Clinical characteristics analysis of 9 Cases COVID-19 patients receiving integrated Traditional Chinese and Western medicine: a retrospective study

doi:10.21203/rs.3.rs-21337/v1

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Clinical characteristics analysis of 9 Cases COVID-19 patients receiving integrated Traditional Chinese and Western medicine: a retrospective study

https://doi.org/10.21203/rs.3.rs-21337/v1

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Background Recently, WHO has classified COVID-19 as a global pandemic disease, and it is still spreading rapidly around the world, but no specific medicine or vaccine for 2019-nCov has been developed so far. At present, the epidemic situation in China has been basically controlled.

Methods Here we report 9 COVID-19 patients hospitalized in the First People's Hospital of Zigong City, Zigong, China. In addition to antiviral drug treatment and other supportive treatment, all of them received traditional Chinese medicine prescription according to the different conditions of each patient, and we collected the clinical data of the 9 patients and analyzed the outcome as a retrospective study.

Results The curative effect is very significant, all the patients have been discharged from the hospital, and the shortest course of treatment is only 12 days.

Conclusions Combined with the fact that other parts of China use Traditional Chinese Medicine, including Wuhan Cabin Hospital, we speculate that Chinese medicine plays an encouraging role in this process and may be an adjuvant therapy of COVID-19, which may bring some reference to the treatment of COVID-19 worldwide, in spite of the efficacy and definite conclusions still need further study.

Infectious Diseases

Internal Medicine

2019-nCoV

COVID-19

Chinese Medicine

Western medicine

retrospective study

A new pneumonia called 2019 novel coronavirus disease (COVID-19) caused by the 2019 novel coronavirus (2019-nCoV) is a highly pathogenic and high risk disease, and was first reported in Wuhan, Hubei Province, China, in December, 2019, then broke out across Hubei Province and other parts of China[1–2].Recently, the COVID-19 has been effectively controlled in China, but the epidemic has been spreading rapidly around the world, especially in Italy, Iran, South Korea and Japan. Up to March 16, there are 167,511 confirmed (13,903 new) 6,606 deaths (862 new) globally; 86,434 confirmed (13,874 new) 3,388 deaths (848 new) 151 countries/territories/areas (4 new) outside of China [3]. On 11 March 2020, WHO has characterized COVID-19 as a pandemic disease [4].

However, there is no specific medicine or vaccine for 2019-nCov so far. Although it has been reported that Remdesivir and Chloroquine can inhibit the 2019-nCov in vitro [5], It has also been reported that Remdesivir may have a promising clinical therapeutic effect [6], and a Phase III clinical trial of the drug is also under going in China and the United States [7], further Case-Controlled clinical studies of Remdesivir therapy are warranted to verify its therapeutic efficacy [8].

During the epidemic period of 2019-nCov, our hospital admitted 9 COVID-19 patients. Unlike some other hospitals, our hospital applied Traditional Chinese Medicine (TCM) and western medicine at the same time, which obtained significant improvement. As of Feb. 27, the last patient had been discharged. Here, we aim to share some treatment experiences with the hope of providing a possible reference for the treatment of COVID-19 worldwide.

2.1 Patients

We collected the clinical data of 9 patients admitted to our hospital (the First People's Hospital of Zigong City, Zigong, china) from January 23, 2020 to February 27, 2020. And all patients were diagnosed with COVID-19 according to the” Diagnosis and treatment of pneumonia caused by 2019-nCoV (trial fourth edition)” issued by National Health Commission of China [9]. This study was approved by the Ethics Committee of First People's Hospital of Zigong City, and written informed consent was obtained from all patients.

