Glede na sedanjo epidemijo COVID-19 bi SZKMA rada podala mnenje in predlog, podprta z raziskavami, ki vam lahko pomagata pri jemanju strateških odločitev za boj s COVID-19.
Kot pri vsakem izbruhu novo identificiranega virusa imamo tudi pri COVID-19 omejeno farmakološko zdravljenje, ki je posledica pomanjkanja dobro izvedenih kliničnih raziskav. Večina kliničnih odločitev temelji na najboljših do sedaj razpoložljivih dokazih, ki vključujejo retrospektivne kohortne raziskave, raziskave in vivo, in vitro, in silico ter strokovna mnenja o uporabi že obstoječih protivirusnih zdravil, kot raziskavo ali na podlagi sočutja. Ker se metodološka kvaliteta obstoječih raziskav razlikuje, je potreben premislek polnega spektra dosedanjih dokazov in previdna interpretacija in dedukcija slednjih.
Pomanjkljivost močnega dokazanega zdravstvenega režima lahko, temelječ na dosedanjih raziskavah in dokazih, dopolni TKM kot dodatna terapevtska možnost pri obravnavi COVID-19.
Najbolj pogosta slika primera posameznika s COVID-19 je vročina, utrujenost, suh kašelj, zamašenost zgornjih dihal, produkcija sputuma, pomanjkanje zraka, mialgia/artralgija z limfopenijo, povečan protrombinski čas, povečan C-reaktivni protein in povečana laktatna dehidrogeneza. Razmerje z resnimi/hujšimi primeri je okoli 7-10% in povprečen čas do sprejema na intenzivni oddelek je 9,5-10,5 dni, s smrtnostjo 1-2%, odvisno od geografske lege. Podobno kot pri izbruhih novo identificiranih virusih ni dokazanega zdravstvenega režima v konvencionalni medicini in večina dosedanjih poročil o ravnanju s pacienti omenja lopinavir/ritonavir, ribavirin, beta-interferon, glukokortikoide in podporno zdravljenje s remdesivirom, trenutno v klinični raziskavi. V Ljudski republiki Kitajski je TKM predlagana kot možnost zdravljenja v državnih in provinčnih smernicah ter je množično uporabljena. Raziskava [1] je pregledala zadnje državne in provinčne smernice, retrospektivne kohortne raziskave in raziskave primerov vključevanja TKM zdravstvenemu postopku za zdravljenje COVID-19. Prav tako so preverili klinične dokaze ravnanja pri SARS in H1N1 s hipotetičnimi mehanizmi in zadnjimi in silico odkritji z namenom odkritja TKM kandidatov za možne klinične raziskave. Gleda na pomanjkljivost močnega dokazanega zdravstvenega režima, obstoječi dokazi kažejo, da bi morala biti TKM vključena kot dodatna terapevtska možnost pri ravnanju s COVID-19.
TKM pri zdravljenju pacientov okuženih s COVID-19: klinični dokazi
Aplikacija TKM zdravljenja COVID-19 (SARS-CoV-2) v večini temelji na zdravljenju SARS izbruha (SARS-CoV) v koncu leta 2002 v provinci Guangdong Ljudske republike Kitajske, ki se je naglo razširila v letu 2003. Učinkovitost TKM z bojem proti SARS okužbi je bila preučevana preko poročil posameznih primerov, serije primerov, kontroliranih opazovalnih študij in naključnih kliničnih raziskavah (RCT). Dokazi podpirajo pozitiven učinek TKM pri zdravljenju in preventivi SARS okužbe. Na primer, stopnja umrljivosti v Hong Kongu in Singapurju (kjer je bila uporabljena le konvencionalna medicina) je bila približno 18%, v primerjavi s Pekingom, kjer je bila na začetku več kot 52% do 5. maja, kjer je upadla na 4%-1% po 20. maju 2003. Dramatičen upad smrtnosti konec maja 2003 v Pekingu je povezan z uporabo TKM kot dodatek konvencionalni terapiji [2]. Podrobna razlaga mehanizmov vključitve TKM v ravnanje s COVID-19 lahko preberete v sledečem članku: “Traditional Chinese Medicine in the Treatment of Patients Infected with 2019-New Coronavirus (SARS-CoV-2): A Review and Perspective”. [3]
Smernice in raziskovalne usmeritve: integrirana medicina za boljši učinek
Trenutno je kot sosednje države tudi RS podala strategijo zajezitve za upočasnitev širjenja COVID-19. Omejitev gibanja in zapiranje trgovin bo imelo velik učinek na vsakdanje življenje in ekonomijo. Seveda bi v najboljšem primeru zajezili širjenje virusa v 14-30 dneh. Vendar pa obstaja tudi druga strategija, ki sta jo sprejeli Velika Britanija in Nizozemska, da je poleg zmerne zajezitve potrebno ustvariti tudi “čredno imuniteto”, saj nekateri modeli predpostavljajo, da bo COVID-19 ostal več kot 30 dni.
Primeri kažejo, da si velika večina pacientov opomore od COVID-19 okužbe. Republika Slovenija lahko uporabi bolj učinkovito in cenovno učinkovito metodo ravnanja z lažjimi do srednje težkimi primeri okužbe in s tem ustvari čredno imuniteto, pri tem pa prihrani resurse za ravnanje in zdravljenje težkih primerov okužbe s COVID-19. Dosedanje raziskave o uporabi TKM dokazujejo verjetnost pospešenega okrevanja in s tem zmanjšanja bremena zdravstvenega sistema.
Člani SZKMA trenutno delajo v okviru preventive in komplementarnega TKM pristopa pri sezonskih okužbah. Vendar pa je zaradi omejenih sredstev in prepoznavnosti dosedanji pristop omejen na majhno število v Novem mestu, na Dolenjski in na kitajsko skupnost v Ljubljani.
