective	26	23	49
Ineffective	4	3	7
Total	46	45	91

3.3. Effectiveness evaluation

3.3.1. Cost determination.

In pharmacoeconomics research, the cost refers to the financial, human and material resources invested in the entire process of implementing prevention, diagnosis or treatment, generally including direct cost, indirect cost and hidden cost.^[16] Considering that there are many uncertain factors in the determination of indirect and hidden costs for patients and their families, it is difficult to obtain accurate values. Therefore, in this paper, only direct costs (total hospitalization costs) were taken into account.

3.3.2. CEA.

CEA is a commonly used research tool in pharmacoeconomics, which can quantitatively evaluate the advantages and disadvantages of different drugs or treatment programs. The CEA is the most common method in the pharmacoeconomic evaluation in China. And the most common indicator is the C/E, which is the cost spent on adopting a unit effect or the effect generated per monetary unit. For multiple programs, some programs may have higher costs and produce good effects, but the payment cost is also increasing.^[17] It is necessary to use incremental analysis to determine, that is, the incremental cost-effectiveness ratio (ΔC/ΔE). The CEA results of the evaluation group and the control group are shown in Table 13. The C/E of the 2 groups were 104.67 and 112.52, respectively. For each percentage point increase in the effective rate, the patient was willing to pay a maximum of 100 yuan. Incremental analysis is used to determine the optimal treatment plan. Incremental cost-effectiveness ratio is (ICER)=ΔC/ΔE = (10250.69–9765.28)/(93.3–91.3) = 242.71 > 100, indicating that the evaluation group was more economical than the control group.

Table 13.

Cost-effectiveness comparison.

Group	Case	Cost (RMB)	Effective rate (%)	C/E	ICER (ΔC/ΔE)
Evaluation group	46	9765.28	91.3	104.67	242.71
Control group	45	10250.69	93.3	112.52

C/E = cost-effectiveness ratio.

3.3.3. Sensitivity analysis.

In the process of evaluating pharmacoeconomics, sensitivity analysis is essential. The dependability and stability of pharmacoeconomic evaluation can be improved by minimizing the impact of uncertain elements. As part of the sensitivity analysis, the variables that could have an impact on the cost-effectiveness ratio are examined. The relevant ICER value is calculated after increasing the cost by 5%, 10%, and 15% and reducing it by 5%, 10%, and 15%; similarly, after increasing the efficiency by 5% and reducing it by 5%, 10%, 15%. Tables 14 and 15 show that the results of the sensitivity analysis and CEA are in agreement, demonstrating the stability of the evaluation results.

Table 14.

Effect of variation in treatment costs on the cost-effectiveness ratio.

Amplitude	ΔC (RMB)	ΔE (%)	ICER
−15%	412.6	2	206.3
−10%	436.87	2	218.44
−5%	461.14	2	230.57
0	485.41	2	242.71
5%	509.68	2	254.84
10%	533.95	2	266.98
15%	558.22	2	279.11

Table 15.

Effect of changes in effectiveness rate on cost-effectiveness ratio.

Amplitude	ΔC (RMB)	ΔE (%)	ICER
−15%	485.41	1.7	285.54
−10%	485.41	1.8	269.67
−5%	485.41	1.9	255.48
0	485.41	2	242.71
15%	485.41	2.1	231.15

3.4. Innovation evaluation

Through literature searching, clinical research and other methods, only a few cases of children’s prescription drugs were obtained. The instructions of Mokexin and related literature indicated that it should be avoided for children under 18 years old to avoid joint and cartilage damage.^[18] In recent years, some expert studies have shown that moxifloxacin can be used in the treatment of children with multidrug-resistant tuberculosis,^[19] severe Mycoplasma pneumoniae pneumonia in children,^[20] and short-term application in the treatment of severe infections in children.^[21]

3.5. Suitability evaluation

3.5.1. The suitability of the technical characteristics.

The drug descriptions in the instructions and labels of Mokexin and Baifule conform to the principles of common drug descriptions and commodity descriptions published by the State Food and Drug Administration, which are consistent with the content of the drug approval documents.

The storage conditions of Mokexin and Baifule are shading, airtight, and stored above 15℃. By checking the scene and reading the records, it was found that the drug storage environment of each ward in our hospital met the requirements.

3.5.2. The suitability of usage.

Moxifloxacin can be used to treat the following infections in adults (≥18 years) caused by sensitive bacteria: acute bacterial sinusitis, acute exacerbation of chronic bronchitis, community-acquired pneumonia, uncomplicated skin and skin tissue infections, complex skin and Skin tissue infection, complicated intra-abdominal infection, and plague (including pneumonic plague and septicemic plague caused by Yersinia pestis in adults, and plague can also be prevented). After the review of the doctor’s order by the pharmacist and the medication education, the clinical medical staff and the patient’s medication compliance were relatively high, and the patient’s medication frequency, course of treatment, and dosage were in line with the diagnosis and treatment standards. The recommended usage of Mokexin and Baifule is shown in Table 16.

Table 16.

Recommended usage of Mo Kexin and Baifule.