2.2 Data Collection And Analysis

All patients underwent routine blood tests, liver biochemical indicators tests(ALT, AST, ALP, GGT, TP, TBIL, GLU, HDL-C, et al.), renal biochemical indicators tests(BUN,CREA,UA, et al.), hypersensitive C-Reactive Protein(hs-CRP) tests, 2019-nCov nucleic acid test utilizing nasopharyngeal swabs (Novel Coronavirus PCR Fluorescence Diagnostic Kit, BioGerm Medical Biotechnology, Shanghai) [2], and tests of antibodies against pathogens associated with respiratory tract infection(including respiratory syncytial virus, adenovirus, Influenza A virus, Influenza B virus, parainfluenza virus, chlamydia pneumoniae, legionella pneumophila, mycoplasma pneumoniae, Coxsackie A virus, coxsackie B virus, ECHO virus),and in addition to chest computed tomography (CT) imaging, and T-lymphocyte subsets anaylsis (performed by flow cytometry, Beckman Coulter, Navios, USA).

We collected and analyzed their epidemiological, demographic, Clinical manifestations and diagnosis, laboratory, treatment and outcome data by a retrospective study of the medical records. It should be pointed out that our Department Of Clinical Laboratory had been approved by ISO15189 by China National Accreditation Service for Conformity Assessment (CNAS), and our hospital is a designated unit of 2019-nCov detection. Besides, if the patient has other underlying diseases, there will be appropriate screening and monitoring and treatment.

3.1 Patients’ Baseline characteristics

As shown in Table 1, the COVID-19 patients were all middle-aged and elderly people, with the youngest age of 20 years old (Case 3) and the oldest age of 67 years old (Case 7), with an average age of 43.3; 7 females and 2 males (Case 1, Case 4), with a ratio of 3.5:1. All the patients had a history of sojourn in Wuhan or Hubei Province. 7 patients were diagnosed with COVID-19 on the same day, and two were diagnosed within 2 days when they admitted into hospital. 4 of the 9 patients had underlying diseases (Case 2: Syringomyelia, Case 4: Type 2 Diabetes Mellitus, Case 7: Hypertension/fatty liver, Case 8: Hypertension/Gallstone). The patient's condition improved in the shortest 2 days after treatment (Case 3, Case4, Case 6) without recurrence, and improved in the longest 8 days without recurrence (Case 9). 1 of them had recurrent episodes (Case 1), and this one had the longest course, 32 days. The shortest course is only 12 days (Case 4).

Table 1

Basic information of patients
Items	Case 1	Case 2	Case 3	Case 4	Case 5	Case 6	Case 7	Case 8	Case 9
Age(Year)	34	52	20	40	48	39	67	48	42
Average of Age	43.3
Gender	M	F	F	M	F	F	F	F	F
F/M	3.5:1
Whether has Hubei or Wuhan contact history	Y	Y	Y	Y	Y	Y	Y	Y	Y
Date of Admission	26,Jan.	27,Jan.	23,Jan.	25,Jan.	25,Jan.	30,Jan.	25,Jan.	26,Jan.	30,Jan.
Date of Discharge	27,Feb.	25,Feb.	7,Feb.	7,Feb.	20,Feb.	20,Feb.	18,Feb.	20,Feb.	18,Feb.
Disease courses(Days)	32	27	14	12	25	21	24	21	24
Average of Disease courses(Days)	22.2
Time from Admission to Diagnosis	the day	the day	the day	the day	the day	the day	2 Days	the day	2 Days
Time from treatment to first improvement(Days)	5 days, but has relapse	7	2	2	3	2	6	3	8
Other diseases	None	Syringomyelia	None	Type 2 Diabetes Mellitus	None	None	Gastritis/Hypertension (Ⅱ Level, Moderate Group)/Gallstone	Hypertension (Ⅱ Level, Moderate Group)/Fatty Liver	None
Note: M: Male; F: Female; Y: yes.

The above data indicate that if people who are from the epidemic area have the relevant symptoms still need to take relevant measures. And although Case 4 has Type 2 Diabetes Mellitus, but instead he has shortest duration, and the other patients who have underlying diseases were also cured without recurrence, suggest these underlying diseases did not affect the cure of COVID-19. It should also be noted that, except for the relapse in Cases 1, the symptoms of other patients had disappeared one week before discharge. And the virus nucleic acid was tested daily in the hospital to prevent recurrence, and the patients were not discharged until all nucleic acid was negative for 5 consecutive days. Of course, the same measures were taken for Cases 1 before his discharge.