SZKMA predlaga vključitev TKM pri zdravljenju COVID-19 z zagonom visokokakovostnih raziskav, pilotnih programov kombiniranih terapij in komunikacije med profesijami.
V pričakovanju odgovora in dodatnih skupnih dejavnosti.
S Spoštovanjem,
SZKMA
Opinion and suggestion for management of COVID-19
Given the current epidemic of COVID-19, the Association would like to provide our opinion and suggestion backed by the latest evidence which would assist the policy and critical decision making in the battle of COVID-19.
COVID-19, similar to other outbreaks of any newly identified virus, has limited pharmacological treatment options due to the lack of evidence from well-designed clinical trials. Most clinical decisions are based on the best available evidence including but not limited to retrospective cohorts, in vivo, in vitro, in silico and expert opinion with possible off-label use of existing antiviral drugs as trial or on a compassionate basis. As the methodological quality of the existing studies varies, consideration on a full spectrum of evidence followed by careful interpretation and deduction is needed.
Given the paucity of strongly evidence-based regimens, the available data suggest that TCM could be considered as an adjunctive therapeutic option in the management of COVID-19. Common presentations of confirmed cases of COVID-19 include fever, fatigue, dry cough, upper airway congestion, sputum production, shortness of breath, myalgia/arthralgia with lymphopenia, prolonged prothrombin time, elevated C-reactive protein, and elevated lactate dehydrogenase. The reported severe/critical case ratio is approximately 7–10% and median time to intensive care admission is 9.5–10.5 days with mortality of around 1–2% varied geographically. Similar to outbreaks of other newly identified virus, there is no proven regimen from conventional medicine and most reports managed the patients with lopinavir/ritonavir, ribavirin, beta-interferon, glucocorticoid and supportive treatment with remdesivir undergoing clinical trial. In China, Chinese medicine is proposed as a treatment option by national and provincial guidelines with substantial utilization. A study [1] reviewed the latest national and provincial clinical guidelines, retrospective cohort studies, and case series regarding the treatment of COVID-19 by add-on Chinese medicine. They have also reviewed the clinical evidence generated from SARS and H1N1 management with hypothesized mechanisms and latest in silico findings to identify candidate Chinese medicines for the consideration of possible trials and management. Given the paucity of strongly evidence-based regimens, the available data suggest that Chinese medicine could be considered as an adjunctive therapeutic option in the management of COVID-19.
Traditional Chinese Medicine in the treatment of patients infected with COVID-19: clinical evidence
Application of TCM in the treatment of COVID-19 (SARS-CoV-2) is largely inspired by the treatment of SARS caused by outbreak of SARS coronavirus (SARS-CoV) in the late of 2002 in the Guangdong Province of China which spread rapidly during the 2003. Ranging from case reports, case series, controlled observational studies and randomized clinical trials, clinical studies aiming to examine the effect of TCM on SARS have been carried out and reported. There are quite compelling evidences support the notion that TCM has beneficial effect in the treatment or prevention of SARS. For example, the rate of fatality in Hong Kong and Singapore (where only conventional medicine is used) was approximately 18%, while the rate for Beijing was initially more than 52% until the 5th of May and decreased gradually to 4%-1% after the 20th of May in 2003. The dramatic reduced fatality from late May in Beijing was believed to be associated with the use of TCM as a supplement to the conventional therapy [2].
A detailed explanation of mechanism on how TCM could play a role in the management of COVID-19 could be read in this article, “Traditional Chinese Medicine in the Treatment of Patients Infected with 2019-New Coronavirus (SARS-CoV-2): A Review and Perspective”.
Policy and research direction: integrative medicine for better effects
Currently, much like the neighbouring countries, Slovenia is adopting a containment strategy to slow down the spread of COVID-19. The decrease in mobility and closure of shops have a huge impact on daily lives and the economy. It would, of course, be the best case if the virus is controlled after a 14-30 days containment. However, another strategy, adopted by the UK and the Netherlands, is that besides a reasonable degree of containment, the ultimate approach to manage COVID-19 by building herd immunity because there is also another model suggesting the COVID-19 is very likely to stay for way more than 30 days.
Cases show that a considerable number of patients can recover after COVID-19 infection. Should the medical system in Slovenia introduce a more effective and cost-efficient method to manage mild to moderate cases of COVID-19, sparing the resources of intensive care to the riskiest group, this would assist Slovenia in building herd immunity. From current available evidence, TCM is likely to speed up recovery and therefore reduce the burden of health systems.
The members of the association are currently working on TCM as a preventive and complementary approach for seasonal infection. However, due to limited resources and recognition, the current approach is limited to an extremely small group in Novo mesto and Dolenjska and among the Chinese community in Ljubljana.
The association suggests that policymakers and health care institutions shall include TCM as a part of COVID-19 management by initiating high-quality research, pilot programs of combined therapy and communications between professionals.
We are looking forward to feedback and follow-up actions.
SZKMA
[1] Chan KW, Wong VT, Tang SCW.COVID-19: An Update on the Epidemiological, Clinical, Preventive and Therapeutic Evidence and Guidelines of Integrative Chinese–Western Medicine for the Management of 2019 Novel Coronavirus Disease
[2] Chen Z, Nakamura T. Statistical evidence for the usefulness of Chinese medicine in the treatment of SARS. Phytotherapy research: PTR. 2004;18:592-4
[3] Yang Yang. Traditional Chinese Medicine in the Treatment of Patients Infected with 2019-New Coronavirus (SARS-CoV-2): A Review and Perspective. Int J Biol Sci 2020; 16(10):1708-1717. doi:10.7150/ijbs.45538
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