Frequency	Dosage	Method	Concentration	Menstruum	Time (min)
Qd	0.4 g/time	Intravenous drip	0.4g:250 mL	0.9% NS, 5% GS, 10% GS, ringer lactate injection	90

According to the “Guidelines for the Diagnosis and Treatment of Community-Acquired Pneumonia in Chinese Adults (2016),” respiratory quinolones are recommended for CAP patients who need to be hospitalized. Moxifloxacin is suitable for the treatment of CAP in this study. It was found that the drug use of 91 patients in the evaluation group and the control group met the normative requirements.

3.6. Accessibility evaluation

3.6.1. The price.

A total of 13 specifications of moxifloxacin injection were compared in this paper, including 8 specifications of 0.4g: 250 mL (moxifloxacin sodium chloride injection) and 5 specifications of 0.4g: 20 mL (moxifloxacin injection). Meanwhile, 196.7 RMB/bottle had the highest price, 32.7 RMB/bottle had the minimum, 131 RMB/bottle had the median, and the average level was 108.8 RMB/bottle. The price of the evaluated drug was low (35.27 RMB/bottle), and the price level was good. More details are shown in Table 17.

Table 17.

Recommended usage of Mo Kexin and Baifule.

Number	Name	Specification (volume: moxifloxacin: sodium chloride)	Manufacturer	Price (RMB)
1	Moxifloxacin hydrochloride and sodium chloride injection	250 mL: 0.4 g: 2.0 g	Chengdu Zhengkang pharmaceutical industry	32.7
2	Moxifloxacin hydrochloride and sodium chloride injection	250 mL: 0.4 g: 2.0 g	Shijiazhuang Si Yao	32.79
3	Moxifloxacin hydrochloride and sodium chloride injection	250 mL: 0.4 g: 2.0 g	Sichuan Kelun pharmaceutical Co	32.8
4	Moxifloxacin hydrochloride and sodium chloride injection	250 mL: 0.4 g: 2.0 g	Tianjin Chase Sun Pharmaceutical Co	35.08
5	Moxifloxacin hydrochloride and sodium chloride injection	250 mL: 0.4 g: 2.0 g	Hainan Aike pharmaceutical	35.27
6	Moxifloxacin hydrochloride injection	20 mL: 0.4 g	Nanjing Chia Tai Tianqing pharmaceutical	117.67
7	Moxifloxacin hydrochloride and sodium chloride injection	250 mL: 0.4 g: 2.0 g	Yangtze river pharm	131
8	Moxifloxacin hydrochloride injection	20 mL: 0.4 g	PKU medicine	151
9	Moxifloxacin hydrochloride injection	20 mL: 0.4 g	Yangtze river pharm	151
10	Moxifloxacin hydrochloride injection	20 mL: 0.4 g	Chengdu Tiantaishan pharmaceutical	151
11	Moxifloxacin hydrochloride and sodium chloride injection	250 mL: 0.4 g: 2.0 g	Jiangsu Zhengda Fenghai pharmaceutical	153.2
12	Moxifloxacin hydrochloride injection	20 mL: 0.4 g	Nanjing Youke pharmaceutical	194.8
13	Moxifloxacin hydrochloride and sodium chloride injection	250 mL: 0.4 g: 2.0 g	Bayer pharm	196.7

3.6.2. Accessibility.

To investigate the usage of Mokexin at 75 medical institutions in 5 cities of Shandong province, the results are shown in Table 12. More than 80% of medical facilities at Grade 2 and above are equipped in the province. Township/community health facilities are basically not equipped, as shown in Table 18.

Table 18.

Evaluation of drug equipment.

Class	Weifang	Jinan	Qingdao	Yantai	Binzhou	Equipment rate
Class 3	5	5	5	4	4	92%
Class 2	5	5	5	2	4	84%
Township/Community health center	0	0	0	0	0	0

3.6.3. Affordability.

Moxifloxacin belongs to class B of medical insurance. The self-payment proportion of residents medical insurance was 20% and that of employees was 8%. The specific medical insurance restrictions were as follows: lower respiratory tract infection and community-acquired pneumonia; The following infections with clear evidence of drug sensitivity test (acute sinusitis, complex abdominal infection).^[6,7,22]

However, this study had the following shortcomings, such as a small sample size and a narrow research scope. In future studies, the sample size of the study will need to be further increased.

4. Conclusion

The study conducted a comprehensive clinical evaluation on Mokexin from the aspects of safety, effectiveness, economy, innovation, suitability and accessibility. The results showed that the incidence of ADR is low, and the quality is controllable and up to standard. The effective rate of Mokexin and Baifule in the treatment of CAP was the same. Compared with Baifule, Mokexin had better economy in the treatment. The compliance of clinical application of Mokexin and Baifule was high, and the medication is in line with the norms of diagnosis and treatment; Mokexin had a good price level and high equipment rate in Class 3 and Class 2 institutions. The evaluation results of this study are objective and true, which has a practical reference significance for the comprehensive clinical evaluation of these kinds of drugs in the future.

Author contributions

Conceptualization: Hailiang Wang.

Data curation: Hailiang Wang, Lijun Jing.

Methodology: Haiqiang Liu, Meimei Lou, Lanxia Xu, Wei Zhang, Min Fu.

Writing – original draft: Lanxia Xu, Lijun Jing, Min Fu, Bing Liu.

Writing – review & editing: Bing Liu.