3.2 Characteristics Of Clinical Symptoms

As shown in Table 2, except for 2 patients with tachycardia, most of the patients had normal heart rates during the onset(Case 8,Case 9). There was no increase in blood pressure except in two patients with chronic hypertension༈Case 7,Case 8༉. All Respiratory Rates and Oxygen Saturation were normal. All the 9 patients had fever, but most of them had low fever, with the highest body temperature reaching 39.3℃. All the patients had no symptoms such as dizziness rhinobyon rhinorrhoea and headache. 8 out of 9 developed cough symptoms (except Case 1), 3 of them had no phlegm (Case 1, Case 2, Case 4,), and the remaining 6 had phlegm. Only 1 out of 9 patients presented with systemic fatigue symptoms (Case 6), and 2 patients presented with systemic muscle stiffness&myalgia (Case 4, Case 6). In addition, there are 3 patients with Poor Appetite, Nausea, Acid Regurgitation and other gastrointestinal symptoms (Case 6, Case 7, Case 8), 2 patients appeared Chest Stuffiness (Case 5, Case 8), and 1 patients appeared nausea and vomiting after taking antiviral drugs. It can be seen that the patients included in this study had fever and cough as the main symptoms, while the symptoms of fatigue and myodynia were less, which was consistent with previous reports by other study[2].

Table 2

Clinical characteristics of patients
Items	Case 1	Case 2	Case 3	Case 4	Case 5	Case 6	Case 7	Case 8	Case 9
Pulse Rate	86	78	86	86	90	80	85	104	110
Respiratory Rate	20	21	20	20	20	20	20	21	19
Blood Pressure	138/89	118/75	135/85	125/76	127/84	96/62	160/93	154/90	124/88
Blood Oxygen Saturation	96%	97%	99%	97%	98%	98%	96%	99%	97%
Fever(℃)	The highest is 38.6, last 3 days to normal	The highest is 38.0, last 4 days to normal	has fever on 29,Jan.last 3 days to normal, The highest is 37.9	The highest is 38.5, last 11 days and become normal on the second day of Admission	0	The highest is 38.0, last 7 days and become normal on the second day of Admission	The highest is 38.0,last 5 days and become normal on the second day of Admission	The highest is 39.3,last 5 days to normal	The highest is 38.4,last 3 days to normal
Dizziness	0	0	0	0	0	0	0	0	0
Rhinobyon	0	0	0	0	0	0	0	0	0
Rhinorrhoea	0	0	0	0	0	0	0	0	0
Headache	0	0	0	0	0	0	0	0	0
Cough	0	1	1	1	1	1	1	1	1
Phlegm	0	0	1	0	1	1	1	1	1
Dyspnoea	0	0	0	0	0	0	0	0	0
Fatigue	0	0	0	0	0	1	0	0	0
Constipation	0	0	0	0	0	0	0	0	0
Diarrhea	1	1	0	0	1	0	0	1	1
Muscular Stiffness&Myalgia	0	0	0	1	0	1	0	0	0
Other Symptoms	0	0	Nausea And Vomiting After Taking Antiviral Drugs	0	Chest Stuffiness; Palpitation	Poor Appetite; A Catsayer And Discomfort In The Abdomen On 2,Feb.	Ventosity; Poor Appetite; Nausea;Acid Regurgitation On 10, Feb.	Chest Stuffiness; Pharyngalgia;A Catsayer And Discomfort In The Abdomen; Acid Regurgitation	0
Note: 1 means Yes; 0 means No;

It is worth mentioning that Case 1 has neither cough nor phlegm nor muscle soreness and other symptoms, and has only fever and diarrhea with a maximum temperature of 38.6℃. However, it has also been diagnosed as COVID-19. Besides, he also had relapse.

3.3 Examination, Treatment And Outcomes

As mentioned in the Methods part, all patients were underwent routine blood tests, liver biochemical indicators tests, renal biochemical indicators tests, hypersensitive C-Reactive Protein(hs-CRP) tests and T-lymphocyte subsets analysis et al., also in addition to 2019-nCov nucleic acid test and chest CT imaging. In terms of treatment, as shown in Table 3, we applied the antiviral drugs Lopinavir/Oseltamivir/Ritonavir, also used the Recombinant Human Interferon A2b and Chloroquine Phosphate Tablets, and also used specific antibiotics for therapy; Drugs such as Tetralogy of viable bifidobacterium tablet and Montmorillonite Powder were also used to improve the gastrointestinal reactions of patients such as diarrhea and diarrhea. Of course, different from some hospitals, we applied Traditional Chinese Medicine (TCM) treatment at the same time of antiviral and supportive treatment. According to the theory of traditional Chinese medicine, according to the different condition of each patient’s characteristics, our TCM doctors prescribed formulae that are the most consistent with the symptoms of the patients, thus ensure the curative effect and reduced the incidence of side effects.

Table 3

Clinical treatment of patients
Items	Case 1	Case 2	Case 3	Case 4	Case 5	Case 6	Case 7	Case 8	Case 9
lopinavir/Oseltamivir/Ritonavir	1	1	1	1	1	1	1	1	1
TCM ( decoction) *	1	1	1	1	1	1	1	1	1
Chloroquine Phosphate Tablets	1	0	0	1	1	0	0	0	0
Recombinant Human Interferon A 2b	1	1	1	1	1	1	1	1	1
Antibiotic treatment**	1	1	1	1	1	0	1	1	1
Intestinal function improvement***	1	1	1	1	1	1	1	1	1
Note: 1 means Yes; 0 means No;
* Because each patient's symptoms are different, so according to the symptoms of each patient professional Traditional Chinese Medicine (TCM) doctors will appropriately prescribe a formulation to the patient, so here each TCM formulation is different from each other. Each patient's formulation was shown in the Supplementary Materials 3.
**These drugs mainly are Moxifloxacin Hydrochloride, Piperacillin sodium tazobactam sodium et al.
*** These drugs mainly are Tetralogy of viable bifidobacterium tablets;Montmorillonite Powder et al.

According to the test results, in all patients, hs-CRP increased and T-lymphocytes decreased at onset, and in the T-cell subsets, the absolute values of CD4 + T cells and CD8 + T cells decreased(as shown in Table 4). Chest CT examination showed that all patients had presentation of the patchy scattered high-density shadows with the blurred boundary and ground-glass opacity or some consolidation in their bilateral or unilateral lung lobes, the upper lobe or the medial basal segment of the lower lobe, and ground glass opacities and patchy, and streaked shadows were the most common radiologic findings (as shown in Fig. 1, 2, and Supplementary Materials 1), which is consistent with some results of other studies [10–11].Other laboratory tests showed no specific changes (data are not listed here).

Table 4

Changes of Routine Blood Test and T Lymphocyte Subsets Analysis before and after treatment
Item	Case 1		Case 2		Case 3		Case 4		Case 5		Case 6		Case 7			Case 8		Case 9
Item	B	A	B	A	B	A	B	A	B	A	B	A	B		A	B	A	B	A
Routine Blood Test
Hypersensitive c-reactive protein (mg/L;normal range: 0–5)	12.10	0.6	26.7	0.8	1.11	3.6	25.4	1.4	3.94	0.4	0.67	0	94.4		4	14.68	9.2	4.1	0.3
White Blood Cells Count (10^9/L;normal range: 3.5–9.5)	2.9	4.74	2.16	3.38	6.04	5.42	4.84	4.84	4.4	5.79	2.67	4.74	5.38		5.72	5.17	7.7	4.71	4.19
Neutrophile Granulocyte Rate (%; normal range: 40–75)	65.50	51.30	51.3	60.6	46.8	48.5	64.4	44.5	57.3	63.8	43.4	60.2	76.5		63.9	68.4	62.3	59.3	53.6
Lymphocyte Rate (%; normal range: 20–50)	26.90	31.67	34.3	24.3	37.7	35.2	24	42.8	35.2	29.5	42.7	30.6	11.9		22	24.6	29.4	24.8	37.1
T Lymphocyte Subsets Analysis
CD3 + CD4+ Rate (%; normal range:24.9–45.6)	46.11	44.19	49.87	31.59	45.65	39.96	37.79	59.44	42.81	48.53	34.76	37.03		48.53	50.14	56.28	55.19	50.28	49.83
CD3 + CD8+ Rate (%; normal range: 16.4–33.8)	22.3	20.66	19.93	19.75	27.58	29.22	27.9	29.09	15.09	14.49	25.33	25.41		14.19	14.85	11.74	9.73	20.01	21.88
CD3 + CD4 + Absolute Value (10^6/L;normal range: 200–1820)	448	481	211	229	870	977	539	1016	653	807	226	502		285	463	615	932	463	722
CD3 + CD8 + Absolute Value (10^6/L;normal range:130–1350)	217	225	84	143	518	714	398	424	230	241	165	345		83	137	128	164	184	317
CD4/CD8 (normal range:0.89–2.01)	2.07	2.14	2.50	1.60	1.66	1.37	1.35	2.04	2.84	3.35	1.37	1.46		3.42	3.38	4.79	5.67	2.51	2.28
Lymphocyte Absolute Value (10^6/L;normal range:470–3260)	972	1,088	423	724	1851	2,445	1,427	1,716	1548	1,663	651	1,356		588	924	1,094	1,689	921	1,450
Note: B: before treatment; A: after treatment.

And, after treatment, it can be seen that hs-CRP are reduced, the total number of T lymphocytes is increased, and the absolute values of CD4 + T cells and CD8 + T cells in the T cell subsets are also increased (as shown in Table 4, FIG.3, 4 and Supplementary Materials 2), meanwhile the chest CT examination shows that the inflammation is gradually absorbed and finally disappeared. As of Feb. 27, the last patient had been discharged (Case 1).

Here it is worth mentioning that 1 patient (Case 1) showed relapse. The relapse here means that the chest CT examination of the two patients showed that the inflammation had been absorbed, but the viral nucleic acid test was sometimes negative and sometimes positive. Although it is impossible to completely rule out the errors caused by sample collection, transportation, detection reagent and operation, each inspection process is carried out in strict accordance with standard operating procedures. So Here we speculate that the virus may have a variation to reduce virulence, but unfortunately due to our limited conditions, we were unable to conduct further in-depth studies on the specimens of the two patients.

For now, there is no approved specific medicine or vaccine for 2019-nCov. Although it has been reported that Remdesivir may have a promising clinical therapeutic effect [6], further Case-Controlled clinical studies are needed to verify its therapeutic efficacy [8].On the other hand, we can say that the control of the epidemic of COVID-19 in China nationwide is not due to the use of Remdesivir, but due to the widespread use of TCM combined with other western medicine. For example, TCM had appeared in the Trial Fourth Edition of the Clinical Guideline Diagnosis and Treatment Protocol for COVID-19 released by National Health Commission of China and National Administration of Traditional Chinese Medicine issued in January 28, 2020[9], and updated in the subsequent Editions(the newest is Trial Seventh Edition so far) [12]; And National Administration of Traditional Chinese Medicine also issued a specific TCM formulation QingFeiPaiDuTang(Lung cleansing & detoxifying decoction) to treat COVID-19[13] to treat COVID-19; Furthermore, out of the 31 provinces in Chinese mainland, health authorities in 23 provinces had officially issued programs recommending TCM to preventing COVID-19 [14]. And some studies reported that TCM could alleviate symptoms, shorten fever duration, recover radiological changes, and shorten hospital courses[15], Furthermore, the cabin hospitals in Wuhan is the hospitals that mainly treats with TCM, where all the patients in the hospital have been cured and discharged, and the hospital has been closed at March 8. Besides, recently a cohort observational clinical trial on regularity of TCM syndrome and differentiation treatment of COVID-19 has been submitted to the National Library of Medicine (NLM) belonging to National Institutes of Health (NIH), including two groups: Cohort of western medicine and Cohort of integrated TCM and western medicine, and possibly complete on May 2020 [16], which may provide more conclusive proofs for utilizing TCM to COVID-19.

From our experience and results, TCM treatment of COVID-19 does not directly kill the virus, but promote the elimination of the virus by improving the patient's immunity. Our results showed that after treatment, the number of T lymphocytes increased significantly, especially CD4 + T cells and CD8 + T cells (Fig. 1). As we all know that CD4 + T cells are helper T cells that secrete interleukin and interferon, and CD8 + T cells are cytotoxic T cells that play an important role in killing infected cells. Besides, CD4+/ CD8 + ratio also increased in 7 out of 9 patients, which indicated that TCM could improve the patients’ immunity, which are also found in SARS treatment[17]. So the application of TCM is like to equip with more powerful weapons and provide more soldiers for the human body to fight the virus, so the mechanism of TCM is different from that of antibiotics and also other antiviral drugs such as Remdesivir. Furthermore, TCM could play roles in every part of COVID-19, including prevention, Health care and treatment, and also including adult, elderly and children [18–20].

However, our retrospective study also had major drawbacks, such as the failure to establish a control group due to respect for life. Even so, we believe that from the situation of hospitals in other parts of the country that do not use TCM, as well as the curative effect of China using TCM to control COVID-19, there is also the application of TCM in the treatment of SARS in 2003[21–25], and in the treatment of H1N1 in 2009[26–27], TCM could play a significant role in the cure of COVID-19.

On the other aspect, according to the experiences of Wuhan, with the development of the epidemic, there will be a shortage of medical resources such as virus detection, diagnosis and treatment[28–29], which could lead to more infections and social panic, and the battle with COVID-19 is still expected to take months globally. Because TCM has the characteristics of symptom-based diagnosis, individual treatment and no need for large detection equipment, so we believe that in this severe situation of the outbreak of a new type of pathogen, spread and can't find or develop specific targeted drugs for a while, and even the clinical effects of TCM on COVID-19 is far from conclusive, TCM combined with western medicine treatment may be a good additional candidate for the cure of COVID-19.

In conclusion, through our practical experience and Case analysis, we think that in the process of COVID-19 treatment, the application of western medicine is indispensable, however, if apply TCM at the same time, it can quickly alleviate the disease, accelerate the cure, so, we believe that in the severe situation of the outbreak and diffusion of a new type of pathogen, and can't find or develop specific targeted drugs for a while, to some extent the application of TCM should be a rational and even necessary choice for an adjuvant therapy of COVID-19. Our report is expected to provide a meaningful reference for the treatment of COVID-19 worldwide.

TCM,Traditional Chinese Medicine; COVID-19, 2019 novel coronavirus disease; 2019-nCoV, 2019 novel coronavirus

Ethics approval and consent to participate

This study was approved by the Ethics Committee of First People's Hospital of Zigong City, and written informed consent was obtained from all patients.

Consent for publication

All authors have been consent for publication of this paper.

Availability of data and materials

All data and materials are available from the corresponding author anytime.

Competing interests

The authors declare no conflict of interest.

Funding

This work was supported by Key Science and Technology Projects of Science and Technology Bureau of Zigong (2019YLSF01).

Authors' contributions

Conceived and designed the study: Chengjian Cao, Deya Che; Data collection: Liuying Li , Maoli Guo , Fuqiang Shao; Data analysis Chengjian Cao, Fang Zhang, Huixiu Zhong, Weiping Liu; Contributed to the writing of the manuscript: Chengjian Cao, Deya Che.

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Clinical characteristics analysis of 9 Cases COVID-19 patients receiving integrated Traditional Chinese and Western medicine: a retrospective study

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Abstract

Figures

1. Background

2 Methods

2.1 Patients

2.2 Data Collection And Analysis

3. Results

3.1 Patients’ Baseline characteristics

3.2 Characteristics Of Clinical Symptoms

3.3 Examination, Treatment And Outcomes

4. Discussion

5. Conclusion

List of abbreviations

Declarations

References

Supplementary Files

Status:

Version 1